The following guideline can be ordered through the address listed in the "Source/Publisher"-category. In cases in which you can order through the Internet we have established a hyperlink.

FDA Guidance for Industry: Fees for Human Drug Compounding Outsourcing Facilities Under Sections 503B and 744K of the FD&C Act



This guidance is intended for entities that compound human drugs and elect to register as outsourcing facilities under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act), which was added by the Drug Quality and Security Act (DQSA). Once an entity has elected to register as an outsourcing facility, it must pay certain fees to be registered as an outsourcing facility.

Go back

GMP Conferences by Topics