[Federal Register Volume 74, Number 12 (Wednesday, January 21, 2009)]
[Proposed Rules]
[Pages 3480-3487]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-1056]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Parts 1300, 1301, 1304, 1305, and 1307

[Docket No. DEA-316A]
RIN 1117-AB18


Disposal of Controlled Substances by Persons Not Registered With 
the Drug Enforcement Administration

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Advance notice of proposed rulemaking.

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SUMMARY: In response to concerns raised by individuals, public and 
private organizations, the healthcare industry, and the law enforcement 
community, the Drug Enforcement Administration (DEA) is soliciting 
information on the disposal of controlled substances dispensed to 
individual patients, also defined as ultimate users, as well as long 
term care facilities. DEA is seeking options for the safe and 
responsible disposal of dispensed controlled substances in a manner 
consistent with the Controlled Substances Act and its implementing 
regulations.

DATES: Written comments must be postmarked on or before March 23, 2009, 
and electronic comments must be sent on or before midnight Eastern time 
March 23, 2009.

ADDRESSES: To ensure proper handling of comments, please reference 
``Docket No. DEA-316'' on all written and electronic correspondence. 
Written comments being sent via regular or express mail should be sent 
to the Drug Enforcement Administration, Attention: DEA Federal Register 
Representative/ODL, 8701 Morrissette Drive, Springfield, VA 22152. 
Comments may be sent to DEA by sending an electronic message to 
[email protected]. Comments may also be sent 
electronically through http://www.regulations.gov using the electronic 
comment form provided on that site. An electronic copy of this document 
is also available at the http://www.regulations.gov Web site. DEA will 
accept attachments to electronic comments in Microsoft Word, 
WordPerfect, Adobe PDF, or Excel file formats only. DEA will not accept 
any file formats other than those specifically listed here.
    Please note that DEA is requesting that electronic comments be 
submitted before midnight Eastern time on the day the comment period 
closes because http://www.regulations.gov terminates the public's 
ability to submit comments at midnight Eastern time on the day the 
comment period closes. Commenters in time zones other than Eastern time 
may want to consider this so that their electronic comments are 
received. All comments sent via regular or express mail will be 
considered timely if postmarked on the day the comment period closes.

FOR FURTHER INFORMATION CONTACT: Mark W. Caverly, Chief, Liaison and 
Policy Section, Office of Diversion Control, Drug Enforcement 
Administration, 8701 Morrissette Drive, Springfield, VA 22152, 
Telephone (202) 307-7297.

SUPPLEMENTARY INFORMATION:
    Posting of Public Comments: Please note that all comments received 
are considered part of the public record and made available for public 
inspection online at http://www.regulations.gov and in the Drug 
Enforcement Administration's public docket. Such information includes 
personal identifying information (such as your name, address, etc.) 
voluntarily submitted by the commenter.
    If you want to submit personal identifying information (such as 
your name, address, etc.) as part of your comment, but do not want it 
to be posted online or made available in the public docket, you must 
include the phrase ``PERSONAL IDENTIFYING INFORMATION'' in the first 
paragraph of your comment. You must also place all the personal 
identifying information you do not want posted online or made available 
in the public docket in the first paragraph of your comment and 
identify what information you want redacted.
    If you want to submit confidential business information as part of 
your comment, but do not want it to be posted online or made available 
in the

[[Page 3481]]

public docket, you must include the phrase ``CONFIDENTIAL BUSINESS 
INFORMATION'' in the first paragraph of your comment. You must also 
prominently identify confidential business information to be redacted 
within the comment. If a comment has so much confidential business 
information that it cannot be effectively redacted, all or part of that 
comment may not be posted online or made available in the public 
docket.
    Personal identifying information and confidential business 
information identified and located as set forth above will be redacted 
and the comment, in redacted form, will be posted online and placed in 
the Drug Enforcement Administration's public docket file. Please note 
that the Freedom of Information Act applies to all comments received. 
If you wish to inspect the agency's public docket file in person by 
appointment, please see the FOR FURTHER INFORMATION paragraph.

Legal Authority

    The Drug Enforcement Administration (DEA) enforces the 
Comprehensive Drug Abuse Prevention and Control Act of 1970, often 
referred to as the Controlled Substances Act (CSA) and the Controlled 
Substances Import and Export Act (21 U.S.C. 801-971) as amended. DEA 
regulations implementing these statutes are published in Title 21 of 
the Code of Federal Regulations (CFR), Parts 1300 to 1399. These 
regulations are designed to establish a framework for the legal 
distribution of controlled substances to deter their diversion to 
illegal purposes and to ensure that there is a sufficient supply of 
these drugs for legitimate medical, scientific, research, industrial, 
and other purposes. Controlled substances are those substances listed 
in the schedules of the CSA and 21 CFR 1308.11-1308.15, and generally 
include narcotics, stimulants, depressants, and hallucinogens that have 
a potential for abuse and physical and psychological dependence, as 
well as anabolic steroids.
    The CSA and DEA's regulations require that persons involved in the 
manufacture, distribution, research, dispensing, import, and export of 
controlled substances register with DEA (unless exempt), keep track of 
all stocks of controlled substances, and maintain records to account 
for all controlled substances received, distributed, or otherwise 
disposed of.

