Question 1

What is the Meaning of DSCSA?

Accepted Answer

DSCSA stands for the Drug Supply Chain Security Act, a crucial piece of United States federal legislation designed to establish a national system for tracing pharmaceutical products through the supply chain. This regulatory framework aims to prevent counterfeit, contaminated, or stolen drugs from reaching patients, thereby safeguarding public health and the integrity of hormonal medications. Compliance is mandatory for manufacturers, repackagers, wholesale distributors, and dispensers, including compounding pharmacies.

Question 2

What is the Origin of DSCSA?

Accepted Answer

The Act was signed into law in 2013, originating from a growing concern over drug integrity and security within the complex, multi-layered pharmaceutical distribution system in the United States. Its legislative intent was to replace the prior patchwork of state-level pedigree laws with a uniform, national standard for drug traceability. This act fundamentally shifts the responsibility for drug security onto the entire chain of custody.

Question 3

What is the Mechanism of DSCSA?

Accepted Answer

The DSCSA mandates the use of a unique product identifier, known as serialization, on most prescription drug packages, which allows for unit-level tracking. It requires trading partners to exchange transaction information, history, and statements for certain prescription drug products at each transfer of ownership. By tracking the movement of drugs from the manufacturer to the dispenser, the system creates an electronic, interoperable product tracing system, ensuring the authenticity and integrity of all dispensed medications.

DSCSA

Meaning

Origin

Mechanism

What Are the Regulatory Implications of Real-Time Data in Pharmaceutical Logistics?

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