As GLP-1 weight loss drugs have surged in popularity, the Food and Drug Administration (FDA) has ordered medical professionals offering compounded versions of these drugs to stop services on April 22. Compounding allows licensed medical professionals to mix the active ingredients of a drug with other substances. In the case of GLP-1 drugs, they may be mixed with vitamins or additional peptides.
The FDA permits compounding when a drug is considered in shortage. But in the past year the makers of brand name GLP-1 drugs like Ozempic and Mounjaro fought to have their products removed from the shortage list. GLP-1 drugs are now a multi-billion dollar industry, and while the brand names can cost upwards of $1,000 a month, compounders are able to offer their versions for significantly less.
Tanna Donalson, a certified physician assistant and owner of Redbud Medical Spa in Denver, expressed concern over the impact of the FDA’s decision on her patients.
“It’s not just losing 25 pounds. It’s the pre-diabetic who gets to never be diabetic, someone with hypothyroidism who’s now off of their meds,” Donalson said.
The situation remains fluid, with an ongoing lawsuit against the FDA filed by the Outsourcing Facilities Association. Until a resolution is reached, a spokesperson with the Department of Health and Human Services said the agency will refrain from taking action against state-licensed pharmacists or physicians compounding semaglutide, the active ingredient in several GLP-1 medications. In a statement, HHS indicated they would allow a transition period until April 22, 2025, or until the court’s decision regarding the preliminary injunction motion.
Donalson said patient safety is of the utmost importance, and she’s committed to maintaining both safety and access for her patients.
“My nod to the FDA is that they are trying to shut down the bad actors, because they do exist,” Donalson said.
Her products come with a certificate of analysis confirming their safety and efficacy.
Denver7 is committed to making a difference in our community by standing up for what's right, listening, lending a helping hand and following through on promises. See that work in action, in the videos above.