DEA Reviews New Importer for Controlled Meds
Published Date: 2/13/2026
Notice
Summary
S&B Pharma LLC, also known as Norac Pharma, wants to become an official importer of certain controlled drugs. This means they’ll be allowed to bring in specific medicines that need special handling. If anyone has concerns or wants a hearing, they must speak up by March 16, 2026, so don’t miss the deadline!
Analyzed Economic Effects
4 provisions identified: 2 benefits, 2 costs, 0 mixed.
Application to Import Two Schedule II Drugs
On January 13, 2026, S&B Pharma LLC DBA Norac Pharma applied to be registered to import ANPP (controlled substance code 8333, Schedule II) and Tapentadol (code 9780, Schedule II). The company plans to import intermediate forms of Tapentadol for further manufacturing and to import ANPP to bulk manufacture other controlled substances for distribution to its customers.
Finished Dosage Forms Not Authorized
The DEA 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 under this registration. The registration, if approved, is limited to the activities described in the application.
Deadline to Comment or Request Hearing
Registered bulk manufacturers of the affected drug classes and other applicants may submit comments or objections, or file a written request for a hearing, on or before March 16, 2026. Comments must be submitted electronically at https://www.regulations.gov and hearing requests must be sent to the DEA addresses listed in the notice.
Approval Conditional on Statutory Consistency
The notice states that approval of permit applications will occur only when the registrant's business activity is consistent with 21 U.S.C. 952(a)(2). That statutory consistency is a condition for authorization.
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