This month, the window open to an era when compounded versions of glucagon-like peptide 1 (GLP-1) weight loss medications became available is expected to close.
GLP-1 medications include tirzepatide and semaglutide. They are used to help patients with diabetes and they can also be used for weight loss, and common brand names for the drugs include Ozempic, Wegovy and Zepbound.
“What they do most importantly is they work at your pancreas to increase the amount of insulin your body is making,” Dr. Diana Thiara, an internist at UCSF Health and director of the UCSF Medical Weight Management Program, told Audacy. She said that the drugs also work on the stomach to decrease gastric emptying, which leads to a feeling of fullness.
USA Today explained that “many Americans have turned to compounding pharmacies,” to get the popular medications (by last summer, an estimated 12% of U.S. adults had used a GLP-1 drug) due to expensive prices and a shortage. When the drugs were in short supply, the federal government allowed compounding pharmacies – pharmacies that offer custom-made medicines – to sell them.
With the government’s declaration that the drugs are no longer in short supply, “consumers who use telehealth companies or medical spas to get less expensive, compounded versions will need to get their medications elsewhere,” USA Today said.
In a March 10 update on the status of the medications, the U.S. Food and Drug Administration explained that a court denied a preliminary injunction motion filed in the Outsourcing Facilities Association v. FDA was denied by a district court in early March. That lawsuit was filed over what the OFA saw as an “arbitrary resolution of the tirzepatide injection shortage in October,” according to the Alliance for Pharmacy Compounding.
Per that March 10 update, the FDA did not intend to take action against compounders for violations arising from conditions that depend on tirzepatide injection products’ inclusion on FDA’s drug shortage list until March 19. As for semaglutide, the agency intends to start taking action related to state-licensed pharmacy or physician compounding under section 503A of the FD&C Act until April 22 at the earliest. Outsourcing facilities under section 503B (which has different testing requirements that 503A) of the FD&C Act have until May 22 at the earliest.
“FDA is aware that some patients and health care professionals may look to unapproved versions of GLP-1 (glucagon-like peptide-1 (GLP-1) receptor agonists) drugs, including semaglutide and tirzepatide, as an option for weight loss. This can be risky for patients, as unapproved versions do not undergo FDA’s review for safety, effectiveness and quality before they are marketed,” said the administration in a March 17 update.
It also said that it has “received multiple reports of adverse events, some requiring hospitalization, that may be related to dosing errors associated with compounded injectable semaglutide products.” By the end of February the FDA had received more than 455 reports of adverse events with compounded semaglutide and more than 320 reports of adverse events with compounded tirzepatide.
Scott Brunner, CAE of the Alliance for Pharmacy Compounding, said in a Monday statement that the “drugmaker spin” and” vague FDA statements” have had a negative impact on the pharmacy compounding industry.
“Compounding pharmacies like yours, which have long filled critical gaps in patient care, are being painted continually with the same brush as counterfeiters and black-market operators,” he said. More than 26,000 people had also signed an online petition calling for compounding pharmacies to be allowed to offer the GLP-1 drugs as of Tuesday morning.