21 CFR § 607.21 - Times for establishment registration and blood product listing.

---
identifier: "/us/cfr/t21/s607.21"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 607.21 - Times for establishment registration and blood product listing."
title_number: 21
title_name: "Food and Drugs"
section_number: "607.21"
section_name: "Times for establishment registration and blood product listing."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "F"
subchapter_name: "BIOLOGICS"
part_number: "607"
part_name: "ESTABLISHMENT REGISTRATION AND PRODUCT LISTING FOR MANUFACTURERS OF HUMAN BLOOD AND BLOOD PRODUCTS AND LICENSED DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 321, 331, 351, 352, 355, 360, 371, 374, 381, 393; 42 U.S.C. 262, 264, 271."
regulatory_source: "40 FR 52788, Nov. 12, 1975, unless otherwise noted."
cfr_part: "607"
---


# 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) 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.

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