FDA Halts Sale of Off-Brand Ozempic
The FDA has declared the shortage of Ozempic and similar medications to be over, a decision that ends the legal ability of compounding pharmacies to produce and sell off-brand versions. This change impacts patients who rely on semaglutide for diabetes or weight loss and also addresses the FDA’s repeated warnings about the safety risks and false labeling associated with these compounded products. Here’s what this means for you and what to do if you’re struggling to afford your medications.
What Is Ozempic?
Ozempic is a prescription injection that contains semaglutide as its active ingredient. It’s an effective option for managing blood sugar levels in people who have Type 2 diabetes, and it has even shown benefits for those struggling with cardiovascular issues.
How Does Ozempic Work?
Ozempic works by mimicking a natural hormone called GLP-1, which your small intestine produces when you eat. This hormone tells your brain when you’re full, slows digestion, and also helps you produce more insulin. By mimicking GLP-1, Ozempic has become a sought-after option for weight loss, too.
Why Can’t All Patients Afford Ozempic?
Many patients who require semaglutide for the management of diabetes might not be able to purchase Ozempic, whether there’s a shortage or not. Some health insurance plans only cover Ozempic for those with advanced diabetes, while others don’t cover it at all. The out-of-pocket costs can be significant.
How Did Off-Brand Ozempic Come to Market?
Ozempic has become one of the most popular ways to lose weight and address blood sugar level problems in people who have diabetes. This drug became so popular several months ago that shortages threatened to harm patients who depend on the medication.
Because of these shortages, the Food & Drug Administration (FDA) allowed compounding pharmacies to create off-brand Ozempic to supplement stocks. As of March 2025, however, the FDA declared the end of the shortage. Off-brand Ozempic can no longer be legally produced or sold.
Why Did the FDA Stop Compounded Ozempic?
1. Compounded Medications Are Not FDA-Approved
Compounded medications don’t have FDA approval, meaning they have not gone through the rigorous evaluation process that proves them safe. A compounded drug may vary in purity and could cause unexpected interactions.
2. The FDA Found Fraudulent Products
Some compounded semaglutide products carried false labels or were tied to fake pharmacies. In other cases, real pharmacies’ names were used without their knowledge. These fraudulent drugs posed serious safety risks.
3. Patients Have Reported Safety Concerns
The FDA received multiple reports of adverse effects, including hospitalizations. Problems often stemmed from dosing errors (either patients taking too much or pharmacists preparing unsafe injections).
4. Salt Forms Are a Concern for the FDA and Patients
Some providers offered semaglutide sodium or semaglutide acetate, which are different active ingredients from those in Ozempic. These may not have the same benefits and could put patients at risk.
What This Means for Your Medications
Despite the FDA claiming that there’s enough Ozempic to address the current demand and that manufacturers have the capacity to continue producing the medication at a fast rate, some medical professionals are not as certain. There is concern that there won’t be enough of the drug for those who need it for diabetes treatment.
Since there is a high demand for Ozempic and worries about supply, prices likely won’t diminish. Pharmaceutical companies don’t have the incentive to lower costs. For people who struggle to afford their medications every month, this could mean going without the treatments that can help stabilize their blood sugar levels. For more on how FDA changes may affect drug prices beyond Ozempic, see our blog: New FDA Rules Could Raise Medication Prices & Slow Access.
How Patient Assistance Programs Can Help with Ozempic
For patients who face high out-of-pocket costs for their Ozempic, patient assistance programs (PAPs) can provide critical support. These programs are often sponsored by drug manufacturers, nonprofit organizations, or pharmacies and help eligible patients access medications at little or no cost.
Typical benefits include:
- Discounted or free prescriptions for qualified patients
- Support with insurance paperwork and program applications
- Ongoing enrollment management to ensure patients don’t lose access
- Options for uninsured or underinsured patients
Get Affordable Access to Prescription Medications
Simplefill is a full-service prescription assistance company that researches, qualifies, and maintains patients’ enrollment in all sources of assistance available to them.
Apply today by calling 877-386-0206. A caring Simplefill representative will contact you within 24 hours to discuss your application and, if qualified, enroll you in the program.
Frequently Asked Questions
Can I still buy off-brand Ozempic?
No. As of March 2025, the FDA declared the shortage over, meaning compounding pharmacies can no longer legally produce or sell off-brand Ozempic.
Why is Ozempic so expensive?
Ozempic can cost over $900 to $1,200 per month without insurance. Many health plans only cover it for advanced diabetes, not for weight loss, leaving patients with high out-of-pocket costs.
Are compounded medications FDA-approved?
No. Compounded versions of Ozempic were never FDA-approved. They skipped the normal safety and efficacy review, which is why the FDA raised concerns.
What risks were linked to off-brand Ozempic?
The FDA cited reports of overdoses, improper dosing, false labeling, and unsafe “salt forms” like semaglutide sodium and acetate that differ from brand-name Ozempic.
How can I afford Ozempic if my insurance doesn’t cover it?
Programs like Simplefill’s patient assistance program can help you apply for discounts and support so you don’t have to skip doses.