Glucagon-like peptide-1 (GLP-1) receptor agonists (RAs) have become popular thanks to their ability to treat type 2 diabetes and obesity. From 2022 to 2023 alone, spending on GLP-1 RAs increased by 62% in the United States. With demand growing, businesses must be able to ship their GLP-1 RAs without efficacy loss. As these products travel from manufacturers to pharmacies and end users, businesses rely on cold chain shipping strategies to ensure product quality.
What Are GLP-1 Drugs?
Glucagon-like peptide-1 is a hormone that plays a role in regulating blood sugar and appetite. GLP-1 RAs, such as Ozempic and Wegovy, are medications that mimic this hormone. They were created to help treat type 2 diabetes and, more recently, obesity. GLP-1 medications require consistent cold storage and temperature control, from shipping to storage.
Do GLP-1 Drugs Need to Be Refrigerated?
Yes, GLP-1 medications like semaglutide need refrigeration to preserve their stability. They must be kept between 35.6 and 46.4 degrees Fahrenheit, and they must not be frozen. Once GLP-1 drugs have been opened, they can be stored at room temperature for a set period, depending on the medication.
Why Maintaining the Cold Chain Is Crucial for GLP-1 Medications
Shipping refrigerated medications like GLP-1 RAs requires careful planning. These peptides cannot tolerate excessive heat, freezing or temperature changes. Cold chain transportation protects them and the patients who need them.
1. Effects of Temperature Excursions on Drug Efficacy
Exposing GLP-1 medications to temperatures outside the recommended range can cause structure degradation, which might reduce the drug’s ability to regulate glucose or support weight management. Patients taking degraded products will receive less effective doses.
2. Patient Safety Risks and Compliance Concerns
Degraded GLP-1 drugs aren’t just less effective — they can also pose a safety risk. Patients managing chronic conditions like diabetes depend on this medication to protect them from blood sugar-related issues. Additionally, efficacy concerns might lead to batch recalls, regulatory issues or expensive reimbursement claims. Cold chain shipping directly impacts a business’s ability to support patient care.
Regulatory Requirements for Shipping GLP-1 Drugs
Because GLP-1 medications are considered temperature-sensitive pharmaceuticals, businesses must create temperature-control systems to remain compliant with the following regulations.
1. FDA, EMA and Global Guidelines
Where drugs are manufactured and where they travel during shipping can affect regulations. Different countries may enforce unique standards. Make sure you’re following all relevant shipping regulations for your area, which could include guidelines from regulators like:
- Food and Drug Administration (FDA): In the U.S., the FDA follows the Food Safety Modernization Act (FSMA) and Good Distribution Practices (GDP) to ensure the safe storage and transportation of temperature-sensitive drugs.
- European Medicines Agency (EMA): The European Union’s EMA oversees the safety of medicines.
- World Health Organization (WHO): WHO provides guidelines for storing and transporting temperature-sensitive pharmaceuticals.
2. Documentation and Validation in Cold Chain Logistics
Documentation helps validate regulation compliance during shipping. Shippers must have records of shipping solution testing and practice to prove they’re maintaining safe conditions. Make sure to document testing under:
- High heat.
- Storage delays.
- Extended transit.
- Other challenges.
Validation confirms effectiveness. Businesses can use data loggers, test shipments and temperature mapping to maintain temperature control. With good documentation and validation, you can prove your shipping methods are protecting GLP-1 products as intended.
Best Practices for Shipping Refrigerated Medications
Shipping GLP-1 products successfully requires effective cooling, careful planning and detailed documentation. You need to identify and address issues before they occur to avoid costly losses. Follow these tips to protect your items.
1. Choose the Right Cold Chain Packaging for GLP-1
Use proper insulation and gel packs to control temperatures during shipping. Gel packs surrounding the product help maintain ideal temperatures and prevent spikes while moving. Combine this with high-performance insulation for a longer-lasting cold that doesn’t freeze your products.
Look for leakproof gel packs with a flexible exterior to minimize wasted space and safeguard products. You can also use “sweat-proof” gel packs with a moisture-wicking exterior to protect GLP-1 products from the water droplets that can result from the normal condensation of humidity on the gel pack surface.
2. Minimize Dead Space
Even with the right number of high-quality gel packs, you can still experience cooling issues. Cold air can leak out of an empty space inside a shipping container. Prevent this by strategically designing your pack-outs. Use inserts, cushioning material or molded trays to stabilize contents and prevent dead space. Tighter pack-outs also keep gel packs in close contact with the medication, improving cooling.
3. Use Real-Time Temperature Monitoring
Digital temperature loggers and temperature alerts protect your shipments further. Use real-time temperature data to ensure your shipments are consistently cooled. Pass/fail alerts will warn you when packages exceed climate thresholds. These tools help businesses detect problems early and respond to issues faster.
4. Document Data
Record all cold chain packaging use, results and temperature logs. Detailed documentation protects you from regulatory concerns and makes it easier to spot problem areas. If there’s a history of temperature drops, you can adjust your strategy and refine it to protect GLP-1 RAs during transit.
Partnering With the Right Cold Chain Logistics Provider
Choosing the right cold chain partner is essential when shipping GLP-1 medications. A reliable provider offers quality packaging solutions and works with your needs to build tailored solutions. Experienced partners with a history of providing solutions for pharmaceuticals will understand validation, transit and temperature monitoring.
Pelton Shepherd Industries supports pharmaceutical manufacturers and distributors with gel pack solutions tailored to your shipping and regulatory guidelines. Our team works directly with yours to meet medication standards while providing a consistent cool, no matter the transport time. Our gel packs are available in various shapes, sizes and eutectic points to meet your needs, and we also offer eco-friendly gel pack options to minimize the impact on the environment.
Protect GLP-1 Drug Integrity From Manufacturer to Patient With Pelton Shepherd
Maintaining temperature stability is more than a packing challenge. It’s a key part of protecting patient health. Whether you’re shipping across the country or delivering to homes, you must have an optimized cold chain. With GLP-1 drugs in high demand and under tight regulations, you need to reassess your shipping strategy.
Pelton Shepherd offers peace of mind for your pharmaceutical products. We offer a range of gel packs and cold chain solutions to meet your unique applications. Contact us for a quote and to see how we can help you reduce risk and deliver medications safely.
