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FDA Extends Deadline for Pharmacies' Track and Trace Compliance

Jul 1, 2015

The deadline for pharmacies to comply with federal track and trace requirements under the Drug Supply Chain Security Act (DSCSA) has been extended by an additional four months, Regulatory Affairs Professionals Society (RAPS) reports. The U.S. Food and Drug Administration (FDA) is giving drug dispensers until November 1, 2015 as opposed to July 1, 2015 to comply with the new regulations.

The DSCSA is part of the Drug Quality and Security Act (DQSA), which was signed into law in 2013. The main purpose of DSCA is to implement a "track and trace" system among pharmacies nationwide. The law requires drug packages to have a unique serial number, making it easier to detect and trace any problems and prevent counterfeits. The package is to be tracked by every entity in the supply chain so that the FDA can find the source of a problem if it arises.

Drug dispensers, however, say that the deadline has approached too quickly for them to implement the new system. The National Community Pharmacists Association (NCPA) wrote a June 22nd letter to the FDA asking for an extension on the July 1st deadline to "forestall potential disruptions in the pharmaceutical supply chain." In their letter, NCPA said "about half" of its members were unsure of information would be transferred between parties.

The FDA has granted an additional four months to comply with DSCSA regulations and said it would use its "enforcement discretion" to give pharmacies more time, even though the statutory date of compliance has not changed. The agency 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."

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