The owner or operator of an establishment entering into an operation defined in § 607.3(d) shall register such establishment within 5 days after the beginning of such operation and submit a list of every blood product in commercial distribution at the time. If the owner or operator of the establishment has not previously entered into such operation (defined in § 607.3(d) of this chapter ) for which a license is required, registration shall follow within 5 days after the submission of a biologics license application in order to manufacture blood products. Owners or operators of all establishments so engaged must register annually between October 1 and December 31 and must update their blood product listing every June and December.
21 CFR Part 607 · Establishment Registration and Product Listing for Manufacturers of Human Blood and Blood Products and Licensed Devices
§ 607.21 Times for establishment registration and blood product listing
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 § 607.21
Amendment history
Federal Register documents that created or amended this section.
- 40 FR 52788 12 Nov 1975
- 64 FR 56453 20 Oct 1999
- 81 FR 60222 31 Aug 2016