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Federal Register / Vol. 86, No. 51 / Thursday, March 18, 2021 / Proposed Rules
jbell on DSKJLSW7X2PROD with PROPOSALS

According to HHS, there are no FDAapproved new drug applications for fentanyl carbamate, ortho-fluoroacryl fentanyl, ortho-fluoro isobutyryl fentanyl, and para-fluoro furanyl fentanyl in the United States. There are no known therapeutic applications for these fentanyl-related substances and thus they have no currently accepted medical use in the United States.8
3 There is a lack of accepted safety for use of fentanyl carbamate, orthofluoroacryl fentanyl, ortho-fluoro isobutyryl fentanyl, and para-fluoro furanyl fentanyl under medical supervision.
Because fentanyl carbamate, orthofluoroacryl fentanyl, ortho-fluoro isobutyryl fentanyl, and para-fluoro furanyl fentanyl have no FDA-approved medical use and have not been thoroughly investigated as new drugs, their safety for use under medical supervision is undetermined. Thus, there is a lack of accepted safety for use of fentanyl carbamate, ortho-fluoroacryl fentanyl, ortho-fluoro isobutyryl fentanyl, and para-fluoro furanyl fentanyl under medical supervision.
Based on these findings, the Acting Administrator of DEA concludes that fentanyl carbamate, ortho-fluoroacryl fentanyl, ortho-fluoro isobutyryl fentanyl, and para-fluoro furanyl fentanyl, including their isomers, esters, ethers, salts, and salts of isomers, esters, and ethers, warrant continued control in schedule I of the CSA. 21 U.S.C.
812b1.
Requirements for Handling fentanyl carbamate, ortho-fluoroacryl fentanyl, ortho-fluoro isobutyryl fentanyl, and para-fluoro furanyl fentanyl.
If this rule is finalized as proposed, fentanyl carbamate, ortho-fluoroacryl fentanyl, ortho-fluoro isobutyryl fentanyl, and para-fluoro furanyl 8 Although there is no evidence suggesting that fentanyl carbamate, ortho-fluoroacryl fentanyl, ortho-fluoro isobutyryl fentanyl, and para-fluoro furanyl fentanyl have 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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fentanyl would continue 9 to be subject to the CSAs schedule I regulatory controls and administrative, civil, and criminal sanctions applicable to the manufacture, distribution, reverse distribution, dispensing, importation, exportation, research, and conduct of instructional activities, 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, or who desires to handle, fentanyl carbamate, ortho-fluoroacryl fentanyl, ortho-fluoro isobutyryl fentanyl, and para-fluoro furanyl fentanyl is required to be 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.
2. Security. Fentanyl carbamate, ortho-fluoroacryl fentanyl, ortho-fluoro isobutyryl fentanyl, and para-fluoro furanyl fentanyl are subject to schedule I security requirements and must be handled and stored pursuant to 21
U.S.C. 821, 823, and in accordance with 21 CFR 1301.711301.76. Nonpractitioners handling fentanyl carbamate, ortho-fluoroacryl fentanyl, ortho-fluoro isobutyryl fentanyl, and para-fluoro furanyl fentanyl also must comply with the employee screening requirements of 21 CFR 1301.90
1301.93.
3. Labeling and Packaging. All labels, labeling, and packaging for commercial containers of fentanyl carbamate, orthofluoroacryl fentanyl, ortho-fluoro isobutyryl fentanyl, and para-fluoro furanyl fentanyl must be in compliance with 21 U.S.C. 825 and 958e, and be in accordance with 21 CFR part 1302.
4. Quota. Only registered manufacturers are permitted to manufacture fentanyl carbamate, ortho fluoroacryl fentanyl, orthofluoroisobutyryl fentanyl, and parafluoro furanyl fentanyl in accordance with a quota assigned pursuant to 21
U.S.C. 826 and in accordance with 21
CFR part 1303.
5. Inventory. Any person registered with DEA to handle fentanyl carbamate, ortho fluoroacryl fentanyl, orthofluoroisobutyryl fentanyl, and parafluoro furanyl fentanyl must have an initial inventory of all stocks of controlled substances including these 9 Fentanyl carbamate, ortho-fluoroacryl fentanyl, ortho-fluoro isobutyryl fentanyl, and para-fluoro furanyl fentanyl, are covered by the February 6, 2018, temporary scheduling order, and are currently subject to schedule I controls on a temporary basis, pursuant to 21 U.S.C. 811h. 83 FR 5188.

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substances 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 fentanyl carbamate, ortho fluoroacryl fentanyl, orthofluoroisobutyryl fentanyl, and parafluoro furanyl fentanyl 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.
6. Records and Reports. Every DEA
registrant is required to maintain records and submit reports with respect to fentanyl carbamate, ortho fluoroacryl fentanyl, ortho-fluoroisobutyryl fentanyl, and para-fluoro furanyl fentanyl, pursuant to 21 U.S.C. 827 and 958e, and in accordance with 21 CFR
1301.74b and c and parts 1304, 1312, and 1317.
7. Order Forms. Every DEA registrant who distributes fentanyl carbamate, ortho fluoroacryl fentanyl, orthofluoroisobutyryl fentanyl, and parafluoro furanyl fentanyl is required to comply with the order form requirements, pursuant to 21 U.S.C. 828
and 21 CFR part 1305.
8. Importation and Exportation. All importation and exportation of fentanyl carbamate, ortho fluoroacryl fentanyl, ortho-fluoroisobutyryl fentanyl, and para-fluoro furanyl fentanyl must be in compliance with 21 U.S.C. 952, 953, 957, and 958, and in accordance with 21
CFR part 1312.
9. Liability. Any activity involving fentanyl carbamate, ortho fluoroacryl fentanyl, ortho-fluoroisobutyryl fentanyl, and para-fluoro furanyl fentanyl not authorized by, or in violation of, the CSA or its implementing regulations is unlawful, and could subject the person to administrative, civil, and/or criminal sanctions.
Regulatory Analyses Executive Orders 12866 Regulatory Planning and Review and 13563
Improving Regulation and Regulatory Review In accordance with 21 U.S.C. 811a, this proposed scheduling action is subject to formal rulemaking procedures done 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 criteria for scheduling a drug or other substance. Such actions are exempt from review by the Office of
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