StacksVerified U.S. regulatory reference

21 CFR §600.15

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
The following products shall be maintained during shipment at the specified temperatures:
  1. (a)Products.
  2. (b)Exemptions. Exemptions or modifications shall be made only upon written approval, in the form of a supplement to the biologics license application, approved by the Director, Center for Biologics Evaluation and Research.