[Federal Register Volume 82, Number 224 (Wednesday, November 22, 2017)]
[Rules and Regulations]
[Pages 55504-55506]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-25275]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-344]
Schedules of Controlled Substances: Placement of FDA-Approved
Products of Oral Solutions Containing Dronabinol [(-)-delta-9-trans-
tetrahydrocannabinol (delta-9-THC)] in Schedule II
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Final rule.
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SUMMARY: This final rule adopts without changes an interim final rule
with request for comments published in the Federal Register on March
23, 2017. On July 1, 2016, the U.S. Food and Drug Administration (FDA)
approved a new drug application for Syndros, a drug product consisting
of dronabinol [(-)-delta-9-trans-tetrahydrocannabinol (delta-9-THC)]
oral solution. The Drug Enforcement Administration (DEA) maintains FDA-
approved products of oral solutions containing dronabinol in schedule
II of the Controlled Substances Act.
DATES: The effective date of this final rulemaking is November 22,
2017.
FOR FURTHER INFORMATION CONTACT: Michael J. Lewis, Diversion Control
Division, Drug Enforcement Administration; Mailing Address: 8701
[[Page 55505]]
Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 598-
8953.
SUPPLEMENTARY INFORMATION:
Background
On March 23, 2017, the DEA published an interim final rule to make
FDA-approved products containing dronabinol in an oral solution a
schedule II controlled substance. 82 FR 14815. 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
April 24, 2017.
Comments Received
In response to the interim final rule, the DEA received 10
comments.
1. Support for rulemaking: Four commenters supported the interim
final rule.
DEA Response: The DEA appreciates the comments supporting
the interim final rule.
2. Opposition for rulemaking: One commenter indicated that FDA-
approved products of oral solutions containing dronabinol are in
schedule II, but marijuana is in schedule I. Two commenters expressed
concern that pharmaceutical companies are making a profit from approved
drugs containing marijuana constituents. One commenter indicated that
FDA should not approve drugs containing constituents of marijuana
because, as the commenter alleged, of the lethality of those drugs.
DEA Response: The DEA notes that FDA-approved products of
oral solutions containing dronabinol have an approved medical use,
whereas marijuana does not have an approved medical use and therefore
remains in schedule I. Regarding the comments related to pharmaceutical
companies and the approval of FDA drugs, these comments are outside the
scope of this rulemaking because they do not relate to the factors
determinative of control of a substance [21 U.S.C. 811(c)] or the
criteria for placement of a substance in a particular schedule [21
U.S.C. 812(b)].
3. Request for clarification: One other commenter wanted
clarification of the approval process, including effectiveness on a
long-term basis. One commenter indicated hope that the regulation would
clarify hiring practices for people testing positive for THC.
DEA Response: The DEA notes that the comment regarding the
approval process is written in vague terms; we interpret the comment to
pertain to the FDA-approved drug product Syndros, rather than the
regulatory process for the interim final rule, and respond accordingly.
As such, the DEA notes that the FDA approved a New Drug Application
(NDA) for Syndros which is an oral product containing dronabinol and
provided the DEA with a scheduling recommendation for Syndros. The
scheduling recommendation by HHS and the FDA approval of the NDA
initiated the DEA review and scheduling action. As stated in the
interim final rule, after careful consideration of data from
preclinical and clinical studies, the DEA concurred with the HHS
recommendation that Syndros has abuse potential comparable to other
schedule II substances and therefore supported--and continues to
support in this final rule--placement of FDA-approved products
containing dronabinol in an oral solution in Schedule II under the
Controlled Substances Act (CSA). Regarding the commenter seeking
clarification on hiring practices, this comment is outside the scope of
this rulemaking because it does not relate to the factors determinative
of control of a substance [21 U.S.C. 811(c)] or the criteria for
placement of a substance in a particular schedule [21 U.S.C. 812(b)].
The DEA did not receive any requests for hearing or waiver. Based
on the rationale set forth in the interim final rule, the DEA adopts
the interim final rule, without change.
