eCFR Reference Browser

---

title: "21 CFR §601.21"

source: "https://www.ecfr.gov/current/title-21/section-601.21"

title_number: "21"

volume_number: "7"

chapter_number: "Unknown"

subchapter_code: "F"

subchapter_subject: "BIOLOGICS"

part_code: "601"

part_subject: "LICENSING"

subpart_code: "C"

subpart_subject: "Biologics Licensing"

section_number: "601.21"

section_subject: "Products under development."

cfr_reference: "21 CFR 601.21"

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"

---

A biological product undergoing development, but not yet ready for a biologics license, may be shipped or otherwise delivered from one State or possession into another State or possession provided such shipment or delivery is not for introduction or delivery for introduction into interstate commerce, except as provided in sections 505(i) and 520(g) of the Federal Food, Drug, and Cosmetic Act, as amended, and the regulations thereunder (21 CFR parts 312 and 812).

§601.21 - Products under development.