Temperatures during shipment.

21 C.F.R. § 600.15
in effectEffective: 2024-07-01
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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.

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