[Federal Register Volume 79, Number 174 (Tuesday, September 9, 2014)]
[Rules and Regulations]
[Pages 53520-53570]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-20926]
[[Page 53519]]
Vol. 79
Tuesday,
No. 174
September 9, 2014
Part II
Department of Justice
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Drug Enforcement Administration
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21 CFR Parts 1300, 1301, 1304, et al.
Disposal of Controlled Substances; Final Rule
Federal Register / Vol. 79 , No. 174 / Tuesday, September 9, 2014 /
Rules and Regulations
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Parts 1300, 1301, 1304, 1305, 1307, and 1317
[Docket No. DEA-316]
RIN 1117-AB18
Disposal of Controlled Substances
AGENCY: Drug Enforcement Administration (DEA), Department of Justice.
ACTION: Final rule.
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SUMMARY: This rule governs the secure disposal of controlled substances
by registrants and ultimate users. These regulations will implement the
Secure and Responsible Drug Disposal Act of 2010 by expanding the
options available to collect controlled substances from ultimate users
for the purpose of disposal, including: Take-back events, mail-back
programs, and collection receptacle locations. These regulations
contain specific language allowing law enforcement to voluntarily
continue to conduct take-back events, administer mail-back programs,
and maintain collection receptacles. These regulations will allow
authorized manufacturers, distributors, reverse distributors, narcotic
treatment programs (NTPs), hospitals/clinics with an on-site pharmacy,
and retail pharmacies to voluntarily administer mail-back programs and
maintain collection receptacles. In addition, this rule expands the
authority of authorized hospitals/clinics and retail pharmacies to
voluntarily maintain collection receptacles at long-term care
facilities. This rule also reorganizes and consolidates previously
existing regulations on disposal, including the role of reverse
distributors.
DATES: Effective Date: This rule is effective October 9, 2014.
Compliance Date: All Memoranda of Agreement (MOAs) and Memoranda of
Understanding (MOUs) issued pursuant to current 21 CFR 1307.21 will not
be effective after October 9, 2014. Registrants may consult Sec.
1317.05(a)(5) for information on requesting new MOAs and MOUs for
disposal of controlled substances.
FOR FURTHER INFORMATION CONTACT: Imelda L. Paredes, Office of Diversion
Control, Drug Enforcement Administration; Mailing Address: 8701
Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 598-
6812.
SUPPLEMENTARY INFORMATION:
Outline
I. Executive Summary
A. Purpose of the Regulatory Action
B. Summary of the Major Provisions of the Regulatory Action
C. Summary of Changes in the Final Rule
II. Background and Legal Authority
III. Discussion of Comments
A. Support for the Proposed Rule (1 Issue)
B. Definitions and Terms (12 Issues)
C. Types of Entities That May Operate a Collection Program (9
Issues)
D. Locations Where Authorized Collectors May Maintain Collection
Receptacles or Host Take-Back Events (1 Issue)
E. Registration Requirements for Authorized Collectors (5
Issues)
F. Law Enforcement (7 Issues)
G. Collection Receptacle Design, Inner Liners, Placement, and
Security (24 Issues)
H. Mail-Back Programs (11 Issues)
I. Take-Back Events (6 Issues)
J. Prohibition on Handling, Sorting, and Inventorying Inner
Liner Contents and Mail-Back Package Contents (8 Issues)
K. Long-Term Care Facilities (LTCFs) (21 Issues)
L. Disposing on Behalf of Ultimate Users (Other than Residents
of LTCFs) (3 Issues)
M. Registrant Return, Recall, and Transfer (3 Issues)
N. Destruction (19 Issues)
O. Economic Concerns (18 Issues)
P. Recordkeeping and Reporting (8 Issues)
Q. Hazardous Materials Transportation and Hazardous Waste
Destruction (3 Issues)
R. Transporting Collected Substances (3 Issues)
S. Miscellaneous Comments (2 Issues)
IV. Regulatory Analyses
I. Executive Summary
A. Purpose of the Regulatory Action
On October 12, 2010, the Secure and Responsible Drug Disposal Act
of 2010 (Disposal Act) was enacted (Pub. L. 111-273, 124 Stat. 2858).
Before the Disposal Act, ultimate users who wanted to dispose of
unused, unwanted, or expired pharmaceutical controlled substances had
limited disposal options. The Controlled Substances Act (CSA) only
permitted ultimate users to destroy those substances themselves (e.g.,
by flushing or discarding), surrender them to law enforcement, or seek
assistance from the United States Drug Enforcement Administration
(DEA). These restrictions resulted in the accumulation of
pharmaceutical controlled substances in household medicine cabinets
that were available for abuse, misuse, diversion, and accidental
ingestion.
The Disposal Act amended the CSA to authorize ultimate users to
deliver their pharmaceutical controlled substances to another person
for the purpose of disposal in accordance with regulations promulgated
by the Attorney General. 21 U.S.C. 822(g), 828(b)(3). This final rule
implements regulations that expand the entities to which ultimate users
may transfer unused, unwanted, or expired pharmaceutical controlled
substances for the purpose of disposal, as well as the methods by which
such pharmaceutical controlled substances may be collected. Specified
entities may voluntarily administer any of the authorized collection
methods in accordance with these regulations.
B. Summary of the Major Provisions of the Regulatory Action
The DEA is implementing new regulations for the disposal of
pharmaceutical controlled substances by ultimate users in accordance
with the Disposal Act. In drafting the implementing regulations, the
DEA considered the public health and safety, ease and cost of program
implementation, and participation by various communities. To this end,
the DEA found that in order to properly address the disposal of
controlled substances by ultimate users, it was necessary to conduct a
comprehensive review of DEA policies and regulations related to each
element of the disposal process, including the transfer, delivery,
collection, destruction, return, and recall of controlled substances,
by both registrants and non-registrants (i.e., ultimate users). The
reverse distributor registration category, which is pertinent to the
process of registrant disposal, was included in this comprehensive
review. These regulations are incorporated into a new part 1317 on
disposal. Definitions relating to the disposal of controlled substances
are added to Sec. 1300.05(b), including definitions for ``employee,''
``law enforcement officer,'' ``non-retrievable,'' and ``on-site'' and
definitions relating to controlled substances generally are revised or
added to Sec. 1300.01.
The goal of this new part on disposal, consistent with Congress's
goal in the Disposal Act, is to set parameters for controlled substance
diversion prevention that will encourage public and private entities to
develop a variety of methods for collecting and destroying
pharmaceutical controlled substances in a secure, convenient, and
responsible manner. Also, consistent with the Disposal Act's goal to
decrease the amount of pharmaceutical controlled substances introduced
into the environment, particularly into the water, these regulations
provide individuals with various additional options to dispose of their
unwanted or unused pharmaceutical controlled substances beyond
discarding or
[[Page 53521]]
flushing the substances. As a result of these regulations, the DEA
hopes that the supply of unused pharmaceutical controlled substances in
the home will decrease, thereby reducing the risk of diversion or harm.
Ultimate User Disposal
An ultimate user is defined by the CSA as a ``person who has
lawfully obtained, and who possesses, a controlled substance for his
own use or for the use of a member of his household or for an animal
owned by him or by a member of his household.'' 21 U.S.C. 802(27). This
rule provides three voluntary options for ultimate user disposal: (1)
Take-back events, (2) mail-back programs, and (3) collection
receptacles. Individuals lawfully entitled to dispose of an ultimate
user decedent's property are authorized to dispose of the ultimate
user's pharmaceutical controlled substances by utilizing any of the
three disposal options. All of the collection methods are voluntary and
no person is required to establish or operate a disposal program. The
rule also does not require ultimate users to utilize any of these three
methods for disposal of controlled substances. Although the three
methods of disposal allowed by this rule seek to help protect the
environment and prevent controlled substances from being diverted to
illicit uses, this rule does not prohibit ultimate users from using
existing lawful methods.
The DEA regulations provide specific language that will continue to
allow Federal, State, tribal, and local law enforcement to maintain
collection receptacles at the law enforcement's physical location; and
either independently or in partnership with private entities or
community groups, to voluntarily hold take-back events and administer
mail-back programs. 21 CFR 1317.35. Thus, ultimate users will continue
to be able to surrender their unwanted pharmaceutical controlled
substances to law enforcement.
The DEA is also authorizing certain registrants (manufacturers,
distributors, reverse distributors, narcotic treatment programs (NTPs),
hospitals/clinics with an on-site pharmacy, and retail pharmacies) to
be ``collectors,'' with authorization to conduct mail-back programs. 21
CFR 1317.40 and 1317.70. All registrants that choose to establish mail-
back programs must provide specific mail-back packages to the public,
either at no cost or for a fee, 21 CFR 1317.70. Collectors that conduct
mail-back programs must have and utilize an on-site method of
destruction to destroy returned packages, 21 CFR 1317.05.
These DEA regulations authorize collectors to maintain collection
receptacles at their registered location. 21 CFR 1317.40. Thus,
ultimate users will be able to carry their unwanted pharmaceutical
controlled substances to an authorized retail pharmacy or other
authorized collector location and deposit those controlled substances
in a secure container for disposal. Hospitals/clinics and retail
pharmacies that are authorized to be collectors may also maintain
collection receptacles at long-term care facilities (LTCFs). 21 CFR
1317.40. LTCFs may dispose of pharmaceutical controlled substances on
behalf of an ultimate user who resides, or has resided, at that LTCF,
21 CFR 1317.80, through a collection receptacle that is maintained by
an authorized hospital/clinic or retail pharmacy at that LTCF. 21 CFR
1317.40 and 1317.80.
With this rule, the DEA allows all pharmaceutical controlled
substances collected through take-back events, mail-back programs, and
collection receptacles to be comingled with non-controlled substances,
although such comingling is not required. 21CFR 1317.65, 1317.70, and
1317.75. Pharmaceutical controlled substances collected by collectors
may not be individually counted or inventoried. 21 CFR 1317.75. This
rule also imposes various registration, security, and recordkeeping
requirements.
The DEA appreciates there is a cost to entities that choose
voluntarily to provide these methods of collection and destruction. The
DEA acknowledges that some State and local pharmaceutical disposal
programs receive funding and other support from numerous sources,
including conservation groups, local governments, State grants, and
public and private donations. These expanded methods of disposal are
expected to benefit the public by decreasing the supply of
pharmaceutical controlled substances available for misuse, abuse,
diversion, and accidental ingestion, and protect the environment from
potentially harmful contaminants by providing alternate means of
disposal for ultimate users. However, other advantages may accrue
directly to those entities that opt to maintain a disposal program. For
example, those authorized registrants that choose to maintain
collection receptacles may be enhanced by the increased consumer
presence at their registered locations and the goodwill that develops
from providing a valuable community service. In addition, mail-back
program collectors may partner with third parties to make mail-back
packages available to the public. Those authorized registrants that
choose to administer mail-back programs may gain from the opportunity
to distribute to consumers promotional, educational, or other
informational materials with the mail-back packages.
DEA Registrant Disposal
The DEA has deleted the existing rule related to registrant
disposal, 21 CFR 1307.21, and incorporated similar requirements on
proper disposal procedure and security in a new part 1317 on disposal.
These changes provide consistent disposal procedures for each
registrant category, regardless of geographic location. In addition,
the DEA has modified DEA Form 41 and is explicitly requiring that form
to be used to record the destruction of controlled substances that
remain in the closed system of distribution and also to account for
registrant destruction of pharmaceutical controlled substances
collected from ultimate users and other non-registrants pursuant to the
Disposal Act. As stated in the NPRM, a controlled substance dispensed
for immediate administration pursuant to an order for medication in an
institutional setting remains under the custody and control of that
registered institution even if the substance is not fully exhausted
(e.g., some of the substance remains in a vial, tube, transdermal
patch, or syringe after administration but cannot or may not be further
utilized, commonly referred to as ``drug wastage'' and ``pharmaceutical
wastage''). Such remaining substance must be properly recorded, stored,
and destroyed in accordance with DEA regulations (e.g., Sec.
1304.22(c)), and all applicable Federal, State, tribal, and local laws
and regulations, although the destruction need not be recorded on a DEA
Form 41.
Reverse Distributors
The DEA is providing regulations for entities that reverse
distribute that are clear and consistent. Entities that reverse
distribute are often the last registrant to possess controlled
substances prior to destruction; however, the recordkeeping safeguards
that exist when controlled substances are distributed between
registrants are not present when these registrants destroy controlled
substances. Because reverse distributors routinely acquire controlled
substances for destruction from other registrants and may also be
authorized as collectors, reverse distributors accumulate greater
amounts of controlled substances that are destined for destruction in
comparison to other registrants. The DEA is defining ``reverse
distribute;'' revising the definition of ``reverse distributor;'' (21
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CFR part 1300) outlining security (21 CFR part 1301), inventory,
recordkeeping requirements, and other procedures that reverse
distributors must follow to acquire controlled substances from
registrants and to destroy such acquired substances. 21 CFR part 1304.
The DEA also is clarifying that these security, inventory, and
recordkeeping requirements apply to certain specified entities that
reverse distribute but are not registered as reverse distributors. See,
e.g., 21 CFR 1304.11(e)(3) (``each person registered or authorized to
reverse distribute''). The DEA believes that these regulations will
help all registrants that reverse distribute comply with the CSA in a
manner that decreases the risk of the diversion of controlled
substances during the disposal process.
Return and Recall
This rule removes the existing regulation on return and recall, 21
CFR 1307.12, and incorporates separate return and recall requirements
for registrants and non-registrants into new Sec. Sec. 1317.10 and
1317.85. This rule also imposes various recordkeeping requirements
pertaining to controlled substances acquired for the purpose of return
or recall in Sec. Sec. 1304.22 and 1305.03. The DEA has simplified the
requirements of Sec. 1317.10(a) to more clearly describe the records
that registrants must keep.
Methods of Destruction
Existing DEA regulations do not specify a standard to which
controlled substances must be destroyed. With this final rule, the DEA
is implementing a standard of destruction--non-retrievable--for
registrants that destroy controlled substances, and procedures for the
destruction of controlled substances. 21 CFR 1300.05 (``non-
retrievable''), 1317.90, and 1317.95. The DEA is not requiring a
particular method of destruction, so long as the desired result is
achieved. This standard is intended to allow public and private
entities to develop a variety of destruction methods that are secure,
convenient, and responsible, consistent with preventing the diversion
of such substances. Destruction of controlled substances must also meet
all other applicable Federal, State, tribal, and local laws and
regulations. Once a controlled substance is rendered ``non-
retrievable,'' it is no longer subject to the requirements of the DEA
regulations.
As explained above under ``Compliance Date,'' this final rule
supersedes all existing MOAs and MOUs that registrants may have
pursuant to Sec. 1307.21, including MOAs and MOUs pertinent to storage
of controlled substances. The DEA retains in the new part 1317 the
ability for practitioners to request assistance from the local Special
Agent in Charge (SAC) regarding the disposal of controlled substances.
21 CFR 1317.05. Practitioners may request a new MOA or MOU pursuant to
the new Sec. 1317.05(a)(5).
C. Summary of the Changes in the Final Rule
The DEA carefully considered the 192 individually-submitted
comments received in response to the Notice of Proposed Rulemaking
(NPRM) on the Disposal of Controlled Substances.\1\ 77 FR 75784, Dec.
21, 2012. The comment period closed on February 19, 2013. The DEA is
making a number of significant changes after thorough consideration of
the issues raised by the comments and the potential diversion risks
associated with these changes.
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\1\ All of the comments submitted, except two comments, are
available for public inspection online at www.regulations.gov. Two
comments are not posted (at the commenters' request) in order to
protect confidential business information.
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In response to concerns regarding ultimate users' ability to have
convenient disposal options, the DEA is vastly expanding those entities
that may be authorized as collectors, expanding the authority of those
collectors to maintain collection receptacles at LCTFs, and relaxing
some of the proposed security requirements related to storage and
destruction of controlled substances.
Authorized Collectors
In addition to manufacturers, distributors, reverse distributors,
and retail pharmacies, the final rule also authorizes registered NTPs,
as well as hospitals/clinics with an on-site pharmacy, to operate
disposal programs. 21 CFR 1317.40. By permitting these additional
registrant categories to be collectors, the DEA anticipates that
ultimate users will now have even more locations where they can
securely, safely, responsibly, and conveniently dispose of their
unwanted pharmaceutical controlled substances.
In this final rule, the DEA is permitting those entities registered
as NTPs to become authorized collectors to manage collection
receptacles at their registered locations. As stated in the Disposal
Act, ``the nonmedical use of prescription drugs is a growing problem in
the United States.'' Multiple commenters, including a national
organization that represents NTPs, recommended that the DEA include
NTPs as authorized collectors. The DEA recognizes the valuable role
that NTPs have in helping those seeking substance abuse treatment.
After considering the importance of providing secure, convenient, and
responsible disposal options for those ultimate users currently
receiving treatment for narcotic substance abuse or entering a narcotic
treatment program, and the benefits of allowing NTPs to provide the
opportunity to patients to dispose of unused controlled substances, the
DEA is permitting NTPs to be collectors with certain enhanced security
controls. 21 CFR 1317.75.
Due to the nature of the healthcare provided, NTPs face unique
security challenges and heightened diversion risks and, as such, the
final rule requires NTPs to securely place and maintain collection
receptacles in a room that does not contain any other controlled
substances and is securely locked with controlled access. 21 CFR
1317.75. The DEA understands that this security measure will require
employees of the NTP to accompany the patient to the collection
receptacle to facilitate the patient's disposal. See 21 CFR 1317.75.
Additionally, as the Disposal Act and these regulations are intended to
address the prescription drug abuse problem, NTPs and other collectors
are not authorized to collect schedule I controlled substances. E.g.,
21 CFR 1317.75. Collectors must be vigilant in ensuring that such
illicit substances are not collected intentionally or inadvertently.
E.g., 21 CFR 1317.70 and 1317.75.
After extensive review and careful deliberation, in this final
rule, the DEA is also permitting registered hospitals/clinics with an
on-site pharmacy to become authorized collectors to maintain collection
receptacles inside their registered locations or at LTCFs, and to
conduct mail-back programs. 21 CFR 1317.30, 1317.40, 1317.70, and
1317.80. In response to the NPRM, many commenters stated that
collection receptacles located inside of hospitals would provide
ultimate users with an opportunity to dispose of medication that may no
longer be needed or may be expired. In determining whether to allow
hospitals/clinics to become authorized collectors, the DEA carefully
weighed the diversion risks with the convenience of authorizing such
entities to be collectors. The DEA determined that the diversion risks
require the DEA to limit those registered hospitals/clinics that may
become collectors to those with on-site pharmacies, and also impose
separate security conditions on the monitoring and location of
collection receptacles inside hospitals/
[[Page 53523]]
clinics that become authorized collectors. 21 CFR 1317.75.
The DEA is requiring these additional security measures in order to
help protect against the diversion of collected controlled substances
because hospitals/clinics are generally much larger and are open to a
much larger general population than the other registrants authorized to
be collectors; and, as discussed in the NPRM, hospitals/clinics do not
operate under the same business model or with similar theft and loss
prevention procedures as the other registrants authorized to become
collectors. For example, the general public typically enters retail
pharmacies for short durations in order to conduct retail business and
retail pharmacies generally have open, clearly observable common areas
with little opportunity to conceal an unlawful purpose. It would be
unusual and suspicious for a person to spend an extended amount of time
in a retail pharmacy without a known, specific purpose, triggering
routine theft and loss prevention measures.
In contrast, hospitals are generally open 24-hours per day and
allow for unsupervised public access for extended periods of time; they
are much larger than retail pharmacies and many interactions occur
behind closed doors without routine theft and loss prevention measures;
and foot traffic generally is not routinely monitored for unlawful
purposes. The DEA believes that limiting authorized collection
activities to hospitals/clinics with an on-site pharmacy is necessary
to help protect against diversion because these hospitals/clinics
routinely handle a large volume of controlled substances that are
dispensed to in-patients as well as to the public, and these entities
are more experienced with security, theft and loss prevention
procedures, and inventory, recordkeeping and reporting requirements
than those hospitals/clinics without an on-site pharmacy.
For reasons discussed in the NPRM, this final rule generally
requires that, when authorized collectors choose to install collection
receptacles, those collection receptacles must be placed inside their
registered locations in the immediate proximity of a designated area
where controlled substances are stored and at which an employee is
present. 21 CFR 1317.75; see also 1317.05. The DEA recognizes that
hospitals/clinics with an on-site pharmacy can be unique in their
design and it may be more effective to install collection receptacles
at various locations within the hospital/clinic, depending on factors
such as security, convenience, and accessibility. As such, it would be
challenging for authorized hospitals/clinics to adhere to the general
rule to place collection receptacles in the immediate proximity of
where controlled substances are stored and at which an employee is
present. Accordingly, the DEA is requiring hospitals/clinics that are
collectors to place collection receptacles in locations that are
regularly monitored by employees. 21 CFR 1317.75. In addition, the DEA
is prohibiting such collectors from placing collection receptacles in
the proximity of any area where emergency or urgent care is provided.
In the DEA's experience, the risk of diversion is particularly high in
areas where emergency or urgent care is provided because of the often
chaotic environment and the extended amounts of time persons spend in
such areas.
This rule also makes clear that DEA registrants cannot use the
collection receptacles to dispose of unused controlled substances in
their inventory or stock. 21 CFR 1317.05 and 1317.75. Pharmaceutical
controlled substances remain under the custody and control of the DEA
registrant if they are dispensed by a practitioner for immediate
administration at the practitioner's registered location (such as a
hospital) pursuant to an order for medication. If that substance is not
fully exhausted (e.g., some of the substance remains in a vial, tube,
or syringe after administration but cannot or may not be further
utilized), then the DEA registrant is obligated to destroy the
remaining, unusable controlled substances, and record the destruction
in accordance with Sec. 1304.22(c). The DEA registrant shall not place
such remaining, unusable controlled substance in a collection
receptacle as a means of disposal. Hospital/clinic staff must also not
dispose of any controlled substances in inventory or stock in a
collection receptacle.
The security requirements described above are the minimum required
in order to detect and prevent diversion in the unique circumstances of
NTPs and hospitals/clinics. These registrants should be vigilant in the
execution of their responsibilities as registrants to ensure that
collected controlled substances are not diverted to illicit use, and
that they do not collect illicit substances. Finally, all registrants
are reminded of the responsibility to report theft and significant loss
of controlled substances within one business day of discovery.
Long-Term Care Facilities (LTCFs)
Significant changes are made in this final rule to help ensure that
LTCFs have adequate disposal options. In addition to allowing retail
pharmacies to manage and maintain collection receptacles at LTCFs, the
DEA is also allowing hospitals/clinics with an on-site pharmacy to
manage and maintain collection receptacles at LTCFs. The DEA hopes that
expanding those authorized to collect at LTCFs will maximize disposal
opportunities for LTCF residents.
In addition, the DEA is alleviating two security requirements
proposed to apply to collection receptacles located at LTCFs. First,
the DEA is permitting authorized hospitals/clinics and retail
pharmacies to store inner liners that have been sealed upon removal
from a collection receptacle at LTCFs in a securely locked,
substantially constructed cabinet or a securely locked room with
controlled access for up to three business days until the liners can be
transferred for destruction. The DEA encourages collectors to schedule
inner liner removals and installations to coincide with existing LTCF
visits when possible, for example, arranging a routine system in which
medication deliveries coincide with the removal and transfer of sealed
inner liners for appropriate destruction, thereby making storage of
sealed inner liners unnecessary. Collectors may not transfer sealed
inner liners from LTCFs to their primary registered location (i.e., the
hospital/clinic or retail pharmacy location). As echoed in the
comments, the DEA remains concerned about the security risks of
hospital/clinic and retail pharmacy employees transporting large
quantities of collected substances, making them potential targets for
drug seekers. Instead, collectors should deliver sealed inner liners to
a reverse distributor or distributor's registered location by common or
contract carrier pick-up or by reverse distributor or distributor pick-
up at the LTCF, pursuant to Sec. 1317.05(c)(2)(iv).
Second, the DEA relaxed the two-employee integrity requirement for
inner liner installation, removal, storage, and transfer at LTCFs.
Collectors will retain the option to authorize two of their own
employees to install, remove, store, and transfer inner liners;
however, the DEA is permitting collectors the option to designate a
supervisor-level employee of the LTCF (e.g., a charge nurse,
supervisor, or similar employee) to install, remove, store, or transfer
inner liners with only one employee of the collector.
The DEA modified the above security requirements (storage and two-
person integrity) to provide flexibility sufficient to encourage
authorized hospitals/clinics and retail pharmacies to collect at LTCFs,
while ensuring the minimum protections required to prevent
[[Page 53524]]
diversion at LTCFs. The DEA hopes that the inclusion of certain
hospitals/clinics as authorized to maintain collection receptacles at
LTCFs, and the modifications described above will result in expanded
safe and secure disposal options for LTCF residents. The DEA emphasizes
that if LTCFs dispose of LTCF residents' controlled substances in
collection receptacles, such activity must be in accordance with this
regulation and all other applicable Federal, State, tribal and local
laws and regulations, including environmental laws and regulations.
The DEA acknowledges that there may be some LTCFs that will not
have a collection receptacle, and there will be instances where LTCF
residents are incapable of disposing of their own unused or unwanted
medication. As ultimate users, LTCF residents may use any of the
disposal options afforded other ultimate users in this final rule
(e.g., mail-back programs), in addition to the disposal options
currently available to ultimate users (e.g., flushing or otherwise
discarding) that will remain options even after this final rule is
implemented. For example, an LTCF resident may request that LTCF
personnel place the resident's unwanted medication in a mail-back
package, seal the mail-back package, and deposit that package into the
facility's outgoing mail system. 21 CFR 1317.70. LTCFs should be
mindful however that the touchstone for this disposal method is the
individual nature of the disposal activity; institutional facilities
such as LTCFs should ensure that the individual patient is the
disposer, and should be wary of establishing any protocols whereby the
facility itself is engaging in collection activities. Simply providing
the method of disposal (e.g., mail-back packages) does not implicate
that concern.
Destruction
After careful and thorough consideration of comments received
regarding the burdens associated with the proposed 14-day destruction
requirement, the DEA is extending the time those registrants that
reverse distribute have to destroy controlled substances to 30 days. 21
CFR 1317.15(d). The DEA anticipates that this extension will allow
reverse distributors and distributors adequate time to collect and
destroy controlled substances in a safe, convenient, and secure manner,
while also preventing diversion and diversion opportunities.
Practitioner Physical Security
In this final rule, the DEA is not amending Sec. 1301.75(b)
pertaining to practitioner physical security and is instead adding a
new paragraph (c) to clarify that practitioners shall only store sealed
mail-back packages and inner liners containing collected substances at
their registered location in a securely locked, substantially
constructed cabinet or a securely locked room with controlled access.
The DEA has made corresponding changes to Sec. Sec. 1317.05(c)(1)(ii)
and (c)(2)(ii). Part of this requirement was included in the proposed
rule; however, after careful consideration of a number of comments, the
DEA believes that the proposed requirement did not provide sufficient
controls to protect against diversion and was impracticable. Pharmacies
and institutional practitioners cannot store sealed inner liners or
returned mail-back packages by dispersing them throughout the stock of
noncontrolled substances. 21 CFR 1301.75(b) and (c).
Other Changes to the Final Rule
In addition to the changes described above, the DEA determined that
the rule, as proposed, required other modifications, as generally
described below. The DEA is also implementing additional technical
modifications that will not have a substantive effect on this rule
(e.g., relocating some sections in proposed part 1317 to other sections
within title 21 of the CFR, re-phrasing some sections from the proposed
rule to be simpler, clearer and easier to understand, and eliminating
redundancy).
In the general definitions section of the DEA regulations, the DEA
is amending Sec. 1300.01(b) to be clear that the definitions that
generally apply to most other parts of chapter II of title 21 of the
CFR also apply to part 1317. In response to a number of comments, in
Sec. 1300.01(b) the DEA is amending the definition of ``reverse
distributor'' to clarify that a reverse distributor is a person
registered with the DEA as a reverse distributor.
Definitions were moved from Sec. 1317.02 to Sec. 1300.05 to
provide consistency within the CFR pertaining to definitions. The DEA
adds Sec. 1300.05 ``Definitions relating to the disposal of controlled
substances,'' moves the terms ``authorized employee,'' ``law
enforcement officer,'' and ``non-retrievable'' from part 1317 to Sec.
1300.05(b), adds a definition of ``on-site'' to Sec. 1300.05(b), and
deletes the definitions of ``for cause'' and ``inner liner'' that were
in proposed part 1317. The DEA also moves the definition of
``collection'' to Sec. 1300.01(b). These changes are in response to
comments or related to the movement of several other requirements from
part 1317 to other parts, as discussed below.
In addition to moving them to Sec. 1300.05(b), the DEA amends the
definitions of ``authorized employee'' and ``law enforcement officer.''
The DEA is omitting the word ``authorized'' from the definition of
``authorized employee,'' and codifying the definition of ``employee''
in harmony with the general common law of agency. The DEA is modifying
the definition of ``law enforcement officer'' in part 1317 to
specifically include officers from law enforcement components of
Federal agencies, and authorized police officers of the Veterans Health
Administration and the Department of Defense. In addition, this rule
clarifies who may qualify as a ``law enforcement officer'' for the
purpose of disposal. The DEA is changing references to ``law
enforcement agencies'' to ``law enforcement'' in order to include law
enforcement components of Federal agencies.
Although the DEA defined ``inner liner'' in the NPRM, the final
rule does not amend the CFR to add a definition for inner liner. As
described below, inner liners used in the collection of controlled
substances must meet the specifications outlined in Sec. 1317.60. The
DEA also is not amending the CFR to add a definition of ``for cause,''
and instead is providing an explanation of ``for cause'' as it relates
to the sections to which it applies.
The DEA added a definition of ``on-site'' to Sec. 1300.05(b) to
clarify that ``on-site'' means ``located on or at the physical premises
of the registrant's registered location'' for purposes of destruction
and registration as a collector. Specifically, a controlled substance
is destroyed ``on-site'' when destruction occurs on the physical
premises of the destroying registrant's registered location, and a
hospital/clinic has an ``on-site'' pharmacy when it has a pharmacy
located on the physical premises of the registrant's registered
location.
Text was added to the registration table in Sec. 1301.13 to
reflect that distributors, as a coincident activity to distribution,
may acquire controlled substances from collectors for the purpose of
destruction. The registration table was updated so that it would be
consistent with the regulations in the final rule, which authorize
distributors to destroy controlled substances acquired from collectors.
The DEA received a number of comments indicating confusion
regarding the procedures a registrant must follow to modify their DEA
registration to become a collector. In
[[Page 53525]]
order to clarify such requirements, the DEA is further revising Sec.
1301.51. The additional revisions clarify the requirements by listing
them independently of other types of registration modifications (e.g.,
change of name or address) and clearly indicating that any
modifications may be made in writing by mail or online. 21 CFR part
1301. Also, the submission method has been modified from ``letter'' to
``written request'' to accurately encompass the various ways the
modification request may be submitted (e.g., online), and the phrase
``to be paid'' was deleted from Sec. 1301.51(c) for stylistic reasons.
Similarly, the DEA is further revising Sec. 1301.52 to clarify that
any registrant who has been authorized as a collector and who desires
to discontinue their collection of pharmaceutical controlled substances
from ultimate users must notify the DEA.
The DEA is also streamlining certain registration and security
procedures by moving certain requirements from part 1317, as proposed
in the NPRM, to part 1301. Reverse distributor employee security
requirements in proposed Sec. 1317.20 were moved to Sec. 1301.74(m)
for ease of reference and consistency. Collector security requirements
in proposed Sec. 1317.45 were moved to Sec. 1301.71(f) for clarity
and consistency.
The DEA determined that inclusion of recordkeeping and reporting
requirements in part 1317 may lead to confusion among registrants. As
such, the DEA is moving all recordkeeping and reporting requirements
from part 1317, as proposed in the NPRM, to part 1304--Records and
Reports of DEA Registrants--in order to maintain consistency and
consolidate all recordkeeping and reporting requirements into one part.
In Sec. 1304.03, ``each'' was changed to ``every,'' and ``who'' was
changed to ``that'' for stylistic reasons. In Sec. 1304.11(e)(2), the
first sentence, pertaining to an exception for reverse distributors,
was removed and incorporated into Sec. 1304.11(e)(3) of the final rule
to accurately reflect the type of registrants to which the section
applies.
The DEA is expanding the locations where a collector may maintain
records in Sec. 1304.04(a)(3). The text in Sec. 1304.21(a) was
updated to specifically include inner liners and mail-back packages,
which were inadvertently overlooked in the NPRM. 21 CFR Sec.
1304.21(c) was updated to include the general recordkeeping
requirements for collection activities as outlined in the final rule.
The recordkeeping requirements for disposal of controlled substances in
21 CFR Sec. 1307.21 were moved to Sec. 1304.21(e) and amended to
include recordkeeping procedures for destruction. The title and
introductory text in Sec. 1304.22 were updated to accurately reflect
their contents. Additionally, Sec. 1304.22 was modified to include
recordkeeping requirements for collected controlled substances. The
second sentence in both Sec. 1304.25(a)(9) and Sec. 1304.25(b)(9),
which required compliance with part 1317 when destroying narcotic
controlled substances, were removed as superfluous. All disposal and
destruction activities are clearly delineated in part 1317. Also,
various Automation of Reports and Consolidated Ordering System (ARCOS)
requirements are removed from part 1317, as proposed in the NPRM, and
are consolidated and moved to Sec. 1304.33. In addition, the title of
Sec. 1304.33 has been changed to add clarity, and the acronym
``ARCOS'' is clearly spelled out. The formatting for Sec. 1304.33(f)
was modified for ease of understanding, and ``who'' was changed to
``that'' in two locations for consistency.
The DEA is also amending Sec. 1305.03 to add a new paragraph (f)
to clarify that collectors are exempt from order form requirements for
pharmaceutical controlled substances collected through mail-back
programs and collection receptacles for the purpose of disposal. The
title of Sec. 1307.11 no longer references reverse distributors and
has been changed to ``Distribution by dispenser to another
practitioner'' because reverse distributor activities were moved to
part 1317.
As discussed in the preamble to the NPRM and as mentioned in
proposed Sec. 1317.100, the DEA clarifies in Sec. 1304.21 of this
final rule that, in addition to any other recordkeeping requirements,
all registrants that destroy or cause the destruction of a controlled
substance must maintain a record of that destruction on a DEA Form 41.
This requirement had been discussed in the preamble to the proposed
rule, and in proposed Sec. 1317.100 the DEA stated ``any registered
person that destroys or causes the destruction of a controlled
substance shall maintain a record of destruction on a form issued by
DEA . . ..'' The DEA has determined that this requirement to keep such
records on DEA Form 41 should be explicitly stated in the regulatory
text, and not just the preamble, for registrants to clearly understand
the requirements to which they are bound. As stated above, this
requirement to record destruction activities on the DEA Form 41 does
not apply to drug wastage or pharmaceutical wastage which must be
properly recorded, stored, and destroyed in accordance with DEA
regulations, and all applicable Federal, State, tribal, and local laws
and regulations. 21 CFR part 1304.
The DEA is modifying proposed Sec. 1317.70 to address the
procedures that a collector must follow when ceasing operation of a
mail-back program. This modification requires such collector to make
reasonable efforts to notify the public of their intent to cease mail-
back collection activities. 21 CFR 1317.70. Such collector must also
establish an agreement with another collector authorized to conduct a
mail-back program to receive all remaining packages and arrange for the
forwarding of such packages to the second collector's registered
location. These procedures will ensure that another authorized entity
will be responsible for receiving and destroying any mail-back packages
that were disseminated but not received back by the collector prior to
the time that they ceased operation of their mail-back program.
Finally, the DEA is modifying proposed Sec. 1317.75 for two
purposes. The first modification clarifies that collected controlled
and non-controlled substances can be comingled, but are not required to
be comingled. 21 CFR 1317.75. As previously discussed, the second
modification to this section allows certain LTCF employees, as
designated by the collector authorized to maintain a collection
receptacle at that LTCF, to install, seal, remove, store, and transfer
for destruction the inner liners of the collection receptacle along
with an employee of the collector. 21 CFR 1317.80. This modification
allows greater flexibility for collectors authorized to maintain
collection receptacles at LTCFs.
