ASHP Backs the Guardrails, Not the Shortcut, on Peptide Compounding

Organized pharmacy's response to the federal peptide compounding policy came within a day of its announcement, and it is not a celebration. ASHP says the policy's guardrails match what it asked for, and that relying on enforcement discretion instead of rulemaking is the wrong way to hold them up. [1]

What ASHP said

In an October 29 statement, ASHP urged FDA to enforce the requirements of the new interim enforcement discretion policy on peptide compounding, the HHS policy published in the Federal Register the following day. The policy covers six peptides (BPC-157, epitalon, KPV, MOTS-c, semax and TB-500) compounded by state-licensed pharmacies, federal facilities and licensed physicians. [1][2]

ASHP's statement notes the policy includes guardrails the organization supports and had requested in a recent letter to the agency: a prohibition on using research-grade products, a requirement that bulk substance manufacturers be FDA-registered and CGMP compliant, a prohibition on stacking multiple peptides in one compounded product, and safety tracking and reporting. [1]

Where it pushes back

The support stops at the mechanism. "Relying on enforcement discretion rather than the established rulemaking process is troubling given these products have limited clinical and safety data," said Tom Kraus, ASHP's chief advocacy officer, in the statement. He called it "critical that the agency takes an aggressive approach to enforcement against compounders that fail to comply with all of the interim policy's requirements." [1]

ASHP's statement also underscores what the July advisory committee vote was not: the Pharmacy Compounding Advisory Committee's recommendation to include the six peptides on the 503A bulks list is, in its words, "a preliminary step in the rulemaking process" and "does not represent FDA approval of these peptides." [1]

The formal channels are filling up

ASHP's position lands inside a process that is now formally open. The policy's comment docket, HHS-OASH-2026-0496, began accepting public comments on October 30 and runs through November 13. The Partnership for Safe Medicines has separately filed a citizen petition urging FDA to disregard the advisory committee's July recommendation. Support for the guardrails, opposition to the pathway, and skepticism about enforcement are all now on the record in the same two-week window. [1][2][4]

ASHP is not fighting the guardrails. It is fighting the shortcut around rulemaking, and asking FDA to police the interim policy hard.

What it means for a clinic: The peptide policy now has ASHP on record: guardrails welcomed, discretion distrusted, enforcement demanded. For a clinic, that mix matters practically. If your suppliers touch compounded peptides, the ten conditions are the checklist ASHP wants FDA to enforce aggressively, so they are the checklist your sourcing should already meet. And if you want the durable version of this policy, the rulemaking route ASHP prefers, the comment docket is open through November 13.