Drug Enforcement Administration May 2024 – Federal Register Recent Federal Regulation Documents
Results 1 - 29 of 29
Bulk Manufacturer of Controlled Substances Application: ANI Pharmaceuticals, Inc.
ANI Pharmaceuticals, 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.
Importer of Controlled Substances Application: Royal Emerald Pharmaceuticals
Royal Emerald Pharmaceuticals 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.
Importer of Controlled Substances Application: United States Pharmacopeial Convention
United States Pharmacopeial Convention 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.
Importer of Controlled Substances Application: Quagen Pharmaceuticals LLC
Quagen Pharmaceuticals 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.
Importer of Controlled Substances Application: Skalar Pharma, LLC
Skalar Pharma, 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.
Bulk Manufacturer of Controlled Substances Application: AMPAC Fine Chemicals Virginia LLC
AMPAC Fine Chemicals Virginia 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.
Bulk Manufacturer of Controlled Substances Application: Royal Emerald Pharmaceuticals
Royal Emerald Pharmaceuticals 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.
Importer of Controlled Substances Application: VA Cooperative Studies Program
VA Cooperative Studies Program 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.
Importer of Controlled Substances Application: ANI Pharmaceuticals Inc.
ANI Pharmaceuticals Inc., 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.
Importer of Controlled Substances Application: Revvity, Inc.
Revvity, 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.
Importer of Controlled Substances Application: Veranova, L.P.
Veranova, L.P. 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.
Importer of Controlled Substances Application: Vici Health Sciences, LLC
Vici Health Sciences, 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.
Importer of Controlled Substances Application: Almac Clinical Services Incorporate
Almac Clinical Services Incorp (ACSI) 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.
Bulk Manufacturer of Controlled Substances Application: Chemtos, LLC
Chemtos, 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.
Bulk Manufacturer of Controlled Substances Application: Pharmaron Manufacturing Services (US) LLC; Correction
The Drug Enforcement Administration (DEA) published a document in the Federal Register on May 6, 2024, concerning an application for a Bulk Manufacturer of Controlled Substances. A request was made for the removal of the following information: "The company plans to bulk manufacture the listed controlled substances for the purpose of producing material for clinical trials." Please correct notice to read as follows as stated under Supplementary Information.
Schedules of Controlled Substances: Rescheduling of Marijuana
The Department of Justice ("DOJ") proposes to transfer marijuana from schedule I of the Controlled Substances Act ("CSA") to schedule III of the CSA, consistent with the view of the Department of Health and Human Services ("HHS") that marijuana has a currently accepted medical use as well as HHS's views about marijuana's abuse potential and level of physical or psychological dependence. The CSA requires that such actions be made through formal rulemaking on the record after opportunity for a hearing. If the transfer to schedule III is finalized, the regulatory controls applicable to schedule III controlled substances would apply, as appropriate, along with existing marijuana-specific requirements and any additional controls that might be implemented, including those that might be implemented to meet U.S. treaty obligations. If marijuana is transferred into schedule III, the manufacture, distribution, dispensing, and possession of marijuana would remain subject to the applicable criminal prohibitions of the CSA. Any drugs containing a substance within the CSA's definition of "marijuana" would also remain subject to the applicable prohibitions in the Federal Food, Drug, and Cosmetic Act ("FDCA"). DOJ is soliciting comments on this proposal.
Exempt Chemical Preparations Under the Controlled Substances Act
The applications for exempt chemical preparations received by the Drug Enforcement Administration between April 28, 2022, and September 30, 2023, as listed below, were accepted for filing and have been approved or denied as indicated.
Bulk Manufacturer of Controlled Substances Application: Curia New York, Inc.
Curia New York, 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.
Bulk Manufacturer of Controlled Substances Application: Veranova, L.P.
Veranova, L.P. 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.
Importer of Controlled Substances Application: Wedgewood Village Pharmacy, LLC
Wedgewood Village Pharmacy, 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.
Bulk Manufacturer of Controlled Substances Application: Pharmaron Manufacturing Services (US) LLC
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.
Importer of Controlled Substances Application: Restek Corporation
Restek Corporation 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.
Importer of Controlled Substances Application: Lipomed
Lipomed 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.
Bulk Manufacturer of Controlled Substances Application: Bulk Manufacturer of Marihuana: Entheogen Pharmaceuticals Inc
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.
Importer of Controlled Substances Application: AndersonBrecon dba PCI Pharma Services
AndersonBrecon dba PCI Pharma Services 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.
Importer of Controlled Substances Application: AndersonBrecon dba PCI Pharma Services; Correction
The Drug Enforcement Administration (DEA) published a document in the Federal Register on March 6, 2024, concerning an application for an Importer of Controlled Substances. The document request removal of Dimethyltrytamine.
Bulk Manufacturer of Controlled Substances Application: Research Triangle Institute
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.
Importer of Controlled Substances Application: NSI Lab Solutions, Inc.
NSI Lab Solutions, 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.
Bulk Manufacturer of Controlled Substances Application: Pisgah Laboratories Inc.
Pisgah Laboratories 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.
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