Labs Seek OK to Import Niche Controlled Substances
Published Date: 1/24/2025
Notice
Summary
VHG Labs, also known as LGC Standards, wants to become an official importer of certain controlled substances like Amineptine and Mesocarb. This affects companies involved in drug manufacturing and importation, who can comment or request a hearing by February 24, 2025. No fees or immediate changes happen yet, but this step could impact drug supply chains soon.
Analyzed Economic Effects
2 provisions identified: 0 benefits, 1 costs, 1 mixed.
Import Authorization Limited to Testing Materials
The company plans to import the listed controlled substances only for distribution for analytical testing purposes; no other activities for these drug codes are authorized for this registration. The authorization explicitly will not extend to import of FDA-approved or non-approved finished dosage forms for commercial sale.
VHG Labs Applied to Import Many Controlled Substances
VHG Labs (dba LGC Standards) applied on November 1, 2024 to be registered as an importer of a long list of Schedule I and II controlled substances, including Amineptine and Mesocarb. If you run a drug manufacturing, testing, or import business, you may submit electronic comments or objections or request a hearing on the application on or before February 24, 2025.
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