Compounding: Key Policies and Advocacy

Memorandum of Understanding
Addressing Certain Distributions
of Compounded Drugs

Policy

  • 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

Policy

Advocacy

  • 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

Policy

Advocacy

Beta-Lactam Compounding

Policy

  • FDA Guidance: Compounding Certain Beta-Lactam Products in Shortage Under Section 503A of the Federal Food Drug and Cosmetic Act (November 2022)

USP Compounding Chapters <795> and <797>

Policy

Compounded Hormones

Advocacy

FDA Guidances

Policy

Advocacy

  • NCPA comments to prohibition on wholesaling under 503B (August 2023)

MAKENA

Policy

  • FDA's Final Decision on Withdrawal of MAKENA

Advocacy

FDA's Listening Session on Compounding (June 2023)

Pharmacy Compounding Advisory
Committee (PCAC) meetings

Policy

  • June 2022 meeting

    • PCAC recommended that glutathione be added to 503A Bulks List

    • PCAC meeting recording

    • PCAC meeting details

  • June 2021 meeting

    • PCAC recommended that the FDA keep methylcobalamin on the 503A Bulk List

Advocacy

Links and Resources

FDA

USP

Other