Not prepared for track & trace? US FDA grants amnesty until May

By Dan Stanton contact

- Last updated on GMT

US FDA will not take action against manufacturers that have missed the January 1 product tracing information deadline
US FDA will not take action against manufacturers that have missed the January 1 product tracing information deadline

Related tags: Supply chain management, Fda

The US FDA will give drugmakers and distributors until May to comply with new track and trace laws in order to minimise disruptions in the supply chain.

Like much of the world on New Year’s Day, drug manufacturers and wholesale distributors expected a headache or worse as the first requirements under the Drug Supply Chain Security Act (DSCSA) to implement product tracing information were set to begin.

But in draft guidance issued late last month​, the US Food and Drug Administration (FDA) administered a four-month painkiller by saying it does “not intend to take action against manufacturers, wholesale distributors, or repackagers who do not, prior to May 1 2015, provide or capture the product tracing information required,”​ as required by the new law.

“Some trading partners have expressed concern that unforeseen complications with the exchange of the required information may result in disruptions in the supply chain,”​ the guidance says.

“FDA recognizes that some manufacturers, wholesale distributors, and repackagers may need additional time beyond January 1 2015, to work with trading partners to ensure that all of the product tracing information required under section 582 of the FD&C Act is provided to and captured by the recipient trading partner.”

The DSCSA was signed into US law in November 2013​, and contains amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act) to help minimise the risk of falsified or contaminated medicinal products entering the supply chain.

The first stages of the Act have already been implemented. Third-party logistics providers have been required to report licensure and other information to FDA since last November​, and since the start of 2015 wholesale distributors have had to do the same.

New requirements, development of standards, and the system for product tracing will continue to be phased in over the next nine years, according to the FDA.

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