Background

    Under the CSA, Congress established a ``closed system'' of 
distribution designed to prevent the diversion of controlled 
substances.\1\ As part of this closed system, all persons who lawfully 
handle controlled substances must be registered with DEA or exempt from 
registration by the CSA or DEA regulations. Another central element of 
this closed system is that DEA registrants must maintain strict records 
of all transactions in controlled substances. Consistent with the CSA 
requirements, current DEA regulations employ a system to account for 
all controlled substances received, stored, distributed, dispensed, or 
otherwise disposed of. Under this system, all controlled substances 
used in legitimate commerce may be transferred only between persons or 
entities who are DEA registrants or who are exempted from the 
requirement of registration, until they are dispensed to the ultimate 
user. Thus, for example, a controlled substance, after being 
manufactured by a DEA-registered manufacturer, may be transferred to a 
DEA-registered distributor for subsequent distribution to a DEA-
registered retail pharmacy. After a DEA-registered practitioner, such 
as a physician or a dentist, issues a prescription for a controlled 
substance to a patient (i.e., the ultimate user), that patient can fill 
that prescription at a retail pharmacy to obtain that controlled 
substance. In this system, the manufacturer, the distributor, the 
practitioner, and the retail pharmacy are all required to be DEA 
registrants, or to be exempted from the requirement of registration, to 
participate in the process.
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    \1\ H.R. Rep. No. 91-1444 at 3 (1970).
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    As set forth in the CSA, an ultimate user is exempt from the 
requirement of registration--but only to the extent the ultimate user 
possesses a controlled substance that has been lawfully obtained for 
his own use or 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. 822(c)(3), 
802(27)). Beyond such circumstances, the CSA and its implementing 
regulations do not currently contemplate a situation in which an 
ultimate user would distribute a controlled substance. Thus, such 
distribution, regardless of the purpose, is illegal.
    Under the Controlled Substances Act, specifically 21 U.S.C. 
802(27), the term ``ultimate user'' means 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. Ultimate users are not required to 
register with DEA to possess controlled substances.
    Every person who manufactures or distributes any controlled 
substance or List I chemical, or who proposes to engage in the 
manufacture or distribution of any controlled substance or List I 
chemical, shall obtain annually a registration issued by the Attorney 
General in accordance with the rules and regulations promulgated by him 
(21 U.S.C. 822(a)). ``The term `distribute' means to deliver (other 
than by administering or dispensing) a controlled substance or a listed 
chemical'' (21 U.S.C. 802(11)). ``The terms `deliver' or `delivery' 
mean the actual, constructive, or attempted transfer of a controlled 
substance or a listed chemical, whether or not there exists an agency 
relationship.'' (21 U.S.C. 802(8)). Thus, because the terms deliver and 
distribute, as defined in the CSA, encompass all methods of delivery 
and distribution of controlled substances, and because the CSA allows 
ultimate users to obtain and possess controlled substances solely for 
purposes of use, under current law, an ultimate user may not deliver or 
distribute controlled substances for purposes of disposal (unless the 
ultimate user is also a DEA registrant).
    DEA issues registrations to certain business firms, called reverse 
distributors, to authorize them to take controlled substances that are 
expired or otherwise unwanted from other DEA registrants for subsequent 
disposal or distribution back to the manufacturer. Reverse distributors 
are the only DEA registrants permitted to receive controlled substances 
from other registrants expressly for the purpose of disposal; other 
registrants, e.g., pharmacies, may dispose of controlled substances 
already in their possession that have expired, been damaged, or 
contaminated, but may not accept controlled substances from another 
person solely for the purpose of disposal. Under 21 CFR 1300.01(b)(41):

    The term ``reverse distributor'' means a registrant who receives 
controlled substances acquired from another DEA registrant for the 
purpose of--
    (i) Returning unwanted, unusable, or outdated controlled 
substances to the manufacturer or the manufacturer's agent; or
    (ii) Where necessary, processing such substances or arranging 
for processing such substances for disposal.

    DEA issues these firms registrations as reverse distributors and 
they must adhere to certain security and recordkeeping requirements to 
ensure that unwanted controlled substances are accounted for and 
disposed of in accordance with all relevant State and

[[Page 3482]]

Federal laws and regulations. In addition, reverse distributors must 
adhere to any local, county, State, and/or Federal environmental 
regulations when they dispose of the unwanted controlled substances. 
While a reverse distributor is registered by DEA at a specific location 
and is permitted to store controlled substances at that location, it is 
important to note that the reverse distributor is not required to 
dispose of the controlled substances at its registered location. 
Opportunities for large scale disposal (including by reverse 
distributors) of unused or expired controlled substances have been 
complicated by existing statutory requirements under the Controlled 
Substances Act and Federal and State waste disposal laws.
    By regulation, a reverse distributor cannot take unwanted 
controlled substances from non-DEA registrants. For example, as stated 
previously, once a controlled substance has been dispensed to a patient 
as the ultimate user, either by prescription or through other means, 
the ultimate user cannot give the controlled substance to a reverse 
distributor. Such furnishing of a controlled substance by the ultimate 
user would be a distribution, which an ultimate user is not permitted 
to make without being registered. Further, the reverse distributor 
cannot currently take custody of the controlled substance because 
reverse distributors are only permitted to receive controlled 
substances from other DEA registrants. Members of the public have told 
DEA that the inability to use a reverse distributor in the disposal 
process is one of the reasons that ultimate users have difficulty 
safely disposing of unwanted medications, especially controlled 
substances.
    Aside from ultimate users not being permitted to distribute 
controlled substances for purposes of disposal without being separately 
registered and reverse distributors not being permitted to receive 
controlled substances from non-registered ultimate users, recordkeeping 
requirements also apply to the disposal of controlled substances. The 
CSA requires every registrant who manufactures, distributes, or 
dispenses a controlled substance or substances to maintain, on a 
current basis, a complete and accurate record of each such substance 
manufactured, received, sold, delivered, or otherwise disposed of by 
the registrant (21 U.S.C. 827(a)(3)). Records must contain such 
information as the Attorney General requires to be kept by regulation 
(21 U.S.C. 827(b)(1)). For reverse distributors, these records include, 
for each controlled substance in finished form, the following:

