Company Wants to Import Coca Leaves and Raw Opium Legally
Published Date: 2/13/2025
Notice
Summary
Veranova, L.P. wants to become an official importer of certain controlled substances like coca leaves and opium. People and companies involved with these drugs can share their thoughts or ask for a hearing by March 17, 2025. This move could impact businesses handling these substances and involves a formal review process with no immediate cost changes announced.
Analyzed Economic Effects
3 provisions identified: 1 benefits, 1 costs, 1 mixed.
Importing raw materials to make APIs
Veranova, L.P. applied on November 15, 2024 to be registered to import Coca Leaves (9040, Schedule II), Opium, raw (9600, Schedule II), and Poppy Straw Concentrate (9670, Schedule II). The company says it plans to import these substances to bulk manufacture Active Pharmaceutical Ingredients (APIs) for distribution to its customers.
Reference standards limited to testing Veranova APIs
Veranova applied to import Thebaine (9333, Schedule II), Noroxymorphone (9668, Schedule II), and Fentanyl (9801, Schedule II) to use as analytical reference standards. The notice says those standards will be used internally and may be sold to customers only to support testing of Veranova, L.P. APIs.
No authorization for finished drug products
The notice states that authorization will not extend to the import of Food and Drug Administration-approved or non-approved finished dosage forms for commercial sale. Veranova's application, as described, covers import for bulk API manufacture and limited analytical standards only.
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