Washington Multistate Pharmacy Jurisprudence MPJE Practice Exam

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What factor is NOT considered during risk-based inspections under 503B for compounding pharmacies?

Geographic location
Compliance history
History of recalls
Inspection history and frequency

The correct answer is: Geographic location

Factors to be considered during risk-based inspections under 503B for compounding pharmacies include compliance history, history of recalls, and inspection history and frequency. Geographic location is not considered because it does not directly impact the risk associated with the compounding pharmacy's practices and compliance with regulations. Factors such as the pharmacy's size, product complexity, and volume of production are more relevant to risk-based inspections. Additionally, geographic location can vary greatly and does not necessarily indicate the quality or safety of products produced by a compounding pharmacy. Therefore, geographic location is not considered during risk-based inspections.