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Best Practices for the FDA Drug Supply Chain Security Act

Unfortunately, these concerns sometimes resurface over time. With a proliferation of medicinal treatments, increased drug recalls, and subsequent concerns over opioid addiction, the FDA is faced with a very similar landscape.

Fast forward and this is how the FDA Drug Supply Chain Security Act comes into play—specifically in the form of product tracing. Signed into law by President Obama in 2013, the Drug Supply Chain Security Act establishes rules for an electronic, interconnected system that could identify and trace prescription drugs throughout the supply chain within the U.S. Under the new law, dispensers in the drug and pharmaceutical supply chain must be able to exchange information about prescription drugs they carry, including not only what it is, but who handled it, and every time it is sold in the U.S. market and where it went.

While the law went into effect in 2013, the FDA will be phasing in product tracing requirements through 2023. While dispensers have a longer period of time to become compliant, wholesalers and manufacturers must start.

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