The U.S. Senate this week passed a measure that will establish a system to track prescription drugs from the time they are manufactured until they are sold at a drugstore, The News & Observer reports. The bill awaits President Obama’s signature.
Over the next seven years, The Drug Quality and Security Act calls for drug manufacturers, repackagers, wholesale distributors and dispensers to pass and hold onto key information about each drug’s distribution history. The goal is to allow unit-level product tracing within 10 years. Four years after the law is enacted, manufacturers will serialize drugs in a consistent way across the industry, to allow for efficient tracing to respond to recalls and notices of theft and counterfeiting.
“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.”