[Federal Register Volume 84, Number 35 (Thursday, February 21, 2019)]
[Proposed Rules]
[Pages 5395-5403]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-02875]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1305
[Docket No. DEA-453]
RIN 1117-AB44
New Single-Sheet Format for U.S. Official Order Form for Schedule
I and II Controlled Substances (DEA Form 222)
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Notice of proposed rulemaking.
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SUMMARY: The Drug Enforcement Administration (DEA) is proposing to
amend its regulations to implement a new single-sheet format for order
forms (DEA Form 222) which are issued by DEA to DEA registrants to
allow them to order schedule I and/or II controlled substances. DEA
published a notice of proposed rulemaking about this new format in
November 2007 but did not finalize it. Due to the passage of time and
procedural considerations, DEA is reissuing another notice of proposed
rulemaking. This proposal supersedes the November 2007 proposal. This
proposed rule calls for allowing the continued use of the existing
triplicate DEA Form 222 until a sunset date of two years after the
final rule becomes effective, which would be included in the final
rule. DEA also proposes minor procedural changes, including among other
things, to clarify the procedure involving who can issue the power of
attorney that is required for others to sign DEA Form 222.
DATES: Electronic comments must be submitted, and written comments must
be postmarked, on or before April 22, 2019. Commenters should be aware
that the electronic Federal Docket Management System will not accept
comments after 11:59 p.m. Eastern Time on the last day of the comment
period.
ADDRESSES: To ensure proper handling of comments, please reference
``Docket No. DEA-453'' on all correspondence, including any
attachments.
Electronic comments: The Drug Enforcement Administration encourages
that all comments be submitted electronically through the Federal
eRulemaking Portal, which provides the ability to type short comments
directly into the comment field on the web page or to attach a file for
lengthier comments. Please go to http://www.regulations.gov and follow
the online instructions to submit comments. Upon submission of your
comment, you will receive a Comment Tracking Number. Please be aware
that submitted comments are not instantaneously available for public
view on Regulations.gov. If you have received a Comment Tracking
Number, your comment has been successfully submitted and there is no
need to resubmit the same comment.
Paper comments: Paper comments that duplicate an electronic
submission are not necessary and are discouraged. Should you wish to
mail a paper comment in lieu of an electronic comment, it should be
sent via regular or express mail to: Drug Enforcement Administration,
Attn: DEA Federal Register Representative/DPW, 8701 Morrissette Drive,
Springfield, Virginia 22152.
FOR FURTHER INFORMATION CONTACT: Kathy L. Federico, Diversion Control
Division, Drug Enforcement Administration; Mailing Address: 8701
Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 598-
6812.
SUPPLEMENTARY INFORMATION:
Posting of Public Comments
Please note that all comments received are considered part of the
public record. They will, unless reasonable cause is given, be made
available by the Drug Enforcement Administration for public inspection
online at http://www.regulations.gov. Such information includes
personal identifying information (such as your name, address, etc.)
voluntarily
[[Page 5396]]
submitted by the commenter. The Freedom of Information Act (FOIA)
applies to all comments received. 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 made publicly available, you
must include the phrase ``PERSONAL IDENTIFYING INFORMATION'' in the
first paragraph of your comment. You must also place the personal
identifying information you do not want to be made publicly available
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 made publicly available, 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.
Comments containing personal identifying information and
confidential business information identified as directed above will
generally be made publicly available in redacted form. If a comment has
so much confidential business information or personal identifying
information that it cannot be effectively redacted, all or part of that
comment may not be made publicly available. Comments posted to http://www.regulations.gov may include any personal identifying information
(such as name, address, and phone number) or confidential business
information included in the text of your electronic submission that is
not identified as directed above as confidential.
An electronic copy of this document is available at http://www.regulations.gov for easy reference.
Legal Authority and Background
The Controlled Substances Act (CSA) grants the Attorney General
authority to promulgate rules and regulations relating to the
registration and control of the manufacture, distribution, and
dispensing of controlled substances (21 U.S.C. 821); maintenance and
submission of records and reports (21 U.S.C. 827); and for the
efficient execution of his statutory functions (21 U.S.C. 871(b)). The
Attorney General is further authorized by the CSA to promulgate rules
and regulations relating to the registration and control of importers
and exporters of controlled substances. 21 U.S.C. 958(f). The Attorney
General has delegated these authorities to the Administrator of the
DEA. 28 CFR 0.100(b).
The DEA previously published a notice of proposed rulemaking (NPRM)
on this matter in the Federal Register on November 27, 2007 (72 FR
66118). The rulemaking proposed revising the DEA regulations to
implement a new format for order forms (DEA Form 222)--issued by DEA to
DEA registrants to allow them to order schedule I and/or II controlled
substances--by replacing the three-part carbon-copy form with a single
sheet form. During the comment period, DEA received comments from six
entities: An organization representing pharmacists, an organization
representing pharmaceutical manufacturers and distributors, a
pharmaceutical distributor, two reverse distributors, and one
individual. Two commenters opposed the proposed rule as written, one
supported it with significant concerns, two commenters requested simply
the number of line items on the DEA Form 222 be expanded, and one
commenter supported the rule and had specific questions regarding
distribution of copies for reverse distributors.
The DEA is reissuing another NPRM, superseding the November 2007
NPRM. In this NRPM, the DEA also proposes minor changes to clarify who
can issue the power of attorney (POA) that is required for others to
sign DEA Form 222.
Order Forms
The CSA requires that schedule I and II controlled substances be
only distributed pursuant to a written order made by the purchaser on a
form issued by the Attorney General. 21 U.S.C. 828(a). This
responsibility has been delegated to the Administrator of DEA (28 CFR
0.100(b)) and redelegated to the Deputy Assistant Administrator of the
DEA Diversion Control Division (28 CFR 0.104; section 7(d) of 28 CFR
part 0, appendix to subpart R).\1\ The DEA uses these order forms to
allow tracking of distributions of schedule I and II controlled
substances.
