The FDA gave compounders a grace period to wind down their production of the drugs after the shortage was over. Small pharmacies had until February 18 to comply, while larger outsourcing facilities had until March 19. (Semaglutide compounders were ordered to cease mass production this spring, with smaller compounders given a deadline of April 22 and outsourcing facilities given until May 22.)
While many compounding pharmacies and telehealth providers have halted production and sales, others have continued to offer tirzepatide products with add-on ingredients, unapproved dosages, or in different forms, such as oral versions. “It’s a minority,” says Jayne Hornung, chief clinical officer at the pharmaceutical analytics company MMIT.
Hornung says that companies continuing to sell tirzepatide are hoping the vitamin additives and other tweaks will allow them to argue they aren’t selling straightforward copies of Lilly’s patented drugs. “They’re getting very creative,” she says.
Compounding pharmacies are generally permitted to create customized medicines for patients even when they’re not in shortage, such as for individuals who may be allergic to certain ingredients or need carefully calibrated doses. The crux of Lilly’s argument is that, when it comes to tirzepatide, the medications telehealth companies are offering are not truly personalized because they are being mass produced and prescribed to many patients.
“There are some ways that compounders tailor a medication to the patient, such as by adding another ingredient that might help with a side effect or an additional concern or diagnosis,” says Annie Lambert, a pharmacist and clinical program manager at information services firm Wolters Kluwer. “But there needs to be good science and evidence behind the safety of combining those things.”
Mass-producing compounded versions of existing drugs with additives was not widespread until recently, according to Nicole Snow, a pharmacist at the compounding company Olympia Pharmaceuticals, which previously produced compounded tirzepatide but stopped after the shortage ended and never included additives. “We’d seen it from time to time, but not in this magnitude,” she says. “It wasn’t a very popular thing until we got into GLP-1s.”
In its suit against Mochi, Eli Lilly claims the telehealth company “switched dosages and prescriptions for patients en masse at least five times—with corporate interests, rather than doctor decisionmaking—driving the changes.”
Those changes, Lilly alleges, included creating two new formulas containing a niacinamide additive and pyridoxine, both forms of vitamin B that the pharma company argues have not been proven to be safe or effective when combined with tirzepatide. Mochi’s own compounder, Aequita Pharmacy, made some of those products. In March, regulators in Washington state ordered production to be halted at Aequita Pharmacy, citing safety violations connected to GLP-1 medications.
In another lawsuit filed in the same California court, Lilly claims that Fella & Delilah Health switched all of its patients from a compounded tirzepatide product with no additives to a version containing untested amino acid additives late last year.
The pharmaceutical giant’s lawsuit against Henry Meds, which offers oral and injectable GLP-1 medications, accuses the company of “creating the false impression” that clinical trials have confirmed the effectiveness of its drugs, “materially omitting that no such clinical trial data exists.”
