This week marks a pivotal moment in the ongoing saga of compounded medications, specifically the weight-loss drug Zepbound and its diabetes counterpart, Mounjaro, produced by Eli Lilly. As the U.S. Food and Drug Administration (FDA) has lifted its shortage status on these medications, a new chapter begins for compounding pharmacies that have relied on producing copycat versions of these drugs.
In recent years, the landscape of weight-loss and diabetes treatments has been transformed by the popularity of GLP-1 receptor agonists, such as Zepbound and Mounjaro. The FDA’s classification of these brand-name drugs as being in short supply has led to a boom in compounding pharmacies creating alternative versions, which has been a lifeline for many patients seeking accessible solutions. However, the FDA’s recent declaration that these medications are now readily available has brought this booming business model into question.
Despite the FDA’s new regulations, many compounding pharmacies are navigating the terrain with varying degrees of compliance. Websites like Amble, EllieMD, and Mochi Health continue to advertise compounded versions of tirzepatide—the active ingredient in Zepbound—demonstrating a clear defiance of the FDA’s tightening grip. Myra Ahmad, CEO of Mochi Health, is optimistic about the future of her business, asserting that the customization offered through compounded medications will be a key differentiator. “It can be different dosing schedules… some patients prefer to go up in dosage much more slowly,” she explained. This tailored approach can be vital for patients who experience side effects from standard formulations and need adjustments to their treatment plans.
The practice of compounding allows pharmacists to mix ingredients to meet specific patient needs—be it for allergies, dosage preferences, or alternative delivery methods. For instance, a patient allergic to a dye used in a branded medication could find relief through a compounded alternative. However, as the FDA has set stricter guidelines, the distinction between personalized formulations and “essentially copies” of commercially available drugs blurs, raising concerns among both pharmacists and patients.
Scott Brunner, CEO of the Alliance for Pharmacy Compounding, emphasized the legal risks that compounding pharmacies face if they continue to create versions of tirzepatide that closely resemble the commercial product. “FDA guidance is pretty clear about what is and is not a copy,” he cautioned. His remarks underline the precarious balance between meeting patient needs and abiding by regulatory frameworks.
Pharmacists like John Herr, owner of Town & Country Compounding Pharmacy, have already decided to halt the compounding of tirzepatide, citing the risks involved. Despite having a loyal patient base, Herr recognized the potential legal repercussions of ignoring FDA guidelines. His pharmacy charged patients approximately $200 a month for the compounded version, significantly less than the commercial price of Zepbound, thus highlighting the financial implications for patients if access to compounded versions diminishes.
Looking forward, the enforcement of these new regulations will largely depend on the FDA’s commitment to monitoring compliance. Although Eli Lilly may pursue legal action against non-compliant pharmacies, past experiences suggest that such efforts may face challenges in court. A noteworthy precedent was set last year when a Florida judge dismissed one of Lilly’s lawsuits, stating that only the FDA could enforce such regulations.
As the dust settles, the next few months will be crucial for both patients and providers. The FDA’s deadline for halting mass compounding of semaglutide, the active ingredient in Novo Nordisk’s Ozempic and Wegovy, looms at the end of May. Companies like Hims & Hers Health have already stated their intention to stop selling commercially available doses of semaglutide, though they will continue to support personalized dosing regimens.
In summary, the evolving landscape of compounded medications in relation to popular diabetes and weight-loss drugs poses significant questions about access, regulation, and patient care. As compounding pharmacies adapt to the new rules, the focus remains on the delicate balance of providing personalized care while navigating the regulatory environment. For patients, the outcomes of this regulatory shift will likely determine not just their treatment options but also the affordability and accessibility of these essential medications. The coming months will be critical in shaping the future of compounding pharmacies and their role in healthcare.