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\1\ The introductory text of section 7 of 28 CFR part 0,
appendix to subpart R allows for the redelegation of responsibility
to the Deputy Assistant Administrator of the DEA Office of Diversion
Control. However, this office has been reorganized to the DEA
Diversion Control Division.
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Order forms are required for distribution of schedule I and II
controlled substances. 21 U.S.C. 828(a); 21 CFR 1305.03. The order
forms are issued by DEA to authorized DEA registrants to allow
distribution of schedule I and II controlled substances. The order
forms are designated as DEA Form 222. The regulations stipulate the
forms will be serially numbered and issued with the name, address, and
registration number of the registrant, the authorized activity, and the
schedules of the registrant (21 CFR 1305.11(d)). Currently, order forms
are three-part carbon forms, printed on interleaved carbon sheets,
hereafter also referred to as current or triplicate forms.
Whenever a DEA registrant wishes to acquire a schedule I and/or II
controlled substance, that registrant must complete the order form,
pursuant to the form instructions, to include the name and address of
the supplying DEA registrant, the date requested, the number of
packages of controlled substance(s) ordered, the size of the package of
the controlled substance(s) ordered, and the name of the controlled
substance(s) ordered. Under the current procedures outlined in 21 CFR
1305.13(a), (b), (d), and (e), the purchaser retains one copy (Copy 3)
of the triplicate form and sends two copies (Copy 1 and Copy 2) to the
supplier so that the order for a controlled substance can be filled.
The supplier completes the form by entering the actual number of
packages of the controlled substance(s) shipped and the actual date
shipped. The supplier retains one copy (Copy 1) of the order form sent
to him/her by the purchaser, and sends the other copy (Copy 2) of the
order form to the DEA Special Agent in Charge in the area where the
supplier is located. Upon receiving the controlled substance(s), the
purchaser writes the number of packages of the controlled substance(s)
ordered which are actually received and the date received on its copy
(Copy 3). Under current 21 CFR 1305.17(a) through (c), both the
purchaser and the supplier must preserve their respective copy of the
order form for two years and make it available to officials of the DEA
for inspection, if requested.
Justification for New Order Form
The proposed new format for DEA Form 222 would employ a single-
sheet form, hereafter also referred to as the new form(s). In executing
a transaction involving a schedule I and/or II controlled substance, a
DEA registrant (purchaser) would process the new single-sheet form in a
similar manner to the processing of the current form. The proposed
changes in processing include the purchaser retaining a readily
retrievable copy, in which copies can be scanned and stored
electronically rather than retaining the pre-printed carbon copy. In
addition, any registrant supplier who is not required to report
acquisition/distribution transactions to the Automation of Reports and
Consolidated Orders System (ARCOS) under Sec. 1304.33(c) (such as a
practitioner) would be required to make
[[Page 5397]]
and submit a copy of the original DEA Form 222 to DEA by mail, fax, or
email instead of the supplier sending a copy of the original order
form. This proposed procedure would replace requiring all suppliers,
regardless of ARCOS reporting requirements, to submit Copy 2 to the DEA
Special Agent in charge in the area where the supplier is located. The
purchaser and supplier would preserve the original order form and a
copy of the original order form, respectively, for two years and make
it available to officials of the DEA for inspection, if requested. DEA
would continue to preprint and issue the new forms.
The single-sheet form would have an issued order form number with
enhanced security features over the current form. DEA would preprint
the new single-sheet form on security paper to ensure the identity of
the original while making it difficult to copy for counterfeit
purposes.
The single-sheet form will be more convenient for DEA registrants
to utilize. The current format was created more than forty years ago
and processing a transaction with carbon copies is outdated. Today, new
office technology exists, such as laser printers, scanners and
photocopiers, which will allow DEA registrants greater ease in
utilizing the single-sheet form.
The single-sheet form will benefit DEA as well. There is only one
vendor that produces the current three-part carbon forms which is
costly. The Dot Matrix printer used to print the forms is outdated, and
DEA can only get replacement parts from one vendor. Maintaining the
equipment is costly, difficult, and time-consuming.
Transition From Current to New Order Form
If this regulation is finalized, the new single-sheet form will be
used, and DEA would not issue any more triplicate forms. DEA
registrants will be allowed to exhaust their supply of the current
forms as part of the transition period. When a registrant's supply of
triplicate forms is depleted, the DEA would issue the new single-sheet
forms. The final rule would include a ``sunset date''--a date after
which use of the triplicate forms would not be allowed--of two years
after the final rule becomes effective. Thus, business firms will have
time to shift their processes to accommodate the new single form. For
clarity, this rule would revise the existing regulations in part 1305,
subpart B to follow the procedures for the issuance and use of the new
single-sheet form for the future. The transition procedures allowing
the continued use of existing supplies of the triplicate DEA Form 222
would be relocated to a new Sec. 1305.20.
Revision of DEA Regulations To Accommodate New Order Form
DEA proposes to amend its regulations pertaining to orders for
schedule I and II controlled substances, set forth in 21 CFR part 1305,
to provide for the use of the single-sheet DEA Form 222. As discussed
above, to ease the transition, DEA will allow the continued use of
existing stocks of the triplicate forms for a two year transition
period.
