FDA again delays drug ‘track and trace’ enforcement

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 agency previously intended to begin enforcing the policy July 1 for all businesses involved in the prescription drug supply chain. The policy is intended to speed the ability to find harmful products and remove them from the supply chain.

At the end of last year, the agency announced a phased approach to enforcing the rules, beginning with manufacturers, wholesale distributors and repackagers on Jan. 1. The FDA twice delayed enforcement for those companies, finally pushing the date to July 1 after they complained that complications in the exchange of information could disrupt patients’ access to drugs.

A coalition of pharmacy organizations, including the National Community Pharmacists Association, similarly argued that patients would face disruptions because pharmacies were not prepared to meet the July 1 deadline.

In a guidance document posted Tuesday, the FDA said some pharmacies told the agency that electronic systems for capturing and exchanging the tracking information would not be ready by the July 1 deadline.

To accommodate those businesses, the government will not impose penalties on pharmacies that accept drug shipments without receiving tracing information. The FDA is encouraging pharmacies, however, to work with suppliers to get that information because it serves as an important tool “to identify suspect product, quarantine the product and investigate whether that product is illegitimate.”

“The FDA’s latitude should hopefully allow pharmacies to continue to work with their wholesaler partners in order to achieve compliance with new product tracing requirements intended to enhance the safety of the U.S. pharmaceutical system,” the community pharmacists association said in a statement praising the relief.

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