II. Background and Legal Authority
The DEA implements and enforces titles II and III of the
Comprehensive Drug Abuse Prevention and Control Act of 1970, as
amended. Titles II and III are referred to as the ``Controlled
Substances Act'' and the ``Controlled Substances Import and Export
Act,'' respectively, but are collectively referred to as the
``Controlled Substances Act'' or the ``CSA'' for the purpose of this
action. 21 U.S.C. 801-971. The DEA publishes the implementing
regulations for these statutes in title 21 of the Code of Federal
Regulations (CFR), parts 1300 to 1321. The CSA and its implementing
regulations are designed to prevent, detect, and eliminate the
diversion of controlled substances and listed chemicals into the
illicit market while providing for a sufficient supply of controlled
substances and listed
[[Page 53526]]
chemicals for legitimate medical, scientific, research, and industrial
needs of the United States. Controlled substances have the potential
for abuse and dependence and are controlled to protect the public
health and safety. To this end, controlled substances are classified
into one of five schedules based upon: The potential for abuse,
currently accepted medical use, and the degree of dependence if abused.
21 U.S.C. 812. Listed chemicals are separately classified as list I or
list II chemicals based on their use and importance to the manufacture
of controlled substances. 21 U.S.C. 802(33)-(35).
The CSA establishes a closed system of distribution that requires
the DEA to monitor and control the manufacture, distribution,
dispensing, import, and export of controlled substances and listed
chemicals until they reach their final lawful destination. The secure
destruction of unused, recalled, tainted, expired, or otherwise
unwanted pharmaceutical controlled substances is essential to
preventing the diversion of these substances into the illicit market.
In order to maintain this closed system of distribution, persons
who handle (manufacture, distribute, dispense, import, export, engage
in research, or conduct instructional activities), or propose to
handle, controlled substances and listed chemicals are required to
register with the DEA at each principal place of business or
professional practice. Persons registered with the DEA are permitted to
possess controlled substances and listed chemicals as authorized by
their registration and must comply with the applicable requirements
associated with their registration. 21 U.S.C. 822.
Not all persons who possess controlled substances are required to
register with the DEA. For example, a patient who receives a
pharmaceutical controlled substance pursuant to a lawful prescription,
i.e., an ultimate user, is not required to register with the DEA in
order to receive and possess that substance. 21 U.S.C. 822(c)(3); see
also 21 U.S.C. 957(b)(1)(C).\2\ The CSA defines an ``ultimate user'' as
``a person who has lawfully obtained, and who possesses, a controlled
substance for his own use or for the use of a member of his household
or for an animal owned by him or by a member of his household.'' 21
U.S.C. 802(27).
---------------------------------------------------------------------------
\2\ 21 U.S.C. 822(c)(3) and 957(b)(1)(C) except ``ultimate
users'' who possess substances for purposes referenced in 21 U.S.C.
802(25); however, ``ultimate user'' is defined in 21 U.S.C. 802(27).
---------------------------------------------------------------------------
While Congress envisioned a closed system of distribution that
would control a substance from its manufacture or import through the
traditional chain of distribution moving from registrant to registrant
until it reached its final lawful use (e.g., dispensed to the ultimate
user, etc.), it did not account for circumstances in which
pharmaceutical controlled substances were lawfully dispensed to, and
possessed by, an ultimate user but not fully used. Although ultimate
users are exempt from CSA registration requirements for the possession
of pharmaceutical controlled substances, if they distribute (e.g.,
deliver or transfer) such substances without the appropriate
registration, they are in violation of the CSA.\3\ Such unlawful
distribution includes the transfer of pharmaceutical controlled
substances for the purpose of disposal.\4\
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\3\ It is unlawful to knowingly or intentionally manufacture,
distribute, dispense, or possess with the intent to manufacture,
distribute, or dispense, a controlled substance without the
appropriate registration. 21 U.S.C. 841(a).
\4\ The terms ``disposal,'' ``dispose,'' or ``disposition''
appear several times in the CSA and its implementing regulations,
but are not defined. For example, in the CSA, see 21 U.S.C. 822(g);
824(f)-(g); 826(c), (e)-(f); 827(a)(3), (d)(1); 842(a)(7); 853(n);
880(a)(2); 881(e)(1); 958(d)(6); and in the CFR, see 21 CFR
1307.21(b) and 1304.22(a)(2)(ix). The term ``net disposal,''
however, is defined at 21 CFR 1300.01(b). As used, the terms refer
to a variety of activities that ultimately result in eliminating the
availability of controlled substances for use. For example, within
the meaning of the CSA, a controlled substance can be ``disposed
of'' by destruction, return, recall, sale, or through the
manufacturing process. The Disposal Act allows an ultimate user to
deliver a lawfully obtained controlled substance to another person
``for the purpose of disposal.'' The DEA believes that the ultimate
user disposal authorized by the Disposal Act includes the transfer
or delivery of controlled substances for purposes of destruction,
return, and recall. Such ultimate user activities are consistent
with the intent to remove unused, unwanted, tainted, and expired
substances from households and out of the reach of children and
teenagers thereby reducing the risk of diversion and protecting the
public health and safety. As used in this Final Rule, the DEA uses
the terms ``disposal'' and ``dispose'' to generally refer to the
wide range of activities that result in controlled substances being
unavailable for further use. When necessary to specify a particular
activity within the disposal process, the particular activity is
identified (e.g., transfer, deliver, collect/collection, return,
recall, and destroy/destruction).
---------------------------------------------------------------------------
The Disposal Act, enacted on October 12, 2010, amended the CSA to
allow an ultimate user to ``deliver'' a pharmaceutical controlled
substance ``to another person for the purpose of disposal'' if the
person receiving the substance is authorized to receive it and the
disposal takes place in accordance with regulations issued by the
Attorney General to prevent the diversion of controlled substances. 21
U.S.C. 822(g)(1). The Attorney General delegated responsibility for
promulgating the Disposal Act implementing regulations to the DEA.\5\
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\5\ The Attorney General's delegation of authority to the DEA
may be found at 28 CFR 0.100.
---------------------------------------------------------------------------
In addition to authorizing ultimate users to deliver their
pharmaceutical controlled substances to another person for the purpose
of disposal, the Disposal Act also authorizes any person lawfully
entitled to dispose of an ultimate user decedent's property to deliver
the ultimate user's pharmaceutical controlled substances to another
person for the purpose of disposal if the ultimate user dies while in
lawful possession of the substances. The Disposal Act also gives the
DEA the ability, by regulation, to authorize LTCFs to dispose of
pharmaceutical controlled substances on behalf of ultimate users who
reside, or have resided, at the LTCF. Congress directed the DEA, in
promulgating the Disposal Act implementing regulations, to consider the
public health and safety, ease and cost of program implementation, and
participation by various communities. The implementing regulations may
not require any person to establish or operate a delivery or disposal
program.
III. Discussion of Comments
The DEA had received 192 comments on the NPRM when the comment
period closed on February 19, 2013. These comments are summarized
below, along with the DEA's responses.
A. Support for the Proposed Rule (1 Issue)
[1] Issue: The DEA received 192 comments for this rulemaking during
the 60-day comment period. The vast majority of the comments were
overwhelmingly positive with the commenters agreeing that there should
be more options for secure, convenient, and responsible disposal of
controlled substances. Nineteen commenters supported the rule as
written in the NPRM. Almost every other commenter supported the rule to
some degree, although many commenters had concerns with the
implementation of the specific disposal procedures described in the
NPRM.
Response: The DEA appreciates the support for this rulemaking and
is privileged to implement regulations to allow for the collection and
disposal of controlled substances in a secure, convenient, and
responsible manner. The DEA considered all of the comments and
ramifications of implementing proposed changes to the rule. In
finalizing this rule, the DEA
[[Page 53527]]
considered public health and safety, ease and cost of program
implementation, and participation by various communities.
B. Definitions and Terms \6\ (12 Issues)
---------------------------------------------------------------------------
\6\ Definitions and terms specific to particular comment
categories, such as ``Law Enforcement'' and ``Long-Term Care
Facilities (LTCFs),'' are located in those specific sections.
---------------------------------------------------------------------------
[1] Issue: Five commenters asked the DEA to define ``ultimate
user.''
Response: An ultimate user is defined by the CSA as ``a person who
has lawfully obtained, and who possesses, a controlled substance for
his own use or for the use of a member of his household or for an
animal owned by him or by a member of his household.'' This definition,
codified at 21 U.S.C. 802(27), was not amended or otherwise modified by
the Disposal Act.
[2] Issue: Ten commenters asked the DEA to clarify the term
``retail pharmacy'' and to specify whether ``closed-door pharmacies,''
such as those that service LTCFs, ``Federal pharmacies,'' and other
pharmacies that only provide services to a distinct population are
considered retail pharmacies.
Response: The intended meaning of ``retail pharmacy'' with regard
to collectors was discussed in the NPRM but was not defined in the
proposed rule itself. The DEA intends ``retail pharmacy'' to include
any entity registered with the DEA as a retail pharmacy as opposed to
those entities registered as a hospital/clinic. Depending on a variety
of factors, including State authority and authorized business
practices, some entities that dispense controlled substances may be
registered with the DEA as either a retail pharmacy or a hospital/
clinic. 21 CFR part 1301. In other words, pharmacies are not registered
with the DEA as ``Federal pharmacies,'' ``LTCF pharmacies,'' or even
``closed-door pharmacies.'' All of these pharmacies may be registered
as retail pharmacies provided they meet the requirements of 21 U.S.C.
822 and 823, and they may be authorized as collectors upon proper
application. As previously discussed, the DEA is also allowing entities
registered as hospitals/clinics with an on-site pharmacy to be
collectors. 21 CFR 1317.40. Therefore, patients of pharmacies that
dispense controlled substances pursuant to a hospital/clinic
registration may benefit if the hospital/clinic opts to modify its
registration to become a collector.
[3] Issue: Approximately 10 commenters asked the DEA to expand the
definition of ``authorized employee.'' These commenters expressed
concern that the definition of ``authorized employee'' in the NPRM was
too limited in scope, and would result in a burden on smaller-staffed
pharmacies, as well as pharmacies that employ contract pharmacists and
part-time employees. One commenter asked whether or not physician-
owners will be considered authorized employees.
Response: The DEA carefully considered the commenters' concerns and
is modifying the proposed definition of ``authorized employee.'' 21 CFR
Sec. 1300.05(b). In this rule, the DEA is omitting the word
``authorized'' from the definition of ``authorized employee'' because
the rule already specifies what conditions qualify employees to conduct
certain disposal activities (i.e., authorized collectors may not
employ, as an agent or employee who has access to or influence over
collected substances, any person who has been convicted of a felony
offense related to controlled substances or who has, at any time, had
an application for registration with DEA denied, had a DEA registration
revoked or suspended, or surrendered a DEA registration for cause).
Also, the DEA is modifying the definition of ``employee'' by adopting
the general common law of agency's definition of the term and moving
the definition from proposed part 1317 to part 1300. As a result of
these changes, part-time personnel and physician-owners may be
considered ``employees'' for the purpose of disposal if they meet the
relevant criteria.
Where Congress does not define ``employee,'' the DEA utilizes the
common law to determine who is an ``employee.'' Under U.S. Supreme
Court precedent, the factors relevant to determining whether a person
is an ``employee'' under the common law include, but are not limited
to: The hiring party's right to control the manner and means by which
the product is accomplished; the skill required; the source of the
instrumentalities and tools; the location of the work; the duration of
the relationship between the parties; whether the hiring party has the
right to assign additional projects to the hired party; the extent of
the hired party's discretion over when and how long to work; the method
of payment; the hired party's role in hiring and paying assistants;
whether the work is part of the regular business of the hiring party;
whether the hiring party is in business; the provision of employee
benefits; and the tax treatment of the hired party. See Nationwide Mut.
Ins. Co. v. Darden, 503 U.S. 318, 323-24 (1992). Other applicable
factors may be considered and no one factor is dispositive. See id. at
324.
After evaluating the relevant factors in the context of controlled
substance security and diversion prevention, in the context of
disposal, the following criteria will determine whether a person is an
``employee'' regardless of the number of hours per week the person
works: Persons who are directly paid by the registrant; who are subject
to direct oversight by the registrant; who are required, as a condition
of employment, to follow the registrant's procedures and guidelines
pertaining to the handling of controlled substances; who receive a
performance rating or performance evaluation on a regular/routine basis
from the registrant; who are subject to disciplinary action by the
registrant; and who render services at the registrant's registered
location. This definition is incorporated in the new Sec. 1300.05,
titled ``Definitions Relating to the Disposal of Controlled
Substances.'' These criteria focus on the degree of management and
control that a registrant has over the person, and thus, adherence to
these criteria will directly impact the security of controlled
substances within the registrant's custody and control. The DEA
believes that these criteria are the minimum required to ensure
controlled substances are accounted for and not diverted to illicit
purposes. Under the definition, contract personnel who do not meet
these criteria are not ``employees'' for the purposes of disposal.
[4] Issue: One commenter stated that the proposed definition of
``authorized employee'' was too expansive, and that controlled
substances should be handled only by individuals who hold a
professional license.
Response: The DEA carefully considered the diversion risks
associated with allowing various types of persons to handle collected
substances. The definition of ``employee,'' as stated in this final
rule, will help reduce diversion risks while ensuring that authorized
collectors have sufficient ability to safely and securely manage the
collection of controlled substances. 21 CFR part 1300. Individuals who
do not hold a professional license are considered ``employees'' if they
meet the criteria as explained above.
[5] Issue: Five commenters asked the DEA to define the term
``common or contract carrier.''
Response: The DEA declines to define this term for the purpose of
this rule. The DEA's primary concern regarding common or contract
carriers is not about how these terms are defined, but whether there is
adequate security to
[[Page 53528]]
prevent diversion when controlled substances are being transported. As
explained in Sec. 1301.74(e), when shipping controlled substances,
non-practitioner registrants are responsible for selecting common or
contract carriers that provide adequate security to guard against in-
transit losses. In addition, non-practitioner registrants are
responsible for employing precautions (e.g., assuring that shipping
containers do not indicate that contents are controlled substances) to
guard against in-transit losses. Although these specific requirements
apply to non-practitioners, all registrants (practitioners and non-
practitioners) shall provide effective controls and procedures to guard
against theft and diversion of controlled substances. 21 CFR part 1301.
[6] Issue: One commenter suggested that the DEA modify the
definition of ``non-retrievable'' to read: ``means to permanently alter
any controlled substance's physical and/or chemical state through
essentially irreversible means in order to render that controlled
substance unavailable and unusable for all practical purposes. This
definition is not intended to require destruction beyond the state at
which a controlled substance becomes unavailable, unusable, and,
subsequently, no longer available for diversion.''
Response: The DEA declines to modify the definition as suggested.
Such a change would significantly weaken the non-retrievable standard
to a state where controlled substances could easily be diverted. The
permanent and irreversible alteration of controlled substances is the
cornerstone of the non-retrievable standard.
[7] Issue: Some commenters asked the DEA to clarify the meaning of
the terms ``regularly'' and ``practitioner'' used in the proposed Sec.
1317.05(a)(4).
Response: ``Practitioner'' is defined in the CSA at 21 U.S.C.
802(21) as ``a physician, dentist, veterinarian, scientific
investigator, pharmacy, hospital, or other person licensed, registered,
or otherwise permitted, by the United States or the jurisdiction in
which he practices or does research, to distribute, dispense, conduct
research with respect to, administer, or use in teaching or chemical
analysis, a controlled substance in the course of professional practice
or research.'' The term ``regularly'' has its ordinary meaning, with no
specific or technical implications. The DEA understands the ordinary
meaning of ``regularly'' to generally be considered as being on a
routine basis or at routine intervals.
[8] Issue: One commenter suggested that the DEA distinguish reverse
distributors who only collect controlled substances for the purpose of
disposal from reverse distributors who also handle non-controlled
substances and other waste products. This commenter suggested that the
DEA lessen the requirements for those reverse distributors that only
collect controlled substances for disposal.
Response: The DEA does not distinguish between different ``types''
of reverse distributors. All reverse distributors receive controlled
substances for the purpose of disposal--either through return to the
manufacturer who accepts returns, or through destruction. 21 CFR part
1300. The regulations impose the minimum requirements for reverse
distributors when handling controlled substances regardless of whether
they also handle other substances. Therefore, there is no basis to
relax the requirements for reverse distributors whose activities are
limited solely to the collection of pharmaceutical controlled
substances for the purpose of disposal.
[9] Issue: One commenter asked the DEA to clarify the difference
between ``transfer'' and ``transport'' as used in proposed Sec.
1317.95.
Response: These terms have their ordinary meaning. Generally, the
DEA uses the term ``transport'' to refer to the physical movement of an
item from one location to another while ``transfer'' is used to refer
to conveying possession or control (actual or constructive) from one
entity to another.
[10] Issue: One commenter asked the DEA to clarify the phrase
``causes the destruction'' as it could be interpreted to mean any
person involved in the process.
Response: As previously discussed, proposed Sec. 1317.100 is
relocated in this final rule to Sec. 1304.21(e). The DEA included the
term ``causes the destruction'' to encompass such circumstances where a
registrant does not itself destroy the controlled substance but is
still responsible for the destruction; for example, when a registrant
or a registrant's employee initiates the destruction process by
engaging a third-party destruction facility that will perform the
actual destruction pursuant to Sec. 1317.95(c). This final rule
clarifies this distinction in Sec. Sec. 1317.95(c) and 1304.21(e).
[11] Issue: One commenter stated that the rule should be clarified
in use of the word ``may'' with regard to individual counting and
inventorying of collected substances. The commenter indicated that the
word seems open for interpretation.
Response: The commenter is specifically referring to the NPRM
statement ``[c]ontrolled substances collected by collectors may not be
individually counted or inventoried.'' The DEA understands that this
phrase may be misinterpreted to mean that authorized collectors are not
required to count or inventory collected substances. To clarify, the
DEA is modifying Sec. Sec. 1317.60 and 1317.70 to clearly indicate
that sealed inner liners and returned mail-back packages ``shall not be
opened, x-rayed, analyzed, or otherwise penetrated.'' The DEA also
modifies Sec. 1317.75(c) to specify that this prohibition includes
counting or inventorying collected substances prior to sealing and
removing an inner liner that contains collected substances, as well as
after the inner liner is sealed. The DEA discusses below the different
requirements applying to law enforcement.
[12] Issue: One commenter noted that the DEA used inconsistent time
requirements throughout the proposed rule, such as ``timely,''
``prompt,'' and ``as soon as practicable, but no later than 14 days.''
Additionally, several commenters requested clarification regarding the
definition of the word ``prompt'' in the proposed rule, and commenters
asked for clarification regarding how the DEA would determine whether
an action is ``prompt.'' Commenters asked for guidance as to what time
range the DEA would find reasonably acceptable.
Response: The DEA's use of different time standards throughout the
proposed rule was intentional as the different circumstances of each
requirement warrant different standards. The various timing
requirements are intended to be flexible enough to account for
individual circumstances while also ensuring sufficient and adequate
controls to prevent diversion and opportunities for diversion. The DEA
considered imposing specific timelines (e.g., three days, five days);
however, the wide variety of business models and activities made it
impossible in most circumstances to set a specific deadline that would
prevent diversion and diversion opportunities. Additionally, violations
of specific timelines would be per se violations of the regulations,
whereas violations of the flexible ``prompt'' and ``as soon as
practicable'' standards would be considered under each registrant's
individual circumstances. The DEA's determination will be guided by
whether the registrant has fulfilled its responsibility to provide
effective controls and procedures to guard against theft and diversion.
All controlled substances destined for destruction must be rendered
non-retrievable in order to be destroyed in a manner
[[Page 53529]]
consistent with this rule. As such, a controlled substance will have
been promptly destroyed if it is promptly rendered non-retrievable. 21
CFR 1317.95. ``Timely'' refers to actions that have a specific time
period for compliance, e.g., 30 days. Therefore, in each instance in
which the rule uses the word ``timely'' to refer to destruction
requirements for reverse distributors, it refers to the specific time
period (14 days in the proposed rule, 30 days in the final rule) in
which reverse distributors are required to destroy controlled
substances. 21 CFR 1317.15.
C. Types of Entities That May Operate a Collection Program (9 Issues)
[1] Issue: Several commenters asked the DEA to retain the provision
in the proposed rule to permit retail pharmacies to maintain collection
receptacles. These commenters stated that retail pharmacies will
provide a convenient option for ultimate users who desire to safely and
securely dispose of their unused or unneeded controlled substances.
Commenters also asked the DEA to retain the provision to permit retail
pharmacies to manage collection receptacles at LTCFs.
Response: The DEA appreciates the support for the provisions in the
rule that permit retail pharmacies to manage collection receptacles at
not only the primary registered location of the retail pharmacy, but
also LTCFs. 21 CFR 1317.40 and 1317.80. The DEA believes that these two
provisions will provide ultimate users and others with convenient
options to safely and securely dispose of unused controlled substances.
The DEA retained these provisions in the final rule.
[2] Issue: Eighteen commenters asked the DEA to permit hospitals to
become authorized collectors so that they may maintain collection
receptacles. An additional two commenters asked the DEA to allow
specialized hospitals and clinics to maintain collection receptacles.
These commenters stated that collection receptacles located inside of
hospitals would provide ultimate users with an opportunity to dispose
of medication that may no longer be needed or may be expired.
Response: The DEA selected methods for disposal that provide
opportunities for ultimate users to securely, conveniently, and
responsibly dispose of their unused, unwanted, and expired
pharmaceutical controlled substances while also preventing diversion.
As previously discussed, after extensive review and careful
deliberation, the DEA is permitting certain registered hospitals/
clinics to become authorized collectors. 21 CFR 1317.40. In order to
counterbalance the diversion risks of allowing collection receptacles
to be located inside hospitals/clinics, the DEA is only allowing those
hospitals/clinics with on-site pharmacies to become collectors. The DEA
is requiring these collectors to place collection receptacles in
locations that are regularly monitored by employees, and is prohibiting
these collectors from placing collection receptacles in the proximity
of any area where emergency or urgent care is provided. 21 CFR 1317.75.
[3] Issue: One commenter suggested that hospitals of a certain size
be required to become authorized collectors.
Response: The DEA is not requiring, nor is the DEA authorized to
require, any entity to implement a collection program or maintain a
collection receptacle. The Disposal Act explicitly states that the
``regulations may not require any entity to establish or operate a
delivery or disposal program.'' 21 U.S.C. 822(g)(2).
[4] Issue: It was requested that the DEA allow military treatment
facility pharmacies (registered with the DEA as a hospital/clinic), and
the Indian Health Service (IHS), including IHS pharmacies (IHS, Tribal,
and Urban programs) to become authorized collectors. One commenter also
suggested that the DEA permit collection receptacles in select areas of
military installations, such as ambulatory care clinics and service
member barracks.
Response: As previously discussed, any registered hospital/clinic
with an on-site pharmacy and any retail pharmacy may be authorized to
be a collector. 21 CFR 1317.40. Ambulatory care clinics and service
member barracks are generally not registrants. As discussed in the
NPRM, the Disposal Act did not give the DEA authority to create new
classes of registration solely for the purpose of conducting ultimate
user disposal activities. The DEA is allowing hospitals/clinics with an
on-site pharmacy and retail pharmacies to be responsible for and manage
collection receptacles in non-registrant LTCFs because the Disposal Act
acknowledged that LTCFs ``face a distinct set of obstacles to the safe
disposal of controlled substances due to the increased volume of
controlled substances they handle.'' 21 CFR 1317.80. LTCF residents
generally have limited mobility; accordingly, this final rule
authorizes LTCFs to dispose of controlled substances on behalf of
ultimate users who reside or have resided at the LTCF. 21 CFR 1317.30.
Furthermore, un-registered ambulatory care clinics and service member
barracks generally lack adequate safeguards to ensure the security of
collected pharmaceutical controlled substances; thus, allowing
collection receptacles at such locations poses an unacceptable risk of
diversion and threatens the public health and safety.
[5] Issue: Eight commenters asked the DEA to permit non-registrants
to collect non-controlled substances for the purpose of disposal.
Response: The DEA's authority regarding drug disposal is specific
to pharmaceutical controlled substances. Non-registrants may collect
non-controlled substances pursuant to all applicable Federal, State,
tribal, and local laws and regulations; however, all regulations and
laws relevant to controlled substances will apply if controlled
substances are collected, even inadvertently.
[6] Issue: One commenter asked the DEA to permit LTCFs to become
authorized collectors.
Response: The DEA is without authority to permit LTCFs to become
authorized collectors. As discussed in the NPRM, authorized collectors
must first be registrants in order for the DEA to impose and enforce
these regulations upon them. A majority of LTCFs do not have State
authority with respect to controlled substances--a fundamental
prerequisite to obtaining a DEA registration. The Disposal Act
authorized the development of regulations to permit LTCFs to dispose of
controlled substances on behalf of ultimate users who reside or have
resided in their facilities. The DEA is permitting hospitals/clinics
with an on-site pharmacy and retail pharmacies to become authorized
collectors with authority to install and maintain collection
receptacles at LTCFs, and declines to extend this authority to the
LTCFs themselves. 21 CFR 1317.40.
[7] Issue: Several commenters urged the DEA to create a new status
that permits non-registrant organizations to become authorized
collectors for the sole purpose of collecting controlled substances
from ultimate users and others authorized to dispose of controlled
substances on behalf of ultimate users. One commenter asked that the
DEA allow non-profit, non-registrant organizations to register as
authorized collectors with a reduced fee.
Response: The DEA is not developing a new category of registrant
specifically for collecting pharmaceutical controlled substances from
ultimate users. Any entity that wishes to collect controlled substances
from ultimate users must do so in accordance with this rule, which
includes provisions for specified
[[Page 53530]]
existing registrant categories to modify their registration to become
authorized as collectors. Any person not already registered with the
DEA, wishing to become authorized as a collector must first satisfy all
of the requirements for registration identified in the CSA and its
implementing regulations. Non-registrant organizations may partner with
law enforcement and with registrants that are collectors. 21 CFR
1317.65.
[8] Issue: One commenter asked the DEA to clarify how a local
government may register with the DEA to become an authorized collector.
Response: As discussed above, the DEA is not creating a new
registration category for the exclusive purpose of collecting
controlled substances from ultimate users. Persons registered with the
DEA as manufacturers, distributors, reverse distributors, NTPs,
hospitals/clinics with an on-site pharmacy, or retail pharmacies may
apply to modify their registration to become an authorized collector in
the manner proscribed by this final rule. 21 CFR part 1301. Any person
not already registered with the DEA, wishing to become authorized as a
collector must first satisfy all of the requirements for registration
identified in the CSA and its implementing regulations. These
requirements include being authorized to handle controlled substances
by the State in which the applicant is located unless exempt by statute
or regulation. The DEA encourages entities that are not registrants to
partner with authorized collectors or law enforcement. 21 CFR 1317.65.
For example, local governments may partner with authorized mail-back
collectors to provide mail-back packages to the public.
[9] Issue: One commenter asked the DEA to clarify that no Federal
or State government entity may require registrants to amend their DEA
registration to become authorized collectors.
Response: The Disposal Act specifically prohibits the DEA from
requiring any entity to establish or operate a delivery or disposal
program. 21 U.S.C. 822(g)(2). The prohibition does not extend to every
Federal and State agency and the DEA does not have the authority to
institute such a prohibition.
D. Locations Where Authorized Collectors May Maintain Collection
Receptacles or Host Take-Back Events (1 Issue)
[1] Issue: Six commenters asked the DEA to permit retail pharmacies
to manage collection receptacles at establishments other than the
retail pharmacy's registered location, such as community centers.
Commenters stated other locations may be more convenient for ultimate
users and would thus maximize participation. Two commenters asked the
DEA to allow collection receptacles at unregistered locations such as
permanent household hazardous waste collection sites.
Response: The DEA acknowledges that in some locations, and under
certain circumstances, alternative settings may be more convenient for
ultimate users, but that is not the only consideration. The DEA
believes that in order to adequately ensure the safety and welfare of
the public, collection receptacles must be located inside the DEA-
registered location of authorized collectors. 21 CFR part 1317.75.
Authorized collectors, as registrants, are readily familiar with the
security procedures and other requirements to handle controlled
substances. Most publicly-accessible locations where controlled
substances are not typically handled, such as community centers and
hazardous waste collection sites, are not targets for theft in the same
manner as those locations where pharmaceutical controlled substances
are regularly handled. Thus, those locations are unlikely to be
familiar with, or to have in place, the security controls necessary to
ensure the security of collected substances and prevent diversion of
controlled substances. However, law enforcement may continue to conduct
take-back events, and other persons may partner with law enforcement to
conduct such take-back events at various locations. 21 CFR 1317.65.
E. Registration Requirements for Authorized Collectors (5 Issues)
[1] Issue: Several commenters asked the DEA to clarify whether or
not registration modifications for authorized collectors may be
conducted online.
Response: Registration modifications may be conducted online. For
the final rule, the DEA is modifying the text of Sec. 1301.51 to
clarify that online modifications are indeed permitted. Registrants may
go to www.DEAdiversion.usdoj.gov to modify their registration when they
start or stop collection activities.
[2] Issue: Three commenters stated that it is overly burdensome to
require authorized collectors to modify their registration each time
they start or stop collection activities. These commenters asked that
the DEA provide additional details regarding the registration
modification process.
Response: The DEA carefully reviewed the registration requirements
and did not find indications to suggest that registration modifications
will be overly burdensome. The rule requires that a registrant must
apply to modify their DEA registration prior to initiating any
collection activities. 21 CFR part 1301. Authorization as a collector
is subject to renewal in the same manner as registration. The DEA will
consider an authorized collector to be conducting collection activities
until the registration is modified, revoked, surrendered, suspended, or
otherwise terminated. If an authorized collector stops collection
activities, he/she must modify his/her registration to indicate such.
The requirement to modify a registration requires a simple written
notification to the DEA. This written notification can be easily and
quickly conducted online in a few minutes. 21 CFR part 1301. The
registrant may go online and select the option to indicate that the
registrant has ceased collecting. Registrants without ready access to
the online notification method can easily and quickly communicate such
information to the DEA in writing via the mail, which the DEA will
process promptly upon receipt.
[3] Issue: One commenter suggested that the DEA relax requirements
for registration modifications regarding LTCF collection receptacles.
This commenter was concerned that registration modifications may
outpace the DEA's resources.
Response: The DEA evaluated this request and determined that the
registration requirements regarding LTCF collection receptacle
management are necessary to ensure accountability and prevent
diversion; the related procedures are the minimum necessary to ensure
that authorized collectors maintain the receptacles in a manner that is
consistent with the applicable regulations. 21 CFR part 1301.
[4] Issue: One commenter asked the DEA to clarify whether or not an
entity may apply for registration as a reverse distributor with the
sole intent of providing destruction services for collected substances.
Response: Any entity may apply for registration as a reverse
distributor pursuant to and in accordance with 21 U.S.C. 822-823, and
21 CFR part 1301. Reverse distributors are not required to conduct all
activities that they are authorized to perform.
[5] Issue: Two commenters asked the DEA to clarify whether a
destruction facility must be registered with the DEA.
Response: Pursuant to this rule, a destruction facility is not
required to register with the DEA simply because a
[[Page 53531]]
registrant utilizes that facility to destroy controlled substances in a
manner consistent with this rule and all other applicable Federal,
State, tribal, and local laws and regulations. At this time, the DEA
does not believe it is appropriate to require these entities to be
registered because the destroying registrant maintains possession and
control of the substances (and therefore retains responsibility and
accountability) until the substances are rendered non-retrievable. 21
CFR part 1301. All handling, monitoring, reporting, recordkeeping, and
witnessing with regard to the destruction of pharmaceutical controlled
substances must be performed by registrants or their employees. The DEA
has omitted the language that was proposed for Sec. 1317.15(c)(4) in
order to prevent confusion.
F. Law Enforcement (7 Issues)
[1] Issue: Several commenters asked the DEA to expand the
definition of ``law enforcement officer'' to include law enforcement
components of Federal agencies and civilian law enforcement officers.
Response: The final rule definition is expanded from the proposed
rule to specifically include officers of the law enforcement components
of Federal agencies, and police officers of the Veterans Health
Administration and the Department of Defense. The NPRM proposed a
definition of ``law enforcement officer'' to include persons who are
employees of a ``law enforcement agency.'' The DEA is modifying this
definition in the final rule to specifically include employees of law
enforcement components of Federal agencies. Any person who meets the
criteria for ``employee'' and ``law enforcement officer'' outlined in
the final rule will be a qualified officer for the purposes of disposal
of pharmaceutical controlled substances, regardless of whether the
person is considered a ``civilian'' law enforcement officer. 21 CFR
part 1300.
[2] Issue: Four commenters stated it would be overly burdensome to
require law enforcement to have a collection receptacle that fits the
specifications in the NPRM. These commenters stated that the collection
receptacle would pose logistical issues, and that the volume of drugs
collected would likely exceed the volume that the receptacle could
contain. Commenters also noted that it is unnecessary to mandate that
law enforcement utilize collection receptacles at take-back events.
Response: Law enforcement are not required to have a collection
receptacle that meets all of the specifications in the rule, and the
text of the rule is amended to clarify that the specifications apply to
authorized collectors and not law enforcement. The only suggested
requirements for the physical construction of collection receptacles
maintained by law enforcement are that they be securely placed and
maintained at the law enforcement's physical location. 21 CFR 1317.35.
Also, law enforcement are not required to utilize collection
receptacles at take-back events. The text of the final rule states,
``[e]ach take-back event should have at least one receptacle for the
collection of permitted substances . . .'' 21 CFR 1317.65. Thus, law
enforcement should have some sort receptacle at take-back events.
[3] Issue: Commenters expressed concern that law enforcement may
not have the facilities to store the collected substances until they
are shipped to a destruction facility.
Response: The rule suggests that law enforcement store collected
substances in a manner that is consistent with its standard procedures
for storing illicit controlled substances. The language used in the
text of the rule, ``should,'' is suggestive. Law enforcement are
encouraged to follow the guidance in 21 CFR 1317.35; however, they are
not required to do so. It should be noted that the requirements in 21
CFR 1317.65 pertaining to law enforcement presence at take-back events
are mandated; however, the DEA only suggests procedures for the storage
and transportation of pharmaceutical controlled substances collected at
take-back events.
[4] Issue: One commenter asked the DEA to permit entities other
than law enforcement to conduct take-back events.
Response: If an authorized collector or other entity wishes to
conduct a take-back event, the event must be held in partnership with
law enforcement, as provided in the rule. 21 CFR 1317.65. Take-back
events are intended to be limited-duration events that may take place
at an unregistered location that is easily accessible to the public,
such as a community center or town center. Given the likelihood of
publicity and low physical security at such locations, the DEA believes
that it is imperative to ensure active law enforcement participation
for the safety of the event participants and the community, as well as
to help deter theft and diversion of pharmaceutical controlled
substances.
[5] Issue: Commenters urged the DEA to relax the ``authorized
employee'' requirement for civilian law enforcement officers. These
commenters stated that the DEA should treat civilian law enforcement
officers as ``authorized employees'' for the purposes of this rule.
They stated that these officers and employees currently assist with
take-back events, and if they were no longer permitted to, there would
be a staffing shortage to assist with take-back events. Additionally,
several commenters encouraged the DEA to allow civilian law enforcement
employees to handle collected substances if they meet the same
requirements as an employee or handle the substances in a manner
consistent with law enforcement protocols.
Response: In the NPRM, ``authorized employee'' referred to those
registrant personnel who would be permitted to directly participate in
the disposal process. ``Authorized employee'' did not pertain to law
enforcement officers or to take-back events. In the final rule the
definition is modified, but it still only pertains to those persons who
may be permitted to directly participate in the disposal process. 21
CFR part 1300. With respect to law enforcement and take-back events, as
discussed above, any person who meets the criteria for ``employee'' and
``law enforcement officer'' outlined in the final rule will be a
qualified officer for the purposes of disposal of pharmaceutical
controlled substances, regardless of whether the person is considered a
``civilian'' law enforcement officer. The DEA declines to expand the
law enforcement authority to specifically include civilian law
enforcement employees. Only employed law enforcement officers, as
defined by this final rule, may handle pharmaceutical controlled
substances at take-back events. As discussed in the NPRM and previous
responses to this issue, the DEA believes that this level of security
is necessary to prevent theft and diversion and to ensure the safety of
the public due to the highly publicized nature of take-back events and
the fact that such events are likely to occur at locations with minimal
security. The DEA does not believe that this requirement will hinder
the success of take-back events. As previously discussed, only one law
enforcement officer must oversee the take-back event, and at the
discretion of the law enforcement agency or law enforcement component
of a Federal agency, this officer may also be the law enforcement
officer who maintains control and custody of the collected substances.
21 CFR 1317.65. There are no prohibitions against other persons
assisting law enforcement officers conduct the take-back event.
[6] Issue: One commenter asked the DEA to address what rights
Military
[[Page 53532]]
Provost Marshal Officers have with respect to collecting controlled
substances from ultimate users.
