Drug Enforcement Administration 2021 – Federal Register Recent Federal Regulation Documents

Patheon Pharmaceuticals Inc has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplemental Information listed below for further drug information.

The Drug Enforcement Administration proposes placing N-(1-(2- fluorophenethyl)piperidin-4-yl)-N-(2-fluorophenyl)propionamid e (2'- fluoro ortho-fluorofentanyl), N-(1-(4-methylphenethyl)piperidin-4-yl)- N-phenylacetamide (4'-methyl acetyl fentanyl), N-(1-phenethylpiperidin- 4-yl)-N,3-diphenylpropanamide ([beta]'-phenyl fentanyl; 3- phenylpropanoyl fentanyl), N-phenyl-N-(1-(2-phenylpropyl)piperidin-4- yl)propionamide ([beta]-methyl fentanyl), N-(2-fluorophenyl)-N-(1- phenethylpiperidin-4-yl)butyramide (ortho-fluorobutyryl fentanyl; 2- fluorobutyryl fentanyl), N-(2-methylphenyl)-N-(1-phenethylpiperidin-4- yl)acetamide (ortho-methyl acetylfentanyl; 2-methyl acetylfentanyl), 2- methoxy-N-(2-methylphenyl)-N-(1-phenethylpiperidin-4-yl)aceta mide (ortho-methyl methoxyacetylfentanyl), N-(4-methylphenyl)-N-(1- phenethylpiperidin-4-yl)propionamide (para-methylfentanyl; 4- methylfentanyl), N-(1-phenethylpiperidin-4-yl)-N-phenylbenzamide (phenyl fentanyl; benzoyl fentanyl), N-(1-phenethylpiperidin-4-yl)-N- phenylthiophene-2-carboxamide (thiofuranyl fentanyl), including their isomers, esters, ethers, salts, and salts of isomers, esters, and ethers, in schedule I of the Controlled Substances Act. These ten 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 2'- fluoro ortho-fluorofentanyl, 4'-methyl acetyl fentanyl, [beta]'-phenyl fentanyl, [beta]-methyl fentanyl, ortho-fluorobutyryl fentanyl, ortho- methyl acetylfentanyl, ortho-methyl methoxyacetyl fentanyl, para- methylfentanyl, phenyl fentanyl, and thiofuranyl fentanyl.

Stepan Company 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.

Groff NA Hemplex, 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.

Microgenics Corporation Thermo Fisher Scientific 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.

S&B Pharma, Inc., has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplemental Information listed below for further drug information.

On November 2, 2020, the Drug Enforcement Administration published in the Federal Register a notice of proposed rulemaking (NPRM) soliciting comments on the proposed revisions relating to the suspicious orders of controlled substances. The NPRM provided for a comment period ending on January 4, 2021, and the opportunity to comment ended accordingly. DEA has determined that a reopening of the comment period from February 25, 2021 until March 29, 2021 is appropriate as registrants who would be primarily affected by this rule are uniquely preoccupied with mitigating the global pandemic caused by COVID-19. Accordingly, this reopening will permit additional time to prepare and submit comments.

Sigma Aldrich Research Biochemicals, Inc, 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.

Synthcon LLC, has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplemental 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.

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.

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

Siegfried USA, LLC has applied to be registered as an importer 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 (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.

Sterling Pharma USA LLC has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplemental Information listed below for further drug information.

Mylan Pharmaceuticals 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.

Siemens Healthcare Diagnostics Inc. has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplemental Information listed below for further drug information.

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

Medi-Physics, Inc. dba GE Healthcare 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) 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.

This rule proposes to amend the Drug Enforcement Administration (DEA) regulations to require all initial and renewal applications for DEA registration to be submitted online.