US set for track and trace after Senate passes quality and security Bill
The decision – which was expected and is in line with that of the US House of Representatives late in October – brings to an end years of negotiations about how best to develop a system that can ensure that only top quality medicines and not substandard pills or fakes reach pharmacy shelves.
The track and trace measures set out in the Bill will be phased in over the next few years, starting with the application of serial numbers of drug containers before progressing to barcodes and later some form of electronic labelling on individual products.
The latter system will make track and trace legislation due to come into force in California in 2015 redundant and prevent other States following suit and developing their own systems according to John Gray from the Healthcare Distribution Management Association (HDMA).
“Today the Senate voted to establish a national traceability framework for prescription medicines. The federal pre-emption of state laws to further strengthen the US pharmaceutical supply chain represents one of the most significant legislative accomplishments for our industry and, is especially important for the healthcare providers, pharmacies — and their patients.
He added that: “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.”
US drug giant Pfizer is of a similar opinion.
In a letter sent to US Senate leaders Harry Reid and Mitch Connell earlier this year the firm said that: “This bill will increase the security of the United States’ already strong drug supply chain by creating a national traceability system and replacing the patchwork of state laws now in place.”
“Specifically, this bill provides greater safeguards for patients by requiring the placement of unique serial numbers on each drug package, and tracking them as they move through the distribution system, lessening the threat of illicit and counterfeit medicines entering the drug supply chain.”