    (i) The name of the substance.
    (ii) Each finished form (e.g., 10-milligram tablet or 10-
milligram concentration per fluid ounce or milliliter) and the 
number of units or volume of finished form in each commercial 
container (e.g., 100-tablet bottle or 3-milliliter vial).
    (iii) The number of commercial containers of each such finished 
form received from other persons, including the date of and number 
of containers in each receipt and the name, address, and 
registration number of the person from whom the containers were 
received.
    (iv) The number of commercial containers of each such finished 
form distributed back to the original manufacturer of the substance 
or manufacturer's agent, including the date of and number of 
containers in each such distribution and the name, address, and 
registration number of the manufacturer or manufacturer's agent to 
whom the containers were distributed.
    (v) The number of units or volume of finished forms and/or 
commercial containers disposed of including the date and manner of 
disposal, the quantity of the substance in finished form disposed, 
and the signatures of two responsible employees of the registrant 
who witnessed the disposal.

(21 CFR 1304.22(e)(2))

    Based on current law and DEA regulations, if ultimate users were 
otherwise permitted to provide their unwanted controlled substances to 
reverse distributors then the above recordkeeping requirements would 
continue to apply to the reverse distributors, unless an exemption is 
granted by regulation pursuant to 21 U.S.C. 827(c)(3).

Redistribution or Reuse

    As discussed below, nonregistrants may dispose of controlled 
substances upon instruction by DEA Special Agents in Charge. However, 
no provisions in the CSA or DEA regulations allow a DEA registrant to 
routinely acquire controlled substances from a non-registrant (i.e. 
individual patient). Hence, patients are currently prohibited from 
furnishing controlled substances to reverse distributors for disposal 
and from returning controlled substances to a registrant for the 
purpose of redistribution or reuse. According to the National 
Conference of State Legislatures, in 2007, 10 States passed laws 
allowing or encouraging the donation of unused pharmaceutical drugs. 
Many of these programs involve health care facilities, nursing homes or 
other pharmacies. However, the CSA and current DEA regulations prohibit 
ultimate users from delivering or distributing controlled substances--
even if such distribution takes the form of a donation to a DEA 
registrant participating in one of these State authorized programs--and 
prohibit registrants from accepting such donations from ultimate users. 
Consequently, these State laws do not provide a mechanism consistent 
with Federal law for donation, return, or reuse of controlled 
substances.
    The Food and Drug Administration (FDA) does not generally permit 
the redistribution of medications, except under limited circumstances. 
The FDA Compliance Policy Guides Manual, Chapter 4, Human Drugs, 
Section 460.300 reads as follows:

Sec. 460.300 Return of Unused Prescription Drugs to Pharmacy Stock (CPG 
7132.09)

POLICY:

    A pharmacist should not return drugs [sic] products to his stock 
once they have been out of his possession. It could be a dangerous 
practice for pharmacists to accept and return to stock the unused 
portions of prescriptions that are returned by patrons, because he 
would no longer have any assurance of the strength, quality, purity 
or identity of the articles.
    Many state boards of pharmacy have issued regulations 
specifically forbidding the practice. We endorse the actions of 
these State boards as being in the interest of public health.
    The pharmacist or doctor dispensing a drug is legally 
responsible for all hazards of contamination or adulteration that 
may arise, should he mix returned portions of drugs to his shelf 
stocks. Some of our investigations in the past have shown that drugs 
returned by patrons and subsequently resold by the pharmacist were 
responsible for injuries.\2\
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    \2\ Food and Drug Administration, Compliance Guides Policy 
Manual Section 460.300, Return of Unused Prescription Drugs to 
Pharmacy Stock (CPG 7132.09). October 1, 1980. http://www.fda.gov/ora/compliance_ref/cpg/cpgdrg/cpg460-300.html.

    DEA shares similar concerns regarding the redistribution of 
controlled substances. This practice is not addressed by the CSA or its 
implementing regulations.

