What is the main purpose of USP 797?

The main purpose of USP 797 is to establish standards for sterile compounding. This set of guidelines is crucial for ensuring the safety and effectiveness of compounded sterile preparations (CSPs). By creating a structured framework, USP 797 aims to minimize the risks of microbial contamination, excessive chemical or physical contamination, and incorrect strength or dosage of medications.

The guidelines encompass various aspects of sterile compounding, including the environments where compounding occurs, the training and qualifications of personnel, and the procedures for preparing and handling sterile products. Adhering to these standards is essential for healthcare facilities and pharmacists to protect patient safety and ensure high-quality pharmaceutical care.

While the other options address different areas of pharmacy practice, they do not pertain directly to the fundamental intent of USP 797. For instance, guidelines for non-sterile compounds fall under different standards, medication pricing is related to economic aspects rather than compounding practices, and over-the-counter drug regulation is covered by separate regulations that focus on non-prescription medication safety and labeling.