DEA to OK Coca Leaves, Meth Precursor Imports?!
Published Date: 3/27/2025
Notice
Summary
SpecGx LLC wants to become an official importer of some strong controlled substances like phenylacetone, coca leaves, and thebaine. This affects companies and people involved in handling these drugs, who can share their thoughts or ask for a hearing by April 28, 2025. No direct money changes yet, but this move could shake up the drug import scene soon!
Analyzed Economic Effects
3 provisions identified: 2 benefits, 1 costs, 0 mixed.
Deadline to Comment or Request Hearing
If you are a registered bulk manufacturer of the listed controlled substances, or an applicant, you can submit electronic comments or objections through https://www.regulations.gov, or file a written request for a hearing, on or before April 28, 2025. The notice states you will receive a Comment Tracking Number when your electronic comment is successfully submitted.
SpecGx Applied to Import Specific Schedule II Drugs
On February 17, 2025, SpecGx LLC applied to be registered to import these Schedule II controlled substances: Phenylacetone (code 8501), Coca Leaves (code 9040), Thebaine (code 9333), Opium, raw (code 9600), Poppy Straw Concentrate (code 9670), and Tapentadol (code 9780). The company plans to import the listed substances for bulk manufacture into Active Pharmaceutical Ingredients for distribution to its customers, and plans to import intermediate forms of Tapentadol (9780) and Thebaine (9333) for further manufacturing before distribution.
Registration Limits and Permit Approval Rules
The notice explicitly says that placement of these controlled-substance codes on SpecGx's registration does not automatically approve future import permits. Approvals will occur only when the registrant's business activity is consistent with 21 U.S.C. 952(a)(2), and the authorization will not cover import of FDA-approved or non-approved finished dosage forms for commercial sale.
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