“Many of these patients have now been caught off guard. They have a prescription for a compounded medication that can no longer be filled,” says Scott Brunner, executive director of the Alliance for Pharmacy Compounding. “I don’t think the way the FDA has done it has been productive.” The APC, which represents more than 600 compounding pharmacies in the U.S., sent a letter to the FDA urging it to use enforcement discretion and allow compounding manufacturers an expanded off-ramp to help patients in transition.
The FDA has expressed its willingness to provide “regulatory flexibility” to compounders who continue to fulfill requests made before the shortage ended. “The FDA recognizes that there may be circumstances in which an outsourcing facility cannot predict when a drug shortage will be resolved, and the facility may have internal orders for a compounded drug that were in progress when the drug was withdrawn from the market. FDA Drug Shortage List,” says FDA Press Officer Amanda M. Hils. But, according to Hils, the regulator can take action against facilities that comply with new orders, as well as facilities that comply with old orders after a 60-day grace period.
Hallandale, one of the most popular suppliers of compounded tirzepatide to telehealth companies, stopped production to comply with the law. (“Unlike others who may have taken a different stance,” he noted in a letter to patients and prescribers.) It canceled all ongoing orders and recommended that patients switch to compounded semaglutide if they can. It also encouraged patients to complain to the FDA about how difficult the situation is, including a link to leave a comment to regulators.
For now, many patients and providers remain on shaky ground. Some telehealth providers, such as Henry Meds, still advertise and sell compounded tirzepatide. Some offer only tirzepatide with additives such as wisteria, niacinamideand B vitamins, and in different doses than those offered by Eli Lilly products; Since these formulations are different from direct copies, they may try to argue that it is still legally viable to combine them. However, that may not stop the lawsuits. “Lilly is exploring all options to help address the patient safety risks posed by counterfeit, counterfeit and illegal tirzepatide compounds,” says Eli Lilly spokeswoman Antoinette Forbes, who also says Lilly is asking regulators to take action against “illegal imitations”.
Others have already stopped selling, like Eden, who has created a special landing page declare that the compound tirzepatide is “banned throughout the country.” Ro, one of the most prominent telehealth companies in the sector, also stopped offering the product. “We are working to ensure our patients have the best options available to preserve continuity of care. “We will follow FDA compounding guidelines and all applicable laws and regulations,” says Ro spokesperson Nicholas Samonas. The company continues to sell compounded semaglutide, as well as Zepbound and Wegovy. (It still lists Zepbound supply as “inconsistent” and Wegovy as “shortage.”)
Other providers explicitly tell patients to stock up on medications. Telehealth clinic Emerge, for example, sent an email to patients indicating it planned to offer longer-term prescriptions. “If the situation and the pharmacy allow it, we will offer the option to order tirzepatide for many months,” he says. However, in the long term, he notes that patients may need to switch to compounded semaglutide.