As published in Pharma's Almanac Q2 2017.
New requirements under the U.S. Drug Supply Chain Security Act (DSCSA) have been set for pharmaceutical manufacturers, repackagers, wholesale distributors, dispensers and third-party logistics providers. Some of these requirements began in 2014; additional requirements will be phased in until 2023. The next deadline — November 2017 — applies to manufacturers. Compliance is challenging, but noncompliance carries the risk of significant consequences. In addition, challenges won’t end with implementation: there will be vast quantities of data to manage to support serialized production moving forward.