Response: Under Sec. 1317.35 of the new regulation, Federal law
enforcement may continue to conduct take-back events and mail-back
programs, and operate collection receptacles as further detailed in the
regulation. If the Office of the Provost Marshal is considered
``Federal law enforcement,'' it would be eligible to conduct such
collection activities. Federal law enforcement can, and in some cases
must, appoint a law enforcement officer to oversee those activities.
The appointed officer would then have the authority granted by his/her
agency.
[7] Issue: One commenter asked the DEA to clarify how law
enforcement may transport and deliver collected substances to a
destruction facility (i.e., whether they may ship such substances using
a common carrier) and how law enforcement can comply with Department of
Transportation (DOT) requirements when transporting substances that may
contain hazardous materials.
Response: The DEA has no expertise or authority to interpret or
apply the DOT laws, regulations, or guidelines regarding transportation
of pharmaceutical controlled substances that may constitute hazardous
materials. As such, interested persons are encouraged to contact the
DOT directly with their specific circumstances, and such persons can
obtain more information at www.phmsa.dot.gov/hazmat. However, the DEA
understands that the DOT's Hazardous Materials Regulations apply to
entities that place hazardous materials in commercial transportation,
and not government vehicles operated by government personnel solely for
non-commercial purposes. If more detailed guidance is necessary, the
DEA encourages law enforcement and other entities to consult the DOT
for guidance on transporting collected substances that may contain
hazardous materials. For additional commentary on hazardous material
disposal please see comment section ``Q.'' entitled ``Hazardous
Materials Transportation and Hazardous Waste Destruction.''
G. Collection Receptacle Design, Inner Liners, Placement, and Security
(24 Issues)
Clarification of Terms
[1] Issue: One commenter noted that the DEA interchangeably used
the terms ``container'' and ``shell'' when referring to the outer
collection receptacle.
Response: The DEA is modifying the final rule to consistently use
the term ``container'' when referring to the outer portion of
collection receptacles. This change is purely for stylistic consistency
and makes no substantive change to the rule.
Collection Receptacle Design
[2] Issue: The DEA specifically requested comments regarding the
value of the use of a uniform symbol to be placed on collection
receptacles. The DEA received 22 comments regarding the use of a
uniform symbol. Five commenters supported the use of a uniform symbol,
and 17 commenters opposed the use of a uniform symbol. One commenter
suggested that the symbol be yellow. Four commenters noted that the use
of such a symbol is unnecessary given the requirement to clearly mark
and label the receptacles. Three commenters expressed concern that the
use of such symbols would result in the receptacles becoming targets
for diversion. One commenter was not opposed to the use of a uniform
symbol but does not believe it is essential. One commenter indicated
that the use of a uniform symbol should be contingent upon the location
and security of the collection receptacle.
Response: The DEA appreciates all of the comments submitted in
response to this request. After careful consideration, the DEA declines
to include a uniform symbol requirement in this final rule. However,
the DEA may consider requiring a uniform symbol on collection
receptacles after a sufficient time to observe the effects of the
existing requirement to clearly mark and label collection receptacles.
[3] Issue: Eleven commenters stated that any signage indicating
what ultimate users may deposit into the collection receptacle should
be in plain language. These commenters noted that most ultimate users
cannot distinguish between controlled substances and non-controlled
substances. Other commenters stated that no sign should be required at
all, and others suggested the use of pictograms instead of words.
Others raised concerns that signage will draw attention to the
receptacles, thus increasing risk for theft and diversion.
Response: The final rule does not require any specific language,
design, or color choice for the display on the collection receptacle as
long as the sign indicates that only schedules II-V controlled
substances and non-controlled substances are acceptable. 21 CFR
1317.75. As explained above, comingling is permitted but not required.
21 CFR 1317.75. Plain language, pictograms, or a combination of the
two, may be used, as long as it is clear that schedule I controlled
substances, controlled substances not lawfully possessed by the
ultimate user, and illicit or dangerous substances are not permitted to
be placed in the container. The DEA believes that some notice regarding
what substances may be disposed in collection receptacles is necessary
in order to provide guidance to the public and to discourage the use of
receptacles for disposing trash or other items. While the diversion
risks presented by the requirement for signage is mitigated by physical
security requirements (e.g., that the receptacle be securely fastened
to a permanent structure), authorized collectors should be mindful that
the selected signage not transform the receptacle into a target for
theft or diversion.
[4] Issue: Four commenters suggested that the collection receptacle
sign encourage ultimate users to remove medication from its container
before placing the medication in the collection receptacle. Several of
the commenters who had participated in authorized pharmaceutical
controlled substance take-back programs noted that the packaging for
medication is voluminous, and that including such packaging will be
burdensome since it will necessitate changing inner liners more
frequently.
Response: The DEA appreciates these commenters' concerns. Although
collectors may encourage ultimate users to remove substances from their
containers before depositing them into a collection receptacle or mail-
back package, the DEA declines to require it. The DEA has declined to
mandate whether substances must be disposed of, with or without
packaging, because such requirements would not necessarily affect
security or increase the risks of diversion, and as such, should be
left to the individual collectors and other relevant authorities who
best know the needs and requirements of their programs and locations.
[5] Issue: Other commenters indicated that some hazardous waste
disposal regulations require the disposal of medication containers,
which may not fit into the receptacles.
Response: As discussed in the immediately preceding comment, the
DEA is neither requiring nor prohibiting medication containers to be
disposed of with pharmaceutical controlled substances. Moreover, there
is no indication that the vast majority of medications will not fit
into the ``small opening'' that the collection receptacles
specifications require. For additional commentary on hazardous waste
[[Page 53533]]
disposal please see comment section ``Q.'', entitled ``Hazardous
Materials Transportation and Hazardous Waste Destruction.''
[6] Issue: The DEA received comments that the inner liner should be
a large plastic tub or bucket within a receptacle that can be easily
removed and the collected items either dumped into smaller containers
or sorted before being secured into storage for disposal or prior to
destruction.
Response: The DEA carefully considered the specifications of both
the inner liner and the outer container of the collection receptacle.
To prevent diversion and protect the public health and safety, the DEA
drafted this rule with the precisely considered objective of limiting
the number of people who handle the collected substances. The DEA's
extensive experiences in regulating and enforcing the closed system of
distribution established by the CSA have demonstrated that a key factor
in reducing diversion risk is limiting the handling of controlled
substances. In the context of disposal, this means prohibiting the
sorting of collected substances once they are deposited into a
collection receptacle.
[7] Issue: One commenter stated that the collection receptacle
design specifications will require current collection programs for non-
controlled substances to install new collection receptacles if those
programs wish to additionally collect pharmaceutical controlled
substances. This commenter stated that such installations will be
burdensome and will discourage participation for these programs.
Response: The DEA deeply appreciates the concern and activism of
local communities and other groups currently conducting non-controlled
substance drug take-back programs and their wish to expand collection
activities to pharmaceutical controlled substances. Programs such as
these are an important and vital component of the communities they
serve. The DEA understands that publication of this final rule may
necessitate the need for some programs to implement new procedures and
install new equipment in order to additionally collect pharmaceutical
controlled substances. The DEA has not established the new requirements
lightly or without considerable deliberation as to its impacts on
existing programs. However, the risk of diversion for non-controlled
substances is relatively low compared to the much higher risk of
diversion, and the corresponding and associated risks to public health
and safety, for pharmaceutical controlled substances. The DEA has been
charged by Congress with the enforcement of the controlled substance
laws of the United States, and must ensure that pharmaceutical
controlled substances are properly secured and not easily susceptible
to theft or diversion. Accordingly, the collection receptacle design
specifications outlined in Sec. 1317.75 will be implemented as
proposed.
[8] Issue: A commenter asked the DEA to permit the use of similar
receptacles that may already exist and were designed for the deposit
and storage of medical waste.
Response: The DEA is not prohibiting the use of collection
receptacles that currently exist on the market as long as such
receptacles meet all of the design specifications outlined in Sec.
1317.75 of this rule.
[9] Issue: Five commenters stated that the requirement for a
collection receptacle to be fastened to a permanent structure is
burdensome. Several commenters pointed out that many pharmacies do not
own the property that is their DEA-registered location, and such
fixtures and installments are prohibited. One commenter pointed out
that this requirement would be particularly burdensome for small, rural
pharmacies. Another commenter asked if the requirement applies if the
collection receptacle is located in a locked room, inaccessible to the
public.
Response: The DEA appreciates the willingness of pharmacies to aid
in the societal goal of helping to combat unauthorized access to and
abuse of pharmaceutical controlled substances. The DEA understands that
there may be logistical concerns for some retail pharmacies that wish
to maintain a collection receptacle at their registered location.
However, the DEA believes that permanently-secured, fixed containers
are the minimum required to prevent diversion and theft of collected
substances. The requirement that collection receptacles be securely
fastened to a permanent structure applies to all authorized collectors'
collection receptacles, no matter the location of the registrant. 21
CFR 1317.75. Although the final rule does not expressly prohibit
collection receptacles from being placed in a locked room that is
inaccessible to the public, the final rule does mandate that collection
receptacles at authorized collectors' registered locations must be
accessible to ultimate users, and others authorized to dispose of
controlled substances on behalf of ultimate users, as they are the only
people who may deposit pharmaceutical controlled substances into a
collection receptacle (e.g., ultimate users cannot transfer
pharmaceutical controlled substances to pharmacy staff). 21 CFR
1317.30. The DEA encourages retail pharmacies leasing their commercial
space to work with their landlords to allow for the installation of
collection receptacles under the conditions established by this rule.
[10] Issue: Nine commenters stated that requiring an outer
container with an inner liner is unnecessary and burdensome. These
commenters proposed that the collection receptacle be designed in such
a way that it can be returned to the reverse distributor as a complete
unit.
Response: The DEA appreciates the value in utilizing temporarily
secured containers that can be sealed and shipped for destruction;
however, the DEA believes that such systems present an unreasonable
risk of diversion because, even when secured, such containers can be
relatively easily removed when compared to a securely fastened and
locked outer container. Relatedly, the DEA is requiring that collection
receptacles be ``substantially constructed,'' which is intended to
ensure that the construction is such that unauthorized access to the
contents of the receptacle is not easily obtained. 21 CFR 1317.75.
Accordingly, the DEA is requiring that collection receptacles have a
substantially-constructed outer container and removable inner liners.
21 CFR 1317.60 and 1317.75.
[11] Issue: Three commenters stated that the collection receptacle
should not be required to have a traditional lock, but that its opening
be designed so that that the contents cannot be removed.
Response: In implementing the Disposal Act to provide secure and
responsible disposal methods for pharmaceutical controlled substances
by ultimate users, the DEA must ensure that collected substances are
properly secured and not easily susceptible to theft or diversion. The
requirements pertaining to collection receptacles were carefully
considered and designed to limit the handling of the controlled
substances, from ultimate user to destruction. These considerations
dictated the size of the opening. However, the NPRM and the final rule
allow for flexibility regarding a traditional lock, and require that
``the small opening in the outer container of the collection receptacle
shall be locked or made otherwise inaccessible to the public when an
employee is not present (e.g., when the pharmacy is closed).'' 21 CFR
1317.75(f).
[12] Issue: One commenter suggested that the DEA conduct a national
pilot program prior to implementation of the final rule to ensure that
collection
[[Page 53534]]
receptacle requirements are feasible and effective.
Response: The DEA believes that the need to implement this rule in
order to allow secure convenient options for disposal outweighs the
delay and limited benefit that may be obtained by implementing any
pilot programs or other testing or research. Through various outreach
efforts, including the public meeting the DEA held in January 2011,
comments from industry, and information obtained from pilot programs,
the DEA believes that it has effectively researched and analyzed the
various aspects of this rule. Also, the DEA believes that
implementation of this rule is important to helping reduce the amount
of unwanted pharmaceutical controlled substances available for theft,
diversion, and accidental ingestion.
[13] Issue: One commenter asked the DEA to allow a Special Agent in
Charge (SAC) to approve container and inner liner designs.
Response: As discussed in the NPRM, the DEA determined that the
elimination of individual SAC approval for various aspects of disposal
or destruction is necessary in order to ensure clear and consistent
requirements throughout the United States, thus reducing the potential
for confusion regarding requirements for ultimate users and authorized
collectors. Specific approval of individual collection receptacles and
inner liner designs is not required. All collection receptacles and
inner liner designs must meet the specifications outlined in this final
rule. 21 CFR 1317.60 and 1317.75.
[14] Issue: One commenter suggested that national pharmacy
organizations educate the public on proper disposal methods and various
disposal options. This commenter suggested that such organizations post
information online and disseminate leaflets at retail establishments.
Response: With regard to patient information regarding disposal,
the DEA is not requiring any entity to educate the public on proper
disposal methods and their various disposal options. However, the DEA
anticipates that many entities will voluntarily choose to do so. The
DEA applauds and encourages voluntary, educational outreach to the
public on issues related to the abuse potential and proper disposal of
pharmaceutical controlled substances, whether it be through law
enforcement, community groups, or professional organizations.
Collection Receptacle Inner Liners
[15] Issue: Several commenters asked for clarification regarding
inner liner tracking requirements. Specifically, commenters asked how
unique identification numbers should be assigned, how tracking systems
are to be implemented, and what entity will be responsible for placing
identification numbers on inner liners. One commenter suggested that
the DEA regulate the manufacture of inner liners or require that inner
liners be sequentially numbered.
Response: The rule outlines the design requirements and the
recordkeeping requirements for inner liners. The purpose of a unique
identification number is to provide for complete and accurate records
that can be inventoried to ensure that each liner is accounted for from
receipt, to installation, removal, storage, transfer, and destruction.
21 CFR part 1304. The unique identification numbers therefore must be
unique to the individual collector. 21 CFR 1317.60. The DEA does not
intend to require any particular method for assigning such numbers and
is modifying the text of proposed Sec. 1317.60(e) by indicating that
only inner liners must bear a permanent, unique identification number.
The company manufacturing the inner liners may assign the numbers. The
DEA does not have authority to directly regulate the manufacturers of
the inner liners.
[16] Issue: One commenter suggested that the inner liner be clear
so that it can be visually inspected for non-compliant items.
Response: Due to associated increased risks for diversion, the DEA
determined that the contents of the inner liners must not be viewable
once the inner liner is sealed. 21 CFR 1317.60. The DEA appreciates the
concerns regarding certain non-compliant items being placed in
collection receptacles; however, for reasons discussed in previous
comments, no one is permitted to handle the contents of inner liners.
21 CFR 1317.75. The DEA would like to point out that the text of the
rule does not prohibit items from being observed prior to being placed
in the collection receptacle, which could be an effective way to ensure
that such non-compliant items are not placed in the collection
receptacle.
[17] Issue: Several commenters indicated that the requirement to
store sealed inner liners in the same manner as schedule II controlled
substances will be overly burdensome and will reduce the amount of
space available for storing schedule II inventory at retail pharmacies.
These commenters suggested that the DEA allow the authorized collector
to transfer collected substances in inner liners to a secure warehouse
facility for storage until they can be picked up or shipped.
Response: The DEA appreciates these concerns but declines to permit
authorized collectors to transfer collected substances to warehouse
facilities for storage. Filled inner liners must be stored only at
primary registered locations (and at LTCFs in accordance with Sec.
1317.80(c)) and may not be transported to off-site warehouses. The
basis for this requirement is that the risk of diversion increases each
time inner liners change hands or are transported. However, as
previously discussed, this final rule expands the NPRM requirement and
authorizes practitioners to store collected substances at their
registered location in either a securely locked, substantially
constructed cabinet or a securely locked room with controlled access.
21 CFR 1317.05.
[18] Issue: Four commenters stated that the DEA should permit
schedule I controlled substances to be disposed of via collection
receptacles, mail-back packages, or take-back events.
Response: The Disposal Act addresses the issue of unused
prescription drugs, and it allows the DEA to provide ultimate users
with a secure and responsible method to dispose of pharmaceutical
controlled substances. This rule does not address the disposal of
illicit controlled substances, e.g., those substances controlled in
schedule I of the CSA. Schedule I controlled substances, by definition,
have no accepted medical use in treatment in the United States, and may
not be lawfully prescribed or otherwise distributed to any person. In
fact, any transfer of a schedule I controlled substance by an ultimate
user is a violation of the CSA, unless the ultimate user is
participating in an investigational use of drugs pursuant to 21 U.S.C.
355(i) and 360b(j), and the delivery is conducted in accordance with 21
CFR 1317.85.
Collection Receptacle Placement and Safety
[19] Issue: Ten commenters expressed concern regarding security in
retail pharmacies with collection receptacles. Several commenters asked
the DEA to provide guidance for proper security measures. One commenter
asked for clarification on an authorized collector's liability should a
receptacle become subject to diversion or if improper substances are
deposited.
Response: The DEA appreciates the concerns of the commenters and
has carefully considered the risks and benefits associated with
collection receptacles located in authorized retail pharmacies. The
DEA's rationale for
[[Page 53535]]
allowing collection at authorized retail pharmacies was described in
the NPRM. As previously noted, the DEA is not requiring any pharmacy to
provide a collection receptacle. Each registrant is free to weigh the
risks and benefits in determining whether or not to seek status as an
authorized collector. The DEA proposed the rule with the security
requirement for permanently-secured, fixed containers based on a
determination that this was the minimum required to help reduce the
risk of diversion and theft of pharmaceutical controlled substances. 21
CFR 1317.75. At retail pharmacies, the location of collection
receptacles within the immediate proximity of a designated area where
controlled substances are stored and at which an employee is present is
anticipated to provide an additional layer of security due to the
increased visibility of the receptacles. 21 CFR 1317.75. While
potential violations of the CSA and its implementing regulations are
investigated and assessed independently, this final rule imposes the
minimum required procedures to prevent and detect diversion. Even so,
each authorized collector's circumstances are unique. All registrants
should be mindful of their responsibility to provide effective controls
and procedures to guard against theft and diversion under 21 CFR
1301.71(a), and their duty to report thefts and significant losses of
controlled substances under 21 CFR 1301.74 and 1301.76.
[20] Issue: One commenter suggested that the inner liners be
nondescript and free of any markings that would indicate their
contents. This commenter was concerned that any markings on the inner
liners would increase diversion risks and make them potential targets
for drug seekers.
Response: The DEA appreciates the commenter's concern for potential
diversion risks that inner liners might pose, and made the
determination to require them only after careful consideration of the
associated risks and benefits of their use, and alternatives to their
use. The DEA is requiring the size of the inner liner to be clearly
marked on the outside of the liner, and for the inner liner to bear a
unique identification number in order to help ensure accountability,
and to identify and prevent diversion. 21 CFR 1317.60. Given the
totality of information reviewed, the DEA concluded that a requirement
for the contents to be non-viewable once the inner liner is sealed will
help reduce diversion risks and deter drug seekers.
[21] Issue: One commenter stated that requiring contents of the
inner liner to be non-viewable could lead to diversion as staff could
record controlled substances as being disposed of without actually
placing them into the receptacle.
Response: The rule prohibits authorized collectors' staff from
handling collected substances, even for the purpose of depositing them
into the collection receptacle. Ultimate users, and those who are
authorized to handle controlled substances on behalf of ultimate users
for the purpose of disposal, are the only persons who may deposit
pharmaceutical controlled substances into a collection receptacle. 21
CFR 1317.30. Therefore, the DEA does not envision a circumstance where
pharmaceutical controlled substances might be recorded as having been
disposed of, but were in actuality diverted as a result of pharmacy
staff never having placed the substances into the collection
receptacle.
[22] Issue: One commenter indicated that the use of an inner liner
that is removable and sealable immediately upon removal without
emptying or touching the contents is impractical because the contents
may spill or fall out and then must be handled.
Response: The DEA carefully considered the design and security
requirements for inner liners and determined that the collection
receptacle option will help to minimize the risk of diversion while
ensuring safety and convenience for ultimate users and collectors. As
discussed in the NPRM, inner liners that allow opportunities for
collectors to sort or otherwise handle the collected substances would
decrease security and increase the risk of diversion. The DEA does not
believe that overfill or spillage from the inner liners will be a
concern as the requirement that inner liners fit within the outer
container of the collection receptacle is designed to prevent such
occurrences. However, security requirements, such as the presence of
two employees to remove or supervise the removal of an inner liner,
help reduce the risk of theft and diversion if such instances do occur.
21 CFR 1304.22, 1317.60, and 1317.75. If spillage occurs, a
registrant's responsibility to provide effective controls and
procedures to guard against theft and diversion of controlled
substances would require the registrant to take corrective action to
prevent spillage from recurring.
[23] Issue: Several commenters asked the DEA to identify the
maximum allowable capacity for a receptacle and the maximum duration
that controlled substances may be stored in the receptacle.
Response: There is no maximum or minimum capacity for collection
receptacles at this time. Although there is no maximum duration that
the collected substances may remain in the collection receptacle at
this time, authorized collectors are reminded of their responsibility
to provide effective controls and procedures to guard against theft and
diversion, 21 CFR 1301.71(a), and their duty to report thefts and
significant losses of controlled substances under 21 CFR 1301.74 and
1301.76.
[24] Issue: Several commenters asked the DEA to allow ``disposal
companies,'' distributors, and reverse distributors to manage and
maintain collection receptacles at the registered locations of
authorized collector retail pharmacies and at LTCFs on behalf of the
authorized collector retail pharmacies. These commenters also asked if
such entities may establish a fee system for such services.
Response: Distributors and reverse distributors will not be
permitted to manage or maintain collection receptacles at retail
pharmacies or LTCFs. 21 CFR 1317.40 and 1317.80. The DEA determined
that no entities other than retail pharmacies and hospitals/clinics
with an on-site pharmacy will be permitted to manage collection
receptacles at LTCFs. 21 CFR 1317.40 and 1317.80. As discussed in the
NPRM, this rule establishes a checked system of transfers where each
registrant who handles collected substances serves as a source of
verification for the other registrants that handle the same substances,
thus ensuring that the collected substances reach their intended
destination with accountability and a reduced risk of diversion. In
order to maintain this system, all collected substances must be handled
in the manner described in this rule, including the requirement that
the handling of a collection receptacle inner liner be restricted to
employees of the authorized collector as provided, with the limited
exception for LTCFs. 21 CFR 1317.80. Such requirements ensure that
persons handling collected substances during the disposal process are
accountable to their employer, and the number of entities handling the
collected substances is reduced while also providing a secure system of
checks that increases the level of accountability.
H. Mail-Back Programs (11 Issues)
[1] Issue: Thirteen commenters stated that the on-site destruction
requirement for mail-back programs is severely
[[Page 53536]]
limiting due to the limited number of commercial incinerators. These
commenters urged the DEA to allow collectors to receive mail-back
packages whether or not they have a means of on-site destruction.
Several commenters also asked the DEA to allow collectors to use a
third party to destroy mail-back packages.
Response: As discussed in the NPRM, an on-site method of
destruction for mail-back packages is the minimum necessary to prevent
diversion of controlled substances destined for destruction. 21 CFR
1317.05. Importantly, an on-site method of destruction reduces the
accumulation of controlled substances in a single location, and
minimizes the transfer of controlled substances between various
locations. This is intended to help minimize the risk of diversion. For
each of the three methods of ultimate user disposal included in this
rule, the DEA has attempted to minimize the number of entities that
handle the collected substances in order to minimize the risk of
diversion, which increases each time a controlled substance is
transferred to a new person. It is emphasized that authorized
collectors may partner with reverse distributors and other authorized
registrants with on-site methods of destruction to promote mail-back
programs, e.g., empty mail-back packages may be disseminated at
hospitals/clinics and retail pharmacies and mailed back to a reverse
distributor with an on-site method of destruction.
[2] Issue: One commenter strongly supports the requirement that
authorized collectors who conduct a mail-back program use an on-site
method of destruction; however, other commenters expressed concern that
the requirement would discourage authorized collectors from conducting
mail-back programs. Several commenters noted that very few destruction
facilities currently exist and there was concern that such facilities
do not have proper security to handle controlled substances.
Response: As indicated in the previous response, mail-back programs
have the potential to provide a secure and responsible means of
disposal without geographical restriction within the United States. As
such, the existence of a small number of appropriate destruction sites
should not impact ultimate users' ability to participate or the
potential for mail-back programs to develop. In other words, a single
destruction site can support many different mail-back programs and an
unlimited number of mail-back packages may be provided to ultimate
users at various locations throughout the United States to be mailed
back to a single destruction site. Also, as discussed in the NPRM, the
DEA hopes that the rule will encourage innovation and expansion of
destruction methods beyond incineration so that additional entities may
provide destruction services for mail-back programs in the future.
[3] Issue: A few commenters expressed concern that no entities will
undertake the implementation of a mail-back program because of the
related expense, noting that the requirement that mail-back packages be
pre-addressed with pre-paid postage will be very costly. A commenter
also asked the DEA to clarify whether unregistered retail pharmacies
working with a registered authorized collector would be permitted to
make mail-back packages available to patients.
Response: As discussed in the NPRM, authorized collectors who
conduct mail-back programs are encouraged to collaborate to operate
mail-back programs by partnering with other entities to assist with the
dissemination of mail-back packages to ultimate users, in order to
minimize costs. Additionally, pre-paid postage will ensure that the
package is not returned to sender, which will help reduce its handling
and therefore, the diversion risks. Pre-addressed envelopes will help
ensure that the package is delivered to the authorized location.
[4] Issue: One commenter asked the DEA to clarify whether there are
specific testing requirements in regard to the packaging standards
(e.g., water/spill proof, tear resistant, sealable, etc.). One
commenter asked the DEA to clarify the distinction between packages
damaged as part of normal transport and packages damaged by other
means, such as tampering.
Response: The DEA is not requiring specific testing requirements to
ensure packages meet the standards provided in Sec. 1317.70 (e.g.,
water/spill proof, tear resistant, sealable, etc.). However, the
packages must be consistent with these standards. Collectors authorized
to receive mail-back packages must make a determination based on the
facts and circumstances as to whether or not an apparently damaged
package became so through normal transportation or through tampering or
other intentional means.
[5] Issue: Commenters expressed concern that the requirement for
mail-back collectors to issue mail-back packages with unique
identification numbers is burdensome and does not seem to provide any
useful information since ultimate users are not required to notify
collectors that they have mailed a package, and it is likely that many
packages will not be used. Five commenters asked the DEA to explicitly
state that authorized collectors who conduct mail-back programs will
not be responsible for reconciling mail-back packages that were never
returned.
Response: The DEA believes that recording the unique identification
numbers of mail-back packages in accordance with Sec. 1317.70 is a
reasonable recordkeeping requirement designed to help identify and
prevent diversion; this information can aid investigations and is
useful for that purpose alone. The DEA recognizes that disseminated
packages may go unused, and this alone should not form the basis for
unreasonable scrutiny of authorized collectors. Additionally, at this
time, authorized collectors are not responsible for tracking mail-back
packages that were disseminated but never returned.
[6] Issue: One commenter disagreed with the DEA's assessment that
mail-back programs are more susceptible to diversion and therefore
require stricter controls.
Response: The DEA carefully considered the diversion risks in mail-
back programs. Based on the DEA's experience, the DEA believes that the
risks of diversion associated with mail-back programs are great because
of necessary actions including the handling of the packages, mail
sorting, and mail delivery by non-registrants. The DEA believes that
the security measures established by this rule are the minimum required
to reduce the risk of diversion inherent to mail-back programs.
[7] Issue: One commenter expressed concern that mail-back packages
would be subject to greater risks of diversion in rural areas.
Response: The DEA appreciates the commenter's concern. The DEA has
considered the diversion risks for mail-back programs, including
packages originating in rural areas. It may be true that mail-back
packages originating in some rural areas may be subject to an increased
risk of diversion due to fewer people being able to readily witness
theft from a mailbox. However, it may also be true that risks of
diversion from mail-back programs might be lower in rural areas due to
less traffic (pedestrian, vehicular, or equine), resulting in fewer
opportunities for tampering with or theft of mail-back packages.
Regardless, the DEA believes that the relative risks of diversion of
mail-back packages in rural areas are mitigated by the required
security procedures and are outweighed by the benefits of providing
ultimate users a means to dispose of unused, unwanted,
[[Page 53537]]
or expired pharmaceutical controlled substances.
[8] Issue: The United States Postal Service (USPS) has raised a
number of issues relating specifically to the mail-back program, and
also to the disposal regulations in general. The USPS asked the DEA to
make several changes to the terminology used in the proposed rule, so
that the DEA regulations will be consistent with standard USPS products
and services. The USPS also requested that the DEA clarify that all
registrants must comply with USPS laws and regulations, including
applicable USPS requirements for packaging and mailing pharmaceuticals.
The USPS asked the DEA to consistently refer to ``mail-back
packages'' as ``mailing packages'' rather than ``mailers'' as the USPS
refers to ``mailers'' as persons or entities entering a mailing. The
USPS also asked the DEA to remove any references to ``business reply
mail'' that are inconsistent with the USPS's use of the term. The USPS
asked that proposed Sec. 1317.85 specify that ultimate users may
return recalled controlled substances to the manufacturer or other
authorized registrant by U.S. Mail. The USPS also asked the DEA to
clarify that inner liners are requirements for collection receptacles--
not mail-back packages.
The USPS also requested that the DEA state that collectors
operating a mail-back program must exclusively use the United States
Postal Service. The USPS also asked the DEA to make all references to
``mail system'' in the preamble refer exclusively to the United States
Postal Service. The USPS asked that they not be prohibited from
transporting controlled substances to a reverse distributor on behalf
of law enforcement, especially in light of the fact that law
enforcement may operate mail-back programs.
Response: The DEA appreciates the time taken by the USPS to review
the proposed rule and submit thoughtful comments with their concerns
and suggestions. In addition, the DEA acknowledges that the USPS
understands these regulations and has experience responsibly handling
controlled substances. The DEA is modifying some of the terminology
that was used in the NPRM, per the USPS's concerns and suggestions.
Rather than use the term ``mailing packages,'' all references to
``mailers'' are changed to ``mail-back packages.'' The DEA believes
this will better avoid the confusion regarding ``mailers'' being
defined as persons or entities that enter a ``mailing.'' The reference
to ``business reply mail'' is also removed. The DEA declines to specify
that ``mail'' or ``mail system'' refers exclusively to the USPS;
however, the USPS is a shipping option.
Additionally, in Sec. 1317.85, ultimate users still have the
options to return a recalled controlled substance as is currently
allowed under Sec. 1307.12 of the existing regulations. The text of
the rule clearly states that all persons and entities must comply with
applicable Federal laws and regulations, which includes USPS laws and
regulations. Also, inner liners are requirements for collection
receptacles--not mail-back packages. The mail-back package
specifications are outlined in Sec. 1317.70.
While the USPS asked that the text of the regulation specifically
state that mail-back packages may be sent via the U.S. Postal Service
as well as by common or contract carrier, the DEA declines to make this
change. The DEA considers the USPS to be a common or contract carrier
for purposes of the CSA.
[9] Issue: One commenter asked the DEA to clarify whether the
regulation that requires mail-back programs to include only mail-back
packages mailed from within the United States will preclude USPS-
serviced mail-back programs in any of the areas in which it operates
(e.g., the Caribbean District, other territories such as Guam, and
United States military installations).
Response: The term ``import'' means ``any bringing in or
introduction of'' a controlled substance into any area. Pursuant to 21
U.S.C. 952, it is unlawful to import controlled substances into the
customs territory of the United States (the 50 States, the District of
Columbia, and Puerto Rico), except under specific circumstances not
relevant to ultimate user disposal. Thus, an ultimate user located
outside of the customs territory of the United States is not permitted
to send a mail-back package into the customs territory of the United
States.
[10] Issue: One commenter asked the DEA to clarify whether
authorized collectors operating mail-back programs may use carrier
services that allow packages to be held at a carrier facility until the
packages can be picked up.
Response: Although some changes to business operations may need to
occur in order for an authorized collector to effectively establish and
maintain a mail-back program, the requirements established by this rule
are the minimum required to detect and prevent diversion. As described
in this rule, mail-back packages must be pre-addressed to the
authorized mail-back location with the on-site destruction method, and
thus, the packages must be delivered to the authorized mail-back
location rather than picked up by the collector. 21 CFR 1317.70. The
pre-addressed delivery location must be capable of receiving such
deliveries on a regular basis without interruption. Otherwise, the
opportunities for diversion increase as the packages are delayed or
stored during transit.
[11] Issue: One commenter suggested that the DEA establish a
national mail-back program.
Response: This rule authorizes certain collectors to conduct mail-
back programs. 21 CFR 1317.40 and 1317.70. There is no limitation
regarding the geographic coverage of mail-back programs within the
United States if the programs comply with all applicable Federal,
State, tribal, and local laws and regulations. At this time, the DEA
does not have the resources to operate a national mail-back program.
I. Take-Back Events (6 Issues)
[1] Issue: One commenter indicated it would be difficult for
ultimate users to participate in take-back events, particularly in
rural areas.
Response: The DEA has attempted to expand the variety of disposal
options while also ensuring secure and responsible drug disposal, and
the DEA anticipates that the expansion to include certain hospitals/
clinics to become authorized as collectors will provide more disposal
options for ultimate users, including those in rural areas.
Additionally, the DEA encourages those persons living in rural areas
who are unable to utilize a collection receptacle or attend a take-back
event to dispose of unwanted pharmaceutical controlled substances in
the same manner in which the pharmaceutical controlled substances were
received, i.e., if the substances were delivered by a mail-order
pharmacy, the DEA encourages the pharmacy to include a mail-back
package for safe disposal; or, if the substances were dispensed at a
pharmacy, the DEA encourages pharmacies to have a collection receptacle
available for safe disposal. Nonetheless, the DEA recognizes that some
ultimate users may not have convenient access to any of the disposal
options available in this rule. Until the availability of these
disposal options increases, ultimate users who wish to dispose of
unwanted pharmaceutical controlled substances may continue to dispose
of them in manners consistent with all applicable Federal, State,
tribal, and local laws and regulations. The DEA's Office of Diversion
Control Web site provides information regarding safe disposal of
pharmaceutical controlled substances, including guidance from the FDA
and the EPA. Ultimate users can find this information at
www.DEAdiversion.usdoj.gov.
[[Page 53538]]
[2] Issue: Several people asked the DEA to clarify the role of law
enforcement at take-back events. One commenter asked the DEA to relax
the two-employee requirement for law enforcement officers handling
collected substances. Another commenter stated that law enforcement
officer supervision, rather than direct participation, should suffice.
Response: Law enforcement must appoint at least one law enforcement
officer employed by the agency to oversee collection at the take-back
event. 21 CFR 1317.65. ``Oversee'' has its common, everyday meaning: To
supervise, manage, watch over, and direct in an official capacity. The
direct participation this rule mandates is that a law enforcement
officer must maintain custody and control of the collected substances
from the time they are collected to the point in time that they are
securely transferred, stored, or destroyed. 21 CFR 1317.65. This rule
does not require two law enforcement officers to be present at take-
back events; however, law enforcement may determine that two or more
law enforcement officers are necessary at a particular take-back event
due to safety and security concerns. In the alternative, law
enforcement may determine that the same law enforcement officer may
oversee the take back event and also maintain custody and control of
the collected substances from the time the substances are collected
from the ultimate user or person authorized to dispose of the ultimate
user decedent's property until secure transfer, storage, or destruction
has occurred, as outlined in Sec. 1317.65(b). Although the
participation of law enforcement is required at take-back events, the
DEA is not requiring law enforcement to hold or participate in take-
back events. As discussed in the NPRM, law enforcement must determine
how often available resources allow them to hold take-back events.
[3] Issue: A few commenters requested that the DEA allow other
authorized collectors, such as retail pharmacies and reverse
distributors, to become authorized to hold take-back events. One
commenter stated that law enforcement officers' presence should be
optional if there is a collection receptacle at the event that meets
the specifications in the rule.
Response: If an authorized collector or other entity wishes to
conduct a take-back event, the event must be held in partnership with
law enforcement. 21 CFR 1317.65. Take-back events are intended to be
limited-duration events that may take place at an unsecure location
that is easily accessible to the public, such as a community center or
town center. Given the likelihood of publicity and limited physical
security at such locations, the DEA believes that it is important to
ensure active law enforcement participation for the safety of the event
participants and the community. The DEA believes that active law
enforcement participation will help deter theft and reduce diversion
risks. The presence of a collection receptacle at a take-back event
does not preclude the need for law enforcement presence at the
collection site because the publicity for the event increases the
receptacle's visibility for drug seekers, thus increasing diversion
risks.
[4] Issue: A number of entities expressed concern that the
implementation of this rule will result in the cessation of DEA-
sponsored national take-back events. These commenters felt that take-
back events will be too costly for communities and law enforcement, and
commenters suggested that the DEA continue take-back events and provide
a transition plan from the national take-back events until
implementation of the rule.
