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
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
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)
APC article #1
APC article #2
APC/NCPA joint letter
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
FDA Letters
To Federation of State Medical Boards (November 2022)
To NABP (November 2022)
To NABP (September 2022)
Advocacy
APC resources
Webpage on DTE advocacy
Preliminary briefing document (September 2022)
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
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
USP presentation to NCPA Compounding Committee (November 2022)
Recordings and Slides of USP's Virtual Open Forum Series (November 2022)
Advocacy
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)
FDA Guidances
Policy
- FDA Guidances
Insanitary Conditions at Compounding Facilities (November 2020)
Section 503A Bulks List Final Rule Questions and Answers (May 2019)
Advocacy
NCPA comments to prohibition on wholesaling under 503B (August 2023)
MAKENA
Policy
FDA's Final Decision on Withdrawal of MAKENA
FDA published notice (May 2023)
FDA press release (April 2023)
Advocacy
NCPA's comments (November 2022)
FDA's Listening Session on Compounding (May 2024)
Pharmacy Compounding Advisory Committee (PCAC) meetings
Policy
June 2022 meeting
June 2021 meeting
PCAC recommended that the FDA keep methylcobalamin on the 503A Bulk List
Advocacy
Links and Resources
FDA
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
eLearning: USP 1160 Pharmaceutical Calculations in Pharmacy Practice
PAAS National's compliance program for USP <800>
PCCA's resources for USP <795>, <797> and <800>
NABP's presentation on <795> and <797> (May 2023)
Other
CompoundingToday.com, a website by the International Journal of Pharmaceutical Compounding