Does compounded semaglutide lose its potency? An essential guide to medication stability

October 10, 2025 •

5 min read

Reports from the FDA highlight significant concerns regarding the quality of compounded drugs, including semaglutide, with some batches containing incorrect dosages or ingredients. This raises the critical question: Does compounded semaglutide lose its potency over time, and what factors contribute to its stability?

Quick Summary

Compounded semaglutide's potency can degrade due to improper storage, heat, light, and formulation inconsistencies, unlike strictly regulated FDA-approved versions. Beyond-Use Dates (BUD) are shorter, and quality control varies, presenting risks of reduced effectiveness and potential harm.

Key Points

Less Stable Formulation: Compounded semaglutide is generally less stable than FDA-approved versions due to formulation inconsistencies and the potential use of unproven semaglutide salts.
Temperature is Critical: Potency loss can occur rapidly if compounded semaglutide is exposed to extreme temperatures, heat, or light; it must be consistently refrigerated between 36-46°F (2-8°C).
Shorter Shelf Life: Compounded semaglutide has a Beyond-Use Date (BUD) that is typically much shorter (e.g., 28-90 days) than the expiration date of FDA-approved products, and potency is not guaranteed beyond this period.
Signs of Degradation: Watch for visual cues like discoloration, cloudiness, or particles, which indicate the medication has likely lost its effectiveness and should be discarded.
Not FDA Approved: The FDA does not review or approve compounded semaglutide for safety and effectiveness, meaning its quality and potency are not guaranteed by federal standards.
Discard if Frozen: Freezing will destroy the protein structure of semaglutide, permanently reducing its effectiveness, and any medication that has been frozen must be discarded.

Compounded semaglutide is a custom-made version of the medication prepared by compounding pharmacies, primarily used as an alternative during drug shortages or for patients with specific needs, such as a dye allergy. While it contains the same active ingredient, semaglutide, it differs significantly from its FDA-approved brand-name counterparts like Ozempic and Wegovy. The key difference lies in the level of regulatory oversight, which directly impacts the medication's consistency, quality, and stability. The answer to whether does compounded semaglutide lose its potency is a complex one, but the short answer is yes, and with more variables than regulated products.

Why Potency Is a Concern for Compounded Medications

Unlike commercially manufactured drugs that undergo a rigorous, standardized FDA approval process, compounded medications are not subject to the same stringent safety, effectiveness, and manufacturing quality reviews. This lack of federal oversight is the primary reason for inconsistencies and potential potency issues with compounded semaglutide. The FDA has repeatedly warned both healthcare providers and patients about the risks associated with these unapproved versions.

The Impact of Manufacturing and Ingredients

The formulation of compounded semaglutide can vary considerably between different compounding pharmacies. Factors that influence quality and stability include:

Unproven Ingredients: The FDA warns that some compounders have used semaglutide salts (like semaglutide sodium or acetate) instead of the base form found in approved drugs. These salt forms have not been proven to be safe and effective and may have different chemical and pharmacological properties.
Ingredient Sourcing: Without robust supply chain controls, there is a greater risk of using substandard or illegally sourced active pharmaceutical ingredients (APIs).
Inconsistent Manufacturing: Errors in measurement, mixing, or sterile procedures can lead to batches with varying concentrations or contamination. This variability means one batch could be more potent, while another is significantly weaker, or even dangerous.

Key Factors that Cause Potency Loss

For any injectable medication, proper storage is crucial for maintaining its stability and effectiveness. For compounded semaglutide, this is especially important due to the formulation's potential lack of robust stabilizers or preservatives.

The Role of Temperature

Temperature is a major factor that accelerates the degradation of semaglutide, which is a peptide-based drug.

Refrigeration is Crucial: Compounded semaglutide must be stored in the refrigerator at 36-46°F (2-8°C) to maintain its chemical integrity. Storing it at room temperature for an extended period, particularly above 86°F (30°C), will cause the medication to degrade and lose potency.
Never Freeze: Freezing semaglutide is strictly prohibited. The freezing process can irreversibly damage the peptide's molecular structure, rendering it ineffective and potentially triggering adverse reactions upon injection.

Understanding Beyond-Use Dates (BUD)

Instead of an expiration date, compounded drugs are assigned a Beyond-Use Date (BUD). This date is assigned by the compounding pharmacy and indicates the time after which the medication may no longer be safe and effective, and it is almost always shorter than the expiration date on FDA-approved products.

Shorter Shelf Life: While FDA-approved Ozempic pens can be stable for up to 56 days after opening (at room temperature or refrigerated), compounded semaglutide often has a BUD of 28 to 90 days from the compounding date, regardless of when it was first used. The specific BUD depends on the pharmacy's specific formulation, ingredients, and stability data.

