Why ASHP and safety groups challenge the HHS peptide policy

The American Society of Health-System Pharmacists welcomed several safeguards in the HHS peptide compounding policy but still questioned whether its enforcement approach would protect patients. Its October 29 response brings the disagreement into focus: controls on ingredients and reporting address real risks, while questions about clinical evidence and enforcement remain.[1]

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Reported analysis of October 2026 policy documents and public statements. No clinical outcome or FDA approval is implied by the interim policy.

The petition came before the policy

The opposition began before the interim policy became public. In an October 26 announcement, the Partnership for Safe Medicines said it had filed a citizen petition on October 16 asking FDA to prevent an expansion of peptide compounding.[2] The linked petition is dated October 23 and says it was resubmitted to correct a signature-block problem. Those dates describe the announced filing and the corrected document, respectively.[3]

PSM challenged both the proposed expansion and the advisory process behind it, including alleged conflicts on the Pharmacy Compounding Advisory Committee. These are the petitioner’s arguments, not findings that a court or FDA has adopted. The distinction matters: a request to halt a policy is evidence of opposition, not proof that the policy is unlawful.[3]

Two October 26 letters asked for different responses

ASHP’s October 26 letter to acting FDA administrator Kyle Diamantas called for strict review of safety and efficacy before substances are added to the 503A bulks list. It also sought more surveillance, action against research-grade ingredients marketed for human use, and a “green list” of trusted ingredient suppliers. Jillanne Schulte Wall signed for the professional society, which said it represented more than 65,000 pharmacists, student pharmacists and pharmacy technicians.[4]

The Alliance for Safe Biologic Medicines took a more explicit pause position. Its separate October 26 letter renewed an October 15 request to hold the expansion until scientific objections and oversight gaps were addressed. It called for an independent review of advisory conflicts and stronger reporting, traceability and enforcement. The signatories were ASBM executive director Michael Reilly and Philip J. Schneider, identified as a past ASHP president. This was an ASBM letter, not a joint statement from the two organizations.[5]

ASBM’s central objection was that correctly labelled products and inspected factories cannot, by themselves, establish whether an experimental drug is safe or effective. That argument concerns the evidence needed before widening access, beyond the ability to identify what a pharmacy receives.[5]

After release, ASHP acknowledged safeguards

ASHP’s October 29 statement credited four features: excluding research-grade products, requiring the bulk manufacturer to register with FDA and comply with current good manufacturing practice, limiting each compounded product to a single active ingredient, and tracking and reporting safety problems. It nevertheless questioned whether enforcement would protect consumers. Chief advocacy officer Tom Kraus also objected to relying on enforcement discretion while clinical and safety data remained limited.[1]

The Federal Register notice was filed on October 28 and published on October 30. It announced availability of the draft policy and contemplated later rulemaking on the bulks list. It was not a final rule adding the substances to that list. The pre-release letters and post-release response therefore address different stages of the same dispute.[7] Our existing policy explainer covers the full conditions.

What the safeguards address and leave unresolved

HHS describes its approach as a more controlled alternative to research-use-only supply. Its conditions target sourcing: the original bulk manufacturer must be FDA-registered and comply with current good manufacturing practice. A valid certificate of analysis must characterize the substance, including identity, purity and potency, with checks for harmful contaminants.[6] These requirements speak directly to the ingredient concerns ASHP raised.[4]

Safety reporting addresses a different problem. The policy calls for serious adverse events and product-quality issues to be reported to FDA and relevant states, including serious events not considered drug-related. Its single-active-ingredient condition is intended to make outcomes easier to attribute.[6] Those provisions create a way to detect emerging problems; ASHP’s remaining concern is whether the enforcement approach will work.[1]

The comparison exposes two separate tests for the policy: whether its safeguards are followed, and whether the evidence justifies expanded access. ASBM asks HHS to resolve scientific objections before proceeding.[5] HHS instead allows conditional access while rulemaking continues, and says it may revisit the policy if a safety signal or quality problem arises. It explicitly states that compounded drugs are not FDA-approved.[6]

Who is arguing, and what would settle the questions?

The advocacy groups have interests worth disclosing alongside their arguments. PSM’s published membership list includes the pharmaceutical industry group PhRMA, and its page says members are expected to pay dues or obtain a hardship waiver.[8] ASBM says its activities are funded by member partners. Its list includes AbbVie, Amgen and Genentech alongside patient and professional organizations.[9] These disclosures give context for the lobbying. They do not decide the merits of the objections.

FDA action against noncompliant suppliers or compounders would show how the safeguards are enforced.[1] Clinical evidence would address the safety-and-efficacy objection.[5] A final bulks-list rule would establish which substances, if any, are added to the list.[7]