---
kind: "section"
citation: "21 C.F.R. § 607.21"
title: "21"
number: "607.21"
heading: "Times for establishment registration and blood product listing."
url: "https://uscodex.org/cfr/21/607.21"
---

# §607.21. Times for establishment registration and blood product listing.


The owner or operator of an establishment entering into an operation defined in [§ 607.3(d)](/cfr/21/607.3.md?p=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)](/cfr/21/607.3.md?p=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.


## Notes

### Amendments

[40 FR 52788, Nov. 12, 1975, as amended at 64 FR 56453, Oct. 20, 1999; 81 FR 60222, Aug. 31, 2016]

### Authority

Authority: 21 U.S.C. 321, 331, 351, 352, 355, 360, 371, 374, 381, 393; 42 U.S.C. 262, 264, 271.

### Source

Source: 40 FR 52788, Nov. 12, 1975, unless otherwise noted.

### Amendments

[40 FR 52788, Nov. 12, 1975, as amended at 64 FR 56453, Oct. 20, 1999; 81 FR 60222, Aug. 31, 2016]