On Tuesday, APC met with the White House Office of Information and Regulatory Affairs to make the case for allowing compounding of six peptides under a framework that includes essential patient-safety guardrails. Here are the points we raised. That same day, we released a new episode of our ESSENTIAL podcast featuring Board Chair Philip Smyth and CEO Scott Brunner discussing the issue. On Wednesday, we briefed House health staffers on Capitol Hill about the case for a regulated pathway for peptide compounding.
And just before that Hill briefing began, HHS released its interim enforcement discretion policy for six peptides.
As our statement above explains, it's an important first step — one that incorporates several of the patient-safety guardrails APC has advocated, including API quality and traceability, serious adverse event reporting, and utilization data collection.
We have questions, of course — about when the policy takes effect, how API testing and certificates of analysis will be validated, how reporting will work, and how the policy intersects with state pharmacy laws and regulations. We're reaching out to FDA for clarification and will share what we learn.
For now, one thing is certain: This was a consequential week for peptide compounding, and APC was at the table helping shape what comes next.