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Shelf life of semaglutide compound is a critical consideration for patients using custom-prepared formulations of this GLP-1 receptor agonist medication. Unlike FDA-approved products such as Ozempic and Wegovy with manufacturer-determined expiration dates, compounded semaglutide carries a beyond-use date (BUD) that is typically shorter and varies by pharmacy. Understanding proper storage requirements, factors affecting stability, and signs of degradation is essential for maintaining medication safety and therapeutic effectiveness. This guide provides comprehensive information on compounded semaglutide shelf life, helping patients and healthcare providers ensure optimal medication quality throughout the treatment period.
Summary: Compounded semaglutide typically has a beyond-use date (BUD) that is shorter than FDA-approved formulations, generally requiring refrigerated storage at 2°C to 8°C with specific timeframes determined by the compounding pharmacy.
Compounded semaglutide refers to custom-prepared formulations of the glucagon-like peptide-1 (GLP-1) receptor agonist semaglutide, created by specialized compounding pharmacies. Unlike FDA-approved brand-name products such as Ozempic and Wegovy, which undergo rigorous manufacturing standards and stability testing, compounded versions are prepared individually according to prescriber specifications and are not FDA-approved.
The primary difference lies in manufacturing and quality assurance. FDA-approved semaglutide products contain precisely measured active ingredient with established potency, sterility, and stability profiles validated through extensive clinical trials. Ozempic and Wegovy have different formulations and excipients—Ozempic is a multi-dose pen containing preservatives, while Wegovy is available in single-dose pens. Compounded semaglutide, conversely, may vary in formulation composition, concentration, and preparation methods depending on the compounding pharmacy's protocols.
Compounding pharmacies typically prepare semaglutide from bulk active pharmaceutical ingredients (APIs) rather than reconstituting commercial products. This practice is only permitted under specific circumstances, such as during FDA-recognized drug shortages or when a patient has a specific medical need that cannot be met by an approved product. The FDA has specifically warned against using semaglutide salt forms (such as semaglutide sodium or acetate), which are not the same active ingredient as in FDA-approved products.
Patients should understand that compounded medications do not undergo the same pre-market approval process as FDA-regulated drugs. While compounding serves legitimate medical needs—such as dose customization or allergen avoidance—the lack of standardized stability data means shelf life and storage requirements may differ significantly from commercial products. Healthcare providers prescribing compounded semaglutide should source from reputable 503B outsourcing facilities or state-licensed 503A pharmacies that follow United States Pharmacopeia (USP) standards for sterile compounding.
The shelf life of compounded semaglutide varies considerably and is generally shorter than FDA-approved formulations, which carry manufacturer-determined expiration dates when stored according to label instructions. Compounded semaglutide typically has a beyond-use date (BUD) rather than an expiration date, reflecting the limited stability data available for custom-prepared formulations.
Under current USP Chapter <797> (2023) guidelines for sterile compounding, compounded semaglutide would typically be assigned a BUD based on its preparation category. For Category 1 or Category 2 compounded sterile preparations stored under refrigeration (2°C to 8°C or 36°F to 46°F), default BUDs are limited unless the pharmacy has conducted specific stability, sterility, and container-closure integrity testing. Some compounding facilities perform extended stability studies that may support longer BUDs under Category 3, but these are not standardized across the industry.
Once reconstituted or first punctured, multi-dose compounded semaglutide vials should be used within the timeframe specified by the compounding pharmacy. While the CDC and USP generally recommend a 28-day limit for multi-dose vials containing preservatives after first puncture (when manufacturer guidance is absent), this does not extend a shorter BUD assigned by the compounder. By comparison, FDA-approved Ozempic pens remain stable for 56 days after first use when refrigerated. The difference stems from variations in formulation composition, container closure systems, and the controlled manufacturing environment of FDA-approved products.
Patients must recognize that the BUD assigned by their compounding pharmacy represents the maximum time the medication should be considered safe and effective. Using compounded semaglutide beyond this date risks receiving subpotent medication with reduced therapeutic effect. Additionally, degraded peptide products may theoretically pose safety concerns, though clinical data on this specific risk remains limited. Always verify the BUD on your medication label and consult your pharmacist if unclear about proper storage duration.
Multiple variables influence the stability and shelf life of compounded semaglutide, with temperature exposure being the most critical factor. Semaglutide is a 31-amino acid peptide that undergoes degradation through several pathways, including deamidation, oxidation, and aggregation when exposed to suboptimal conditions. Even brief temperature excursions outside the recommended 2°C to 8°C (36°F to 46°F) range can accelerate degradation and reduce potency.
Formulation composition significantly impacts stability. Ozempic contains excipients including disodium phosphate dihydrate, propylene glycol, and phenol as a preservative, while Wegovy has a different formulation appropriate for its single-dose delivery system. Compounded versions may use different buffer systems, pH adjusters, or preservative combinations that affect long-term stability. The pH of the solution is particularly important for peptide stability, and deviations can promote degradation. Some compounding pharmacies may not achieve the precise pH control maintained in commercial manufacturing.
Container type and sterility maintenance also affect shelf life. Multi-dose vials require preservatives to prevent microbial growth after repeated punctures, and the quality of the rubber stopper and vial seal influences both sterility and drug stability. Exposure to light can degrade peptide medications, making amber or opaque vials preferable. The frequency of vial access and needle punctures introduces contamination risk and allows air exposure that may oxidize the peptide.
