Up to 30% of GLP-1 medications are acquired by patients through compounding pharmacies instead of the weight loss drugs' manufacturers like Novo Nordisk or Eli Lilly, according to KFF Health News.
The blockbuster drug class made up of Wegovy, Ozempic, Mounjaro, Zepbound and more quickly made way for the rise of 'faux-zempic' and copycat medications marketed directly to the consumer.
Online health companies like Hims & Hers, Ro, Henry Meds, and others have begun to offer direct-to-consumer GLP-1 knockoffs.
Compounding pharmacies are legally producing the medications, as the FDA allows this to happen during drug shortages – which for this drug class has almost become a norm. GLP-1 drugs, recently, have been more commonly prescribed for weight-loss than to control Type 2 diabetes, which was the drugs' original purpose.
Interest and potential uses for GLP-1 drugs continues to expand, further driving demand, as they have been shown to also aid with other health conditions ranging from drug addiction to heart, kidney and liver diseases.
But concerns over the quality and safety of the compounded GLP-1 drugs have been raised by drugmaker giants, and some like Eli Lilly have even filed lawsuits to stop the spread of the medications.
There is also a concern over the discrepancy of pharmacy regulations. Large 503B compounding pharmacies are FDA-regulated, but smaller 503A classified pharmacies receive oversight from state regulators. But either way, compounded drugs are not FDA-approved.
While pharmaceutical giants have called out the possible risks of these different pharmacies producing GLP-1 medications using unregulated compounds purchased overseas, others insist expanding access to the drugs is crucial.
"If you don’t want a 503B facility to make a copy, it's pretty simple: Don't go short," Lee Rosebush, chair of a trade association for 503B pharmacies, told KFF News. "FDA created this system because these are necessary drugs."