DEA proposes to amend its regulations to reflect that only one
original DEA Form 222 will be provided to authorized registrants by
DEA. If finalized, registrants that wish to obtain schedule I and II
controlled substances (purchasers) would be required to complete and
retain a copy of the form and send the original to their supplier for
filling. The supplier would be required to record certain information
related to the filling on the original and retain such original. In
addition, any supplier who is not required to report acquisition/
distribution transactions to the Automation of Reports and Consolidated
Orders System (ARCOS) under Sec. 1304.33(c) (such as a practitioner)
would be required to make and submit a copy of the original DEA Form
222 to DEA by mail (Drug Enforcement Administration, Attn: Registration
Section/DRR, P.O. Box 2639, Springfield, VA 22152-2639), fax to (202)
307-5602 or email to [email protected]. The purchaser would be
required to record on their copy of the single-sheet form certain
information related to the items furnished by the supplier. It is
important to note that the process for handling the DEA Forms 222
remains unchanged. The only changes made by these proposed amendments,
if finalized, are to require purchasers and suppliers to retain the
original of the single-sheet form or to make and retain readily
retrievable copies of the form, as applicable, rather than retaining
the pre-printed carbon copies. If finalized, the rule also would
provide other general procedures related to the single-sheet form
(e.g., endorsing forms, cancelling forms, lost or stolen forms,
unaccepted or defective forms).
Currently, triplicate forms are issued in mailing envelopes
containing seven forms (informally referred to as ``books''). The new
single-sheet form will not be produced in ``books,'' giving DEA and
registrants greater flexibility to request a specific number of order
forms. Therefore, in Sec. 1305.11(a), DEA is proposing to modify the
language regarding the new single-sheet DEA Form 222 to indicate that a
predetermined number of order forms, based on the business activity of
the registrant, will be issued, rather than the current ``books'' of
seven order forms. DEA also proposes to revise Sec. 1305.11(c) to
remove language pertaining to ``books of DEA Forms 222.''
Other Minor Regulatory Changes
The DEA is proposing several minor regulatory changes as part of
this rulemaking, as discussed below.
Pursuant to Sec. 1305.05(a), a registrant may authorize one or
more individuals, whether or not located at his or her registered
location, to issue orders for schedule I and II controlled substances
on the registrant's behalf by executing a power of attorney (POA) for
each such individual, if the POA is retained in the files, with
executed DEA Forms 222 where applicable, for the same period as any
order bearing the signature of the POA. The POA must be available for
inspection together with other order records.
Under Sec. 1305.05(d), a POA must be executed by the person who
signed the most recent application for DEA registration or
reregistration; the person to whom the POA is being granted; and two
witnesses. DEA proposes to modify this language to increase the
accountability to permit other individuals to authorize the POA on
behalf of the registrant who is unavailable and is similar to the
language found in 21 CFR 1301.13(j) regarding who can sign an
application for a DEA registration. For example, if the legal entity
that is applying for a DEA registration is a partnership, then either
partner may sign the application. If the legal entity that is applying
for a DEA registration is a corporation, then any corporate officer may
sign the application. DEA is proposing to allow the registrant, if an
individual, to execute a POA even though that individual did not sign
the last application.
In Sec. 1305.11(b), DEA is proposing to revise the procedure for
requisitioning DEA Forms 222 by any person with an active registration
that is authorized to order schedule I and II controlled substances to
include obtaining them through a secured network connection. As
previously discussed, DEA would only be issuing single-sheet forms if
the proposed rule were finalized. Due to the advancement of technology,
the Diversion Control Division can look at other methods and procedures
when single-sheet forms are requested only through a secured network
connection
[[Page 5398]]
between devices. In Sec. 1305.11(d), DEA is proposing to add
procedures for reporting any errors on a DEA Form 222 to the local
Division Office.
In Sec. 1305.12(a), DEA is proposing to add a ``computer printer''
to the list of acceptable methods for filling out a DEA Form 222, in
addition to the existing use of a typewriter, pen, or indelible pencil.
Currently, Sec. 1305.13(d) preserves triplicate copies of DEA Form
222 for the supplier. DEA proposes to modify the language to a single-
sheet form. A single-sheet Form 222 needs to be available for
inspection for a period of two years in accordance with proposed Sec.
1305.17(c).
In Sec. 1305.14(b), DEA is proposing to remove the exception where
the name of the supplier is requested on the reporting form, the second
supplier must record the name, address, and registration number of the
first supplier. DEA has noticed that distribution centers, when
reporting to ARCOS, would report themselves as the supplier and not try
to record the name, address, and registration number of the first
supplier. DEA believes that removing this exception would enable more
accurate reporting and recordkeeping.
Regulatory Analysis
DEA conducted a regulatory analysis of the proposed rule to
determine how its provisions will impact registrants and the DEA. The
results of this analysis are outlined below.
Executive Orders 12866 (Regulatory Planning and Review), 13563,
(Improving Regulation and Regulatory Review), and 13771 (Reducing
Regulation and Controlling Regulatory Costs)
This proposed rule was developed in accordance with the principles
of Executive Orders 12866, 13563 and 13771. Executive Order 12866
directs agencies to assess all costs and benefits of available
regulatory alternatives and, if regulation is necessary, to select
regulatory approaches that maximize net benefits (including potential
economic, environmental, public health, and safety effects;
distributive impacts; and equity). Executive Order 13563 is
supplemental to and reaffirms the principles, structures, and
definitions governing regulatory review as established in Executive
Order 12866. Executive Order 12866 classifies a ``significant
regulatory action,'' requiring review by the Office of Management and
Budget (OMB), as any regulatory action that is likely to result in a
rule that may: (1) 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; (2) create a serious inconsistency or otherwise interfere
with an action taken or planned by another agency; (3) materially alter
the budgetary impact of entitlements, grants, user fees, or loan
programs or the rights and obligations of recipients thereof; or (4)
raise novel legal or policy issues arising out of legal mandates, the
President's priorities, or the principles set forth in the Executive
Order.
