21 CFR 600.15

§ 600.15 Temperatures during shipment.

United States · 21 CFR — Food and Drugs · Status: effective

Cite this

Citation: 21 CFR 600.15, § 600.15 Temperatures during shipment, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/88302
Permanent ID: ys:prov:88302@1
SHA-256: 9f327559e0d4a98dad3e0f5d80b639dc910092a1974681b618c4c6827c5ac3c8

The hash is SHA-256 of this version's text, with every run of whitespace collapsed to a single space and the ends trimmed. The ID always leads back here, and checking it says whether the text you cited is still the current version.

Full text

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.

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.