Letter to FDA RE: Meeting of the Pharmacy Compounding Advisory Committee on Peptides

"We are writing with concern about the recent meeting of the Pharmacy Compounding Advisory Committee (PCAC or Advisory Committee), held on July 23-24, 2026, at which the Advisory Committee, in a series of close votes, chose to recommend six of seven peptides under consideration for inclusion on the 503A bulk drug substance compounding list (503A Bulks List). Not only do those substances pose a risk to public health and safety, but the Advisory Committee’s convening and vote, if followed by a corresponding rulemaking, violates established FDA criteria for listing new substances and is substantively and procedurally defective.

"For years, the Agency has exercised appropriate caution with respect to these seven peptides. In September 2023, based on the available evidence (or lack thereof), the Agency issued an interim restriction placing these substances in Category 2, a designation for “Bulk Drug Substances that Raise Significant Safety Concerns.” This continues to be the view of expert Agency staff, who, in briefing materials made available to PCAC’s members, recommended against the listing of all seven peptides considered."

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