Code of Federal Regulations · Section
§ 600.15 — Temperatures During Shipment
21 C.F.R. § 600.15
View:
The following products shall be maintained during shipment at the specified temperatures:
(a) Products.
(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.
Authorizing Statute
-
Definitions; generally21 U.S.C. § 321
-
Regulations42 U.S.C. § 216