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

§ 207.25 What information is required for registration?

Subpart B - Registration Official text on eCFR Amendment history

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.

Independent copy, not an official legal edition. 21 CFR is a U.S. Government work in the public domain; this text comes from the eCFR and the annual CFR edition, and may lag recent amendments. The authoritative version is on ecfr.gov. Compliome is not affiliated with or endorsed by FDA. Not legal advice.

Warning letters citing § 207.25

1 FDA warning letters since 2017 cite this section :

FDA guidance that cites § 207.25

Amendment history

Federal Register documents that created or amended this section.