Establishment registration and product listing of blood banks and other firms manufacturing human blood and blood products.
(a) 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 shall comply with this part. Registration does not permit any blood bank or similar establishment to ship blood products in interstate commerce.
(b) Forms for registration of an establishment are obtainable on request from the Center for Biologics Evaluation and Research (HFM-375) (see mailing addresses in § 600.2 of this chapter ), or at any of the Food and Drug Administration district offices.
(c) The completed form should be mailed to the Center for Biologics Evaluation and Research (HFM-375) (see mailing addresses in § 600.2 of this chapter ).
[40 FR 52788, Nov. 12, 1975, as amended at 49 FR 23833, June 8, 1984; 55 FR 11014, Mar. 26, 1990; 66 FR 59158, Nov. 27, 2001; 70 FR 14984, Mar. 24, 2005]
Title 21 published on 2012-04-01
no entries appear in the Federal Register after this date.
This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.