Washington Multistate Pharmacy Jurisprudence MPJE Practice Exam

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What must an outsourcing facility send to the FDA every 6 months?

  1. A list of all employees

  2. A list of manufactured devices

  3. A list of compounded drugs

  4. Their annual profit report

The correct answer is: A list of compounded drugs

An outsourcing facility is a type of compounding pharmacy that produces large quantities of compounded drugs. Compounding is the process of combining, mixing, or altering ingredients to create customized medications for patients. The FDA requires outsourcing facilities to submit a list of compounded drugs every 6 months to ensure compliance with safety and quality standards. This list should include the names and quantities of all compounded drugs produced during that time period. Options A and B are incorrect because they are not relevant to the reporting requirements of an outsourcing facility. Option D is incorrect because it is not the annual profit report that the FDA requires from outsourcing facilities, but rather a list of compounded drugs.

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