The FDA has posted a reminder for telehealth companies promoting compounded drugs, especially compounded GLP-1s: Remember the law, and don’t be implying your products are FDA approved … and don’t play fast and loose with your marketing language. Don’t say they’re “generic” versions of approved drugs or even that they’re “clinically proven” — oh, and be clear who is doing the compounding.
We appreciate this kind of specificity. We love that the FDA is naming exactly the kinds of promotional claims that mislead patients and put compliant pharmacies and outsourcing facilities at risk by association.
While it was reminding telehealth companies what the law is (see above), the FDA also fired shots at 25 of them it says are breaking those rules, posting warning letters for “False & Misleading Claims/Misbranded (Telehealth)”.
The biggest issues it found were claims that compounded drugs used ‘clinically studied ingredients’ or were sourced from an “FDA-registered pharmacy.” In some cases, the agency called out images on the companies’ sites it says implied that the companies themselves did the compounding, rather than an external pharmacy. That’s a no-no, too.