The Drug Supply Chain Security Act (DSCSA) is Title II of the Drug Quality and Security Act (DQSA) and is designed to protect consumers from potentially harmful drugs. New requirements roll out on November 27th of each year. Each new requirement progresses toward building an electronic, interoperable system to identify and trace certain prescription drugs […]
The Drug Supply Chain Security Act (DSCSA) is Title II of the Drug Quality and Security Act (DQSA), which was enacted to enhance FDA’s ability to protect consumers from exposure to potentially harmful drugs. The act outlines steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed […]
The ConsortiEX family is currently ramping up for the 2019 ASHP Midyear Clinical Meeting, but we want to take a moment to thank all of our customers for their continued partnership on our journey to improve patient outcomes, and in securing the pharmaceutical supply chain. We remain committed to providing health care pharmacists and clinicians […]
Many hospitals struggle to achieve optimal compliance with the Drug Supply Chain Security Act (DSCSA). The challenge to comply seems to come from an incomplete or inaccurate understanding of the regulations, which is understandable given the Act’s complexity. DSCSA was put in place to protect consumers from harmful drugs, such as those that are stolen […]
The FDA has issued a guidance to 503B facilities regarding Current Good Manufacturing Practice (gCMB) Healthcare Packaging explains: “A Dec. 10 statement from FDA Commissioner Scott Gottlieb, M.D. and Deputy Commissioner Anna Abram focused on the importance of ensuring compounded product quality. FDA noted that it continues to implement its 2018 Compounding Priorities Plan as part of […]