Proposed Rule2022-15265
Providing Controlled Substances to Ocean Vessels, Aircraft, and Other Entities
Primary source
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Published
July 18, 2022
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
The Drug Enforcement Administration (DEA) is issuing this advance notice of proposed rulemaking to obtain information regarding the procurement of controlled substances by a medical officer for emergency kits on board ocean vessels, aircraft, and certain other entities. The regulations permitting controlled substances acquired by and dispensed under the general supervision of a medical officer to be stored in and dispensed from emergency kits on board ocean vessels, aircraft, and other entities were established in 1971 and have not been significantly modified since. DEA is considering revising these regulations and seeks to gain a better understanding of the industry's current needs and practices.
Full Text
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<title>Federal Register, Volume 87 Issue 136 (Monday, July 18, 2022)</title>
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[Federal Register Volume 87, Number 136 (Monday, July 18, 2022)]
[Proposed Rules]
[Pages 42662-42665]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-15265]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1301
[Docket No. DEA-598]
RIN 1117-AB60
Providing Controlled Substances to Ocean Vessels, Aircraft, and
Other Entities
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Advance notice of proposed rulemaking.
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SUMMARY: The Drug Enforcement Administration (DEA) is issuing this
advance notice of proposed rulemaking to obtain information regarding
the procurement of controlled substances by a medical officer for
emergency kits on board ocean vessels, aircraft, and certain other
entities. The regulations permitting controlled substances acquired by
and dispensed under the general supervision of a medical officer to be
stored in and dispensed from emergency kits on board ocean vessels,
aircraft, and other entities were established in 1971 and have not been
significantly modified since. DEA is considering revising these
regulations and seeks to gain a better understanding of the industry's
current needs and practices.
[[Page 42663]]
DATES: Electronic comments must be submitted, and written comments must
be postmarked, on or before September 16, 2022. 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
``RIN 1117-AB60/Docket No. DEA-598'' on all correspondence, including
any attachments.
<bullet> Electronic comments: DEA 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 <a href="http://www.regulations.gov">http://www.regulations.gov</a> and follow the online
instructions at that site for submitting comments. Upon completion of
your submission, you will receive a Comment Tracking Number for your
comment. Please be aware that submitted comments are not
instantaneously available for public view on <a href="http://Regulations.gov">Regulations.gov</a>. If you
have received a Comment Tracking Number, your comment has been
successfully submitted, and there is no need to resubmit the same
comment.
<bullet> Paper comments: Paper comments that duplicate the
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, VA 22152.
FOR FURTHER INFORMATION CONTACT: Scott A. Brinks, Regulatory Drafting
and Policy Support Section, Diversion Control Division, Drug
Enforcement Administration; Telephone: (571) 776-2265.
SUPPLEMENTARY INFORMATION:
Posting of Public Comments
Please note that all comments received in response to this docket
are considered part of the public record. They will, unless reasonable
cause is given, be made available by DEA for public inspection online
at <a href="http://www.regulations.gov">http://www.regulations.gov</a>. Such information includes personal
identifying information (such as your name, address, etc.) voluntarily
submitted by the commenter. The Freedom of Information Act 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 all of the personal identifying
information you do not want 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 the
confidential business information to be redacted within the comment.
Comments containing personal identifying information or
confidential business information identified as directed above will 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 <a href="http://www.regulations.gov">http://www.regulations.gov</a> may include any personal identifying information
(such as your name, address, etc.) included in the text of your
electronic submission that is not identified as directed above as
confidential.
An electronic copy of this advance notice of proposed rulemaking is
available at <a href="http://www.regulations.gov">http://www.regulations.gov</a> for ease of reference.
Legal Authority
The Drug Enforcement Administration (DEA) implements and 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, as amended.\1\ DEA publishes the
implementing regulations for these statutes in 21 CFR parts 1300 to
end. These regulations are designed to ensure a sufficient supply of
controlled substances for medical, scientific, and other legitimate
purposes, and to deter the diversion of controlled substances for
illicit purposes.
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\1\ 21 U.S.C. 801-971.
