Compounding Pharmacies for Weight-Loss Drugs Are Booming. Should You Trust Them?

This is not supposed to be how compounding pharmacies work, says Shabbir Safdar, executive director of the Partnership for Safe Medicines, a public-health group that aims to protect consumers from counterfeit or unsafe medicines. In 2012, when Congress created 503Bs in response to the New England Compounding Center tragedy, it assumed that 503As would stop mass-producing drugs, he says. But “they didn’t count on the 503As saying, ‘Yeah, I know you did that, but I don’t care. I’m going to mass produce drugs.’” (The FDA said, in a response to a query from TIME, that federal law limits when compounders can make copies of FDA-approved drugs.) 

Eli Lilly has taken a position similar to Safdar’s on compounding. “Everyone who needs medicine deserves real medicine that has been trialed, tested, and manufactured in compliance with the law,” an Eli Lilly spokesperson wrote in a statement to TIME. Many compounding pharmacies, the spokesperson said, have been “unlawfully mass-producing knockoff drugs.” The spokesperson added that “anyone selling mass compounded products—including by referring to them as ‘personalized’ or ‘tailored’—is breaking the law and putting patient safety at risk.” (Novo Nordisk did not return TIME’s request for comment.)