Response: The DEA-sponsored national take-back events were
initiated as a means of providing safe and convenient disposal of
pharmaceutical controlled substances by ultimate users until
alternative options could be implemented. The DEA is committed to
continuing national take-back events until the effective date of this
final rule. The DEA believes that implementation of disposal methods is
best tailored to local communities by local communities. The DEA
encourages public and private partnerships to optimize the expanded
disposal options in a cost-efficient manner.
[5] Issue: One commenter expressed concern that existing take-back
events would likely be unable to continue under this rule. This
commenter was concerned that the prohibition of sorting would cause a
burden since non-controlled substances and packaging could not be
sorted from controlled substances. This commenter stated that it will
be overly burdensome for programs to handle all collected substances as
schedule II controlled substances.
Response: The DEA does not intend for this rule to require changes
to existing non-controlled substance take-back programs. The security
measures required by this rule are the minimum necessary to ensure a
safe and secure means of disposal of pharmaceutical controlled
substances. It should be noted however, that law enforcement are not
required to follow the physical security requirements for handling,
sorting, or storing collected controlled substances. 21 CFR 1317.35.
The physical security requirements applicable to law enforcement in the
final rule at Sec. Sec. 1317.35 and 1317.65 state that law enforcement
``should'' take certain measures; and that law enforcement ``shall''
appoint a law enforcement officer to oversee a take-back event and law
enforcement officers ``shall'' maintain custody and control of the
collected substances. Additionally, this rule provides a number of
previously unavailable means of ultimate user disposal that are likely
to decrease the frequency of and need for community take-back events.
The DEA would like to clarify that comingling of controlled and non-
controlled substances is permitted, but not required, and co-sponsors
of take-back events may specify that only controlled substances will be
accepted. Another method to alleviate the burdens would be to provide a
separate receptacle for non-controlled substances at the take-back
event. Additionally, as discussed in response to previous comments,
this rule does not require that collected substances be in their
original packaging, and law enforcement may discourage or prohibit
ultimate users from disposing of original packaging into the collection
receptacle for controlled substances at take back-events.
[6] Issue: One commenter indicated that municipalities and other
organizations should be permitted to ``take the lead'' in organizing
and conducting take-back events in conjunction with, and in the
presence of, law enforcement. Other commenters raised concerns that
such events conducted in partnership with local government and
community groups would no longer be allowed, and that the requirements
would prevent controlled substance take-back events from being held
concurrently with other take-back events, such as for the disposal of
hazardous waste and non-controlled substances.
Response: The rule permits any entity to partner with law
enforcement to hold a pharmaceutical controlled substances take-back
event. 21 CFR 1317.65(a). Municipalities or other organizations may
partner with law enforcement as long as such events are conducted in
accordance with all applicable laws and regulations pertaining to the
disposal of pharmaceutical controlled substances. The DEA emphasizes
that take-back events are intended to be one-time or periodic events
held in a community center or other convenient and accessible location,
and that there is no
[[Page 53539]]
prohibition against holding such events in conjunction with events for
the disposal of other substances, such as hazardous waste or non-
controlled pharmaceuticals.
J. Prohibition on Handling, Sorting, and Inventorying Inner Liner
Contents and Mail-Back Package Contents (8 Issues)
[1] Issue: One commenter adamantly stated that collected substances
should not be sorted under any circumstances. This commenter expressed
concerns about diversion risks and the brokering of unused controlled
substances.
Response: The DEA agrees that the diversion risks of handling,
sorting, or inventorying collected substances outweigh any perceived
benefits. The DEA has carefully considered all of the various
commenters' concerns on the prohibition of handling, sorting, and
inventorying inner liner contents and mail-back package contents, and
will retain these prohibitions. As provided in Sec. Sec. 1317.60(c)
and 1317.70(f), inner liners shall be sealed immediately upon removal
from the permanent outer container; sealed inner liners and returned
mail-back packages shall not be opened, x-rayed, analyzed, or otherwise
penetrated. Accordingly, their contents shall not be sorted or
inventoried subsequent to being placed into a collection receptacle or
mail-back package. To clarify this, Sec. 1317.75(c) was modified to
add the prohibition against individually handling substances after they
have been deposited into a collection receptacle. These specific
security measures are designed to help prevent and reduce the
opportunities for diversion (including the re-introduction of tainted
pharmaceutical controlled substances into the stream of commerce).
[2] Issue: Twenty-four commenters stated that pharmacists and
other volunteers should be permitted to sort collected substances,
particularly in the presence of law enforcement officers at take-back
events. One commenter stated that the DEA should recognize the
accountability, expertise, and experience of healthcare professionals,
and the DEA should utilize these experts in an effort to broaden
medication disposal efforts.
Response: The DEA appreciates the valuable expertise and experience
of healthcare professionals, including pharmacists. The DEA has
carefully considered the comments in response to the NPRM, and the
remarks at the January 2011 public meeting. The DEA believes that the
disposal methods outlined in this rule will provide ultimate users and
their authorized representatives with expanded options to safely and
securely dispose of unwanted, unused, and expired pharmaceutical
controlled substances. Pursuant to Sec. 1317.65, law enforcement may
continue to conduct take-back events when a law enforcement officer
maintains control and custody of collected substances at take-back
events and only the ultimate user transfers controlled substances to
law enforcement control and custody. However, non-law enforcement
personnel may assist the law enforcement officer, and the final rule
does not prohibit healthcare professionals from voluntarily polling
ultimate users about the substances they are discarding or from
assisting ultimate users to separate pharmaceutical controlled
substances from non-controlled substances during the disposal process,
and inventorying the non-controlled substances.
Furthermore, nothing in this rule prohibits law enforcement from
partnering with authorized collectors or other entities to inventory or
sort substances that have been collected by law enforcement provided
that the collected substances remain under the control and custody of
law enforcement. This final rule in Sec. 1317.65(b) requires that law
enforcement maintain control and custody of the collected substances
from the time the substances are collected until secure transfer,
storage, and destruction has occurred. Therefore, if law enforcement
opts to inventory or sort collected substances within their possession,
law enforcement should provide adequate security to prevent diversion
or theft of controlled substances within their possession and control
as a result of, or during, inventorying or sorting.
[3] Issue: Thirty-eight commenters stated that the DEA should
permit collectors or certain non-registered persons to handle, sort,
and inventory collected substances for data collection and research
purposes. Many of these commenters urged the DEA to provide an
exception to allow pharmacists and volunteers to inventory and sort
controlled substances under the supervision of law enforcement
officers. Numerous commenters stated that inventorying collected
substances is crucial to determining a root cause analysis of
medication waste. Others stated that such information could help guide
prescribing practices and be used in educational settings. Several
commenters stated that inventorying collected substances is necessary
to determine outcome measures for grants for disposal programs. Also,
several commenters stated that the DEA should provide an exception for
Institutional Review Board-approved research projects.
Response: The DEA understands and appreciates these comments. As
discussed in the preceding response, law enforcement has the discretion
to partner with other entities to conduct a take-back event pursuant to
Sec. 1317.65(a). There are no restrictions on how law enforcement
handles the collected substances so long as they maintain control and
custody of the substance. Accordingly, law enforcement may inventory
and sort substances that law enforcement collects. The diversion-
related concerns present when authorized registrants collect controlled
substances from ultimate users is not present when law enforcement
collects substances from ultimate users. Taking into account the
totality of the various risks and benefits, the DEA believes that this
final rule imposes the minimum necessary controls to allow a secure and
responsible means by which ultimate users can dispose of pharmaceutical
controlled substances. Relying on its experience, and as discussed in
the NPRM, the DEA finds that any potential benefits of allowing
authorized collectors or unregistered persons to independently
inventory or sort controlled substances after receipt from the ultimate
user do not outweigh the risks of diversion, except when the controlled
substances remain in the control and custody of law enforcement, as
mentioned in the previous response.
Data collection is not impossible under the rule even though
collected substances cannot be sorted or inventoried after they have
been deposited into a collection receptacle or received by a collector
through a mail-back package (unless the collection is conducted by law
enforcement and the substances are within the custody and control of
law enforcement). For example, authorized collectors may seek
information voluntarily from ultimate users regarding the substances
the ultimate user is disposing. And, data such as the weight of the
inner liners, the number of ultimate users attending a take-back event,
and the number of mail-back packages received in relation to the number
of packages disseminated, can be useful measures. The rule only
prohibits authorized collectors from physically handling the
substances, such as taking the substances from the ultimate user, or
sorting substances after the ultimate user has deposited them into a
receptacle or mail-back package. 21 CFR 1317.70 and 1317.75.
[4] Issue: Twenty-two commenters stated that contents should be
sorted to ensure adequate storage space. Several
[[Page 53540]]
commenters stated that packaging and pill bottles should be sorted
since they are voluminous. Other commenters stated that non-controlled
substances should be sorted from controlled substances.
Response: Pursuant to Sec. Sec. 1317.70(b) and 1317.75(b),
comingling of controlled and non-controlled substances is permitted,
but it is not required. In addition, this rule does not require
pharmaceutical controlled substances collected from ultimate users to
be collected and stored in the original packaging, and collectors may
institute procedures to prevent inadvertently collecting packaging.
Authorized collectors may address adequacy of space issues by choosing
not to collect comingled pharmaceutical controlled substances and non-
controlled substances, refusing to accept the original controlled
substance packaging, or by increasing destruction frequencies. In
addition, the DEA has expanded the available storage options for
practitioners in this final rule by allowing practitioners to store
sealed inner liners and returned mail-back packages in a securely
locked room with controlled access. 21 CFR 1317.05.
[5] Issue: A commenter noted that authorized collectors should
have direct supervision over the substances that are placed into
collection receptacles to prevent undesirable materials from being
deposited into collection receptacles.
Response: Each potential authorized collector must weigh all of the
potential risks and benefits in deciding whether to implement and
manage any ultimate user disposal program, including any necessary
steps to prevent the unwanted collection of regulated hazardous waste
or otherwise undesirable materials, in a manner consistent with this
rule and all other applicable Federal, State, tribal, and local laws
and regulations. Authorized collectors may view what ultimate users
deposit into collection receptacles, and they may ask what substances
are being deposited. Although the actual disposal of a pharmaceutical
controlled substance into a collection receptacle must be performed by
an ultimate user in accordance with Sec. 1317.30, the authorized
collector maintains ultimate control over that receptacle and should
institute necessary measures to protect against the collection of
unwanted substances so long as such measures are consistent with this
rule and all other applicable Federal, State, tribal, and local laws
and regulations.
[6] Issue: Several commenters asked that the DEA permit pharmacy
staff to deposit collected substances into collection receptacles.
These commenters asked the DEA to consider situations where the
pharmacy is completely blocked from the public (such as with a bullet-
proof barrier).
Response: For the reasons discussed in the NPRM and in previous
comment responses, the DEA declines to allow pharmacy staff to handle
pharmaceutical controlled substances collected from ultimate users. The
registered location of any retail pharmacy that wishes to become an
authorized collector must satisfy the specifications for collection
receptacles and inner liners. 21 CFR 1317.60 and 1317.75. If a retail
pharmacy desires to be an authorized collector, that pharmacy shall
only allow ultimate users (and others authorized to dispose of
controlled substances on behalf of ultimate users) to deposit the
pharmaceutical controlled substances directly into the collection
receptacles in accordance with Sec. 1317.30. The requirements of the
collection receptacles were carefully considered and designed to limit
the number of hands that handled the pharmaceutical controlled
substances in order to prevent diversion and diversion opportunities,
as well as to prevent the re-introduction of tainted pharmaceutical
controlled substances into the closed system of distribution.
[7] Issue: Twenty commenters suggested that the DEA permit some
sort of inspection for inner liner and mail-back package contents to
ensure that unacceptable contents are removed, such as x-raying and
scanning. These commenters were particularly concerned about mercury-
containing thermometers, iodine-containing medications, medical sharps,
compressed cylinders, and other hazardous waste. Other commenters
expressed concern that by allowing comingling of substances in
collection receptacles, employees may be subjected to hazardous
conditions if unsafe or hazardous materials are deposited.
Response: The DEA understands and appreciates these concerns of the
commenters; however, the DEA has concluded that allowing inspection of
inner liners and mail-back packages presents an unacceptable risk of
diversion. These issues were closely reviewed prior to the NPRM and re-
reviewed in association with these comments. Whether an authorized
collector comingles ultimate users' pharmaceutical controlled
substances with non-controlled substances is within the discretion of
that authorized collector. This rule does not mandate comingling. 21
CFR 1317.75. Each potential authorized collector must weigh all of the
potential risks and benefits in deciding whether to implement and
manage any ultimate user disposal program, including any necessary
steps to prevent the unwanted collection of regulated hazardous waste
or otherwise undesirable materials, in a manner consistent with this
rule and all other applicable Federal, State, tribal, and local laws
and regulations. As discussed in response to previous comments,
collectors may control the substances collected, and they may view
substances before they are deposited into collection receptacles. For
additional commentary on hazardous waste disposal, please see comment
section ``Q.'', entitled ``Hazardous Materials Transportation and
Hazardous Waste Destruction.''
[8] Issue: Some commenters urged the DEA to require authorized
collectors to provide clear instructions on what may and may not be
placed in mail-back packages in order to reduce instances in which
hazardous materials/waste may be inadvertently destroyed in a manner
that is not consistent with environmental or other applicable laws or
regulations due to the prohibition against opening or inspecting the
contents of mail-back packages.
Response: The rule includes a requirement for the collector to
provide packages with instructions indicating what substances are
permitted to be included in the package. 21 CFR 1317.70. The rule does
not require specific language for such instructions, which must
ultimately be determined by the collector in a manner consistent with
the rule.
K. Long-Term Care Facilities (LTCFs) (21 Issues)
Definitions and Terms Specific to LTCFs
[1] Issue: Commenters asked the DEA to clarify the meaning of
``LTCF'' with regard to assisted living facilities, hospice facilities,
and residential care in private homes, as the meaning of LTCF often
varies by State.
Response: LTCF is defined at Sec. 1300.01(b) and ``means a nursing
home, retirement care, mental care or other facility or institution
which provides extended health care to resident patients.''
[2] Issue: Commenters asked the DEA to clarify the meaning of
``have resided'' with regard to a LTCF's ability to dispose of
controlled substances on behalf of residents.
Response: The phrase ``have resided,'' is utilized in the Disposal
Act, but was not defined by Congress. The DEA has
[[Page 53541]]
not determined a need to apply a technical definition for this phrase
apart from its ordinary meaning. The DEA understands the ordinary
meaning of ``have resided'' to be typically understood as persons who
have died or otherwise recently departed a location without manifesting
intent to return. Thus, for example, as discussed in response to issue
[7] below, when a LTCF resident is transferred to another facility, the
resident ``has resided'' at the LTCF, and the LTCF may dispose of the
former resident's pharmaceutical controlled substances in an authorized
collection receptacle. 21 CFR 1317.30.
Registration of Collection Receptacles at LTCFs
[3] Issue: Commenters asked the DEA to clarify whether an
authorized LTCF location where an authorized collector maintains a
collection receptacle would be considered a ``registered location'' of
the retail pharmacy.
Response: The location of the collection receptacle is both a
registered location and a controlled premise. It is a registered
location of the authorized hospital/clinic or retail pharmacy because
the authorized collector may only install and manage a collection
receptacle at a LTCF pursuant to the authority granted by the DEA, and
they are limited at that location to conducting only those activities
that are specifically authorized and required under this rule as
necessary to the installation and maintenance of that authorized
collection receptacle. LTCFs with authorized collection receptacles are
``controlled premises'' pursuant to 21 U.S.C. 880(a) and 21 CFR
1316.02(c); accordingly, the DEA may enter LTCFs and conduct
administrative inspections in furtherance of, and in carrying out, the
responsibilities charged to the DEA by the CSA pursuant to 21 U.S.C.
880(b) and 21 CFR 1316.03.
Disposal Methods and Procedures at LTCFs
[4] Issue: A commenter asked the DEA if LTCFs may use an on-site
method of destruction. Three commenters specifically asked if LTCFs may
continue their current drug disposal method of ``sewering.'' Other
commenters asked the DEA to clarify how existing methods of disposal
utilized by LTCFs will be impacted by this rule and to provide for an
interim method of disposal for LTCFs.
Response: Although the DEA appreciates the commenters' concerns,
the DEA cannot comment on each potential method of disposal occurring
at LTCFs prior to these regulations. The implementation of authorized
disposal methods for ultimate users is strictly voluntary and, with the
exception of law enforcement-sponsored programs, generally such
programs have no lawful means of existence prior to the effective date
of this rule. It is important to note that this rule provides
additional options for disposal and does not prohibit any methods
currently used by LTCFs that are consistent with Federal, State,
tribal, and local laws and regulations. For example, LTCFs are not
prohibited by this final rule from destroying patients' unwanted
pharmaceutical controlled substances at the LTCF, on behalf of the
resident patients, in accordance with applicable Federal, State,
tribal, and local laws and regulations, including environmental laws
and regulations. However, as explained further below, the DEA has
considered the diversion risks and determined that the installation and
maintenance of collection receptacles by authorized hospitals/clinics
and retail pharmacies is the most secure and responsible means by which
registrants may collect and dispose of LTCF residents' pharmaceutical
controlled substances.
As stated in Sec. 1317.90(a), the requirement to render controlled
substances ``non-retrievable'' applies only to DEA registrants that
destroy controlled substances. The ``non-retrievable'' language does
not apply to ultimate users. As discussed in the NPRM, the DEA does not
believe that ``sewering'' would render a pharmaceutical controlled
substance ``non-retrievable.'' However, such a requirement would not
apply to a LTCF unless the LTCF is itself a registrant and destroying
its own pharmaceutical controlled substance stock pursuant to Sec.
1317.05(a).
[5] Issue: Many commenters indicated that the DEA should provide
LTCFs with additional options for disposal of controlled substances on
behalf of residents. Approximately fifteen commenters asked the DEA to
expand which registrants are permitted to manage collection receptacles
at LTCFs. Seven commenters asked the DEA to permit LTCFs to use mail-
back packages. Several commenters stated that LTCFs should be allowed
to use the same disposal options that this rule affords ultimate users.
Response: As previously discussed, this rule in Sec. 1317.40
expands the types of registrants that may be authorized as collectors,
and permitted to manage and maintain collection receptacles at LTCFs.
In addition to retail pharmacies (including ``closed-door pharmacies''
that service LTCFs), hospitals/clinics with an on-site pharmacy may
maintain collection receptacles at LTCFs. Furthermore, the options
available to all ultimate users to dispose of their pharmaceutical
controlled substances are also available to LTCF residents. As ultimate
users (defined in 21 U.S.C. 802(27) as persons who have lawfully
obtained, and who possess, a controlled substance for their own use or
for the use of a member of their household), LTCF residents may avail
themselves of all disposal methods made available by this rule to
ultimate users, including participation in authorized mail-back
programs. For example, on behalf of an LTCF resident, an LTCF employee
may place the resident's unwanted pharmaceutical controlled substances
in a mail-back package, seal it, and deposit it into the facility's
outgoing mail system. Care should be taken to ensure that LTCF
residents' use of mail-back programs does not result in the
accumulation of pharmaceutical controlled substances in a single
location susceptible to internal or external diversion threats.
The DEA has carefully considered the risks and benefits of
collection activities at LTCFs. Among the DEA's specific considerations
were that LTCFs typically have large volumes of controlled substances
on-site and that they are typically not registered with the DEA. The
DEA also specifically considered the risks and benefits associated with
LTCF personnel disposing of pharmaceutical controlled substances on
behalf of persons who reside or have resided at that LTCF. The DEA
determined that in order to adequately protect the public health and
safety, and to prevent diversion, the collection of such substances
must be limited to certain registrants that are well-equipped to handle
the unique circumstances surrounding the disposal of controlled
substances at LTCFs. After careful deliberation, the DEA determined
such registrants should be limited to retail pharmacies and hospitals/
clinics with an on-site pharmacy. 21 CFR 1317.40. In making its
determination, the DEA took consideration of the fact that hospitals/
clinics with on-site pharmacies, and retail pharmacies, routinely
dispense large volumes of controlled substances in a public setting.
Additionally, many hospitals/clinics with on-site pharmacies and retail
pharmacies have experience working closely with LTCFs or have well-
established, on-going relationships with LTCFs. For example, many
retail pharmacies and hospitals/clinics directly deliver pharmaceutical
controlled substances to LTCF residents, some retail pharmacies have
developed
[[Page 53542]]
expertise in dispensing substances at LTCFs via an automated dispensing
system (ADS) (i.e., mechanical systems that perform operations or
activities relative to the dispensing of medications), and some LTCFs
share common management or ownership with hospitals/clinics.
The DEA recognizes that other types of registrants also have
relationships with LTCFs, and considered authorizing other types of
registrants to install and manage collection receptacles at LTCFs.
However, after careful consideration, the DEA determined that the
presence of certain factors that increase opportunities for diversion
in the specified circumstances weigh against further expanding the
types of registrants that may collect at LTCFs.
Specifically, the DEA declines to allow reverse distributors to
install and maintain collection receptacles at LTCFs because reverse
distributors are at the end of the supply chain. It would be contrary
to the public health and safety and pose an increased risk of diversion
to authorize a reverse distributor to independently install and
maintain a collection receptacle at an LTCF, remove the inner liner,
transport collected substances to the final destruction location, and
ensure they are destroyed. One of the principal factors considered by
the DEA in coming to this conclusion is the fact that in such a
situation, the reverse distributor would be the sole registrant to
maintain the only records of installation, removal, and destruction.
Such an authorization would be contrary to the closed system of
distribution where each registrant who handles controlled substances
serves as a source of verification for the other registrants that
handle the same substances, thus ensuring that controlled substances
reach their intended destination with accountability and a reduced risk
of diversion. The regulations implemented by this final rule
specifically utilize this system of checks for collection activities at
LTCFs. Retail pharmacies and hospitals/clinics with an on-site pharmacy
are registrants. As established in this final rule, when retail
pharmacies and hospitals/clinics maintain collection receptacles at an
LTCF, they may not transport sealed inner liners. Rather, they are
expected to transfer sealed inner liners to another registrant for
destruction pursuant to Sec. 1317.05(c)(2)(iv). Two-registrant
integrity allows the DEA to verify and cross-check each registrants'
records. Conversely, LTCFs and destruction facilities are generally not
registrants. Therefore, if a reverse distributor were authorized to
install and maintain collection receptacles at LTCFs, and also pick-up,
transport, and destroy sealed inner liners from LTCFs, the DEA would be
unable to verify the reverse distributor's removal or destruction
records with another registrant's records. Allowing this would not meet
the two-registrant integrity requirement that is the minimum required
to ensure accountability, particularly when collected substances are
destined for destruction.
As discussed in responses to other comments, because LTCFs are
generally not registrants, the DEA is unable to allow such facilities
to be authorized collectors for the purpose of disposing ultimate user-
collected substances, or handle disposed substances on behalf of
another registrant. We note that although LTCFs may not use mail-back
packages or administer a mail-back program, ultimate users who reside
in LTCFs may use mail-back packages under this rule. 21 CFR 1317.30 and
1317.70.
[6] Issue: One commenter asked the DEA to allow a LTCF resident,
or the resident's legal representative, to dispose of controlled
substances through all available means, whether the resident is alive
or deceased.
Response: All means of disposing of pharmaceutical controlled
substances are available to ultimate users and persons lawfully
entitled to dispose of an ultimate user decedent's property, including
those ultimate users who reside, or have resided, in a LTCF. 21 CFR
1317.30.
[7] Issue: Commenters also asked the DEA to address how LTCFs
should handle situations in which a resident is transferred to a
hospital and the resident leaves unwanted medication at the LTCF.
Response: Pursuant to the Disposal Act, Congress provided the DEA
authority to authorize LTCFs only to ``dispose of controlled substances
on behalf of ultimate users who reside, or have resided,'' at the LTCF.
21 CFR 1317.30. When a LTCF resident is transferred to a hospital or
other facility, the resident ``has resided'' at the LTCF, and if the
medication is intentionally left at the LTCF, it is ``unwanted,'' and
the resident has discontinued use. Accordingly, the LTCF may dispose of
the former resident's pharmaceutical controlled substances by
depositing the substances into an authorized collection receptacle
immediately, but no longer than three business days after
discontinuation of use. 21 CFR 1317.80.
[8] Issue: Several commenters indicated that the three-day
disposal provision for LTCFs is overly restrictive and potentially
costly for residents. These commenters stated that three days is too
short a time span and will result in residents being forced to purchase
additional medications when there is a short break in use as a result
of illness, hospitalization, or a trial dosage reduction. One commenter
stated that three days is not a long enough time period to determine if
the patient may need the medication again in the future.
Response: The DEA declines to extend the timeframe for LTCFs to
dispose of pharmaceutical controlled substances on behalf of LTCF
residents. As previously discussed, LTCFs are required to dispose of
pharmaceutical controlled substances ``immediately, but no longer than
three business days after the discontinuation of use'' in Sec.
1317.80(a). With respect to ``discontinuation of use,'' the final rule
modifies Sec. 1317.80(a) to include a permanent discontinuation as
directed by the prescriber, as a result of the resident's transfer from
the LTCF, or as a result of death. The DEA cannot readily foresee a
circumstance where a short break in use as a result of illness, short-
term hospitalization, or a trial dosage reduction would be considered a
discontinuation of use. Also, if the prescriber has not yet determined
whether or not a medication is needed in the future, then it is likely
that there has not yet been a ``discontinuation of use.''
Collection Receptacle Maintenance at LTCFs
[9] Issue: Fifteen commenters indicated that the requirement to
have two employees of the authorized collector retail pharmacy remove
and install inner liners is burdensome, and it will discourage retail
pharmacies from installing and maintaining collection receptacles at
LTCFs. The commenters suggested that the DEA allow LTCF personnel to
remove, store, and replace the inner liners. A commenter suggested that
LTCF personnel be permitted to sort out non-controlled substances to
reduce the amount of material collected in the receptacles.
Response: As explained above, the DEA is amending the final rule to
allow flexibility in the requirement that two employees of the
authorized collector be present for the installation and removal of
inner liners at LTCF collection receptacles. As amended, the final rule
in Sec. 1317.80(c) provides that installation, storage, and removal
may also be performed by one employee of the authorized collector and
one supervisor-level employee of the LTCF (e.g., a charge nurse,
supervisor, or similar employee) designated by the
[[Page 53543]]
hospital/clinic or retail pharmacy authorized to collect at that
location. Hospitals/clinics and retail pharmacies that choose the
flexibility allowed by using a supervisor-level employee from the LTCF
are reminded that they are still ultimately responsible for the
security of the collected substances, as well as keeping complete and
accurate records and fulfilling reporting requirements. The contents of
the inner liners may not be sorted once deposited into a receptacle,
pursuant to Sec. 1317.75(c), but, as previously stated, Sec.
1317.75(b) states that comingling of controlled and non-controlled
substances is permitted but not required. Therefore, the authorized
collector or the LTCF may choose to limit the collected substances to
pharmaceutical controlled substances to maximize available space in the
collection receptacle. This can be easily accomplished at LTCFs because
trained medical personnel will be depositing substances into collection
receptacles and should be well-equipped to sort controlled substances
from non-controlled substances before depositing the substances into a
collection receptacle. Also, as previously discussed, inner liners may
be stored at LTCFs in accordance with Sec. 1317.80(d). Another
available option to manage volume and the prohibition of on-site
storage is for an authorized collector to maintain more than one
collection receptacle at an LTCF.
[10] Issue: Commenters asked the DEA to clarify whether reverse
distributors are permitted to pick up collection receptacle inner
liners from an authorized LTCF location.
Response: In accordance with Sec. 1317.05(c)(2)(iv), reverse
distributors may pick up inner liners from collection receptacles
located at authorized LTCFs, and reverse distributors may receive the
inner liners that are sent to the reverse distributor's registered
location from the LTCF by common or contract carrier. However, the
inner liner must be removed from the collection receptacle under the
supervision of either two employees from the hospital/clinic or retail
pharmacy that is managing the receptacle, or one employee from the
managing hospital/clinic or retail pharmacy and one supervisor-level
employee of the LTCF (e.g., a charge nurse, supervisor, or similar
employee) designated by the authorized collector, pursuant to Sec.
1317.80(c).
[11] Issue: Several commenters expressed concern regarding the
transportation and storage of substances collected from LTCFs,
specifically with regard to the safety of employees who transport
collected substances from LTCFs and logistical difficulties (e.g.,
storage space) that may result in fewer retail pharmacies willing to
install and maintain collection receptacles at LTCFs.
Response: As previously discussed, hospitals/clinics and retail
pharmacies may store sealed inner liners at the LTCF in a securely
locked, substantially constructed cabinet, or a securely locked room
with controlled access for up to three business days pursuant to Sec.
1317.80(d). However, the DEA encourages LTCFs and authorized collectors
managing collection receptacles at LTCFs to exhaust other, more secure,
alternatives, including: Arranging regularly scheduled pick-ups by
reverse distributors or common or contract carriers to coincide with
removal of the inner liner or delivery of controlled substances to the
LTCF; operating multiple collection receptacles at a LTCF to help
minimize overflow; and pursuing ultimate user disposal options through
members of the patients household or other persons lawfully entitled to
dispose of a LTCF patient's property. The DEA believes these
alternatives are better options than storage at LTCFs. LTCFs are
generally unregistered locations with large quantities of highly
pilferable controlled substances in high doses. The DEA carefully
weighed the benefits with the risks of allowing storage at LTCFs,
including the potential for creating a new avenue of diversion at a
location over which the DEA has limited regulatory oversight. However,
in consideration of the circumstances unique to LTCFs, and to ease the
burden on LTCFs and authorized collectors, the DEA is permitting in
this final rule sealed inner liners to be stored at LTCFs in accordance
with Sec. 1317.80(d).
The DEA has also relaxed the rule, in Sec. 1317.80(c), to allow
flexibility in the two-person integrity requirement with respect to
collection at LTCFs by allowing authorized hospitals/clinics and retail
pharmacies to designate a supervisory-level employee of the LTCF as one
of the authorized persons to conduct or oversee the installation,
removal, storage and transfer inner liners. However, the authorized
collector may opt to have two or more of its own employees perform or
oversee these activities. In addition, authorized collectors that are
practitioners may not themselves transport collected substances to a
destruction location. 21 CFR 1317.05. Rather, the practitioner may
destroy the collected substances by delivering the sealed inner liners
to a reverse distributor or distributor's registered location by common
or contract carrier, or a reverse distributor or distributor may pick-
up sealed inner liners at the LTCF. 21 CFR 1317.05.
[12] Issue: Commenters indicated that the installation and
maintenance of collection receptacles by retail pharmacies at LTCFs
will likely result in considerable costs, burdens, and other
liabilities, and, as such, few retail pharmacies will be willing to
install and maintain collection receptacles at LTCFs, and few LTCFs
will want to bear the costs.
Response: The DEA carefully considered the costs associated with
all aspects of disposal, along with all other considerations such as
convenience, safety, and the risk of diversion, including the security
and design of collection receptacles. As discussed in the preamble to
this rule, participation in any disposal program for ultimate users is
voluntary and the DEA is not authorized to impose the burden of costs
upon any specific entity. As such, each registrant that may become
authorized as a collector must individually weigh the associated
benefits and burdens in determining whether to do so. In order to
accommodate LTCF residents, the DEA has expanded the authorized
collectors that may maintain collection receptacles at LTCFs to include
certain hospitals/clinics and retail pharmacies. 21 CFR 1317.40. The
DEA has also relaxed the two-person integrity requirements with respect
to LTCFs, and is allowing for storage of sealed inner liners at the
LTCF in order to reduce the burdens on hospitals/clinics and retail
pharmacies. 21 CFR 1317.80. These are the minimum requirements to
ensure that safety and security of LTCF residents, and to deter and
detect diversion.
[13] Issue: Several commenters expressed concerns over liability
when a collection receptacle is installed at a LTCF because the
collector pharmacy is fully responsible for the receptacle but does not
have constant, direct supervision over it. The commenters did not
specify what type of liability (e.g., criminal, civil, administrative,
etc.) was concerning, however, the commenters suggested that the DEA
provide the authorized collector retail pharmacies a release from
responsibility when installing and maintaining a collection receptacle
at a LTCF.
Response: It would be contrary to the public health and safety to
authorize an entity to collect pharmaceutical controlled substances
from ultimate users, and also absolve that entity from any
responsibility for such collection. In any event, the DEA does not have
authority to provide a general release from liability to all hospitals/
clinics and retail pharmacies that apply for, and are
[[Page 53544]]
authorized to, install and maintain a collection receptacle at a LTCF
as part of their registered activities. Part of the purpose in
authorizing only certain hospitals/clinics and retail pharmacies to
install and maintain collection receptacles at LTCFs is to ensure that
a responsible registrant under the regulatory authority of the DEA is
charged with ensuring the secure and responsible collection of
pharmaceutical controlled substances at LTCFs. As such, with regard to
authorized collection receptacles at LTCFs, all responsibility for such
receptacles, including compliance with the CSA and DEA regulations,
rests with the hospital/clinic or retail pharmacy authorized to install
and maintain the collection receptacle. The DEA designed the physical
security controls and other accountability measures (e.g.,
recordkeeping, two-person integrity, regular monitoring by LTCF
personnel) for collection receptacles at LTCFs in an effort to minimize
the risk of diversion in circumstances where constant, direct
supervision by the hospital/clinic or retail pharmacy is not feasible.
In the event an authorized collector knows or has reason to know
diversion from collection receptacles is occurring, the authorized
collector must take steps to prevent the diversion, including reporting
to the appropriate authorities pursuant to Sec. Sec. 1301.74 and
1301.76. Such action stems from the responsibility to provide effective
controls and procedures to guard against theft and diversion as
required by Sec. 1301.71(a).
Security at LTCFs
[14] Issue: One commenter asked the DEA to clarify the required
security measures for collection receptacles at LTCFs. Two commenters
asked the DEA to outline what LTCF staff must do to monitor the
collection receptacle.
Response: The required security measures outlined in Sec. Sec.
1317.60 and 1317.75 that apply to all collection receptacles also apply
to those located at LTCFs unless stated otherwise in the rule. The rule
provides that a collection receptacle must be located in an area that
is regularly monitored by LTCF personnel. 21 CFR 1317.75(d)(2)(iii).
``Regularly monitored'' has its ordinary meaning. The goal of this
requirement is to prevent diversion; accordingly, specific examples
would depend on individual circumstances. However, a sub-basement or
other seldom-used storage area would not be considered to be regularly
monitored by LTCF personnel because those areas are not routinely
accessed by LTCF personnel in the course of conducting the everyday the
business of the LTCF. The requirement that the receptacle be
``regularly monitored'' is designed to prevent diversion opportunities,
and to ensure that diversion would be detected as soon as possible.
Only authorized collectors may install, manage, and maintain collection
receptacles at LTCFs, therefore, only the authorized collectors may
remove, seal, transfer, and store or supervise the removal, sealing,
transfer, and storage of sealed liners. 21 CFR Sec. 1317.80(b). The
authorized collector is responsible for ensuring the regular monitoring
of LTCF personnel and ensuring the appropriate security procedures are
in place at LTCFs in the event of suspected tampering or diversion. If
tampering or diversion is suspected, LTCF personnel should notify law
enforcement authorities and the authorized collector, as the
circumstances warrant.
[15] Issue: Eight commenters expressed concern for the safety of
residents of LTCFs. These commenters are concerned that collection
receptacles in LTCFs may affect resident safety due to these locations
becoming a potential target for drug seekers. Five commenters suggested
that the DEA increase penalties for offenses related to collected
substances at LTCFs. One commenter encouraged the DEA not to authorize
the installation of collection receptacles at LTCFs because their
presence may compromise the safety of staff and residents.
Response: Congress authorized the DEA to implement regulations
authorizing LTCFs to dispose of controlled substances on behalf of
ultimate users who reside, or have resided, at such LTCFs. The DEA has
considered the risks associated with authorizing the installation and
maintenance of collection receptacles at LTCFs, as discussed in the
NPRM, and determined that the security measures described in this rule,
in Sec. 1317.75, are the minimum required to ensure the safe and
secure disposal of pharmaceutical controlled substances at LTCFs. If
authorized collectors or LTCFs believe the presence of a collection
receptacle endangers the safety or security of the LTCF residents under
particular circumstances, they should take additional measures as
appropriate to ensure the safety of the residents and staff, and to
ensure the security of the collected substances. And, if those other
alternatives have failed to abate the observed dangers, the authorized
collector can choose to discontinue placing a collection receptacle at
a particular LTCF.
The CSA already provides for administrative, civil, and criminal
sanctions for individuals and registrants that violate the CSA. The DEA
is without authority to mandate enhanced penalties for violations of
the CSA that involve LTCFs.
