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Federal Register / Vol. 86, No. 120 / Friday, June 25, 2021 / Rules and Regulations 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 for Health of HHS and review of all other available data, the Acting Administrator of DEA Acting Administrator, pursuant to 21 U.S.C.
811a and 812b1, finds that:
1 The Drug or Substance Has a High Potential for Abuse PMMA has a mechanism of action similar to that of MDMA, a schedule I
controlled substance. Similar to MDMA, PMMA increases levels of monoamines, specifically DA and 5HT, in the brain reward circuitry. Data from animal studies demonstrate that PMMA fully substitutes for the discriminative stimulus effect of MDMA, which is indicative of similar subjective effects.
Although there is currently no data that has directly assessed the psychological or physiological dependence liability of PMMA, its pharmacological similarities to MDMA suggest it likely has low physical dependence liability. Evidence demonstrates that users of PMMA are often seeking MDMA, which may be mixed with PMMA. PMMA shares a pharmacological mechanism of action and psychoactive effects similar to the schedule I controlled substance MDMA
and therefore has a high potential for abuse.
2 The Drug or Substance Has No Currently Accepted Medical Use in Treatment in the United States
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According to HHS, the Food and Drug Administration FDA has not approved any marketing application for a drug product containing PMMA for any indication. In addition, there are no clinical studies or petitioners that have claimed an accepted medical use of PMMA in the United States. Thus, PMMA has no currently accepted medical use in treatment in the United States.2
2 Although there is no evidence suggesting that PMMA has a currently accepted medical uses 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 wellcontrolled 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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3 There is a Lack of Accepted Safety for Use of the Drug or Substance Under Medical Supervision The safety of PMMA for use under medical supervision has not been determined because it has no approved medical use in treatment in the United States and has not been investigated as a new drug. Therefore, there is a lack of accepted safety for use of PMMA under medical supervision.
Based on these findings, the Acting Administrator concludes that PMMA as well as its salts, isomers, and salts of isomers whenever the existence of such isomers and salts is possible within the specific chemical designation warrants control in schedule I of the CSA. 21
U.S.C. 812b1.
Summary of Minor Change in the Final Rule As discussed in the above NPRM
section, DEA proposed to place PMMA
in 21 CFR 1301.11d as paragraph number 79. Since the publication of this NPRM, DEA has issued several final rules which updated the numbering of listed hallucinogenic substances in paragraph d. As a result, this final rule assigns paragraph number 88 to PMMA.
Requirements for Handling PMMA
PMMA is subject to the CSAs schedule I regulatory controls and administrative, civil, and criminal sanctions applicable to the manufacture, distribution, reverse distribution, import, export, engagement in research, 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, PMMA must be registered with DEA to conduct such activities pursuant to 21 U.S.C. 822, 823, 957, 958, and in accordance with 21 CFR parts 1301 and 1312.
2. Disposal of stocks. Any person who does not desire or is not able to obtain a schedule I registration to handle PMMA must surrender all quantities of currently held PMMA, or transfer all quantities of currently held PMMA to a person registered with DEA. PMMA
must be disposed of in accordance with 21 CFR part 1317, in addition to all other applicable Federal, State, local, and tribal laws.
3. Security. PMMA is subject to schedule I security requirements and must be handled and stored pursuant to
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21 U.S.C. 823 and in accordance with 21
CFR 1301.711301.76. Non-practitioners handling PMMA 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 PMMA must comply with 21 U.S.C. 825, and be in accordance with 21 CFR part 1302.
5. Quota. Only registered manufacturers are permitted to manufacture PMMA in accordance with a quota assigned, pursuant to 21 U.S.C.
826 and in accordance with 21 CFR part 1303.
6. Inventory. Every DEA registrant who possesses any quantity of PMMA
must take an inventory of PMMA on hand pursuant to 21 U.S.C. 827, and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11a and d.
Any person who becomes registered with DEA must take an initial inventory of all stocks of controlled substances including PMMA on hand on the date the registrant first engages in the handling of controlled substances, pursuant to 21 U.S.C. 827,and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11a and b.
After the initial inventory, every DEA
registrant must take an inventory of all controlled substances including PMMA on hand every two years, pursuant to 21 U.S.C. 827, 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 PMMA, or products containing PMMA, pursuant to 21
U.S.C. 827, and in accordance with 21
CFR 1301.74b and c and parts 1304, 1312, and 1317. Manufacturers and distributors must submit reports regarding PMMA to the Automation of Reports and Consolidated Order System pursuant to 21 U.S.C. 827 and in accordance with 21 CFR parts 1304 and 1312.
8. Order Forms. Every DEA registrant who distributes PMMA must comply with order form requirements, pursuant to 21 U.S.C. 828, and in accordance with 21 CFR part 1305.
9. Importation and Exportation. All importation and exportation of PMMA
must be in compliance with 21 U.S.C.
952, 953, 957, and 958, and in accordance with 21 CFR part 1312.
10. Liability. Any activity involving PMMA 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.

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