82 FR 55504 - Schedules of Controlled Substances: Placement of FDA-Approved Products of Oral Solutions Containing Dronabinol [(-)-delta-9-trans-tetrahydrocannabinol (delta-9-THC)] in Schedule II

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 82, Issue 224 (November 22, 2017)

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.

[Federal Register Volume 82, Number 224 (Wednesday, November 22, 2017)]
[Rules and Regulations]
[Pages 55504-55506]
From the Federal Register Online  [www.thefederalregister.org]
[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]
 BILLING CODE 4410-09-P