Compounded Ozempic and Zepbound Still Widely Available After Shortages End

The Persistent Market for Compounded GLP-1 Medications

For millions of Americans seeking effective weight management solutions, the availability of GLP-1 receptor agonists like semaglutide and tirzepatide has been a critical factor. Following widespread shortages that began in 2022, the U.S. Food and Drug Administration (FDA) officially declared that supply chains for these medications had stabilized by May 2025. However, a recent investigation indicates that the market for compounded versions of these drugs has not diminished as many experts predicted.

A study published in JAMA Health Forum on July 17, 2026, highlights that Americans are continuing to purchase compounded versions of Ozempic and Zepbound more than a year after federal regulators announced the end of drug shortages. This persistence raises significant questions regarding drug safety, regulatory oversight, and the quality of care patients receive when seeking affordable alternatives to brand-name medications.

Study Findings: The Scope of Unregulated Availability

Lead researcher Michael DiStefano, an assistant professor at the University of Colorado Anschutz Skaggs School of Pharmacy and Pharmaceutical Sciences, led a team that conducted an unannounced survey of clinics and medical spas. The goal was to determine the actual accessibility of compounded GLP-1 drugs in regions with high demand.

Key Data Points from the Investigation

The research team contacted 75 brick-and-mortar weight-loss clinics and medical spas in Oklahoma and West Virginia. They posed as potential customers to assess whether these businesses could provide compounded versions of semaglutide (Ozempic/Wegovy) and tirzepatide (Mounjaro/Zepbound). The results were stark:

• 56% of businesses offered compounded versions containing additional ingredients, such as vitamin B12.
• Nearly 10% offered GLP-1 compounds in pill form, despite these medications typically requiring injection for efficacy.
• 23 compounding pharmacies were identified as the suppliers for these clinics.

DiStefano noted that the actual number of businesses offering these products is likely higher. Since the team could not contact one-quarter of the originally identified businesses, they estimate that more than 4,000 such businesses may exist across the United States. This suggests a robust, diffuse market that has not contracted following the official end of the shortage.

Regulatory Landscape and FDA Enforcement

To understand why these compounded drugs remain available, it is necessary to look at the regulatory history of GLP-1 medications. Demand for semaglutide and tirzepatide quickly outpaced supply following their approval, landing them on the FDA's shortage list in 2022. During this period, the FDA temporarily allowed pharmacies to compound copies of the drugs to help meet public demand.

However, the FDA has a specific timeline for resuming enforcement. By the end of May 2025, the agency declared it would resume enforcement of laws prohibiting compounded copies of drugs that are no longer in short supply. The expectation among many in the medical community was that this enforcement would shrink the market for compounded versions significantly.

Instead, the market has remained remarkably robust. This discrepancy highlights a gap between federal policy and on-the-ground reality. As DiStefano explained, "Our findings suggest this market didn't shrink after the shortages ended as many expected." This persistence raises important questions about how these products are regulated and how patients can verify whether they are receiving medications that meet appropriate quality standards.

Safety Risks Associated with Non-Sterile Compounding

The primary concern regarding the continued availability of compounded GLP-1 drugs is safety. Injectable medications, including GLP-1s, require strict sterile practices during the compounding process. When drugs are injected directly into the bloodstream, contamination can lead to life-threatening infections.

Identified Compliance Issues

Among the 23 compounding pharmacies identified in the study, four lacked licenses for sterile compounding. Several others had recent disciplinary actions or FDA warning letters related to sterile compounding practices. These findings are particularly concerning because sterile compounding is not optional for injectable medications; it is a fundamental requirement for patient safety.

Contaminated drugs can introduce bacteria, endotoxins, or particulate matter into the body. For patients who rely on weekly injections for weight management or diabetes control, a compromised sterile environment poses a direct health risk that outweighs the cost savings of the compounded product.

