How to Ship GLP‑1 Medications Safely: Protecting Potency & Patient Outcome
Why GLP‑1s Need a True Cold Chain
GLP‑1 medications (e.g., semaglutide, tirzepatide) are temperature‑sensitive biologics. Exposure outside labeled ranges can reduce potency, shorten shelf life, and compromise patient outcomes. A reliable cold chain preserves temperature from the manufacturer to the patient – during storage, pick/pack, line‑haul, last‑mile, and handoff.
Key facts:
- Most GLP‑1s require refrigerated storage (check the product label for exact ranges and room‑temperature allowances)
- Thermal excursions – even brief – can degrade the active ingredients
- A documented, end‑to‑end chain of custody supports quality, safety, and compliance
Compliance Requirements Shipping GLP-1s
GLP-1s are classified as temperature-sensitive biologic drugs, therefore pharmacies and distributors must follow regulatory agency guidelines like the FDA and other Good Distribution Practices (GDP).
Two other major governing bodies include URAC and ACHC accreditation, who govern pharmacies shipping GLP-1s and other medications.
To protect patient safety, organizations must use insulated packaging that keeps medications within the labeled temperature range, ensure chain-of-custody, and manage risks like delays, temperature fluctuations, or improper handling in transit.
CTA: Dive deeper into Regulations for Pharmacies
FAQs: GLP-1 Shipping & Patient Safety
Q: What temperature should GLP-1 drugs be shipped at?
Follow each product’s label. Many GLP-1s ship refrigerated (2°C and 8°C) and must stay within the labeled range throughout transit. Use a validated insulated shipper and pre-conditioned refrigerants to maintain that range.
Q: Does semaglutide need to be refrigerated?
Yes. Semaglutide (including brands like Ozempic® and Wegovy®) must be kept refrigerated within the temperature range specified on the product label. Some products may allow limited time at room temperature but always follow manufacturer instructions to avoid potency loss. Design your packout and carrier service so total transit time stays well inside the allowed window, with buffer for delays.
Q: Can you freeze semaglutide?
No. Semaglutide should never be frozen. Freezing can damage the active ingredient and make the medication unsafe or ineffective. Always store and ship according to the product label, typically under refrigerated conditions.
Q: What is the best packaging for GLP-1 shipping?
A validated insulated shipper matched to your lane (summer/winter), with the correct type and mass of refrigerant (PCM/gel/ice), documented pre-conditioning, and an SOP for packout.
Q: Can pharmacies ship GLP-1 medications directly to patients?
Yes, where permitted. Pharmacies must follow state regulations, product labeling, and quality procedures for DTP delivery – including temperature control, documentation, and patient instructions on immediate refrigeration.
Q: Which regulations apply to GLP-1 cold-chain shipping?
Follow product labeling; apply GDP principles; comply with State Board of Pharmacy requirements for dispensing/delivery; and use documented qualification/validation and staff training to support quality.
Q: How do I choose between overnight vs. 2-day shipping for GLP-1s?
Base it on qualified hold time plus buffer. If your packout is qualified for 60 hours in expected ambient conditions, 2-day may be acceptable; if not, choose overnight or upgrade packaging. If in doubt, always discuss with your logistics partner.
Q: Are reusable cold-chain shippers appropriate for GLP-1s?
They can be – if your operations support reverse logistics and cleaning, and the solution is qualified for your lanes. Reusable packaging can cut waste and total cost over time. Consult with your thermal packaging provider if you want to learn more, ThermoSafe is happy to guide you.
What’s the Right Cold Chain Packaging for GLP-1 Medications?
- Thoroughly tested insulated shipper sized for the payload to limit air space
- Phase change materials (PCM) or gel/ice packs matched to lane ambient profiles and hold-time needs
- Pre-conditioning of refrigerants and shippers per the qualification SOP
- Absorbent, cushioning, and leak-proof inner containment for patient safety
ThermoSafe Leads the Way
ThermoSafe’s portfolio of temperature assurance packaging is engineered to support the unique requirements of GLP-1 therapies. From validated insulated shippersthat maintain refrigerated ranges to advanced direct-to-patient delivery systems, ThermoSafe ensures medicines arrive potent, safe, and compliant with FDA expectations.
- Insulted Shippers for Direct-to-Patient Shipments – to lock in cold for extended hold times
- Biodegradable EPS Insulated Shippers – superior temperature control with peace of mind that biodegradable material breaks 90% in under 4 years.
- Curbside Recyclable EOS paper-based shipper – combines thermal reliability with easy patient disposal.