Disposal of Unused or Unwanted Medications by Ultimate Users

    As stated previously, the CSA and its implementing regulations do 
not contemplate a situation in which an ultimate user would distribute 
controlled substances. However, 21 CFR 1307.21 provides the procedure 
for disposing of controlled substances by persons who are not 
registrants. This procedure involves the nonregistrant submitting a 
letter to the local DEA Special Agent in Charge. The letter must 
include the name and address of the person; the name and quantity of 
each controlled substance to be disposed of; how the applicant obtained 
the controlled substance, if known; and the name, address, and 
registration number, if known, of the person who possessed

[[Page 3483]]

the controlled substances prior to the applicant, if known (21 CFR 
1307.21(a)(2)). Provided such disposal is permissible under the CSA, 
the Special Agent in Charge shall authorize and instruct the applicant 
to dispose of the controlled substance through any of the following 
methods: Transfer of the substance to a person registered under the CSA 
and authorized to possess the substance; delivery to an agent of the 
Administration or to the nearest office of the Administration; by 
destruction in the presence of an agent of the Administration or other 
authorized person; or, by such other means as the Special Agent in 
Charge may determine to ensure that the substance does not become 
available to unauthorized persons (21 CFR 1307.21(b)). Though this is 
an option currently available to ultimate users, it is used in 
extremely limited circumstances.
    Another option available for the disposal of unwanted controlled 
substances dispensed to ultimate users is through take-back programs 
that comply with applicable Federal and state law. Take-back programs 
are organized collection events designed to reduce the amount of 
unwanted or unused pharmaceuticals that may pose a risk to public 
health and safety, may be accessible to diversion, or that otherwise 
may be disposed of in a manner that does not comply with State or 
Federal laws or regulations. As previously stated, the distribution of 
a controlled substance by an ultimate user for the purpose of disposal 
is a scenario not contemplated by the CSA and its closed system of 
distribution. However, as indicated above, ultimate users, and other 
DEA nonregistrants, in possession of controlled substances may dispose 
of those substances by receiving permission from the local DEA Special 
Agent in Charge, provided such disposal takes place in a manner 
consistent with the structure of the CSA.
    In the absence of regulations expressly addressing the disposal of 
controlled substances dispensed to ultimate users, DEA has recently 
granted temporary permission to law enforcement agencies who have 
requested authorization to accept for disposal controlled substances 
that have been dispensed to ultimate users. In granting such temporary 
authorization, DEA has imposed certain conditions to ensure that the 
controlled substances do not become available to unauthorized persons, 
consistent with 21 CFR 1307.21, and to promote consistency with the 
structure of the CSA. Thus, the only take-back programs for which DEA 
has recently granted temporary allowances are those in which law 
enforcement officials directly receive the controlled substances from 
the ultimate users. Recognizing that there might be additional 
appropriate methods of allowing for the disposal of controlled 
substances dispensed to ultimate users, DEA is seeking information to 
provide more accessible ways to safely and responsibly dispose of 
dispensed controlled substances in a manner consistent with the CSA.

Disposal of Unused Medications by Long Term Care Facilities (LTCFs)

    The term ``long term care facility'' (LTCF) is defined to mean ``a 
nursing home, retirement care, mental care, or other facility or 
institution which provides extended health care to resident patients.'' 
(21 CFR 1300.01(b)(25)). Most LTCFs are not DEA registered entities.
    When patients residing at LTCFs require controlled substances their 
practitioner issues a prescription which is usually dispensed for the 
full amount by a registered pharmacy. The LTCF holds the prescribed 
drugs in a custodial manner for the patient and dispenses the 
medications on the schedule the practitioner orders. As a result of 
these dispensing practices, when patients die, leave the facility, or 
their medication is discontinued or changed, the LTCF may be left with 
excess controlled substances that must be disposed of to avoid 
diversion.
    DEA has been acutely aware of the problems surrounding the disposal 
of dispensed controlled substances at LTCFs for some time, and has 
worked to reduce the accumulation of controlled substances at LTCFs 
through a number of regulatory actions. Prescribing practitioners are 
required by regulation to specify the quantity prescribed on the 
prescriptions. However, DEA recognized that LTCF patients are a unique 
part of society, and may often need the Schedule II controlled 
substances medications they are prescribed changed on short notice 
based on their rapidly changing health conditions. Consequently, 
patients might not need the full quantity of the Schedule II controlled 
substance that the practitioner had initially prescribed. To reduce the 
potential excess amounts of dispensed controlled substances, 
practitioners prescribing Schedule II controlled substances for LTCF 
patients needed the ability to prescribe smaller quantities of those 
substances more frequently than would be necessary for other patients. 
Practitioners are required to manually sign prescriptions for Schedule 
II controlled substances for the prescription to be valid (21 CFR 
1306.05(a)), and the dispensing pharmacy is unable to dispense the 
needed controlled substance until it receives a valid prescription (21 
CFR 1306.11(a)). It became evident that this requirement made it more 
difficult for prescribing practitioners to be responsive to the 
immediate and changing needs of LTCF patients. To address this 
circumstance, DEA promulgated regulations that permit the facsimile 
transmission of written, manually signed Schedule II prescriptions for 
residents of LTCFs by the practitioner or the practitioner's agent to 
the dispensing pharmacy (21 CFR 1306.11(f)). The facsimile serves as 
the original prescription for the dispensing pharmacy's records. DEA 
has also permitted the facsimile transmission of written, manually 
signed Schedule II controlled substance prescriptions for patients 
enrolled in hospice care programs certified and/or paid for by Medicare 
under Title XVIII of the United States Code, or hospice programs 
licensed by the State (21 CFR 1306.11(g)).
    DEA has also established partial dispensing provisions for 
Schedules II-V prescriptions (including unit-dose dispensing, if 
desired), to limit the quantity of controlled substances dispensed at 
one time and avoid waste if the treatment was changed or discontinued. 
These regulations include specific provisions for residents of LTCFs or 
patients with medical diagnoses documenting a terminal illness (21 CFR 
1306.13(b), 1306.23). According to the pharmacy industry, however, 
dispensing fees, reimbursement practices, and difficulties in educating 
practitioners regarding the need to prescribe controlled substances in 
anticipation of a patient's actual need for the controlled substance 
have, for the most part, precluded using that approach.
    To further prevent the accumulation of controlled substances at 
LTCFs, DEA has permitted retail pharmacies to install and operate 
automated dispensing systems (ADS) at LTCFs (21 CFR 1301.27). ADS are 
conceptually similar to a vending machine. A pharmacy stores bulk 
controlled substances in the ADS in separate bins or containers and 
programs and controls the ADS remotely. Only authorized staff at the 
LTCF has access to the ADS's 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,

