Pharmacy Law Practice Exam

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How many standard operating procedures does USP 795 establish as a minimum guideline for non-sterile compounding?

  1. 15 SOPs

  2. 20 SOPs

  3. 30 SOPs

  4. 46 SOPs

The correct answer is: 20 SOPs

The correct answer reflects that USP 795 establishes a minimum of 20 Standard Operating Procedures (SOPs) for non-sterile compounding. These SOPs are essential as they provide a framework for ensuring quality and consistency in the preparation of non-sterile compounded medications. They cover various aspects including the compounding process, documentation, personnel training, equipment maintenance, and quality control measures. This guideline aims to enhance patient safety by establishing clear procedures that compounding pharmacies must follow. By implementing these SOPs, pharmacies can better manage risks associated with compounding, such as contamination and errors in the preparation process. SOPs are foundational for compliance with regulatory standards and best practices in pharmacy operations. The other options regarding different numbers of SOPs do not accurately reflect the requirements set forth by USP 795 and therefore do not serve as the correct answer.

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