An FDA deadline instructing compounding pharmacies and telehealth companies to stop selling compounded versions of Ozempic and Zepbound has not stopped the copycat market, The Wall Street Journal reported May 18.
After the FDA declared the yearslong shortages of Novo Nordisk’s Ozempic and Wegovy and Eli Lilly’s Zepbound and Mounjaro as resolved, a group of compounding pharmacies filed lawsuits against the agency, arguing the drugs remained in short supply. The lawsuits were unsuccessful.
The FDA directed compounding pharmacies and physicians to cease compounding Ozempic and Wegovy by April 22, and outsourcing facilities to stop producing and distributing the medications by May 22. The deadline for Zepbound was in late March.
Hims & Hers, a telehealth company, continues to offer compounded versions of Ozempic and Wegovy tailored to individual prescriptions. It has also partnered with Novo Nordisk to expand access to GLP-1 medications.
Other loopholes to the deadline are allowing companies to make and sell slightly different versions from the FDA-approved drugs. These variations may include nonstandard dosages, added ingredients such as vitamins B3 or B12, or converting the injectable medications into oral forms, according to the report.
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