Cold chain shipping

Why do Wegovy and Zepbound pens need cold chain shipping?

UNICEF describes a cold chain as "a chain of precisely coordinated events in temperature-controlled environments to store, manage and transport" products [1]. Pen injectors for Wegovy and Zepbound carry their own label rules. Wegovy's label reads: "Store the WEGOVY prefilled single-dose pen or single-dose syringe in the refrigerator from 2°C to 8°C (36°F to 46°F)" [2]. Zepbound's label reads: "Store ZEPBOUND single-dose pen and single-dose vial in a refrigerator at 2°C to 8°C (36°F to 46°F)" [3]. Both labels say not to use the drug if it has been frozen [2][3].

What do the labels allow outside the refrigerator, and what does federal law require?

Each label allows limited time at room temperature, if needed. For Wegovy, "prior to the pen or syringe cap removal, the pen can be kept from 8°C to 30°C (46°F to 86°F) up to 28 days" [2]. For Zepbound, "each single-dose pen or single-dose vial can be stored unrefrigerated at temperatures not to exceed 30°C (86°F) for up to a total of 21 days" [3]. Federal licensing guidelines for wholesale distributors say drugs "shall be stored at appropriate temperatures and under appropriate conditions in accordance with requirements, if any, in the labeling of such drugs," with temperature records or logs kept to document proper storage [4].