Changes in individual ownership, corporate or partnership structure, location, or blood product handling activity must be submitted electronically through the Blood Establishment Registration and Product Listing system, or any future superseding electronic system, as an amendment to registration within 5 calendar days of such changes. Changes in the names of officers and directors of the corporations do not require such amendment but must be shown at time of annual registration.
21 CFR Part 607 · Establishment Registration and Product Listing for Manufacturers of Human Blood and Blood Products and Licensed Devices
§ 607.26 Amendments to establishment registration
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 § 607.26
- Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture: Final Guidance 1 Dec 2014
- 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.
- 40 FR 52788 12 Nov 1975
- 66 FR 59158 27 Nov 2001
- 81 FR 60222 31 Aug 2016