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)
Drug Enforcement Administration
Federal Register Volume 82, Issue 224 (November 22, 2017)
| Page Range | 55504-55506 | |
| FR Document | 2017-25275 |
[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] ======================================================================= ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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
![55504 Federal Register / Vol. 82, No. 224 / Wednesday, November 22, 2017 / Rules and Regulations
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Submissions’’ and ‘‘Instructions’’). guidance at any time (see 21 CFR This guidance refers to previously
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written/paper submissions): Dockets www.regulations.gov and insert the
Reduction Act of 1995 (44 U.S.C. 3501–
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well as any attachments, except for See the SUPPLEMENTARY INFORMATION may obtain the SECG at either https://
information submitted, marked and section for electronic access to the www.fda.gov/FoodGuidances or https://
identified, as confidential, if submitted SECG. www.regulations.gov. Use the FDA Web
as detailed in ‘‘Instructions.’’ FOR FURTHER INFORMATION CONTACT: site listed in the previous sentence to
Instructions: All submissions received Carrol Burgundy, Center for Food Safety find the most current version of the
must include the Docket No. FDA– and Applied Nutrition, Food and Drug guidance.
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I. Background Legislation, and Analysis.
Compliance Guide.’’ Received
comments will be placed in the docket [FR Doc. 2017–25204 Filed 11–21–17; 8:45 am]
In the Federal Register of April 6,
and, except for those submitted as 2016 (81 FR 20091), we issued a final BILLING CODE 4164–01–P
‘‘Confidential Submissions,’’ publicly rule entitled ‘‘Sanitary Transportation of
viewable at https://www.regulations.gov Human and Animal Food’’ (the final
or at the Dockets Management Staff rule) that establishes requirements for DEPARTMENT OF JUSTICE
between 9 a.m. and 4 p.m., Monday shippers, loaders, carriers by motor
through Friday. vehicle and rail vehicle, and receivers Drug Enforcement Administration
• Confidential Submissions—To engaged in the transportation of food,
submit a comment with confidential including food for animals, to use 21 CFR Part 1308
information that you do not wish to be sanitary transportation practices to [Docket No. DEA–344]
made publicly available, submit your ensure the safety of the food they
comments only as a written/paper transport. The final rule, which is Schedules of Controlled Substances:
submission. You should submit two codified at 21 CFR part 1, subpart O, Placement of FDA-Approved Products
copies total. One copy will include the became effective June 6, 2016, and has of Oral Solutions Containing
information you claim to be confidential compliance dates that started April 6, Dronabinol [(-)-delta-9-trans-
with a heading or cover note that states 2017. tetrahydrocannabinol (delta-9-THC)] in
‘‘THIS DOCUMENT CONTAINS We examined the economic Schedule II
CONFIDENTIAL INFORMATION.’’ The implications of the final rule as required
Agency will review this copy, including by the Regulatory Flexibility Act (5 AGENCY: Drug Enforcement
the claimed confidential information, in U.S.C. 601–612) and determined that Administration, Department of Justice.
its consideration of comments. The the final rule will have a significant ACTION: Final rule.
second copy, which will have the economic impact on a substantial
claimed confidential information number of small entities. In compliance SUMMARY: This final rule adopts without
redacted/blacked out, will be available with section 212 of the Small Business changes an interim final rule with
for public viewing and posted on Regulatory Enforcement Fairness Act request for comments published in the
https://www.regulations.gov. Submit (Pub. L. 104–121, as amended by Pub. Federal Register on March 23, 2017. On
both copies to the Dockets Management L. 110–28), we are making available the July 1, 2016, the U.S. Food and Drug
Staff. If you do not wish your name and SECG to reduce the burden of Administration (FDA) approved a new
contact information to be made publicly determining how to comply by further drug application for Syndros, a drug
available, you can provide this explaining and clarifying the actions product consisting of dronabinol [(-)-
information on the cover sheet and not that a small entity must take to comply delta-9-trans-tetrahydrocannabinol
in the body of your comments and you with the rule. (delta-9-THC)] oral solution. The Drug
must identify this information as We are issuing the SECG consistent Enforcement Administration (DEA)
‘‘confidential.’’ Any information marked with our good guidance practices maintains FDA-approved products of
as ‘‘confidential’’ will not be disclosed regulation (21 CFR 10.115(c)(2)). The oral solutions containing dronabinol in
except in accordance with 21 CFR 10.20 SECG represents the current thinking of schedule II of the Controlled Substances
and other applicable disclosure law. For FDA on this topic. It does not establish Act.
