SpecGx wants coca leaves, meth precursor imports: Comment now or forever hold
Published Date: 3/26/2025
Notice
Summary
SpecGx LLC wants to become an official importer of some strong controlled substances like phenylacetone, coca leaves, and thebaine. This affects companies involved in drug manufacturing and importation, who can comment or request a hearing by April 25, 2025. No direct costs are mentioned, but this move could shake up the supply chain for these substances.
Analyzed Economic Effects
2 provisions identified: 1 benefits, 1 costs, 0 mixed.
Import authorization limited; finished drugs excluded
The notice states that adding the listed controlled-substance codes to SpecGx's registration does not automatically approve future import permits; approvals will occur only when the registrant's activity is consistent with 21 U.S.C. 952(a)(2). The authorization explicitly will not extend to import of Food and Drug Administration–approved or non-approved finished dosage forms for commercial sale.
SpecGx applied to import specific Schedule II drugs
On February 17, 2025, SpecGx LLC applied to be registered to import six Schedule II controlled substances, including phenylacetone (code 8501), coca leaves (9040), thebaine (9333), opium raw (9600), poppy straw concentrate (9670), and tapentadol (9780). The company plans to import these substances for bulk manufacture into active pharmaceutical ingredients (APIs) and to distribute those APIs to its customers; for tapentadol and thebaine it plans to import intermediate forms for further manufacturing. Interested registered bulk manufacturers and applicants may submit comments or request a hearing by April 25, 2025.
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