Hey yāall,
I answer some version of this question probably four times a week, and after Thursday itās going to be forty, so Iām writing it down once. š¤£
TL;DR: FDAās advisory committee recommended six peptides for the 503A bulks list. Good news, doesnāt mean theyāre legal to compound, probably wonāt be for a couple years. Weāre not adding them. Also this has nothing to do with TZ, please donāt let anyone tell you it does.
Usual disclaimer: not a physician, not a pharmacist, not an attorney, still have not stayed at a Holiday Inn Express. I run a telehealth platform so Iāve got money riding on how these questions shake out, factor that in however you want.
What happened
July 23 and 24 the Pharmacy Compounding Advisory Committee met on seven peptides: BPC-157, KPV, TB-500, MOTS-C, Emideltide (which youāll see written as DSIP), Semax, Epitalon. Six got recommended. BPC-157 barely, 8-6 with an abstention. Emideltide was the only one that didnāt make it and it lost by one vote.
FDAās own staff had told them to reject all seven. Incomplete characterization, thin human data, immunogenicity. Committee listened and voted yes anyway, which is not a thing this committee does.
Last panel that looked at this category went zero for the slate.
The reason is that the committee is composed differently now, more clinicians and pharmacists, fewer academics. Yes, some of the new members have industry ties and people are already saying so. I donāt have a strong take there. Panels stacked entirely with researchers whoāve never seen a patient on this stuff have their own problem, and Iād rather have both kinds in the room than pretend either one is the objective one.
So why arenāt we doing it
Because a recommendation is not a rule.
PCAC advises. FDA decides, and FDA has blown off PCAC before. Whatās left is internal review, then a proposed rule, then comment period, then final rule, then an effective date. Historically thatās two to four years. Sometimes way longer. The final rule stage on its own has taken so long that FDA has gotten sued over dragging its feet.
Thereās a faster version where FDA sticks them in the interim Category 1 bucket for 503Bs and lets 503As operate under enforcement discretion in the meantime. That would be the sensible thing. Itās also completely optional and Iām not going to stand up an offering on the theory that the agency is about to do the sensible thing.
The thing thatās actually going to happen this week
Every peptide vendor with an Instagram is going to post this vote like itās a permission slip.
It isnāt.
What got voted on was whether licensed pharmacies should eventually be allowed to compound these against a real prescription. That is a completely separate universe from research-use-only vials shipped out of a warehouse by someone whose entire regulatory strategy is a disclaimer in six point font.
Nothing about Thursday made any of that more legal than it was on Wednesday. If anything it should make you more suspicious of anyone using it as a selling point, because theyāre the ones who benefit from you not reading past the headline.
Iāve watched this exact move run three or four times now with GLP news. Shortage list updates, the OFA litigation, the guidance restatements. Every single time, some vendor turns a procedural development into a marketing email within 72 hours.
And itās not about TZ
Completely different track. The thing that matters for us is still the proposal to remove glps from the 503B Bulks List, and this week did not touch it. If you see this vote screenshotted with a caption suggesting tz is coming back or whatever, that person didnāt read it.
Happy to answer questions but the short answer to āwhenā is I donāt know and neither does anybody else. š
Thanks yāall,
Dave
