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Federal Register / Vol. 86, No. 38 / Monday, March 1, 2021 / Rules and Regulations the illicit market may serve as a portal to problematic opioid use for those seeking these powerful opioids.
Brorphine has been co-identified with other substances in seven post-mortem toxicology cases in June and July 2020.
These substances include other opioids such as fentanyl and heroin, and other substance classes such as benzodiazepines. These deaths occurred in three states: Illinois, Arizona, and Minnesota. Information gathered from case history findings shows that brorphine use is similar to that of classic opioid agonists. As documented by toxicology reports, poly-substance abuse remains common in fatalities associated with the abuse of brorphine.
Finding of Necessity of Schedule I
Placement To Avoid Imminent Hazard to Public Safety In accordance with 21 U.S.C.
811h3, based on the available data and information summarized above, the uncontrolled manufacture, distribution, reverse distribution, importation, exportation, conduct of research and chemical analysis, possession, and abuse of brorphine pose an imminent hazard to the public safety. DEA is not aware of any currently accepted medical uses for brorphine in the United States.8
A substance meeting the statutory requirements for temporary scheduling, found in 21 U.S.C. 811h1, may only be placed in schedule I. Substances in schedule I are those that have a high potential for abuse, no currently accepted medical use in treatment in the United States, and a lack of accepted safety for use under medical supervision. Available data and information for brorphine indicate that this substance has a high potential for abuse, no currently accepted medical use in treatment in the United States, and a lack of accepted safety for use under medical supervision. As required by 21 U.S.C. 811h4, the Acting 8 Although
there is no evidence suggesting that brorphine has a currently accepted medical use in treatment in the United States, it bears noting that a drug cannot be found to have such medical use unless DEA concludes that it satisfies a five-part test. Specifically, with respect to a drug that has not been approved by FDA, to have a currently accepted medical use in treatment in the United States, all of the following must be demonstrated:
i. The drugs chemistry must be known and reproducible;
ii. there must be adequate safety studies;
iii. there must be adequate and well-controlled studies proving efficacy;
iv. the drug must be accepted by qualified experts; and v. the scientific evidence must be widely available.
57 FR 10499 1992, pet. for rev. denied, Alliance for Cannabis Therapeutics v. DEA, 15 F.3d 1131, 1135 D.C. Cir. 1994.

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Administrator, through a letter dated September 22, 2020, notified the Assistant Secretary of DEAs intention to temporarily place brorphine in schedule I. DEA subsequently published a notice of intent on December 3, 2020.
85 FR 78047.
Conclusion In accordance with 21 U.S.C.
811h1 and 3, the Acting Administrator considered available data and information, herein set forth the grounds for his determination that it is necessary to temporarily schedule brorphine in schedule I of the CSA and finds that placement of this substance in schedule I of the CSA is necessary in order to avoid an imminent hazard to the public safety.
This temporary order scheduling this substance will be effective on the date the order is published in the Federal Register and will be in effect for a period of two years, with a possible extension of one additional year, pending completion of the regular permanent scheduling process. 21
U.S.C. 811h1 and 2.
The CSA sets forth specific criteria for scheduling a drug or other substance.
Regular scheduling actions in accordance with 21 U.S.C. 811a are subject to formal rulemaking procedures done on the record after opportunity for a hearing conducted pursuant to the provisions of 5 U.S.C. 556 and 557.
21 U.S.C. 811. The regular scheduling process of formal rulemaking affords interested parties with appropriate process and the government with any additional relevant information needed to make a determination. Final decisions that conclude the regular scheduling process of formal rulemaking are subject to judicial review. 21 U.S.C. 877. Temporary scheduling orders are not subject to judicial review. 21 U.S.C. 811h6.
Requirements for Handling Upon the effective date of this temporary order, brorphine will be subject to the regulatory controls and administrative, civil, and criminal sanctions applicable to the manufacture, distribution, reverse distribution, importation, exportation, engagement in research, and conduct of instructional activities or chemical analysis with, and possession of schedule I controlled substances, including the following:
1. Registration. Any person who handles manufactures, distributes, reverse distributes, imports, exports, engages in research, or conducts instructional activities or chemical analysis with, or possesses, or who desires to handle, brorphine must be
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registered with 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, as of March 1, 2021. Any person who currently handles brorphine, and is not registered with DEA, must submit an application for registration and may not continue to handle brorphine as of March 1, 2021, unless DEA has approved that application for registration pursuant to 21 U.S.C. 822, 823, 957, and 958, and in accordance with 21 CFR parts 1301 and 1312. Retail sales of schedule I controlled substances to the general public are not allowed under the CSA. Possession of any quantity of this substance in a manner not authorized by the CSA on or after March 1, 2021 is unlawful and those in possession of any quantity of these substances may be subject to prosecution pursuant to the CSA.
2. Disposal of stocks. Any person who does not desire or is not able to obtain a schedule I registration to handle brorphine must surrender all currently held quantities of brorphine.
3. Security. Brorphine is subject to schedule I security requirements and must be handled and stored pursuant to 21 U.S.C. 821, 823, 871b and in accordance with 21 CFR 1301.71
1301.93, as of March 1, 2021. Nonpractitioners handling brorphine must also comply with the employee screening requirements of 21 CFR
1301.901301.93.
4. Labeling and Packaging. All labels, labeling, and packaging for commercial containers of brorphine must be in compliance with 21 U.S.C. 825, 958e and be in accordance with 21 CFR part 1302. Current DEA registrants will have 30 calendar days from March 1, 2021 to comply with all labeling and packaging requirements.
5. Inventory. Every DEA registrant who possesses any quantity of brorphine on the effective date of this order must take an inventory of all stocks of these substances on hand, pursuant to 21 U.S.C. 827 and 958 and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11. Current DEA
registrants will have 30 calendar days from the effective date of this order to be in compliance with all inventory requirements. After the initial inventory, every DEA registrant must take an inventory of all controlled substances including brorphine on hand on a biennial basis, pursuant to 21
U.S.C. 827 and 958 and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11.
6. Records. All DEA registrants must maintain records with respect to brorphine, pursuant to 21 U.S.C. 827

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