New FDA Guidance: Verification Systems for DSCSA
Late last week, the U.S. Food & Drug Administration (FDA) posted draft guidance on the Federal Register titled "Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs" to share their interpretation of the Drug Supply Chain Security Act (DSCSA) requirements for verification systems, processes in suspect or illegitimate product scenarios and saleable returns verification, and recommendations for cleared product notifications.
Read the summary of this guidance, which was designed to help all industry stakeholders involved in verification processes to:
- Understand the information and business process expectations from the FDA given DSCSA requirements.
- Learn the FDA recommendations for managing verification.
- Determine how to manage the quarantine and investigation/disposal of suspect and illegitimate product.