Compounding: Key Policies and Advocacy

Memorandum of Understanding Addressing Certain Distributions of Compounded Drugs


  • FDA extension of period before FDA intends to begin enforcing the statutory 5 percent limit (October 2022)

  • FDA's standard MOU [suspended] (October 2020)

GFI #256: Compounding Animal Drugs from Bulk Drug Substances



  • FDA CVM response #2 to NCPA, APC (March 2023)

  • FDA CVM response to NCPA, APC (February 2023)

  • APC/NCPA letter to FDA CVM requesting clarity on compliance/enforcement (February 2023)

  • Delaware Administrative Code Proposal (November 2022)

  • Congressional letter to FDA CVM director Dr. Steven Solomon (October 2022)

  • NCPA, APC joint letter to the CVM FDA (July 2022)

  • NCPA, APC, the American College of Veterinary Pharmacists, the American Pharmacists Association, and the Society of Veterinary Hospital Pharmacists shorter letter (July 2022)

Desiccated Thyroid Extract (DTE) Compounding Issue