Blueprint Document (In Progress):
- This document outlines key federal statutes and regulations that impose burdens on pharmacy compounding without demonstrable benefit to patient safety. We provide recommendations for administrative action to revise, clarify, or rescind them. Our proposed reforms aim to restore a more balanced regulatory environment—one that supports quality compounding practices while protecting patient access to personalized care.
- In January 2025, APC submitted a letter to then President-elect Trump's transition team urging the new administration to address FDA overreach in regulating pharmacy compounding. The letter highlights the important role of compounding pharmacies in mitigating drug shortages and emphasizes the need to preserve access to essential compounded medications, including bioidentical hormone therapies, by ensuring that FDA regulations align with statutory authority and congressional intent.
- Trump Transition Letter, January 15, 2025
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Drug Shortages and GLP-1s:
- Objection to FDA’s Recent Statement on Compounded GLP-1 Adverse Events, March 19, 2025
- APC Letter regarding the shortage of FDA-approved tirzepatide injection products, December 17, 2024
- APC Comments regarding the ongoing shortage of FDA-Approved semaglutide injection products, Docket No. FDA-2015-N-0030-0001, November 18, 2024
- APC Comments regarding the ongoing shortage of FDA-approved semaglutide injection products, Docket No, FDA-2015-N-0030-0001, November 15, 2024
- Issue Brief: Compounded GLP-1 Drugs and Patient Adverse Events, Looking at the Federal Adverse Event Reporting System and its Limitations, November 2024
- Issue Brief: Five Things You Need to Know About Compounded GLP-1 Drugs, September 2024
- Education for Prescribers, Regulators, or the Media: Compounding 101 and GLP-1 Drugs, June 2024
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Shortage Drug Issues:
- Kaine, Cotton, Spanberger, & Smith Introduce Bipartisan, Bicameral End Drug Shortages Act, November 21, 2024
- Issue Brief: Anticipating and Alleviating Drug Shortages, September 2024
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Demonstrably Difficult to Compound List and Drugmaker Requests:
- Have patients click HERE to send a letter to the FDA urging tirzepatide and semaglutide not be placed on the DDC Lists
- APC-NCPA Comments on Docket No. FDA-2015-N-0030 – Opposition to Novo Nordisk and Eli Lilly’s Requests to Place GLP-1 Medications on the Demonstrably Difficult to Compound List, December 18, 2024
- Response to Citizen Petition on Docket No. FDA-2024-P-5378 filed by Novo Nordisk to add semaglutide to the DDC Lists, December 18, 2024
- Response in opposition to Novo Nordisk’s nomination of semaglutide to the DDC lists on Docket No. FDA-2017-N-2562, November 26, 2024
- Response in opposition to Eli Lilly’s nomination of tirzepatide to the DDC lists on Docket No. FDA-2017-N-2562, November 7, 2024
- Issue Brief: FDA’s Proposed “Demonstrably Difficult to Compound” rule exceeds its authority and puts essential therapies at risk, September 2024
- Response to Docket No. FDA-2023-N-0061, a proposed rule that would add initial categories to the 503A and 503B DDC lists, June 18, 2024
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Threat to Compounded Hormones:
- A 2020 FDA-funded report published by the National Academies of Science, Engineering, and Medicine on the safety and utility of compounded hormones is compromised by potential bias, conflicts of interest and bad science — so says an independent, third-party analysis
- FDA-funded report on compounded hormones is tainted: Synopsis
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503B sourcing to 503As draft guidance:
- FDA’s Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act Guidance for Industry: Draft Guidance
- Comment submitted to Docket No. FDA-2023-D-0939, Regarding the 503B Sourcing Draft Guidance, August 28, 2023
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Statements:
- APC Letter: Objection to FDA’s recent statement on compounded GLP-1 adverse events, March 19, 2025
- Statement regarding the Marketing of Compounded Medications, February 7, 2025
- APC Response to the American Diabetes Association’s Statement on the use of compounded GLP-1 drugs, January 2025
- Statement following warning letters issued to online sellers of illegal peptide products, December 18, 2024
- Understanding laws and regulation governing the compounding of peptide products, December 18, 2024
- APC Letter to FDA Regarding Stability Study Delays at Testing Labs, April 22, 2024
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DEA:
- APC Letter to DEA About Delivery of Controlled Substance Prescriptions Products to Entities Other than the End User or their Agent, September 10, 2024
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Animal Drug Compounding:
- FDA’s Guidance for Industry #256: Compounding Animal Drugs From Bulk Drug Substances
- Issue Brief: FDA’s Center for Veterinary Medicine is tightening the noose on animal drug compounding from bulk substances, September 2024
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Other:
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American Enterprise Institute Panel on Compounded Drugs:
- Compounded GLP-1s and Price: Watch
- How Pharmacies Acquire API: Watch
- How State-Licensed Compounding Pharmacies are Regulated: Watch
- The Essential Role of Compounded Drugs: Watch
- Why Compounded Drugs?: Watch
- Why Compounded Drugs Are Not FDA Approved: Watch
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