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more information about FDA’s posting any rights for any person and is not DATES: The effective date of this final
of comments to public dockets, see 80 binding on FDA or the public. You can rulemaking is November 22, 2017.
FR 56469, September 18, 2015, or access use an alternative approach if it satisfies FOR FURTHER INFORMATION CONTACT:
the information at: https://www.gpo.gov/ the requirements of the applicable Michael J. Lewis, Diversion Control
fdsys/pkg/FR-2015-09-18/pdf/2015- statutes and regulations. This guidance Division, Drug Enforcement
23389.pdf. is not subject to Executive Order 12866. Administration; Mailing Address: 8701
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Morrissette Drive, Springfield, Virginia Application (NDA) for Syndros which is and possession involving schedule II
22152; Telephone: (202) 598–8953. an oral product containing dronabinol substances, including the following:
SUPPLEMENTARY INFORMATION: and provided the DEA with a 1. Registration. Any person who
scheduling recommendation for handles (manufactures, distributes,
Background Syndros. The scheduling reverse distributes, dispenses, imports,
On March 23, 2017, the DEA recommendation by HHS and the FDA exports, engages in research, or
published an interim final rule to make approval of the NDA initiated the DEA conducts instructional activities or
FDA-approved products containing review and scheduling action. As stated chemical analysis with, or possesses)
dronabinol in an oral solution a in the interim final rule, after careful FDA-approved products containing
schedule II controlled substance. 82 FR consideration of data from preclinical dronabinol in an oral solution, or who
14815. The interim final rule provided and clinical studies, the DEA concurred desires to handle such products, must
an opportunity for interested persons to with the HHS recommendation that be registered with the DEA to conduct
file written comments as well as a Syndros has abuse potential comparable such activities pursuant to 21 U.S.C.
request for hearing or waiver of hearing, to other schedule II substances and 822, 823, 957, and 958 and in
on or before April 24, 2017. therefore supported—and continues to accordance with 21 CFR parts 1301 and
support in this final rule—placement of 1312.
Comments Received 2. Quota. Only registered
FDA-approved products containing
In response to the interim final rule, dronabinol in an oral solution in manufacturers are permitted to
the DEA received 10 comments. Schedule II under the Controlled manufacture FDA-approved products
1. Support for rulemaking: Four Substances Act (CSA). Regarding the containing dronabinol in an oral
commenters supported the interim final commenter seeking clarification on solution in accordance with a quota
rule. hiring practices, this comment is assigned pursuant to 21 U.S.C. 826 and
• DEA Response: The DEA in accordance with 21 CFR part 1303.
outside the scope of this rulemaking
appreciates the comments supporting 3. Disposal of stocks. Upon obtaining
because it does not relate to the factors
the interim final rule. a schedule II registration to handle FDA-
2. Opposition for rulemaking: One determinative of control of a substance
[21 U.S.C. 811(c)] or the criteria for approved products containing
commenter indicated that FDA- dronabinol in an oral solution, any
approved products of oral solutions placement of a substance in a particular
schedule [21 U.S.C. 812(b)]. person who does not desire or is not
containing dronabinol are in schedule able to maintain such registration must
II, but marijuana is in schedule I. Two The DEA did not receive any requests
surrender all quantities of such
commenters expressed concern that for hearing or waiver. Based on the
products, or may transfer all quantities
pharmaceutical companies are making a rationale set forth in the interim final
of such products to a person registered
profit from approved drugs containing rule, the DEA adopts the interim final
with the DEA in accordance with 21
marijuana constituents. One commenter rule, without change.
CFR part 1317, in addition to all other
indicated that FDA should not approve Requirements for Handling FDA- applicable federal, state, local, and tribal
drugs containing constituents of Approved Products Containing laws.
marijuana because, as the commenter Dronabinol in an Oral Solution 4. Security. FDA-approved products
alleged, of the lethality of those drugs. containing dronabinol in an oral
• DEA Response: The DEA notes that As DEA stated in the interim final solution are subject to schedule II
FDA-approved products of oral rule, it should be noted as a preliminary security requirements and must be
solutions containing dronabinol have an matter that any form of dronabinol other handled and stored pursuant to 21
approved medical use, whereas than in an FDA-approved drug product U.S.C. 821, 823, and in accordance with
marijuana does not have an approved remains a schedule I controlled 21 CFR 1301.71–1301.93.
