DEA Eyes Importing GHB: Date-Rape Drug Gets Pharma Pass?
Published Date: 2/26/2025
Notice
Summary
Sharp Clinical Services, LLC wants to become an official importer of certain controlled substances, like Gamma Hydroxybutyric Acid. If you’re a registered manufacturer or interested party, you have until March 28, 2025, to share your thoughts or ask for a hearing. This move could impact companies dealing with these drugs and the government’s oversight of imports.
Analyzed Economic Effects
3 provisions identified: 2 benefits, 1 costs, 0 mixed.
Application to Import Four Schedule I Drugs
Sharp Clinical Services, LLC applied on January 7, 2025 to be registered to import four Schedule I substances: Gamma Hydroxybutyric Acid (GHB), 3,4-methylenedioxymethamphetamine (MDMA), 5‑Methoxy‑N‑N‑dimethyltryptamine (5‑MeO‑DMT), and psilocybin. The company says it plans to import these substances for distribution and for clinical trials only.
Approval Limits: No Finished Dosage Imports for Sale
The notice states that any registration approval will only be granted if the applicant's business activity is consistent with 21 U.S.C. 952(a)(2), and the authorization will not permit importation of Food and Drug Administration‑approved or non‑approved finished dosage forms for commercial sale.
March 28, 2025 Comment and Hearing Deadline
Registered bulk manufacturers of the listed drug classes and other applicants may submit electronic comments or objections, or file a written request for a hearing, on or before March 28, 2025, via https://www.regulations.gov or by the addresses listed in the notice. Comments will produce a Comment Tracking Number when successfully submitted.
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