21 CFR § 207.25 - What information is required for registration?

---
identifier: "/us/cfr/t21/s207.25"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 207.25 - What information is required for registration?"
title_number: 21
title_name: "Food and Drugs"
section_number: "207.25"
section_name: "What information is required for registration?"
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "C"
subchapter_name: "DRUGS: GENERAL"
part_number: "207"
part_name: "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"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 321, 331, 351, 352, 355, 360, 360b, 371, 374, 381, 393; 42 U.S.C. 262, 264, 271."
regulatory_source: "81 FR 60212, Aug. 31, 2016, unless otherwise noted."
cfr_part: "207"
---


# 207.25 What information is required for registration?

Registrants must provide the following information:

(a) Name of the owner or operator of each establishment; if a partnership, the name of each partner; if a corporation, the name of each corporate officer and director, and the place of incorporation;

(b) Each establishment's name, physical address, and telephone number(s);

(c) All name(s) of the establishment, including names under which the establishment conducts business or names by which the establishment is known;

(d) Registration number of each establishment, if previously assigned by FDA;

(e) A Unique Facility Identifier in accordance with the system specified under section 510 of the Federal Food, Drug, and Cosmetic Act.

(f) All types of operations performed at each establishment;

(g) Name, mailing address, telephone number, and email address of the official contact for the establishment, as provided in § 207.69(a); and

(h) Additionally, with respect to foreign establishments subject to registration, the name, mailing address, telephone number, and email address must be provided for:

(1) The United States agent, as provided in § 207.69(b);

(2) Each importer in the United States of drugs manufactured, repacked, relabeled, or salvaged at the establishment that is known to the establishment; and

(3) Each person who imports or offers for import such drug to the United States.