Drug Enforcement Administration November 2023 – Federal Register Recent Federal Regulation Documents

Pharmaron Manufacturing Services (US) LLC 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.

Organic Standards Solutions International, 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.

Organix Chemistry Solutions, LLC 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.

Groff NA Hemplex LLC. 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.

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.

Noramco 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.

Mylan Technologies Inc. as 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) proposes to establish the 2024 aggregate production quotas (APQ) for controlled substances in schedules I and II of the Controlled Substances Act (CSA) and the assessment of annual needs (AAN) for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine. For the 2024 quota year, DEA intends to allocate procurement quotas to DEA-registered manufacturers of schedule II controlled substances on a quarterly basis. In order to address domestic drug shortages of controlled substances, procurement quota allocations will be divided between quantities authorized for domestic sales and quantities authorized for export sales.