Most compounded versions of popular drugs used for weight loss including Wegovy and Zepbound may soon no longer be available after a U.S. judge declined an initial injunction to allow compounding pharmacies to continue making versions.
Compound drugs are copies of U.S. Food and Drug Administration-approved medications. They are made by licensed pharmacies, but not approved or inspected by the FDA.
Drug compounding is allowed when drugs are on the FDA's shortage list, or in circumstances when a patient can't take a version of a drug made by a pharmaceutical company and they need an alternative.
In recent months, Eli Lilly, the maker of Zepbound and Mounjaro, and Novo Nordisk, the maker of Ozempic and Wegovy, have each said that they are able to meet the demand for the medications after facing shortages since 2022 due to the drugs' growing popularity.
The FDA has declared the shortages as “resolved," removing the drugs from its shortage list.
In October, the compounding industry group Alliance for Pharmacy Compounding filed a lawsuit against the FDA's decision that there was no longer a shortage of tirzepatide, the active ingredient fin Zepbound and Mounjaro. The FDA said it would not take enforcement action against compounders before the court ruled.
Now, the FDA has announced a timeline for when most compounded versions may no longer be made.
“The agency in October ended the tirzepatide injection shortage prematurely based on representations from drugmakers and incomplete data on demand for the compounded versions of the drug,” Alliance for Pharmacy Compounding CEO Scott Brunner said a statement to ABC News. “That premature decision resulted in unnecessary patient angst and interruptions of therapy when pharmacies could not access the FDA-approved drugs for those patients. When pharmacies consistently can't obtain the FDA-approved drug in quantities they need to meet patient demand, that drug is not commercially available – the very definition of a shortage.”
Here are five questions answered about the FDA's decision to halt compounded versions of GLP-1 drugs.
The FDA says state-licensed compounding pharmacies must immediately stop making most compound versions of GLP-1 drugs based on tirzepatide.
Larger outsourcing pharmacies making compound versions of Zepbound have until March 19 to stop, according to the FDA.
State-licensed pharmacies must stop making most compounded semaglutide (copies of Novo Nordisk’s Wegovy and Ozempic) by April 22, and larger outsourcing pharmacies by May 22, or when district court rules on a pending injuction – whichever is first.
ABC News chief medical correspondent Dr. Tara Narula said Tuesday on "Good Morning America" that the FDA's decision to halt the making of compound versions of GLP-1 drugs will impact many people who have found the compound versions of the drugs easier to access and lower in price.
Narula said people currently taking compound versions of GLP-1 medications should reach out now to their health care provider to ask for a prescription for the branded version of the medication.
Yes, there are some ways to help lower the price of GLP-1 medications, which can cost upward of $1,000 per month without insurance coverage.
If insurance coverage is not an option, people can look for outside coupons, often found on drug manufacturers' websites, to help lower the cost, according to Narula.
Woman says she got less expensive drug for weight loss after being denied by insuranceBoth Eli Lilly and Novo Nordisk now also offer consumers who lack insurance coverage the option to buy Zepbound and Wegovy, respectively, on direct-to-consumer platforms at a lower cost.
The FDA has previously warned consumers about using compounded versions of FDA-approved medications.
"Compounded drugs pose a higher risk to patient than FDA-approved drugs because compounded drugs do not undergo FDA premarket review for safety, effectiveness, or quality," the agency said in a statement to ABC News in 2023. "The FDA's compounding program aims to protect patients from poor quality compounded drugs, while preserving access to lawfully marketed compounded drugs for patients."
Compound versions of drugs -- made for individual patients using raw ingredients -- are not required to go through the FDA's rigorous approval process.
Zepbound is approved by the FDA as a weight loss management treatment for people with obesity or those who are overweight with at least one weight-related condition such as high blood pressure.
Zepbound contains the same active ingredient, tirzepatide, as Mounjaro, which is also made by Lilly and is FDA-approved to treat Type 2 diabetes. Some doctors also prescribe Mounjaro "off-label" for weight loss, as is permissible by the FDA.
Tirzepatide works by helping the pancreas increase the production of insulin to move sugar from the blood into body tissues.
It also slows down the movement of food through the stomach and curbs appetite, thereby causing weight loss.
Some people are overdosing on semaglutide, FDA warnsOzempic is approved by the FDA to treat Type 2 diabetes, but some doctors prescribe the medication "off-label" for weight loss, as is permissible by the FDA.
Wegovy contains the same main ingredient as Ozempic, semaglutide, and is FDA-approved for weight loss in people with obesity or who are overweight with at least one weight-related condition. It is also approved to reduce the risk of major cardiovascular events in adults with obesity or who are overweight with established cardiovascular disease.
Semaglutide also works by slowing down movement of food through the stomach and curbing appetite, thereby causing weight loss.
Editor’s note: This story has been updated to clarify that a US judge has denied an injunction that prompted the FDA to update their guidance.
