Being an exceptional compounding professional means you never stop learning
28 October 2026 | APC welcomes the Administration's decision to allow compounding of six peptides under a new interim enforcement discretion policy. It's an important step for patients, and we note that HHS has incorporated several of the patient-safety guardrails APC has been advocating.
We've said all along that the question isn't whether patients are using these peptides. They are. The question is where they're getting them. Right now, far too many patients are obtaining peptides from illicit suppliers with little assurance about what's actually in the vial. That's an existing public health threat, and one that isn't going away simply because compounding of the substances is prohibited.
Allowing state-licensed pharmacies to prepare these medications pursuant to legitimate prescriptions, using appropriately sourced and tested API, offers a more accountable alternative. It also brings patients into a system where pharmacy standards, regulatory oversight, and serious adverse event reporting apply.
But access without meaningful safeguards would serve no one. That's why APC has consistently advocated guardrails focused on API quality and traceability, serious adverse event reporting, and utilization data. We're encouraged that the HHS policy addresses those priorities, including requiring API from FDA-registered manufacturers, verification and review of certificates of analysis, extensive testing and documentation, and reporting of serious adverse events and product quality issues. The API-specific testing rigor of this policy is particularly noteworthy.
The policy also places some limits on compounding these peptides. It permits only single-ingredient preparations – no combinations with other APIs. And while certain oral formulations are permitted, pharmacies must document adequate bioavailability in humans.
The details matter, though, and it’s important to note what the policy does not do:
For starters, this policy doesn't add these peptides to the Category 1 List or the 503A Bulks List or make them FDA-approved drugs. Instead, it establishes a temporary enforcement discretion pathway with specific conditions. Nor does it authorize use of research-grade API. The policy's requirements for API quality are substantial – as they should be – and pharmacies must be diligent in complying with them.
And let's be clear: Today's announcement doesn't necessarily mean pharmacies can begin dispensing these peptides immediately. Suppliers will need to demonstrate that their API meets the extensive requirements in the policy, and pharmacies will need to verify that documentation. That may take time, and patients and prescribers should understand that.
Open questions
APC will be seeking clarification from HHS and FDA on several issues, including when the policy takes effect, how API testing and certificates of analysis are to be validated, exactly how product and utilization reporting will work, and how the policy will be coordinated with state boards of pharmacy.
That last point is especially important. A credible federal policy with meaningful patientsafety safeguards gives states a sound basis for their own oversight and helps discourage a patchwork of state rules and restrictions that could undermine the access HHS is trying to provide.
APC will work with pharmacies, API suppliers, and regulators to help translate these requirements into workable best practices. We also urge the Administration to continue aggressive enforcement against illicit peptide suppliers who operate outside the protections of our pharmacy regulatory system.
This is a welcome and consequential step. Now we need to get the implementation right – for patients, first and foremost.
Scott Brunner, CAE
Chief Executive Officer
scott@a4pc.org
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