2021-08-23
1. Who must register, when, and how?
The owner or operator of an establishment entering into the manufacture, preparation,
propagation, compounding, or processing (which includes, among other things, repackaging and relabeling) of a drug or drugs and not exempt under section 510(g) of the Act or subpart B of 21 CFR part 207, must register the establishment with FDA within 5 days after beginning the operation (21 CFR 207.21(a) and 21 CFR 207.3(a)(8)). Alternatively, if the establishment has not previously entered into such an operation, the owner or operator must register within 5 days after submitting (among other things) a drug application, biological license application, or medicated feed mill license application. (21 CFR 207.21(a)). Owners or operators must renew
their registration information annually (Section 510(b)(1) of the Act; 21 CFR 207.21(a)).
Establishments within any foreign country that engage in the manufacture, preparation, propagation, compounding, or processing (which includes, among other things, repackaging and relabeling) of a drug that is imported or offered for import into the United States (and that are not exempt) must upon first engaging in such activity immediately register and register annually thereafter (Section 510(i) of the Act; 21 CFR 207.40).
Amendments to drug establishment registration must be submitted in accordance with 21 CFR 207.26.
Section 510(p) of the Act, as amended by FDAAA, now requires drug establishment
registrations to be submitted electronically unless a waiver is granted. Therefore, registration information should now be submitted electronically using SPL files with coded data fields.
Failure to register in accordance with section 510 of the Act is a prohibited act under section 301(p) of the Act. Also, under section 502(o) of the Act, a drug is misbranded if it is manufactured in an establishment in any State not duly registered under section 510 of the Act.
2. What information is submitted for drug establishment registration?
Section 510 of the Act and 21 CFR Part 207 set forth registration information required to be submitted by domestic and foreign drug establishments. (See sections 510(b), (c), (d), and (i) of the Act and 21 CFR 207.25(a), 21 CFR 207.26, and 21 CFR 207.40). Under these provisions, all registrants must provide the name and full address of each establishment, all trade names used by the establishment, the kind of ownership or operation (e.g., individually owned, partnership, or corporation), and the name of the owner or operator (including in the case of a partnership the name of each partner, and in the case of a corporation, the name and title of each corporate officer and director and the State of incorporation).
In addition to the information required for all registered establishments, certain additional information must be provided to register a foreign establishment. For example, a foreign registrant must submit:
1) the name, address, and phone number of the foreign registrant’s United States agent
(Section 510(i)(1)(A) of the Act and 21 CFR 207.40) c));
2) the name of each importer that is known to the establishment (Section 510(i)(1)(A) of the Act). (This means each U.S. company or individual in the United States that is an owner, consignee, or recipient of the foreign establishment’s drug that is imported into the United States. An importer does not include the consumer or patient who ultimately purchases, receives, or is administered the drug, unless the foreign establishment ships the drug directly to the consumer or patient.); and
3) the name of each person who imports or offers for import such drug (Section 510(i)(1)(A) of the Act). (This means the name of each agent, broker, or other entity, other than a carrier, that the foreign drug establishment uses to facilitate the import of their drug into the United States).
To facilitate correspondence between registrants and FDA, foreign registrants should submit the email address for the U.S. agent, and the telephone number(s) and email address for the importer and person who imports or offers for import described in section III.A.2 of this document.
Historically, registrants have also included additional drug establishment registration information when making submissions, using Form FDA 2656. Likewise, for electronic submission, registrants should submit the following additional information in their SPL file:
1) Official contact’s name, mailing address, telephone number(s), and email address; and
2) The type of operation(s) performed at each establishment.
Under section 510(e) of the Act, FDA may assign a registration number to any person or registered establishment. FDA intends to use the Data Universal Numbering System (D-U-NS®) as the registration number for the electronic system. Therefore, to facilitate and expedite processing of the SPL file, the registrant should submit their D-U-N-S® Number with the registration information. If the business entity does not submit a D-U-N-S® Number with its submission, FDA intends to make arrangements for obtaining a D-U-N-S® Number for that entity. An explanation of the D-U-N-S® Number and how to obtain one is described in section IV.B of this document.