medical use and therefore remains in substance, and those who handle such 5. Labeling and Packaging. All labels,
schedule I. Regarding the comments material remain subject to the regulatory labeling, and packaging for commercial
related to pharmaceutical companies controls, and administrative, civil, and containers of FDA-approved products
and the approval of FDA drugs, these criminal sanctions, applicable to containing dronabinol in an oral
comments are outside the scope of this schedule I controlled substances set solution must comply with 21 U.S.C.
rulemaking because they do not relate to forth in the CSA and DEA regulations. 825 and 958(e), and be in accordance
the factors determinative of control of a However, for those who handle with 21 CFR part 1302.
substance [21 U.S.C. 811(c)] or the dronabinol oral solution exclusively in 6. Inventory. Every DEA registrant
criteria for placement of a substance in the form of an FDA-approved drug who possesses any quantity of FDA-
a particular schedule [21 U.S.C. 812(b)]. product, the following is a summary of approved products containing
3. Request for clarification: One other the schedule II regulatory requirements dronabinol in an oral solution must take
commenter wanted clarification of the that remain in effect as a result of this an inventory of such products on hand,
approval process, including final rule. pursuant to 21 U.S.C. 827 and 958, and
effectiveness on a long-term basis. One FDA-approved products containing in accordance with 21 CFR 1304.03,
commenter indicated hope that the dronabinol in an oral solution have been 1304.04, and 1304.11.
regulation would clarify hiring practices controlled as a schedule II controlled 7. Records and Reports. Every DEA
for people testing positive for THC. substance since March 23, 2017. With registrant must maintain records and
• DEA Response: The DEA notes that publication of this final rule, such submit reports for FDA-approved
the comment regarding the approval products remain subject to the CSA’s products containing dronabinol in an
process is written in vague terms; we schedule II regulatory controls and
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oral solution, pursuant to 21 U.S.C. 827
interpret the comment to pertain to the administrative, civil, and criminal and 958(e), and in accordance with 21
FDA-approved drug product Syndros, sanctions applicable to the manufacture, CFR parts 1304, 1312, and 1317.
rather than the regulatory process for distribution, reverse distribution, 8. Order Forms. Every DEA registrant
the interim final rule, and respond dispensing, importing, exporting, who distributes FDA-approved products
accordingly. As such, the DEA notes research, and conduct of instructional containing dronabinol in an oral
that the FDA approved a New Drug activities and chemical analysis with, solution is required to comply with
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order form requirements, pursuant to 21 formal rulemaking procedures result ‘‘in the expenditure by State,
U.S.C. 828, and in accordance with 21 performed ‘‘on the record after local, and tribal governments, in the
CFR part 1305. opportunity for a hearing,’’ which are aggregate, or by the private sector, of
9. Prescriptions. All prescriptions for conducted pursuant to the provisions of $100,000,000 or more (adjusted for
FDA-approved products containing 5 U.S.C. 556 and 557. The CSA sets inflation) in any one year.’’ Therefore,
dronabinol in an oral solution must forth the procedures and criteria for neither a Small Government Agency
comply with 21 U.S.C. 829, and be scheduling a drug or other substance. Plan nor any other action is required
issued in accordance with 21 CFR parts Such actions are exempt from review by under UMRA of 1995.
1306 and 1311, subpart C. the Office of Management and Budget
10. Manufacturing and Distributing. (OMB) pursuant to section 3(d)(1) of Paperwork Reduction Act of 1995
In addition to the general requirements Executive Order 12866 and the
of the CSA and DEA regulations that are principles reaffirmed in Executive Order This action does not impose a new
applicable to manufacturers and 13563. collection of information requirement
distributors of schedule II controlled under the Paperwork Reduction Act of
Executive Order 12988, Civil Justice 1995. 44 U.S.C. 3501–3521. This action
substances, such registrants should be
Reform would not impose recordkeeping or
advised that (consistent with the
foregoing considerations) any This regulation meets the applicable reporting requirements on State or local
manufacturing or distribution of FDA- standards set forth in sections 3(a) and governments, individuals, businesses, or
approved products containing 3(b)(2) of Executive Order 12988 to organizations. An agency may not
dronabinol in an oral solution may only eliminate drafting errors and ambiguity, conduct or sponsor, and a person is not
be for the legitimate purposes minimize litigation, provide a clear legal required to respond to, a collection of
authorized by the FDCA and CSA. standard for affected conduct, and information unless it displays a
11. Importation and Exportation. All promote simplification and burden currently valid OMB control number.
importation and exportation of FDA- reduction.
approved products containing Congressional Review Act
Executive Order 13132, Federalism
dronabinol in an oral solution must be This rule is not a major rule as
in compliance with 21 U.S.C. 952, 953, This rulemaking does not have
federalism implications warranting the defined by section 804 of the Small
957, and 958, and in accordance with 21
application of Executive Order 13132. Business Regulatory Enforcement
CFR part 1312.
