Product Serialization Seen as Next Objective for Drug Supply Security Act

September 20, 2016

A year from now, each drug product processed and moved through the U.S. supply chain could have its own unique identifier under the Drug Supply Security Act, FDA and industry officials said at a meeting.

In a speech at the PDA/FDA Regulatory Conference, Ilisa Bernstein, deputy director of the Office of Compliance for CDER, gave an update on the 2013 statute — what has been accomplished so far and what will be done over the next year and further down the road.

The next step in the process is a method that will confirm product serialization and identification, set to be implemented by late 2017. According to Bernstein, each package that goes through the supply chain and is processed will have its own unique identifier.

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