Outside Publication

Pharmaceutical Packaging and Product Identifiers – US Requirements Coming in 2017, European Pharmaceutical Review Vol. 21 Issue 4

August 2016

Since passage of the Drug Supply Chain and Security Act (DSCSA) of 2013, Section 582 of the Federal Food, Drug and Cosmetic Act (FFDCA) (21 U.S.C. § 360eee-1), pharmaceutical product manufacturers have been implementing systems and processes to track and trace drug product through the drug supply chain in the US. The first of these requirements relating to providing transaction documentation, much like a passport, which trails the product throughout its passage through the US, became effective in 2015.

View the full European Pharmaceutical Review article >>