Pharmacies Skirt FDA Rules to Keep Selling Popular Drugs

The FDA recently declared that compounding pharmacies should stop making knockoff versions of popular weight-loss and diabetes drugs, such as Zepbound and Mounjaro. However, many online pharmacies are still advertising these drugs, despite the FDA's ban. This is because some pharmacies are finding loopholes in the rules to continue their operations. The FDA's ban targeted the mass production of these drugs, but smaller pharmacies can still make personalized versions. This means that if a patient has a specific need, like an allergy to a dye in the branded medication, they can still get a compounded version. Some pharmacies are even mixing these drugs with other medications, like vitamin B12, to make them unique. This is a gray area, as the FDA considers a copy to be a drug that is within 10% of the commercially available drug's dosage or combines two or more commercially available drugs. Mochi Health is one of the pharmacies that plans to continue operating. They use a network of about 500 providers to write prescriptions for weight-loss drugs, including compounded versions. They believe that offering personalized versions of the drugs will keep them out of trouble. Other websites like Amble, EllieMD, and Willow are also still advertising these drugs, but they did not respond to requests for comment. The FDA's ban was put in place because the drugs were previously in short supply, but now they are readily available. This created a booming business for pharmacies compounding these drugs. However, the FDA's ban means that larger facilities can no longer compound these drugs at all, and smaller ones can't make products that are essentially copies of a commercially available drug. Some pharmacies, like Town & Country Compounding Pharmacy, have stopped compounding these drugs. They didn't want to take the risk, even though their patients were upset about losing access. They were charging patients about $200 a month, which is much less than the list price for Zepbound. The next two months will be informative, as the FDA's ban on mass compounding of semaglutide — the active ingredient in Novo Nordisk's Ozempic and Wegovy — goes into effect at the end of May. It will be interesting to see how pharmacies adapt to this new rule.