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Pharmaceutical Tracing – About the Law

The DSCSA establishes a national system for tracing prescription drugs and combats counterfeiting and contamination.

On November 27, 2013, the Drug Quality and Security Act (H.R. 3204) was signed into law. Title II of the act – the Drug Supply Chain Security Act (DSCSA) – establishes a national system for tracing pharmaceutical products through the supply chain and sets national licensing standards for wholesale distributors and third-party logistics providers.

The legislation covers only prescription drugs in finished dosage form for human use; it excludes the following:

  • drugs dispensed to patients pursuant to a prescription
  • blood and blood components intended for transfusion
  • radioactive drugs and radioactive biologics
  • limited intravenous products
  • compounded drugs
  • certain drugs contained in medical device convenience kits, and
  • over-the-counter drugs

The legislation immediately pre-empted the patchwork of state pedigree laws and regulations. Cardinal Health worked across the supply chain to ensure a smooth transition from state pedigree compliance to federal compliance.

More details about the law are available on the FDA website.

Drug Tracing Timeline

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37KB – PDF