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U.S. Department of Health and Human Services

For Industry

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If I am required to register my drug facility and list my drug product, how do I proceed?

The Food and Drug Administration Amendments Act of 2007 (Public Law 110-85) (FDAAA) require that drug establishment registration and drug listing information be submitted electronically unless a waiver is granted. To facilitate the submission of drug establishment registration and drug listing information (including labeling as specified under 21 Code of Federal Regulations (CFR) 207.25 ), FDA is adopting the use of extensible markup language (XML) files in a standard SPL format. The automated submission process functions most efficiently and effectively when this information is provided in a standardized format with defined code sets and codes. Our Guidance for Industry: Providing Regulatory Submissions in Electronic Format - Drug Establishment Registration and Drug Listing (PDF - 123KB) and accompanying technical documents describe how to make these submissions using the SPL format, which FDA can process, review, and archive.

Currently, all drug establishments, foreign and domestic, must register their establishments and list all of their drug products in commercial distribution in the United States. 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 Code of Federal Regulations (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.

In addition, foreign establishments whose products are imported or offered for import into the United States are required to identify a United States agent (only one) during the registration process. The United States agent must be physically located in the United States and will be the point of contact between the FDA and the firm concerning site registration and drug product listings. 21 CFR 207.40 describes drug listing requirements for foreign establishments.

Registrants are also required to submit registration information for their establishments on or before December 31 of each year. At the time of registration, registrants must also submit required listing information. Additionally, registrants are required to update listing information in June and December of each year to include information for drugs that have not been previously listed. Certain changes to information for previously listed drugs must also be submitted every June and December.

Relevant Resources:

Drug Registration and Listing

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