[Federal Register Volume 84, Number 117 (Tuesday, June 18, 2019)]
[Rules and Regulations]
[Pages 28212-28214]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-12735]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Parts 1301, 1305, and 1308
[Docket No. DEA-375]
Schedules of Controlled Substances: Placement of Thiafentanil in
Schedule II
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Final rule.
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SUMMARY: On August 26, 2016, the Drug Enforcement Administration (DEA)
published in the Federal Register an interim final rule with request
for comments placing the substance thiafentanil, including its isomers,
esters, ethers, salts and salts of isomers, esters and ethers, in
schedule II of the Controlled Substances Act. This final rule adopts
that interim final rule without change.
DATES: The effective date of this rule is June 18, 2019.
FOR FURTHER INFORMATION CONTACT: Lynnette M. Wingert, Regulatory
Drafting and Policy Support Section, Diversion Control Division, Drug
Enforcement Administration; Mailing Address: 8701 Morrissette Drive,
Springfield, Virginia 22152; Telephone: (202) 598-6812.
SUPPLEMENTARY INFORMATION:
Legal Authority
Under the Controlled Substances Act (CSA), as amended in 2015 by
the Improving Regulatory Transparency for New Medical Therapies Act
(Pub. L. 114-89), where the Drug Enforcement Administration (DEA)
receives notification from the Department of Health and Human Services
(HHS) that the Secretary has indexed a drug under section 572 of the
Federal Food, Drug, and Cosmetic Act (FDCA), the DEA is required to
issue an interim final rule, with opportunity for public comment and to
request a hearing, controlling the drug not later than 90 days after
receiving such notification from HHS and subsequently to issue a final
rule. 21 U.S.C. 811(j). When controlling a drug pursuant to section
811(j), the DEA must apply the scheduling criteria of subsections
811(b), (c), and (d) and section 812(b). 21 U.S.C. 811(j)(3).
Background
On August 26, 2016, the DEA published an interim final rule with
request for comments [81 FR 58834] to make thiafentanil (including its
salts) a schedule II controlled substance(s). See 21 CFR 1308.12(c)(29)
(DEA Controlled Substance Code 9729).
Over time, alternative chemical names have been used to describe
this same specific substance. In the preamble to the interim final
rule, the DEA provided ``4-(methoxycarbonyl)-4-(N-
phenmethoxyacetamido)-1-[2-(thienyl)ethyl]piperidine'' \1\ as the
chemical name for thiafentanil. However, the DEA believes it is more
accurate to use ``methyl 4-(2-methoxy-N-phenylacetamido)-1-(2-
(thiophen-2-yl)ethyl)piperidine-4-carboxylate)'' \2\ in the preamble of
this final rule. It bears emphasis that the chemical that is the
subject of this final rule is the same substance that was the subject
of the interim final rule. The DEA simply is using an alternative
chemical description to refer to that same substance in this preamble.
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\1\ The interim final rule also mentioned the other chemical
name, 4-(methoxycarbonyl)-4-(N-phenylmethoxyacetamido)-1-[2-(2-
thienyl)ethyl]piperidine in the section entitled ``Background, Legal
Authority, and Basis for This Scheduling Action''.
\2\ Other chemical names have been used for thiafentanil. The
HHS referred to the substance as ``4-(methoxycarbonyl)-4-(N-
phenymethoxyacetamido)-1-[2-(thienyl)ethyl]piperidine'' and ``4-
methoxycarbonyl-4(N-phenyl-methoxyacetamido)-1-(2'-(2''-
thienyl)ethyl]-piperidine'' in its November 2011 scientific and
medical evaluation and scheduling recommendation, and as ``4-
(methoxycarbonyl)-4-(N-phenmethoxyacetamido)-1-[2-
(thienyl)ethyl]piperidium'' in its March 2016 supplemental analysis.
