StacksVerified U.S. regulatory reference

21 CFR §207.25

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov
Registrants must provide the following information:
  1. (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;
  2. (b)Each establishment's name, physical address, and telephone number(s);
  3. (c)All name(s) of the establishment, including names under which the establishment conducts business or names by which the establishment is known;
  4. (d)Registration number of each establishment, if previously assigned by FDA;
  5. (e)A Unique Facility Identifier in accordance with the system specified under section 510 of the Federal Food, Drug, and Cosmetic Act.
  6. (f)All types of operations performed at each establishment;
  7. (g)Name, mailing address, telephone number, and email address of the official contact for the establishment, as provided in § 207.69(a); and
  8. (h)Additionally, with respect to foreign establishments subject to registration, the name, mailing address, telephone number, and email address must be provided for:
    1. (1)The United States agent, as provided in § 207.69(b);
    2. (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. (3)Each person who imports or offers for import such drug to the United States.