[16] Issue: Two commenters expressed concern about security issues
due to potential stockpiling of unwanted controlled substances at
LTCFs. These commenters listed the following reasons as the bases for
their concerns: The three business day disposal requirement, the lack
of guidance on the frequency at which inner liners must be removed, the
two employee requirement for installing and removing inner liners, and
lack of a realistic alternative for disposal if no retail pharmacy
manages a collection receptacle at the facility. These commenters
stated that stockpiling would increase diversion risks and would be a
liability for the LTCF.
Response: As discussed in the NPRM and in response to comments in
this final rule, these new regulations expand the options available to
ultimate users (including LTCF residents) to dispose of excess
pharmaceutical controlled substances. A resident, a member of the
resident's household, and an individual lawfully entitled to dispose of
the decedent resident's property all may dispose of a resident's
pharmaceutical controlled substances using any of the several methods
of disposal mentioned here. 21 CFR 1317.30.
If there is a collection receptacle at the LTCF, the collected
substances should not accumulate under the procedures outlined in this
rule. One of the primary goals of the procedures outlined in these new
regulations is to prevent the accumulation of collected substances
while awaiting destruction. For example, LTCFs are required to deposit
pharmaceutical controlled substances into collection receptacles
``immediately, but no longer than three business days after the
discontinuation of use,'' pursuant to Sec. 1317.80(a). Although the
DEA has not specifically proposed regulations regarding the frequency
at which the inner liners of collection receptacles must be replaced,
an authorized collector that maintains a collection receptacle at a
LTCF should coordinate with that LTCF in order to ensure that the inner
liners are replaced at a frequency suitable to ensure continuous safe
and secure disposal by the LTCF. This type of coordination is part of
an authorized collector's responsibility to provide effective controls
and procedures to guard against theft and diversion as required by
Sec. 1301.71(a). Controls against diversion are ineffective when
stockpiling of unused pharmaceutical controlled
[[Page 53545]]
substances at a LTCF is the result of an authorized collector's failure
to adequately maintain a collection receptacle. It is emphasized that
there is no limit on the number of collection receptacles that an
authorized collector may install and maintain at a LTCF. Accordingly,
the number of receptacles may be increased to account for volume and/or
pick-up schedules.
As previously discussed, this rule allows but does not require
authorized collectors to store sealed inner liners at a LTCF for up to
three business days in a securely locked, substantially constructed
cabinet or a securely locked room with controlled access, pursuant to
Sec. 1317.80(d). However, the DEA encourages collectors to schedule
inner liner removals and installations to coincide with existing LTCF
visits when possible, for example, arranging a routine system in which
medication deliveries coincide with the removal and transfer of sealed
inner liners for appropriate destruction, thereby making sealed inner
liner storage unnecessary.
Other Concerns Regarding LTCF Drug Disposal
[17] Issue: One commenter expressed concern that the DEA's
assumption that controlled substances in LTCFs have been dispensed to,
and are thus the property of, a resident may result in the reluctance
of LTCFs to use automated dispensing systems to dispense to an ultimate
user as needed.
Response: Congress has defined ``dispense'' to mean the delivery of
a controlled substance to an ultimate user by, or pursuant to the
lawful order of, a practitioner. 21 U.S.C. 802(10). The DEA is bound to
this definition. Accordingly, once a pharmaceutical controlled
substance has been dispensed to a patient, including a resident of a
LTCF, the substance is the property of the patient or ultimate user.
The use of an automated dispensing system (ADS) does not change the
analysis. An ADS is conceptually similar to a vending machine. A
pharmacy stores bulk drugs in the machine in separate bins or
containers and programs and controls the ADS remotely. Only authorized
staff at the LTCF would have access to its contents, which are
dispensed on a single-dose basis at the time of administration pursuant
to a prescription. The ADS electronically records each dispensing, thus
maintaining dispensing records for the pharmacy. Because the controlled
substances are not considered dispensed until the system provides them,
substances in the ADS are counted as pharmacy stock. Even though ADSs
in LTCFs are used to dispense medications for administration on an as-
needed basis (i.e., one dose at a time) in accordance with a
practitioner's prescription, the substance is the property of the LTCF
resident once dispensed. Even though a pharmaceutical controlled
substance is the property of the ultimate user once dispensed from the
ADS, the LTCF may dispose of the medication on behalf of an ultimate
user who resides, or has resided at an LTCF by depositing the
medication into an authorized collection receptacle located in the
LTCF. 21 CFR Sec. 1317.80. Controlled substances held within the ADS
that have not been dispensed to a patient are considered inventory or
stock of the registrant and therefore must be disposed of by the
registrant in accordance with 21 CFR Sec. 1317.05.
[18] Issue: Commenters indicated that LTCFs may be serviced by
multiple pharmacies which could result in controlled substances from
multiple servicing pharmacies being disposed of in a single receptacle
installed by one such pharmacy and asked the DEA to clarify how to
manage such situations (e.g., how other pharmacies would contribute to
the efforts of collection; whether drugs dispensed by other pharmacies
can be disposed of in the receptacle). Commenters also asked the DEA to
clarify the process and requirements for the collection receptacle when
the LTCF changes ownership or pharmacy service.
Response: This rule allows certain hospitals/clinics and retail
pharmacies to become collectors at LTCFs pursuant to Sec. 1317.40,
after properly modifying their registrations, in accordance with part
1301. This rule does not require authorized collectors to have any pre-
existing or other relationships with the LTCF. Depending on the
circumstances, there may be more than one authorized collection
receptacle at a single LTCF. Other than the regulations specific to the
installation and maintenance of collection receptacles and all related
laws and regulations, the DEA is not, at this time, regulating the
relationship between the authorized collector and the LTCF, or between
multiple authorized collectors that have relationships with the LTCF,
and the DEA is not prohibiting collectors from refusing to collect any
certain specified pharmaceutical controlled substances. However,
conduct that implements exclusionary or anti-competitive actions at an
LTCF that adversely affects competing registrants will be referred to
the appropriate authorities for action. It is important to remind
authorized collectors with collection receptacles at LTCFs that they
are solely responsible for the security, integrity, and maintenance of
their own collection receptacles and they must be vigilant and ensure
complete accountability for any pharmaceutical controlled substances
they collect at LTCFs. If a LTCF changes ownership and changes its
name, the authorized collector must modify its registration in
accordance with Sec. 1301.51(b)(2) to reflect the new name of the
LTCF.
[19] Issue: One commenter specifically suggested that the DEA
restrict collection receptacles at LTCFs to the collection of
controlled substances and to require signage indicating such in order
to ensure compliance with State Medicaid program directives requiring
the recovering of non-controlled drugs for potential credit or
restocking.
Response: The DEA is modifying the final rule in Sec. Sec.
1317.70(b) and 1317.75(b) to clearly indicate that comingling of
controlled and non-controlled substances is permitted but not required.
The DEA's authority is limited to controlled substances. As such, the
DEA cannot promulgate regulations requiring signage pertaining to
compliance with State Medicaid programs or any other programs outside
the DEA's scope of authority, but collectors are free to post signage
pertaining to non-controlled substances. Moreover, collectors may post
any information they deem appropriate for the safe and secure disposal
of controlled substances. All collections that may include
pharmaceutical controlled substances, whether comingled or not, must be
consistent with this rule, and all other applicable Federal, State,
tribal, and local laws and regulations.
[20] Issue: Two commenters referenced prescription labeling
requirements that prohibit the transfer of controlled substances to a
person other than to whom it was prescribed. The commenters asked for
clarification regarding such transfers and transfers to a person
lawfully entitled to dispose of an ultimate user decedent's property.
The commenters indicated that such transfers could be considered
dispensing and therefore outside of the authority of the LTCF employee.
Additional concerns included State laws that prohibit LTCFs from giving
back unused controlled substances to the resident or another person and
those that require such substances to be destroyed at the facility.
Response: Pursuant to 21 U.S.C. 825(c), FDA regulations require
that when a schedule II, III, or IV controlled substance is dispensed
to or for a patient, the label include a warning that Federal law
``prohibits the transfer of
[[Page 53546]]
the drug to any person other than the patient for whom it was
prescribed.'' 21 CFR 290.5. This is not a regulation within the DEA's
authority; however, the regulation does not appear to be inconsistent
with the Disposal Act. As described in detail in the NPRM, the CSA
expressly provides that it is unlawful to distribute a controlled
substance except as provided. The CSA permits an ultimate user who has
lawfully obtained a pharmaceutical controlled substance to deliver the
controlled substance to another person for the purpose of disposal only
if that person is authorized to receive such substance and in
accordance with the implementing regulations. The CSA further provides
that if a person dies while lawfully in possession of a pharmaceutical
controlled substance, any person lawfully entitled to dispose of the
decedent's property may deliver the substance to another person for the
purpose of disposal under the same conditions described above. Pursuant
to the Disposal Act, a LTCF may dispose of a resident's pharmaceutical
controlled substances in accordance with these regulations. When a LTCF
deposits a pharmaceutical controlled substance into a collection
receptacle in accordance with these regulations, it is not
``dispensing.'' As discussed, ``dispense'' means the delivery of a
controlled substance to an ultimate user by, or pursuant to the lawful
order of, a practitioner. 21 U.S.C. 802(10).
With regard to State laws, the DEA cannot comment on the laws of
each individual State because these laws are outside of the DEA's
purview. The DEA is tasked by Congress with implementing Federal laws
related to controlled substances. However, nothing contained within the
DEA regulations should be construed as authorizing or permitting any
person to do any act he/she is not authorized or permitted to do under
other Federal laws or under the law of the State in which he/she
desires to perform such act, nor shall compliance with the DEA's
regulations be construed as compliance with other Federal or State
laws. 21 CFR 1307.02.
[21] Issue: One commenter asked the DEA to discuss whether the HHS
reviewed the rule with regard to their ``anti-kickback'' statute. This
commenter expressed concern over whether or not the HHS would permit a
retail pharmacy that dispenses to a particular LTCF to provide
collection services to the same LTCF free of charge.
Response: All collection and disposal of controlled substances must
be conducted in accordance with all applicable laws and regulations,
including HHS regulations. This rule neither imposes requirements or
regulations for the funding of disposal programs, nor imposes
requirements or regulations regarding fees that registrants may charge
to operate disposal programs.
L. Disposing on Behalf of Ultimate Users (Other Than Residents of
LTCFs) (3 Issues)
[1] Issue: Commenters asked the DEA to clarify how hospitals,
schools, summer camps, or other entities may dispose of controlled
substances that unintentionally end up in their possession (e.g., when
persons abandon controlled substances and return is not possible).
Also, several commenters asked the DEA to explain how controlled
substances may be disposed of when the ultimate user or other
authorized person is unable to dispose of them due to death or
incapacitation.
Response: The DEA has limited authority regarding who may deliver
pharmaceutical controlled substances for the purpose of disposal.
Pursuant to the Disposal Act, Congress granted the DEA authority to
authorize three groups of people to deliver controlled substances for
the purpose of disposal. First, an ``ultimate user'' who has lawfully
obtained a pharmaceutical controlled substance may deliver the
substance to another person who is authorized to accept it for the
purpose of disposal. The CSA defines ``ultimate user'' as ``a person
who has lawfully obtained, and who possesses, a controlled substance
for his own use or for the use of a member of his household or for an
animal owned by him or by a member of his household.'' 21 U.S.C.
802(27). Second, if a person dies while lawfully in possession of a
pharmaceutical controlled substance, any person lawfully entitled to
dispose of the decedent's property may deliver the substance to another
person for the purpose of disposal. 21 CFR 1317.30. Third, LTCFs may
dispose of pharmaceutical controlled substances on behalf of ultimate
users who reside or have resided at such facilities. 21 U.S.C. 822(g).
The DEA has no authority to expand the types of individuals and
entities lawfully permitted to deliver pharmaceutical controlled
substances for the purpose of disposal. The DEA has carefully
considered its statutory authority, diversion risks, public safety,
convenience for ultimate users, and the interests of the public. The
DEA believes that this rule provides safe and convenient disposal
options for ultimate users and other authorized persons. The DEA
understands that there may be circumstances where there is no
authorized person to dispose of the controlled substances, such as when
controlled substances are abandoned at a school or summer camp, and
return to the ultimate user is not feasible. In such instances, the
affected entities should contact local law enforcement or their local
DEA office for guidance on proper disposal procedures.
[2] Issue: The DEA received a number of comments regarding the
lack of provisions for hospice and other homecare programs to dispose
of controlled substances on behalf of patients. According to the
commenters, many hospices have written policies and procedures in place
for the management and disposal of controlled substances in the
patient's home. Given the available options for ultimate user disposal,
commenters expressed concern that hospices may no longer be able to
assist families in disposing of a deceased patient's drugs. Commenters
suggested that the DEA allow hospice staff to dispose of a decedent's
controlled substances by sewering or landfill disposal.
Response: The DEA appreciates the difficulties facing home hospice
staff with regard to the disposal of pharmaceutical controlled
substances. The Disposal Act provides that ``if a person dies while
lawfully in possession of a controlled substance for personal use, any
person lawfully entitled to dispose of the decedent's property may
deliver the controlled substance to another person for the purpose of
disposal under the same conditions as provided'' for ultimate users. 21
U.S.C. 822(g)(4). Otherwise, home hospice and homecare personnel are
not authorized to receive pharmaceutical controlled substances from
ultimate users for the purpose of disposal. In addition, an ultimate
user includes ``a person who has lawfully obtained, and possesses, a
controlled substance for his own use or for the use of a member of his
household.'' 21 U.S.C. 802(27). Accordingly, a member of the hospice
patient's household may dispose of the patient's pharmaceutical
controlled substances, but the home hospice or homecare provider cannot
do so unless otherwise authorized by law (for example, under state law)
to dispose of the decedent's personal property.
This rule provides a number of options for ultimate users and
persons lawfully entitled to dispose of a deceased ultimate user's
property to safely and securely dispose of pharmaceutical controlled
substances, yet the DEA does not require ultimate users to utilize
these options. However, it is unlawful for ultimate users to transfer
pharmaceutical controlled
[[Page 53547]]
substances to unauthorized persons, and it is unlawful for unauthorized
persons to receive such substances. It is also unlawful for any person
to possess a controlled substance unless authorized to do so under the
CSA (i.e., an ultimate user, an entity registered with the DEA, or an
entity exempt from registration with the DEA). 21 U.S.C. 844(a). Home
hospice and other homecare providers are encouraged to assist their
patients, and their patients' families, in disposing of pharmaceutical
controlled substances in accordance with the CSA and its implementing
regulations. While education is paramount, home healthcare agencies are
also encouraged to partner with authorized collectors to promote or
jointly conduct mail-back programs.
[3] Issue: One commenter asked the DEA to clarify the authority
for a hospice employee to utilize a LTCF's collection receptacle for
the disposal of controlled substances of a LTCF resident who is also a
patient of the hospice.
Response: This rule does not specifically address hospice care or
hospice employees, who are typically not registrants. As discussed, it
is unlawful to possess a controlled substance unless authorized to do
so under the CSA. 21 U.S.C. 844(a). The DEA has, however, provided
options for the disposal of pharmaceutical controlled substances by a
LTCF on behalf of a person who resides, or has resided, at the LTCF,
regardless of whether or not that person is also receiving hospice
care. The Disposal Act authorized the Attorney General to allow LTCFs
to dispose of controlled substances on behalf of ultimate users who
reside, or have resided, at the LTCF, in a manner determined by the
Attorney General. 21 U.S.C. 822(g)(3). LTCF is defined as ``a nursing
home, retirement care, mental care, or other facility or institution
which provides extended health care to resident patients.'' 21 CFR part
1300. Congress specifically allowed the Attorney General to consider
permitting LTCFs to dispose of pharmaceutical controlled substances on
behalf of LTCF residents. This allowance did not extend to other
persons who are simply attending to a person who is resident of the
LTCF. As such, a hospice employee is not authorized to dispose of
pharmaceutical controlled substances on behalf of a person who resides
or has resided at a LTCF.
M. Registrant Return, Recall, and Transfer (3 Issues)
[1] Issue: One commenter urged the DEA to retain the existing
regulations in part 1307. This commenter stated that part 1307
adequately addresses registrant return, recall, and transfer. The
commenter stated that part 1307 functions properly; thus, there is no
need to change it, and the commenter expressed concern that the new
regulations will disrupt existing business practices. The commenter was
particularly concerned that most controlled substances returned to
distributors are re-salable and ``not intended for disposal.'' Other
commenters indicated confusion with regard to registrants seeking
assistance from a SAC when disposing of controlled substances.
Response: The DEA first notes that the terms ``disposal'' and
``destruction'' are not interchangeable in the context of the rule. As
described in the NPRM at footnote 4 and in this final rule at footnote
4, the terms ``disposal,'' ``dispose,'' and ``disposition'' appear
several times in the CSA but are not defined. In the NPRM and this
final rule, the DEA uses the terms ``disposal'' and ``dispose'' to
refer generally to the wide range of activities that result in
controlled substances being unavailable for further use or one entity
ridding themselves of such substances (e.g., returns). Within the CSA,
a controlled substance can be ``disposed of'' by destruction, return,
recall, sale, or through the manufacturing process. As such, the
modified regulations regarding registrant disposal codify existing
practice, expand available options, and implement consistent procedures
among registrants in accordance with their authorized business
activities. This required deleting the existing regulations at Sec.
1307.21 which authorized the SACs to individually authorize disposal.
The new rule eliminates the authority of the SACs to individually
authorize disposal methods for non-practitioners, and retains this
option for practitioners. 21 CFR 1317.05. Otherwise, the new
regulations maintain existing disposal practices for registrant
inventory and authorize: Prompt on-site destruction; prompt delivery of
controlled substances to a reverse distributor; and prompt delivery
(for the purposes of return and recall) to the person from whom the
controlled substance was obtained, the manufacturer, or a registrant
authorized to accept returns on the manufacturer's behalf.
Additionally, non-practitioners may promptly transport the controlled
substances to a reverse distributor, a destruction location, or the
location of any person authorized to receive the controlled substances
for the purpose of return or recall. 21 CFR 1317.05. The DEA
appreciates that by eliminating the option for a SAC to authorize
specific disposal procedures on a case-by-case basis for non-
practitioners, some reverse distributors may need to alter their
disposal practices. Although this change may impact current business
practices, as discussed in the NPRM, nationwide consistency is
necessary in the disposal pharmaceutical controlled substances.
[2] Issue: One commenter asked the DEA to clarify what method of
return is permitted other than via a freight forwarding facility
pursuant to Sec. 1317.10.
Response: With regard to the use of freight forwarding facilities
pursuant to 21 CFR 1317.10(c), use of the word ``may'' indicates that
the use of freight forwarding facilities is permitted but not required.
Other authorized methods of transferring pharmaceutical controlled
substances for the purpose of return or recall are outlined in Sec.
1317.05(a)(3) and (4) for practitioners, and in 21 CFR 1317.05(b)(3)
and (4) for non-practitioners.
[3] Issue: One commenter stated that it will be difficult for
reverse distributors to adjust current business operations to meet the
14-day destruction requirement for recalled controlled substances,
because product returns may be received from thousands of customers
across the country. Additionally, this requirement may not be
consistent with other agencies' regulations and policies governing
manufacturers' voluntary recalls and other product recalls.
Response: As explained further below, the 14-day destruction
requirement (which this final rule extends to 30 days) does not apply
to recalled pharmaceutical controlled substances. 21 CFR 1317.15.
N. Destruction (19 Issues)
Non-Retrievable Destruction Standard
[1] Issue: Forty commenters asked the DEA to outline performance
standards and parameters for the ``non-retrievable'' destruction
standard. Although many commenters applauded the DEA for proposing a
standard that will permit future innovation, many commenters felt that
innovation may be hindered by the uncertain terms. Commenters asked the
DEA to list currently-approved methods, and to outline how the DEA will
evaluate new technology intended to render controlled substances ``non-
retrievable.''
Response: In the NPRM, the DEA indicated that incineration and
chemical digestion are some examples of current technology that may be
utilized to achieve the non-retrievable
[[Page 53548]]
standard. The preamble of the NPRM states that sewering (disposal by
flushing down a toilet or sink) and landfill disposal (mixing
controlled substances with undesirable items such as kitty litter or
coffee grounds and depositing in a garbage collection) are examples of
current methods of disposal that do not meet the non-retrievable
standard. The term non-retrievable is defined in the rule and is
results-oriented because the DEA's concern is that the substance be
permanently rendered to an unusable state. The performance standard is
that the method renders the substance so that it cannot be transformed
to a physical or chemical condition or state as a controlled substance
or controlled substance analogue. 21 CFR part 1300. The DEA will not be
routinely engaged in evaluating new technologies intended to render
controlled substances ``non-retrievable.'' Much like the DEA does not
evaluate, review, or approve the specific processes or methods utilized
to produce, synthesize or propagate a controlled substance, the DEA
will not evaluate, review, or approve the processes or methods utilized
to render a controlled substance non-retrievable, as long as the
desired result is achieved.
[2] Issue: Twenty commenters asked the DEA to include the language
regarding sewering and landfill disposal in the text of the regulation.
These commenters applauded the DEA for stating that sewering and
landfill disposal do not meet the ``non-retrievable'' standard;
however, these commenters asked the DEA to include this same language
in the text of the regulation.
Response: The DEA has determined that the most effective way of
ensuring that the non-retrievable standard of destruction remains
current with continuously changing technology is to provide a required
end result rather than specify what means achieve or fail to achieve
that result. A substance is rendered non-retrievable when its physical
or chemical state is permanently and irreversibly altered and it may be
unique to a substance's chemical or physical properties; the same means
of destruction may not render every controlled substance non-
retrievable. 21 CFR part 1300. Thus, the DEA declines to amend the text
of the regulation to include such a broad prohibition. In consideration
of the Disposal Act's goal to decrease the amount of pharmaceutical
controlled substances introduced into the environment, the DEA
emphasizes that sewering and landfill alone do not meet the non-
retrievable standard. Once a controlled substance is rendered non-
retrievable, it is no longer subject to the requirements of the DEA
regulations.
[3] Issue: Several commenters requested that the DEA review and
approve new destruction methods prior to allowing their use.
Response: As discussed in the immediately preceding responses, the
DEA will not be engaged in reviewing or approving new destruction
methods prior to allowing their use.
[4] Issue: One commenter suggested that the DEA provide a
transition period to allow for additional research into the means by
which a non-retrievable state may be achieved. This commenter proposed
a timeframe, such as five years, to allow appropriate technology to
develop. This commenter also suggested that the DEA permit sewering and
landfill disposal in the interim.
Response: The DEA believes that technology by which pharmaceutical
controlled substances may be rendered non-retrievable currently exists,
thus providing existing opportunities for compliance with this rule and
negating the need for a transition period beyond the effective date of
this rule.
[5] Issue: Several commenters suggested that the DEA collaborate
with the United States Environmental Protection Agency (EPA) to develop
best practices for achieving a non-retrievable state using
environmentally responsible methods.
Response: The DEA appreciates the environmental concerns
surrounding the destruction of pharmaceutical controlled substances.
The DEA has worked with, and is continuing to work with, the EPA
regarding secure and responsible drug disposal, particularly for
pharmaceutical controlled substances that may also be considered
hazardous wastes. Additionally, the DEA has clearly stated in the rule
that all methods of destruction must comply with all applicable
Federal, State, tribal, and local laws and regulations, including EPA
regulations.
[6] Issue: A commenter asked the DEA to clarify whether or not the
non-retrievable standard of destruction applies to substances disposed
from households, and this commenter stated that the DEA should develop
and endorse a practical solution for in-home disposal.
Response: Ultimate users may continue to dispose of their own
pharmaceutical controlled substances in the manner recommended by other
Federal and State agencies, such as the FDA, Office of National Drug
Control Policy (ONDCP), and EPA. The non-retrievable standard is only
applicable to inventoried controlled substances (i.e., a registrant's
stock) and collected controlled substances (i.e., substances collected
from ultimate users by authorized collectors) to be disposed of by
registrants, pursuant to Sec. 1317.90. The non-retrievable standard
does not apply to non-registrants.
[7] Issue: Several commenters asked the DEA to clarify whether or
not controlled substances that were rendered ``non-retrievable'' will
be regulated by the DEA.
Response: As provided in the definition, a controlled substance is
considered non-retrievable when it cannot be transformed to a physical
or chemical condition or state as a controlled substance or controlled
substance analogue. 21 CFR part 1300. Once a substance is rendered non-
retrievable, it is no longer subject to the requirements of the DEA
regulations. The DEA believes that further regulations regarding
substances that have been rendered non-retrievable are currently
unnecessary because a non-retrievable substance cannot be abused and
diversion to illicit use is futile.
Incineration and Chemical Digestion Destruction Methods
[8] Issue: Several commenters asked the DEA to specifically
recommend incineration as the preferred method to achieve a non-
retrievable state.
Response: The DEA believes that any actual or perceived endorsement
or recommendation of a specific destruction method, beyond the
provision of examples of current methods in the preamble, could
suppress exploration and implementation of new technologies as people
may assume that the endorsed or recommended methods are required at the
exclusion of other methods. As such, the DEA is specifying a required
result--non-retrievable--rather than a required method for achieving
that result. 21 CFR 1317.90.
On-Site Destruction Methods
[9] Issue: Several commenters asked the DEA to clarify what ``on-
site destruction'' means.
Response: As provided in Sec. 1300.05(b) of the final rule, on-
site destruction means that the controlled substances are destroyed on
the physical premises of the destroying registrant's registered
location. Collectors that are authorized to conduct mail-back programs
must have and utilize an on-site method of destruction, pursuant to 21
CFR 1317.05(c)(1). The requirement for an on-site method of destruction
does not apply to non-registrants.
[10] Issue: Commenters also expressed concern that distributors are
unlikely to have an existing on-site
[[Page 53549]]
method of destruction because they are not typically licensed as waste
handlers and suggested that the DEA provide alternatives to on-site
destruction for hospitals and other medical facilities.
Response: This rule does not require any distributor or other
registrant to utilize an on-site method of destruction except under
certain circumstances in order to conduct a voluntary activity (e.g.,
receipt of mail-back packages as an authorized collector in accordance
with Sec. 1317.05(c)(1)).
[11] Issue: One commenter asked the DEA to consider the use of
collection receptacles with deactivation technology.
Response: This rule does not prohibit on-site destruction of
pharmaceutical controlled substances by authorized collectors with
``deactivation'' capability so long as such destruction is consistent
with the standards set forth in the rule and the destruction results in
a non-retrievable state. 21 CFR 1317.90.
Other Destruction-Related Concerns
[12] Issue: Approximately 20 commenters stated that the 14-day
destruction requirement is impractical. These commenters suggested that
the DEA allow more time since there are a limited number of commercial
incinerators in the United States. Several commenters stated that
reverse distributors must accumulate large amounts of controlled
substances in order to obtain favorable pricing. Other commenters
stated that the requirement will make it difficult for reverse
distributors to properly process and record all transactions, and it
will impose substantial financial and operational restrictions on
reverse distributors as most reverse distributors do not have on-site
destruction and may need to travel long distances to reach an
appropriate destruction facility.
Response: The DEA has carefully and thoroughly considered these
concerns, and the final rule in Sec. 1317.15(d) extends the
destruction requirement timeframe from 14 calendar days to 30 calendar
days and eliminates the ``as soon as practicable'' standard with
respect to this destruction requirement. The DEA remains concerned
about increased diversion risks due to pharmaceutical controlled
substances remaining at a single location for extended periods of time.
As discussed in detail in the NPRM, prescription drug abuse is an
American epidemic, and it is America's fastest growing drug problem.
When large volumes of pharmaceutical controlled substances accumulate,
they become an attractive target for drug seekers and drug abusers.
Accordingly, regardless of the applicable timeframe to destroy
controlled substances, reverse distributors are reminded that they must
be vigilant and adhere to the requirements in the CSA and the
implementing regulations. Finally, these registrants are reminded of
their responsibility to provide effective controls and procedures to
guard against theft and diversion, and their responsibility to notify
the DEA of any theft or significant loss of any controlled substances
within one business day of discovery. 21 CFR part 1301. The DEA
continuously monitors compliance with the CSA and applicable
regulations to ensure that controlled substances are not diverted to
illicit purposes. If necessary, the DEA may consider revising the
requirements applicable to reverse distributors' destruction
activities, or imposing additional security requirements.
[13] Issue: Several commenters asked the DEA to clarify the day the
clock starts for the 14-day destruction requirement.
Response: As discussed above, the final rule extends the timeframe
from 14 days to 30 days. Day 1 is the day the substances are physically
acquired through pick-up or delivery. 21 CFR 1317.15.
[14] Issue: One commenter asked the DEA to clarify whether or not
the 14-day destruction requirement applies to law enforcement.
Response: This destruction requirement does not apply to law
enforcement. Law enforcement guidelines are outlined in Sec. 1317.35.
[15] Issue: One commenter suggested that the DEA apply the 14-day
destruction requirement to all authorized collectors that destroy or
cause the destruction of controlled substances, not just reverse
distributors.
Response: As previously discussed, the final rule extends the
destruction requirement timeframe from 14 days to 30 days. 21 CFR
1317.15. This requirement applies to reverse distributors destroying
any controlled substance, as well as distributors when destroying
sealed inner liners acquired from authorized collectors for
destruction. Pursuant to Sec. 1317.05(c), authorized collectors that
maintain mail-back programs or collection receptacles must promptly
destroy mail-back packages and inner liners, without adhering to a
certain number of days in order to provide them some flexibility
depending upon their particular circumstances.
[16] Issue: Two commenters stated that all management and disposal
of controlled substances should be restricted to DEA-registered
hazardous waste disposal companies.
Response: The DEA believes that restricting the management and
disposal of controlled substances as suggested would severely burden
registrants without adding benefit. Pursuant to this rule, a
destruction facility is not required to register with the DEA simply
because a registrant utilizes that facility to destroy pharmaceutical
controlled substances in a manner consistent with this rule and all
other applicable Federal, State, tribal, and local laws and
regulations. The DEA does not find it necessary to register these
entities because the destroying registrant maintains possession and
control of the substances (and therefore retains responsibility and
accountability) until the substances are rendered non-retrievable. This
is because all handling, monitoring, security, recordkeeping, and
witnessing with regard to the pharmaceutical controlled substances is
performed or supervised by registrants.
[17] Issue: One commenter indicated that the DEA should provide for
broader Federal approval for methods of destruction rather than
allowing for regionally-based guidance through the relevant SAC.
Response: As discussed, this rule expands the options available to
registrants for proper disposal, but does not require any particular
method of destruction, so long as the substances are rendered non-
retrievable. This rule does not authorize SACs to specifically
authorize any particular method of destruction, but it does allow a
practitioner to seek guidance from the relevant SAC regarding the
disposal of controlled substances. 21 CFR 1317.05.
[18] Issue: Several commenters asked for clarification regarding
the means by which an authorized collector may promptly destroy
collected substances, and whether chemical treatment of controlled
substances until such time as controlled substances can be retrieved
for destruction would be considered prompt destruction.
Response: As discussed, the DEA is not requiring any particular
method or means of destruction. All controlled substances destined for
destruction must be rendered non-retrievable in order to be destroyed
in a manner consistent with this rule. 21 CFR 1317.90. If chemical
treatment renders a substance non-retrievable, it has been properly
destroyed and is no longer subject to the DEA's regulations.
[19] Issue: One commenter suggested that the DEA require controlled
substances to be partially destroyed prior to disposal in collection
[[Page 53550]]
receptacles, such as by grinding them up and mixing them with kitty
litter.
Response: With regard to mixing pharmaceutical controlled
substances with other substances prior to depositing them in a
collection receptacle, this rule neither prohibits nor requires such
activity. Some authorized collectors may find it desirable to direct
ultimate users to mix pharmaceutical controlled substances with non-
hazardous items, such as kitty litter, prior to depositing in
receptacles; however, the DEA declines to mandate such a requirement
for all authorized collectors. The security controls required by this
rule are the minimum required to ensure the safe and secure disposal of
pharmaceutical controlled substances.
O. Economic Concerns (18 Issues)
Continuation of Existing Programs
[1] Issue: Eighteen commenters with experience operating a
disposal program stated that following the new regulations will be
prohibitively costly, and their current program will be forced to stop
collection activities. These commenters stated that they sort
controlled substances from non-controlled substances and packaging.
According to these commenters, controlled substances represent a small
fraction of their total volume of collected substances, and the sorting
prohibition will substantially increase costs.
Response: As explained above, comingling of controlled and non-
controlled substances is permitted by the rule in Sec. 1317.75, but it
is not required, and this rule does not require pharmaceutical
controlled substances collected from ultimate users to be collected and
stored in the original packaging. Authorized collectors may choose to
address adequacy of space issues by choosing not to collect comingled
controlled substances and non-controlled substances and by excluding
packaging materials from being deposited into the collection
receptacle. Also, law enforcement continues to have autonomy regarding
their collection activities, and this rule does not prohibit law
enforcement from handling collected substances. Prior to the effective
date of this rule, it is unlawful for ultimate users to transfer
controlled substances to any entity (excluding law enforcement), except
in the limited circumstances allowed under 21 CFR 1307.21(a)(2).
[2] Issue: Several commenters stated that they would have to hire
additional help for their program to continue, and that they would no
longer be able to rely on volunteers or other personnel that did not
meet the NPRM's ``authorized employee'' definition.
Response: As discussed, in Sec. 1300.05(b) the final rule modifies
the proposed definition of ``authorized employee'' to omit the word
``authorized.'' In this final rule, the DEA is adopting the general
common law of agency's definition of the term ``employee.'' Any person
who meets certain criteria may have access to or influence over
collected substances on behalf of an authorized collector. Also, under
this rule, volunteers may assist with disposal programs or take-back
events as long as they do not have access to or influence over the
collected controlled substances.
Two Employee Requirement
[3] Issue: Approximately 30 commenters felt that it would be
infeasible for two employees to oversee disposal procedures due to
limited personnel. Commenters suggested allowing an ``authorized
employee'' of another registrant, such as a reverse distributor, to
satisfy the second ``authorized employee'' requirement. One commenter
stated that the DEA should clarify that under proposed Sec.
1317.75(g), installation and removal of inner liners may be performed
by a law enforcement officer instead of two employees.
Response: The DEA believes that the two-employee integrity
requirement is a necessary security measure to effectively guard
against diversion and to ensure that the controlled substances are
handled, transferred, and recorded in a manner that is consistent with
all applicable laws and regulations. The DEA carefully considered the
various concerns and took steps to alleviate some of these concerns.
First, as just discussed, the final rule modifies the proposed
definition of ``authorized employee'' to instead adopt the common law
of agency's definition of the term ``employee,'' thus including
employees that were excluded by the definition proposed in the NPRM
(e.g., part-time employees and off-duty law enforcement officers). 21
CFR part 1300. Second, as previously discussed, the final rule relaxes
the two employee requirement for collection receptacles located at
LTCFs in Sec. 1317.80(c). The DEA is making this exception because of
the unique circumstances faced by LTCFs, as recognized by the Disposal
Act, and in keeping with the DEA's historically accommodating
regulations with respect to LTCFs (e.g., Sec. Sec. 1306.11(f) and
1306.13(b) regarding faxing schedule II prescriptions and dispensing
partial prescriptions). The DEA believes that the above changes will
alleviate some of the concerns expressed by the commenters while
maintaining the necessary security to reduce diversion risks.
[4] Issue: Twenty-seven commenters stated that the requirement to
have two employees from the pharmacy present to remove and install a
collection receptacle's inner liner is excessive and too costly.
Several commenters noted that this requirement alone will dissuade
retail pharmacies from managing collection receptacles. Several
commenters stated that small pharmacies may not have two employees
working during the same shift, or even have two people employed full-
time by the pharmacy. Two commenters suggested requiring a dual-lock
system on collection receptacles, where the collector registrant
retains one key and a reverse distributor retains the other.
Response: The DEA carefully considered the commenters' concerns,
and amended the text of the rule to address this issue. In the context
of this issue, the two-employee requirement only applies to
installation and removal of the inner liners which does not need to be
accomplished by two employees on the same shift. Also, dual-locks on
collection receptacles at retail pharmacies are not a reasonable
alternative because collectors are authorized only at their own
registered location or controlled premise. If a retail pharmacy
employee retained one key in a dual-lock system, and a reverse
distributor retained the other key, then the reverse distributor would
be handling collected substances at the retail pharmacy's registered
location or controlled premise, an activity that is not permitted.
Reasonable alternatives include installing and removing an inner liner
during a shift change, or other times when there is more than one
employee present. The final rule also modifies the proposed definition
of ``authorized employee,'' by adopting the common law of agency's
definition of ``employee'' and correspondingly eliminating the
requirement that employees authorized to conduct disposal activities be
employed full-time by the authorized collector. 21 CFR part 1300. The
DEA believes that the two-employee integrity requirement is a necessary
security measure to effectively guard against diversion and to ensure
that the controlled substances are handled, transferred, and recorded
in a manner that is consistent with all applicable laws and
regulations.
