FDA issues draft guidances on compounding and repackaging

FDA has issued five draft documents on drug compounding and repackaging that are applicable to pharmacies, outsourcing facilities, and physicians.

“The draft guidance documents provide information to pharmacies, outsourcing facilities, healthcare entities, and others about these FDA-proposed policies, which are critical to protecting the public health,” said Janet Woodcock, MD, director of FDA’s Center for Drug Evaluation and Research.

New regs give FDA broader powers over compounding

The five drafts concern policies related to FDA oversight of drugs produced by state-licensed pharmacies, federal facilities, and outsourcing facilities. 

They are available for public comment for 90 days. Click here to read the draft documents listed below:

· Draft Guidance: For Entities Considering Whether to Register As Outsourcing Facilities under Section 503B of the Federal Food, Drug, and Cosmetic Act


· Draft Guidance for Industry: Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities    

· Draft Guidance for Industry: Adverse Event Reporting for Outsourcing Facilities under Section 503B of the Federal Food, Drug, and Cosmetic Act


· Draft Memorandum of Understanding Between A State and the U.S. Food and Drug Administration Addressing Certain Distributions of Compounded Human Drug Products


· Draft Guidance for Industry: Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application (BLA)