Compounded vs. FDA-Approved Semaglutide: A Comparison


Feature	FDA-Approved Semaglutide (Ozempic/Wegovy)	Compounded Semaglutide	Benefits of FDA-Approved	Risks of Compounded
Regulation	FDA-approved, with strict quality control for safety, purity, and potency.	Not FDA-approved or regulated for safety and effectiveness.	Guarantees of consistency, safety, and effectiveness.	Significant variability, risk of inconsistent dosing.
Stability	Highly tested and stable up to the labeled expiration date when stored correctly. Ozempic can be kept for up to 56 days after opening.	Dependent on the compounding pharmacy's process and ingredients. Often less stable with a shorter Beyond-Use Date (BUD).	Predictable stability and a longer shelf life once opened.	Faster degradation, especially if not stored perfectly.
Ingredients	Uses the pure, base form of semaglutide, confirmed in clinical trials.	May use unproven semaglutide salts (acetate or sodium) with unknown safety and efficacy profiles.	Ingredients are verified for safety and therapeutic effect.	Untested active ingredients with potentially different effects or risks.
Cost	Typically higher, with cost dependent on insurance coverage.	Usually cheaper, which can be a motivator for many patients.	Offers patient support programs and insurance pathways.	Affordability can come at the cost of safety and reliability.

How to Tell If Compounded Semaglutide Has Lost Potency

Since you cannot test the concentration of the active ingredient yourself, you must rely on storage protocols and visual inspection. If potency is reduced, your treatment effectiveness will likely suffer. You may see slower weight loss results or less effective blood sugar control.

Signs of degradation and potential loss of potency include:

Changes in Appearance: The liquid should be clear and colorless. If it appears cloudy, discolored, or contains particles, it has likely degraded and should not be used.
Improper Storage: If the vial was left unrefrigerated for an extended period, exposed to freezing temperatures, or left in direct sunlight, its potency is compromised. Even without visual changes, it is not guaranteed to be effective.
Past the Beyond-Use Date: Using the medication beyond its BUD is a primary indicator that its potency is no longer assured.

FDA Warnings and Recommendations

The FDA maintains a clear stance on compounded semaglutide. According to the FDA, compounded drugs should only be used when an FDA-approved drug is not available to meet a patient’s specific medical needs. Concerns include dosing errors, use of unproven semaglutide salts, and reports of adverse events. Due to the resolution of the FDA-listed drug shortages, compounding for semaglutide is no longer legally permitted, except in limited cases. Patients should be vigilant about the source of their medication and always choose FDA-approved products when possible.

Conclusion: The Bottom Line on Potency

While FDA-approved semaglutide is a highly stable medication when stored correctly, compounded semaglutide carries a significant risk of losing its potency. Factors contributing to this include the lack of robust regulatory oversight, variable manufacturing practices, the potential use of unproven ingredients like semaglutide salts, and a shorter Beyond-Use Date. The primary responsibility falls on the patient to adhere to strict storage requirements, including consistent refrigeration and avoiding temperature extremes like freezing. Any deviation from these guidelines, or use past the BUD, means the medication’s safety and effectiveness are no longer guaranteed. For reliable and consistent treatment, the FDA recommends using only approved versions of the drug when they are available. Protecting your health requires informed decisions about where your medication comes from and how it is handled.

For more information on the dangers of using unapproved versions of GLP-1 drugs, consult the FDA's official concerns with unapproved GLP-1 drugs.

Frequently Asked Questions

Compounded semaglutide's potency is less reliable because it is not subject to the FDA's strict quality control, manufacturing, and stability testing that FDA-approved drugs undergo. This can lead to variations in formulation and active ingredient concentration between batches.

A Beyond-Use Date (BUD) is assigned by a compounding pharmacy and indicates the date after which a compounded medication should not be used. Unlike an expiration date on an FDA-approved drug, which is based on extensive stability testing, the BUD for compounded products is often shorter and based on more limited data.

Compounded semaglutide should be stored in the refrigerator at temperatures between 36-46°F (2-8°C). It should be protected from direct sunlight, heat, and never be frozen, as these conditions cause the medication to degrade.

If left unrefrigerated, compounded semaglutide can quickly lose its potency as the peptide-based active ingredient is sensitive to temperature changes. This can result in reduced effectiveness for blood sugar control or weight management.

Risks include a loss of effectiveness, leading to poor treatment outcomes; unpredictable potency, which can affect dosing; and, in rare cases, chemical degradation that may produce harmful byproducts or increase the risk of contamination.

Visual inspection can offer clues, but it's not a reliable way to confirm potency. If the liquid appears cloudy, discolored, or contains particles, it should be discarded. However, loss of potency can occur without any visible changes.

The FDA has warned patients and healthcare providers about the use of unapproved compounded semaglutide, noting reports of dosing errors and the use of untested salt forms. The FDA advises using FDA-approved drugs when available and not in shortage.

No. According to the FDA, semaglutide salts (like sodium or acetate) have not been shown to be safe and effective and may not have the same properties as the base form found in FDA-approved products.