1. The DEA expects that this proposed rule will not have an annual
effect on the economy of $100 million or more in at least one year and
therefore is not an economically significant regulatory action. DEA's
analysis finds that this proposed rule will result in an annual cost-
savings of $25.9 million; approximately $22.1 million to purchasers
(persons executing DEA Form 222s) primarily due to efficiencies gained
from having more lines per form, anticipated reduction of instances of
form failure, allowing the use of a printer, and general ease of use;
approximately $0.2 million to non-dispensing suppliers (manufacturers
and distributors) due to the elimination of the requirement that
registrants mail copies of their completed order forms to their DEA
field office; $2.9 million to dispensing suppliers due to having the
option to fax or scan-and-email completed order forms; and $0.8 million
to DEA from reduction in cost of forms production, postage, and
equipment maintenance.
2. This regulatory action is not likely to result in a rule that
may create a serious inconsistency or otherwise interfere with an
action taken or planned by another agency.
3. This regulatory action is not likely to result in a rule that
may materially alter the budgetary impact of entitlements, grants, user
fees, or loan programs or the rights and obligations of recipients
thereof.
4. This regulatory action is not likely to result in a rule that
may raise novel legal or policy issues arising out of legal mandates,
the President's priorities, or the principles set forth in the
Executive Order.
This proposed rule is estimated to have a total cost savings of
$25.9 million. Although this proposed rule is not a significant
regulatory action under E.O. 12866, this proposed rule is expected to
be an E.O. 13771 deregulatory action.
An economic analysis of the proposed rule can be found in the
rulemaking docket at http://www.regulations.gov.
Executive Order 12988, Civil Justice Reform
This proposed rule meets the applicable standards set forth in
sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice
Reform to eliminate ambiguity, minimize litigation, establish clear
legal standards, and reduce burden.
Executive Order 13132, Federalism
This proposed rulemaking does not have federalism implications
warranting the application of Executive Order 13132. The proposed rule
does not have substantial direct effects on the States, on the
relationship between the national government and the States, or the
distribution of power and responsibilities among the various levels of
government.
Executive Order 13175, Consultation and Coordination With Indian Tribal
Governments
This proposed rule does not have substantial direct effects on the
States, on the relationship between the national government and the
States, or the distribution of power and responsibilities between the
Federal Government and Indian tribes.
Regulatory Flexibility Act
The Administrator hereby certifies that this proposed rule has been
drafted, in accordance with the Regulatory Flexibility Act (5 U.S.C.
605(b)), and by approving it, certifies that this rule will not, if
promulgated, have a significant economic impact upon a substantial
number of small entities.
In accordance with the RFA, the DEA evaluated the impact of this
rule on small entities. The DEA is proposing to amend its regulations
to implement a new single-sheet format for order forms (DEA Form 222)
which are issued by DEA to DEA registrants to allow them to order
schedule I and/or II controlled substances. DEA also proposes minor
procedural changes, including among other things, who can issue the
power of attorney that is required for others to sign DEA Form 222.
This proposed rule affects all parties (purchaser and suppliers) to
transactions where a DEA Form 222 is used.
Based on its records, the DEA estimates that 71,481 entities are
affected by this rule, which consist of 336 manufacturers, 378
distributors, 31,887 pharmacies, 7,980 hospitals and clinics and 30,900
practitioners. The DEA estimates that 65,984 (92.3%) of
[[Page 5399]]
the total 71,481 affected entities are small entities (312
manufacturers, 364 distributors, 31,217 pharmacies, 3,716 hospitals and
clinics and 30,375 practitioners). The estimated economic impact varies
for purchasers and suppliers, and among the suppliers, dispensing
suppliers and non-dispensing suppliers.
``Purchasers'' are registrants (primarily pharmacies,
practitioners, hospitals and clinics) who execute DEA Form 222 to order
Schedules I and II controlled substances. The use of the new single
sheet form will require purchasers to make a copy (photocopy or scan)
prior to submission to a supplier at an estimated cost of $0.22 per
form, or a total of $734,646 per year. However, some cost savings are
expected due to efficiencies gained from the new form. Key advantages
include: (1) Reduction in number of forms executed due to increased
number of lines per form, (2) reduction in form failure due to upgraded
high-quality secure paper (fewer incidences of tears, carbon not
copying through, improper tear of perforated edges, etc.), and (3)
increased efficiency in completing the form due to ability to use a
computer printer to fill the form (in addition to the existing
allowable methods of typewriter, pen, or indelible pencil). Purchasers,
as a group, are anticipated to save $22,794,750, for a net savings of
$22,060,104, or $312 per entity.
``Dispensing suppliers'' are individual or institutional
practitioners (e.g., physicians, pharmacies, hospitals, clinics, etc.)
that are registered to dispense a controlled substance and may also
distribute (without being registered to distribute) a quantity of such
substance to another practitioner using a DEA Form 222. The proposed
rule would allow the dispensing supplier to submit their copy of the
order form to DEA via fax or email, in addition to the currently
required submission by mail. Assuming dispensers will opt for the less
costly fax or scan-and-email method, based on an estimated 17,480
dispensing suppliers, the DEA estimates the dispensing suppliers, as a
group, would save $2,861,977 per year or $164 per supplier.
``Non-dispensing suppliers'' are persons registered with the DEA as
manufacturers or distributors of controlled substances listed in
Schedules I or II. The proposed rule and new form would remove the
requirement to ship their copies of the received order forms to their
DEA field office at the end of each month. The DEA estimates, by
removing this requirement, the non-dispensing suppliers, as a group
would save $239,657 per year, or $336 per entity.
In summary, the proposed rule is estimated to save Purchasers,
Dispensing Suppliers, and Non-Dispensing Suppliers, $312, $164, and
$336 per entity per year, respectively. The DEA uses 3% of annual
revenue as threshold for ``significant economic impact.'' The annual
revenue at which $312, $164, and $336 is 3% equates to $10,400, $5,467,
and $11,200, respectively. The DEA estimates the annual revenues of
purchasers, dispensing suppliers, and non-dispensing suppliers are
greater than $10,400, $5,467, and $11,200, respectively, resulting in
an economic impact of less than 3% of annual revenue.
