Pharmacies have an additional four months to meet track and trace requirements under the Drug Supply Chain Security Act (DSCSA), Regulatory Affairs Professionals Society (RAPS) reports. The DSCSA is under the Drug Quality and Security Act (DQSA) signed into law in 2013 and seeks to keep track of drug products in the supply chain nationwide. The U.S. Food and Drug Administration (FDA) has extended the deadline from July 2, 2015 to November 1, 2015 in response drug dispensers’ requests. The agency said it would use its “enforcement discretion” to allow more time even though the statutory date of compliance remains the same.
The DSCA requires drug packages to carry a unique serial number so that they can easily be tracked by federal regulators. This allows the FDA to more easily pinpoint the source of a problem and reduce the risk of counterfeit products. Every entity in the supply chain must keep track of the packages through this system.
In a letter dated June 22nd,the National Community Pharmacists Association (NCPA) asked the FDA asking for the deadline to be pushed back in order to “forestall potential disruptions in the pharmaceutical supply chain.” NCPA said “about half” of its members were unsure of how information would be transferred between parties. The agency granted the request and stated that “FDA does not intend to take action against dispensers who, prior to November 1, 2015, accept ownership of product without receiving the product tracing information, as required by [the DSCSA].”
“Although the DSCSA allows product tracing information to be exchanged through paper in certain circumstances, FDA understands that many dispensers intend to utilize electronic systems to capture and maintain product tracing information,” the FDA said in its guidance. “Thus, FDA recognizes that some dispensers may need additional time beyond July 1, 2015, to work with trading partners to ensure that the product tracing information required by section 582 is captured and maintained by dispensers.”