[5] Issue: Several commenters stated that the requirement that two
employees from a retail pharmacy be present to
[[Page 53551]]
install and remove inner liners at LTCFs is prohibitively burdensome.
Several commenters stated that most retail pharmacies do not have a
vehicle for this purpose, and it is a liability to have pharmacy
employees traveling to LTCFs to change inner liners. Two commenters
suggested that the requirement should be one employee from the pharmacy
and one employee from the LTCF.
Response: The DEA carefully considered alternatives that will
provide convenient options for the unique population of LTCF residents,
but will also provide safe and secure disposal. As amended, the final
rule in Sec. 1317.80(c) provides that inner liner installations,
storage, removals, and transfers at LTCFs may be performed either by
two employees of the authorized collector, or by one employee of the
authorized collector and a supervisor-level employee of the LTCF
designated by the authorized collector. The DEA believes that this
modification is important to encourage hospitals/clinics and retail
pharmacies to maintain collection receptacles for LTCF residents, by
easing the burdens on authorized collectors who maintain collection
receptacles at LTCFs--the only collectors who maintain collection
receptacles at locations away from their primary registered locations.
Additionally, the DEA recognizes that some authorized collectors do not
have a vehicle specifically for the purpose of travelling to LTCFs, or
currently allow employees to travel. The DEA notes that no particular
vehicle is required to transport employees of the authorized collector
to the LTCF, and, as discussed above, the DEA encourages authorized
collectors managing a collection receptacle at a LTCF to coordinate
removal of inner liners with the delivery of controlled substances
dispensed to LTCF residents.
[6] Issue: Fifteen commenters stated that it will be economically
burdensome to have two employees of the reverse distributor accompany
the collected substances to the point of destruction to witness the
destruction. These commenters noted that waste management companies
often travel hundreds of miles to reach a destruction facility. The
commenters stated that it is unreasonable to have two employees of the
reverse distributor accompany the collected substances and witness the
destruction, and some commenters suggested that the DEA permit other
security mechanisms, such as GPS devices and security cameras, to serve
in lieu of the second employee.
Response: The DEA believes that the two-employee integrity
requirement is a necessary security measure to effectively guard
against diversion and to ensure that the collected substances are
handled, transferred, and recorded in a manner that is consistent with
all applicable laws and regulations. 21 CFR 1317.95. The DEA notes that
the DEA registrants who expressed concern regarding this requirement
already adhere to it in their current business practices. However, the
DEA has thoroughly and carefully considered the commenters' concerns
and considered the following alternatives to the two-person integrity
requirement: (1) Requiring destruction facilities to register with the
DEA; (2) requiring the transferring registrant (e.g., retail
pharmacies, hospitals/clinics, etc.) to accompany the controlled
substances to the point of destruction; (3) requiring on-site
destruction; (4) requiring additional recordkeeping and witnessing at
the point of destruction by the non-registrant destruction facility;
and (5) requiring GPS devices or security cameras to serve in lieu of
the second employee. The DEA did not elect these alternatives because
the DEA is without sufficient authority to impose them, or the
alternatives were impractical, excessive, did not provide adequate
security, would result in voluminous, difficult to maintain and verify
records, and/or would reduce the disposal options available to ultimate
users.
The two-person integrity requirement is of paramount importance
when transporting controlled substances to the point of destruction
because these persons are uniquely entrusted with ensuring the
substances are destroyed and not diverted to illicit purposes.
Registrants that destroy on-site also face diversion risks and security
concerns and must adhere to the two-person integrity requirement when
destroying controlled substances. These diversion risks and security
concerns increase substantially in the case of reverse distributors
because they routinely acquire from other registrants large volumes of
controlled substances destined for destruction, and they routinely
transport those substances to a remote, un-registered location for
destruction, yet there is no independent mechanism to ensure or verify
that the substances within their possession are actually destroyed and
not diverted.
Furthermore, as explained previously, in every other transfer of
controlled substances in the closed system of distribution, there are
two registrants on each side of the transfer to ensure accountability
and identify and prevent diversion. When controlled substances are
transferred for destruction, there may not be a registrant verifying
the destruction of the controlled substances. Adherence to the two-
employee integrity requirement will provide accountability for the
controlled substances during the destruction process, preventing
possible loss, possible theft, and diversion of the controlled
substances.
Similarly, the DEA declines to allow GPS devices or security
cameras to serve in lieu of a second employee. These types of security
measures can be compromised, and do not provide the same level of
deterrence or risk mitigation as the presence of a second person
because they are strictly after-the-fact methods of diversion control
as opposed to providing security throughout the transportation and
destruction process. GPS devices cannot provide information as to
whether or not controlled substances were removed from the transporting
vehicle, and cameras cannot observe transportation and destruction from
all angles. For example, a single driver being monitored by GPS and
video could drive to the destruction facility on the approved route,
remove the controlled substances from the vehicle, move with the
controlled substances out of the view of the camera, and place the
controlled substances into a separate vehicle or hidden spot off camera
rather than destroying them. In such a scenario, neither the GPS, nor
the camera would indicate any sort of diversion, whereas a second
person would be present throughout transportation and destruction to
serve as a deterrent and ensure that the controlled substances were
actually destroyed.
For these reasons, the DEA believes that the two-person integrity
requirement is the most reasonable, secure, and economic substitute for
another registrant serving as an independent verification method at the
end of the closed system of distribution.
Implementation Costs
[7] Issue: One commenter indicated that the enhanced security
procedures proposed for the disposal process will be overly burdensome
and costly. This commenter recommended that the DEA meet with industry
stakeholders to identify options that will allow innovation while
maintaining security.
Response: The security requirements in this rule are the minimum
needed to protect the public health and safety, to ensure
accountability, and to reduce the risk of diversion during the disposal
process. In addition, there were multiple opportunities for industry
stakeholders (and any other interested persons) to participate in the
[[Page 53552]]
rulemaking process for this rule through participation in the public
meeting held in January 2011, and the submission of written comments
during the open comment period. The DEA carefully considered discussion
from the meeting, as well as the written comments submitted in response
to the NPRM.
[8] Issue: Eleven commenters stated that the regulations proposed
in the NPRM are too costly, and the costs will discourage potential
collectors from participating. Several commenters expressed concern
about the costs associated with retail pharmacies managing collection
receptacles, particularly at LTCFs.
Response: As provided in the Disposal Act and discussed in the
NPRM, the DEA cannot require any entity to establish or maintain a
disposal program. Based on information received from the public and
industry during the public meeting in 2011, as well as information
received in response to the NPRM, the DEA believes that many entities
are eager to voluntarily establish disposal programs. Entities may
choose to establish disposal programs for various reasons, including
for profit, to build goodwill in the community, to attract customers,
to advertise businesses, and to preserve the environment.
[9] Issue: Several commenters provided feedback regarding costs
related to voluntary implementation and maintenance of disposal
programs, although none provided any actual data that could be applied
to the cost analysis except for a suggestion that the DEA review
information from a report on waste collection, and one commenter that
provided an estimate without any supporting data. Generally, commenters
indicated that the proposed methods of collection would have associated
costs incurred through recordkeeping, purchase of inner liners, changes
in procedures, increases in destruction costs, and development of mail-
back packages and collection receptacles. Commenters encouraged the DEA
to further explore the potential costs of the proposed options as well
as additional alternatives.
Response: The DEA appreciates the commenters' concerns regarding
potential costs associated with the implementation and maintenance of
disposal programs. The DEA has updated its economic analysis to
address, directly, the costs of this rule with respect to those
registrants that do choose to establish a collection program. Such
implementation, however, is strictly voluntary; thus, any entity that
does not wish to incur the related costs may choose not to participate.
Additionally, as described in the NPRM, the DEA anticipates that a
variety of interest groups, corporations, community groups, and other
entities will work together to provide secure and responsible disposal
options pursuant to this rule.
[10] Issue: One commenter suggested that the DEA provide an
exception for analytical labs from the requirements of proposed Sec.
1317.95(c) (Sec. 1317.95(d) in the final rule), which requires that
two employees handle the destruction of controlled substances, in
instances where the testing renders a substance non-retrievable.
Response: The DEA declines to provide a blanket exception for
analytical laboratories for the described situation. The DEA believes
that such instances as described by the commenter will be incidental to
testing. If the testing is specifically designed to develop new methods
of destruction or destruction is otherwise not incidental to testing,
all destruction must be in accordance with the provisions in subpart C
of this rule.
[11] Issue: One commenter expressed concern that this rule will
impose obligations on authorized collectors that are inconsistent with
obligations imposed by other agencies, particularly the FDA, EPA, and
DOT. The commenter stated that the potential liability stemming from
such conflicts will discourage participation.
Response: The DEA has worked directly with other Federal agencies
regarding the implementation of this rule, including the EPA and DOT.
The DEA believes that authorized collectors may comply with this rule
and other agency regulations. Authorized collectors should contact
applicable agencies for further guidance if they believe that their
specific circumstances may lead to conflicts.
Funding and Incentives
[12] Issue: One commenter asked the DEA to allow private/public
partnerships for collection receptacles, mail-back programs, and take-
back events.
Response: This rule does not dictate what funding sources are
permitted or prohibited. Entity partnerships are not prohibited as long
as the authorized collector follows all procedures outlined in this
rule.
[13] Issue: Ten commenters expressed concern that there is no
mandate, funding, or incentive for collectors to participate. Two
commenters suggested that the DEA establish incentives to encourage
participation, or require all pharmacies to install and maintain
collection receptacles. Several commenters indicated that without a
clear source of funding, cost mitigation, or participation incentive,
it is unlikely that registrants will voluntarily accept the financial
burdens associated with the provision of collection opportunities.
Response: The DEA appreciates the suggestions and concerns of the
commenters regarding funding for voluntary controlled substances
collection programs. The DEA points out that the Disposal Act did not
authorize the DEA to assign responsibility of funding to any entity,
and the Disposal Act specifically required the DEA to promulgate the
implementing regulations in such a way that participation would not be
mandatory. The DEA's intent in soliciting comments regarding this
rule's potential economic impact was to gain knowledge regarding
potential costs--not which entities should fund disposal programs. The
DEA has attempted to provide regulations that minimize the financial
burden while retaining a level of security to ensure public safety and
reduce diversion risks. This rule does not address the responsibility
of costs associated with any collection program. The DEA recognizes
that collection programs will have associated costs and each entity
that chooses to establish and maintain such a program must determine
how to manage such costs.
Other Economic Concerns
[14] Issue: A number of commenters urged the DEA not to impose
additional fees on registrants that choose to become authorized
collectors. These commenters asked the DEA to clarify whether or not
there will be any cost to modify a registration to become an authorized
collector. One commenter suggested that the DEA offer a reduced fee for
non-profit organizations to become registered as reverse distributors.
Response: Section 1301.51(c) states that no fee will be required to
modify a registration to become authorized as a collector. Pursuant to
21 U.S.C. 886a, fees charged by the DEA under its diversion control
program must be set at a level that ensures the recovery of the full
costs of operating the various aspects of the program. The DEA last
modified the registration fees on April 16, 2012. 77 FR 15234. If the
DEA determines in the future that such fees should be modified in order
to ensure the recovery of the full costs of the diversion control
program, including those contained in this rule, the DEA will propose a
modified fee schedule
[[Page 53553]]
pursuant to the notice-and-comment rulemaking process. The DEA
currently provides limited exceptions and exemptions from registration
fees to very specific groups and entities as identified in part 1301.
At this time, the DEA does not anticipate expanding such exceptions and
exemptions as a result of or in conjunction with the implementation of
this rule.
[15] Issue: A few commenters noted that DEA's Economic Impact
Analysis estimated the universe of potential respondents to include
distributors, reverse distributors, manufacturers, and retail
pharmacies, without considering hospitals, surgery centers, dental
clinics, veterinary practices, or physicians' offices.
Response: The DEA's analysis included a universe of potential
respondents comprised of only those entities that may be affected by
the rule--those registrants that are eligible to become authorized
collectors (i.e., distributors, reverse distributors, manufacturers,
NTPs, and hospitals/clinics with an on-site pharmacy, and retail
pharmacies).
[16] Issue: Two commenters stated that the DEA did not
appropriately calculate the costs associated with the proposed rule.
One commenter stated that the DEA should acknowledge the costs
associated with recordkeeping requirements, purchasing inner liners,
purchasing mail-back packages, procedural changes, and increased
destruction costs.
Response: As discussed previously, the economic analysis of the
final rule takes into account costs associated with voluntary
performance of collection activities even though the provisions that
facilitate non-registrant disposal are completely voluntary, not
mandated. Any collector, reverse distributor, distributor, or law
enforcement that chooses to engage in the voluntary activities
described in this section, does so based on its own evaluation of costs
and benefits (tangible and intangible).
[17] Issue: One commenter stated that the economic impact analysis
is inadequate because it does not acknowledge that parts of this rule
are an ``indirect'' mandate for LTCFs. This commenter referred to
incidents where LTCFs will have no other options for controlled
substance disposal if patients are unable to dispose of the medication
and there is no other person authorized to dispose of the controlled
substances.
Response: In response to this comment, the final rule modifies the
language of Sec. 1317.80(a), as proposed, which appeared to prohibit
LTCFs from using any disposal method other than a collection
receptacle. Under the final rule, LTCFs may dispose of controlled
substances on behalf of an ultimate user who resides, or has resided,
at such LTCF. 21 CFR 1317.30 and 1317.80. The DEA notes that the
decision to implement and manage a collection program for ultimate user
disposal is voluntary. It should be noted that LTCF residents are
ultimate users themselves and they, members of their households, and
persons lawfully entitled to dispose of a decedent's personal property,
may avail themselves of all disposal methods made available by this
rule. 21 CFR 1317.30.
[18] Issue: One commenter stated that the DEA did not consider
veterinary practices, prisons, or clinics when calculating the economic
impact analysis.
Response: In the proposed rule, the DEA considered veterinary
practices, prisons, and clinics in the accompanying calculations
concerning economic impact to the extent that these entities would be
registered as practitioners or non-practitioners. For the final rule,
the DEA calculated the economic impact on these entities to the extent
that they could become collectors. Not all registrants are eligible to
become authorized collectors. Of this specified list of entities
inquired about by the commenter, only a small subsection, specifically
hospitals/clinics with on-site pharmacies, may become authorized as
collectors in accordance with this final rule. 21 CFR 1317.40 and
1317.70.
P. Recordkeeping and Reporting (8 Issues)
[1] Issue: One commenter asked the DEA to clarify whether or not
the recordkeeping requirements in the rule apply to all registrants or
only authorized collectors.
Response: The new recordkeeping requirements contained in this rule
are applicable to all registrants, including authorized collectors. To
clarify this important distinction, the DEA moved the recordkeeping
provisions in proposed part 1317 to part 1304.
[2] Issue: Several commenters urged the DEA to remove the inventory
and recordkeeping requirements for mail-back packages and inner liners.
The commenters believe that such recordkeeping will be challenging and
provide limited benefits. One commenter suggested that the DEA instead
adopt tracking procedures currently used in some non-controlled
substance collection programs.
Response: As described in the NPRM, inventory and recordkeeping
requirements for collected substances are necessary for a number of
reasons, including accountability of collected substances within the
possession and control of authorized collectors. The inventory and
recordkeeping requirements included in this rule are generally
consistent with those otherwise required of registrants, thus
minimizing burden. The DEA believes that these inventory and
recordkeeping requirements are necessary to help minimize the risk of
diversion and to identify diversion of controlled substances destined
for destruction.
[3] Issue: One commenter suggested that the DEA eliminate ARCOS
reporting requirements for reverse distributors regarding collected
substances from ultimate users. Another commenter asked the DEA to
clarify what information is required for ARCOS reporting.
Response: In this final rule, Sec. 1304.33(g) (relocated from
proposed Sec. 1317.50) exempts reverse distributors and distributors
that acquire controlled substances from collectors or law enforcement
from reporting to ARCOS with respect to pharmaceutical controlled
substances collected through mail-back programs and collection
receptacles.
[4] Issue: One commenter asked the DEA to clarify what records
reverse distributors must keep when receiving collected substances from
law enforcement.
Response: The recordkeeping requirements in Sec. 1304.22(e)(4)
that apply to controlled substances acquired by registrants that
reverse distribute from collectors also apply to those acquired from
law enforcement. The final rule also adds a new paragraph in Sec.
1304.11(e)(3)(iii) specifying the information relating to controlled
substances acquired from collectors and law enforcement that a
registrant that reverse distributes must maintain in its inventories.
Under the revised Sec. 1304.03(a), these provisions relating to
reverse distributors apply to any entity that reverse distributes, as
defined in Sec. 1300.01(b), whether or not it is registered with the
DEA as a reverse distributor. Finally, the requirement in Sec.
1304.21(e) to maintain a DEA Form 41 applies to the destruction of a
sealed inner liner or mail-back package by a registrant that reverse
distributes.
[5] Issue: Commenters asked the DEA to clarify who is responsible
for tracking the mail-back packages, and how mail-back packages that
were disseminated but not returned to the authorized collector will be
reconciled with the inventory.
Response: There is currently no requirement for the authorized
collector to reconcile the inventory in order to
[[Page 53554]]
determine which packages were not returned. As discussed in the NPRM,
the DEA does not believe that requiring authorized collectors to
institute a tracking or notification system for ultimate users is
necessary at this time, although such systems are not prohibited so
long as the collector does not require the ultimate user to provide
personally identifiable information, as specified in Sec. 1317.70(d).
[6] Issue: Commenters asked the DEA to eliminate the following
recordkeeping requirements for inner liners: Tracking unused inner
liners on hand, recording the acquisition date, recording the
installation date, and the requirement that two employees witness the
removal and installation of inner liners.
Response: As previously discussed, the DEA believes that all of the
inventory and recordkeeping requirements in part 1304 are the minimum
necessary to ensure accountability and identify diversion.
[7] Issue: Two commenters asked the DEA if reporting to the FDA is
sufficient to satisfy the DEA's reporting requirements for cases of
controlled substance recalls.
Response: No. Regardless of any other Federal, State, tribal, or
local agency requirements, each registrant must maintain records and
make reports to the DEA in a manner consistent with the requirements of
chapter II of title 21 of the CFR.
[8] Issue: One commenter asked the DEA to clarify the recordkeeping
requirements of Sec. 1317.50(b)(2)(iii)--specifically, the requirement
to record the registration number of the collection location when the
collection occurs at a LTCF, which typically does not have a
registration number.
Response: The final rule moves the referenced requirements to new
Sec. 1304.22(f). The record should include the approved collection
location address of the LTCF and the authorized collector's
registration number.
Q. Hazardous Materials Transportation and Hazardous Waste Destruction
(3 Issues)
[1] Issue: Approximately 20 commenters expressed concern that the
requirements outlined in this rule for the transportation of collected
substances conflict with current regulations under the DOT's Pipeline
and Hazardous Materials Safety Administration (PHMSA). One concern
involved the comingling of collected substances that the DOT considers
``hazardous materials'' with nonhazardous materials or hazardous
materials of a different class. Other concerns included how inner
liners from collection receptacles that contain hazardous materials
should be labeled and packaged for transport, and other notice
requirements for hazardous waste under the DOT's PHMSA.
Response: All drug disposal activities must be conducted in a
manner consistent with this rule and all other applicable Federal,
State, tribal, and local laws and regulations. Compliance with the
destruction requirements outlined in subpart C of this rule does not
exempt any entity from complying with other Federal, State, tribal, or
local laws or regulations. It is not within DEA's expertise or
authority to opine what pharmaceutical controlled substances could be
hazardous materials subject to DOT regulations. However, the DEA
consulted with the DOT during various stages of this rulemaking. The
DEA has been informed that if collected substances include hazardous
materials, the transportation of those materials is subject to all
applicable DOT regulations, including the ``Hazardous Materials
Regulations'' (HMR). The DEA encourages entities to consult
www.phmsa.dot.gov/hazmat for information regarding the HMR. In
particular, the DEA encourages entities to contact the DOT's PHMSA
regarding its ``Approvals and Permits Program.'' PHMSA issues approvals
and special permits to entities that apply for authorization to use
agency approved alternatives to the HMR. Interested entities may
consult www.phmsa.dot.gov/hazmat/regs/sp-a. for more information. The
DEA has worked with the DOT to facilitate this process in an effort to
ensure maximum participation in the collection of controlled substances
for secure and responsible disposal, and the DEA will continue to work
with the DOT to facilitate registrant compliance with all applicable
laws and regulations. For these purposes, it should be noted that
sealed collection receptacle inner liners may be transported inside of
a shipping container that is labeled and packaged for transport with
the necessary notice requirements applicable to hazardous waste under
the DOT's PHMSA.
[2] Issue: One commenter asked whether or not law enforcement must
comply with the DOT's PHMSA requirements for transporting collected
substances that may contain hazardous materials.
Response: It is not within the DEA's expertise or authority to
opine on the applicability of DOT regulations. However, the DEA
believes that the DOT's Hazardous Materials Regulations apply to
entities that place hazardous materials in commercial transportation,
and not government vehicles operated by government personnel solely for
non-commercial purposes. However, State and local governments may have
different regulations that do apply to government entities or law
enforcement. The DEA encourages these entities to consult the DOT as
well as their State and local governments for specific guidance on
transporting collected substances that may contain hazardous materials.
[3] Issue: Commenters asked the DEA whether or not collected
substances must be destroyed as hazardous waste under the EPA's
Resource Conversation and Recovery Act (RCRA).
Response: It is not within the DEA's expertise or authority to
opine what pharmaceutical controlled substances could be hazardous
waste subject to EPA regulations. The DEA does not have the authority
to regulate hazardous waste and thus cannot advise on whether or not
collected substances must be destroyed as hazardous waste pursuant to
RCRA. However, the DEA has worked with the EPA at various stages of
this rulemaking, and the DEA continues to work with the EPA to ensure
the secure and responsible disposal of controlled substances, including
those that may be considered hazardous waste. The DEA believes that
there is a small portion of pharmaceuticals that are regulated as
hazardous waste, and an even smaller portion of pharmaceuticals that
are regulated as both controlled substances and hazardous waste.
However, pharmaceutical controlled substances that are collected
directly from ultimate users via mail-back programs or collection
receptacles may fall under RCRA's Household Hazardous Waste Exemption;
if so, EPA RCRA regulations would not apply in those instances. The DEA
acknowledges that some state and local regulations may be more
stringent.
The DEA is working with the EPA to ensure that this final rule will
enable LTCF residents to responsibly, securely, and safely dispose of
controlled substances that may also be considered hazardous waste.
Collected substances from LTCFs may pose a unique challenge since the
EPA currently uses a bifurcated system to determine whether
pharmaceutical waste from LTCFs must be treated as hazardous waste
under the RCRA. If the waste is generated by the resident, it does not
have to be treated as hazardous waste and is exempt under the Household
Hazardous Waste Exemption. If the waste is generated by the LTCF, it
must be treated as hazardous waste unless it is otherwise exempt.
Hazardous waste generated by LTCFs may be exempt if
[[Page 53555]]
the LTCF is a ``conditionally-exempt small quantity generator.'' To
qualify under such exemption, the LTCF must generate less than or equal
to 100 kilograms of non-acute hazardous waste, and less than or equal
to one kilogram of acute hazardous waste on a monthly basis. The DEA
believes that most LTCFs may qualify under this conditional exemption.
Also, the DEA acknowledges that many pharmaceuticals that are
recognized as acute hazardous waste (e.g., blood thinners) are non-
controlled substances. The DEA hopes that authorized collectors and
LTCFs will collaborate to minimize the impact that disposing of such
pharmaceuticals may have on collection efforts by separating these non-
controlled substances from controlled substances to be deposited into
collection receptacles.
The EPA is aware of the concerns regarding collected substances at
LTCFs, and according to the Fall 2013 Regulatory Agenda, the EPA is
currently drafting regulations to address hazardous waste
pharmaceuticals, including the small group of pharmaceutical controlled
substances that the EPA classifies as hazardous waste under the RCRA,
when discarded. According to the Regulatory Agenda, the EPA's proposal,
``Management Standards for Hazardous Waste Pharmaceuticals,'' may
propose to ``revise the regulations to improve management and disposal
of hazardous waste pharmaceuticals,'' and clarify regulation of reverse
distribution. The abstract for the proposal may be viewed at
www.reginfo.gov. Interested persons are encouraged to follow the
progress of this pending regulatory action.
The DEA encourages authorized collectors and others to seek
guidance directly from the EPA, and the DEA encourages such persons to
consult www.epa.gov for more information. All drug disposal and
destruction must be conducted in a manner consistent with this rule and
all other applicable Federal, State, tribal, and local laws and
regulations.
R. Transporting Collected Substances (3 Issues)
[1] Issue: One commenter indicated that transporting collected
substances directly to the destruction location will be virtually
impossible because drivers must stop for rest breaks.
Response: The DEA recognizes that transportation to destruction
facilities may occur over long distances. The requirement to transport
collected substances directly to the destruction facility means that
the collected substances should be constantly moving towards their
final destruction destination and unnecessary or unrelated stops, and
stops of an extended duration should not occur. The final rule in
Sec. Sec. 1317.05(b)(4) and 1317.95(c)(1) is modified to specify this
requirement, which is designed to reduce the opportunities for
diversion.
[2] Issue: Several commenters were concerned that this rule will
change their existing transport procedures that were already approved
by their local SAC.
Response: In promulgating this rule, the DEA carefully considered
the impact of these changes to existing procedures and is requiring the
minimum procedures necessary to ensure safe and secure means of
transporting controlled substances. The rule provides a nationwide
standard, and allows non-practitioners the flexibility to determine the
best method of transportation considering their own individual
circumstances while also ensuring accountability and reducing theft and
diversion risks. Any previous waivers, Memorandums of Understanding, or
Memorandums of Agreement issued in accordance with Sec. 1307.21 shall
be superseded by this final rule once it becomes effective. However,
practitioners may seek assistance from their local SAC pursuant to
Sec. 1317.05(a)(4).
[3] Issue: Other commenters sought guidance on whether or not the
DEA will limit the quantity of controlled substances that may be
transported, and whether or not there will be additional requirements
for interstate transport of collected substances.
Response: This final rule does not impose any transportation
quantity limits or any requirements specific to interstate transport of
controlled substances.
S. Miscellaneous Comments (2 Issues)
[1] Issue: Approximately eight commenters asked the DEA to expand
the rule to include procedures for controlled substances that have been
``partially administered'' or ``partially dispensed.'' These commenters
referred to institutional settings where transdermal patches are used,
as these used patches may contain residual amounts of controlled
substances.
Response: As previously discussed, destruction of the residual
amounts of controlled substances administered by a practitioner to a
patient that remain in the delivery apparatus (in this instance, the
transdermal patch) must continue to be recorded in accordance with
existing Sec. 1304.22(c). In accordance with the revised Sec.
1304.21, these destructions are not required to be recorded on DEA Form
41. All disposals of inventory must be accomplished in accordance with
Sec. 1317.05(a), and all other applicable recordkeeping and inventory
requirements.
[2] Issue: One commenter indicated that Sec. Sec. 1317.15 and
1317.95 may conflict in that Sec. 1317.15 allows for storage by a
reverse distributor while Sec. 1317.95 does not.
Response: The DEA has reviewed the relevant portions of this rule
and determined that Sec. Sec. 1317.15 and 1317.95 do not conflict.
Section 1317.15 encompasses the wider topic of reverse distributor
activities, including the acquisition and storage of controlled
substances from other registrants, whereas Sec. 1317.95 deals
exclusively with the actual destruction process and the procedures that
are required for destruction once substances are in the possession and
control of the reverse distributor (including securely stored
substances).
IV. Regulatory Analyses
Regulatory Flexibility Act
The Administrator, in accordance with the Regulatory Flexibility
Act of 1980 (RFA) (5 U.S.C. 601-612), has reviewed this rule and by
approving it certifies that it will not have a significant economic
impact on a substantial number of small entities. In developing this
rule, the DEA considered numerous alternatives for each requirement and
method of collection and evaluated the impact of this rule on small
entities. The DEA has concluded that the rule will not have a
significant economic impact on a substantial number of small entities.
The DEA updated the economic impact analysis after considering comments
made by the public in response to the NPRM. The updated economic impact
analysis of the final rule may be viewed in the rulemaking docket at
www.regulations.gov.
In developing this rule, the DEA considered several options for
both registrant and non-registrant disposal and reverse distributor
destruction requirements. The DEA analyzed alternative methodology
approaches keeping in mind its obligations under the CSA. The DEA
considered three options for non-registrant disposal: (1) ``Single
Collection,'' which would permit non-registrants to utilize only one
method of collection to dispose of their lawfully possessed controlled
substances; (2) ``Open Collection,'' which would authorize any person
to collect controlled substances from ultimate users for disposal,
regardless of their status as a registrant; and (3)
[[Page 53556]]
``Multiple Collection,'' which would authorize non-registrants to
utilize more than one method of collection to transfer controlled
substances for the purpose of disposal to law enforcement and certain
registrants. In addition, the DEA considered two options for registrant
disposal: (1) ``Retain Existing Regulations,'' which would make no
changes to the existing registrant disposal regulations (Sec. Sec.
1307.12 and 1307.21); and (2) ``Establish Consistent National
Standards,'' which would eliminate existing regulations on the disposal
of controlled substances (Sec. Sec. 1307.12 and 1307.21) and
promulgate a new part that would comprehensively outline the process
and procedure for the disposal of controlled substances by registrants
and non-registrants.
Finally, the DEA considered four options for reverse distributors:
(1) ``On-site Requirement,'' which would require reverse distributors
to have and utilize an on-site method of destruction; (2) ``Prompt
Requirement,'' which would require reverse distributors, like all other
registrants, to promptly destroy controlled substances; (3) ``No
Requirement,'' which would retain the current destruction standard and
would not put a deadline on when reverse distributors must destroy
controlled substances acquired for destruction; and (4) ``No Later Than
30 Calendar Day Requirement,'' which would require reverse distributors
to destroy controlled substances received for the purpose of
destruction no later than 30 calendar days from receipt. The DEA
performed a qualitative analysis of each of these alternatives and
selected the ``Multiple Collection'' option for non-registrant
disposal, the ``Establish Consistent National Standards'' option for
registrant disposal, and the ``No Later than 30 Calendar Day
Requirement'' option for reverse distributors.
In accordance with the RFA, the DEA evaluated the impact of this
rule on small entities. While all 1.5 million DEA registrants must
comply with the rule as it relates to the disposal of pharmaceutical
controlled substances, only a small subset of the registrants are
associated with activities where the rule imposes new mandatory
requirements or provides options for voluntary activities. Therefore,
the DEA examined the impact of two mandatory provisions in the rule:
The 30-day destruction requirement for reverse distributors and the two
employee transportation requirement for manufacturers, distributors,
and reverse distributors. Additionally, the DEA estimated the level of
voluntary participation in collection activities in accordance with the
rule and the resulting cost impact.
The mandatory provisions and voluntary participation activities are
estimated to affect 53,533 entities (439 manufacturers, 585
distributors, 55 reverse distributors, 656 narcotic treatment programs
(NTPs), 3,068 hospitals/clinics, 29,582 pharmacies, and 19,148 long
term care facilities (LTCFs). Of the 53,533 affected entities, 50,714
(423 manufacturers, 555 distributors, 38 reverse distributors, 610
NTPs, 1,346 hospitals/clinics, 29,328 pharmacies, and 18,414 long term
care facilities), or 94.7% are estimated to be small entities.
Both the 30-day destruction and the two employee transportation
requirements associated with the mandatory portions of the rule will
apply to the 55 reverse distributors that receive controlled substances
from other registrants for disposal, of which 38 were estimated to be
small entities. The potential increase in destruction, transport,
travel, and labor cost associated with these two requirements was
analyzed for each of the 38 small entities. Additionally, reverse
distributors with on-site destruction facilities may receive
authorization to voluntarily operate a mail-back program. The DEA
estimates that the three small reverse distributors with on-site
destruction facilities will each operate a mail-back program. The DEA
does not estimate that any reverse distributors will operate collection
receptacles at their registered locations because of the small numbers
of employees that work at those locations. However, reverse
distributors will be impacted by the destruction of controlled
substances from collection receptacles that are transferred to them for
destruction. The total estimated cost of the mandatory portions and
voluntary participation aspects of the rule was compared to the
estimated annual revenue for each of the small reverse distributors.
The economic impact of the mandatory portion and voluntary
participation aspects of this rule is estimated to be significant,
greater than one percent of annual revenue, for two (5%) of 38 affected
small businesses.
The two-person transportation requirement associated with the
mandatory portions of the rule also affects 423 small manufacturers and
555 small distributors that transport to reverse distributors or to an
unregistered, off-site location for destruction. The potential increase
in labor cost associated with the two-person requirement was analyzed
for manufacturers and distributors. Additionally, a small number of
manufacturers and distributors are estimated to volunteer to operate
collection receptacles at their registered locations primarily for use
by their employees. However, the DEA believes that manufacturers and
distributors will not operate collection receptacles at their
registered locations unless they believe there will be a benefit to
them for the service. The economic impact of the mandatory portion and
voluntary participation aspects of this rule is estimated to be
significant for none (0.0%) of the 423 small manufacturers and none
(0.0%) of the 555 small distributors.
The rule also permits certain other registrant categories to
voluntarily conduct collection activities. The DEA estimates some
retail pharmacies, hospitals/clinics with on-site pharmacies, and NTPs
will voluntarily participate as collectors by operating collection
receptacles at their locations. Some retail pharmacies and hospitals/
clinics with an on-site pharmacy are also estimated to operate
collection receptacles at LTCFs. The level of participation and
operating costs were estimated to determine the number of small
entities with impact greater than 1% of revenue.
In summary, the DEA estimates that zero (0.0%) of the 423 small
manufacturers, zero (0.0%) of the 555 small distributors, two (5.0%) of
38 small reverse distributors, 62 (10.2%) of the small NTPs, zero
(0.0%) of the 1,349 small hospitals/clinics, 810 (2.8%) of the 29,328
small pharmacies, and zero (0.0%) of the 18,414 small long term care
facilities may be significantly impacted by this rule (that is, where
the annual cost is estimated to be greater than 1% of annual revenue).
But DEA emphasizes that these estimates are entirely dependent on the
level of voluntary participation by these entities. All of the
provisions relating to collection activities by manufacturers,
distributors, NTPs, hospitals/clinics, pharmacies, and LTCFs are
completely voluntary and these entities would be free to choose whether
or not to participate based on their own review of the cost to them and
the anticipated benefits in providing collection receptacles.
In total, the DEA estimates that 874 (1.7%) of the 50,714 affected
small entities may be significantly affected by this rule. The DEA's
assessment of economic impact by size category indicates that the rule
will not have a significant effect on a substantial number of these
small business entities.
In accordance with the RFA (5 U.S.C. 605(b)), the Administrator
hereby certifies that this rulemaking has been
[[Page 53557]]
drafted consistent with the RFA, that a regulatory analysis on the
effects or impacts of this rulemaking on small entities has been done,
and that the rule will not have a significant economic impact on a
substantial number of small entities.
Executive Orders 12866 and 13563
This rule was developed in accordance with the principles of
Executive Orders 12866 and 13563. Based on the completed economic
analysis, the DEA does not anticipate that this rulemaking will have an
annual effect on the economy of $100 million or more or adversely
affect, in a material way, the economy, a sector of the economy,
productivity, competition, jobs, the environment, public health or
safety, or State, local, or tribal governments or communities. An
economic analysis of the final rule can be found in the rulemaking
docket at www.regulations.gov. Public comment was received in public
meetings held on January 19-20, 2011, and through a solicitation for
comment in the NPRM to help inform and develop these rules. Although
not an economically significant rule, this rule on the disposal of
controlled substances has been reviewed by the Office of Management and
Budget (OMB).
The DEA has determined that reverse distributors currently destroy
controlled substances within the ``No Later than 30 Calendar Day''
requirement the majority of the time. However, it is recognized that
there may be instances when reverse distributors do not currently meet
this requirement. Additionally, many manufacturers, distributors, and
reverse distributors currently employ two persons to transport
controlled substances for destruction. However, it is recognized that
there may be instances when manufacturers, distributors, and reverse
distributors do not currently meet this requirement. For these
instances, the DEA estimated the cost to accommodate the requirements
and has determined the cost is not a significant economic impact.
Moreover, the DEA estimated a range of costs of voluntary
participation for manufacturers, distributors, reverse distributors,
narcotic treatment programs, hospitals/clinics with an on-site
pharmacy, and retail pharmacies that may participate to collect
ultimate user pharmaceutical controlled substances.
