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Senate, Congress pass national drug traceability legislation

The US Senate by voice vote today passed the Drug Quality and Security Act/H.R. 3204, pharmaceutical traceability legislation that establishes a national requirement for tracing of pharmaceuticals through the supply chain.

In preempting traceability regulations by the states, the measure creates a uniform standard that calls for supply chain parties to implement chain-of-custody reporting practices, moving after ten years to tracing product at the unit level using interoperable electronic systems. 

The legislation affords supply chain members additional time to build out a traceability network  in preempting  Calfornia’s requirement and deadlines for an e-pedigree system. 

Manufacturers for example under H.R. 3204 will have four years from the date of enactment to apply standard numerical identifiers,  where they were facing a 2015 deadline under the state’s law.

HR 3204 calls for a lot-based tracking system in the first phase, as industry develops unit-level tracking capability guided by FDA public hearings.

The measure also sets out a federal “floor” of licensure requirements for distributors, 3PLS, and repackagers, which states can go beyond. 

“Today the Senate voted to establish a national traceability framework for prescription medicines. The federal preemption of state laws to further strengthen the U.S. pharmaceutical supply chain represents one of the most significant legislative accomplishments for our industry and, is especially important for the healthcare providers and pharmacies — and their patients — who count on the safe and efficient distribution of prescription medicines,” said HDMA President and CEO John M. Gray in a statement.

“Thanks to the commitment and hard work of the U.S. Congress, the 50-state patchwork of regulations will be replaced with one federal solution, ensuring the seamless movement and traceability of pharmaceuticals throughout the supply chain. This victory is the culmination of nearly a decade’s worth of work by HDMA and all those who championed this issue. We applaud Congress for passing legislation to establish one national solution for a safer, more secure pharmaceutical supply chain, and urge President Obama to swiftly sign the bill into law.”

{Continue the conversation about federal pharmaceutical traceability on Twitter through the hashtag #1RxSolution).            

The Pew Charitable Trusts hailed the passage as a step forward for drug and patient safety:

“Even in the midst of partisan stalemate, Congress can still come together to pass meaningful legislation to protect the public’s health. We applaud Senate passage of the bill and urge President Obama to sign it immediately. Counterfeit and contaminated drugs have taken hundreds of American lives and added hundreds of millions of dollars to our nation’s health-care costs. This legislation will help protect lives and alleviate these costs by ensuring that prescription drugs are safe, effective, and of the highest quality,” said Allan Coukell, senior director of drugs and medical devices.

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