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.