The FDA is developing standards for a system that will help identify and trace certain prescription drugs as they’re distributed within the U.S.


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“The ultimate goal is to identify each individual prescription drug package in a way that will enable rapid and accurate verification of the legitimacy of the product, which will be an important tool in the fight against counterfeit drugs,” explained Ilisa Bernstein, deputy director of the Office of Compliance in FDA’s Center for Drug Evaluation and Research, in a blog post.

The system will be interoperable, giving different stakeholders in the drug supply chain the ability to communicate and share information about a drug and its location, according to Bernstein.

Under the Drug Supply Chain Security Act, the FDA must issue draft guidance by Nov. 27, 2014, and many stakeholders must establish systems for compliance by Jan. 1, 2015.

The FDA has opened a docket in the Federal Register with questions for stakeholders about the systems they use to exchange information related to prescription drug transactions. The docket is open until April 21.

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