FDA Guidance for Industry: Fees for Human Drug Compounding Outsourcing Facilities Under Sections 503B and 744K of the FD&C Act
Title:
FDA Guidance for Industry: Fees for Human Drug Compounding Outsourcing Facilities Under Sections 503B and 744K of the FD&C Act
Origin/Publisher:
FDA, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM391102.pdf
Content:
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.