individuals who have been using compounded versions of GLP-1 drugs will likely need to seek alternative sources for their medication, following the U.S. Food and Drug Administration (FDA) ban that took effect on May 22. This ban prohibits the production and sale of these off-brand medications in the united States.

The increased demand starting in 2022 lead to shortages of semaglutide injections, marketed by Novo Nordisk as Ozempic and Wegovy, and tirzepatide injections, sold by Eli Lilly under the brand names Zepbound and Mounjaro.

According to Nate Wood,MD,a primary care doctor and co-leader of the weight management clinic at the New Haven Primary Care Consortium,”Once patients found out how effective these medications were,word of mouth really drove up demand and outpaced the ability of these drug companies to manufacture them.”

The FDA permits pharmacies to compound copies of drugs facing shortages. Compounding involves a licensed pharmacist altering or combining ingredients to create a medication tailored to an individual’s needs.

Mike DiStefano, PhD, an assistant professor at the Center for Pharmaceutical Outcomes Research at the University of Colorado in Anschutz, stated, “The very high demand combined with the very high prices and limited insurance coverage for these weight loss drugs drove the rise of the market for compounded GLP-1s.”

However, supply-related access issues are no longer a factor, as GLP-1s are no longer in shortage.

FDA Concerns Regarding Compounded GLP-1 Medications

Dr. Wood notes that while compounded versions helped bridge the gap during shortages and offered affordability, they were a “highly imperfect solution.”

He added, “I think that there is general agreement that these medications cost too much and not enough people have access to them, but I think very few people think that compounding them solves the problem due to the safety risks.”

“I think that there is general agreement that these medications cost too much and not enough people have access to them, but I think very few people think that compounding them solves the problem due to the safety risks.”

The FDA has issued warnings about the potential dangers of compounded GLP-1s,including:

• Unapproved status: Compounded drugs lack FDA review for safety and effectiveness.
• Overdosing risks: Reports exist of accidental overdoses with severe side effects requiring hospitalization.
• Unapproved ingredients: Some compounded versions contain ingredients like retatrutide, which is illegal for compounding and lacks FDA approval.
• Problematic salt forms: The use of semaglutide sodium or semaglutide acetate in some versions raises concerns about differing safety and effectiveness.
• Counterfeit drugs: Fake Ozempic and other GLP-1 drugs are in circulation, possibly containing harmful or incorrect ingredients.
• “research use only” products: Illegal sales of unapproved drugs labeled for research pose risks if used by humans.

Dr. DiStefano co-authored a study on compounded GLP-1 drugs in Colorado, revealing that manny contained ingredients absent in FDA-approved versions, such as B vitamins and BPC-157, which the FDA deems unsafe for compounding.

He stated,”For many people,these drugs may work similarly to the branded products. However, depending on where the semaglutide is sourced from and