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Pharmaceutical Track-and-Trace Gains Momentum

Counterfeit drugs being sold by illegal online pharmacies may pose a very significant threat to patients around the world. Over the last few months, both the U.S. House of Representatives and the U.S. Senate have demonstrated their clear commitment to protecting consumers by developing strong national track-and-trace standards.

In May, Senators Harkin, Alexander, Bennet and Burr submitted draft legislation to the Committee on Health, Education, Labor and Pensions. This bipartisan action represents a very real step toward the establishment of standards necessary to ensure that patients who purchase medications online, and in brick and mortar pharmacies, receive safe and effective drugs.

Just this past month, the U.S. House of Representatives passed legislation to establish a nationwide “track and trace” system (The “Safeguarding America’s Pharmaceuticals Act of 2013” H.R. 1919). Following passage by the House, the Senate Health, Education, Labor and Pensions Committee approved their own version of the legislation, the Pharmaceutical Distribution Supply Chain Act, S. 957. The House and Senate bills now have to be reconciled and approved by President Barack Obama.

H.R. 1919, combined with S. 957 would:

  • use cutting-edge technology such as barcoding or electronic tagging to ensure that medications and the ingredients used to compound them are both genuine and unadulterated;
  • establish a national standard of product tracing requirements for manufacturers, wholesale distributors, pharmacies and repackagers;
  • improve safety, eliminate duplicative regulations, while ensuring certainty for all members of the pharmaceutical supply chain;
  • help prevent increases in drug prices, avoid additional drug shortages, both online and in brick and mortar pharmacies, around the world.

“Because of the hard work that has already been put in on this issue and the importance of protecting our families from counterfeit drugs, I am hopeful we can get a product to the President’s desk by the August recess,” said Representative Upton, who supports passage of the Bill.

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The Center for Safe Internet Pharmacies (CSIP) and our 12 member companies have the shared goal of helping address the growing problem of consumer access to illegitimate pharmaceutical products on the Internet. Continue to read this blog for updates on CSIP’s education, enforcement and information-sharing efforts.