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Thiafentanil, a potent opioid, is an analogue of fentanyl. In June
2016, the Food and Drug Administration (FDA) reviewed and determined
that the product Thianil (thiafentanil oxalate, a salt form of
thiafentanil) met the requirements for addition to the Index of Legally
Marketed Unapproved New Animal Drugs for Minor Species (the Index) (21
U.S.C. 360ccc-1) as set forth by the Minor Use and Minor Species Animal
Health Act of 2004 (MUMS Act).\3\ As discussed in the preamble to the
interim final rule, the HHS provided the requisite notification to DEA
that HHS/FDA added Thianil (thiafentanil oxalate) to the Index (Minor
Species Index File (MIF) 900000) under section 572 of the FDCA.
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\3\ The MUMS Act amended the FDCA to allow for the legal
marketing of unapproved new animal drugs intended for use in minor
species.
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The DEA based its scheduling decision, and issuance of the interim
final rule, on 21 U.S.C. 811(j), the HHS's November 2011 scientific and
medical evaluation and scheduling recommendation, the HHS's March 2016
supplemental analysis, the MUMS Act indication by the HHS/FDA, and the
DEA's determination. The interim final rule provided an opportunity for
interested persons to file written comments, as well as a request for
hearing or waiver of hearing, on or before September 26, 2016.
Comments Received
The DEA received one comment from the American Veterinary Medical
Association supporting the interim final rule to control thiafentanil
as a schedule II substance of the CSA.
DEA Response. The DEA appreciates the support for this rulemaking.
The DEA did not receive any requests for hearing or waiver of
hearing. Based on the rationale set forth in the interim final rule,
the DEA adopts the interim final rule, without change.
Requirements for Handling Thiafentanil
As indicated above, thiafentanil has been a schedule II controlled
substance for more than two years by virtue of the interim final rule
issued by the DEA in 2016. Thus, this final rule does not alter the
regulatory requirements applicable to handlers of thiafentanil that
have been in place since that time. Nonetheless, for informational
purposes, we restate here those requirements. Thiafentanil is subject
to the CSA's schedule II regulatory controls and administrative, civil,
and criminal sanctions applicable to the manufacture, distribution,
reverse distribution, dispensing, importing, exporting, research, and
conduct of instructional activities and chemical analysis with, and
possession involving schedule II substances, including the following:
1. Registration. Any person who desires to handle thiafentanil
[[Page 28213]]
(manufacture, distribute, reverse distribute, dispense, import, export,
engage in research, or conduct instructional activities or chemical
analysis with, or possess), must be registered with the DEA to conduct
such activities pursuant to 21 U.S.C. 822, 823, 957, and 958 and in
accordance with 21 CFR parts 1301 and 1312.
2. Quota. Only registered manufacturers are permitted to
manufacture thiafentanil in accordance with a quota assigned pursuant
to 21 U.S.C. 826 and in accordance with 21 CFR part 1303.
3. Disposal of stocks. Upon obtaining a schedule II registration to
handle thiafentanil, and if subsequently, any person who does not
desire or is not able to maintain a schedule II registration must
surrender all quantities of currently held thiafentanil, or may
transfer all quantities of currently held thiafentanil to a person
registered with the DEA in accordance with 21 CFR part 1317, in
addition to all other applicable federal, state, local, and tribal
laws.
4. Security. Thiafentanil is subject to schedule II security
requirements and must be handled and stored pursuant to 21 U.S.C. 821
and 823, and in accordance with 21 CFR 1301.71-1301.93.
5. Labeling and Packaging. All labels, labeling, and packaging for
commercial containers of thiafentanil must comply with 21 U.S.C. 825
and 958(e), and be in accordance with 21 CFR part 1302. In addition,
thiafentanil is subject to additional labeling requirements provided by
the FDA. Thiafentanil must be labeled, distributed, and promoted in
accordance with the Index entry of the new animal drug and the FDA may
remove a new animal drug from the Index if the conditions and
limitations of use have not been followed. 21 U.S.C. 360ccc-l(d)(l)(G);
(f)(l)(F). The labeling of an indexed new animal drug must prominently
state that the extra-label use of the product is prohibited. 21 U.S.C.
