Compounding: Key Policies and Advocacy
Memorandum of Understanding
Addressing Certain Distributions
of Compounded Drugs
Policy
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FDA extension of period before FDA intends to begin enforcing the statutory 5 percent limit (October 2022)
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FDA's standard MOU [suspended] (October 2020)
GFI #256: Compounding Animal Drugs
from Bulk Drug Substances
Policy
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FDA's FAQs on GFI #256 (March 2023)
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FDA CVM announced delayed enforcement of the GFI to April 2023 (September 2022)
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FDA's Final Guidance for Industry on #256 (August 2022)
Advocacy
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FDA CVM response #2 to NCPA, APC (March 2023)
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FDA CVM response to NCPA, APC (February 2023)
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APC/NCPA letter to FDA CVM requesting clarity on compliance/enforcement (February 2023)
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Delaware Administrative Code Proposal (November 2022)
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APC article #1
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APC article #2
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APC/NCPA joint letter
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Congressional letter to FDA CVM director Dr. Steven Solomon (October 2022)
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NCPA, APC joint letter to the CVM FDA (July 2022)
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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
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FDA Letters
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To Federation of State Medical Boards (November 2022)
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To NABP (November 2022)
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To NABP (September 2022)
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Advocacy
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APC resources
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Webpage on DTE advocacy
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Preliminary briefing document (September 2022)
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Beta-Lactam Compounding
Policy
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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
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2022 Revisions to USP General Chapters to 795 and 797 (November 2022)
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Includes FAQs, Fact Sheets and Revisions
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USP presentation to NCPA Compounding Committee (November 2022)
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Recordings and Slides of USP's Virtual Open Forum Series (November 2022)
Compounded Hormones
Advocacy
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APC's physician sign-on letter Re: Prescribing (July 2022)
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APC's official statement on the NASEM report (July 2020)
MAKENA
Policy
FDA's Final Decision on Withdrawal of MAKENA
FDA published notice (May 2023)
FDA press release (April 2023)
Advocacy
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NCPA's comments (November 2022)
FDA's Listening Session on Compounding (June 2023)
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Statement of Steve Hoffart
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Statement of Cheri Garvin
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NCPA statement for the record
Pharmacy Compounding Advisory
Committee (PCAC) meetings
Policy
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June 2022 meeting
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June 2021 meeting
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PCAC recommended that the FDA keep methylcobalamin on the 503A Bulk List
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Advocacy
Links and Resources
FDA
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FDA Guidances
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Insanitary Conditions at Compounding Facilities (November 2020)
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Section 503A Bulks List Final Rule Questions and Answers (May 2019)
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- Compounding Quality Center of Excellence Training Programs
USP
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General Chapter <795> on Pharmaceutical Compounding of Nonsterile Preparations
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General Chapter <797> on Pharmaceutical Compounding of Sterile Preparations
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General Chapter <800> on Hazardous Drugs, Handling in Healthcare Settings
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eLearning: USP 1160 Pharmaceutical Calculations in Pharmacy Practice
Other
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CompoundingToday.com, a website by the International Journal of Pharmaceutical Compounding