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As mandated by the CSA, DEA establishes and maintains a closed
system of control for manufacturing, distribution, and dispensing of
controlled substances, and requires any person who manufactures,
distributes, dispenses, imports, exports, or conducts research or
chemical analysis with controlled substances to register with DEA,
unless they meet an exemption.\2\ The CSA authorizes the DEA
Administrator (Administrator), by delegation from the Attorney General,
to register an applicant to manufacture, distribute, or dispense
controlled substances if such registration is determined to be
consistent with the public interest.\3\ The CSA further authorizes the
Administrator to promulgate regulations necessary and appropriate to
execute the functions of subchapter I (Control and Enforcement) and
subchapter II (Import and Export) of the CSA,\4\ or relating to the
registration and control of the manufacture, distribution, and
dispensing of controlled substances.\5\ By this authority, DEA is
considering revising the regulations that permit controlled substances
acquired by and dispensed under the general supervision of a medical
officer to be stored in and dispensed from medicine chests, first aid
packets, or dispensaries on board ocean vessels, aircraft, and in any
other entity of fixed or transient location approved by the
Administrator.\6\
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\2\ 21 U.S.C. 822.
\3\ 21 U.S.C. 823.
\4\ 21 U.S.C. 871(b).
\5\ 21 U.S.C. 821.
\6\ 21 CFR 1301.25(a).
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Background
The existing regulations in 21 CFR 1301.25 that allow controlled
substances to be held for stocking, maintained in, and dispensed from
medicine chests, first aid packets, and dispensaries on board ocean
vessels, aircraft, and in certain other entities were published in 1971
as part of the original regulations implementing the CSA.\7\ Since
then, only minor changes have been made to these regulations. In 1972,
21 CFR 301.28, ``Registration regarding ocean vessels,'' and 21 CFR
301.29, ``Registration regarding commercial aircraft,'' were combined
into one section, 21 CFR 301.28, ``Registration regarding ocean
vessels, commercial aircraft and certain other entities.'' \8\ In 1973,
all parts and sections of Title 21 of the CFR were re-designated upward
by one thousand; thus, 21 CFR 301.28 became 21 CFR 1301.28.\9\ In 1997,
the section was re-designated again and became 21 CFR
[[Page 42664]]
1301.25.\10\ DEA is soliciting information from entities acquiring
controlled substances in accordance with 21 CFR 1301.25 to better
understand current industry practices.
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\7\ Proposed Regulations Implementing the Comprehensive Drug
Abuse Prevention Act of 1970, 36 FR 4928 (March 13, 1971) and
Regulations Implementing the Comprehensive Drug Abuse Prevention Act
of 1970, 36 FR 7776 (April 24, 1971).
\8\ 37 FR 15917 (August 8, 1972).
\9\ 38 FR 26609 (September 24, 1973).
\10\ 62 FR 13938 (March 24, 1997).
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Current Regulations
The current regulations allow controlled substances to be kept in
emergency kits on board vessels, aircraft, and other entities if they
are acquired by and dispensed under the general supervision of a
medical officer or the master or first officer of certain vessels.\11\
The regulations specify vessels as those engaged in international
trade, in trade between ports of the United States, any merchant vessel
belonging to the U.S. Government, and aircraft ``operated by an air
carrier under a certificate of permit issued pursuant to the Federal
Aviation Act of 1958 . . . .'' \12\ This language suggests that the
regulations were intended to accommodate commercial entities. However,
vessels and aircraft used primarily for recreation (e.g., private
yachts, planes or jets) are not specifically addressed. Thus, DEA seeks
information regarding emergency kits for recreational vessels and
aircraft containing controlled substances acquired pursuant to the
regulations in 21 CFR 1301.25. Specifically, DEA is seeking a detailed
description of the circumstances in which controlled substances would
be needed, the current process for obtaining controlled substances
(e.g., through the use of a medical officer or directly from a pharmacy
or distributor), and any recordkeeping procedures pertaining to the
controlled substances in emergency kits on recreational vessels and
aircraft.
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\11\ 21 CFR 1301.25(a).
\12\ 21 CFR 1301.25(a).
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DEA notes that all passenger-carrying aircraft certified by the
Federal Aviation Administration are required to have an approved
emergency medical kit on board.\13\ However, the list of contents
required to be maintained in approved emergency medical kits does not
include any controlled substances.\14\ Thus, DEA seeks information with
regard to the maintenance of controlled substances in emergency kits on
commercial aircraft.
