Regulatory Policy Information--the FDA Put The Compounding Regulatory Information for Human Compounds on One Page

 

Guidance for Industry: Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act (PDF - 91KB)¹ (Draft Guidance)

• Guidance for Industry: Registration for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act (PDF - 60KB)² (Draft Guidance)
• Guidance for Industry: Interim Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act (PDF - 107KB)³ (Draft Guidance)
• List of Bulk Drug Substances That May Be Used in Pharmacy Compounding; Bulk Drug Substances That May Be Used to Compound Drug Products in Accordance With Section 503A of the Federal Food, Drug, and Cosmetic Act; Request for Nominations⁴
• Bulk Drug Substances That May Be Used to Compound Drug Products in Accordance With Section 503B of the Federal Food, Drug, and Cosmetic Act Concerning Outsourcing Facilities; Request for Nominations⁵
• Drug Products That Present Demonstrable Difficulties for Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act; Request for Nominations⁶
• List of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness: Final Rule⁷  (PDF - 32KB⁸) (3/9/1999)

quoted from FDA page found here

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