Importer of Controlled Substances Application: Sharp Clinical Services, LLC
Published Date: 2/2/2026
Notice
Summary
Sharp Clinical Services, LLC wants to become an official importer of certain controlled substances, including some Schedule I drugs like Gamma Hydroxybutyric Acid and MDMA. This affects companies involved in drug manufacturing and regulation, who can comment or request a hearing by March 4, 2026. No fees or immediate changes yet, but this step could impact drug supply chains soon.
Analyzed Economic Effects
2 provisions identified: 0 benefits, 1 costs, 1 mixed.
Import Use Limited; No Commercial Finished Drugs
The company plans to import the listed substances for distribution and clinical trials only; the registration would not authorize any other activities for these drug codes. The authorization explicitly will not extend to importing Food and Drug Administration‑approved or non‑approved finished dosage forms for commercial sale.
New Importer Seeks Schedule I Registration
Sharp Clinical Services, LLC applied on January 9, 2026 to be registered as an importer of four Schedule I controlled substances: Gamma Hydroxybutyric Acid (code 2010), 3,4‑Methylenedioxy‑methamphetamine (MDMA, code 7405), 5‑Methoxy‑N‑N‑dimethyltryptamine (code 7431), and Psilocybin (code 7437). Registered bulk manufacturers and other interested parties may submit comments or request a hearing on the application on or before March 4, 2026.
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