Washington Multistate Pharmacy Jurisprudence MPJE Practice Exam

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What must entities engaged in large volume compounding, particularly of sterile products, do?

Voluntarily withdraw from the market
Submit an annual report to the FDA
Voluntarily register with FDA
Purchase liability insurance

The correct answer is: Voluntarily register with FDA

Entities engaged in large volume compounding, particularly of sterile products, are required to voluntarily register with the FDA. This means that they must notify the FDA of their compounding activities and comply with any necessary regulations. Option A, voluntarily withdrawing from the market, is incorrect because it would not address the issue of large volume compounding. Option B, submitting an annual report to the FDA, is incorrect because it is not a requirement for compounding entities to submit reports. Option D, purchasing liability insurance, is incorrect because it is not specified as a requirement for entities engaged in large volume compounding.