eCFR Reference Browser

---

title: "21 CFR §600.15"

source: "https://www.ecfr.gov/current/title-21/section-600.15"

title_number: "21"

volume_number: "7"

chapter_number: "Unknown"

subchapter_code: "F"

subchapter_subject: "BIOLOGICS"

part_code: "600"

part_subject: "BIOLOGICAL PRODUCTS: GENERAL"

subpart_code: "B"

subpart_subject: "Establishment Standards"

section_number: "600.15"

section_subject: "Temperatures during shipment."

cfr_reference: "21 CFR 600.15"

title_name: "Title 21"

title_subject: "Food and Drugs"

parts_covered: "Parts 600 to 799"

revised_date: "Revised as of April 1, 2019"

publication_date: "As of April 1, 2019"

contains_description: "Containing a codification of documents of general applicability and future effect"

publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"

---

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.

§600.15 - Temperatures during shipment.