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Today, Congressman Bob Latta (R-Bowling Green) introduced H.R.1919, Safeguarding America's Pharmaceuticals Act of 2013, a bipartisan bill to strengthen and secure our nation’s pharmaceutical distribution supply chain to protect American families against counterfeit pharmaceuticals. This legislation is a result of collaboration and input from stakeholders throughout the pharmaceutical supply chain. H.R. 1919 was coauthored by Rep. Jim Matheson (D-UT).

Currently, standards for the pharmaceutical distribution supply chain vary by state. This bill will establish a national standard of tracing requirements for manufacturers, wholesale distributors, pharmacies and repackagers based on changes in ownership. Further, the bill establishes a collaborative, transparent process between the Food and Drug Administration (FDA) and stakeholders to study ways to even further secure the pharmaceutical supply chain.

“Pharmaceutical distribution occurs nationwide and it is estimated that within the United States there are more than 4 billion prescriptions filled each year. By replacing the current patchwork of multiple state laws with a uniform national standard we improve safety, eliminate duplicative regulations, and create certainty for members of the pharmaceutical supply chain,” said Congressman Latta. “When an individual takes a prescribed medication they should have full confidence that the medication is real and will not impose harm. It is of utmost importance that we implement commonsense solutions to safeguard our distribution supply chain against counterfeits and improve security and integrity throughout the supply chain. This legislation is an important step forward to ensure greater patient safety for all Americans.”

Over the past year, the FDA has issued three warnings that counterfeit drugs, including those intended for cancer patients, had infiltrated our nation’s pharmaceutical supply chain, potentially reaching some of our nation’s sickest patients.

Important provisions contained within this legislation are:

• Establishing lot-level tracing requirements for manufacturers, wholesale distributors, pharmacies and repackagers based on changes in ownership. 
• Requires the affiliates of the supply chain, including third-party logistics providers to undertake verification and notification activities regarding suspect or illegitimate products.
• Require members of the supply chain to only transact with registered or licensed entities.
• Requires the FDA to establish and report to Congress on pilot projects and hold biannual public meetings in order to foster collaboration with stakeholders regarding moving to unit-level traceability.

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