21 CFR 207.77
What legal status is conferred by registration and listing?
21 CFR 207.77 is the regulation titled “What legal status is conferred by registration and listing?” 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, 19 FDA warning letters have cited it.
- Letters citing it
- 19 since 2021
- Jan 1 to Oct 30, 2026
- 3 against 4 on the same dates in 2025
- Most often cited with
- 21 CFR 201.128, in 17 letters
- Closed out
- 0% of these letters have a published close-out
Letters citing it, by year issued
Most are drug letters (18 of 19). 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 207.77 most often, as written in the letters.
- 1 letterDAESI Hand Sanitizer is further misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a), because the “FDA” logo is displayed on the product label above the NDC number, which creates the impression that the…
- 1 letterIn addition, DISINFECT™ & SHIELD HAND SANITIZER is misbranded under section 502(a) of the FD&C Act, 21 U.S.C. § 352(a), because your firm’s website misleadingly implies that FDA has endorsed or approved your DISINFECT™…
- 1 letteryour SaniiSwab™ product is also misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a), because your product’s website falsely states that the FDA has approved your product
The regulation
Read the text of 21 CFR 207.77 (eCFR, as of Sep 1, 2026)
(a) Registration of an establishment or listing of a drug does not denote approval of the establishment, the drug, or other drugs of the establishment, nor does it mean that a product may be legally marketed. Any representation that creates an impression of official approval or that a drug is approved or is legally marketable because of registration or listing is misleading and constitutes misbranding.
(b) FDA's acceptance of registration and listing information, inclusion of a drug in our database of drugs, or assignment of an NDC does not denote approval of the establishment or the drug or any other drugs of the establishment, nor does it mean that the drug may be legally marketed. Any representation that creates the impression that a drug is approved or is legally marketable because it appears in our database of drugs, has been assigned or displays an NDC, or the establishment has been assigned an establishment registration number or Unique Facility Identifier is misleading and constitutes misbranding. Failure to comply with § 207.37 may also constitute misbranding.
(c) Neither registration nor listing constitutes a determination by FDA that a product is a drug as defined by section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act. Registration or listing may, however, be evidence that a facility intends to or does manufacture, repack, relabel, distribute, or salvage drugs or that a product is intended to be a drug.
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 207.77.
- 21 CFR 201.128Meaning of “intended uses”17 letters cite both
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures11 letters cite both
- 21 CFR 201.66Format and content requirements for over-the-counter (OTC) drug product labeling9 letters cite both
- 21 CFR 211.22Responsibilities of quality control unit9 letters cite both
- 21 CFR 211.100Written procedures; deviations6 letters cite both
- 21 CFR 211.188Batch production and control records6 letters cite both
- 21 CFR 211.165Testing and release for distribution5 letters cite both
- 21 CFR 211.166Stability testing5 letters cite both
Latest letters citing it
The 3 letters citing 21 CFR 207.77 that FDA posted most recently.
- DrugsView PolleyMed, LLCSaniiSwab nasal cleaning and sanitizing productIssuedMay 14, 2026PostedMay 19, 2026
- DrugsView New Life Pharma LLCSemaglutide Sterile Multi-Dose Vial and Tirzepatide Sterile Multi-Dose VialIssuedApr 14, 2026PostedApr 21, 2026
- DrugsView Chemco CorporationPRO Nail FUNGUS KILLER, SPA REDI Gelle-n-Detox Massage Lotion LAVENDER & ROSEMARY, SPA REDI Gelle-n-Detox Massage Lotion ICY MINT, Eternal…IssuedApr 7, 2026PostedApr 14, 2026
Put this kind of reading to
work on your own records.
Botable builds and runs a custom AI layer around the software you already use, so your team can do the job you hired them for.
Counts include every citation in a letter, as the Letters filter does. How this database is built.