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Federal Register / Vol. 86, No. 84 / Tuesday, May 4, 2021 / Rules and Regulations
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substances, and were mostly pleas to help save lives from grieving parents who had lost a child due to an accidental overdose of fentanyl or fentanyl poisoning. These 11
comments are not germane to this rulemaking. Therefore, DEA will not respond to these comments.
Support of the Proposed Rule Comment. Twenty-one commenters supported controlling fentanyl carbamate, ortho-fluoroacryl fentanyl, ortho-fluoro isobutyryl fentanyl, and para-fluoro furanyl fentanyl as schedule I controlled substances. These commenters indicated that permanent scheduling of these substances helps deter illicit manufacturing and trafficking of these substances. Further, commenters noted safety concerns with fentanyl, such as deaths, overdoses, addiction, and the involvement of fentanyl and fentanyl-related substances in the current public health crisis associated with the opioid abuse epidemic. Most commenters indicated that DEA needs to impose the permanent control on these substances to help curb addiction and opioid overdose. In addition to supporting control of these four substances, a commenter, who is a member of grief groups for parents who have lost a child due to an accidental overdose particular drugs or substances not specified by the commenter, noted the fentanyl epidemic and growth of these groups. Specifically, this commenter stated that members have grown from about 4,000 to 12,000 during the pandemicwhich DEA interprets to mean, in context, the Coronavirus Disease 2019 COVID19 pandemic with no sign of decline.
DEA Response. DEA appreciates the support for this rulemaking.
Comment. Three commenters supported the proposal, but it is not clear whether they were referring to these specific four fentanyl-related substances or the class of fentanylrelated substances. Two of these commenters mentioned the dangers to health and safety from fentanyl, the illicit trafficking of fentanyl and fentanyl-related substances, and their desires that the temporary ban on the class of fentanyl-related substances which they noted expires in May 2021
be made permanent. One of the two specifically requested that Congress pass the legislation to extend the temporary ban, and the other requested DEAs support in making the proposed temporary ban permanent. The third commenter did not mention the expiring legislation, and simply requested that efforts be continued to
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maintain the ban on fentanyl and fentanyl-related substances.
DEA Response. DEA agrees with the commenters on the importance that this temporary ban be extended or made permanent. However, as one of the three commenters correctly notes, for the scheduling of fentanyl-related substances to be made permanent by legislative action, Congress rather than DEA would have to take such action.
Scheduling Conclusion After consideration of the relevant matter presented through public comments, the scientific and medical evaluation and accompanying recommendation of HHS, and after its own eight-factor evaluation, DEA finds that these facts and all other relevant data constitute substantial evidence of the potential for abuse of fentanyl carbamate, ortho-fluoroacryl fentanyl, ortho-fluoro isobutyryl fentanyl, and para-fluoro furanyl fentanyl. DEA is therefore permanently scheduling these four specific fentanyl-related substances as controlled substances under the CSA.
Determination of Appropriate Schedule The CSA establishes five schedules of controlled substances known as schedules I, II, III, IV, and V. The CSA
also outlines the findings required to place a drug or other substance in any particular schedule. 21 U.S.C. 812b.
After consideration of the analysis and recommendation of the Assistant Secretary and review of all other available data, the Acting Administrator, pursuant to 21 U.S.C.
811a and 812b1, finds that:
1 Fentanyl carbamate, orthofluoroacryl fentanyl, ortho-fluoro isobutyryl fentanyl, and para-fluoro furanyl fentanyl have a high potential for abuse that is comparable to other schedule I substances such as acetyl fentanyl and furanyl fentanyl.
2 Fentanyl carbamate, orthofluoroacryl fentanyl, ortho-fluoro isobutyryl fentanyl, and para-fluoro furanyl fentanyl have no currently accepted medical use in treatment in the United States 1; and 1 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;

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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. Based on these findings, the Acting Administrator 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 whenever the existence of such isomers, esters, ethers, and salts is possible, 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 Fentanyl carbamate, ortho-fluoroacryl fentanyl, ortho-fluoro isobutyryl fentanyl, and para-fluoro furanyl fentanyl will continue 2 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 involving the handling of controlled 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, or who desires to handle, fentanyl carbamate, ortho-fluoroacryl fentanyl, orthofluoro isobutyryl fentanyl, and para-fluoro furanyl fentanyl must 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, orthofluoroacryl 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. Non-practitioners handling fentanyl carbamate, orthofluoroacryl fentanyl, ortho-fluoro isobutyryl fentanyl, and para-fluoro furanyl fentanyl also must comply with the employee 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.
2 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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