What does “listing under section 510 of the FD&C Act” mean?
For user fee assessments, this applies only to FY 2002 and before: Section 510 of the FD&C Act requires manufacturers, repackers, and relabelers that engage in the manufacture, preparation, propagation, compounding or processing of human or veterinary products to register their establishments and submit a list of every product in commercial distribution with the FDA. Additional information on drug registration and listing can be found at http://www.fda.gov/cder/drls/registration_listing.
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