Health Law Daily Wrap Up, ADMINISTRATION OF FDC ACT—NOTICES: Importer of controlled substances application: CalCog Inc., (Jun 10, 2026)

By WK Editorial Staff

Authorization will not extend to the import of FDA-approved or non-approved finished dosage forms for commercial sale.

CalCog Inc. has applied to be registered as an importer of basic class(es) of controlled substance(s). The company plans to import t ...

By WK Editorial Staff

Authorization will not extend to the import of FDA-approved or non-approved finished dosage forms for commercial sale.

CalCog Inc. has applied to be registered as an importer of basic class(es) of controlled substance(s). The company plans to import the above listed controlled substance(s) as dosage units for clinical trials only. No other activities for these drug codes are authorized for this registration. Approval of permit applications will occur only when the registrant’s business activity is consistent with what is authorized under 21 U.S.C. 952(a)(2) (Notice, 91 Fed. Reg. 34654 (June 8, 2026)).

Dates. Registered bulk manufacturers of the affected basic class(es), and applicants, therefore, may submit electronic comments on or objections to the issuance of the proposed registration on or before July 8, 2026.

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