[[Page 3484]]

controlled substances in the ADS are pharmacy stock, not waste.
    Despite DEA's efforts to reduce the accumulation of dispensed 
controlled substances at LTCFs, accumulation continues to be a concern. 
LTCFs that are not DEA registrants may not transfer the controlled 
substances to either the pharmacy that supplied them or to a reverse 
distributor for disposal.

Purpose of Advance Notice of Proposed Rulemaking

    On February 20, 2007, in recognition of the advice being provided 
by environmental organizations to the public to dispose of medications 
in household trash (as opposed to flushing them into the waste-water 
system), the U.S. Office of National Drug Control Policy (ONDCP) 
announced guidelines for the disposal of ultimate user medications, 
including dispensed controlled substances. The guidelines were 
published by ONDCP in conjunction with the Department of Health and 
Human Services (HHS), and the EPA.\3\ The guidelines advise the public 
to flush medications only if the prescription label or accompanying 
patient information specifically states to do so. Instead of flushing, 
ONDCP recommends that, after performing a minimal deactivation 
procedure, the medications be disposed of in common household trash or 
at community pharmaceutical ``take-back'' programs. The press release 
announcing the guidelines stated:
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    \3\ Office of National Drug Control Policy, Executive Office of 
the President. Proper Disposal of Prescription Drugs. February 2007. 
http://www.whitehousedrugpolicy.gov/publications/pdf/prescrip_disposal.pdf.

    The new Federal guidelines are a balance between public health 
concerns and potential environmental concerns. ``While EPA continues 
to research the effects of pharmaceuticals in water sources, one 
thing is clear: Improper drug disposal is a prescription for 
environmental and societal concern,'' said EPA Administrator Stephen 
L. Johnson. ``Following these new guidelines will protect our 
Nation's waterways and keep pharmaceuticals out of the hands of 
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potential abusers.''

    In addition to environmental concerns, there are safety concerns 
that medications, especially controlled substances, could be either 
intentionally or unintentionally abused. Children may retrieve a 
medication from the trash and ingest it without the specific intention 
of abusing it. For these reasons, some medications include flushing 
disposal instructions to make them less available and to mitigate 
safety risks.
    The illicit use of prescription medication is a growing problem 
among young adults. According to the 2007 National Survey on Drug Use 
and Health, more persons age 12 and above are engaged in the non-
medical use of psychotherapeutic drugs than those abusing cocaine, 
heroin, and methamphetamine combined. Prescription drug abuse is second 
only to marijuana use.\4\ The 2005 Partnership Attitude Tracking Study 
(PATS) reported that 62 percent of teens say prescription pain 
relievers are easy to get from parents' medicine cabinets.\5\
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    \4\ Office of National Drug Control Policy, Executive Office of 
the President. Prescription for Danger, A Report on the Troubling 
Trend of Prescription and Over-the-Counter Drug Abuse Among the 
Nation's Teens. January 2008.
    \5\ Partnership for a Drug-Free America, The Partnership 
Attitude Tracking Study (PATS): Teens in grades 7 through 12 (2005). 
May 16, 2006.
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    DEA is seeking options for the disposal of controlled substances 
dispensed to DEA nonregistrants that protect public health and safety, 
minimize the possibility of diversion, are consistent with the CSA and 
DEA regulations, and provide sound environmental solutions.

Request for Information

    DEA seeks comments regarding the promulgation of regulations to 
permit the disposal of controlled substances by ultimate users and long 
term care facilities consistent with the Controlled Substances Act and 
its implementing regulations. DEA seeks comments regarding how various 
entities would address the issue of the disposal of dispensed 
controlled substances held by DEA nonregistrants in light of the 
current restrictions that are in place. Commenters are encouraged to 
include the question number enumerated below in their response. 
Although all comments are welcome, DEA is particularly interested in 
comments regarding the questions listed below. These questions are 
separated into groups by area of interest. The groups are:
     Ultimate Users
     State and Local Law Enforcement Agencies & Publicly Owned 
Treatment Works
     Concerned Interest Groups
     Long Term Care Facilities
     Hospices and In-Home Care Groups
     Pharmacies
     Narcotic Treatment Programs
     Reverse Distributors
     State Regulatory Agencies
     All Interested Parties

For Ultimate Users (Patients or Family Members of Patients Who Possess 
Controlled Substances Which Have Been Legally Dispensed)

