On July 20, 2017, the Food and Drug Administration (FDA) published a notice announcing three public meetings entitled “Enhanced Drug Distribution Security Under the Drug Supply Chain Security Act” (DSCSA), and a notice announcing a pilot program project under the DSCSA. The FDA requests comments on the meeting topics and the pilot program.
The DSCSA, enacted on November 27, 2013, established a new track-and-trace system for prescription drugs distributed in the United States, and sets forth a series of requirements that will culminate in the establishment of a fully electronic, interoperable system to identify and trace certain prescription drugs by 2023. This system is intended to enhance the FDA’s ability to protect U.S. consumers from exposure to drugs that may be counterfeit, diverted, stolen, intentionally adulterated or otherwise harmful by improving the detection and removal of potentially dangerous drugs from the drug supply chain.
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