Nov 18 2013
Secures pharmaceutical supply chain, ensures safety of compounded drugs
Washington—Senator Dianne Feinstein (D-Calif.) today applauded the passage of the Drug Quality and Security Act of 2013, a bill to increase regulation of high-risk drug compounding practices and establish safeguards for the drug distribution supply chain.
In 2004, California passed a law to require additional oversight of the drug supply chain. There is currently no federal standard to track how medicine moves through the supply chain.
“California has long been a leader in pharmaceutical supply chain safety, and I’m proud that California’s law is now a model for action at the national level.” Feinstein said.
Last year, the New England Compounding Center, a compounding manufacturer in Framingham, Mass., produced contaminated medicine that sickened more than 750 people and killed 64 people across the country.
In 2009, 129,000 vials of insulin were stolen and later reappeared from an unknown source, who sold them to pharmacies and hospitals with no way of knowing how they were handled or whether they were stored under the appropriate conditions.
Feinstein added: “When a parent walks into a pharmacy to pick up a prescription for a sick child, she should be confident the drugs she receives are safe. I’m hopeful this bipartisan bill will bring peace of mind to consumers by increasing oversight of large-scale compounding manufacturers and providing new safety protocols throughout the supply chain.”
The Drug Quality and Security Act of 2013:
- Establishes a comprehensive, electronic framework to trace the distribution history of every individual unit that passes through the drug supply chain, establishing a chain of custody for each prescription drug dispensed to patients;
- Distinguishes compounders engaged in traditional pharmacy practice from those making large volumes of compounded drugs without individual prescriptions and better defines the Food and Drug Administration’s role in oversight of outsourcing facilities.
Similar legislation has already passed the House of Representatives and now heads to President Obama’s desk for signature.