Three companies have applied for Drug Enforcement Administration (DEA) authorization to import or manufacture marijuana and related controlled substances for clinical research and pharmaceutical development, according to notices scheduled for publication in the Federal Register on September 8.
Fisher Clinical Services, Inc., based in Breinigsville, Pennsylvania, applied in August to become a registered importer of marijuana, marijuana extract and tetrahydrocannabinols for use in clinical trials. The application also covers several other controlled substances, including psilocybin, MDMA, dimethyltryptamine (DMT) and 5-MeO-DMT.
DEA said the substances would be imported solely for clinical trials, with no other activities authorized under the proposed registration.
On the same day, Irvine Labs, Inc., of Huntington Beach, California, applied to become a bulk manufacturer of marijuana, marijuana extract and tetrahydrocannabinols. The company plans to manufacture active pharmaceutical ingredients for product development and distribution to DEA-registered researchers.
A third company, AndersonBrecon, Inc., doing business as PCI Pharma Services, applied August 6 to import marijuana in dosage form for analytical and clinical research trials. The Rockford, Illinois-based company would not be authorized under the registration to import finished marijuana products for commercial sale.
The applications do not mean the companies have been approved. DEA is publishing notices allowing registered bulk manufacturers and other eligible parties to submit comments, objections or hearing requests before the agency determines whether to issue the registrations.
The notices come as marijuana remains federally classified as a Schedule I controlled substance, although state-legal and FDA-approved medical cannabis has been moved to Schedule III. Fisher’s application similarly lists marijuana extract and THC under Schedule I, while Irvine Labs is seeking authorization to manufacture all three substances under that schedule.
The filings add to the number of companies seeking federal authorization to handle marijuana for clinical research and pharmaceutical development, an area that remains subject to DEA registration requirements despite the expansion of state-legal medical and recreational marijuana markets.
