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Product Serialization & Tracking (DSCSA)

PTCB Flashcards · 15 cards

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Question

What is the primary purpose of the Drug Supply Chain Security Act (DSCSA)?

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Answer
A.To regulate pharmacist licensing exams
B.To set federal drug pricing controls
C.To build an electronic, interoperable system to trace prescription drugs as they move through the supply chain, protecting against counterfeit, diverted, or stolen product
D.To determine which drugs require a REMS program
DSCSA's core purpose is establishing electronic traceability across the pharmaceutical supply chain to detect and remove counterfeit, stolen, or otherwise illegitimate product. It does not govern licensing exams (A), pricing (B), or REMS determinations (D), which are separate regulatory frameworks.