NASP Submits Comments on Proposed Regulations for Extended Producer Responsibility and Requests Exemption of Cold Chain Packaging for Prescription Drugs and Biologics
NASP urged the Maryland Department of the Environment to revise proposed Extended Producer Responsibility regulations to fully exempt all cold chain packaging used for prescription drugs and biologics, warning that the current proposal threatens patient safety and access to care. In comments on amendments to COMAR 26.04.14, NASP argued that exempting only primary drug packaging while subjecting required secondary and tertiary cold chain materials to EPR obligations contradicts statutory intent, conflicts with FDA and state pharmacy requirements, and imposes unsustainable costs on specialty pharmacies. NASP emphasized that cold chain packaging is a regulatory necessity, not a business choice, and cautioned that added compliance burdens could increase drug costs, incentivize changes to validated packaging systems, and raise the risk of temperature excursions that compromise drug efficacy.