Which product is subject to DSCSA?

• A. Prescription drugs
• B. Over-the-counter products
• C. Medical devices
• D. Blood and blood components for transfusion

Answer: (A)

DSCSA focuses on tracking and tracing prescription drug products through the supply chain to protect patients from counterfeit or unsafe medications. It applies specifically to prescription drug products in finished dosage form intended for human use, and to the entities that handle them in the supply chain. Because of this scope, prescription drugs are subject to DSCSA requirements, such as tracing information, verification, and serialization. Medical devices and blood components are regulated under different rules, and the DSCSA’s serialization and tracking provisions center on prescription medicines rather than OTC drugs. Therefore, the product category subject to DSCSA is prescription drugs.