South Carolina Multistate Pharmacy Jurisprudence Examination (MPJE) Practice Exam

What does USP 795 specifically apply to?

1. Sterile compounding

2. Non-sterile compounding

3. Pharmacy technology

4. Pharmaceutical products

The correct answer is: Non-sterile compounding

USP 795 specifically applies to non-sterile compounding, providing guidelines and standards for the preparation of compounded medications that are not intended to be sterile. This includes compounding practices and procedures aimed at ensuring the quality, safety, and efficacy of these preparations. The guidelines cover various aspects such as the proper techniques for compounding, the selection of appropriate excipients, and the documentation required to ensure compliance with regulatory standards. Understanding non-sterile compounding is essential for pharmacists, as it involves the formulation of medications that may be in the form of creams, ointments, powders, or other dosage forms that don't require a sterile environment. This knowledge is critical in promoting patient safety and ensuring that compounded products meet the necessary quality standards. In contrast, sterile compounding, which is addressed in USP 797, involves more stringent requirements to prevent contamination due to the nature of the products being prepared for intravenous use or other sterile applications. Therefore, recognizing that USP 795 is dedicated to non-sterile compounding clarifies its specific application and focus within the broader scope of pharmacy compounding practices.