Zepbound Copycats Remain Online Despite FDA Ban

Compounding Pharmacies Defy FDA Ban on Copycat Versions of Weight-Loss and Diabetes Drugs

This week was supposed to mark the end of compounding pharmacies making copycat versions of Eli Lilly’s weight-loss drug Zepbound and diabetes drug Mounjaro. However, online, it doesn’t look like much has changed.

Popular websites like Amble, EllieMD, Willow, and Mochi Health are still advertising versions of tirzepatide, the active ingredient in Zepbound. Some, like Ivim, have stopped taking new patients. Mochi Health, however, has no plans to stop, and neither do the four pharmacies it uses to supply patients with the medications. The company uses a network of about 500 providers to write prescriptions for weight-loss drugs, including compounded versions.

Personalization is Key

According to Mochi CEO Myra Ahmad, offering personalized versions of the drugs will keep the company out of the crosshairs. "It can be different dosing schedules … some patients prefer to go up in dosage much more slowly," she 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."

What is Compounding?

Compounding is where pharmacies mix ingredients of a drug to create a specialized version for specific patients. Say someone is allergic to a dye in a branded medication or needs a liquid form and the main manufacturer only sells capsules. In that case, the patient can turn to a compounded version. When drugs are in short supply, they can be compounded in larger quantities to help fill the gap.

FDA Guidance

The FDA has been clear about what is and is not a copy. According to the agency, a copy is a product that has a dosage within 10% of the commercially available drug or combines two or more commercially available drugs. Mochi insists all of its prescriptions are personalized, including doses that differ from the standard Zepbound strengths. Other websites like EllieMD are advertising tirzepatide mixed with vitamin B12.

What’s Next?

The next two months will be informative. Mass compounding of semaglutide, the active ingredient in Novo Nordisk’s Ozempic and Wegovy, needs to stop by the end of May, according to the FDA. Hims & Hers Health has already said it will stop selling commercially available doses of semaglutide when the time comes. Customers who have a personalized dosing regimen will be able to continue without any change.

Conclusion

The FDA’s ban on mass compounding of tirzepatide and semaglutide has left many pharmacists and patients in a difficult position. While some pharmacies like Mochi Health have found a way to continue offering personalized versions of the drugs, others like Ivim have stopped taking new patients. The next few months will be crucial in determining the future of compounding pharmacies and their role in the healthcare industry.

FAQs

Q: What is compounding?
A: Compounding is where pharmacies mix ingredients of a drug to create a specialized version for specific patients.

Q: Why are some pharmacies still offering copycat versions of Zepbound and Mounjaro?
A: Some pharmacies believe that offering personalized versions of the drugs will keep them out of the crosshairs.

Q: What is the FDA’s stance on compounding?
A: The FDA sees copies as products that have a dosage within 10% of the commercially available drug or combine two or more commercially available drugs.

Q: What happens if pharmacies continue to offer copycat versions of tirzepatide and semaglutide?
A: Pharmacies that continue to offer copycat versions of the drugs may be putting themselves at risk of legal action from the FDA and drug manufacturers.