Question 1

What does the acronym DSCSA stand for, and when was it enacted?

Accepted Answer

The Drug Supply Chain Security Act — Title II of the Drug Quality and Security Act, signed into law November 27, 2013, to build an electronic, interoperable system for tracing prescription drugs through the supply chain.

Question 2

Which products are covered by DSCSA product tracing requirements?

Accepted Answer

Most human prescription drugs in finished dosage form moving through manufacturers, repackagers, wholesale distributors, and dispensers (primarily pharmacies). DSCSA tracing does not apply to over-the-counter drugs or to animal drugs.

Question 3

How does a "market withdrawal" differ from a recall?

Accepted Answer

A market withdrawal is a firm's removal or correction of a distributed product involving only a minor violation FDA would not pursue legal action over, or no violation at all — for example, normal stock rotation or routine equipment repairs.

Question 4

What is a "stock recovery" under FDA recall regulations?

Accepted Answer

A firm's removal or correction of a product that has not yet been marketed or has not left the firm's direct control — the product is still on premises the firm owns or controls, and no portion of the lot has been released for sale or use.

Question 5

Who must be registered with iPLEDGE before isotretinoin can be dispensed to a patient?

Accepted Answer

Prescribers, pharmacies, and patients must all be registered — and isotretinoin may only be dispensed by a pharmacy that is registered and activated with iPLEDGE.

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