The US Food and Drug Administration has determined that semaglutide is no longer in shortage, a move that will have implications for patients taking cheaper, compounded versions of the drug.
Semaglutide, the active ingredient in Novo Nordisk’s blockbuster diabetes and weight-loss medications Ozempic and Wegovy, has been on the FDA’s shortage list since March 2022. Supply could not keep pace with fervent demand for the drug, which reached such dizzying levels of popularity that it transformed Novo Nordisk into one of the world’s most valuable companies, with a market capitalization larger than the rest of the economy of its home nation of Denmark.
In the intervening years, a lucrative industry of telehealth companies, medical spas, and pharmacies making and selling “compounded” copies of the medications has arisen. These off-brand copies are sold at a steep discount—sometimes under $100 a vial—compared to the name-brand medications, which can be over $1,000 a month without insurance.
At the end of October, the FDA changed the status of all dosages of Ozempic and Wegovy to “available,” signaling that the end of the official shortage was likely in sight. It took until today, nearly four months later, for regulators to conclude that the drug was widely available enough to remove it from the shortage list.
The FDA is giving “503A” compounders, typically state-licensed pharmacies or physician compounders that run smaller operations, until April 22 to cease producing the drug. It is giving “503B” compounders, which are larger outsourcing facilities that follow stricter manufacturing guidelines, until May 22.
Under ordinary circumstances, it’s not especially contentious when drugs come off a shortage list. But there is reason to believe that players within this industry will push back on this announcement.
Drug compounding is a well-established practice; pharmacists are permitted to make copies of medications when there’s a drug shortage or when patients need versions made in specific dosages or without allergens. But the GLP-1 boom has created an opportunity for compounders that has transformed pockets of the industry, with compounding pharmacies producing off-brand duplicates for likely millions of patients.
Robert MacArthur, director of pharmacy at the Rockefeller University Hospital, says that once a drug comes off the FDA shortage list, outsourcing pharmacies that make large batches of compounded drugs for health care facilities are not supposed to compound that drug anymore. But for smaller, traditional compounding pharmacies that make drugs for home use, it’s a legal gray area.
“They can compound it if the physician writes the prescription for an individual patient and feels there’s some compelling reason why that given patient needs that special compounded product,” MacArthur says. That reason could be adjusting the dose or tailoring the medication to a specific patient.
In December, the FDA declared that tirzepatide, the other popular GLP-1 drug, was no longer in shortage. The small 503A compounders had 60 days to stop production, while the larger 503B outsourcing facilities had 90 days to wrap up sales. Eli Lilly, which sells tirzepatide under the brand names Mounjaro and Zepbound, sent a flurry of cease-and-desist letters to hundreds of companies selling compounded versions. The compounding industry pushed back, with a trade group filing a lawsuit against the FDA, arguing that the drug was actually still hard to access for patients. As of now, the FDA has set deadlines for compounders to stop producing tirzepatide products, but it is not enforcing the deadlines at the moment as the lawsuit is ongoing.