FDA issues guidance regarding fees for drug compounding outsourcing facilities.
FDA issued guidance on Aug. 2, 2015 for drug-compounding companies who register as outsourcing facilities under section 503B of the Federal Food, Drug, and Cosmetic Act. Companies that register as a drug-compounding outsourcing facility are required to pay fees to the agency.
The FDA guidance details the type and amount of the fees as well as adjustments to fees required by law. The guidance also details how outsourcing facilities can submit payment to FDA and the consequences of outsourcing facilities’ failure to pay fees. FDA also discusses how an outsourcing facility can qualify as a small business to obtain a reduction in fees.
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Separate guidance documents describe FDA’s requirements for registration and reporting for outsourcing facilities.
