January 13, 2023

Compounding directives included in FDA appropriation

The report that accompanies the FDA appropriation bill recently signed by President Biden includes several compounding directives for the agency. APC and its partners worked with members of Congress to include language expressing Congress’ expectations of the agency on a handful of compounding matters, from animal compounding to compounded hormones. Here’s a snapshot:

  • Pharmacy and 503B outsourcing facility inspections: Within 120 days of enactment, the FDA must submit a report on the average time it takes from inspection to regulatory action or closure letter and analysis on challenges conducting inspections.
  • Access to compounded hormones: Congress urges FDA to engage with compounders to ensure continued access to compounded drugs.
  • Animal drug compounding: FDA is directed to ensure expedited review of animal drugs nominated for compounding of office stock under GFI #256