“A lot of these patients have now been left flat-footed. They’ve got a prescription for a compounded drug that can’t be filled anymore,” says Alliance for Pharmacy Compounding CEO Scott Brunner. “I don’t think the way the FDA has done this has been productive.” The APC, which represents over 600 compounding pharmacies in the US, has sent a letter to the FDA urging it to use enforcement discretion and allow compounders an extended off-ramp to help transition patients.
The FDA has expressed willingness to provide “regulatory flexibility” towards compounders that keep filling requests that were made prior to the shortage ending. “The FDA recognizes that there may be circumstances where an outsourcing facility may not be able to predict when a drug shortage will be resolved, and the facility may have orders for a compounded drug in-house that were in progress when the drug was removed from FDA’s drug shortage list,” says FDA press officer Amanda M. Hils. But, according to Hils, the regulator may take action against facilities that fill new orders, as well as facilities filling old orders after a 60 day grace period.
One of the most popular compounded tirzepatide suppliers for telehealth companies, Hallandale, ceased production to stay in compliance with the law. (“Unlike others who may have taken a different stance,” it noted in a letter to patients and prescribers.) It has canceled all orders in progress, and recommended that patients switch to compounded semaglutide if they are able. It also encouraged patients to complain to the FDA about how difficult the situation is, including a link out to leave the regulators a comment.
For now, many patients and providers remain on unsteady ground. Some telehealth providers, like Henry Meds, are still advertising and selling compounded tirzepatide. Some are offering only tirzepatide with additives like glycine, niacinamide, and B vitamins, and in doses that are different than those offered by Eli Lilly’s products—since these formulations are different from direct copies, they may try to argue that it is still legally viable to compound them. That may not stop lawsuits, though. “Lilly is exploring all options to help address the patient safety risks posed by counterfeit, fake, and illegal compounded tirzepatide,” says Eli Lilly spokesperson Antoinette Forbes, who also says that Lilly calls upon regulators to take action against “illegal knockoffs.”
Others have already stopped sales, like Eden, which has created a special landing page declaring compounded tirzepatide to be “banned nationwide!” Ro, one of the most prominent telehealth companies in the space, has also stopped offering the product. “We are working to ensure our patients have the best options available to them to preserve continuity of care. We’ll follow the FDA’s guidance on compounding and all applicable laws and regulations,” says Ro spokesperson Nicholas Samonas. The company is still selling compounded semaglutide, as well as Zepbound and Wegovy. (It still lists Zepbound’s supply as “inconsistent” and Wegovy as in “shortage.”)
Other providers are explicitly telling patients to stock up on the medications. Telehealth clinic Emerge, for example, sent an email to patients noting that it was planning to offer longer-term prescriptions. “If the situation and pharmacy permits, we’ll offer the option to place orders for many months of tirzepatide,” it says. In the longer term, though, it notes that patients may need to switch to compounded semaglutide.