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\13\ 14 CFR 121.803(c).
\14\ 14 CFR part 121; Appendix A to part 121--First Aid Kits and
Emergency Medical Kits.
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The current regulations also allow controlled substances to be kept
in emergency kits ``in any entity of fixed or transient location
approved by the Administrator. . . .'' \15\ In a previously published
notice of proposed rulemaking preamble, DEA stated that this provision
was added to accommodate ``other situations where controlled substances
are held at scattered locations for emergency purposes: [o]ffshore oil
rigs, landing fields in Alaska, remote industrial locations, and so
forth.'' \16\ DEA seeks information regarding controlled substances
held in emergency kits at field sites of an industrial firm (e.g.,
airplane hangars, factories, mines, etc.), in oil rigs, platforms,
barges, or any other technology related to offshore drilling and
mining. Specifically, DEA is seeking a detailed description of the
entity where the emergency kit is held, the process for obtaining
controlled substances for the emergency kit, recordkeeping procedures,
and controlled substance dispensing and administration requirements.
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\15\ 21 CFR 1301.25(a)(3).
\16\ Drug Abuse Prevention and Control Notice of Proposed Rule
Making, 37 FR 10370 (May 20, 1972) and Drug Abuse Prevention and
Control, 37 FR 15917 (August 8, 1972).
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Medical Officers
The regulations require the medical officer to be licensed as a
physician, employed by the owner or operator of the vessel, aircraft,
or other entity, and registered with DEA at the principal office of the
owner or operator of the vessel, aircraft, or other entity.\17\ The
controlled substances must be ordered by the medical officer, who is
the DEA registrant, and shipped to the registered location of the
medical officer, as opposed to being shipped directly to the vessel,
aircraft, or other entity. Representatives from the maritime industry
have noted the challenges they face as a result of this requirement. In
response to a previously published advance notice of proposed
rulemaking (ANPRM),\18\ commenters reported that some medical officers
are employed on a part-time basis and often serve as medical officers
for more than one owner or operator. Commenters stated that this can
result in significant delays and vessels being inadequately supplied,
as controlled substances may sit at the medical officer's registered
location for weeks. In addition, one commenter believed that the
regulations do not provide any alternatives for fixed offshore
installations with no medical officer to acquire controlled substances
for emergency kits. However, DEA notes that for controlled substances,
specifically those in schedule II, the regulations state that the
controlled substances must be shipped only to the purchaser (i.e., the
medical officer) at the registered location.\19\ Therefore, DEA seeks
information regarding a registration option for ocean vessels,
aircraft, and other entities.
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\17\ 21 CFR 1301.25(b).
\18\ 61 FR 49086 (September 18, 1996).
\19\ 21 CFR 1305.13(c).
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The regulations also provide that, in the absence of a registered
medical officer, the master or first officer of a vessel may purchase
controlled substances by personally appearing before a registered
manufacturer, distributor, or authorized pharmacy.\20\ The master or
first officer must present proper identification and a written
requisition for the controlled substances, prepared using the vessel's
official stationery or purchase order form. In response to a previously
published ANPRM, commenters opposed the requirement that the master or
first officer must personally appear at the vendor's place of business,
stating that it did not align with current industry practice.\21\ The
commenters also noted that having the master or first officer go ashore
to purchase controlled substances is difficult because of their
shipboard duties and the length of time vessels are in port. DEA seeks
information regarding the purchase of controlled substances by the
master or first officer of a vessel. Specifically, DEA wishes to
understand whether masters or first officers routinely go ashore to
purchase controlled substances or only occasionally.
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\20\ 21 CFR 1301.25(d).
\21\ 61 FR 49086 (September 18, 1996).
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Comments Requested
DEA is soliciting information from the maritime and aviation and
other industries to gain a better understanding of current industry
practices, needs, and requirements with respect to controlled
substances maintained in emergency kits. Although all comments are
welcome, DEA is particularly interested in comments regarding the
questions listed below.
1. Please describe in detail the procedures followed by vessels,
aircraft, or any other approved entity to obtain controlled substances
for medicine chests, first aid packets, or dispensaries.