The rule does not have substantial Fairness Act of 1996 (Congressional
12. Liability. Any activity involving
FDA-approved products containing direct effects on the States, on the Review Act (CRA)). This rule will not
dronabinol in an oral solution not relationship between the national result in: An annual effect on the
authorized by, or in violation of, the government and the States, or on the economy of $100,000,000 or more; a
CSA or its implementing regulations, is distribution of power and major increase in costs or prices for
unlawful, and may subject the person to responsibilities among the various consumers, individual industries,
administrative, civil, and/or criminal levels of government. Federal, State, or local government
sanctions. agencies, or geographic regions; or
Executive Order 13175, Consultation
and Coordination With Indian Tribal significant adverse effects on
Regulatory Analyses competition, employment, investment,
Governments
Administrative Procedure Act productivity, innovation, or on the
This rule does not have tribal ability of U.S.-based companies to
This final rule, without change, implications warranting the application
affirms the amendment made by the compete with foreign based companies
of Executive Order 13175. It does not in domestic and export markets.
interim final rule that is already in have substantial direct effects on one or
effect. Section 553 of the Administrative However, pursuant to the CRA, the DEA
more Indian tribes, on the relationship
Procedure Act (APA) (5 U.S.C. 553) has submitted a copy of this final rule
between the Federal government and
generally requires notice and comment Indian tribes, or on the distribution of to both Houses of Congress and to the
for rulemakings. However, Public Law power and responsibilities between the Comptroller General.
114–89 was signed into law, amending Federal government and Indian tribes. List of Subjects in 21 CFR Part 1308
21 U.S.C. 811. This amendment
provides that in cases where a new drug Regulatory Flexibility Act Administrative practice and
is (1) approved by the Department of The Regulatory Flexibility Act (RFA) procedure, Drug traffic control,
Health and Human Services (HHS) and (5 U.S.C. 601–612) applies to rules that Reporting and recordkeeping
(2) HHS recommends control in CSA are subject to notice and comment requirements.
schedule II–V, the DEA shall issue an under section 553(b) of the APA. As
interim final rule scheduling the drug noted in the above discussion regarding PART 1308—SCHEDULES OF
within 90 days. This action was taken applicability of the Administrative CONTROLLED SUBSTANCES
March 23, 2017. Additionally, the law Procedure Act, the DEA was not
specifies that the rulemaking shall required to publish a general notice of ■ Accordingly, the interim final rule
become immediately effective as an proposed rulemaking prior to this final amending 21 CFR part 1308, published
interim final rule without requiring the rule. Consequently, the RFA does not on March 23, 2017 (82 FR 14815), is
DEA to demonstrate good cause. apply. adopted as a final rule without change.
ethrower on DSK3G9T082PROD with RULES
Executive Orders 12866, Regulatory Unfunded Mandates Reform Act of 1995 Dated: November 6, 2017.
Planning and Review, and 13563, In accordance with the Unfunded Robert W. Patterson,
Improving Regulation and Regulatory Mandates Reform Act (UMRA) of 1995,
Review Acting Administrator.
2 U.S.C. 1501 et seq., the DEA has [FR Doc. 2017–25275 Filed 11–21–17; 8:45 am]
In accordance with 21 U.S.C. 811(j), determined that this action would not
BILLING CODE 4410–09–P
this scheduling action is subject to result in any Federal mandate that may
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Document Created: 2017-11-22 00:48:45
Document Modified: 2017-11-22 00:48:45
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Final rule. | |
| Dates | The effective date of this final rulemaking is November 22, 2017. | |
| Contact | Michael J. Lewis, Diversion Control | |
| FR Citation | 82 FR 55504 | |
| CFR Associated | Administrative Practice and Procedure; Drug Traffic Control and Reporting and Recordkeeping Requirements |
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