Table of Contents
NEW YORK – Despite an FDA deadline for compounding pharmacies to stop making copycat versions of Eli Lilly’s weight-loss drug Zepbound and diabetes drug Mounjaro, online pharmacies continue to offer compounded versions of tirzepatide, the active ingredient in both medications.
Popular websites like Amble, EllieMD, Willow, and Mochi Health still advertise tirzepatide, while some, like Ivim, have stopped taking new patients. Mochi Health CEO Myra Ahmad confirmed to CNBC that her company and its network of 500 providers have no plans to cease offering compounded versions, arguing that customized formulations provide patients with more flexibility in dosing and ingredient combinations.
Thorvardur de Shong
“It can be different dosing schedules … some patients prefer to go up in dosage much more slowly,” Ahmad said. “Some patients like to mix a number of other medications into their compounded formulations, depending on the side effects that they’re having. Some patients have side effects with any additives and brand name formulations. Compounding really opens up the door for so much personalization.”
Compounding pharmacies create specialized drug formulations for patients with specific needs, such as allergies to dyes or difficulty swallowing pills. When a drug is in short supply, the FDA allows pharmacies to compound it in larger quantities to meet demand. This exception has fueled a booming market for compounded versions of popular weight-loss and diabetes drugs, including Novo Nordisk’s Wegovy and Ozempic.
However, in late 2024, the FDA declared that Mounjaro and Zepbound were no longer in short supply, effectively ending mass compounding of tirzepatide. After months of legal challenges, the agency set deadlines for pharmacies to comply: larger facilities had to stop by this week, while smaller pharmacies were barred from making direct copies of commercially available drugs.
Mochi Health and other providers argue their formulations are distinct enough to comply with FDA rules. Some websites, such as EllieMD, advertise tirzepatide mixed with vitamin B12, but experts warn that such combinations could still be considered copies under a strict reading of FDA guidance.
Scott Brunner, CEO of the Alliance for Pharmacy Compounding, said pharmacies continuing to compound tirzepatide could face legal risks. “FDA guidance are pretty clear about what is and is not a copy. And I would say any compounding pharmacy or outsourcing facility that continues to prepare copies of tirzepatide injection after today are putting themselves in a certain amount of legal risks,” Brunner said to CNBC.
Some pharmacies, like Town & Country Compounding Pharmacy in New Jersey, have stopped compounding tirzepatide, citing legal concerns. “Our 300 to 400 patients on it have been calling nonstop to complain,” said owner John Herr, whose pharmacy had been charging about $200 per month—far below the list price for Zepbound.
The FDA is largely responsible for enforcing the ban, but it has yet to comment on how it will proceed. Lilly could pursue legal action against compounding pharmacies, but previous attempts to sue have been dismissed in court.
Looking ahead, the FDA has given compounding pharmacies until the end of May to halt mass production of semaglutide, the active ingredient in Novo Nordisk’s Ozempic and Wegovy. Companies like Hims & Hers Health have already announced plans to comply, stating that only patients with personalized dosing regimens will continue receiving the medication.
As regulatory enforcement looms, the future of compounded weight-loss drugs remains uncertain. Pharmacies, patients, and manufacturers are closely watching the next steps.
