7 changes matching "21 CFR 1301.33(a)"

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AJNA Biosciences Bulk Manufacturer of Controlled Substances Application

The Drug Enforcement Administration published notice that AJNA Biosciences applied on March 23, 2026 to be registered as a bulk manufacturer of Schedule I controlled substances psilocybin (drug code 7437) and psilocyn (drug code 7438). The company plans to bulk manufacture psilocybin-containing mushrooms for internal research, clinical trials, and analytical purposes, and to distribute to customers conducting Schedule I clinical research. The public comment period closes June 22, 2026.

Routine Notice Pharmaceuticals
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Purisys LLC Controlled Substance Bulk Manufacturer Registration Notice

The DEA published a notice that Purisys, LLC applied on February 4, 2026, to be registered as a bulk manufacturer of Schedule I and II controlled substances. The application covers 69 controlled substances including cocaine, fentanyl, heroin, LSD, psilocybin, and various opioids and stimulants. The DEA is soliciting electronic comments or objections from registered bulk manufacturers and other interested parties.

Routine Notice Pharmaceuticals
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Research Triangle Institute Controlled Substance Bulk Manufacturer Registration Application

DEA published notice that Research Triangle Institute applied for bulk manufacturer registration of Tetrahydrocannabinols (Schedule I controlled substance, Drug Code 7370). The company plans to manufacture synthetic THC for research and analytical reference standards. Comments and hearing requests may be submitted until June 2, 2026.

Routine Consultation Pharmaceuticals
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Royal Emerald Pharmaceuticals Bulk Manufacturer Registration Application

The DEA published notice that Royal Emerald Pharmaceuticals applied to be registered as a bulk manufacturer of Schedule I controlled substances including Marihuana Extract (7350), Marihuana (7360), and Tetrahydrocannabinols (7370). The company, located in Desert Hot Springs, California, plans to provide cannabis botanical raw material and API to DEA-registered researchers and manufacturers. Comments and objections on the application are due June 1, 2026.

Routine Notice Pharmaceuticals
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Bulk Manufacturer of Controlled Substances Application: Royal Emerald Pharmaceuticals

The DEA published a notice that Royal Emerald Pharmaceuticals applied to register as a bulk manufacturer of Schedule I controlled substances including Marihuana Extract (7350), Marihuana (7360), and Tetrahydrocannabinols (7370) at its facility in Desert Hot Springs, California. The company proposes to provide cannabis botanical raw material and active pharmaceutical ingredients (API) to DEA-registered researchers and manufacturers. Public comments on the application are due June 1, 2026.

Routine Notice Cannabis
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Bulk Manufacturer of Controlled Substances Application: Pharmaron Manufacturing Services (US) LLC

The DEA published a notice that Pharmaron Manufacturing Services (US) LLC applied on February 10, 2026 to be registered as a bulk manufacturer of Schedule II controlled substances (Oxycodone, Thebaine, Oxymorphone, and Noroxymorphone) at its facility in Coventry, Rhode Island. The company plans to produce material for clinical trials only. The public has until June 1, 2026 to submit comments or objections to the application.

Routine Notice Pharmaceuticals
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DEA Notice: Patheon API Services Controlled Substance Application

The DEA has published a notice regarding an application from Patheon API Services Inc. to be registered as a bulk manufacturer of controlled substances, including Dimethyltryptamine, Psilocybin, Psilocyn, Amphetamine, and Methadone. Interested parties can submit comments or requests for a hearing by May 12, 2026.

Priority review Consultation Pharmaceuticals

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