The FDA has delayed enforcement of “track and trace”

Hear that? That’s a collective sigh of relief from pharmacy directors everywhere.

Modern Healthcare: “The Food and Drug Administration is giving pharmacies another four months before they’re penalized if they can’t document the chain of custody for the drugs they dispense. The requirement was adopted under a 2013 law passed in response to a meningitis outbreak traced to a compounding pharmacy.” – The original deadline for enforcement was July 1. Groups such as ASHP have been lobbying to get the FDA to hold off enforcing the July 1 deadline. Looks like it worked.

Just in case you didn’t know, the Drug Quality and Security Act (DQSA) was signed into law on on November 27, 2013. Title II of the DQSA, the Drug Supply Chain Security Act (DSCSA) creates new definitions and requirements related to product tracing. The idea of the DSCSA is to build an electronic, interoperable system of tracking prescription drugs (“products”) by November 27, 2023.

The DSCSA replaces the pedigree requirements of the Prescription Drug Marketing Act (PDMA) and preempts state requirements – killing what California was trying to do – and applies to transactions or changes in ownership of products.

Under the DSCSA manufacturers, wholesale distributors, repackagers, and dispensers are required to provide the subsequent purchaser with product tracing information when engaging in transactions involving certain prescription drugs, thus creating a barrier for counterfeit medications entering the market.

People have been scrambling for a while to be compliant, but it’s been an uphill battle for many. I’ve sat through several webinars, and it’s clear that there is still much confusion. It’s a good thing the FDA handed out a four month reprieve. However, it’s unclear whether or not an additional four months is enough.

You can read more about the DSCSA at the FDA website here. Enjoy!

One thought on “The FDA has delayed enforcement of “track and trace””

  1. I’m a surgeon at UMass Med School. Stumbled onto your blog – its great. I’m curious about some issues related to barcoding pills-specifically narcotics. Can you drop me an email? thanks jack

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