Therefore, the DEA's evaluation of economic impact by size category
indicates that the rule will not, if promulgated, have a significant
economic impact on a substantial number of small entities.
Unfunded Mandates Reform Act of 1995
This proposed rule will not 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, and will not significantly or uniquely affect small governments.
Therefore, no actions were deemed necessary under the provisions of the
Unfunded Mandates Reform Act of 1995, 2 U.S.C. 1532.
Paperwork Reduction Act of 1995
Pursuant to section 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 proposed rule. A person is
not required to respond to a collection of information unless it
displays a valid Office of Management and Budget (OMB) control number.
Copies of existing information collections approved by OMB may be
obtained at http://www.reginfo.gov/public/do/PRAMain.
A. Collections of Information Associated With the Notice of Proposed
Rulemaking
Title: U.S. Official Order Forms for Schedules I & II Controlled
Substances (Accountable Forms), Order Form Requisition.
OMB Control Number: 1117-0010.
Form Number: DEA-222.
The DEA Form 222 provides the DEA with oversight and control over
the distribution of schedules I and II controlled substances. The form
is the only document that can authorize the distribution of schedules I
and II controlled substances within the closed system of distribution.
The DEA is proposing to amend its regulations to implement a new
single-sheet format for order forms (DEA Form 222) which are issued by
DEA to DEA registrants to allow them to order schedule I and/or II
controlled substances. Currently, the DEA Form 222 is a triplicate form
with interleaved carbon paper.
The new single-sheet format is expected to lower labor burden due
to efficiencies gained from having more lines per form, anticipated
reduction of instances of form failure, allowing the use of a printer,
and general ease of use. Additionally, the proposed rule removes the
requirement for Automation of Reports and Consolidated Orders System
(ARCOS)-reporting suppliers to mail/ship completed order forms to the
DEA field offices. Finally, the proposed rule would also allow non-
ARCOS reporting suppliers (generally dispensers who distribute) to
submit completed order forms to the respective DEA field offices via
fax or email, in addition to mail.
DEA registrants will be allowed to exhaust their supply of the
current forms as part of the transition period. When a registrant's
supply of triplicate forms is depleted, the DEA would issue the new
single-sheet forms. The final rule would include a ``sunset date''--a
date after which use of the triplicate forms would not be allowed--of
two years after the final rule becomes effective.
This proposed rule does not impact those who use the electronic
equivalent order form. The DEA estimates the following number of
respondents and burden associated with this collection of information
(which includes DEA Form 222 and the electronic equivalent):
Number of respondents: 125,435.
Frequency of response: 59.
Number of responses: 7,400,000 (3,300,000 paper DEA Form
222, 4,100,000 electronic equivalent).
Burden per response: $0.1392.
Total annual hour burden: 1,030,000.
Due to the elimination for suppliers to mail completed DEA Form 222
to the local DEA field office, the Cost Burden is also eliminated. Due
to the provisions of this proposed rule requiring purchasers to make
copies of the new single-sheet format for order forms (DEA Form 222),
the cost is reduced to $130,350.
B. Request for Comments Regarding the Proposed Collections of
Information
Written comments and suggestions from the public and affected
entities
[[Page 5400]]
concerning the proposed collections of information are encouraged.
Under the PRA, the DEA is required to provide a notice regarding the
proposed collections of information in the Federal Register with the
Notice of Proposed Rulemaking and solicit public comment. Pursuant to
section 3506(c)(2) of the PRA (44 U.S.C. 3506(c)(2)), the DEA solicits
comment on the following issues:
[ssquf] Whether the proposed collection of information is necessary
for the proper performance of the functions of the DEA, including
whether the information will have practical utility.
[ssquf] The accuracy of the DEA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used.
[ssquf] Recommendations to enhance the quality, utility, and
clarity of the information to be collected.
[ssquf] Recommendations to minimize the burden of the collection of
information on those who are to respond, including through the use of
automated collection techniques or other forms of information
technology.
Please send written comments to the Office of Information and
Regulatory Affairs, OMB, Attention: Desk Officer for DOJ, Washington,
DC 20503. Please state that your comments refer to RIN 1117-0010/Docket
No. DEA-453. All comments must be submitted to OMB on or before April
22, 2019. The final rule will respond to any OMB or public comments on
the information collection requirements contained in this proposal.
Congressional Review Act
This proposed rule is not a major rule as defined by Section 804 of
the Small Business Regulatory Enforcement Fairness Act of 1996
(Congressional Review Act). This proposed 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 significant adverse effects on competition,
employment, investment, productivity, innovation, or on the ability of
United States-based companies to compete with foreign-based companies
in domestic and export markets.
List of Subjects in 21 CFR Part 1305
Drug traffic control, Reporting and recordkeeping requirements.
For the reasons set forth above, the DEA proposes to amend 21 CFR
part 1305 as follows:
PART 1305--ORDERS FOR SCHEDULE I AND II CONTROLLED SUBSTANCES
0
1. The authority citation for part 1305 continues to read as follows:
Authority: 21 U.S.C. 821, 828, 871(b), unless otherwise noted.
0
2. Amend Sec. 1305.05 by revising paragraph (d) to read as follows:
Sec. 1305.05 Power of attorney.
* * * * *
(d) A power of attorney must be executed by the registrant, if an
individual; by a partner of the registrant, if a partnership; or by an
officer of the registrant, if a corporation, corporate division,
association, trust or other entity; the person to whom the power of
attorney is being granted; and two witnesses.
* * * * *
0
3. Revise Sec. 1305.11 to read as follows:
Sec. 1305.11 Procedure for obtaining DEA Forms 222.