    1. Can you distinguish a controlled substance from a non-controlled 
substance?
    2. Why do you have unwanted or outdated controlled substances in 
your possession?
    3. What method, if any, do you currently use to dispose of your 
unwanted or outdated pharmaceuticals, including controlled substances?
    4. Are you willing to seek locations outside of your home to 
dispose of unwanted pharmaceuticals?
    5. Does your community, county, or State have laws, regulations, or 
policies in place that prohibit medications, including controlled 
substances, from being flushed or placed in the garbage?
    6. Does your community have take-back programs during which you can 
provide pharmaceuticals to an entity for disposal? If so, do you know 
whether these programs accept controlled substances?
    7. If your community has take-back programs, who sponsors the 
program?
    8. If you participated in a take-back program, please describe how 
the program worked.
    9. If you participated in a take-back program, was a law 
enforcement agency involved?
    10. If you participated in a take-back program, did you encounter 
any problems? Please explain.
    11. What do you believe is the best method of disposing of unwanted 
or outdated pharmaceuticals, including controlled substances dispensed 
to ultimate users?
    12. Would you be willing to pay a fee to have your medication 
disposed of in a manner that minimizes the possibility of the diversion 
of legally obtained controlled substance medications for illegal 
purposes and is environmentally safe? If so, how much would you be 
willing to pay?
    13. Would you consider using a postage paid mailing container to 
dispose of unwanted medications?
    14. Where would you be willing to go to obtain such a postage paid 
mailing container (e.g., local pharmacy, police department, take-back 
event)?
    15. Would you be willing to pay the postage on a mailing container 
used to ship controlled substances and other pharmaceuticals to another 
location for disposal? If so, how much would you be willing to pay?
    16. Would you consider the use of a mailing container more 
convenient or less convenient than taking unwanted

[[Page 3485]]

controlled substances to a pharmacy or to a take-back event?
    17. What other means of disposal would you consider convenient?

For State and Local Law Enforcement Agencies and Publicly Owned 
Treatment Works

    18. Is the disposal of unwanted or outdated pharmaceuticals a 
problem in your area?
    19. Do individuals bring their unwanted or outdated 
pharmaceuticals, including controlled substances which have been 
legally obtained, to your department for disposal?
    20. Does your department encourage or discourage such activity? 
Please explain.
    21. If individuals bring their unwanted or outdated 
pharmaceuticals, including controlled substances which have been 
legally obtained, to your department for your department to dispose of, 
how does that process work? Do individuals drop the pharmaceuticals in 
a container, hand them to a department employee, or hand them to a law 
enforcement officer?
    22. Have you ever had any challenges or difficulties with taking 
individuals' unwanted or outdated pharmaceuticals, including controlled 
substances, for disposal? If so, please explain.
    23. Does your department/facility participate in take-back 
programs?
    24. If your department/facility participates in take-back programs, 
what is the nature of your participation?
    25. Have you ever encountered any challenges or difficulties when 
participating in such programs? Please explain.
    26. If your department/facility does not participate in take-back 
programs, what, if anything, prevents such participation?
    27. Does your department/facility have the staffing and resources 
to participate in take-back programs?
    28. Is your department aware of any cases of diversion involving 
take-back programs? If so, did the diversion result in the arrest or 
prosecution of any individuals?
    29. Regardless of how you receive the medications (e.g., take-back 
program, individual drop off) for disposal, do you differentiate 
between controlled substances and noncontrolled substances? If so, how?
    30. Regardless of how you receive the medications for disposal, 
what would you estimate to be the percentage, quantity, or other 
measurable unit of controlled substances as compared to noncontrolled 
substances?
    31. Regardless of how you receive the medications for disposal, 
prior to disposal, where do you store these pharmaceuticals and under 
what security?
    32. How do you dispose of the controlled substances that you 
receive?
    33. What records do you generate regarding what you receive and 
what you dispose of?
    34. How far must you travel to dispose of pharmaceuticals, 
including controlled substances?
    35. What do you do if the landfill or incinerator you plan to use 
is closed, nonoperational, or otherwise unavailable?
    36. How much money has your participation in pharmaceutical 
disposal cost your department/facility in the previous year?
    37. How many man-hours has your participation in drug disposal cost 
your department/facility in the previous year?
    38. If you are receiving unwanted or outdated pharmaceuticals for 
disposal, are you doing so as a result of local or State policy, law, 
or regulation?
    39. If your department does not currently receive pharmaceuticals 
for disposal, would it be interested in receiving them?
    40. Would your department/facility be willing to make available 
postage paid envelopes to be used by the public to mail pharmaceuticals 
to a reverse distributor or a law enforcement agency for disposal?
    41. What do you believe is the best method of safely disposing of 
unwanted or outdated controlled substances held by DEA nonregistrants?

For Concerned Interest Groups

    42. What prompted you to get involved in the issue of drug 
disposal?
    43. What is your group doing to address this issue?
    44. What have been your successes?
    45. What challenges or difficulties have you encountered?
    46. If you accept medications for disposal, what records do you 
maintain, if any?
    47. If you accept medications for disposal, how do you store and 
secure these medications prior to disposal?
    48. If you accept medications for disposal, do you differentiate 
between controlled substances and noncontrolled substances? If so, how?
    49. What has been law enforcement's involvement in the disposal of 
these medications, if any?
    50. What would you estimate to be the percentage, quantity, or 
other measurable unit of controlled substances as compared to 
noncontrolled substances that your disposal programs received?
    51. If you have a pharmaceutical disposal program in place, how is 
it funded?
    52. There is concern that residue from pharmaceuticals is being 
found in drinking water. What is your understanding of the percentage 
of this problem that is due to ultimate users flushing their unused or 
unwanted medications?

