Links to FDA / OIG DSCSA Guidance:
What is the Drug Supply Chain Security Act?
The Drug Supply Chain Security Act (DSCSA) was passed because the counterfeit medication market—a multi-billion dollar industry—accounts for more than a million deaths worldwide annually. This law outlines critical steps to build an electronic, interoperable system to identify and trace certain prescription drugs distributed in the United States and intends to hold accountable those who dispense medication to patients that is not legitimate.
The DSCSA protects consumers from counterfeit prescription medication by requiring all healthcare organizations that dispense pharmaceuticals to:
- All entities are registered licensed and in good standings
- You have received, tracked, and store product information
- Track and trace:
- All drug products from manufacturing origin to the final dispensing location
- At a lot level, or at a serialization level
- Provide tracking information within 48 hours of a request
- Potentially counterfeit or suspicious drugs
- Millions of pedigrees
- 6 years of data on a rolling basis