(a) DEA Forms 222 are issued in mailing envelopes containing a
predetermined number of forms based on the business activity of the
registrant, each form consisting of one single-sheet. A limit, which is
based on the business activity of the registrant, will be imposed on
the number of DEA Forms 222 which will be furnished on any requisition
unless additional forms are specifically requested and a reasonable
need for such additional forms is shown.
(b) Any person with an active registration that is authorized to
order schedule I and II controlled substances would be entitled to
obtain a DEA Form 222, which will be supplied at any time after the DEA
registration is granted. Any person holding a registration authorizing
him or her to obtain a DEA Form 222 may requisition the forms through a
DEA secured network connection or by contacting any Division Office or
the Registration Section of the Administration through the customer
service center.
(c) Each requisition must show the name, address, and registration
number of the registrant and the number of DEA Forms 222 desired. Each
requisition must be signed and dated by the same person who signed the
most recent application for registration or for reregistration, or by
any person authorized to obtain and execute DEA Forms 222 by a power of
attorney under Sec. 1305.05.
(d) DEA Forms 222 will have an order form number and be issued with
the name, address and registration number of the registrant, the
authorized activity, and schedules of the registrant. This information
cannot be altered or changed by the registrant; the registrant must
report any errors to the local Division Office or the Registration
Section of the Administration to modify the registration.
0
4. Amend Sec. 1305.12 by revising paragraph (a) to read as follows:
Sec. 1305.12 Procedure for executing DEA Forms 222.
(a) A purchaser must prepare and execute a DEA Form 222 by use of a
typewriter, computer printer, pen, or indelible pencil.
* * * * *
0
5. Amend Sec. 1305.13 by revising paragraphs (a), (b), (d), and (e) to
read as follows:
Sec. 1305.13 Procedure for filling DEA Forms 222.
(a) A purchaser must submit the original DEA Form 222 to the
supplier and retain a copy in the purchaser's files.
(b) A supplier may fill the order, if possible and if the supplier
desires to do so, and must record on the original and a copy their DEA
registration number and the number of commercial or bulk containers
furnished on each item and the date on which the containers are shipped
to the purchaser. If an order cannot be filled in its entirety, it may
be filled in part and the balance supplied by additional shipments
within 60 days following the date of the DEA Form 222. No DEA Form 222
is valid more than 60 days after its execution by the purchaser, except
as specified in paragraph (f) of this section.
* * * * *
(d) The supplier must retain the original DEA Form 222 for his or
her files in accordance with Sec. 1305.17(c). Any supplier who is not
required to report acquisition/disposition transactions to the
Automation of Reports and Consolidated Orders System (ARCOS) under
Sec. 1304.33(c) of this chapter (such as a practitioner) must make and
submit a copy of the original DEA Form 222 to DEA by mail (Drug
Enforcement Administration, Attn: Registration Section/DRR), fax (202)
307-5602), or email to ([email protected]). The copy must be
forwarded at the close of the month during which the order is filled.
If an order is filled by partial shipments, the copy must be forwarded
at the close of the month during which the final shipment is made or
the 60-day validity period expires.
(e) The purchaser must record on its copy of the DEA Form 222 the
number of commercial or bulk containers
[[Page 5401]]
furnished on each item and the dates on which the containers are
received by the purchaser.
* * * * *
0
6. Amend Sec. 1305.14 by revising the first two sentences of paragraph
(a) and paragraph (b) to read as follows:
Sec. 1305.14 Procedure for endorsing DEA Forms 222.
(a) A DEA Form 222, made out to any supplier who cannot fill all or
a part of the order within the time limitation set forth in Sec.
1305.13, may be endorsed to another supplier for filling. The
endorsement must be made only by the supplier to whom the DEA Form 222
was first made, must state (in the spaces provided in Part 3 on the
original DEA Form 222) the DEA number of the second supplier, and must
be signed and dated by a person authorized to obtain and execute DEA
Forms 222 on behalf of the first supplier. * * *
(b) Distributions made on endorsed DEA Forms 222 must be reported
by the second supplier in the same manner as all other distributions.
0
7. Amend Sec. 1305.15 by revising paragraphs (b) and (d) to read as
follows:
Sec. 1305.15 Unaccepted and defective DEA Forms 222.
* * * * *
(b) If a DEA Form 222 cannot be filled for any reason under this
section, the supplier must return the original DEA Form 222 to the
purchaser with a statement as to the reason (e.g. illegible or
altered).
* * * * *
(d) When a purchaser receives an unaccepted order, the original DEA
Form 222 and the statement must be retained in the files of the
purchaser in accordance with Sec. 1305.17. A defective DEA Form 222
may not be corrected; it must be replaced by a new DEA Form 222 for the
order to be filled.
0
8. Amend Sec. 1305.16 by revising paragraphs (a) and (d) to read as
follows:
Sec. 1305.16 Lost and stolen DEA Forms 222.
(a) If a purchaser ascertains that an unfilled DEA Form 222 has
been lost, he or she must execute another and attach a statement
containing the order form number and date of the lost form, and stating
that the goods covered by the first DEA Form 222 were not received
through loss of that DEA Form 222. A copy of the second form and a copy
of the statement must be retained with a copy of the DEA Form 222 first
executed. A copy of the statement must be attached to a copy of the
second DEA Form 222 sent to the supplier. If the first DEA Form 222 is
subsequently received by the supplier to whom it was directed, the
supplier must mark upon the face ``Not accepted'' and return the
original DEA Form 222 to the purchaser, who must attach it to the
statement.
* * * * *
(d) If any DEA Forms 222 are lost or stolen, and the purchaser is
unable to state the order form numbers of the DEA Forms 222, the
purchaser must report, in lieu of numbers of the forms, the date or
approximate date of issuance.
* * * * *
0
9. Amend Sec. 1305.17 by revising paragraphs (a), (b), and (c) to read
as follows:
Sec. 1305.17 Preservation of DEA Forms 222.
