OMB control number
Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution
OMB 0910-0045 · HHS/FDA.
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.
The latest form for Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution expires 2028-07-31 and can be found here.
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Initial establishment registration Initial establishment registration
Federal Enterprise Architecture: Health - Consumer Health and Safety