Responding to stakeholder concerns, the U.S. Food and Drug Administration (FDA) announced that it will establish a one-year stabilization period for the Drug Supply Chain Security Act (DSCSA) traceability requirements to ensure continuity of the supply chain and product availability to patients.
The Drug Supply Chain Security Act (DSCSA)
Enacted in 2013, the DSCSA is part of the Drug Quality and Security Act (DQSA) and establishes requirements to facilitate the electronic tracing of prescription drugs throughout the product lifecycle, from manufacturer to retailers. These requirements are intended to enhance consumer safety and assist with identifying and removing counterfeit, stolen, contaminated, or otherwise harmful products from the supply chain.
The DSCSA initially was set to enter full implementation on November 27, 2023, but trading partners – which includes manufacturers, wholesale distributors, dispensers, and repackagers – will now have until November 27, 2024 “to implement, troubleshoot and mature their electronic, interoperable systems.” The FDA was clear in its announcement that this stabilization period is “not intended to provide…a justification for delaying efforts to comply with the DSCSA” but should rather be used to establish and test interoperable systems and ensure continuity of product availability.
Enhancing traceability across industries
Enhanced traceability has become a priority for regulators and businesses alike across industries. New technologies that make it easier to track and monitor products, isolate contaminated products, and communicate with other partners in the supply chain could improve quality control and product safety. Enhanced traceability also allows for more effective product recalls due to the ability to more precisely identify potentially contaminated products and immediately communicate across the supply chain the need to remove them from the market.
While the FDA will not be enforcing the enhanced drug security requirements established by DSCSA under section 582(g)(1) of the Federal Food, Drug, and Cosmetic (FD&C) Act, trading partners should continue as though DSCSA were fully enforceable. Just as companies should be practicing mock recalls, this stabilization period should be treated as a trial run for their electronic interoperable systems.
Ensuring brand protection and product safety
With increased consumer scrutiny and stricter regulatory oversight of the pharmaceutical industry, product recalls and other missteps by businesses are more costly than ever before. Businesses should make full use of the resources available to them, whether that is guidance from the FDA, regulatory lawyers, or third-party experts, to ensure they have a solid foundation. When it comes to brand protection and product safety, there is no such thing as “too prepared.”
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