Requirements for Handling FDA-Approved Products Containing Dronabinol
in an Oral Solution
As DEA stated in the interim final rule, it should be noted as a
preliminary matter that any form of dronabinol other than in an FDA-
approved drug product remains a schedule I controlled substance, and
those who handle such material remain subject to the regulatory
controls, and administrative, civil, and criminal sanctions, applicable
to schedule I controlled substances set forth in the CSA and DEA
regulations. However, for those who handle dronabinol oral solution
exclusively in the form of an FDA-approved drug product, the following
is a summary of the schedule II regulatory requirements that remain in
effect as a result of this final rule.
FDA-approved products containing dronabinol in an oral solution
have been controlled as a schedule II controlled substance since March
23, 2017. With publication of this final rule, such products remain
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 handles (manufactures, distributes,
reverse distributes, dispenses, imports, exports, engages in research,
or conducts instructional activities or chemical analysis with, or
possesses) FDA-approved products containing dronabinol in an oral
solution, or who desires to handle such products, 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 FDA-approved products containing dronabinol in an oral
solution 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 FDA-approved products containing dronabinol in an oral solution,
any person who does not desire or is not able to maintain such
registration must surrender all quantities of such products, or may
transfer all quantities of such products 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. FDA-approved products containing dronabinol in an oral
solution are subject to schedule II security requirements and must be
handled and stored pursuant to 21 U.S.C. 821, 823, and in accordance
with 21 CFR 1301.71-1301.93.
5. Labeling and Packaging. All labels, labeling, and packaging for
commercial containers of FDA-approved products containing dronabinol in
an oral solution must comply with 21 U.S.C. 825 and 958(e), and be in
accordance with 21 CFR part 1302.
6. Inventory. Every DEA registrant who possesses any quantity of
FDA-approved products containing dronabinol in an oral solution must
take an inventory of such products on hand, 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 FDA-approved products containing dronabinol in
an oral solution, pursuant to 21 U.S.C. 827 and 958(e), and in
accordance with 21 CFR parts 1304, 1312, and 1317.
8. Order Forms. Every DEA registrant who distributes FDA-approved
products containing dronabinol in an oral solution is required to
comply with
[[Page 55506]]
order form requirements, pursuant to 21 U.S.C. 828, and in accordance
with 21 CFR part 1305.
9. Prescriptions. All prescriptions for FDA-approved products
containing dronabinol in an oral solution must comply with 21 U.S.C.
829, and be issued in accordance with 21 CFR parts 1306 and 1311,
subpart C.
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 FDA-approved
products containing dronabinol in an oral solution may only be for the
legitimate purposes authorized by the FDCA and CSA.
11. Importation and Exportation. All importation and exportation of
FDA-approved products containing dronabinol in an oral solution 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 FDA-approved products
containing dronabinol in an oral solution 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, without change, affirms the amendment made by the
interim final rule that is 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 was
signed into law, amending 21 U.S.C. 811. This amendment provides that
in cases where a new drug is (1) approved 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 March 23, 2017. 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 Orders 12866, Regulatory Planning and Review, and 13563,
Improving Regulation and Regulatory Review
In accordance with 21 U.S.C. 811(j), 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.
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.
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 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 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 rule is not a major rule as defined by section 804 of the
Small Business Regulatory Enforcement Fairness Act of 1996
(Congressional Review Act (CRA)). This rule will not result in: An
annual effect on the economy of $100,000,000 or more; a major increase
in costs or prices for consumers, individual industries, Federal,
State, or local government agencies, or geographic regions; or
significant adverse effects on competition, employment, investment,
productivity, innovation, or on the ability of U.S.-based companies to
compete with foreign based companies in domestic and export markets.
However, pursuant to the CRA, the DEA has submitted a copy of this
final rule to both Houses of Congress and to the Comptroller General.
List of Subjects in 21 CFR Part 1308
Administrative practice and procedure, Drug traffic control,
Reporting and recordkeeping requirements.
PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES
0
Accordingly, the interim final rule amending 21 CFR part 1308,
published on March 23, 2017 (82 FR 14815), is adopted as a final rule
without change.
Dated: November 6, 2017.
Robert W. Patterson,
Acting Administrator.
[FR Doc. 2017-25275 Filed 11-21-17; 8:45 am]
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