End of Compounded Versions of Mounjaro and Zepbound: What Lies Ahead?
This week marked a significant moment in the pharmaceutical industry as compounding pharmacies faced new regulations concerning the production of weight-loss drug Zepbound and diabetes medication Mounjaro, both of which contain the ingredient tirzepatide. Despite these new rules, the landscape appears largely unchanged online, with several pharmacies still promoting compounded alternatives.
Persistence of Compounding Pharmacies
Pharmacies such as Amble, EllieMD, Willow, and Mochi Health continue to advertise versions of tirzepatide, despite the FDA’s recent enforcement efforts to curb these practices. Mochi Health, in particular, remains committed to its operations. CEO Myra Ahmad noted that the company collaborates with around 500 healthcare providers to prescribe personalized variations of the drug.
What is Compounding?
Pharmacy compounding involves the creation of customized medications tailored to the unique needs of individual patients. This process enables pharmacists to mix active ingredients to accommodate those with specific allergies or those needing different formulations, such as liquid versions versus tablets. It has gained traction, especially during drug shortages.
Background on Regulatory Changes
Over the past few years, copycat versions of medications like Mounjaro and Zepbound have become common due to FDA-designated shortages of the original products. However, the FDA announced in late 2022 that all dosages of these drugs were sufficiently available, thus revoking their shortage status. This change marked the beginning of stringent regulations aimed at halting the mass compounding of these medications.
Compounding Restrictions and FDA Guidelines
As of this month, compounding pharmacies must adhere to new FDA directives. Larger pharmacies are outright prohibited from compounding tirzepatide, while smaller entities are restricted from producing versions that closely resemble commercially available drugs. A significant parameter defined by the FDA is that compounded products must not have dosages within 10% of the approved versions or combine multiple commercially available drugs.
Despite this guidance, some pharmacies argue that their formulations are sufficiently differentiated. For instance, Ahmad claims that Mochi Health’s prescriptions offer personalized doses that diverge from standard options.
Legal and Operational Implications
Please note that the ramifications of these regulations are still unfolding. John Herr, the pharmacist and owner of Town & Country Compounding Pharmacy, recently decided to discontinue compounding tirzepatide due to perceived legal risks, even though many patients expressed concerns over losing access to this treatment. The pharmacy’s pricing was significantly lower than that of the brand-name drugs, enhancing its appeal.
Beyond regulatory compliance, the future for comprehensive enforcement of these bans hinges on the FDA’s actions moving forward. While Eli Lilly, the manufacturer of Zepbound, may seek legal remedies against non-compliant pharmacies, previous legal challenges have favored the pharmacies, as courts have often ruled that such enforcement falls under FDA jurisdiction.
What’s Next for Patients and Pharmacies?
As the industry adapts to these changes, it remains to be seen how patients will navigate their treatment options. The response from customers will play a crucial role in shaping future pharmaceutical practices. Companies like Hims & Hers Health, for example, have declared their intent to stop selling officially recognized doses of another GLP-1 medication, semaglutide, but will continue to provide personalized dosing regimens.
In summary, the landscape surrounding compounded versions of medications such as Mounjaro and Zepbound is in a state of transition. Regulatory compliance, patient needs, and the legal landscape will shape the pharmaceutical industry’s response in the months to come.
-Report contributed by Leanne Miller, CNBC
