The USP released in July 2018 proposed changes to Packaging and Storage Requirements, USP <659> and Good Storage and Distribution Practices for Drug Products, USP <1079>, and have also released a stimuli article on the Use of Mean Kinetic Temperature to Aid Evaluation of Temperature Excursions: Proper and Important Application. The proposed changes could have an immediate impact on how we manage our temperature-controlled storage and shipments. In this session we will explore and discuss the proposed changes, so that we can take away the tools we need to manage our temperature-controlled supply chain.