Restek Wants to Import Schedule I Controlled Substances Officially
Published Date: 3/27/2025
Notice
Summary
Restek Corporation wants to become an official importer of certain controlled substances, including some drugs on Schedule I. People and companies already registered or applying can share their thoughts or ask for a hearing by April 28, 2025. This move could affect businesses dealing with these substances and involves a formal review process but no immediate costs are mentioned.
Analyzed Economic Effects
2 provisions identified: 0 benefits, 1 costs, 1 mixed.
Finished dosage forms not authorized
The registration, if granted, will not authorize the import of Food and Drug Administration-approved or non-approved finished dosage forms for commercial sale. Approval is limited to the activities consistent with 21 U.S.C. 952(a)(2) and the stated use for certified reference materials.
Restek applied to import many Schedule I drugs
On February 20, 2025, Restek Corporation applied to be registered as an importer of the listed controlled substances, including many drugs on Schedule I. The company says it plans to import those substances for use in the manufacture of exempted certified reference materials, and the registration would authorize only those import activities.
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