| An FDA committee will meet next month to discuss lifting a ban on a number of peptides marketed for wellness. Compounding pharmacies have been gearing up for the moment. |
| One compounder, Olympia Pharmaceuticals, told me it’s been researching some of these peptides for over a year and a half. That entails tasks like sourcing active ingredients, developing formulas, testing for endotoxins and potency, and making sure products are sterile and stable. |
| “It takes a long time to bring a product to market,” Olympia President Joshua Fritzler told me. “We have done a lot of that background work.” |
| It also takes millions of dollars of investment for each one, he said. |
| As an FDA-registered 503B outsourcing facility, Olympia makes large batches of compounded drugs, typically to fill gaps when there are drug shortages. It also operates a 503A pharmacy, making drugs pursuant to individual prescriptions. It offered GLP-1 weight loss drugs when brand-name versions were in short supply, but stopped when the FDA said the shortages had been resolved. It currently makes other peptides like glutathione, sermorelin and non-sterile GHK Copper, which are permitted to be compounded today, but it’s looking forward to expanding its business. |
| The FDA will review July 23-24 whether compounders should be able to make seven currently restricted peptides. It’ll review an additional five peptides in 2027. Olympia thinks the market for these peptides could be 10 times bigger than the compounded GLP-1 market. That’s because they’re sold for many purported health uses, from wound-healing to anti-inflammation, and they’d be approved for compounding indefinitely, rather than during a shortage. |
| Fritzler said a green light from the FDA could conservatively increase Olympia’s vials sold by 35% over the first few months, likely starting in the fall. |
| I asked Olympia execs about the relatively limited evidence backing up popular peptides under consideration. CEO Mark Mikhael said, “If this was truly a safety concern, which I think we're hearing from a lot of people, then the amount of side effects and adverse events that would be reported would be astronomical, but you're really not hearing that or seeing that.” |
| Instead, there are plenty of anecdotes about the peptides’ benefits, he argued. He said (as have other compounders) that shifting production of peptides from unregulated channels to compounding facilities is actually the safe thing to do. |
| “The thing that scares me the most about this is the public consumption is there today via black and gray markets,” Mikhael said. “Would you rather people consume this from the black and gray market” or from “heavily regulated compounding facilities, where you know the end product is safe for the public?” |
| Of course, while there are compounders following the rules, there are others that haven’t been so scrupulous. |
| - Shelby |
