Pharmacy Technician Certification Exam Practice Question

For certain medications that carry serious safety risks, the FDA may require a(n):

Correct Answer: B

Rationale: A boxed warning is a strong warning placed on the label of prescription medications that carry significant risks, alerting both healthcare providers and patients to potential dangers. This is essential for ensuring informed decision-making regarding treatment options.

Auxiliary labels (A) provide additional information but lack the prominence of boxed warnings. MedWatch reports (C) are used for post-market surveillance and reporting adverse events, not for initial labeling. A drug pedigree statement (D) tracks the distribution of the drug but does not directly address safety risks. Thus, the boxed warning is crucial for highlighting serious safety concerns effectively.

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