Voglio sapere a riguardo di…

32633

Rules and Regulations
Federal Register Vol. 86, No. 117
Tuesday, June 22, 2021

This section of the FEDERAL REGISTER
contains regulatory documents having general applicability and legal effect, most of which are keyed to and codified in the Code of Federal Regulations, which is published under 50 titles pursuant to 44 U.S.C. 1510.
The Code of Federal Regulations is sold by the Superintendent of Documents.

DEPARTMENT OF JUSTICE
Drug Enforcement Administration 21 CFR Part 1308
Docket No. DEA819

Specific Listing for 4FMDMB
BINACA, a Currently Controlled Schedule I Substance Drug Enforcement Administration, Department of Justice.
ACTION: Final rule.
AGENCY:

The Drug Enforcement Administration is establishing a specific listing and Administration Controlled Substances Code Number drug code for 4FMDMBBINACA also known as 4FMDMBBUTINACA or methyl 2-14-fluorobutyl-1H-indazole-3carboxamido-3,3-dimethylbutanoate in schedule I of the Controlled Substances Act CSA. Although 4FMDMB
BINACA is not specifically listed in schedule I of the CSA with its own unique drug code, it has been controlled in the United States since April 2017 as a positional isomer of 5FAMB, a schedule I hallucinogen. Therefore, DEA
is simply amending the schedule I
hallucinogenic substances list in its regulations to separately include 4F
MDMBBINACA.
DATES: Effective June 22, 2021.
FOR FURTHER INFORMATION CONTACT:
Terrence L. Boos, Drug and Chemical Evaluation, Diversion Control Division, Drug Enforcement Administration;
Telephone: 571 3623249.
SUPPLEMENTARY INFORMATION:
SUMMARY:

lotter on DSK11XQN23PROD with RULES1

4FMDMBBINACA Control 4FMDMBBINACA also known as 4FMDMBBUTINACA or methyl 2-14-fluorobutyl-1H-indazole-3carboxamido-3,3-dimethylbutanoate is a chemical substance which is structurally related to 5FAMB also known as methyl 2-1-5-fluoropentyl1H-indazole-3-carboxamido-3-

VerDate Sep<11>2014

18:13 Jun 21, 2021

Jkt 253001

methylbutanoate. 5FAMB is listed as a hallucinogenic substance in schedule I at 21 CFR 1308.11d74. The introductory text to subparagraph d provides: 1 A listed substance includes any of its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible, and 2 the term isomer includes the optical, positional, and geometric isomers.
When compared to the chemical structure of 5FAMB, 4FMDMB
BINACA meets the statutory definition of a positional isomer in 21 CFR
1300.01b, which cross-references the term positional isomer in 21 CFR
1308.11d. Both 5FAMB and 4F
MDMBBINACA possess the same molecular formula and core structure, and have the same functional groups.
They only differ from one another by a rearrangement of an alkyl moiety between functional groups.
Accordingly, under 21 CFR 1308.11d, 4FMDMBBINACA, as a positional isomer of 5FAMB, has been and continues to be a schedule I controlled substance.1
The Drug Enforcement Administrations Authority To Control 4FMDMB
BINACA
This rule is prompted by a letter dated May 7, 2020, in which the United States government was informed by the Secretary-General of the United Nations that 4FMDMBBINACA has been added to Schedule II of the Convention on Psychotropic Substances of 1971
1971 Convention. This letter was prompted by a decision at the 63rd Session of the Commission on Narcotic Drugs CND in March 2020 to schedule 4FMDMBBINACA under Schedule II
of the 1971 Convention CND Dec/63/8.
Preceding this decision, the Food and Drug Administration FDA, on behalf of the Secretary of Health and Human Services and pursuant to 21 U.S.C.
811d2, published two notices in the Federal Register with an opportunity to submit domestic information and opportunity to comment on this action, Sept. 10, 2019, 84 FR 47521 and Dec.
1 5FAMB and its isomers has been subject to schedule I controls since April 2017, first pursuant to a temporary scheduling order April 10, 2017, 82
FR 17119 and the subsequent one-year extension of that order April 8, 2019, 84 FR 13796, and then permanently pursuant to a final rule which continued the imposition of those controls Jan. 24, 2020, 85 FR 4211.

PO 00000

Frm 00001

Fmt 4700

Sfmt 4700

31, 2019, 84 FR 72370. In both instances, FDA noted that 4FMDMB
BINACA was already controlled in schedule I of the Controlled Substances Act CSA as a positional isomer of 5F
AMB, and the December 2019 notice stated that no additional permanent controls for 4FMDMBBINACA under the CSA would be necessary to fulfill United States obligations as a party to the 1971 Convention.
As discussed above in this final rule, 4FMDMBBINACAby virtue of being a positional isomer of 5FAMBhas been controlled in schedule I of the CSA
temporarily since April 10, 2017 82 FR
17119, and permanently since January 24, 2020 85 FR 4211. Therefore, all regulations and criminal sanctions applicable to schedule I substances have been and remain applicable to 4F
MDMBBINACA. Drugs controlled in schedule I of the CSA satisfy and exceed the required domestic controls of Schedule II under Article 2 of the 1971
Convention.
Effect of Action As discussed above, this rule does not affect the continuing status of 4F
MDMBBINACA as a schedule I
controlled substance in any way. This action, as an administrative matter, merely establishes a separate, specific listing for 4FMDMBBINACA in schedule I of the CSA and assigns a DEA
controlled substances code number drug code for the substance. This action will allow DEA to establish an aggregate production quota and grant individual manufacturing and procurement quotas to DEA-registered manufacturers of 4FMDMBBINACA, who had previously been granted individual quotas for such purposes under the drug code for 5FAMB.
Regulatory Analyses Administrative Procedure Act An agency may find good cause to exempt a rule from certain provisions of the Administrative Procedure Act APA
5 U.S.C. 553, including notice of proposed rulemaking and the opportunity for public comment, if it is determined to be unnecessary, impracticable, or contrary to the public interest. 4FMDMBBINACA is currently controlled in schedule I as a positional isomer of 5FAMB, and 4F
MDMBBINACA has no currently accepted medical use in treatment to
E:FRFM22JNR1.SGM

22JNR1