Pharma Company Applies to Import Controlled Fentanyl
Published Date: 11/2/2026
Notice
Summary
Globyz Pharma LLC wants to become an official importer of fentanyl, a powerful controlled substance. People and companies involved with these drugs can share their thoughts or ask for a hearing by December 2, 2026. This move could affect how fentanyl is brought into the U.S., with important deadlines coming up for feedback.
Analyzed Economic Effects
2 provisions identified: 1 benefits, 1 costs, 0 mixed.
Import Authorization Excludes Commercial Finished Drugs
The notice states that authorization for this registration will not extend to the import of Food and Drug Administration-approved or non-approved finished dosage forms for commercial sale. Approval will occur only when the registrant's business activity is consistent with 21 U.S.C. 952(a)(2).
Application to Import Schedule II Fentanyl
On September 29, 2026, Globyz Pharma LLC applied to be registered as an importer of fentanyl (controlled substance code 9801, Schedule II). The company says it plans to import the drug in dosage form for use in analytical testing and development; no other activity for this drug code is authorized.
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