For Long Term Care Facilities

    53. Is the issue of unwanted or unused pharmaceuticals, including 
controlled substances, a concern at your facility?
    54. What are the reasons why your facility is in possession of 
unwanted or outdated pharmaceuticals, including controlled substances?
    55. At the end of each month is your facility in possession of a 
significant amount of unwanted or outdated pharmaceuticals? How much? 
Of those pharmaceuticals, what would you estimate the percentage of 
controlled substances to be?
    56. How do you normally dispose of these pharmaceuticals, including 
controlled substances?
    57. Does law enforcement, or some other State agency, assist you in 
disposing of controlled substances?
    58. Are you mandated by any local or State law or regulation to 
dispose of these medications, including controlled substances, in a 
specific manner? If so, how?
    59. Does your facility take unwanted or outdated pharmaceuticals to 
local take-back programs?
    60. Are you aware of automated dispensing systems? If so, does your 
facility use them? Have they reduced the amount of excess medications 
at the facility?
    61. Has the ability of a pharmacy to receive faxed schedule II 
prescriptions for patients in long term care facilities helped to 
reduce the amount of excess medications at your facility?
    62. How do you believe the accumulation of unwanted or outdated 
pharmaceuticals at long term care facilities can be better addressed?
    63. What do you believe is the best method for disposing of these 
pharmaceuticals?

For Hospices and In-Home Care Groups

    64. Is the accumulation of unwanted or outdated controlled 
substances a problem for your business?
    65. If you dispose of unwanted or outdated pharmaceuticals, what 
methods do you currently use to dispose of such pharmaceuticals, 
including controlled substances?

[[Page 3486]]

    66. If you dispose of pharmaceuticals, including controlled 
substances, what have been your successes?
    67. If you dispose of pharmaceuticals, including controlled 
substances, what challenges or difficulties have you encountered?
    68. What do you believe is the best method of disposing of these 
unwanted or outdated pharmaceuticals, including controlled substances?
    69. Has the ability of a pharmacy to receive faxed schedule II 
prescriptions for patients enrolled in hospice programs helped to 
reduce the amount of excess medications?
    70. How do you believe the accumulation of unwanted or outdated 
pharmaceuticals by patients enrolled in hospice programs can be better 
addressed?

For Pharmacies

    71. Is the disposal of unwanted or outdated pharmaceuticals by 
ultimate users a problem in your area?
    72. Does your State permit your pharmacy to take unwanted or 
outdated pharmaceuticals, including dispensed controlled substances, 
from ultimate users?
    73. Does your State permit your pharmacy to place unwanted or 
outdated pharmaceuticals obtained from ultimate users, including 
dispensed controlled substances, back into stock?
    74. If you provide pharmaceuticals, including controlled 
substances, to long term care facilities, does your State permit your 
pharmacy to take back unwanted, unused, or outdated medications from 
those facilities?
    75. Does your State permit your pharmacy to place unwanted or 
outdated pharmaceuticals obtained from long term care facilities, 
including dispensed controlled substances, back into stock?
    76. Does your pharmacy participate in any pharmaceutical take-back 
programs? If so, please describe.
    77. If your pharmacy participates in pharmaceutical take-back 
programs, what have been the successes?
    78. If your pharmacy participates in pharmaceutical take-back 
programs, what challenges or difficulties have you encountered?
    79. Would your pharmacy be willing to make available postage paid 
envelopes to be used by the public to mail unwanted or outdated 
pharmaceuticals to a reverse distributor or law enforcement agency for 
disposal? Would your pharmacy consider paying for any costs associated 
with this activity? If so, how much would your pharmacy be willing to 
pay?
    80. Would your individual pharmacy or chain consider contributing 
financially to offset the expense of a pharmaceutical disposal program? 
If so, what type of program is your pharmacy interested in?
    81. What do you believe is the best method to dispose of unwanted 
or outdated pharmaceuticals obtained from ultimate users, including 
dispensed controlled substances?
    82. Has the ability of a pharmacy to receive faxed schedule II 
prescriptions for patients enrolled in hospice programs or residing at 
long term care facilities helped to reduce the amount of excess 
medications?
    83. How can the accumulation of unwanted or outdated 
pharmaceuticals, including controlled substances, at long term care 
facilities and hospice programs be better addressed?

For Narcotic Treatment Programs

    84. What are the concerns of narcotic treatment programs regarding 
the disposal of controlled substances used in maintenance or 
detoxification treatment?
    85. Would your narcotic treatment program consider contributing 
financially to offset the expense of a pharmaceutical disposal program? 
If so, what type of program would best meet your needs?
    86. What do you believe is the best method to dispose of unwanted 
or outdated dispensed controlled substances?
    87. What are the reasons why NTPs are in possession of controlled 
substances that require disposal?
    88. Have controlled substances awaiting disposal been a source of 
diversion for your NTP?

