Pharma giant applies to import tightly regulated Thebaine drug
Published Date: 3/6/2025
Notice
Summary
Indivior Inc. wants to become an official importer of certain controlled substances, like Thebaine, which are tightly regulated drugs. People and companies involved can share their thoughts or ask for a hearing by April 7, 2025. This move could impact drug supply chains and regulatory oversight, but no costs or fees are mentioned yet.
Analyzed Economic Effects
2 provisions identified: 1 benefits, 1 costs, 0 mixed.
Indivior applies to import Thebaine
Indivior Inc. applied on October 18, 2024 to register as an importer of Thebaine (drug code 9333), a Schedule II controlled substance. The company plans to import limited quantities for research, clinical trials, analytical purposes, and manufacturing process development; no other activity for this drug code is authorized. Registered bulk manufacturers and applicants may submit comments or objections, or request a hearing, on or before April 7, 2025.
No import of finished dosage forms allowed
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. Approval of permit applications will occur only when the registrant's business activity is consistent with 21 U.S.C. 952(a)(2).
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