The US Drug Quality and Security Act has been approved by both US Houses of Congress, and is now headed for signature by President Barack Obama.
On November 18 the Senate voted to pass the bill, which will enable, for the first time, prescription drugs to be tracked from manufacture to collection. It also includes measures to help ensure the safety of compounded drugs.
The “track and trace” part of the Senate version of the bill was developed by Senate Health, Education, Labor and Pensions (HELP) Committee chair, Democrat Tom Harkin, and three of the panel’s members – Republicans Lamar Alexander and Richard Burr, and Democrat Michael Bennet.
It will, among other measures:
- develop a workable pathway to unit-tracing level in a decade. Over seven years, the major sectors of the pharmaceutical supply chain will be passing and holding onto key information about each drug’s distribution history. Within 10 years, supply chain stakeholders will participate in electronic, interoperable product tracing;
- strengthen licensure requirements for wholesale distributors and third-party logistics providers - the latter will be recognised for the first time as part of the drug supply chain. The Food and Drug Administration (FDA) will make a database of wholesalers available to the public through its website; and
- establish nationwide drug serial numbers. Four years after the date of enactment, manufacturers will serialise drugs in a consistent way across the industry, which will allow for efficient tracing to respond to recalls and notices of theft and counterfeiting.
Welcoming the vote, Sen Harkin said that Americans must have the confidence that their drugs are safe, “and that this exactly what this bill does,” while Sen Bennet pointed out that, currently: “we know more from a barcode on a gallon of milk than on a bottle of prescription drugs, which could mean the difference between life and death.”
The bill was passed by the House on September 28. Its champion there, Republican Fred Upton, who chairs the Energy and Commerce Committee, said: “with this bill we are fortifying the drug supply while also cutting needless regulatory red tape, creating an environment conducive to growth and job creation.”
The Act has been welcomed by industry, with the Pharmaceutical Research and Manufacturers of America (PhRMA) saying it will “improve the security of the finished drug supply chain and reduce the impact of the patchwork of state laws related to the pedigree requirements for drug distribution.”
The Generic Pharmaceutical Association (GPhA) also welcomed the vote, and said it also supports electronic labeling provisions that remain under discussion.