Drug supply chain security act (DSCSA) Labeling

About DSCSA

The Drug Supply Chain Security Act (DSCSA) aims to build an electronic, interoperable system to accurately trace prescription drugs throughout the supply chain as they are distributed in the United States. Its goal is to verify legitimate products, detect suspect and illegitimate products, and better facilitate drug product recalls to protect consumers from counterfeit, contaminated, or otherwise harmful products.

The FDA has outlined tiered compliance deadlines for DSCSA implemention, beginning with prescription drug manufacturers by November 27, 2017. Repackagers must reach compliance by November 27, 2018, followed by wholesale distributors by November 27, 2019, and dispensers by November 27, 2020.

DSCSA requires a unique product identifier at the prescription drug package level that consists of:

• • National Drug Code (NDC)
  • Serial number
  • Lot number
• • Expiration date
  • Product identifier in 2D barcode format