21 CFR 607.21
§ 607.21 Times for establishment registration and blood product listing.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 607.21, § 607.21 Times for establishment registration and blood product listing, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/88394
- Permanent ID
ys:prov:88394@1- SHA-256
30f56658615af9d4f570779c982c8db3200f13c9b1f5430f41cb711b80e82770
The hash is SHA-256 of this version's text, with every run of whitespace collapsed to a single space and the ends trimmed. The ID always leads back here, and checking it says whether the text you cited is still the current version.
Full text
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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.