Understanding Modified Formulations and Efficacy

A common strategy observed in the study was the modification of compounded medications by adding substances like vitamin B12. Researchers suggest compounding pharmacies may have added these substances to claim their products are not direct copies of the brand-name drugs, thereby attempting to bypass legal restrictions on compounding.

However, the clinical benefit of these additions remains questionable. DiStefano stated, "One concern is whether we're seeing clinically meaningful personalization or changes that primarily allow compounded products to remain on the market." For many of the added ingredients, there is simply not enough evidence showing they improve safety or effectiveness compared to the standard formulation. Furthermore, offering GLP-1 medications in pill form presents significant pharmacological challenges, as these drugs are typically degraded by stomach acid before they can be absorbed effectively.

Practical Steps for Patients and Health Tracking

While compounded versions tend to be less expensive than brand-name GLP-1 meds, providing access to people of more limited means, patients should not have to choose between affordability and drug quality. The market has grown so large and diffuse that it is difficult for regulators to oversee every pharmacy supplying these medications. This makes patient vigilance essential.

Patients interested in compounded GLP-1 medications should talk with their doctor about why these drugs might be right for them and whether the pharmacy they have heard about meets sterile compounding standards. It is crucial to verify if the pharmacy is licensed for sterile compounding and if they have received any FDA warning letters.

For those currently using GLP-1 therapy, maintaining accurate records is vital for managing health outcomes. Platforms like Shotlee can assist patients in tracking their progress, symptoms, and doses over time. By logging weight trends and side effects, patients can identify patterns that might indicate issues with their medication source or dosage. Consistent health data helps healthcare providers make informed decisions about continuing therapy, adjusting doses, or switching to a verified brand-name product if safety concerns arise.

Patients should not stop taking a prescribed GLP-1 compound based on this study without first discussing it with their doctor. Abruptly stopping weight loss medication can lead to rebound weight gain or metabolic fluctuations. Instead, use the information to have a productive conversation with your care team about the source of your medication and its safety profile.

Conclusion

The study published in JAMA Health Forum underscores a complex reality in the current pharmaceutical landscape. Despite the FDA declaring shortages of semaglutide and tirzepatide over, the demand for compounded versions remains high, driven by cost and accessibility. However, this accessibility comes with risks regarding sterility and formulation accuracy.

Regulatory innovation is needed to preserve access while giving patients greater confidence that the products they are receiving are safe and appropriately manufactured. Until then, patients must exercise caution, verify pharmacy credentials, and maintain open communication with their healthcare providers to ensure their treatment remains both effective and safe.

Frequently Asked Questions

1. Is it legal to buy compounded Ozempic or Zepbound in 2026? Compounded versions are legally restricted once the FDA declares a drug is no longer in shortage. However, enforcement varies, and some pharmacies continue to offer them by adding ingredients like B vitamins to classify them as "modified" rather than direct copies.

2. What are the specific risks of non-sterile compounding? Non-sterile compounding can introduce bacteria, fungi, or particulate matter into injectable medications. This can lead to severe infections, abscesses, or systemic sepsis, particularly when drugs are administered directly into the bloodstream.

3. Why do some clinics offer GLP-1 medications in pill form? This is likely an attempt to bypass regulations or appeal to patients who dislike injections. However, semaglutide and tirzepatide are typically degraded by stomach acid in pill form, meaning they may not be effective orally without specific proprietary technology not present in standard compounding.

4. How can I verify if a pharmacy is licensed for sterile compounding? You can check with your state board of pharmacy or the United States Pharmacopeia (USP) directory. Additionally, look for accreditation from organizations like the Accreditation Commission for Health Care (ACHC) or the International Pharmacy Association of Compounding Pharmacists (IPAC).

5. Should I switch from a compounded GLP-1 to a brand-name medication? This decision depends on your clinical needs and financial situation. Discuss the risks and benefits with your doctor. If you experience side effects or concerns about the medication source, switching to a brand-name product may offer greater safety assurance.