FDA has now submitted an interim access policy for compounding certain peptides for White House review. Nothing is final, but it is a major step since many peptides were moved to FDA's restricted category in 2023.
Here are two things I think every clinic operator should keep in mind.
1. Enforcement discretion is not approval
As reported, the policy would work through enforcement discretion. That means FDA would signal it will not take action against qualifying compounders. The peptides would remain unapproved drugs.
Enforcement discretion can be narrowed or withdrawn. Clinics saw this firsthand when shortage-era compounding of GLP-1 drugs came to an end.
2. Sourcing will be the whole game
Expect conditions around who can compound and how. Clinics should plan for questions about manufacturer registration, certificates of analysis, and quality testing. State boards of pharmacy will still have their say, and state rules on prescribing and administration still apply.
Traceability is where we are focused
If this goes through, being first to add peptides to the menu will matter less than being able to show exactly where every vial came from.
We are building lot traceability into Walla so that lot numbers and beyond-use dates flow in from pharmacies with each order. The goal is simple: when someone asks where a vial came from, the answer is already on file.
The bottom line
Watch the final terms closely. Work only with licensed compounding pharmacies. And get your records in order now, before access opens.
Sources: American Med Spa Association, Holland & Knight