[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.

[[Page 28214]]

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