Supporting appropriate quality and safety standards while preserving lawful access to patient-specific compounded therapies.
What is at stake
The section 503A bulk drug substances list, through FDA public dockets and notice-and-comment rulemaking
Patients who need a medication compounded for them individually, and the pharmacists and prescribers who have to know what may lawfully be used.
Our writing
Compounding
The statement PHA issued on April 15, 2026, on FDA moving a group of peptide compounds toward formal advisory committee review. It names the substances involved and the expected timetable.
Compounding
The announcement PHA issued on December 22, 2025, on a Texas ruling that narrowed the claims against a compounding pharmacy over compounded tirzepatide. PHA's lead strategic advisor led the defense.
Get involved
If your organization has a stake in how this is decided, we would like to hear from you.
Clinical experience is what makes a regulatory argument land. Tell us what you are seeing.
Access questions are not abstract. Your account of them is evidence.
A small number of partners fund this work and sit in the working groups that shape it.