21 CFR 207.57
What information must registrants submit when updating listing information and when?
21 CFR 207.57 is the regulation titled “What information must registrants submit when updating listing information and when?” 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, 27 FDA warning letters have cited it.
- Letters citing it
- 27 since 2021
- Jan 1 to Oct 30, 2026
- 2 against 5 on the same dates in 2025
- Most often cited with
- 21 CFR 207.49, in 14 letters
- Closed out
- 33% 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.
What FDA writes when it cites it
The finding headings that cite 21 CFR 207.57 most often, as written in the letters.
- 1 letterAdditionally, your firm has 61 drug listings that have not been updated or certified as required and therefore have been inactivated by FDA
- 1 letterThe drug listings stated above reference a manufacturing establishment, **(b)(4)**, that has confirmed that it has not been involved in the manufacturing of these drugs for more than five years, yet they continue to be…
The regulation
Read the text of 21 CFR 207.57 (eCFR, as of Sep 1, 2026)
Registrants must review and update listing information at a minimum, as follows:
(a) Registrants must provide listing information at the time of annual establishment registration for any drug manufactured, repacked, relabeled, or salvaged by them for commercial distribution that has not been listed previously.
(b) Registrants must review and update their drug listing information each June and December. When doing so, registrants must:
(1)(i) Provide listing information, in accordance with §§ 207.49, 207.53, and 207.54, for any drug manufactured, repacked, relabeled, or salvaged by them for commercial distribution that has not been previously listed;
(ii) Submit the date that they discontinued the manufacture, repacking, relabeling or salvaging for commercial distribution of a listed drug and provide the expiration date of the last lot manufactured, repacked, relabeled, or salvaged;
(iii) Submit the date that they resumed the manufacture, repacking, or relabeling for commercial distribution of a drug previously discontinued, and provide any required listing information not previously submitted; and
(iv) Submit any material changes in any information previously submitted pursuant to §§ 207.49, 207.53, 207.54, or other relevant sections of this part; or
(2) For each listed drug, certify that no changes subject to reporting under paragraph (b)(1)(iv) of this section have occurred if no such changes have occurred since the last review and update. If a drug is discontinued and FDA has received the information required under paragraph (b)(1)(ii) of this section, no further certifications are necessary for the discontinued drug. After initial electronic listing, registrants may satisfy the listing update requirement with respect to unchanged listing information by making a single “no changes” certification during the annual registration update under § 207.29(b) applicable to all of the registrant's listed drugs for which no changes have been made since the previous annual registration update.
(c) Registrants are encouraged to submit listing information for every drug subject to listing under this part prior to commercial distribution and are encouraged to update listing information at the time of any change affecting information previously submitted.
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 207.57.
- 21 CFR 207.49What listing information must a registrant submit for a drug it manufactures?14 letters cite both
- 21 CFR 211.22Responsibilities of quality control unit10 letters cite both
- 21 CFR 201.128Meaning of “intended uses”9 letters cite both
- 21 CFR 207.33What is the National Drug Code (NDC), how is it assigned, and what are its requirements?8 letters cite both
- 21 CFR 211.100Written procedures; deviations8 letters cite both
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures8 letters cite both
- 21 CFR 207.29What are the requirements for reviewing and updating registration information?7 letters cite both
- 21 CFR 211.165Testing and release for distribution7 letters cite both
Latest letters citing it
The 3 letters citing 21 CFR 207.57 that FDA posted most recently.
- DrugsView Purolea Cosmetics LabHomeopathic drug products and cosmeticsIssuedApr 2, 2026PostedApr 14, 2026
- DrugsView NSE Products, Inc. DBA Nu Skin Enterprises, Inc.AP-24 Fluoride, AP-24, AP-24 WhiteningIssuedMar 2, 2026PostedMar 10, 2026
- DrugsView 3D Imaging Drug Design and Development LLCPET drugs including Fludeoxyglucose F18IssuedDec 4, 2025PostedDec 16, 2025
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Counts include every citation in a letter, as the Letters filter does. How this database is built.