360ccc-l(h).
6. Inventory. Every DEA registrant who desires to possess any
quantity of thiafentanil must take an inventory of thiafentanil on
hand, pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 CFR
1304.03, 1304.04, and 1304.11.
Any person who becomes registered with the DEA to handle
thiafentanil must take an initial inventory of all stocks of controlled
substances (including thiafentanil) on hand on the date the registrant
first engages in the handling of controlled substances, pursuant to 21
U.S.C. 827 and 958, and in accordance with 21 CFR 1304.03, 1304.04, and
1304.11.
After the initial inventory, every DEA registrant must take a new
inventory of all stocks of controlled substances (including
thiafentanil) on hand every two years, pursuant to 21 U.S.C. 827 and
958, and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11.
7. Records and Reports. Every DEA registrant must maintain records
and submit reports for thiafentanil, or products containing
thiafentanil, pursuant to 21 U.S.C. 827 and 958(e), and in accordance
with 21 CFR parts 1304, 1312 and 1317.
8. Orders for thiafentanil. Every DEA registrant who distributes
thiafentanil is required to comply with order form requirements,
pursuant to 21 U.S.C. 828, and in accordance with 21 CFR part 1305.
9. Prescriptions and other dispensing. All prescriptions for
thiafentanil or products containing thiafentanil must comply with 21
U.S.C. 829, and be issued in accordance with 21 CFR parts 1306 and
1311, subpart C. Moreover, given that thiafentanil is not the subject
of an approved new drug application under the FDCA, and that it is only
allowed under the MUMS Act amendments to the FDCA to be marketed for
extremely limited use in minor species, DEA would not consider any
dispensing of thiafentanil for human use to be for a legitimate medical
purpose within the meaning of the CSA. Likewise, DEA would not consider
any dispensing of thiafentanil for animal use beyond the scope of the
drug's labeling authorized under the MUMS Act amendments to the FDCA to
be for a legitimate medical purpose within the meaning of the CSA.
10. Manufacturing and Distributing. In addition to the general
requirements of the CSA and DEA regulations that are applicable to
manufacturers and distributors of schedule II controlled substances,
such registrants should be advised that (consistent with the foregoing
considerations) any manufacturing or distribution of thiafentanil may
only be for the legitimate purposes consistent with the drug's labeling
authorized under the MUMS Act, or for research activities authorized by
the FDCA and CSA.
11. Importation and Exportation. All importation and exportation of
thiafentanil must be in compliance with 21 U.S.C. 952, 953, 957, and
958, and in accordance with 21 CFR part 1312.
12. Liability. Any activity involving thiafentanil not authorized
by, or in violation of, the CSA or its implementing regulations, is
unlawful, and may subject the person to administrative, civil, and/or
criminal sanctions.
Regulatory Analyses
Administrative Procedure Act
This final rule adopts, without change, the amendments made by the
interim final rule that are already in effect. Section 553 of the
Administrative Procedure Act (APA) (5 U.S.C. 553) generally requires
notice and comment for rulemakings. However, Public Law 114-89, which
was signed into law in 2015, amended 21 U.S.C. 811 to provide that in
cases where a new drug is (1) approved or indexed by the Department of
Health and Human Services (HHS) and (2) HHS recommends control in CSA
schedule II-V, the DEA shall issue an interim final rule scheduling the
drug within 90 days. This action was taken August 26, 2016.
Additionally, the law specifies that the rulemaking shall become
immediately effective as an interim final rule without requiring the
DEA to demonstrate good cause.
Executive Order 12866, 13563, and 13771, Regulatory Planning and
Review, Improving Regulation and Regulatory Review, and Reducing
Regulation and Controlling Regulatory Costs
In accordance with Public Law 114-89, this scheduling action is
subject to formal rulemaking procedures performed ``on the record after
opportunity for a hearing,'' which are conducted pursuant to the
provisions of 5 U.S.C. 556 and 557. The CSA sets forth the procedures
and criteria for scheduling a drug or other substance. Such actions are
exempt from review by the Office of Management and Budget (OMB)
pursuant to section 3(d)(1) of Executive Order 12866 and the principles
reaffirmed in Executive Order 13563.
