21 CFR 207.17
Who must register?
21 CFR 207.17 is the regulation titled “Who must register?” 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, 14 FDA warning letters have cited it.
- Letters citing it
- 14 since 2021
- Jan 1 to Oct 30, 2026
- 2 against 0 on the same dates in 2025
- Most often cited with
- 21 CFR 211.22, in 10 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 207.17 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…
The regulation
Read the text of 21 CFR 207.17 (eCFR, as of Sep 1, 2026)
(a) Unless exempt under section 510(g) of the Federal Food, Drug, and Cosmetic Act or this part, all manufacturers, repackers, relabelers, and salvagers must register each domestic establishment that manufactures, repacks, relabels, or salvages a drug, or an animal feed bearing or containing a new animal drug, and each foreign establishment that manufactures, repacks, relabels, or salvages a drug, or an animal feed bearing or containing a new animal drug, that is imported or offered for import into the United States. When operations are conducted at more than one establishment and common ownership and control among all the establishments exists, the parent, subsidiary, or affiliate company may submit registration information for all establishments.
(b) Private label distributors who do not also manufacture, repack, relabel, or salvage drugs are not required to register under this part. FDA will accept registration or listing information submitted by a private label distributor only if it is acting as an authorized agent for and submitting information that pertains to an establishment that manufactures, repacks, relabels, or salvages drugs.
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 207.17.
- 21 CFR 211.22Responsibilities of quality control unit10 letters cite both
- 21 CFR 211.100Written procedures; deviations7 letters cite both
- 21 CFR 211.165Testing and release for distribution7 letters cite both
- 21 CFR 201.128Meaning of “intended uses”5 letters cite both
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures5 letters cite both
- 21 CFR 201.66Format and content requirements for over-the-counter (OTC) drug product labeling4 letters cite both
- 21 CFR 207.29What are the requirements for reviewing and updating registration information?4 letters cite both
- 21 CFR 207.41Who must list drugs and what drugs must they list?4 letters cite both
Latest letters citing it
The 3 letters citing 21 CFR 207.17 that FDA posted most recently.
- DrugsView Babikian Healthcare Products CJSCOver-the-counter (OTC) drug productsIssuedSep 21, 2026PostedSep 29, 2026
- DrugsView BioMylz Pvt. Ltd.Soraresal Cream, NDC 73526-002, and Equate Medicated Vaporizing Steam Liquid, NDC 73559-011IssuedJul 13, 2026PostedJul 21, 2026
- DrugsView Dr. Brite, LLCDr. Brite, LLCIssuedNov 21, 2024PostedDec 10, 2024
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Counts include every citation in a letter, as the Letters filter does. How this database is built.