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Posted 30 June 2015

FDA Gives Pharmacies Another Four Months to Comply With Track and Trace Requirements


The US Food and Drug Administration (FDA) plans to give drug dispensers—i.e. pharmacies—an additional four months to comply with federal track and trace requirements established under the Drug Supply Chain Security Act (DSCSA).


In 2013, the Drug Quality and Security Act (DQSA) was signed into law. While the DQSA is perhaps better known for its extensive pharmaceutical compounding reform provisions, it also contains another major component formally known as the Drug Supply Chain Security Act (DSCSA).

The core of the DSCSA is meant to establish a nationwide pharmaceutical "track and trace" system that deters drug counterfeiting. The basic premise of the law is simple: Drug packages will be required to bear a unique serial number which will be used to track the drug as it moves throughout the supply chain. If something goes wrong with the drug, federal officials can use the unique number to "trace" its path back to the source of the problem.

Each entity in the supply chain, from the original manufacturer to the end distributor, is supposed to keep track of the product coming into and out of its possession, allowing its path to be traced by federal regulators in the event of a problem.

Pharmacies: We Need More Time

But recording that transactional data isn't easy. Systems have to be designed and implemented, and new operating procedures put into place to accommodate the new information.

And for pharmacists, all that work has proven to be a little bit too much—for now. On 22 June 2015, the National Community Pharmacists Association (NCPA) wrote to FDA, asking for a temporary reprieve from a looming 1 July 2015 deadline by which all pharmaceutical dispensers would have to comply with FDA's transactional requirements.

After surveying its members, NCPA said "about half" were unaware of how their information would be transferred between wholesalers, secondary wholesalers and pharmacies. The group's letter asked FDA to extend the DSCSA compliance deadline to "forestall potential disruptions in the pharmaceutical supply chain."

Extension Granted

Now FDA is giving all drug dispensers until 1 November 2015 to comply with DSCSA regulations—an additional four months beyond the current deadline.

While the statutory date of compliance is still 1 July 2015, FDA said it would utilize its "enforcement discretion" to allow companies more time to comply. "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]," it said.

"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," FDA wrote in its guidance, DSCSA Implementation: Product Tracing Requirements for Dispensers — Compliance Policy. "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."

All other entities, including manufacturers, wholesale distributors and repackagers, will still need to comply with the 1 July 2015 deadline, FDA said.


DSCSA Implementation: Product Tracing Requirements for Dispensers — Compliance Policy


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