WASHINGTON — The Food and Drug Administration's Pharmacy Compounding Advisory Committee voted 9-4 Thursday to recommend adding 20 peptide substances to the agency's permitted compounding list, opening a lucrative market for compounding pharmacies that allows them to custom-mix these compounds for patients without the approval process required for new drugs.
The vote followed an aggressive lobbying campaign by the compounding pharmacy industry and wellness groups. The Alliance for Pharmacy Compounding spent over $1.5 million in the past year pushing for expanded access to compounded substances, according to federal disclosure filings. APC President Scott Welles met with committee members and FDA officials six times in the last three months.
Internal FDA scientists had strongly opposed the inclusion of many peptides, citing a lack of long-term safety data and manufacturing quality concerns. A memo from the agency's Office of New Drugs, obtained by this publication, detailed specific risks associated with unregulated production of peptides like sermorelin and ipamorelin, often used for anti-aging and athletic performance.
The decision is a win for companies like Peptide Sciences and Core Peptides, which supply raw materials to compounding pharmacies and stand to see increased demand as pharmacies expand their offerings. Small and mid-sized compounding pharmacies, which often operate on thin margins, gain a new revenue stream from high-demand wellness treatments.
The committee's recommendation now goes to FDA Commissioner Robert Califf, who holds final authority on whether to formalize the list additions. Califf has 90 days to issue a ruling.
Traditional drug manufacturers, who invest hundreds of millions in clinical trials and FDA approval, view the expansion of compounding lists with skepticism. They argue it creates an uneven playing field, allowing compounded substances to enter the market with less stringent oversight and undercutting the established pharmaceutical development model.
Patient safety advocates warn that without robust oversight, quality control for compounded peptides could vary widely. Unlike FDA-approved drugs, compounded medications are not subject to the same rigorous testing for purity, potency and sterile manufacturing — raising the risk of adverse reactions or ineffective treatments.