(a) The purchaser must retain a copy of each executed DEA Form 222
and all copies of unaccepted or defective forms with each statement
attached.
(b) The supplier must retain the original of each DEA Form 222 that
it has filled.
(c) DEA Forms 222 must be maintained separately from all other
records of the registrant. DEA Forms 222 are required to be kept
available for inspection for a period of two years. If a purchaser has
several registered locations, the purchaser must retain a copy of the
executed DEA Form 222 and any attached statements or other related
documents (not including unexecuted DEA Forms 222, which may be kept
elsewhere under Sec. 1305.12(e)), at the registered location printed
on the DEA Form 222.
* * * * *
0
10. Amend Sec. 1305.19 by revising paragraph (a) to read as follows:
Sec. 1305.19 Cancellation and voiding of DEA Forms 222.
(a) A purchaser may cancel part or all of an order on a DEA Form
222 by notifying the supplier in writing of the cancellation. The
supplier must indicate the cancellation on the original DEA Form 222
sent by the purchaser by drawing a line through the canceled items and
printing ``canceled'' in the space provided for the number of items
shipped.
* * * * *
0
11. Add Sec. 1305.20 to read as follows:
Sec. 1305.20 Transition provisions allowing continued use of existing
stocks of triplicate DEA Forms 222.
This section provides the procedures allowing registrants to
continue to use existing stocks of the triplicate DEA Form 222, which
may continue to be used until [Sunset Date of two years after effective
date of final rule]. Registrants are required to use the new single-
sheet DEA Form 222 once the supply of the triplicate forms is
exhausted. The provisions of this part are applicable to the use of
triplicate forms, except for the specific rules as provided in this
section.
(a) Procedure for obtaining DEA Forms 222. As set forth in Sec.
1305.11, DEA will no longer issue triplicate forms. Triplicate DEA
Forms 222 will not be accepted after [Sunset Date of two years after
effective date of final rule].
(b) Procedure for executing the triplicate DEA Forms 222. As set
forth in Sec. 1305.12:
(1) A purchaser must prepare and execute a triplicate DEA Form 222
simultaneously by means of interleaved carbon sheets that are part of
the DEA Form 222. DEA Form 222 must be prepared by use of a typewriter,
pen, or indelible pencil.
(2) Only one item may be entered on each numbered line. An item
must consist of one or more commercial or bulk containers of the same
finished or bulk form and quantity of the same substance. The number of
lines completed must be noted on that form at the bottom of the form,
in the space provided. DEA Forms 222 for carfentanil, etorphine
hydrochloride, and diprenorphine must contain only these substances.
(3) The name and address of the supplier from whom the controlled
substances are being ordered must be entered on the form. Only one
supplier may be listed on any form.
(4) Each DEA Form 222 must be signed and dated by a person
authorized to sign an application for registration or a person granted
power of attorney to sign a DEA Form 222 under Sec. 1305.05. The name
of the purchaser, if different from the individual signing the DEA Form
222, must also be inserted in the signature space.
(5) Unexecuted DEA Forms 222 may be kept and may be executed at a
location other than the registered location printed on the form,
provided that all unexecuted forms are delivered promptly to the
registered location upon an inspection of the location by any officer
authorized to make inspections, or to enforce, any Federal, State, or
local law regarding controlled substances.
(c) Procedure for filling triplicate DEA Forms 222. As set forth in
Sec. 1305.13:
(1) A purchaser must submit Copy 1 and Copy 2 of the triplicate DEA
Form 222 to the supplier and retain Copy 3 in the purchaser's files.
(2) A supplier may fill the order, if possible and if the supplier
desires to do so, and must record on Copies 1 and 2 the number of
commercial or bulk containers furnished on each item and
[[Page 5402]]
the date on which the containers are shipped to the purchaser. If an
order cannot be filled in its entirety, it may be filled in part and
the balance supplied by additional shipments within 60 days following
the date of the DEA Form 222. No DEA Form 222 is valid more than 60
days after its execution by the purchaser, except as specified in
paragraph (c)(6) of this section.
(3) The controlled substances must be shipped only to the purchaser
and the location printed by the Administration on the DEA Form 222,
except as specified in paragraph (c)(6) of this section.
(4) The supplier must retain Copy 1 of the triplicate DEA Form 222
for his or her files in accordance with paragraph (g)(3) of this
section and forward Copy 2 to the Special Agent in Charge of the Drug
Enforcement Administration in the area in which the supplier is
located. Copy 2 must be forwarded at the close of the month during
which the order is filled. If an order is filled by partial shipments,
Copy 2 must be forwarded at the close of the month during which the
final shipment is made or the 60-day validity period expires.
(5) The purchaser must record on Copy 3 of the triplicate DEA Form
222 the number of commercial or bulk containers furnished on each item
and the dates on which the containers are received by the purchaser.
(6) DEA triplicate Forms 222 submitted by registered procurement
officers of the Defense Supply Center of the Defense Logistics Agency
for delivery to armed services establishments within the United States
may be shipped to locations other than the location printed on the DEA
Form 222, and in partial shipments at different times not to exceed six
months from the date of the order, as designated by the procurement
officer when submitting the order.
(d) Procedure for endorsing triplicate DEA Forms 222. As set forth
in Sec. 1305.14:
(1) A triplicate DEA Form 222, made out to any supplier who cannot
fill all or a part of the order within the time limitation set forth in
paragraph (c) of this section, may be endorsed to another supplier for
filling. The endorsement must be made only by the supplier to whom the
DEA Form 222 was first made, must state (in the spaces provided on the
reverse sides of Copies 1 and 2 of the triplicate DEA Form 222) the
name and address of the second supplier, and must be signed by a person
authorized to obtain and execute DEA Forms 222 on behalf of the first
supplier. The first supplier may not fill any part of an order on an
endorsed form. The second supplier may fill the order, if possible and
if the supplier desires to do so, in accordance with paragraphs (c)(2)
through (4) of this section, including shipping all substances directly
to the purchaser.
