Proper Refrigerated Storage Critical for Compounded Semaglutide

Proper Storage is Critical for Compounded Semaglutide

Semaglutide, sold under brand names like Ozempic and Wegovy, has exploded in popularity for dramatic weight loss results. However, the FDA recently issued an important warning about the stability and safety of compounded formulations of this potent medication. So does compounded semaglutide need refrigeration? Read on for newly emerging stability data and best practices for optimizing potency.

Background on Semaglutide and Compounding

Semaglutide belongs to the GLP-1 class of medications used to treat diabetes and obesity. It mimics an appetite-reducing hormone. The FDA has approved branded semaglutide specifically for diabetes and weight management.

Due to extremely high demand but limited commercial supply, many compounding pharmacies now produce their own versions of semaglutide. Compounding means custom-mixing a medication into unique strengths or forms not available from major manufacturers.

Concerns Over Compounding Quality Controls

Unlike large pharmaceutical companies, compounders don’t have to prove to the FDA that their products are safe and effective. The FDA recently shared worries over compounded semaglutide, including:

• Lack of testing to confirm potency and purity
• Questions on sterility of injectable preparations
• Concerns whether off-label high dose usage for weight loss is safe

Complications like vision loss and kidney injury require careful dosing standards that compounders likely don’t meet. But the FDA also called out improper transportation and storage conditions as risks.

Does Compounded Semaglutide Require Refrigeration?

The shot form of branded Ozempic semaglutide doesn’t need refrigeration for a shelf life of 6 weeks stored below 86°F. Wegovy is more temperature sensitive, requiring storage between 36°F to 46°F until usage or within a 5-6 week discard window. What about compounded versions?

New Stability Studies on Compounded Preparations

Traditionally, compounded semaglutide was assumed stable at room temperature for 6 months based on similar peptides. But emerging research undercuts this notion. A 2022 stability analysis on 50mg/mL semaglutide from multiple pharmacies uncovered concerning findings:

• 94% potency loss when stored at room temperature after 12 weeks
• Just a 15.1% drop in strength when refrigerated for 12 weeks

Clearly refrigeration preserves efficacy much better. Researchers concluded compounded semaglutide should be stored long-term between 36°F and 46°F to retain potency, mimicking Wegovy guidance.

Short-Term Storage at Room Temperature

What if you need to keep compounded semaglutide out at room temperature for a period before getting home to refrigerate? The stability review found it retains nearly full 108% potency when stored for up to 1 week at room temperature.

So you likely have up to a 7 day window for temporary room temperature exposure before refrigeration. But optimal stability still centers on consistent 36°F to 46°F refrigerator storage long-term.

Additional Recommendations for Handling Compounded Semaglutide

Refrigeration clearly optimizes retention of compounded semaglutide strength over time. But other careful handling steps also preserve efficacy:

Avoid Freezing Temperatures

Just like Wegovy packaging specifies avoiding freezer storage, keep compounded semaglutide formulations out of the freezer. The medication could suffer damage from frozen precipitation and crystal formation.

Never Expose to Direct Sunlight & Heat

Always store compounded semaglutide preparations away from windowsills, car interiors, kitchen counters or other hot spots. Light and excessive heat accelerate potency degradation.

Gently Mix and Inspect Before Each Dose

Carefully invert each vial or prefilled syringe to re-dissolve any sedimented particles right before you inject. Discard if you observe particulate matter or discoloration which indicates instability.

Follow Exact Discard Window Specified

Even refrigerated, compounded semaglutide slowly loses strength over weeks. Use up each monthly supply within the compounder’s specified discard window, which may range from 4 to 8 weeks from when it was made.

Key Considerations for Obtaining Compounded Semaglutide

Because quality standards vary dramatically among pharmacies, choose your compounder carefully. Before getting any compounded semaglutide preparation prescribed, ask:

Is This Compounder Registered and Accredited?

Confirm your state board of pharmacy officially recognizes the compounding outlet. Additionally verify accreditation through organizations like the Pharmacy Compounding Accreditation Board.

What Validation Testing Do You Perform?

Ask for details on potency confirmation testing. Do they analyze stability and purity over time and across storage conditions? Make sure microbial and fungal cultures check for safety.

What is Your Specific Refrigerated Expiry Window?

Standard room temperature estimates for compounded semaglutide may underestimate actual degradation. Get clear fridge discard details based on the compounder’s test data, not guesses.

Compounded semaglutide offers easier access but demands diligent handling and research into your pharmacy’s quality controls. Refrigeration protects both your health and your investment in this powerful weight loss medication.

Disclaimer: This article is for informational purposes only and does not constitute medical advice. Always consult with a healthcare professional before starting any new treatment regimen.