Washington Multistate Pharmacy Jurisprudence MPJE Practice Exam

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What is NOT required for an outsourcing facility under FDA section 503B?

  1. Annual registration with the FDA

  2. Be a pharmacy

  3. Send a list of compounded drugs to the FDA every 6 months

  4. Comply with the bill's requirements

The correct answer is: Be a pharmacy

An outsourcing facility under FDA section 503B does not have to be a pharmacy, as it can also be a facility that handles only the compounding of drugs without dispensing them. Options A, C, and D are all requirements for an outsourcing facility, while option B is not.

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