In summary, the DEA estimates that the annual total cost to the
economy as a result of the rule is $2,719,319 for the mandatory
provisions of this rule and the total annualized cost of the mandatory
provisions and the voluntary participation aspects of the rule ranges
from $44,896,787 to $73,222,427. The DEA estimates the highest cost in
any given year occurs in the first year, ranging from $45,282,242 to
$99,075,339. Accordingly, the DEA does not anticipate that this
rulemaking will have an annual effect on the economy of $100 million or
more or adversely affect in a material way the economy, a sector of the
economy, productivity, competition, jobs, the environment, public
health or safety, or State, local, or tribal governments or
communities.
Since the aspects of the rule that facilitate non-registrant
disposal are completely voluntary (not mandated), manufacturers,
distributors, reverse distributors, narcotic treatment programs,
hospitals/clinics with an on-site pharmacy, and retail pharmacies may
become collectors if they choose to engage in the voluntary activities
based on its own evaluation of costs and benefits (tangible and
intangible). For the purposes of this analysis, the DEA assumes that an
entity will volunteer to perform the activities to facilitate non-
registrant disposal only if there is a net zero or positive benefit to
the entity. For example, a pharmacy may derive tangible benefits, such
as additional revenue from increased retail traffic to the pharmacy.
Collectors may also derive tangible benefits such as public safety and
good will from their collection activities. Any collector that chooses
to engage in these voluntary activities can decide to cease these
activities at any time. Therefore, for the purposes of this analysis,
the DEA estimates that the cost of the voluntary participation aspects
of this rule are offset by the benefits of the voluntary participation
aspects of this rule and have a net zero economic impact. The total
cost of the mandatory provisions and voluntary participation aspects of
the rule ($73,222,427 at the highest voluntary participation rate) is
compared to the benefit of this rule. In evaluating the costs and
benefits of the rule, the annual cost of the rule is compared with the
anticipated reduction in the growth rate of costs associated with
diversion of controlled substances into the illicit market. The cost-
benefit analysis uses the costs associated with the nonmedical use of
prescription opioids, $8.6 billion in 2001 \7\ and $53.4 billion in
2006.\8\ These are conservative estimates of the rapidly growing total
cost associated with diversion of controlled substances into the
illicit market. Although there is a lack of evidence to quantify the
cost savings or public health impacts of the rule, the DEA believes
that this rule reduces the growth in the cost of the diversion of
controlled substances into the illicit market by at least $44.9 to
$73.2 million annually and, therefore, this rule will have positive net
economic benefits, including benefits related to the health and safety
of the citizens and residents of the United States.
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\7\ Clin. J. Pain (The Clinical Journal of Pain), Volume 22,
Number 8, October 2006.
\8\ Clin. J. Pain (The Clinical Journal of Pain), Volume 27,
Number 3, March/April 2011.
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Paperwork Reduction Act
Pursuant to Sec. 3507(d) of the Paperwork Reduction Act of 1995
(PRA) (44 U.S.C. 3501 et seq.), the DEA has identified the following
collections of information related to this rule and has submitted these
collection requests to the OMB for review and approval. This rule
implements the Disposal Act, in addition to reorganizing and
consolidating existing regulations on disposal into a comprehensive
regulatory framework for the destruction of controlled substances. In
accordance with the CSA, which establishes a closed system of
distribution for all controlled substances, registrants are required to
make a biennial inventory and maintain, on a current basis, a complete
and accurate record of each controlled substance manufactured,
received, sold, delivered, or otherwise disposed of. 21 U.S.C. 827(a)
and 958. These records must be in accordance with and contain such
relevant information as may be required by regulations promulgated by
the DEA. 21 U.S.C. 827(b)(1).
In this rule, the DEA revises existing, and adds a minimum amount
of new, registrant recordkeeping requirements. These requirements are
consistent with requirements already required by statute and
regulation.
Title: Implementation of Registrant Recordkeeping Requirements Pursuant
to the CSA, 21 U.S.C. 827
The records that registrants are required to maintain pursuant to
law are a vital component of the DEA's enforcement and control
responsibilities--such records alert the DEA to problems of diversion
and ensure that the system of controlled substances distribution is
open only to legitimate handlers of such substances.
The DEA is revising the information that reverse distributors are
currently required to record for clarity and consistency, and adding a
minimum amount of new requirements. For all controlled substance
records, reverse distributors will be required to maintain their
existing business records so that
[[Page 53558]]
the record of receipt is maintained with the corresponding record of
return or destruction. By maintaining all relevant business records
together, the DEA will be able to trace each substance received by a
reverse distributor from its acquisition to its disposition, whether by
destruction or return to the manufacturer.
The DEA estimates that there will be 60 respondents to this
information collection and that their estimated frequency of response
will vary because, in accordance with 21 U.S.C. 827 and 958,
registrants make an initial and biennial inventory and maintain, on a
current basis, a complete and accurate record of each controlled
substance manufactured, received, sold, delivered, or otherwise
disposed of. Under existing law, reverse distributors are required to
maintain, for at least two years, inventory records and records of
controlled substances received, delivered, destroyed, or returned to
the manufacturer. The annual hour burden for recordkeeping for reverse
distributors is estimated to increase by 34 hours due to the
requirements in this final rule, and the annualized cost to respondents
is estimated to be $719. The DEA is also modifying information that
registrants are required to record in the return and recall process.
The DEA is eliminating the previous rule on return and recall, Sec.
1307.12, and implementing separate rules on the return and recall of
controlled substances for registrants and non-registrants in part 1317.
The return and recall recordkeeping requirements reflect these changes.
The DEA estimates that the universe of potential respondents to
this information collection will be 1,511,389 respondents (all
registrants may transfer controlled substances for return or recall).
The DEA estimates that the frequency of response will vary, because, in
accordance with 21 U.S.C. 827(a), registrants must make an initial and
biennial inventory and maintain, on a current basis, a complete and
accurate record of each controlled substance manufactured, received,
sold, delivered, or otherwise disposed of. Because registrants are
already required to maintain records in accordance with 21 U.S.C.
827(a)-(b), the DEA anticipates that the annual hour burden will not be
increased by this rule.
The DEA is implementing new recordkeeping requirements for
registrants that collect controlled substances from ultimate users and
other non-registrants in accordance with the new authority provided in
the Disposal Act. The implementation of the Disposal Act regulations
will provide ultimate users, LTCFs, and other non-registrants safe and
convenient options to transfer controlled substances for the purpose of
disposal: Take-back events, mail-back programs, and collection
receptacles. Registered manufacturers, distributors, reverse
distributors, narcotic treatment programs, hospitals/clinics with an
on-site pharmacy, and retail pharmacies may obtain authorization from
the DEA to be a collector pursuant to Sec. 1317.40. A collector is a
registered manufacturer, distributor, reverse distributor, narcotic
treatment program, hospital/clinic with an on-site pharmacy, or retail
pharmacy that is authorized under this rule to receive a pharmaceutical
controlled substance from an ultimate user for the purpose of
destruction, as defined in part 1300. The DEA is requiring information
that collectors must record based on the particular ultimate user
collection method implemented (i.e., mail-back program or collection
receptacle).
The DEA estimates that the universe of potential participants to
this information collection will be 87,736 respondents (Manufacturers--
536, Distributors--829, Reverse Distributors--60, Narcotic Treatment
Programs--1,332, Hospitals/Clinics--15,953, Retail Pharmacies--
69,026).\9\ However, the DEA estimates that the participants to this
information collection will be 54,457 respondents (Manufacturers--107,
Distributors--166, Reverse Distributors--10, Narcotic Treatment
Programs--999, Hospitals/Clinics--2862, Retail Pharmacies--34,513, and
an additional 15,800 hospitals/clinics and retail pharmacies operating
collection receptacles at LTCFs). The DEA estimates that the frequency
of response will vary, because, in accordance with 21 U.S.C. 827(a),
registrants must make an initial and biennial inventory and maintain,
on a current basis, a complete and accurate record of each controlled
substance manufactured, received, sold, delivered, or otherwise
disposed of. The DEA notes, however, that the option to become a
collector is voluntary and no entity is required to establish or
operate a disposal program as a collector. While the authorization to
collect is a new activity, the DEA has estimated the level of
participation. The estimated 54,457 respondents are estimated to have
an annualized hour burden of 89,406 with an estimated annualized cost
of $1,670,064. The DEA will continue to monitor and analyze the
potential burden of the new requirements imposed by this rule.
---------------------------------------------------------------------------
\9\ The universe of potential participants includes all
registrants that could potentially become collectors. It is likely
that this estimate will be adjusted downward once the DEA obtains
more information.
---------------------------------------------------------------------------
The DEA is authorizing reverse distributors to acquire controlled
substances from law enforcement and authorized collectors that have
acquired controlled substances from ultimate users and other non-
registrants. The DEA is also authorizing distributors to acquire
controlled substances from authorized collectors that collect
controlled substances from ultimate users. The DEA is requiring these
reverse distributors and distributors to maintain complete and accurate
records, in accordance with part 1304, of controlled substances
received, delivered, or otherwise transferred for the purpose of
destruction.
The DEA estimates that the universe of potential respondents to
this information collection will be 889 respondents (Distributors--829,
Reverse Distributors--60). The DEA estimates that the frequency of
response will vary, because, in accordance with 21 U.S.C. 827(a),
registrants must make an initial and biennial inventory and maintain,
on a current basis, a complete and accurate record of each controlled
substance manufactured, received, sold, delivered, or otherwise
disposed of. The authorization for reverse distributors to acquire
controlled substances collected by law enforcement and collectors, and
the authorization for distributors to acquire controlled substances
from collectors, is new. Although the DEA has estimated the level of
participation, the DEA is unable to estimate the number of information
collection events because destruction of multiple acquisitions of
controlled substances can be on a single form. The DEA's initial
estimate for the annual hour burden is 472 hours (32 minutes per
event), with an estimated annualized cost of $10,037. The DEA will
continue to analyze the potential burden of the new requirements
imposed by this rule.
Title: Registrant Record of Controlled Substances Destroyed--DEA Form
41
OMB Control Number: 1117-0007.
Form Number: DEA Form 41.
The records that registrants are required to maintain pursuant to
law are a vital component of the DEA's enforcement and control
responsibilities--such records alert the DEA to diversion and ensure
that the system of controlled substances distribution is open only to
legitimate handlers of such substances. The DEA is requiring
registrants involved in the destruction of controlled substances to
record certain information. The record
[[Page 53559]]
of destruction must include the signature of the two employees of the
registrant that witnessed the destruction, in addition to other
information about the controlled substance disposed of and the method
of destruction utilized. The DEA is modifying existing DEA Form 41 to
record the destruction of controlled substances that remain in the
closed system of distribution and to account for registrant destruction
of controlled substances collected from ultimate users and other non-
registrants outside the closed system pursuant to the Disposal Act. DEA
Form 41 has previously been approved by the OMB and assigned OMB
control number 1117-0007. In accordance with the CSA, registrants that
destroy controlled substances and utilize DEA Form 41 will be required
to keep and make available the information in the specified format, for
at least two years, for inspection and copying by officers or employees
of the United States authorized by the Attorney General. 21 U.S.C.
827(b).
The DEA estimates that there will be 87,736 respondents
(Manufacturers--536, Distributors--829, Reverse Distributors--60,
Narcotic Treatment Programs--1,332, Hospitals/Clinics--15,953, Retail
Pharmacies--69,026) to this information collection. The number of
respondents (87,736) represents the total number of registrants in
business activities that are most likely to destroy controlled
substances. The DEA estimates that the frequency of response will vary,
because in accordance with 21 U.S.C. 827(a), registrants must maintain,
on a current basis, a complete and accurate record of each controlled
substance manufactured, received, sold, delivered, or otherwise
disposed of, and, as a result, will make a record of destruction each
time they destroy a controlled substance. The DEA estimates that the
average time per response will be 30 minutes and that the total annual
burden will be 43,868 hours, with an estimated total annual cost burden
of $928,247.
Executive Order 12988
This rule meets the applicable standards set forth in Sec. Sec.
3(a) and 3(b)(2) of Executive Order 12988 to eliminate ambiguity,
minimize litigation, establish clear legal standards, and reduce
burden.
Executive Order 13132
This rulemaking does not preempt or modify any provision of State
law, impose enforcement responsibilities on any State or diminish the
power of any State to enforce its own laws. Accordingly, this
rulemaking does not have federalism implications warranting the
application of Executive Order 13132.
National Environmental Policy Act (NEPA)
This rule provides options for the collection of controlled
substances by registrants and non-registrants consistent with DEA
regulations and Federal, State, tribal, and local laws and regulations.
Provision of these options is intended to result in increased
collection and destruction of unused controlled substances and thereby
prevent diversion of such unused substances to illicit uses and result
in collection and destruction of larger quantities in economical and
environmentally sound manners. This rule establishes legal requirements
for the handling of controlled substances. Destruction of controlled
substances must be consistent with Federal, State, tribal and local
laws and regulations.
The DEA and registrants have disposed of controlled substances
since passage of the CSA. By regulation, the U.S. Department of Justice
categorically excluded the DEA from further NEPA analysis with respect
to regulations relating to the storage and destruction of controlled
substances. This rule does not authorize any new methods of storage,
transportation, or destruction of controlled substances, but is limited
to the procedures and records pertaining to the collection of
controlled substances for destruction. Accordingly, this proposed rule
does not significantly affect the quality of the human environment. The
DEA has, therefore, determined that this rule does not have significant
individual or cumulative effects on the human environment and is
excluded from detailed analysis pursuant to 28 CFR part 61, Appendix B.
Unfunded Mandates Reform Act
In accordance with the Unfunded Mandates Reform Act (UMRA) of 1995
(2 U.S.C. 1501 et seq.), on the basis of information contained in the
``Regulatory Flexibility Act'' section above, the DEA has determined
and certifies pursuant to the UMRA that this action would not result in
any Federal mandate that may result ``in the expenditure by State,
local, and tribal governments, in the aggregate, or by the private
sector, of $100,000,000 or more (adjusted for inflation) in any one
year. . . .'' Therefore, neither a Small Government Agency Plan nor any
other action is required under provisions of the UMRA of 1995.
Executive Order 13175
This rule does not have tribal implications warranting the
application of Executive Order 13175. The rule does not have
substantial direct effects on one or more Indian tribes, on the
relationship between the Federal Government and Indian tribes, or on
the distribution of power and responsibilities between the Federal
Government and Indian tribes.
Congressional Review Act
This rule is not a major rule as defined by the Congressional
Review Act (5 U.S.C. 804). This rule will not result in an annual
effect on the economy of $100,000,000 or more, a major increase in
costs or prices, or have significant adverse effects on competition,
employment, investment, productivity, innovation, or the ability of
United States-based companies to compete with foreign based companies
in domestic and export markets.
Rule Text
List of Subjects
21 CFR Part 1300
Chemicals, Drug traffic control.
21 CFR Part 1301
Administrative practice and procedure, Drug traffic control,
Security measures.
21 CFR Part 1304
Drug traffic control, Reporting and recordkeeping requirements.
21 CFR Part 1305
Drug traffic control.
21 CFR Part 1307
Drug traffic control.
21 CFR Part 1317
Drug traffic control, Security measures.
For the reasons stated in the preamble, the DEA amends 21 CFR
chapter II as follows:
PART 1300--DEFINITIONS
0
1-2. The authority citation for part 1300 is revised to read as
follows:
Authority: 21 U.S.C. 802, 821, 822, 829, 871(b), 951, 958(f).
0
3. In Sec. 1300.01, amend paragraph (b) as follows:
0
a. Revise the introductory text;
0
b. Add a definition of ``Collection'' in alphabetical order;
0
c. Revise the last sentence in the definition of ``Freight forwarding
facility'';
0
d. Add a definition of ``Reverse distribute'' in alphabetical order;
and
[[Page 53560]]
0
e. Revise the definition of ``Reverse distributor''.
The revisions and additions read as follows:
Sec. 1300.01 Definitions relating to controlled substances.
* * * * *
(b) As used in parts 1301 through 1308, 1312, and 1317 of this
chapter, the following terms shall have the meanings specified:
* * * * *
Collection means to receive a controlled substance for the purpose
of destruction from an ultimate user, a person lawfully entitled to
dispose of an ultimate user decedent's property, or a long-term care
facility on behalf of an ultimate user who resides or has resided at
that facility. The term collector means a registered manufacturer,
distributor, reverse distributor, narcotic treatment program, hospital/
clinic with an on-site pharmacy, or retail pharmacy that is authorized
under this chapter to so receive a controlled substance for the purpose
of destruction.
* * * * *
Freight forwarding facility * * * For purposes of this definition,
a distributing registrant is a person who is registered with the
Administration as a manufacturer, distributor (excluding reverse
distributor), and/or importer.
* * * * *
Reverse distribute means to acquire controlled substances from
another registrant or law enforcement for the purpose of:
(1) Return to the registered manufacturer or another registrant
authorized by the manufacturer to accept returns on the manufacturer's
behalf; or
(2) Destruction.
Reverse distributor is a person registered with the Administration
as a reverse distributor.
* * * * *
0
4. Add Sec. 1300.05 to read as follows:
Sec. 1300.05 Definitions relating to the disposal of controlled
substances.
(a) Any term not defined in this part or elsewhere in this chapter
shall have the definition set forth in section 102 of the Act (21
U.S.C. 802).
(b) As used in part 1317 of this chapter, the following terms shall
have the meanings specified:
Employee means an employee as defined under the general common law
of agency. Some of the factors relevant to the determination of
employee status include: The hiring party's right to control the manner
and means by which the product is accomplished; the skill required; the
source of the instrumentalities and tools; the location of the work;
the duration of the relationship between the parties; whether the
hiring party has the right to assign additional projects to the hired
party; the extent of the hired party's discretion over when and how
long to work; the method of payment; the hired party's role in hiring
and paying assistants; whether the work is part of the regular business
of the hiring party; whether the hiring party is in business; the
provision of employee benefits; and the tax treatment of the hired
party. Other applicable factors may be considered and no one factor is
dispositive. The following criteria will determine whether a person is
an employee of a registrant for the purpose of disposal: The person is
directly paid by the registrant; subject to direct oversight by the
registrant; required, as a condition of employment, to follow the
registrant's procedures and guidelines pertaining to the handling of
controlled substances; subject to receive a performance rating or
performance evaluation on a regular/routine basis from the registrant;
subject to disciplinary action by the registrant; and required to
render services at the registrant's registered location.
Law enforcement officer means a person who is described in
paragraph (1), (2) or (3) of this definition:
(1) Meets all of the following criteria:
(i) Employee of either a law enforcement agency, or law enforcement
component of a Federal agency;
(ii) Is under the direction and control of a Federal, State,
tribal, or local government;
(iii) Acting in the course of his/her official duty; and
(iv) Duly sworn and given the authority by a Federal, State,
tribal, or local government to carry firearms, execute and serve
warrants, make arrests without warrant, and make seizures of property;
(2) Is a Veterans Health Administration (VHA) police officer
authorized by the Department of Veterans Affairs to participate in
collection activities conducted by the VHA; or
(3) Is a Department of Defense (DOD) police officer authorized by
the DOD to participate in collection activities conducted by the DOD.
Non-retrievable means, for the purpose of destruction, the
condition or state to which a controlled substance shall be rendered
following a process that permanently alters that controlled substance's
physical or chemical condition or state through irreversible means and
thereby renders the controlled substance unavailable and unusable for
all practical purposes. The process to achieve a non-retrievable
condition or state may be unique to a substance's chemical or physical
properties. A controlled substance is considered ``non-retrievable''
when it cannot be transformed to a physical or chemical condition or
state as a controlled substance or controlled substance analogue. The
purpose of destruction is to render the controlled substance(s) to a
non-retrievable state and thus prevent diversion of any such substance
to illicit purposes.
On-site means located on or at the physical premises of the
registrant's registered location. A controlled substance is destroyed
on-site when destruction occurs on the physical premises of the
destroying registrant's registered location. A hospital/clinic has an
on-site pharmacy when it has a pharmacy located on the physical
premises of the registrant's registered location.
PART 1301--REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND
DISPENSERS OF CONTROLLED SUBSTANCES
0
5. The authority citation for part 1301 is revised to read as follows:
Authority: 21 U.S.C. 821, 822, 823, 824, 831, 871(b), 875, 877,
886a, 951, 952, 953, 956, 957, 958, 965.
0
6. In Sec. 1301.13, revise paragraphs (e)(1)(i) and (ii) to read as
follows:
Sec. 1301.13 Application for registration; time for application;
expiration date; registration for independent activities; application
forms, fees, contents and signature; coincident activities.
* * * * *
(e) * * *
(1)
[[Page 53561]]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Application fee Registration Coincident activities
Business activity Controlled substances DEA application forms ($) period (years) allowed
--------------------------------------------------------------------------------------------------------------------------------------------------------
(i) Manufacturing..................... Schedules I-V............ New--225 Renewal--225a... 3,047 1 Schedules I-V: May
distribute that
substance or class for
which registration was
issued; may not
distribute any
substance or class for
which not registered.
............... ............... Schedules II-V: May
conduct chemical
analysis and
preclinical research
(including quality
control analysis) with
substances listed in
those schedules for
which authorization as
a mfr. was issued.
(ii) Distributing..................... Schedules I-V............ New--225 Renewal--225a... 1,523 1 May acquire Schedules II-
V controlled substances
from collectors for the
purposes of
destruction.
* * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
* * * * *
0
7. In Sec. 1301.25, revise paragraph (i) to read as follows:
Sec. 1301.25 Registration regarding ocean vessels, aircraft, and
other entities.
* * * * *
(i) Controlled substances acquired and possessed in accordance with
this section shall be distributed only to persons under the general
supervision of the medical officer employed by the owner or operator of
the vessel, aircraft, or other entity, except in accordance with part
1317 of this chapter.
0
8. Revise Sec. 1301.51 to read as follows:
Sec. 1301.51 Modification in registration.
(a) Any registrant may apply to modify his/her registration to
authorize the handling of additional controlled substances or to change
his/her name or address by submitting a written request to the
Registration Unit, Drug Enforcement Administration. See the Table of
DEA Mailing Addresses in Sec. 1321.01 of this chapter for the current
mailing address. Additionally, such a request may be submitted on-line
at www.DEAdiversion.usdoj.gov.
(1) The request shall contain:
(i) The registrant's name, address, and registration number as
printed on the certificate of registration;
(ii) The substances and/or schedules to be added to the
registration or the new name or address; and
(iii) A signature in accordance with Sec. 1301.13(j).
(2) If the registrant is seeking to handle additional controlled
substances listed in Schedule I for the purpose of research or
instructional activities, the registrant shall attach three copies of a
research protocol describing each research project involving the
additional substances, or two copies of a statement describing the
nature, extent, and duration of such instructional activities, as
appropriate.
(b) Any manufacturer, distributor, reverse distributor, narcotic
treatment program, hospital/clinic with an on-site pharmacy, or retail
pharmacy registered pursuant to this part, may apply to modify its
registration to become authorized as a collector by submitting a
written request to the Registration Unit, Drug Enforcement
Administration. See the Table of DEA Mailing Addresses in Sec. 1321.01
of this chapter for the current mailing address. Additionally, such
request may be submitted on-line at www.DEAdiversion.usdoj.gov.
(1) The request shall contain:
(i) The registrant's name, address, and registration number as
printed on the certificate of registration;
(ii) The method(s) of collection the registrant intends to conduct
(collection receptacle and/or mail-back program); and
(iii) A signature in accordance with Sec. 1301.13(j).
(2) If a hospital/clinic with an on-site pharmacy or retail
pharmacy is applying for a modification in registration to authorize
such registrant to be a collector to maintain a collection receptacle
at a long-term care facility in accordance with Sec. 1317.80 of this
chapter, the request shall also include the name and physical location
of each long-term care facility at which the hospital/clinic with an
on-site pharmacy, or the retail pharmacy, intends to operate a
collection receptacle.
(c) No fee shall be required for modification. The request for
modification shall be handled in the same manner as an application for
registration. If the modification of registration is approved, the
Administrator shall issue a new certificate of registration (DEA Form
223) to the registrant, who shall maintain it with the old certificate
of registration until expiration.
0
9. In Sec. 1301.52, revise the last sentence of paragraph (c) and add
paragraph (f) to read as follows:
Sec. 1301.52 Termination of registration; transfer of registration;
distribution upon discontinuance of business.
* * * * *
(c) * * * Any controlled substances in his/her possession may be
disposed of in accordance with part 1317 of this chapter.
* * * * *
(f) Any registrant that has been authorized as a collector and
desires to discontinue its collection of controlled substances from
ultimate users shall notify the Administration of its intent by
submitting a written notification to the Registration Unit, Drug
Enforcement Administration. See the Table of DEA Mailing Addresses in
Sec. 1321.01 of this chapter for the current mailing address.
Additionally, such notice may be submitted on-line at
www.DEAdiversion.usdoj.gov. When ceasing collection activities of an
authorized mail-back program, the registrant shall provide the
Administration with the name, registered address, and registration
number of the collector that will receive the remaining mail-back
packages in accordance with Sec. 1317.70(e)(3) of this chapter.
0
10. In Sec. 1301.71, add paragraph (f) to read as follows:
Sec. 1301.71 Security requirements generally.
* * * * *
(f) A collector shall not employ, as an agent or employee who has
access to or influence over controlled substances acquired by
collection, any person who has been convicted of any felony offense
relating to controlled substances or who, at any time, had an
application for registration with DEA denied, had a DEA registration
revoked or suspended,
[[Page 53562]]
or has surrendered a DEA registration for cause. For purposes of this
subsection, ``for cause'' means in lieu of, or as a consequence of, any
Federal or State administrative, civil, or criminal action resulting
from an investigation of the individual's handling of controlled
substances.
0
11. In Sec. 1301.72, revise paragraph (a) introductory text to read as
follows:
Sec. 1301.72 Physical security controls for non-practitioners;
narcotic treatment programs, and compounders for narcotic treatment
programs; storage areas.
(a) Schedules I and II. Raw material, bulk materials awaiting
further processing, finished products which are controlled substances
listed in Schedule I or II (except GHB that is manufactured or
distributed in accordance with an exemption under section 505(i) of the
Federal Food Drug and Cosmetic Act which shall be subject to the
requirements of paragraph (b) of this section), and sealed mail-back
packages and inner liners acquired in accordance with part 1317 of this
chapter, shall be stored in one of the following secured areas:
* * * * *
0
12. In Sec. 1301.74, add paragraph (m) to read as follows:
Sec. 1301.74 Other security controls for non-practitioners; narcotic
treatment programs and compounders for narcotic treatment programs.
* * * * *
(m) A reverse distributor shall not employ, as an agent or employee
who has access to or influence over controlled substances, any person
who has been convicted of any felony offense relating to controlled
substances or who, at any time, had an application for registration
with the DEA denied, had a DEA registration revoked or suspended, or
has surrendered a DEA registration for cause. For purposes of this
subsection, ``for cause'' means in lieu of, or as a consequence of, any
Federal or State administrative, civil, or criminal action resulting
from an investigation of the individual's handling of controlled
substances.
0
13. In Sec. 1301.75, redesignate paragraphs (c) and (d) as paragraphs
(d) and (e) and add a new paragraph (c) to read as follows:
Sec. 1301.75 Physical security controls for practitioners.
* * * * *
(c) Sealed mail-back packages and inner liners collected in
accordance with part 1317 of this chapter shall only be stored at the
registered location in a securely locked, substantially constructed
cabinet or a securely locked room with controlled access, except as
authorized by Sec. 1317.80(d).
* * * * *
0
14. In Sec. 1301.76, revise paragraph (c) to read as follows:
Sec. 1301.76 Other security controls for practitioners.
* * * * *
(c) Whenever the registrant distributes a controlled substance
(without being registered as a distributor as permitted in Sec. Sec.
1301.13(e)(1), 1307.11, 1317.05, and/or 1317.10 of this chapter), he/
she shall comply with the requirements imposed on non-practitioners in
Sec. 1301.74(a), (b), and (e).
* * * * *
PART 1304--RECORDS AND REPORTS OF REGISTRANTS
0
15. The authority citation for part 1304 is revised to read as follows:
Authority: 21 U.S.C. 821, 827, 831, 871(b), 958(e)-(g), and
965, unless otherwise noted.
0
16. Amend Sec. 1304.03 by revising the first and second sentences of
paragraph (a) to read as follows:
Sec. 1304.03 Persons required to keep records and file reports.
(a) Every registrant, including collectors, shall maintain the
records and inventories and shall file the reports required by this
part, except as exempted by this section. Any registrant that is
authorized to conduct other activities without being registered to
conduct those activities, pursuant to Sec. Sec. 1301.22(b), 1307.11,
1307.13, or part 1317 of this chapter, shall maintain the records and
inventories and shall file the reports required by this part for
persons registered or authorized to conduct such activities. * * *
* * * * *
0
17. In Sec. 1304.04, add paragraph (a)(3) to read as follows:
Sec. 1304.04 Maintenance of records and inventories.
(a) * * *
(3) A collector that is authorized to maintain a collection
receptacle at a long-term care facility shall keep all records required
by this part relating to those collection receptacles at the registered
location, or other approved central location.
* * * * *
0
18. In Sec. 1304.11, revise paragraphs (e) introductory text and
(e)(2) and (3) and add paragraphs (e)(6) and (7) to read as follows:
Sec. 1304.11 Inventory requirements.
* * * * *
(e) Inventories of manufacturers, distributors, registrants that
reverse distribute, importers, exporters, chemical analysts,
dispensers, researchers, and collectors. Each person registered or
authorized (by Sec. Sec. 1301.13, 1307.11, 1307.13, or part 1317 of
this chapter) to manufacture, distribute, reverse distribute, dispense,
import, export, conduct research or chemical analysis with controlled
substances, or collect controlled substances from ultimate users, and
required to keep records pursuant to Sec. 1304.03 shall include in the
inventory the information listed below.
* * * * *
(2) Inventories of distributors. Each person registered or
authorized to distribute controlled substances shall include in the
inventory the same information required of manufacturers pursuant to
paragraphs (e)(1)(iii) and (iv) of this section.
(3) Inventories of registrants that reverse distribute. Each person
registered or authorized to reverse distribute controlled substances
shall include in the inventory, the following information:
(i) The name of the substance, and
(ii) The total quantity of the substance:
(A) For controlled substances in bulk form, to the nearest metric
unit weight consistent with unit size;
(B) For each controlled substance in finished form: Each finished
form of the substance (e.g., 10-milligram tablet or 10-milligram
concentration per fluid ounce or milliliter); the number of units or
volume of each finished form in each commercial container (e.g., 100-
tablet bottle or 3-milliliter vial); and the number of commercial
containers of each such finished form (e.g., four 100-tablet bottles or
six 3-milliliter vials); and
(C) For controlled substances in a commercial container, carton,
crate, drum, or other receptacle that has been opened: If the substance
is listed in Schedule I or II, make an exact count or measure of the
contents; or if the substance is listed in Schedule III, IV, or V, make
an estimated count or measure of the contents, unless the container
holds more than 1,000 tablets or capsules in which case an exact count
of the contents shall be made; or
(iii) For controlled substances acquired from collectors and law
enforcement: The number and size (e.g., five 10-gallon liners, etc.) of
sealed inner liners on hand, or
(iv) For controlled substances acquired from law enforcement: the
[[Page 53563]]
number of sealed mail-back packages on hand.
* * * * *
(6) Inventories of dispensers and researchers. Each person
registered or authorized to dispense or conduct research with
controlled substances shall include in the inventory the same
information required of manufacturers pursuant to paragraphs
(e)(1)(iii) and (iv) of this section. In determining the number of
units of each finished form of a controlled substance in a commercial
container that has been opened, the dispenser or researcher shall do as
follows:
(i) If the substance is listed in Schedules I or II, make an exact
count or measure of the contents; or
(ii) If the substance is listed in Schedule III, IV, or V, make an
estimated count or measure of the contents, unless the container holds
more than 1,000 tablets or capsules in which case he/she must make an
exact count of the contents.
(7) Inventories of collectors. Each registrant authorized to
collect controlled substances from ultimate users shall include in the
inventory the following information:
(i) For registrants authorized to collect through a mail-back
program, the record shall include the following information about each
unused mail-back package and each returned mail-back package on hand
awaiting destruction:
(A) The date of the inventory;
(B) The number of mail-back packages; and
(C) The unique identification number of each package on hand,
whether unused or awaiting destruction.
(ii) For registrants authorized to collect through a collection
receptacle, the record shall include the following information about
each unused inner liner on hand and each sealed inner liner on hand
awaiting destruction:
(A) The date of the inventory;
(B) The number and size of inner liners (e.g., five 10-gallon
liners, etc.);
(C) The unique identification number of each inner liner.
0
19. In Sec. 1304.21, revise paragraphs (a), (c), and (d) and add
paragraph (e) to read as follows:
Sec. 1304.21 General requirements for continuing records.
(a) Every registrant required to keep records pursuant to Sec.
1304.03 shall maintain, on a current basis, a complete and accurate
record of each substance manufactured, imported, received, sold,
delivered, exported, or otherwise disposed of by him/her, and each
inner liner, sealed inner liner, and unused and returned mail-back
package, except that no registrant shall be required to maintain a
perpetual inventory.
* * * * *
(c) Separate records shall be maintained by a registrant for each
independent activity and collection activity for which he/she is
registered or authorized, except as provided in Sec. 1304.22(d).
(d) In recording dates of receipt, importation, distribution,
exportation, other transfers, or destruction, the date on which the
controlled substances are actually received, imported, distributed,
exported, otherwise transferred, or destroyed shall be used as the date
of receipt, importation, distribution, exportation, transfer, or
destruction (e.g., invoices, packing slips, or DEA Form 41).
(e) Record of destruction. In addition to any other recordkeeping
requirements, any registered person that destroys a controlled
substance pursuant to Sec. 1317.95(d), or causes the destruction of a
controlled substance pursuant to Sec. 1317.95(c), shall maintain a
record of destruction on a DEA Form 41. The records shall be complete
and accurate, and include the name and signature of the two employees
who witnessed the destruction. Except, destruction of a controlled
substance dispensed by a practitioner for immediate administration at
the practitioner's registered location, when the substance is not fully
exhausted (e.g., some of the substance remains in a vial, tube, or
syringe after administration but cannot or may not be further
utilized), shall be properly recorded in accordance with Sec.
1304.22(c), and such record need not be maintained on a DEA Form 41.
0
20. In Sec. 1304.22, revise the section heading, introductory text,
and paragraph (e) and add paragraph (f) to read as follows:
Sec. 1304.22 Records for manufacturers, distributors, dispensers,
researchers, importers, exporters, registrants that reverse distribute,
and collectors.
Each person registered or authorized (by Sec. Sec. 1301.13(e),
1307.11, 1307.13, or part 1317 of this chapter) to manufacture,
distribute, dispense, import, export, reverse distribute, destroy,
conduct research with controlled substances, or collect controlled
substances from ultimate users, shall maintain records with the
information listed in paragraphs (a) through (f) of this section.
* * * * *
(e) Records for registrants that reverse distribute. Each person
registered or authorized to reverse distribute controlled substances
shall maintain records with the following information for each
controlled substance:
(1) For controlled substances acquired for the purpose of return or
recall to the manufacturer or another registrant authorized by the
manufacturer to accept returns on the manufacturer's behalf pursuant to
part 1317 of this chapter:
(i) The date of receipt; the name and quantity of each controlled
substance received; the name, address, and registration number of the
person from whom the substance was received; and the reason for return
(e.g., recall or return); and
(ii) The date of return to the manufacturer or other registrant
authorized by the manufacturer to accept returns on the manufacturer's
behalf; the name and quantity of each controlled substance returned;
the name, address, and registration number of the person from whom the
substance was received; the name, address, and registration number of
the registrant to whom the substance was returned; and the method of
return (e.g., common or contract carrier).
(2) For controlled substances acquired from registrant inventory
for destruction pursuant to Sec. 1317.05(a)(2), (b)(2), and (b)(4) of
this chapter:
(i) The date of receipt; the name and quantity of each controlled
substance received; and the name, address, and registration number of
the person from whom the substance was received; and
(ii) The date, place, and method of destruction; the name and
quantity of each controlled substance destroyed; the name, address, and
registration number of the person from whom the substance was received;
and the name and signatures of the two employees of the registrant that
witnessed the destruction.
