The Drug Enforcement Administration is considering two applications from a California company seeking federal authorization to import flowering marijuana and cannabis derivatives while also manufacturing pharmaceutical-grade marijuana for research.
Biopharmaceutical Research Company, based in Castroville, California, submitted separate applications July 14 to become a federally registered importer and bulk manufacturer of marijuana, marijuana extract and tetrahydrocannabinols, according to notices filed with the Federal Register today. Both notices are scheduled for formal publication August 25.
Under the import application, the company plans to bring the controlled substances into the United States as flowering plants and cannabis derivatives. DEA says the material would be used for analytical chemistry analyses and research, as well as to manufacture dosage forms for preclinical and clinical trials.
The application would not authorize the import of finished pharmaceutical products for commercial sale. DEA says any future import permits would be limited to activities allowed under federal law.
In a separate application, Biopharmaceutical Research Company is seeking registration as a bulk manufacturer of the same three categories of controlled substances. The company told DEA it plans to manufacture them to provide “pharmaceutical-grade marihuana” for research conducted in compliance with federal, state and local regulations.
The applications do not mean DEA has granted the company permission to begin importing or manufacturing the substances. They initiate the federal registration process and provide existing registered manufacturers and applicants an opportunity to object or request a hearing.
For the import application, eligible parties will have 30 days after publication to submit objections or request a hearing. The bulk manufacturing application provides a 60-day period.
The notices come as marijuana research continues to expand federally, including studies examining pharmaceutical formulations and potential medical uses of marijuana and individual cannabinoids.
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