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FDA warns GLP-1 compounders — again Read in browser
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Thursday, 18 June 2026
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Peptide potential
It wasn’t too many years ago when we were busy theorizing about the market opportunity for GLP-1 weight loss drugs. Now, the big question is the moneymaking potential for other peptides that might soon move to more regulated channels.
The FDA’s Pharmacy Compounding Advisory Committee is set to hold a meeting in late July to discuss whether compounding pharmacies should be allowed to make seven peptides that are already very popular on the black market. Another five peptides are slated to be considered in 2027. These are peptides that their sellers claim will help anything from wound healing to inflammation to getting a tan.
Many in the compounding industry view a positive recommendation from the committee as a foregone conclusion, largely because of HHS Secretary Robert F. Kennedy Jr.'s support. And though there’s rulemaking that must happen before they are legally permitted to churn the peptides out, compounders are champing at the bit. 
It’s no wonder: Leerink Partners estimates that $2.2 billion is up for grabs for telehealth companies, when taking into account the first seven peptides to be considered by the FDA. For Hims, which was one of the biggest providers of compounded GLP-1 drugs and plans to expand into other peptides, the opportunity could be as much as $440 million in revenue, Leerink projected.
A nice Bloomberg Businessweek piece this week on the evolving peptide market noted that it will take time for compounders to ramp up if the FDA greenlights peptides, so they might not be able to satisfy immediate demand. Scott Brunner, CEO of a compounding trade group, said he’d heard estimates of three to nine months for a pharmacy to establish its sources for drug ingredients, according to the report. Some companies are already preparing.
The story also got me thinking about the impact of the peptide craze on the traditional pharmaceutical supply chain. Pharma companies, which originally developed many of the peptides on the black market, are once again facing big competition from compounders and telehealth players, but they’re also losing the incentive to invest in expensive research and development, Bloomberg writes. 
The peptides set to be considered by the FDA generally lack hard evidence for their purported benefits from human trials. I doubt peptide purveyors will be willing to foot the bill for that research. Anecdotes might be all we ever have. 
- Shelby
Here’s what’s new
FDA warns telehealth companies over compounded GLP-1s
The FDA has is­sued a new batch of warn­ing let­ters to 25 tele­health com­pa­nies, ac­cus­ing them of mak­ing false and mis­lead­ing claims in their mar­ket­ing of com­pound­ed GLP-1 weight loss drugs.
Peptide adcomm
July 23-24: The dates to keep in mind for the FDA's meeting on peptides. The two-day meeting could dictate which currently banned peptides become legal to compound.
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