Purisys LLC applies to import pot and pals
Published Date: 2/13/2025
Notice
Summary
Purisys, LLC wants to become an official importer of certain controlled substances like marijuana and related products. People and companies involved with these substances can share their thoughts or ask for a hearing by March 17, 2025. This move could impact businesses handling these drugs and involves a formal review process with no immediate cost changes announced.
Analyzed Economic Effects
3 provisions identified: 2 benefits, 0 costs, 1 mixed.
Import uses limited to APIs and bulk manufacturing
Purisys plans to import Opium (raw 9600, powdered 9639, granulated 9640) to manufacture an active pharmaceutical ingredient (API) for distribution to its customers; Phenylacetone (8501) and Poppy Straw Concentrate (9670) to bulk manufacture other controlled substances for distribution; certain buprenorphine impurities under Thebaine (9333); synthetic Marihuana/THC; and an isomer of methadone (9250) to make a non-controlled substance. The registration explicitly states no other activities for these drug codes are authorized and that authorization will not extend to importing finished dosage forms for commercial sale.
Purisys applied to import listed controlled drugs
On December 10, 2024, Purisys, LLC applied to be registered as an importer of the listed controlled substances, including Marihuana Extract (code 7350, Schedule I), Marihuana (7360, I), Tetrahydrocannabinols (7370, I), and multiple Schedule II substances such as Phenylacetone (8501), Methadone (9250), Thebaine (9333), and Opium (9600, 9639, 9640). The application is published in the Federal Register and is under DEA review.
Stakeholders can comment or request a hearing
Registered bulk manufacturers of the affected classes and applicants may submit electronic comments or objections, or file a written request for a hearing, on or before March 17, 2025, via https://www.regulations.gov or by mail to DEA addresses listed in the notice.
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Key Dates
Department and Agencies
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