High Importance!! FDA Interim Policy for Using Bulk Drug Substances under 503A, 503B, and Compounding of Human Drug Products under 503A

Guidance for Industry:

• Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act
  Guidance for Industry (PDF - 126KB)
• Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act
  Guidance for Industry (PDF - 105KB)
• Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance (PDF - 87KB)