This final rule is not an Executive Order 13771 regulatory action
pursuant to Executive Order 12866 and OMB guidance.\4\
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\4\ Office of Management & Budget, Executive Office of The
President, Interim Guidance Implementing Section 2 of the Executive
Order of January 30, 2017 Titled ``Reducing Regulation and
Controlling Regulatory Costs'' (Feb. 2, 2017).
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Executive Order 12988, Civil Justice Reform
This regulation meets the applicable standards set forth in
sections 3(a) and 3(b)(2) of Executive Order 12988 to eliminate
drafting errors and ambiguity, minimize litigation, provide a clear
legal standard for affected conduct, and promote simplification and
burden reduction.
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Executive Order 13132, Federalism
This rulemaking does not have federalism implications warranting
the application of Executive Order 13132. The rule does not have
substantial direct effects on the States, on the relationship between
the national government and the States, or on the distribution of power
and responsibilities among the various levels of government.
Executive Order 13175, Consultation and Coordination With Indian Tribal
Governments
This final rule does not have tribal implications warranting the
application of Executive Order 13175. It does not have substantial
direct effects on one or more Indian tribes, on the relationship
between the Federal government and Indian tribes, or on the
distribution of power and responsibilities between the Federal
government and Indian tribes.
Regulatory Flexibility Act
The Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612) applies to
rules that are subject to notice and comment under section 553(b) of
the APA. As noted in the above discussion regarding applicability of
the Administrative Procedure Act, the DEA was not required to publish a
general notice of proposed rulemaking prior to this final rule.
Consequently, the RFA does not apply.
Unfunded Mandates Reform Act of 1995
In accordance with the Unfunded Mandates Reform Act (UMRA) of 1995,
2 U.S.C. 1501 et seq., the DEA has determined and certifies that this
action would not result in any Federal mandate that may result ``in the
expenditure by state, local, and tribal governments, in the aggregate,
or by the private sector, of $100,000,000 or more (adjusted for
inflation) in any one year.'' Therefore, neither a Small Government
Agency Plan nor any other action is required under UMRA of 1995.
Paperwork Reduction Act of 1995
This action does not impose a new collection of information
requirement under the Paperwork Reduction Act of 1995. 44 U.S.C. 3501-
3521. This action would not impose recordkeeping or reporting
requirements on State or local governments, individuals, businesses, or
organizations. An agency may not conduct or sponsor, and a person is
not required to respond to, a collection of information unless it
displays a currently valid OMB control number.
Congressional Review Act
This final rule is not a major rule as defined by the Congressional
Review Act (CRA), 5 U.S.C. 804. However, pursuant to the CRA, the DEA
is submitting a copy of this final rule to both Houses of Congress and
to the Comptroller General.
List of Subjects
21 CFR Part 1301
Administrative practice and procedure, Drug traffic control,
Security measures.
21 CFR Part 1305
Drug traffic control, Reporting and recordkeeping requirements.
21 CFR Part 1308
Administrative practice and procedure, Drug traffic control,
Reporting and recordkeeping requirements.
PART 1301--REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND
DISPENSERS OF CONTROLLED SUBSTANCES
PART 1305--ORDERS FOR SCHEDULE I AND II CONTROLLED SUBSTANCES
PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES
0
Accordingly, the interim final rule amending 21 CFR parts 1301, 1305,
and 1308, which was published on August 26, 2016 (81 FR 58834), is
adopted as a final rule without change.
Dated: June 10, 2019.
Uttam Dhillon,
Acting Administrator.
[FR Doc. 2019-12735 Filed 6-17-19; 8:45 am]
BILLING CODE 4410-09-P