The Regulatory Shift: Why Compounded Semaglutide is No Longer Available
For several years, the explosive demand for GLP-1 medications like Ozempic® and Wegovy®, used for type 2 diabetes and weight management, led to significant drug shortages [1.2.3, 1.3.2]. In response, the U.S. Food and Drug Administration (FDA) exercised "enforcement discretion," a temporary policy that allowed licensed compounding pharmacies to prepare their own versions of semaglutide to meet patient needs [1.2.3, 1.2.6]. This was a critical stopgap for many patients facing high costs and lack of availability.
However, in February 2025, the FDA officially declared that the national shortage of semaglutide was resolved [1.2.1, 1.5.1]. With manufacturers like Novo Nordisk now able to meet demand, the legal basis for routine compounding of semaglutide copies has ended [1.2.4, 1.5.5]. The grace period for pharmacies to cease production passed by May 22, 2025, effectively banning the general sale of compounded semaglutide [1.2.3, 1.3.6].
The only exception is for a patient with a specific medical need that cannot be met by the commercially available, FDA-approved drug, such as an allergy to an inactive ingredient [1.5.5]. This requires a prescriber's specific determination and is not a loophole for general use [1.3.5].
The Dangers of Unregulated Compounded Drugs
Throughout the shortage, the FDA and various state boards of pharmacy issued numerous warnings about the risks associated with compounded semaglutide [1.3.1, 1.8.1]. Because they are not FDA-approved, compounded drugs do not undergo the same rigorous review for safety, quality, or effectiveness [1.3.4].
Key risks identified include:
- Use of Improper Ingredients: The FDA has specifically warned against compounders using salt forms of semaglutide, such as semaglutide sodium and semaglutide acetate [1.3.1, 1.4.2]. These are chemically different from the 'base' form of semaglutide found in FDA-approved drugs and have not been proven safe or effective [1.4.1, 1.4.7].
- Potency and Purity Issues: Testing of some compounded products by the manufacturer, Novo Nordisk, revealed significant impurities—up to 33% in one sample—and inaccurate strength labeling [1.3.5]. Some products contained no semaglutide at all, while others were contaminated with bacteria or other substances [1.3.4].
- Risk of Overdose: Brand-name products like Ozempic® come in pre-filled injector pens with built-in safety features to ensure correct dosing [1.3.3]. Compounded versions are often supplied in multi-dose vials, leading to hundreds of reported adverse events due to dosing errors. Patients unfamiliar with using vials and syringes have administered up to 20 times the intended dose, sometimes requiring hospitalization [1.3.1, 1.8.3, 1.8.5].
- Fraudulent Products: The FDA has warned about counterfeit products sold online, some of which were found to contain insulin instead of semaglutide, leading to severe adverse reactions [1.3.2, 1.3.5].
Comparison: Compounded vs. Brand-Name Semaglutide
| Feature | Brand-Name (Ozempic®, Wegovy®) | Compounded Semaglutide (Now Largely Prohibited) |
|---|---|---|
| FDA Approval | Yes, reviewed for safety, efficacy, and quality [1.3.4]. | No, not FDA-approved [1.3.3]. |
| Active Ingredient | Semaglutide 'base' form [1.4.1, 1.4.3]. | May use unproven 'salt' forms (semaglutide acetate/sodium) or have impurities [1.3.1, 1.4.5]. |
| Delivery Method | Prefilled, multi-dose pens with safety features for accurate dosing [1.3.3]. | Multi-dose vials requiring manual measurement with a syringe, increasing overdose risk [1.3.1, 1.8.3]. |
| Cost (Out-of-Pocket) | Approximately $900 - $1,800+ per month [1.7.3, 1.7.5, 1.7.6]. | Was significantly cheaper, often $200 - $500 per month [1.7.4, 1.7.5]. |
| Insurance Coverage | Varies by plan; often covered for Type 2 diabetes, less so for weight loss alone [1.2.3, 1.7.3]. | Rarely covered by insurance [1.3.3, 1.7.3]. |
| Current Legality (as of Sep 2025) | Legal with a valid prescription [1.3.2]. | Production of copies is prohibited as the drug shortage has ended [1.2.6, 1.3.6]. |
How to Find a Reputable Pharmacy and Ensure Safety
With the ban on compounded copies, patients must now transition to FDA-approved brand-name medications. It is crucial to get these drugs from a legitimate source. Avoid any online entity advertising "semaglutide" without requiring a prescription [1.3.3].
To ensure you are using a safe and licensed pharmacy, follow these steps:
- Verify Licensure: Only use state-licensed pharmacies [1.3.4]. You can check a pharmacy's license status on your state's Board of Pharmacy website [1.6.3]. For online pharmacies, look for the
.pharmacydomain ending, which indicates verification by the National Association of Boards of Pharmacy (NABP) [1.6.5]. - Consult Your Doctor: Always obtain medication through a prescription from a licensed healthcare provider who performs a proper medical evaluation [1.3.2, 1.3.4].
- Check for Accreditation: While more relevant for pharmacies that still perform other types of compounding, accreditation from the Pharmacy Compounding Accreditation Board (PCAB) signifies a commitment to high-quality standards [1.6.1, 1.6.2].
Authoritative Link: For the most current information, refer to the FDA's page on medication compounding and drug shortages.
Conclusion: The Path Forward for Patients
The era of easily accessible compounded semaglutide has concluded with the resolution of the national drug shortage. The FDA's decision prioritizes patient safety by steering them toward regulated, tested, and properly dosed brand-name medications like Wegovy® and Ozempic® [1.2.1, 1.5.5]. While the cost difference is significant, the risks associated with unregulated compounded products—from incorrect ingredients to life-threatening overdoses—are too high to ignore. Patients who were using compounded semaglutide should immediately consult their healthcare provider to create a transition plan to an FDA-approved medication and discuss options for managing the cost [1.2.1, 1.2.4].
