All owners or operators of establishments that engage in the manufacturing of blood products are required to register, pursuant to section 510 of the Federal Food, Drug, and Cosmetic Act. Registration and listing of blood products must comply with this part. Registration does not permit any blood bank or similar establishment to ship blood products in interstate commerce.
21 CFR Part 607 · Establishment Registration and Product Listing for Manufacturers of Human Blood and Blood Products and Licensed Devices
§ 607.7 Establishment registration and product listing of blood banks and other firms manufacturing human blood and blood products
Independent copy, not an official legal edition. 21 CFR is a U.S. Government work in the public domain; this text comes from the eCFR and the annual CFR edition, and may lag recent amendments. The authoritative version is on ecfr.gov. Compliome is not affiliated with or endorsed by FDA. Not legal advice.
FDA guidance that cites § 607.7
- Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion: Guidance for Industry 17 Dec 2020
- Recommendations for Collecting Red Blood Cells by Automated Apheresis Methods - Technical Correction February 2001: Guidance for Industry 13 Feb 2001
Amendment history
Federal Register documents that created or amended this section.
- 81 FR 60222 31 Aug 2016