Drug Quality and Security Act includes Track-and-Trace Bill, Compounding Pharmacy Oversight
President Barack Obama today signed into a law a bipartisan, bicameral bill co-authored by Colorado U.S. Senator Michael Bennet to establish new safeguards for the drug distribution supply chain. The changes represent the most comprehensive efforts to secure the drug supply chain in 25 years. The Drug Quality and Security Act would track all prescription drugs from the time they are manufactured to the moment they are delivered to the drugstore and would improve the safety of compounded drugs.
Bennet helped write the drug supply chain security provisions, which are based off a bill he introduced with Senator Richard Burr (R-NC) in May after working to find consensus over the last two years.
“Coloradans deserve and want to know that the prescriptions they receive at their pharmacies are safe and effective,” Bennet said. “This new law will help us know where those pills have been and who has handled them since the day they were manufactured. Whether it’s a stronger drug supply chain or better oversight for compounded drugs, this commonsense bill will help restore confidence in our prescription drugs and protect our families from potential health risks.”
The lack of a strong, uniform system to secure the supply chain has allowed bad actors to exploit a number of vulnerabilities. Problems include drugs that are stolen, tainted, or diluted and sold back into the supply chain, counterfeit drugs, an inability to quickly recall tainted medicine, and drug shortages. All of these problems have led to serious health problems, deaths, and increased health care costs.
Under the prescription drug security provisions of the bill, the FDA will know who has handled which drugs and when they handled them, preventing counterfeit or stolen pharmaceuticals from being sold back into the system and allowing the FDA to respond to recalls and shortages more quickly and efficiently.
The Drug Quality and Security Act reflects a bicameral, bipartisan effort to address prescription drug safety and security issues. The bill also ensures that quality compounded drugs are available to patients who need them through better oversight of compounding pharmacies and outsourcing facilities.
In addition to Senator Bennet, the bill was introduced by Senate HELP Committee Chairman Tom Harkin (D-IA), Ranking Member Lamar Alexander (R-TN), and Senators Al Franken (D-MN), Pat Roberts (R-KS), and Burr.