For Reverse Distributors

    89. Have you been approached by any group or any law enforcement 
agency requesting that you participate in the disposal of 
pharmaceuticals, including controlled substances dispensed to ultimate 
users?
    90. Do you currently accept pharmaceuticals, including dispensed 
controlled substances, from ultimate users for disposal? If so, how?
    91. Are your competitors accepting pharmaceuticals, including 
dispensed controlled substances, from ultimate users for disposal?
    92. If you accept pharmaceuticals, including dispensed controlled 
substances, from ultimate users for disposal, what have your successes 
been?
    93. If you accept pharmaceuticals, including dispensed controlled 
substances, from ultimate users for disposal, what challenges or 
difficulties have you encountered?
    94. If you were able to accept pharmaceuticals, including dispensed 
controlled substances, from ultimate users for disposal, would your 
facility be able to handle this added volume?
    95. What does it cost to dispose of controlled substances?
    96. What do you estimate it would cost to dispose of controlled 
substances dispensed to ultimate users? On what basis are costs 
calculated (e.g., per pound disposed of)?
    97. Do you currently accept pharmaceuticals from long term care 
facilities (LTCFs) for disposal? If so, how?
    98. Are your competitors accepting pharmaceuticals from LTCFs for 
disposal?
    99. If you accept pharmaceuticals from long term care facilities 
for disposal, what have your successes been?
    100. If you accept pharmaceuticals from long term care facilities 
for disposal, what challenges or difficulties have you encountered?
    101. If you were able to accept pharmaceuticals, including 
dispensed controlled substances, from long term care facilities for 
disposal, would your facility be able to handle this added volume?
    102. What do you estimate it would cost to dispose of dispensed 
controlled substances obtained from long term care facilities? On what 
basis are costs calculated (e.g., per pound disposed of)?
    103. What do you believe is the best method of disposing of 
unwanted or outdated pharmaceuticals, including controlled substances 
dispensed to DEA nonregistrants?
    104. Would you accept for disposal controlled substances that have 
been dispensed to ultimate users directly from ultimate users by means 
of individual mailing containers?
    105. Do you perceive any problems with reverse distributors 
accepting dispensed controlled substances directly from ultimate users 
by means of individual mailing containers?
    106. Would your company be interested in contributing financially 
to offset the expense of a disposal program for ultimate users that 
would be instituted at your company?
    107. If reverse distributors were permitted to accept controlled 
substances dispensed to ultimate users for disposal, how do you believe 
the unwanted or outdated controlled substances should be provided by 
the ultimate user to the reverse distributor?

[[Page 3487]]

For State Regulatory Agencies

    108. What current laws or regulations does your State have 
regarding the disposal of dispensed controlled substances and 
noncontrolled substances by ultimate users?
    109. What laws or regulations, if any, is your State considering 
regarding the disposal of dispensed controlled or noncontrolled 
substances by ultimate users?
    110. Does your State agency participate in any initiatives (e.g., 
take-back or mail-back programs) regarding the disposal of dispensed 
controlled and noncontrolled substances by ultimate users at this time? 
If so, please describe.
    111. Is your State agency aware of any cases of diversion regarding 
take-back programs? If so, did the diversion result in the arrest or 
prosecution of any individuals?
    112. If your State agency does not participate in any initiatives 
regarding the disposal of dispensed controlled or noncontrolled 
substances by ultimate users, why not?
    113. If your State agency participates in any initiatives regarding 
the disposal of dispensed controlled and noncontrolled substances by 
ultimate users, what would you estimate to be the percentage, quantity, 
or other measurable unit of controlled substances as compared to 
noncontrolled substances received?
    114. If your State agency participates in any initiatives regarding 
the disposal of dispensed controlled and noncontrolled substances by 
ultimate users, does your agency fund all or part of the initiative? If 
other funding is received, who provides the other funding?
    115. If your State agency participates in any initiatives regarding 
the disposal of dispensed controlled and noncontrolled substances by 
ultimate users, what successes have you seen regarding these 
initiatives?
    116. If your State agency participates in any initiatives regarding 
the disposal of dispensed controlled and noncontrolled substances by 
ultimate users, what challenges or difficulties have you encountered?

For All Interested Parties

    117. DEA also seeks comment from all interested parties regarding 
the funding of the disposal of unwanted or outdated controlled 
substances held by DEA nonregistrants.

Regulatory Certifications

    This action is an Advance Notice of Proposed Rulemaking (ANPRM). 
Accordingly, the requirement of Executive Order 12866 to assess the 
costs and benefits of this action does not apply. Rather, among the 
purposes DEA has in publishing this ANPRM is to seek information from 
the public on the costs, benefits, and other impacts pertaining to the 
disposal of controlled substances dispensed to ultimate users and long 
term care facilities. Similarly, the requirements of section 603 of the 
Regulatory Flexibility Act do not apply to this action since, at this 
stage, it is an ANPRM and not a ``rule'' as defined in section 601 of 
the Regulatory Flexibility Act. Following review of the comments 
received to this ANPRM, if DEA promulgates a Notice or Notices of 
Proposed Rulemaking regarding this issue, DEA will conduct all analyses 
required by the Regulatory Flexibility Act, Executive Order 12866, and 
any other statutes or Executive Orders relevant to those rules and in 
effect at the time of promulgation.

    Dated: January 13, 2009.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control.
 [FR Doc. E9-1056 Filed 1-16-09; 8:45 am]
BILLING CODE 4410-09-P