SpecGx LLC Applies to Import Coca Leaves and Thebaine
Published Date: 3/19/2026
Notice
Summary
SpecGx LLC wants to become an official importer of certain controlled substances like phenylacetone, coca leaves, and thebaine. People and companies already registered can share their thoughts or ask for a hearing by April 20, 2026. This move could impact businesses dealing with these substances and involves careful government review before approval.
Analyzed Economic Effects
3 provisions identified: 2 benefits, 1 costs, 0 mixed.
Import Allowed Only for Bulk/API Manufacture
SpecGx LLC applied on February 3, 2026 to import certain Schedule II substances for bulk manufacture into Active Pharmaceutical Ingredients (APIs); the registration, if approved, will not authorize importation of FDA-approved or non-approved finished dosage forms for commercial sale.
Comment and Hearing Deadline: April 20, 2026
Registered bulk manufacturers of the affected drug classes and other applicants may submit electronic comments or objections, or file a written request for a hearing, on SpecGx LLC's importer application on or before April 20, 2026.
Application Covers Specific Schedule II Substances
The application seeks importer registration for these Schedule II substances and codes: Phenylacetone (8501), Coca Leaves (9040), Thebaine (9333), Opium, raw (9600), Poppy Straw Concentrate (9670), and Tapentadol (9780); Tapentadol and Thebaine are proposed to be imported in intermediate forms for further manufacturing.
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