Under DSCSA, what is a key purpose of product labeling and documentation for tracking and reporting?

• A. For tracking and tracing products and reporting suspect or illegitimate products.
• B. For marketing and branding.
• C. For price control.
• D. For shelf-life labeling only.

Answer: (A)

Under DSCSA, labeling and documentation are about enabling traceability and rapid reporting. The goal is to have clear identifiers and transaction records so each drug product can be tracked through every step of the supply chain, and any suspect or illegitimate product can be quickly reported, investigated, and removed if needed. This protects patient safety by making it possible to pinpoint where a problem arose and to initiate recalls or other actions efficiently. It isn’t about marketing, pricing, or shelf-life labeling alone; the emphasis is on traceability and reporting suspected products.