Biologics Establishment Registration

Blood Establishments

All owners or operators of establishments that manufacture blood products are required to register with the FDA, pursuant to section 510 of the Federal Food, Drug, and Cosmetic Act, unless they are exempt under 21 CFR 607.65. A list of every blood product manufactured, prepared, or processed for commercial distribution must also be submitted. Products must be registered and listed within 5 days of beginning operation, and annually between November 15 and December 31. Blood product listings must be updated every June and December.

Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps) Establishments

Establishments that manufacture HCT/Ps that are regulated solely under section 361 of the PHS Act and the regulations in part 1270 are required to register and list under 21 CFR Part 1271 in 2001.

Establishment that manufacture HCT/Ps that are: 1) Drug, 2) Medical Devices, 3) Biological Products, 4) Hematopoietic stem cells from peripheral and cord blood, 5) Reproductive cells and tissues; or 6) Human heart valves and human dura mater, are required to register with FDA and list HCT/Ps using the registration and listing procedures in 21 CFR part 1271, subpart B. HCT/P establishments that only manufacture HCT/Ps currently under IND or IDE do not need to register and list their HCT/Ps until the investigational HCT/P is approved through a Biologics License Application (BLA), a New Drug Application (NDA), or a Premarket Approval Application (PMA); or cleared through a Premarket Notification Submission (510(k)).