The Drug Quality and Security Act will require drug: manufacturers, repackagers, wholesale distributors, and dispensers to keep information and pass on details regarding each drug’s distribution history. Over the next seven years the goal is to put into place product tracking, down to a single pill within 10 year period.
Manufacturers will be required to serialize their products in a consistent way across the industry, over a four years period after the law is enacted.“This legislation will improve the safety of compounded drugs as well as establish an unprecedented tracing system that will, for the first time ever, track prescription drugs from manufacturing to distribution, thereby thwarting drug counterfeiters,” Senate Health, Education, Labor, and Pensions Committee Chairman Tom Harkin of Iowa said in a news release.
“Americans must have the confidence that their drugs—whether obtained at a hospital, at a doctor’s office, or at the pharmacy counter—are safe, and that is exactly what this bill does.”
John Castellani, President and CEO of the Pharmaceutical Research and Manufacturers of America, said in a statement, “The counterfeiting of prescription drugs is on the rise within the United States but oftentimes goes unnoticed or unreported, leaving many Americans unaware of this problem. In fact, some experts have cited the counterfeiting of these medicines as even more lucrative than the trafficking of illegal drugs like heroin and cocaine. This act 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 bill awaits President Obama’s signature.