FDA extends transactional data deadline for pharmacies

The US FDA has given pharmacies another four months to meet a July 1 deadline in the implementation of federal track-and-trace requirements for medicines.

By the start of this month pharmacies were supposed to have started recording transactional data as medicines passed in and out of their possession, but the US regulator has acceded to a request by a pharmacy-representing body and set the deadline back to November 1.

The scheme is part of the US' new track and trace law - the 2013 Drug Supply Chain Security Act - which sets out an eight-year framework that will eventually allow prescription drugs to be identified and traced as they are distributed in the US supply chain, no matter where they originate.

From this year, the aim is to require trading partners to provide the subsequent purchaser with product tracing information, and also retain the data for at least six years.

The FDA is working with drug manufacturers, wholesale drug distributors, repackagers and dispensers - primarily pharmacies - to allow package-level tracking to enhance the detection of illegitimate drugs and make sure patients are only exposed to genuine medicines.

A letter sent by the National Community Pharmacists Association (NCPA), the American Pharmacists Association (APhA) and the National Alliance of State Pharmacy Associations (NASPA)on June 22 to the deputy director of the FDA's Office of Compliance - Ilisa Bernstein - notes that a recent survey of its membership reveals that most are not yet ready to comply.

Around half of respondents said they were unaware of how the transactional data would be transferred between wholesalers, secondary wholesalers and pharmacies, and fewer than 15 per cent had entered into contractual arrangements with their wholesalers.

"We remain concerned that the DSCSA requires secondary distributors to provide dispensers lot number information in the required documentation, but does not mandate that the information be included in a single document," says the letter.

"This is of great concern to dispensers, particularly in light of the fact that some secondary wholesalers have indicated that the only manner in which they plan to pass the lot number information is on the actual bottle of medication being sold to the pharmacy," it adds.

In guidance dated July 2015, the FDA has indicated that it "does not intend to take action against dispensers who, prior to November 1, 2015, accept ownership of product without receiving the product tracing information" or indeed those who do not capture and maintain that information.

It stresses however that the deadline has not been relaxed for other requirements such as verification of suspect and illegitimate product - including quarantine, investigation, notification and recordkeeping -as well as the need to work only with authorised trading partners.

The DSCSA's track-and-trace requirements sit alongside other initiatives designed to prevent, detect and respond to counterfeit/falsified or substandard medicines, including good manufacturing, distribution, and pharmacy practices, as well as supply chain surveillance, information-sharing and enforcement, according to a recent agency blog post.