(2) Distributions made on endorsed DEA Forms 222 must be reported
by the second supplier in the same manner as all other distributions.
(e) Unaccepted and defective triplicate DEA Forms 222. As set forth
in Sec. 1305.15:
(1) A DEA Form 222 must not be filled if either of the following
apply:
(i) The order is not complete, legible, or properly prepared,
executed, or endorsed.
(ii) The order shows any alteration, erasure, or change of any
description.
(2) If a triplicate DEA Form 222 cannot be filled for any reason
under this section, the supplier must return Copies 1 and 2 to the
purchaser with a statement as to the reason (e.g. illegible or
altered).
(3) A supplier may for any reason refuse to accept any order and if
a supplier refuses to accept the order, a statement that the order is
not accepted is sufficient for purposes of this paragraph (e).
(4) When a purchaser receives an unaccepted order, Copies 1 and 2
of the triplicate DEA Form 222 and the statement must be attached to
Copy 3 and retained in the files of the purchaser in accordance with
paragraph (g) of this section. A defective DEA Form 222 may not be
corrected; it must be replaced by a new DEA Form 222 for the order to
be filled.
(f) Lost and stolen triplicate DEA Forms 222. As set forth in Sec.
1305.16:
(1) If a purchaser ascertains that an unfilled triplicate DEA Form
222 has been lost, he or she must execute another in triplicate and
attach a statement containing the serial number and date of the lost
form, and stating that the goods covered by the first DEA Form 222 were
not received through loss of that DEA Form 222. Copy 3 of the second
form and a copy of the statement must be retained with Copy 3 of the
DEA Form 222 first executed. A copy of the statement must be attached
to Copies 1 and 2 of the second DEA Form 222 sent to the supplier. If
the first DEA Form 222 is subsequently received by the supplier to whom
it was directed, the supplier must mark upon the face ``Not accepted''
and return Copies 1 and 2 to the purchaser, who must attach it to Copy
3 and the statement. However, if the registrant no longer can use
triplicate forms, then the registrant shall proceed by issuing a new
single-sheet form in accordance with Sec. 1305.16.
(2) Whenever any used or unused DEA Forms 222 are stolen or lost
(other than in the course of transmission) by any purchaser or
supplier, the purchaser or supplier must immediately upon discovery of
the theft or loss, report the theft or loss to the Special Agent in
Charge of the Drug Enforcement Administration in the Divisional Office
responsible for the area in which the registrant is located, stating
the serial number of each form stolen or lost.
(3) If the theft or loss includes any original DEA Forms 222
received from purchasers and the supplier is unable to state the serial
numbers of the DEA Forms 222, the supplier must report the date or
approximate date of receipt and the names and addresses of the
purchasers.
(4) If an entire book of triplicate DEA Forms 222 is lost or
stolen, and the purchaser is unable to state the serial numbers of the
DEA Forms 222 in the book, the purchaser must report, in lieu of the
numbers of the forms contained in the book, the date or approximate
date of issuance.
(5) If any unused DEA Form 222 reported stolen or lost is
subsequently recovered or found, the Special Agent in Charge of the
Drug Enforcement Administration in the Divisional Office responsible
for the area in which the registrant is located must immediately be
notified.
(g) Preservation of triplicate DEA Forms 222. As set forth in Sec.
1305.17:
(1) The purchaser must retain Copy 3 of each executed triplicate
DEA Form 222 and all copies of unaccepted or defective forms with each
statement attached.
(2) The supplier must retain Copy 1 of each triplicate DEA Form 222
that it has filled.
(3) Triplicate DEA Forms 222 must be maintained separately from all
other records of the registrant. DEA Forms 222 are required to be kept
available for inspection for a period of two years. If a purchaser has
several registered locations, the purchaser must retain Copy 3 of the
executed triplicate DEA Form 222 and any attached statements or other
related documents (not including unexecuted DEA Forms 222, which may be
kept elsewhere under paragraph (b)(5) of this section), at the
registered location printed on the DEA Form 222.
(4) The supplier of thiafentanil, carfentanil, etorphine
hydrochloride, and diprenorphine must maintain DEA Forms 222 for these
substances separately from all other DEA Forms
[[Page 5403]]
222 and records required to be maintained by the registrant.
(h) Return of unused triplicate DEA Forms 222. As set forth in
Sec. 1305.18, if the registration of any purchaser terminates (because
the purchaser dies, ceases legal existence, discontinues business or
professional practice, or changes the name or address as shown on the
purchaser's registration) or is suspended or revoked under Sec.
1301.36 of this chapter for all schedule I and II controlled substances
for which the purchaser is registered, the purchaser must return all
unused triplicate DEA Forms 222 to the nearest office of the
Administration.
(i) Cancellation and voiding of triplicate DEA Forms 222. As set
forth in Sec. 1305.19:
(1) A purchaser may cancel part or all of an order on a triplicate
DEA Form 222 by notifying the supplier in writing of the cancellation.
The supplier must indicate the cancellation on Copies 1 and 2 of the
triplicate DEA Form 222 by drawing a line through the canceled items
and printing ``canceled'' in the space provided for the number of items
shipped.
(2) A supplier may void part or all of an order on a triplicate DEA
Form 222 by notifying the purchaser in writing of the voiding. The
supplier must indicate the voiding in the manner prescribed for
cancellation in paragraph (i)(1) of this section.
Dated: February 10, 2019.
Uttam Dhillon,
Acting Administrator.
[FR Doc. 2019-02875 Filed 2-20-19; 8:45 am]
BILLING CODE 4410-09-P