Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution

This information collection supports implementation of requirements related to drug establishment registration and listing governed by section 510 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360), including registrant reporting under section 510(j)(3) of the FD&C Act (21 U.S.C. 360(j)(3)) with respect to listed drugs. Establishment registration information helps FDA identify who is manufacturing, repacking, relabeling, and salvaging drugs and where those operations are performed. Drug listing information gives FDA a current inventory of drugs manufactured, repacked, relabeled, or salvaged for commercial distribution. Data reported by registrants under section 510(j)(3) of the FD&C Act on the amount of listed drugs they annually manufacture, prepare, propagate, compound or process provide FDA with a more comprehensive picture of the drug supply chain, which can inform operational decisions and support the Agency’s efforts to reduce drug shortage risk. This information collection supports agency rulemaking titled “Revising the National Drug Code Format and Drug Label Barcode Requirements.” The rule will standardize the format of National Drug Codes (NDC) assigned under section 510(e) of the FD&C Act (21 U.S.C. 360(e)). This final rule modifies FDA's prescription drug product labeling regulations in 21 CFR parts 201 and 207. We are revising 21 CFR part 207 to establish a uniform, 12-digit format for the NDC (21 CFR 207.33). We are also revising the drug barcode label requirements (21 CFR 201.25) to allow the use of either linear or nonlinear barcodes, so long as the barcode format conforms to certain standards and is recognized by FDA. The rule will require manufacturers, repackers, relabelers, drug product salvagers, and private label distributors of such products to update labels with the new NDC format and require application holders and license holders to report label changes under 21 CFR 314.81, 514.80, or 601.12, respectively.

The latest form for Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution expires 2029-05-31 and can be found here.

Initial establishment registration

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