Federal Register #DEA-1745

DEA Registration Applications for Bulk Manufacturing and Importation of Controlled Substances by Cambrex Charles City and Experic LLC

The Department of Justice's Drug Enforcement Administration (DEA) is considering applications from Cambrex Charles City and Experic LLC to register as bulk manufacturers and importers of various controlled substances for clinical trials, formulation development, and internal research. - Government Buyer: - Department of Justice - Drug Enforcement Administration (DEA) - OEMs and Vendors: - Cambrex Charles City - Experic LLC - Products/Services Requested: - Bulk manufacturing and importation of controlled substances, including: - Gamma Hydroxybutyric Acid (2010, Schedule I) - Tetrahydrocannabinols (7370, Schedule I) - Amphetamine (1100, Schedule II) - Lisdexamfetamine (1205, Schedule II) - Methylphenidate (1724, Schedule II) - ANPP (4-Anilino-N-phenethyl-4-piperidine, 8333, Schedule II) - Phenylacetone (8501, Schedule II) - Codeine (9050, Schedule II) - Oxycodone (9143, Schedule II) - Hydromorphone (9150, Schedule II) - Hydrocodone (9193, Schedule II) - Methadone (9250, Schedule II) - Morphine (9300, Schedule II) - Oripavine (9330, Schedule II) - Thebaine (9333, Schedule II) - Opium extracts (9610, Schedule II) - Opium fluid extract (9620, Schedule II) - Opium tincture (9630, Schedule II) - Opium, powdered (9639, Schedule II) - Oxymorphone (9652, Schedule II) - Noroxymorphone (9668, Schedule II) - Fentanyl (9801, Schedule II) - Psilocybin (7437, Schedule I) - Coca Leaves (9040, Schedule II) - Opium Raw (9600, Schedule II) - Poppy Straw Concentrate (9670, Schedule II) - 5-Methoxy-N-Ndimethyltryptamine (7431, Schedule I) - Nabilone (7379, Schedule II) - Unique or Notable Requirements: - Substances will be used for formulation development, clinical trial support, internal research, and manufacturing into other controlled substances for distribution. - Registration and permit approval are contingent on compliance with federal requirements and business activity authorization. - No finished dosage forms for commercial sale are allowed under these registrations. - Public comments and hearing requests are accepted within specified periods.

Description

Cambrex Charles City has applied to be registered as an importer of basic class(es) of controlled substance(s). The company plans to import psilocybin for formulation development and clinical trial support for their customers. The remaining listed controlled substances will be imported to support the manufacture into other controlled substances which will be distributed to their customers. No other activities for these drug codes are authorized for this registration. Approval of permit applications will occur only when the registrants business activity is consistent with what is authorized under 21 U.S.C. 952(a)(2).

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