After years of shortages, the Food and Drug Administration (FDA) has now listed Novo Nordisk’s blockbuster diabetes and obesity medications Wegovy and Ozempic as “available.”

Semaglutide remains on the agency’sdrug shortage list, but all FDA-approved forms of the drug are no longer labeled “currently in shortage.” The agency may soon determine the shortage is resolved and remove the drug from the list entirely.

When an FDA-approved drug is in shortage, compounding pharmacies may legally dispense generic versions for patients who can’t access the brand-name version. Removing the highly popular diabetes and obesity medications from the shortage list could limit options for patients who rely on cheaper and more accessible compounded forms of tirzepatide and semaglutide.

“It is important to note that even when a medication is available, patients may not always be able to immediately fill their prescription at a particular pharmacy,” a Novo Nordisk spokesperson said in a statement to Verywell. “Patients may experience variability at a particular pharmacy location regardless of whether a drug is in shortage.”

The FDA usually updates its drug shortage list based on reports from pharmaceutical companies about their supply. According to Novo Nordisk, the recent availability update is the result of the company’s heavy investment in manufacturing plants to increase its supply in the United States.

Ozempic (Semaglutide) - Subcutaneous

Why the FDA Shortage Status Matters

When a drug is on the FDA shortage list, compounding pharmacies can legally mix off-brand copies of the FDA-approved medication. For drugs like semaglutide and tirzepatide, the compounded versions tend to be much less expensive than the brand-name versions.

There are two types of compounding pharmacies: 503A and 503B.

503A compounding pharmacies work like traditional pharmacies. When your doctor writes you a prescription for a compounded medication, a pharmacist at a 503A will create it for you or dispense a drug made at a 503B facility. 503B outsourcing facilities operate on a large scale, creating compounded drugs to distribute to traditional pharmacies.

People may get a prescription for a compounded medication if they need a dosage size, format, or ingredient mix that differs from the FDA-approved version. When a brand-name drug is on the FDA shortage list, 503B pharmacies may create off-brand versions to help meet demand.

In the lawsuit filed against the FDA, two compounding pharmacy organizations said the agency’s decision to take Zepbound and Mounjaro off the shortage list came “without notice, without soliciting input from affected parties and the public, and without meaningful rationale.”

“Put simply, FDA knows its action will leave many patients with no effective treatment but persisted with that action anyway on an expedited basis and without warning,” thelawsuit alleges.

Days after the lawsuit was filed, the FDA said it would reconsider the status change. In the meantime, compounding pharmacies can continue to provide generic tirzepatide to their patients for six weeks, ending on November 21.

“We believe FDA was capricious in declaring an end to a shortage,” saidScott Brunner,Chief Executive Officer at the Alliance for Pharmacy Compounding, an organization that represents both 503A and 503B pharmacies.

“We believe that the information and data that they relied on was incomplete at best, and we absolutely believe that FDA failed to understand that this shortage is not like other shortages,” he told Verywell.

Is Compounded Semaglutide Safe?

The GLP-1 Drug Shortage Is Not Like Others

Drug shortages are not uncommon in the U.S. There are nearly 300 drugs in shortage currently, most of which are older generic drugs. Many of those are injectable medications used in hospitals and other healthcare settings, according toMichael Ganio, PharmD, MS, senior director of pharmacy practice and quality at the American Society of Health-System Pharmacists (ASHP).

ASHP publishes a drug shortage list independent of the FDA. Healthcare providers or caregivers report a shortage to ASHP, and a team at the University of Utah helps to investigate it. If the shortage is confirmed, it is listed on the ASHP website.

“There is no good metric to understand demand. Prescribing practices change when clinicians know there is a shortage, so the number of prescriptions and the number of products dispensed cannot be used to measure demand,” Ganio said in an email to Verywell.

There are data repositories to track insurance claims for FDA-approved drug prescriptions. But insurance plans usually don’t reimburse for compounded drugs. That means there’s no way to know just how many people have been prescribed off-brand versions of tirzepatide and semaglutide.

Brunner said that if demand for branded tirzepatide and semaglutide increases after patients can no longer access compounded versions, the current drug supply may not be enough to meet patients’ needs.

According to Brunner, some pharmacies have a waiting list with dozens to hundreds of patients seeking Ozempic, Wegovy, Zepbound, or Mounjaro. When there is enough stock for pharmacists to order the medications, they may only be able to get two to five boxes a day.

“The FDA failed to account for the fact that the moment that drug comes off the shortage list, you have the potential to have hundreds of thousands of patients caught flat-footed. They’ve got a prescription now that can no longer be filled,” Brunner said. “An interruption of that therapy could have health consequences for those patients.”

Why Is Ozempic So Expensive? Novo Nordisk Blames Prescription Drug Middlemen

It Will Become Harder to Access Cheap Off-Brand Versions

Legally, clinicians cannot prescribe a compounded drug for price reasons. But compounded tirzepatide and semaglutide can run hundreds of dollars a month cheaper than the brand-name versions, fueling demand for the off-brand versions, Ganio said. Severaltelehealth companiesuse that price difference to market their compounded tirzepatide and semaglutide to consumers.

If a patient’s pharmacy runs out of brand-name versions of their GLP-1 medication and that pharmacy is no longer allowed to offer a compounded version to fill the shortage, patients are left with no options to get their medication, Ganio said.

Many insurance policies don’t cover the cost of tirzepatide and semaglutide. Brunner said he expects that many patients will have to stop taking the drugs entirely because they can’t afford the FDA-approved drug.

“Compounding pharmacies have saved the day for hundreds of thousands of Americans during this period of shortage, when the drug makers have not been able to meet the demand. But compounders’ ability to do that has a shelf life,” Brunner said. “Over the next month or year or so, we’re going to move toward a market that is more normal, in which those FDA-approved drugs will come back into supply, and those are what will, for the most part, be prescribed to patients.”

For people who are worried about losing access to their prescribed compounded semaglutide and tirzepatide, Brunner said not to stockpile the medication. Instead, he recommends talking to a healthcare provider about whether the FDA-approved version of their medication will work for them.

Why People Stop Taking Anti-Obesity Drugs

What This Means For YouIf you have a prescription for compounded tirzepatide or semaglutide, it may soon become inaccessible to you. Speak with your healthcare provider about whether the brand-name version of the drug is right for you and how you can get a prescription for it.

What This Means For You

If you have a prescription for compounded tirzepatide or semaglutide, it may soon become inaccessible to you. Speak with your healthcare provider about whether the brand-name version of the drug is right for you and how you can get a prescription for it.

1 SourceVerywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.Food and Drug Administration.Compounding inspections and oversight frequently asked questions.

1 Source

Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.Food and Drug Administration.Compounding inspections and oversight frequently asked questions.

Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.

Food and Drug Administration.Compounding inspections and oversight frequently asked questions.

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