Drug Enforcement Administration 2021 – Federal Register Recent Federal Regulation Documents

The Drug Enforcement Administration is finalizing a December 21, 2020, notice of proposed rulemaking to designate three chemicals, known as PMK glycidate, PMK glycidic acid, and APAA, as list I chemicals under the Controlled Substances Act (CSA). PMK glycidate and PMK glycidic acid are used in and are important to the manufacture of the schedule I controlled substance 3,4-methylenedioxymethamphetamine (MDMA) and other ``ecstasy''-type substances, and APAA is used in and is important to the manufacture of the schedule II controlled substances amphetamine and methamphetamine. This final rulemaking subjects handlers (manufacturers, distributors, importers, and exporters) of PMK glycidate, PMK glycidic acid, and APAA to the chemical regulatory provisions of the CSA and its implementing regulations.

The Drug Enforcement Administration (DEA) is providing notice of an application it has received from an entity applying to be registered to manufacture in bulk basic class(es) of controlled substances listed in schedule I. DEA intends to evaluate this and other pending applications according to its regulations governing the program of growing marihuana for scientific and medical research under DEA registration.

VHG Labs DBA LGC Standards has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplemental Information listed below for further drug information.

Wildlife Laboratories, LLC has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplemental Information listed below for further drug information.

The Drug Enforcement Administration (DEA), Department of Justice (DOJ), will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995.

Rhodes Technologies has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.

Lipomed has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplemental Information listed below for further drug information.

Research Triangle Institute, has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.

The Drug Enforcement Administration (DEA) is providing notice of an application it has received from an entity applying to be registered to manufacture in bulk basic class(es) of controlled substances listed in schedule I. DEA intends to evaluate this and other pending applications according to its regulations governing the program of growing marihuana for scientific and medical research under DEA registration.

The Drug Enforcement Administration is correcting a final rule that appeared in the Federal Register on November 25, 2020. The document issued an action placing five fentanyl-related substances (cyclopentyl fentanyl (N-(1-phenethylpiperidin-4-yl)-N- phenylcyclopentanecarboxamide), isobutyryl fentanyl (N-(1- phenethylpiperidin-4-yl)-N-phenylisobutyramide), para-chloroisobutyryl fentanyl (N-(4-chlorophenyl)-N-(1-phenethylpiperidin-4- yl)isobutyramide), para-methoxybutyryl fentanyl (N-(4-methoxyphenyl)-N- (1-phenethylpiperidin-4-yl)butyramide), and valeryl fentanyl (N-(1- phenethylpiperidin-4-yl)-N-phenylpentanamide), including their isomers, esters, ethers, salts, and salts of isomers, esters, and ethers, permanently in schedule I of the Controlled Substances Act, specifically to the opiates list under DEA regulations. The published document assigned incorrect paragraph numbers to all five substances, and inadvertently removed four other substances from the listed opiates.

The Acting Administrator of the Drug Enforcement Administration is issuing this order to extend the temporary schedule I status of ethyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3,3- dimethylbutanoate (trivial name: 5F-EDMB-PINACA); methyl 2-(1-(5- fluoropentyl)-1H-indole-3-carboxamido)-3,3-dimethylbutanoate (trivial name: 5F-MDMB-PICA); N-(adamantan-1-yl)-1-(4-fluorobenzyl)-1H-indazole- 3-carboxamide (trivial names: FUB-AKB48; FUB-APINACA; AKB48 N-(4- fluorobenzyl)); 1-(5-fluoropentyl)-N-(2-phenylpropan-2-yl)-1H-indazole- 3-carboxamide (trivial names: 5F-CUMYL-PINACA; SGT-25); and (1-(4- fluorobenzyl)-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)m ethanone (trivial name: FUB-144), and their optical, positional, and geometric isomers, salts, and salts of isomers. The schedule I status of 5F-EDMB- PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F-CUMYL-PINACA and FUB-144 currently is in effect until April 16, 2021. This temporary order will extend the temporary scheduling of 5F-EDMB-PINACA, 5F-MDMB-PICA, FUB-AKB48, 5F- CUMYL-PINACA and FUB-144 for one year or until the permanent scheduling action for these substances is completed, whichever occurs first.

The Drug Enforcement Administration is proposing the control of the chemical methyl alpha-phenylacetoacetate (also known as MAPA; methyl 3-oxo-2-phenylbutanoate; methyl 2-phenylacetoacetate; [alpha]- acetyl-benzeneacetic acid, methyl ester; and CAS Number: 16648-44-5) and its optical isomers as a list I chemical under the Controlled Substances Act (CSA). Methyl alpha-phenylacetoacetate is used in clandestine laboratories to illicitly manufacture the schedule II controlled substances phenylacetone (also known as phenyl-2-propanone or P2P), methamphetamine, and amphetamine and is important to the manufacture of these controlled substances. If finalized, this action would subject handlers of methyl alpha-phenylacetoacetate to the chemical regulatory provisions of the CSA and its implementing regulations. This rulemaking does not establish a threshold for domestic and international transactions of methyl alpha- phenylacetoacetate. As such, all transactions of chemical mixtures containing methyl alpha-phenylacetoacetate would be regulated at any concentration and would be subject to control under the CSA.

Shertech Laboratories, LLC has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplemental Information listed below for further drug information.

Perkinelmer, Inc. has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplemental Information listed below for further drug information.

The Drug Enforcement Administration proposes placing ethyl (1- phenethylpiperidin-4-yl)(phenyl)carbamate (fentanyl carbamate), N-(2- fluorophenyl)-N-(1-phenethylpiperidin-4-yl)acrylamide (ortho- fluoroacryl fentanyl), N-(2-fluorophenyl)-N-(1-phenethylpiperidin-4- yl)isobutyramide (ortho-fluoroisobutyryl fentanyl), and N-(4- fluorophenyl)-N-(1-phenethylpiperidin-4-yl)furan-2-carboxamid e (para- fluoro furanyl fentanyl), including their isomers, esters, ethers, salts, and salts of isomers, esters, and ethers, in schedule I of the Controlled Substances Act. These four specific substances fall within the definition of fentanyl-related substances set forth in the February 6, 2018, temporary scheduling order. Through the Temporary Reauthorization and Study of the Emergency Scheduling of Fentanyl Analogues Act, which became law on February 6, 2020, Congress extended the temporary control of fentanyl-related substances until May 6, 2021. If finalized, this action would make permanent the existing regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances on persons who handle (manufacture, distribute, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis, or possess), or propose to handle fentanyl carbamate, ortho-fluoroacryl fentanyl, ortho-fluoro isobutyryl fentanyl, and para-fluoro furanyl fentanyl.

The Drug Enforcement Administration (DEA) published a document in the Federal Register of September 14, 2020, concerning a notice of application. The document contained a misspelling (Isotype vs. Isotope).

The Drug Enforcement Administration (DEA) is providing notice of an application it has received from an entity applying to be registered to manufacture in bulk basic class(es) of controlled substances listed in schedule I. DEA intends to evaluate this and other pending applications according to its regulations governing the program of growing marihuana for scientific and medical research under DEA registration.