American Food and the Drug Administration Have been confirmed That semaglutide No more shortagethis move will have an impact on cheaper, compound versions of patients taking the drug.
semaglutide, active ingredient Novo Nordisk’s Large pieces of diabetes and weight loss medications Ozempic and Wegovyhas been FDA’s List of shortages since March 2022. Supply can’t keep up A warm demand for drugsit has reached such a dazzling and popular level that it has transformed Novo Nordisk into one of the most valuable companies in the world Market value It is larger than other economies of Denmark’s own country.
In the following years, A profitable industry Telemedicine companies, medical spas and pharmacies Make and sell “composite” copies Drugs have appeared. These non-branded copies are sold at huge discounts (sometimes under $100 per bottle) and are associated with the name-branded drug that can exceed $1,000 per month without insurance.
At the end of October, the FDA changed the status of all doses of Ozempic and Wegovy to “available”, indicating that the end of the formal shortage is likely to have been seen. Until today, nearly four months later, regulators concluded that the drug has been widely used to remove it from the list of shortages.
FDA In dedication The “503a” compound, usually a state-licensed pharmacy or physician compound, is until a minor surgery is performed on April 22 to stop the production of the drug. It offers “503B” compounds, which are larger outsourcing facilities that follow stricter manufacturing guidelines until May 22.
In the usual case, this is not particularly controversial when drugs stand out from the shortage list. But there is reason to believe that players in the industry will postpone the announcement.
Drug compounding is a well-recognized practice. Pharmacists are allowed to make copies of the drug when the drug is short or the patient requires a specific dose or without allergen. But the GLP-1 boom created opportunities for compounds that changed the pockets of the industry, and composite pharmacies generated brand copies for millions of patients.
Robert MacArthur, director of pharmacy at Rockefeller University Hospital, said that once the drug stands out from the FDA’s shortage list, outsourcing pharmacies that use large amounts of compounded drugs for healthcare facilities should no longer complicate the drug. However, for smaller, traditional composite pharmacies, drugs can be made for home use, which is the legal grey area.
“If doctors write prescriptions for individual patients and think there are some compelling reasons for giving patients a special composite product, they can make it more complicated,” MacArthur said. This reason can be adjusted for doses or medications for a specific patient.
Some telemedicine apparel says they intend to continue offering products. “Now that the FDA has determined that the drug shortage for Semaglutide has been resolved, we will continue to provide personalized treatments permitted by law to meet the needs of patients,” Andrew Dudum, founder and CEO of Hims & her Health, Write On X, it added that the company is closely monitoring potential future shortages.
