Difficult to Compound Lists and Categories

Advocacy

• NCPA comments to FDA (June 2024)

GFI #256: Compounding Animal Drugs from Bulk Drug Substances

Policy

• FDA's FAQs on GFI #256 (March 2023)

• FDA CVM announced delayed enforcement of the GFI to April 2023 (September 2022)

• FDA's Final Guidance for Industry on #256 (August 2022)

Advocacy

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

• 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)

USP

Policy

• USP presentation to NCPA Compounding Committee (November 2023)

• 2022 Revisions to USP General Chapters to 795 and 797 (November 2022)

  • Includes FAQs, Fact Sheets and Revisions

Advocacy

• NCPA comments to the types of USP’s expert committees (May 2024 )

• NCPA/APC joint letters to state boards of pharmacy and FDA on delays in stability studies under USP Chapter 797 (April 2024)

Compounded Hormones

Advocacy

• APC's physician sign-on letter Re: Prescribing (July 2022)

• APC's official statement on the NASEM report (July 2020)

Compounding in the States

• NCPA endorsement of Arkansas HB 1801 that would allow pharmacies to purchase compounded drugs from outsourcing facilities (March 2025)

• NCPA endorsement of New York S. 3236/A.678 allowing pharmacy technicians to compound (March 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)

FDA Guidances

Policy

• FDA Guidances

  • Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act (January 2025)

  • Insanitary Conditions at Compounding Facilities (November 2020)

  • Section 503A Bulks List Final Rule Questions and Answers (May 2019)

  • Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry (January 2018)

Advocacy

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

FDA's Listening Session on Compounding (May 2024)

• NCPA statement for the record

Links and Resources

FDA

• Human Drug Compounding

• Compounding Risk Alerts | FDA

• Compounding Laws and Policies

• Compounding and the FDA: Questions and Answers

• Compounding Quality Center of Excellence Training Programs

  • Virtual, Instructor-Led Trainings

  • Self-Guided Online Trainings

USP

• General Chapter <795> on Pharmaceutical Compounding of Nonsterile Preparations

• General Chapter <797> on Pharmaceutical Compounding of Sterile Preparations

• General Chapter <800> on Hazardous Drugs, Handling in Healthcare Settings

  • USP 800: What you need to know for Community and LTC Pharmacy

• eLearning: USP 1160 Pharmaceutical Calculations in Pharmacy Practice

• PAAS National's compliance program for USP <800>

• PRS' compliance programs for USP <795> and <800>

• PCCA's resources for USP <795>, <797> and <800>

• NABP's presentation on <795> and <797> (May 2023)

Other

• Professional Compounding Centers of America (PCCA)

• Alliance for Pharmacy Compounding (APC)

  • Pharmacy Compounding: A Blueprint for Eliminating Redundant, Unauthorized, or Ineffective Regulation that Impedes Patient Access to Compounded Drugs (May 2025)

  • Best Practices for Preparing and Dispensing Compounded Ketamine by Pharmacies (April 2024)

  • Recommended Best Practices for Clinic Direct Billing (Office Pay) for Patient-Specific Compounded Medications by Compounding Pharmacies (April 2024)

  • BRIEFING: Constructive Transfer and Compounding Controlled Substance Medications (April 2024)

  • Statement on Compounding Peptide Products (March 2024)

• Pharmacy Compounding Accreditation Board

• CompoundingToday.com, a website by the International Journal of Pharmaceutical Compounding

• National Institute for Occupational Safety and Health (NIOSH) List of Antineoplastic and Other Hazardous Drugs