Media requests are not uncommon at APC, but the past couple of days have been anything but common. The word “imminent” has been attached to FDA action on peptides for more than a year now, but a newly announced meeting has resparked that urgency among our media friends, and has us wondering whether maybe something is about to happen for once. The FDA has scheduled a PCAC meeting for July 23-24 to consider whether to add several peptides to the 503A bulks list, which, in theory, would open the door for state-licensed compounding pharmacies to produce them legally.
But before anyone gets too excited, it’s important to note what this actually means – and what it doesn’t.
As APC’s Scott Brunner noted on LinkedIn this week, a shoe has dropped, but only one. The PCAC can recommend adding the named substances to the approved list, but the FDA isn't obligated to follow that recommendation. Even if it does, formal notice-and-comment rulemaking would still be required – a protracted process, unless the agency opts for enforcement discretion in the interim.
More importantly, even if everything goes right, there's still the supply chain problem. Pharmaceutical-grade API for most of these peptides doesn't currently exist at scale, because there's been no market incentive to develop it. A regulatory green light without a reliable API supply puts compounding pharmacies in an impossible position.
APC supports adding certain peptides to the approved list. The gray and black markets supplying patients right now pose real public health risks, and compounded peptides prepared by state-licensed pharmacies in sterile, USP-compliant environments are meaningfully safer than what's currently available. But how and when FDA acts matters just as much as whether it acts.
So will peptides be coming to a compounding pharmacy near you? We'll find out this summer…maybe.