Senate Passes Pharmaceutical Supply Chain Safety Bill
Wednesday, November 20, 2013
The U.S. Senate this week approved H.R. 3204, the Drug Quality and Security Act, which will create a single, uniform and national solution to safeguard the nation’s pharmaceutical supply chain against criminal counterfeiting. The bill, which passed the House of Representatives on September 28th, now will be sent to President Obama to sign into law.
This legislation establishes uniform national standards for the supply chain, which will replace the currently fragmented and piecemeal system that varies from state to state. It strengthens the FDA’s ability to keep bad actors out of the system, and requires that prescription drug packaging use advanced technologies so a product’s source and distribution history can be traced nationwide from manufacturer to patient.
"We believe this legislation will further strengthen the biopharmaceutical supply chain to protect patients from potentially counterfeit or adulterated drugs," said Jim Greenwood, President and CEO of BIO.
"A single, uniform and national solution will help supply chain stakeholders avoid the costs and complexity of complying with a maze of contradictory laws, and ultimately protect consumers and patients across the country. Patients, physicians, and the pharmaceutical industry all have a vested interest in making sure that patients are getting products as prescribed," he continued.
Once President Obama signs the legislation into law, the FDA will need to undertake a number of administrative actions in the coming years.