The source and quality of the active pharmaceutical ingredient used by the compounding pharmacy matters considerably. Bulk semaglutide APIs vary in purity and may contain different levels of related substances or degradation products. Reputable compounding facilities source from FDA-registered suppliers and perform certificate of analysis verification, but quality assurance practices are not uniform across all compounding pharmacies. Additionally, compounded combinations (such as semaglutide with vitamin B12) lack validated stability and compatibility data, potentially compromising medication integrity.
Proper storage of compounded semaglutide is essential to maintain medication potency and safety throughout its beyond-use date. Store unopened and opened vials continuously in the refrigerator at 2°C to 8°C (36°F to 46°F). Place the medication in the main refrigerator compartment rather than the door, where temperature fluctuations occur with frequent opening. Avoid storing near the freezer compartment or cooling elements where accidental freezing might occur—frozen semaglutide should never be used, even after thawing, as freezing irreversibly damages the peptide structure.
Protect compounded semaglutide from light exposure by keeping it in its original container, which should be amber or opaque. If your pharmacy provides clear vials, store them in the original box or wrap in aluminum foil. Never transfer compounded semaglutide to different containers, as this compromises sterility and makes tracking the beyond-use date difficult. Keep the medication away from direct sunlight and fluorescent lighting.
When traveling with compounded semaglutide, use an insulated medication cooler with ice packs or gel packs to maintain appropriate temperature. Monitor that ice packs do not directly contact the vial, which could cause localized freezing. For flights, carry medication in carry-on luggage rather than checked baggage, where cargo hold temperatures may fall below freezing. The Transportation Security Administration (TSA) permits medically necessary liquids exceeding 3.4 ounces when properly declared at security checkpoints.
Maintain a medication log noting the date you first puncture a multi-dose vial and calculate the discard date based on your pharmacy's instructions. Use a permanent marker to write the "opened date" and "discard after" date directly on the vial label. Clean the rubber stopper with alcohol before each injection to minimize contamination risk, following CDC injection safety guidelines. Never share vials between patients, even family members, as this violates sterility and poses infection transmission risk. If you miss doses and approach the beyond-use date with significant medication remaining, consult your healthcare provider about whether to continue or obtain a fresh vial—do not extend use beyond the assigned BUD.
Recognizing signs of degraded or expired compounded semaglutide is crucial for medication safety and therapeutic effectiveness. The most obvious indicator is exceeding the beyond-use date printed on the vial label by your compounding pharmacy. Using medication past this date is not recommended, as potency cannot be guaranteed and degradation products may have formed. Even if the solution appears normal, chemical changes invisible to the naked eye may have occurred.
Visual inspection provides important clues about medication integrity. Compounded semaglutide should appear as a clear, colorless to slightly yellow solution. Discard the medication immediately if you observe any of the following: particulate matter (floating particles, sediment, or cloudiness), color changes (darkening, browning, or unusual discoloration), crystallization (visible crystals or precipitate), or changes in viscosity (thickened or gel-like consistency). These physical changes indicate chemical degradation or contamination.
The presence of visible particles is particularly concerning, as this may represent peptide aggregation, microbial contamination, or interaction between the drug and container components. Even small particles that settle at the vial bottom warrant discarding the medication. Do not attempt to filter, heat, cool, or otherwise manipulate medication with any visible abnormalities. Cloudiness or turbidity, even if transient, suggests protein aggregation or bacterial growth.
After injection, monitor for signs of possible contamination, including fever, increasing redness or warmth at the injection site, swelling, or unusual pain. These symptoms could indicate infection and require immediate medical attention. While rare, contaminated injectable medications can cause serious infections.
Reduced therapeutic effectiveness may indicate degraded medication, though this is difficult to assess without laboratory testing. If you notice diminished appetite suppression, lack of expected weight loss, or rising blood glucose levels (if using for diabetes management) despite adherence to your regimen, discuss with your healthcare provider whether medication potency might be compromised. However, many factors affect treatment response, so do not assume medication degradation without clinical evaluation.
If you suspect your compounded semaglutide has expired, been improperly stored, or shows signs of degradation, do not use it. Contact your compounding pharmacy and healthcare provider immediately. Report any adverse effects potentially related to degraded medication to the FDA MedWatch program. Proper disposal of expired or compromised medication is essential—return it to your pharmacy for safe disposal rather than discarding in household trash or flushing down drains.
Compounded semaglutide typically has a beyond-use date assigned by the compounding pharmacy, often following the 28-day guideline for multi-dose vials with preservatives after first puncture, though this varies by facility and formulation. Always follow the specific BUD provided by your pharmacy rather than extending use beyond this timeframe.
No, you should not use compounded semaglutide past its beyond-use date as potency cannot be guaranteed and degradation may have occurred. Using expired medication risks receiving subpotent treatment with reduced therapeutic effect and potential safety concerns.
Compounded semaglutide must be stored continuously refrigerated at 2°C to 8°C (36°F to 46°F) in the main refrigerator compartment, protected from light and never frozen. Temperature excursions outside this range accelerate peptide degradation and compromise medication stability.
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