Compounding: Key Policies and Advocacy

Compounding: Key Policies and Advocacy

Difficult to Compound Lists and Categories

Advocacy

  • NCPA comments to HHS calling for FDA to eliminate the proposed rule on demonstrably difficult to compound lists and categories (July 2025)

GFI #256: Compounding Animal Drugs
from Bulk Drug Substances

Policy

Advocacy

  • NCPA comments to HHS calling for the rescission of GFI #256 (July 2025)
  • NCPA comments to FDA calling for the rescission of GFI #256 (June 2025)

USP

Policy

Compounded Hormones

Advocacy

  • NCPA/APC joint letter to FDA on benefits of testosterone replacement therapy in men with hypogonadism (February 2026)
  • NCPA/APC joint letter to FDA on benefits of menopause hormone therapy (September 2025)

Compounding in Congress

  • NCPA/APC joint letter opposing the SAFE Drug Act (H.R. 6509/S. 3794), and sponsoring the Drug Shortage Compounding Patient Access Act (H.R. 5316) (April 2026)

Compounding in the States

  • NCPA/APC/APhA/OPA joint letter to Ohio Medicaid re: medical necessity policy and application to compounded medications (May 2026)
  • NCPA/APC joint letter to Illinois Board of Pharmacy requesting enforcement discretion for nonresident pharmacies to designate an Illinois-licensed Pharmacist-in-Charge (November 2025)
  • NCPA/APC joint letter to California Board of Pharmacy requesting to amend proposed language on central fill pharmacies (November 2025)

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)

Advocacy

  • NCPA/APC comments to FDA on the information collection burden regarding the MOU (January 2026)
  • NCPA comments to HHS calling for the indefinite suspension of the MOU (July 2025)

FDA's Listening Session on Compounding

FDA Guidances

Policy

Links and Resources

FDA

USP

Other