21 CFR 207.41
Who must list drugs and what drugs must they list?
21 CFR 207.41 is the regulation titled “Who must list drugs and what drugs must they list?” 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, 20 FDA warning letters have cited it.
- Letters citing it
- 20 since 2021
- Jan 1 to Oct 30, 2026
- 5 against 1 on the same dates in 2025
- Most often cited with
- 21 CFR 211.22, in 12 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.
What FDA writes when it cites it
The finding headings that cite 21 CFR 207.41 most often, as written in the letters.
- 1 letterA review of FDA’s establishment registration and drug listing database confirms that PurePurgeTM, located at 2630 Homestead Place, Rancho Dominguez, CA 90220, is not registered as a drug manufacturing facility and…
- 1 letterThe drug products “Vision Clarity Eye Drops,” “Life Extension Brite Eyes III,” “Can-C Eye Drops,” and “Longevity Science Visual Ocuity” are not properly listed with FDA
- 1 letteryou are manufacturing a hand sanitizer for U.S. commercial distribution for which you have not registered your establishment and listed your drug product with the FDA
The regulation
Read the text of 21 CFR 207.41 (eCFR, as of Sep 1, 2026)
(a) Each registrant must list each drug that it manufactures, repacks, relabels, or salvages for commercial distribution. Each domestic registrant must list each such drug regardless of whether the drug enters interstate commerce. When operations are conducted at more than one establishment, and common ownership and control exists among all the establishments, the parent, subsidiary, or affiliate company may submit listing information for any drug manufactured, repacked, relabeled, or salvaged at any such establishment. A drug manufactured, repacked, or relabeled for private label distribution must be listed in accordance with paragraph (c) of this section.
(b) Registrants must provide listing information for each drug in accordance with the listing requirements described in §§ 207.49, 207.53, and 207.54 that correspond to the activity or activities they engage in for that drug.
(c)(1) For both animal and human drugs, each registrant must list each drug it manufactures, repacks, or relabels for commercial distribution under the trade name or label of a private label distributor using an NDC that includes such private label distributor's labeler code.
(2) Additionally, in the case of human drugs, each registrant must list each human drug it manufactures, repacks, or relabels using an NDC that includes the registrant's own labeler code, regardless of whether the drug is commercially distributed under the registrant's own label or trade name or under the label or trade name of a private label distributor.
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 207.41.
- 21 CFR 211.22Responsibilities of quality control unit12 letters cite both
- 21 CFR 201.128Meaning of “intended uses”7 letters cite both
- 21 CFR 207.57What information must registrants submit when updating listing information and when?6 letters cite both
- 21 CFR 211.100Written procedures; deviations6 letters cite both
- 21 CFR 211.165Testing and release for distribution6 letters cite both
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures6 letters cite both
- 21 CFR 207.29What are the requirements for reviewing and updating registration information?5 letters cite both
- 21 CFR 207.49What listing information must a registrant submit for a drug it manufactures?5 letters cite both
Latest letters citing it
The 3 letters citing 21 CFR 207.41 that FDA posted most recently.
- DrugsView Suretec Innovations, LLCOTC sanitizing wipes and hand sanitizersIssuedAug 13, 2026PostedAug 18, 2026
- DrugsView Tianjin Kilo Pharmaceutical Sci-tech Co., Ltd.APIs (including demecarium bromide and chlorambucil)IssuedAug 6, 2026PostedAug 18, 2026
- DrugsView Harbin Jixianglong Biotech Co., Ltd.semaglutide and tirzepatide APIsIssuedMay 1, 2026PostedMay 19, 2026
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Counts include every citation in a letter, as the Letters filter does. How this database is built.