Title 21 Part 607
discusses establishment registration. Facilities that manufacture blood components must register with the FDA and provide a listing of all blood products that are manufactured. Registration is required annually between November 15 and December 31 and the product listing information must be updated every June and December.
However, Subpart D, section provides this exemption:
"Transfusion services which are a part of a facility that is certified under the Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. 263a) and 42 CFR part 493 or has met equivalent requirements as determined by the Centers for Medicare and Medicaid Services and which are engaged in the compatibility testing and transfusion of blood and blood components, but which neither routinely collect nor process blood and blood components. The collection and processing of blood and blood components in an emergency situation as determined by a responsible person and documented in writing, therapeutic collection of blood or plasma, the preparation of recovered human plasma for further manufacturing use, or preparation of red blood cells for transfusion are not acts requiring such transfusion services to register."