Compounding pharmacies are suing the Food and Drug Administration for continuing to make counterfeits of the popular and lucrative drug tirzepatide, such as Munjaro for diabetes and Zepbound for weight loss.
Typically, compounding pharmacies are customized to patients with specific needs, such as when a patient has an allergy to a filler ingredient or when a child requires a liquid medication that is usually provided in capsules. Create prescriptions for prescribed medications. But large-scale compounding operations are also legally allowed to manufacture counterfeit branded drugs as a stopgap for patients when branded drugs are in short supply.
Tirzepatide has certainly been in short supply in recent years. Given the high prevalence of diabetes and obesity in America and the effectiveness of their drugs, demand for tirzepatide and other new GLP-1 class drugs is skyrocketing, leaving many patients struggling to fill their prescriptions. are. FDA recommends tirzepatide Drug shortage list In December 2022, it remained there until last week.
October 2nd, FDA announced it is Tirzepatide shortage resolved He also said that while other drugs in the same class, including semaglutide, remain in short supply, the domestic supply of GLP-1 drugs is stabilizing.
“FDA has checked with the drug manufacturer.” [Eli Lilly] “The availability and manufacturing capacity of the listed products are capable of meeting current and projected national demand,” the agency said in a statement, but as medicines move through the supply chain, Patients and prescribers warned that “intermittent local supply disruptions may still occur.” .
end of an era
This resolution prevents compounding pharmacies from manufacturing tirzepatide. And the FDA emphasized this point to drug companies, writing in bold letters that the agency “reminds formulators of the legal restrictions on making copies of FDA-approved drugs.”
