“The Food and Drug Administration is advising industry partners on new guidance for identifying and tracing prescription drugs as they move through the distribution supply chain to ensure availability of critical drugs during the pandemic, Leigh Verbois, director of FDA’s Office of Drug Security, Integrity and Response, told GovernmentCIO Media & Research.”
“Overall, FDA’s supply chain strategy is aiming to do three things: detect illegitimate products, prevent them from entering the supply chain, and rapidly respond when they are found.”
“The move comes amid President Biden’s Executive Order on America’s Supply Chains and also ahead of drug-distribution security requirements that are set to go into effect in November 2023 as part of the Drug Supply Chain Security Act signed into law in 2013.”
“While the law outlines steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed, it also called on FDA to develop processes for waivers and exceptions, such as for emergency medical reasons or space constraints.”
“'[The new guidance] was triggered because we felt the need to explain emergency medical reasons that were exempted, such as those needed to address the COVID public health emergency,’ Verbois said. ‘This was something that we knew we needed to balance the need to effectively distribute prescription drugs under emergency conditions and help protect consumers from exposure to prescription drugs that could be counterfeit, stolen or otherwise harmful.”
“Since the legislation, the agency has helped create a supply chain that is better at preventing and detecting the introduction of illegitimate products, Verbois said. The FDA will build upon its foundation to make continuous improvements to its supply chain and drive a more secure, robust system…” Read the full article here.
Source: FDA Calls to Protect Drug Supply Chain During Pandemic – By Sarah Sybert, July 6, 2021. GovernmentCIO.
