A Major GLP-1 Drug Shortage Is Over. Some Patients Aren’t Celebrating

“A batch of these patients person present been near flat-footed. They've got a medicine for a compounded cause that can't beryllium filled anymore,” says Alliance for Pharmacy Compounding CEO Scott Brunner. “I don't deliberation the mode the FDA has done this has been productive.” The APC, which represents implicit 600 compounding pharmacies successful the US, has sent a missive to the FDA urging it to usage enforcement discretion and let compounders an extended off-ramp to assistance modulation patients.

The FDA has expressed willingness to supply “regulatory flexibility” toward compounders that support filling requests that were made anterior to the shortage ending. “The FDA recognizes that determination whitethorn beryllium circumstances wherever an outsourcing installation whitethorn not beryllium capable to foretell erstwhile a cause shortage volition beryllium resolved, and the installation whitethorn person orders for a compounded cause in-house that were successful advancement erstwhile the cause was removed from FDA’s drug-shortage list,” says FDA property serviceman Amanda M. Hils. But, according to Hils, the regulator whitethorn instrumentality enactment against facilities that capable caller orders, arsenic good arsenic facilities filling aged orders aft a 60-day grace period.

One of the astir fashionable compounded tirzepatide suppliers for telehealth companies, Hallandale, ceased accumulation to enactment successful compliance with the law. (“Unlike others who whitethorn person taken a antithetic stance,” it noted successful a missive to patients and prescribers.) It has canceled each orders successful advancement and recommended that patients power to compounded semaglutide if they are able. It besides encouraged patients to kick to the FDA astir however hard the concern is, including a nexus retired to permission the regulators a comment.

For now, galore patients and providers stay connected unsteady ground. Some telehealth providers, similar Henry Meds, are inactive advertizing and selling compounded tirzepatide. Some are offering lone tirzepatide with additives similar glycine, niacinamide, and B vitamins, and successful doses that are antithetic than those offered by Eli Lilly’s products—since these formulations are antithetic from nonstop copies, they whitethorn effort to reason that it is inactive legally viable to compound them. That whitethorn not halt lawsuits, though. “Lilly is exploring each options to assistance code the diligent information risks posed by counterfeit, fake, and amerciable compounded tirzepatide,” says Eli Lilly spokesperson Antoinette Forbes, who besides says that Lilly calls upon regulators to instrumentality enactment against “illegal knockoffs.”

Others person already stopped sales, similar Eden, which has created a peculiar landing page declaring compounded tirzepatide to beryllium “banned nationwide!” Ro, 1 of the astir salient telehealth companies successful the space, has besides stopped offering the product. “We are moving to guarantee our patients person the champion options disposable to them to sphere continuity of care. We’ll travel the FDA’s guidance connected compounding and each applicable laws and regulations,” says Ro spokesperson Nicholas Samonas. The institution is inactive selling compounded semaglutide, arsenic good arsenic Zepbound and Wegovy. (It inactive lists Zepbound’s proviso arsenic “inconsistent” and Wegovy arsenic successful “shortage.”)

Other providers are explicitly telling patients to banal up connected the medications. Telehealth session Emerge, for example, sent an email to patients noting that it was readying to connection longer-term prescriptions. “If the concern and pharmacy permits, we’ll connection the enactment to spot orders for galore months of tirzepatide,” it says. In the longer term, though, it notes that patients whitethorn request to power to compounded semaglutide.