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New Drug Law Will Enhance Traceability: FDA

WASHINGTON — The recently passed Drug Quality and Security Act will enable greater traceability and improved detection and removal of potentially dangerous drugs from the supply chain, said Food and Drug Administration Commissioner Margaret Hamburg during a press conference Monday.

Margaret Hamburg
Margaret Hamburg

“This critical new law is designed to protect the public from counterfeit, stolen or otherwise harmful drugs by enabling certain drugs to be traced as they move through the U.S. drug supply chain,” said Hamburg. “The law will require drug manufacturers, repackagers, wholesale drug distributors and dispensers, which are primarily pharmacies, to provide product and transaction information with each sale and notify the FDA and other stakeholders of illegitimate products.”


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Beginning in four years, drug manufacturers and repackagers will be required to affix a unique product identifier to each drug package that contains the drug’s national drug code, serial number, lot number and expiration date.

After four years, wholesale distributors, repackagers and dispensers will be able to verify the product identifier. And six years post-enactment, wholesale distributors, repackagers and dispensers will only be permitted to trade products encoded by identifiers, if those drugs are required to have them.

Read more: FDA Rule Would Allow Swift Drug Label Updates

“Ten years after enactment, supply chain stakeholders and FDA will benefit from an interoperable system that will enable the secure electronic exchange of product and transaction information for each sale of certain prescription drugs, verification of product identifiers at the package level, prompt response to suspect and illegitimate products when found and improved efficiency of recalls,” Hamburg said.

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