(3) The total quantity of each controlled substance shall be
recorded in accordance with the following:
(i) For controlled substances in bulk form: To the nearest metric
unit weight or volume consistent with unit size;
(ii) For controlled substances in finished form: Each finished form
(e.g., 10-milligram tablet or 10-milligram concentration per fluid
ounce or milliliter); the number of units or volume of finished form in
each commercial container (e.g., 100-tablet bottle or 3-milliliter
vial); and the number of commercial containers of each such finished
form (e.g., four 100-tablet bottles or six 3-milliliter vials); and
(iii) For controlled substances in a commercial container, carton,
crate, drum, or other receptacle that has been opened: If the substance
is listed in
[[Page 53564]]
Schedule I or II make an exact count or measure of the contents; or if
the substance is listed in Schedule III, IV, or V, make an estimated
count or measure of the contents, unless the container holds more than
1,000 tablets or capsules in which case an exact count of the contents
shall be made.
(4) For each sealed inner liner acquired from collectors or law
enforcement and each sealed mail-back package acquired from law
enforcement pursuant to Sec. 1317.55 of this chapter:
(i) The number of sealed inner liners acquired from other persons,
including the date of acquisition, the number and, for sealed inner
liners the size (e.g., five 10-gallon liners, etc.), of all sealed
inner liners and mail-back packages acquired to inventory, the unique
identification number of each sealed inner liner and mail-back package,
and the name, address, and, for registrants, the registration number of
the person from whom the sealed inner liners and mail-back packages
were received, and
(ii) The date, place, and method of destruction; the number of
sealed inner liners and mail-back packages destroyed; the name,
address, and, for registrants, the registration number of the person
from whom the sealed inner liners and mail-back packages were received;
the number and, for sealed inner liners the size (e.g., five 10-gallon
liners, etc.), of all sealed inner liners and mail-back packages
destroyed; the unique identification number of each sealed inner liner
and sealed mail-back package destroyed; and the name and signatures of
the two employees of the registrant that witnessed the destruction.
(5) For all records, the record of receipt shall be maintained
together with the corresponding record of return or destruction (DEA
Form 41).
(f) Records for collectors. Each person registered or authorized to
collect controlled substances from ultimate users shall maintain the
following records:
(1) Mail-Back Packages:
(i) For unused packages that the collector makes available to
ultimate users and other authorized non-registrants at the collector's
registered address: The date made available, the number of packages,
and the unique identification number of each package;
(ii) For unused packages provided to a third party to make
available to ultimate users and other authorized non-registrants: The
name of the third party and physical address of the location receiving
the unused packages, date sent, and the number of unused packages sent
with the corresponding unique identification numbers;
(iii) For sealed mail-back packages received by the collector: Date
of receipt and the unique identification number on the individual
package; and
(iv) For sealed mail-back packages destroyed on-site by the
collector: Number of sealed mail-back packages destroyed, the date and
method of destruction, the unique identification number of each mail-
back package destroyed, and the names and signatures of the two
employees of the registrant who witnessed the destruction.
(2) Collection receptacle inner liners:
(i) Date each unused inner liner acquired, unique identification
number and size (e.g., 5-gallon, 10-gallon, etc.) of each unused inner
liner acquired;
(ii) Date each inner liner is installed, the address of the
location where each inner liner is installed, the unique identification
number and size (e.g., 5-gallon, 10-gallon, etc.) of each installed
inner liner, the registration number of the collector, and the names
and signatures of the two employees that witnessed each installation;
(iii) Date each inner liner is removed and sealed, the address of
the location from which each inner liner is removed, the unique
identification number and size (e.g., 5-gallon, 10-gallon, etc.) of
each inner liner removed, the registration number of the collector, and
the names and signatures of the two employees that witnessed each
removal;
(iv) Date each sealed inner liner is transferred to storage, the
unique identification number and size (e.g., 5-gallon, 10-gallon, etc.)
of each sealed inner liner stored, and the names and signatures of the
two employees that transferred each sealed inner liner to storage;
(v) Date each sealed inner liner is transferred for destruction,
the address and registration number of the reverse distributor or
distributor to whom each sealed inner liner was transferred, the unique
identification number and the size (e.g., 5-gallon, 10-gallon, etc.) of
each sealed inner liner transferred, and the names and signatures of
the two employees that transferred each sealed inner liner to the
reverse distributor or distributor; and
(vi) For sealed inner liners destroyed on-site by the collector:
The same information required of reverse distributors in paragraph
(e)(4)(ii) of this section.
0
21. In Sec. 1304.25, revise the section heading and paragraphs (a)(9)
and (b)(9) to read as follows:
Sec. 1304.25 Records for treatment programs that compound narcotics
for treatment programs and other locations.
* * * * *
(a) * * *
(9) The quantity disposed of by destruction, including the reason,
date, and manner of destruction.
(b) * * *
(9) The number of units of finished forms and/or commercial
containers destroyed in any manner by the registrant, including the
reason, date, and manner of destruction.
0
22. Amend Sec. 1304.33 by revising the section heading and paragraph
(f) and adding paragraph (g) to read as follows:
Sec. 1304.33 Reports to Automation of Reports and Consolidated Orders
System (ARCOS).
* * * * *
(f) Exceptions. (1) A registered institutional practitioner that
repackages or relabels exclusively for distribution or that distributes
exclusively to (for dispensing by) agents, employees, or affiliated
institutional practitioners of the registrant may be exempted from
filing reports under this section by applying to the ARCOS Unit of the
Administration.
(2) Registrants that acquire recalled controlled substances from
ultimate users pursuant to Sec. 1317.85 of this chapter may report as
a single transaction all recalled controlled substances of the same
name and finished form (e.g., all 10-milligram tablets or all 5-
milligram concentration per fluid ounce or milliliter) received from
ultimate users for the purpose of reporting acquisition transactions.
(g) Exemptions. (1) Collectors that acquire controlled substances
from ultimate users are exempt from the ARCOS reporting requirements
only with respect to controlled substances collected through mail-back
programs and collection receptacles for the purpose of disposal.
(2) Reverse distributors and distributors that acquire controlled
substances pursuant to Sec. 1317.55(a) or (b) of this chapter are
exempt from the ARCOS reporting requirements in this section with
regard to any controlled substances acquired pursuant to Sec.
1317.55(a) or (b) of this chapter.
* * * * *
PART 1305--ORDERS FOR SCHEDULE I AND II CONTROLLED SUBSTANCES
0
23. The authority citation for part 1305 continues to read as follows:
Authority: 21 U.S.C. 821, 828, 871(b), unless otherwise noted.
0
24. In Sec. 1305.03, add paragraphs (e), (f), and (g) to read as
follows:
Sec. 1305.03 Distributions requiring a Form 222 or a digitally signed
electronic order.
* * * * *
[[Page 53565]]
(e) Deliveries to an authorized DEA registrant by an ultimate user,
a long-term care facility on behalf of an ultimate user who resides or
has resided at that facility, or a person authorized to dispose of the
ultimate user decedent's property.
(f) Distributions to reverse distributors and distributors by
collectors and law enforcement pursuant to Sec. 1317.55 of this
chapter.
(g) Deliveries of controlled substances from ultimate users for the
purpose of recalls pursuant to Sec. 1317.85 of this chapter.
PART 1307--MISCELLANEOUS
0
25. The authority citation for part 1307 continues to read as follows:
Authority: 21 U.S.C. 821, 822(d), 871(b), unless otherwise
noted.
0
26. In Sec. 1307.11, revise section heading and remove and reserve
paragraph (a)(2).
The revision reads as follows:
Sec. 1307.11 Distribution by dispenser to another practitioner.
* * * * *
Sec. 1307.12 [Removed]
0
27. Remove Sec. 1307.12.
0
28. Revise Sec. 1307.13 to read as follows:
Sec. 1307.13 Incidental manufacture of controlled substances.
Any registered manufacturer who, incidentally but necessarily,
manufactures a controlled substance as a result of the manufacture of a
controlled substance or basic class of controlled substance for which
he is registered and has been issued an individual manufacturing quota
pursuant to part 1303 of this chapter (if such substance or class is
listed in Schedule I or II) shall be exempt from the requirement of
registration pursuant to part 1301 of this chapter and, if such
incidentally manufactured substance is listed in Schedule I or II,
shall be exempt from the requirement of an individual manufacturing
quota pursuant to part 1303 of this chapter, if such substances are
disposed of in accordance with part 1317 of this chapter.
Sec. 1307.21 [Removed]
0
29. Remove Sec. 1307.21.
0
30. In Sec. 1307.22, revise the section heading and the first sentence
to read as follows:
Sec. 1307.22 Delivery of surrendered and forfeited controlled
substances.
Any controlled substance surrendered by delivery to the
Administration under part 1317 of this chapter or forfeited pursuant to
section 511 of the Act (21 U.S.C. 881) may be delivered to any
department, bureau, or other agency of the United States or of any
State upon proper application addressed to the Office of Diversion
Control, Drug Enforcement Administration.
* * * * *
0
31. Add part 1317 to read as follows:
PART 1317--DISPOSAL
Sec.
1317.01 Scope.
Subpart A--Disposal of Controlled Substances by Registrants
1317.05 Registrant disposal.
1317.10 Registrant return or recall.
1317.15 Reverse distributor registration requirements and authorized
activities.
Subpart B--Disposal of Controlled Substances Collected From Ultimate
Users and Other Non-Registrants
1317.30 Authorization to collect from non-registrants.
1317.35 Collection by law enforcement.
1317.40 Registrants authorized to collect and authorized collection
activities.
1317.55 Reverse distributor and distributor acquisition of
controlled substances from collectors or law enforcement.
1317.60 Inner liner requirements.
1317.65 Take-back events.
1317.70 Mail-back programs.
1317.75 Collection receptacles.
1317.80 Collection receptacles at long-term care facilities.
1317.85 Ultimate user delivery for the purpose of recall or
investigational use of drugs.
Subpart C--Destruction of Controlled Substances
1317.90 Methods of destruction.
1317.95 Destruction procedures.
Authority: 21 U.S.C. 821, 822, 823, 827, 828, 871(b), and 958.
Sec. 1317.01 Scope.
This part sets forth the rules for the delivery, collection, and
destruction of damaged, expired, returned, recalled, unused, or
otherwise unwanted controlled substances that are lawfully possessed by
registrants (subpart A) and non-registrants (subpart B). The purpose of
such rules is to provide prompt, safe, and effective disposal methods
while providing effective controls against the diversion of controlled
substances.
Subpart A--Disposal of Controlled Substances by Registrants
Sec. 1317.05 Registrant disposal.
(a) Practitioner inventory. Any registered practitioner in lawful
possession of a controlled substance in its inventory that desires to
dispose of that substance shall do so in one of the following ways:
(1) Promptly destroy that controlled substance in accordance with
subpart C of this part using an on-site method of destruction;
(2) Promptly deliver that controlled substance to a reverse
distributor's registered location by common or contract carrier pick-up
or by reverse distributor pick-up at the registrant's registered
location;
(3) For the purpose of return or recall, promptly deliver that
controlled substance by common or contract carrier pick-up or pick-up
by other registrants at the registrant's registered location to: The
registered person from whom it was obtained, the registered
manufacturer of the substance, or another registrant authorized by the
manufacturer to accept returns or recalls on the manufacturer's behalf;
or
(4) Request assistance from the Special Agent in Charge of the
Administration in the area in which the practitioner is located.
(i) The request shall be made by submitting one copy of the DEA
Form 41 to the Special Agent in Charge in the practitioner's area. The
DEA Form 41 shall list the controlled substance or substances which the
registrant desires to dispose.
(ii) The Special Agent in Charge shall instruct the registrant to
dispose of the controlled substance in one of the following manners:
(A) By transfer to a registrant authorized to transport or destroy
the substance;
(B) By delivery to an agent of the Administration or to the nearest
office of the Administration; or
(C) By destruction in the presence of an agent of the
Administration or other authorized person.
(5) In the event that a practitioner is required regularly to
dispose of controlled substances, the Special Agent in Charge may
authorize the practitioner to dispose of such substances, in accordance
with subparagraph (a)(4) of this section, without prior application in
each instance, on the condition that the practitioner keep records of
such disposals and file periodic reports with the Special Agent in
Charge summarizing the disposals. The Special Agent in Charge may place
such conditions as he/she deems proper on practitioner procedures
regarding the disposal of controlled substances.
(b) Non-practitioner inventory. Any registrant that is a non-
practitioner in lawful possession of a controlled substance in its
inventory that desires to dispose of that substance shall do so in one
of the following ways:
[[Page 53566]]
(1) Promptly destroy that controlled substance in accordance with
subpart C of this part using an on-site method of destruction;
(2) Promptly deliver that controlled substance to a reverse
distributor's registered location by common or contract carrier or by
reverse distributor pick-up at the registrant's registered location;
(3) For the purpose of return or recall, promptly deliver that
controlled substance by common or contract carrier or pick-up at the
registrant's registered location to: The registered person from whom it
was obtained, the registered manufacturer of the substance, or another
registrant authorized by the manufacturer to accept returns or recalls
on the manufacturer's behalf; or
(4) Promptly transport that controlled substance by its own means
to the registered location of a reverse distributor, the location of
destruction, or the registered location of any person authorized to
receive that controlled substance for the purpose of return or recall
as described in paragraph (b)(3) of this section.
(i) If a non-practitioner transports controlled substances by its
own means to an unregistered location for destruction, the non-
practitioner shall do so in accordance with the procedures set forth at
Sec. 1317.95(c).
(ii) If a non-practitioner transports controlled substances by its
own means to a registered location for any authorized purpose,
transportation shall be directly to the authorized registered location
and two employees of the transporting non-practitioner shall accompany
the controlled substances to the registered destination location.
Directly transported means the substances shall be constantly moving
towards their final location and unnecessary or unrelated stops and
stops of an extended duration shall not occur.
(c) Collected controlled substances. Any collector in lawful
possession of a controlled substance acquired by collection from an
ultimate user or other authorized non-registrant person shall dispose
of that substance in the following ways:
(1) Mail-back program. Upon receipt of a sealed mail-back package,
the collector shall promptly:
(i) Destroy the package in accordance with subpart C of this part
using an on-site method of destruction; or
(ii) Securely store the package and its contents at the collector's
registered location in a manner consistent with Sec. 1301.75(c) of
this chapter (for practitioners), or in a manner consistent with the
security requirements for Schedule II controlled substances (for non-
practitioners) until prompt on-site destruction can occur.
(2) Collection receptacles. Upon removal from the permanent outer
container, the collector shall seal it and promptly:
(i) Destroy the sealed inner liner and its contents;
(ii) Securely store the sealed inner liner and its contents at the
collector's registered location in a manner consistent with Sec.
1301.75(c) of this chapter (for practitioners), or in a manner
consistent with Sec. 1301.72(a) of this chapter (for non-
practitioners) until prompt destruction can occur; or
(iii) Securely store the sealed inner liner and its contents at a
long-term care facility in accordance with Sec. 1317.80(d).
(iv) Practitioner methods of destruction. Collectors that are
practitioners (i.e., retail pharmacies and hospitals/clinics) shall
dispose of sealed inner liners and their contents by utilizing any
method in paragraph (a)(1), (a)(2), or (a)(4) of this section, or by
delivering sealed inner liners and their contents to a distributor's
registered location by common or contract carrier pick-up or by
distributor pick-up at the collector's authorized collection location.
(v) Non-practitioner methods of destruction. Collectors that are
non-practitioners (i.e., manufacturers, distributors, narcotic
treatment programs, and reverse distributors) shall dispose of sealed
inner liners and their contents by utilizing any method in paragraph
(b)(1), (b)(2), or (b)(4) of this section, or by delivering sealed
inner liners and their contents to a distributor's registered location
by common or contract carrier or by distributor pick-up at the
collector's authorized collection location for destruction. Freight
forwarding facilities may not be utilized to transfer sealed inner
liners and their contents.
Sec. 1317.10 Registrant return or recall.
(a) Each registrant shall maintain a record of each return or
recall transaction in accordance with the information required of
manufacturers in Sec. 1304.22(a)(2)(iv) of this chapter.
(b) Each registrant that delivers a controlled substance in
Schedule I or II for the purpose of return or recall shall use an order
form in the manner described in part 1305 of this chapter.
(c) Deliveries for the purpose of return or recall may be made
through a freight forwarding facility operated by the person to whom
the controlled substance is being returned provided that advance notice
of the return is provided and delivery is directly to an agent or
employee of the person to whom the controlled substance is being
returned.
Sec. 1317.15 Reverse distributor registration requirements and
authorized activities.
(a) Any person that reverse distributes a controlled substance
shall be registered with the Administration as a reverse distributor,
unless exempted by law or otherwise authorized pursuant to this
chapter.
(b) A reverse distributor shall acquire controlled substances from
a registrant pursuant to Sec. Sec. 1317.05 and 1317.55(a) and (c) in
the following manner:
(1) Pick-up controlled substances from a registrant at the
registrant's registered location or authorized collection site; or
(2) Receive controlled substances delivered by common or contract
carrier or delivered directly by a non-practitioner registrant.
(i) Delivery to the reverse distributor by an authorized registrant
directly or by common or contract carrier may only be made to the
reverse distributor at the reverse distributor's registered location.
Once en route, such deliveries may not be re-routed to any other
location or person, regardless of registration status.
(ii) All controlled substance deliveries to a reverse distributor
shall be personally received by an employee of the reverse distributor
at the registered location.
(c) Upon acquisition of a controlled substance by delivery or pick-
up, a reverse distributor shall:
(1) Immediately store the controlled substance, in accordance with
the security controls in parts 1301 and 1317 of this chapter, at the
reverse distributor's registered location or immediately transfer the
controlled substance to the reverse distributor's registered location
for secure storage, in accordance with the security controls in parts
1301 and 1317 of this chapter, until timely destruction or prompt
return of the controlled substance to the registered manufacturer or
other registrant authorized by the manufacturer to accept returns or
recalls on the manufacturer's behalf;
(2) Promptly deliver the controlled substance to the manufacturer
or another registrant authorized by the manufacturer to accept returns
or recalls on the manufacturer's behalf; or
(3) Timely destroy the controlled substance in a manner authorized
in subpart C of this part.
(d) A reverse distributor shall destroy or cause the destruction of
any controlled substance received for the purpose of destruction no
later than 30 calendar days after receipt.
[[Page 53567]]
Subpart B--Disposal of Controlled Substances Collected From
Ultimate Users and Other Non-Registrants
Sec. 1317.30 Authorization to collect from non-registrants.
(a) The following persons are authorized to collect controlled
substances from ultimate users and other non-registrants for
destruction in compliance with this chapter:
(1) Any registrant authorized by the Administration to be a
collector pursuant to Sec. 1317.40; and
(2) Federal, State, tribal, or local law enforcement when in the
course of official duties and pursuant to Sec. 1317.35.
(b) The following non-registrant persons in lawful possession of a
controlled substance in Schedules II, III, IV, or V may transfer that
substance to the authorized persons listed in paragraph (a) of this
section, and in a manner authorized by this part, for the purpose of
disposal:
(1) An ultimate user in lawful possession of a controlled
substance;
(2) Any person lawfully entitled to dispose of a decedent's
property if that decedent was an ultimate user who died while in lawful
possession of a controlled substance; and
(3) A long-term care facility on behalf of an ultimate user who
resides or resided at such long-term care facility and is/was in lawful
possession of a controlled substance, in accordance with Sec. 1317.80
only.
Sec. 1317.35 Collection by law enforcement.
(a) Federal, State, tribal, or local law enforcement may collect
controlled substances from ultimate users and persons lawfully entitled
to dispose of an ultimate user decedent's property using the following
collection methods:
(1) Take-back events in accordance with Sec. 1317.65;
(2) Mail-back programs in accordance with Sec. 1317.70; or
(3) Collection receptacles located inside law enforcement's
physical address.
(b) Law enforcement that conducts a take-back event or a mail-back
program or maintains a collection receptacle should maintain any
records of removal, storage, or destruction of the controlled
substances collected in a manner that is consistent with that agency's
recordkeeping requirements for illicit controlled substances evidence.
(c) Any controlled substances collected by law enforcement through
a take-back event, mail-back program, or collection receptacle should
be stored in a manner that prevents the diversion of controlled
substances and is consistent with that agency's standard procedures for
storing illicit controlled substances.
(d) Any controlled substances collected by law enforcement through
a take-back event, mail-back program, or collection receptacle should
be transferred to a destruction location in a manner that prevents the
diversion of controlled substances and is consistent with that agency's
standard procedures for transferring illicit controlled substances.
(e) Law enforcement that transfers controlled substances collected
from ultimate users pursuant to this part to a reverse distributor for
destruction should maintain a record that contains the following
information: If a sealed inner liner as described in Sec. 1317.60 is
used, the unique identification number of the sealed inner liner
transferred, and the size of the sealed inner liner transferred (e.g.,
5-gallon, 10-gallon, etc.); if a mail-back package as described in
Sec. 1317.70 is used, the unique identification number of each
package; the date of the transfer; and the name, address, and
registration number of the reverse distributor to whom the controlled
substances were transferred.
Sec. 1317.40 Registrants authorized to collect and authorized
collection activities.
(a) Manufacturers, distributors, reverse distributors, narcotic
treatment programs, hospitals/clinics with an on-site pharmacy, and
retail pharmacies that desire to be collectors shall modify their
registration to obtain authorization to be a collector in accordance
with Sec. 1301.51 of this chapter. Authorization to be a collector is
subject to renewal. If a registrant that is authorized to collect
ceases activities as a collector, such registrant shall notify the
Administration in accordance with Sec. 1301.52(f) of this chapter.
(b) Collection by registrants shall occur only at the following
locations:
(1) Those registered locations of manufacturers, distributors,
reverse distributors, narcotic treatment programs, hospitals/clinics
with an on-site pharmacy, and retail pharmacies that are authorized for
collection; and
(2) Long-term care facilities at which registered hospitals/clinics
or retail pharmacies are authorized to maintain collection receptacles.
(c) Collectors may conduct the following activities:
(1) Receive and destroy mail-back packages pursuant to Sec.
1317.70 at an authorized registered location that has an on-site method
of destruction;
(2) Install, manage, and maintain collection receptacles located at
their authorized collection location(s) pursuant to Sec. Sec. 1317.75
and 1317.80; and
(3) Promptly dispose of sealed inner liners and their contents as
provided for in Sec. 1317.05(c)(2).
Sec. 1317.55 Reverse distributor and distributor acquisition of
controlled substances from collectors or law enforcement.
(a) A reverse distributor is authorized to acquire controlled
substances from law enforcement that collected the substances from
ultimate users. A reverse distributor is authorized to acquire
controlled substances collected through a collection receptacle in
accordance with Sec. Sec. 1317.75 and 1317.80.
(b) A distributor is authorized to acquire controlled substances
collected through a collection receptacle in accordance with Sec. Sec.
1317.75 and 1317.80.
(c) A reverse distributor or a distributor that acquires controlled
substances in accordance with paragraph (a) or (b) of this section
shall:
(1) Acquire the controlled substances in the manner authorized for
reverse distributors in Sec. 1317.15(b)(1) and (2);
(2) Dispose of the controlled substances in the manner authorized
for reverse distributors Sec. 1317.15(c) and (d); and
(3) Securely store the controlled substances in a manner consistent
with the security requirements for Schedule II controlled substances
until timely destruction can occur.
Sec. 1317.60 Inner liner requirements.
(a) An inner liner shall meet the following requirements:
(1) The inner liner shall be waterproof, tamper-evident, and tear-
resistant;
(2) The inner liner shall be removable and sealable immediately
upon removal without emptying or touching the contents;
(3) The contents of the inner liner shall not be viewable from the
outside when sealed;
(4) The size of the inner liner shall be clearly marked on the
outside of the liner (e.g., 5-gallon, 10-gallon, etc.); and
(5) The inner liner shall bear a permanent, unique identification
number that enables the inner liner to be tracked.
(b) Access to the inner liner shall be restricted to employees of
the collector.
(c) The inner liner shall be sealed by two employees immediately
upon removal from the permanent outer container and the sealed inner
liner shall not be opened, x-rayed, analyzed, or otherwise penetrated.
[[Page 53568]]
Sec. 1317.65 Take-back events.
(a) Federal, State, tribal, or local law enforcement may conduct a
take-back event and collect controlled substances from ultimate users
and persons lawfully entitled to dispose of an ultimate user decedent's
property in accordance with this section. Any person may partner with
law enforcement to hold a collection take-back event in accordance with
this section.
(b) Law enforcement shall appoint a law enforcement officer
employed by the agency to oversee the collection. Law enforcement
officers employed and authorized by the law enforcement agency or law
enforcement component of a Federal agency conducting a take-back event
shall maintain control and custody of the collected substances from the
time the substances are collected from the ultimate user or person
authorized to dispose of the ultimate user decedent's property until
secure transfer, storage, or destruction of the controlled substances
has occurred.
(c) Each take-back event should have at least one receptacle for
the collection of controlled substances. The collection receptacle
should be a securely locked, substantially constructed container with
an outer container and a removable inner liner as specified in Sec.
1317.60 of this chapter. The outer container should include a small
opening that allows contents to be added to the inner liner, but that
does not allow removal of the inner liner's contents.
(d) Only those controlled substances listed in Schedule II, III,
IV, or V that are lawfully possessed by an ultimate user or person
entitled to dispose of an ultimate user decedent's property may be
collected. Controlled and non-controlled substances may be collected
together and be comingled, although comingling is not required.
(e) Only ultimate users and persons entitled to dispose of an
ultimate user decedent's property in lawful possession of a controlled
substance in Schedule II, III, IV, or V may transfer such substances to
law enforcement during the take-back event. No other person may handle
the controlled substances at any time.
Sec. 1317.70 Mail-back programs.
(a) A mail-back program may be conducted by Federal, State, tribal,
or local law enforcement or any collector. A collector conducting a
mail-back program shall have and utilize at their registered location a
method of destruction consistent with Sec. 1317.90 of this chapter.
(b) Only those controlled substances listed in Schedule II, III,
IV, or V that are lawfully possessed by an ultimate user or person
lawfully entitled to dispose of an ultimate user decedent's property
may be collected. Controlled and non-controlled substances may be
collected together and be comingled, although comingling is not
required.
(c) Collectors or law enforcement that conduct a mail-back program
shall make packages available (for sale or for free) as specified in
this paragraph to ultimate users and persons lawfully entitled to
dispose of an ultimate user decedent's property, for the collection of
controlled substances by common or contract carrier. Any person may
partner with a collector or law enforcement to make such packages
available in accordance with this section. The packages made available
shall meet the following specifications:
(1) The package shall be nondescript and shall not include any
markings or other information that might indicate that the package
contains controlled substances;
(2) The package shall be water- and spill-proof; tamper-evident;
tear-resistant; and sealable;
(3) The package shall be preaddressed with and delivered to the
collector's registered address or the participating law enforcement's
physical address;
(4) The cost of shipping the package shall be postage paid;
(5) The package shall have a unique identification number that
enables the package to be tracked; and
(6) The package shall include instructions for the user that
indicate the process for mailing back the package, the substances that
can be sent, notice that packages may only be mailed from within the
customs territory of the United States (the 50 States, the District of
Columbia, and Puerto Rico), and notice that only packages provided by
the collector will be accepted for destruction.
(d) Ultimate users and persons lawfully entitled to dispose of an
ultimate user decedent's property shall not be required to provide any
personally identifiable information when mailing back controlled
substances to a collector. The collector or law enforcement may
implement a system that allows ultimate users or persons lawfully
entitled to dispose of an ultimate user decedent's property to notify
the collector or law enforcement that they are sending one of the
designated packages by giving the unique identification number on the
package.
(e) A collector that conducts a mail-back program pursuant to
paragraph (a) shall:
(1) Accept only those controlled substances contained within
packages that the collector made available for the collection of
controlled substances by mail and packages that are lawfully forwarded
to the collector pursuant to paragraph (e)(3) of this section.
(2) Within three business days of receipt, notify the Field
Division Office of the Administration in their area of the receipt of a
package that likely contains controlled substances that the collector
did not make available or did not agree to receive pursuant to
subparagraph (e)(3) of this section.
(3) When discontinuing activities as a collector or ceasing an
authorized mail-back program:
(i) Make a reasonable effort to notify the public prior to
discontinuing such activities or ceasing the authorized mail-back
program; and
(ii) Obtain the written agreement of another collector that has and
utilizes at its registered location a method of destruction consistent
with Sec. 1317.90 of this chapter to receive all remaining mail-back
packages that were disseminated but not returned and arrange for the
forwarding of only such packages to that location.
(f) Only law enforcement officers employed by the law enforcement
agency or law enforcement component of a Federal agency and employees
of the collector shall handle packages received through an authorized
mail-back program. Upon receipt of a mail-back package by a collector
conducting a mail-back program, the package shall not be opened, x-
rayed, analyzed, or otherwise penetrated.
Sec. 1317.75 Collection receptacles.
(a) Collectors or Federal, State, tribal, or local law enforcement
may manage and maintain collection receptacles for disposal.
(b) Only those controlled substances listed in Schedule II, III,
IV, or V that are lawfully possessed by an ultimate user or other
authorized non-registrant person may be collected. Controlled and non-
controlled substances may be collected together and be comingled,
although comingling is not required.
(c) Collectors shall only allow ultimate users and other authorized
non-registrant persons in lawful possession of a controlled substance
in Schedule II, III, IV, or V to deposit such substances in a
collection receptacle at a registered location. Collectors shall not
permit an ultimate user to transfer such substance to any person for
any reason. Once a substance has been deposited into a collection
receptacle, the substance shall not be counted,
[[Page 53569]]
sorted, inventoried, or otherwise individually handled.
(d) Collection receptacles shall be securely placed and maintained:
(1) Inside a collector's registered location, inside law
enforcement's physical location, or at an authorized long-term care
facility;
(2) At a registered location, be located in the immediate proximity
of a designated area where controlled substances are stored and at
which an employee is present (e.g., can be seen from the pharmacy
counter). Except as follows:
(i) At a hospital/clinic: A collection receptacle shall be located
in an area regularly monitored by employees, and shall not be located
in the proximity of any area where emergency or urgent care is
provided;
(ii) At a narcotic treatment program: A collection receptacle shall
be located in a room: That does not contain any other controlled
substances and is securely locked with controlled access;
(iii) At a long-term care facility: A collection receptacle shall
be located in a secured area regularly monitored by long-term care
facility employees.
(e) A controlled substance collection receptacle shall meet the
following design specifications:
(1) Be securely fastened to a permanent structure so that it cannot
be removed;
(2) Be a securely locked, substantially constructed container with
a permanent outer container and a removable inner liner as specified in
Sec. 1317.60 of this chapter;
(3) The outer container shall include a small opening that allows
contents to be added to the inner liner, but does not allow removal of
the inner liner's contents;
(4) The outer container shall prominently display a sign indicating
that only Schedule II-V controlled and non-controlled substances, if a
collector chooses to comingle substances, are acceptable substances
(Schedule I controlled substances, controlled substances that are not
lawfully possessed by the ultimate user, and other illicit or dangerous
substances are not permitted); and
(f) Except at a narcotic treatment program, the small opening in
the outer container of the collection receptacle shall be locked or
made otherwise inaccessible to the public when an employee is not
present (e.g., when the pharmacy is closed), or when the collection
receptacle is not being regularly monitored by long-term care facility
employees.
(g) The installation and removal of the inner liner of the
collection receptacle shall be performed by or under the supervision of
at least two employees of the authorized collector.
Sec. 1317.80 Collection receptacles at long-term care facilities.
(a) A long-term care facility may dispose of controlled substances
in Schedules II, III, IV, and V on behalf of an ultimate user who
resides, or has resided, at such long-term care facility by
transferring those controlled substances into an authorized collection
receptacle located at that long-term care facility. When disposing of
such controlled substances by transferring those substances into a
collection receptacle, such disposal shall occur immediately, but no
longer than three business days after the discontinuation of use by the
ultimate user. Discontinuation of use includes a permanent
discontinuation of use as directed by the prescriber, as a result of
the resident's transfer from the long-term care facility, or as a
result of death.
(b) Only authorized retail pharmacies and hospitals/clinics with an
on-site pharmacy may install, manage, and maintain collection
receptacles at long-term care facilities and remove, seal, transfer,
and store, or supervise the removal, sealing, transfer, and storage of
sealed inner liners at long-term care facilities. Collectors authorized
to install, manage, and maintain collection receptacles at long-term
care facilities shall comply with all requirements of this chapter,
including Sec. Sec. 1317.60, 1317.75, and 1317.80.
(c) The installation, removal, transfer, and storage of inner
liners shall be performed either: By or under the supervision of one
employee of the authorized collector and one supervisor-level employee
of the long-term care facility (e.g., a charge nurse or supervisor)
designated by the authorized collector; or, by or under the supervision
of two employees of the authorized collector.
(d) Upon removal, sealed inner liners may only be stored at the
long-term care facility for up to three business days in a securely
locked, substantially constructed cabinet or a securely locked room
with controlled access until transfer in accordance with Sec.
1317.05(c)(2)(iv).
(e) Neither a hospital/clinic with an on-site pharmacy nor a retail
pharmacy shall operate a collection receptacle at a long-term care
facility until its registration has been modified in accordance with
Sec. 1301.51 of this chapter.
Sec. 1317.85 Ultimate user delivery for the purpose of recall or
investigational use of drugs.
(a) In the event of a product recall, an ultimate user in lawful
possession of a controlled substance listed in Schedule II, III, IV, or
V may deliver the recalled substance to the manufacturer of the
substance or another registrant authorized by the manufacturer to
accept recalled controlled substances on the manufacturer's behalf.
(b) An ultimate user who is participating in an investigational use
of drugs pursuant to 21 U.S.C. 355(i) and 360b(j) and wishes to deliver
any unused controlled substances received as part of that research to
the registered dispenser from which the ultimate user obtained those
substances may do so in accordance with regulations promulgated by the
Secretary of Health and Human Services pursuant to 21 U.S.C. 355(i) and
360b(j).
Subpart C--Destruction of Controlled Substances
Sec. 1317.90 Methods of destruction.
(a) All controlled substances to be destroyed by a registrant, or
caused to be destroyed by a registrant pursuant to Sec. 1317.95(c),
shall be destroyed in compliance with applicable Federal, State,
tribal, and local laws and regulations and shall be rendered non-
retrievable.
(b) Where multiple controlled substances are comingled, the method
of destruction shall be sufficient to render all such controlled
substances non-retrievable. When the actual substances collected for
destruction are unknown but may reasonably include controlled
substances, the method of destruction shall be sufficient to render
non-retrievable any controlled substance likely to be present.
(c) The method of destruction shall be consistent with the purpose
of rendering all controlled substances to a non-retrievable state in
order to prevent diversion of any such substance to illicit purposes
and to protect the public health and safety.
Sec. 1317.95 Destruction procedures.
The destruction of any controlled substance shall be in accordance
with the following requirements:
(a) Transfer to a person registered or authorized to accept
controlled substances for the purpose of destruction. If the controlled
substances are transferred to a person registered or authorized to
accept the controlled substances for the purpose of destruction, two
employees of the transferring registrant shall load and
[[Page 53570]]
unload or observe the loading and unloading of any controlled
substances until transfer is complete.
(b) Transport to a registered location. If the controlled
substances are transported by a registrant to a registered location for
subsequent destruction, the following procedures shall be followed:
(1) Transportation shall be directly to the registered location
(the substances shall be constantly moving towards their final location
and unnecessary or unrelated stops and stops of an extended duration
shall not occur);
(2) Two employees of the transporting registrant shall accompany
the controlled substances to the registered location;
(3) Two employees of the transporting registrant shall load and
unload or observe the loading and unloading of the controlled
substances until transfer is complete;
(c) Transport to a non-registered location. If the controlled
substances are transported by a registrant to a destruction location
that is not a registered location, the following procedures shall be
followed:
(1) Transportation shall be directly to the destruction location
(the substances shall be constantly moving towards their final
destruction location and unnecessary or unrelated stops and stops of an
extended duration shall not occur);
(2) Two employees of the transporting registrant shall accompany
the controlled substances to the destruction location;
(3) Two employees of the transporting registrant shall load and
unload or observe the loading and unloading of the controlled
substances;
(4) Two employees of the transporting registrant shall handle or
observe the handling of any controlled substance until the substance is
rendered non-retrievable; and
(5) Two employees of the transporting registrant shall personally
witness the destruction of the controlled substance until it is
rendered non-retrievable.
(d) On-site destruction. If the controlled substances are destroyed
at a registrant's registered location utilizing an on-site method of
destruction, the following procedures shall be followed:
(1) Two employees of the registrant shall handle or observe the
handling of any controlled substance until the substance is rendered
non-retrievable; and
(2) Two employees of the registrant shall personally witness the
destruction of the controlled substance until it is rendered non-
retrievable.
Dated: August 25, 2014.
Michele M. Leonhart,
Administrator.
[FR Doc. 2014-20926 Filed 9-8-14; 8:45 am]
BILLING CODE 4410-09-P