2. Are there any other regulations, standards, or requirements
(other than DEA regulations) that the entities must comply with when
acquiring and maintaining controlled substances for medicine chests,
first aid packets, or dispensaries?
3. Is a medical officer always involved in the procurement of the
controlled substances? If not, please describe in detail: (1) the
circumstances under which controlled substances are acquired without a
medical officer, and
[[Page 42665]]
(2) the process for acquiring controlled substances under such
circumstances?
4. Please describe in detail the current role of a medical officer,
including all services provided, on board vessels, aircraft, or any
other approved entity.
5. Please describe in detail how controlled substances are acquired
by those entities who do not employ a medical officer.
6. Who generally supplies the controlled substances to the vessels,
aircraft, or other entities? DEA-registered distributors, pharmacies,
manufacturers, etc.?
7. Please describe the safeguards that are in place to provide
effective controls against diversion of controlled substances.
a. Please describe the procedures that must be followed when
handling controlled substances.
b. Who has access to the controlled substances?
c. Who is permitted to dispense or administer controlled substances
and under what circumstances are they permitted to do so?
d. Are there recordkeeping requirements for maintaining inventory,
documenting any controlled substances administered, dispensed, lost,
stolen, or disposed of?
e. Who is responsible for recordkeeping?
8. Please describe the procedures followed for disposing of
damaged, expired, or otherwise unwanted controlled substances.
9. Please describe the procedure for reporting theft or loss of
controlled substances.
10. Please provide any information that would help DEA quantify (or
discuss qualitatively) the potential costs and benefits of a rule that
would promote or restrict the use of contract and part-time medical
officers.
11. Please provide any information that could be used to help DEA
quantify (or discuss qualitatively) the potential costs and benefits of
a rule that would require a DEA registration to obtain controlled
substances for stocking, maintaining in, and dispensing from medicine
chests, first aid packets, or dispensaries on board vessels, aircraft,
or other entities.
12. For the airline industry: Please confirm whether controlled
substances are kept in emergency kits on board airplanes.
a. If so, please describe how the controlled substances are
obtained.
b. Are medical officers frequently employed by the airline
industry?
c. If a medical emergency arises, who on the airplane is permitted
to dispense or administer controlled substances, if needed?
13. For vessels and other offshore entities (e.g., oil rigs and
platforms, mobile offshore drilling units, mining sites, etc.): How and
when are the controlled substances delivered?
a. Are the controlled substances shipped from the medical officer
to the vessel or other entity while in port or prior to offshore
deployment?
b. Are controlled substances ever shipped directly from the vendor
to the vessel or other entity?
c. Who on board the vessel or other entity is responsible for
receiving the shipment?
Regulatory Analyses
This ANPRM was developed in accordance with the principles of
Executive Order (E.O.) 12866, ``Regulatory Planning and Review'' and
E.O. 13563, ``Improving Regulation and Regulatory Review.'' Since this
action is an ANPRM, the requirement of E.O. 12866 to assess the costs
and benefits of this action does not apply.
Furthermore, the requirements of the Regulatory Flexibility Act do
not apply to this action because, at this stage, it is an ANPRM and not
a ``rule'' as defined in 5 U.S.C. 601. Following review of the comments
received in response to this ANPRM, if DEA proceeds with a notice of
proposed rulemaking regarding this matter, DEA will conduct all
relevant analyses as required by statute or Executive Order.
Signing Authority
This document of the Drug Enforcement Administration was signed on
July 13, 2022, by Administrator Anne Milgram. That document with the
original signature and date is maintained by DEA. For administrative
purposes only, and in compliance with requirements of the Office of the
Federal Register, the undersigned DEA Federal Register Liaison Officer
has been authorized to sign and submit the document in electronic
format for publication, as an official document of DEA. This
administrative process in no way alters the legal effect of this
document upon publication in the Federal Register.
Scott Brinks,
Federal Register Liaison Officer, Drug Enforcement Administration.
[FR Doc. 2022-15265 Filed 7-15-22; 8:45 am]
BILLING CODE 4410-09-P
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</html>Indexed from Federal Register on July 18, 2022.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.