Who is primarily responsible for ensuring compliance with USP 797 standards?

The primary responsibility for ensuring compliance with USP 797 standards falls on the pharmacists and compounding staff. This group is directly involved in the compounding process and must adhere to strict guidelines to ensure the sterility and overall quality of compounded sterile preparations. The pharmacists play a critical role in overseeing the compounding procedures, the training of personnel, and the implementation of quality assurance measures. They are also responsible for maintaining appropriate environments for sterile compounding, ensuring that all staff members follow aseptic techniques, and conducting regular checks to adhere to established protocols.

The pharmacy technicians, while integral to the compounding process, work under the supervision of pharmacists. Thus, while they contribute to ensuring compliance, the ultimate responsibility lies with the pharmacists and the entire compounding team.

Patients receiving compounded medications do not play a role in compliance with USP 797 standards, as their focus is on receiving medication and not on the production process. Similarly, suppliers of raw materials have their own set of compliance and quality assurance practices but do not directly manage the compounding environment or processes. Hence, it is the pharmacists and compounding staff who bear the primary responsibility for ensuring that all aspects of USP 797 are followed.