Restek Seeks Approval to Import Rare Controlled Substances
Published Date: 3/4/2026
Notice
Summary
Restek Corporation wants to become an official importer of some controlled substances, including Amineptine and Mesocarb. People and companies involved with these drugs can share their thoughts or ask for a hearing by April 3, 2026. This move could affect how these substances are brought into the U.S., but no direct costs are mentioned yet.
Analyzed Economic Effects
2 provisions identified: 1 benefits, 1 costs, 0 mixed.
Importer Registration to Import Listed Controlled Substances
On February 11, 2026, Restek Corporation applied to be registered as an importer of the listed basic classes of controlled substances (examples include Amineptine and Mesocarb, and many other Schedule I and II substances). The company says it plans to import these substances to manufacture exempted certified reference materials; interested parties may submit comments or request a hearing by April 3, 2026.
Import Authorization Excludes Finished Dosage Forms
The DEA states authorization for this registration will not extend to importing FDA-approved or non-approved finished dosage forms for commercial sale. Approval will be granted only when the registrant's business activity is consistent with 21 U.S.C. 952(a)(2).
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