Drugs

Compounding

For further information on Compounding see: Regulatory Policy Information

Below is a sortable listing of Compounding Guidances

CategoryTitleTypeDate
Compounding/User Fees Fees for Human Drug Compounding Outsourcing Facilities Under Sections 503B and 744K of the FD&C Act (PDF - 119KB) Final Guidance 08/03/15
Compounding/Procedural Guidance For Entities Considering Whether to Register As Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act (PDF - 74KB) Final Guidance 08/11/15
Compounding/Pharmaceutical Quality/Manufacturing Standards (CGMP) Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities (PDF - 646KB) Final Guidance 01/12/17
Compounding/Pharmaceutical Quality/Manufacturing Standards (CGMP) Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application (PDF - 969KB) Draft Guidance, Revised 01/12/17
Compounding/Drug Safety Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act (PDF - 138KB) Final Guidance 10/07/15
Compounding/Procedural Registration for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act (PDF - 71KB) Final Guidance 11/21/14
Compounding/Procedural Electronic Drug Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act.” (PDF - 191KB) Final 12/30/16
Compounding/Pharmaceutical Quality/Manufacturing Standards (CGMP) Current Good Manufacturing Practice — Interim Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act (PDF - 223KB) Draft Guidance 07/01/14
Compounding; Procedural Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance (PDF - 85KB) Final Guidance 06/09/16
Compounding; Procedural Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry (PDF - 134KB) Revised Final Guidance 01/13/17
Compounding; Procedural Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act (PDF - 112KB) Revised Final Guidance 01/13/17
Compounding Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry (PDF - 349KB) Final Guidance 12/28/16
Compounding Hospital and Health System Compounding Under the Federal Food, Drug, and Cosmetic Act Guidance for Industry (PDF - 81KB) Draft Guidance 04/15/16
Compounding Facility Definition Under Section 503B of the Federal Food, Drug, and Cosmetic Act (PDF - 244KB) Draft Guidance 04/15/16
Compounding Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act Guidance for Industry (PDF - 348KB) Draft Guidance 07/07/16
Compounding Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry (PDF - 108KB) Draft Guidance 07/07/16
Compounding Insanitary Conditions at Compounding Facilities Guidance for Industry (PDF - 95KB) Draft Guidance 08/03/16
Compounding Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies and Federal Facilities Guidance for Industry (PDF - 107KB) Draft Guidance 12/28/16
Compounding Compounding and Repackaging of Radiopharmaceuticals By Outsourcing Facilities Guidance for Industry (PDF - 122KB) Draft Guidance 12/28/16

Page Last Updated: 01/13/2017
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