Question 12: What is an 'illegitimate product' under DSCSA?
- A product sold without a valid prescription
- A product that has been recalled by the FDA
- A product not covered by insurance
- A product confirmed to be counterfeit, diverted, stolen, intentionally adulterated, or the subject of a fraudulent transaction
Correct answer: A product confirmed to be counterfeit, diverted, stolen, intentionally adulterated, or the subject of a fraudulent transaction
Explanation: An illegitimate product is a product that has been confirmed (after investigation) to be counterfeit, diverted, stolen, intentionally adulterated, or the subject of a fraudulent transaction. It must be quarantined, disposed of, and reported to the FDA and trading partners within 24 hours.
Source citation: 21 U.S.C. § 360eee(8) - Illegitimate Product Definition
Unscored practice question