21 CFR 207.29
What are the requirements for reviewing and updating registration information?
21 CFR 207.29 is the regulation titled “What are the requirements for reviewing and updating registration information?” in 21 CFR Part 207, Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs, and the National Drug Code. Since 2021, 9 FDA warning letters have cited it.
- Letters citing it
- 9 since 2021
- Jan 1 to Oct 30, 2026
- 2 against 0 on the same dates in 2025
- Most often cited with
- 21 CFR 207.57, in 7 letters
- Closed out
- 0% of these letters have a published close-out
Letters citing it, by year issued
All are drug letters. 2026 runs to Oct 30, 2026. Pick a year to see its letters.
The regulation
Read the text of 21 CFR 207.29 (eCFR, as of Sep 1, 2026)
(a) Expedited updates. Registrants must update their registration information no later than 30 calendar days after:
(1) Closing or selling an establishment;
(2) Changing an establishment's name or physical address; or
(3) Changing the name, mailing address, telephone number, or email address of the official contact or the United States agent. A registrant, official contact, or United States agent may notify FDA about a change of information for the designated official contact or United States agent, but only a registrant is permitted to designate a new official contact or United States agent.
(b) Annual review and update of registration information. Registrants must review and update all registration information required under § 207.25 for each establishment.
(1) The first review and update must occur during the period beginning on October 1 and ending December 31 of the year of initial registration, if the initial registration occurs prior to October 1. Subsequent reviews and updates must occur annually, during the period beginning on October 1 and ending December 31 of each calendar year.
(2) The updates must reflect all changes that have occurred since the last annual review and update.
(3) If no changes have occurred since the last registration, registrants must certify that no changes have occurred.
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 207.29.
- 21 CFR 207.57What information must registrants submit when updating listing information and when?7 letters cite both
- 21 CFR 211.22Responsibilities of quality control unit7 letters cite both
- 21 CFR 201.128Meaning of “intended uses”6 letters cite both
- 21 CFR 207.41Who must list drugs and what drugs must they list?5 letters cite both
- 21 CFR 211.100Written procedures; deviations5 letters cite both
- 21 CFR 211.165Testing and release for distribution5 letters cite both
- 21 CFR 207.17Who must register?4 letters cite both
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures4 letters cite both
Latest letters citing it
The 3 letters citing 21 CFR 207.29 that FDA posted most recently.
- DrugsView Harbin Jixianglong Biotech Co., Ltd.semaglutide and tirzepatide APIsIssuedMay 1, 2026PostedMay 19, 2026
- DrugsView Purolea Cosmetics LabHomeopathic drug products and cosmeticsIssuedApr 2, 2026PostedApr 14, 2026
- DrugsView Dr. Brite, LLCDr. Brite, LLCIssuedNov 21, 2024PostedDec 10, 2024
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