SILVER SPRING, Md. – The Food and Drug Administration (FDA) will impose new restrictions next month on who can manufacture and sell popular weight-loss drugs known as GLP-1s.
The FDA announced that compounding pharmacies, which produce versions of name-brand drugs like Ozempic and Wegovy, will no longer be allowed to sell these medications after April and May.
In 2022, drugs like Ozempic and Wegovy saw a surge in popularity. To meet rising demand, the FDA temporarily allowed compounding pharmacies to produce non-brand-name versions of these medications.
“Compounding pharmacies were given temporary approval by the FDA to make these drugs while manufacturers caught up with demand,” said Dr. Lydia Alexander, president of the Obesity Medicine Association.
However, the FDA now says that brand-name drug manufacturers have caught up, and as of April 22, compounding pharmacies will no longer be allowed to produce GLP-1 drugs. Certain pharmacies will have until May 22 to stop making the medications.
Dr. Alexander explained that the doses and ingredients used in compounded GLP-1 drugs are not as tightly regulated by the FDA. “Some of the medications made are fine, but others may not be,” she said.
She also warned about products sold online, claiming to contain the same active ingredients as Ozempic. “There are many counterfeit products on the market, and they do not meet the same safety standards,” Alexander added.
A recent survey by the Kaiser Family Foundation found that 38% of people using GLP-1 drugs are doing so for weight loss rather than to treat chronic conditions like diabetes or obesity.
Dr. Alexander emphasized the lack of research on the safety of these drugs for individuals who only want to lose a small amount of weight. “We don’t know the long-term effects or safety for people trying to lose five to ten pounds,” she said.
