What’s the 2019 DSCSA Requirement and Why Was it Delayed?
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 in the United States.
New requirements are implemented on November 27th each year. Most recently, the regulation anticipated for November 27th, 2019 for wholesalers was delayed. This article will explore that regulation, why it was delayed, and what that means for your organization.
What is the 2019 DSCSA requirement?
The 2019 DSCSA guidance requires all wholesaler-distributors to verify Transaction Information and Transaction History of all salable returned products. As a whole, the industry is suggesting implementing Verification Router Services (VRS) to fulfill this requirement.
How does this affect dispensers?
It doesn’t. There is a large misconception that dispensers need to take action to implement VRS. However, at this time, there is no requirement for dispensers to verify saleable returns.
What is the delay?
As posted in the Federal Register on Sept. 24, and in a guidance docket on FDA’s site, FDA is allowing a one-year delay of enforcement, to November 2020, in the salable-returns requirements of the Drug Supply Chain Security Act (DSCSA).
This guidance requires wholesale distributors to verify a product identifier prior to further distributing a returned product, beginning on November 27th, 2019. FDA cited minimizing “possible disruptions in the distribution of prescription drugs in the United States” as the reason for the delay and has confirmed they do not intend to take action against wholesale distributors who do not verify product identifiers prior to November 27th, 2020.
The DSCSA requirements will continue to roll out and evolve over the next few years. Pay attention to the FDA site for information on new requirements and what they mean for your organization.
ConsortiEX will always update our customers on upcoming requirements and changes.
Interested in learning more about the upcoming DSCSA regulations for 2020 and beyond? Download this resource to learn more.