Which additional policy is required for sterile compounding besides maintaining appropriate BUD?

For sterile compounding, maintaining appropriate beyond-use dates (BUD) is essential to ensure the safety and effectiveness of compounded medications. In addition to BUD, having a written quality assurance (QA) plan is critical. A comprehensive QA plan helps ensure that all aspects of the compounding process, from the environment to the procedures and personnel training, meet established standards. This plan includes procedures for monitoring and evaluating the compounding activities, as well as methods for addressing any deviations from protocols.

Quality assurance is vital in mitigating risks associated with sterile compounding, where contamination and stability are significant concerns. It provides a structured approach to maintain compliance with regulatory requirements and standards set forth by agencies such as the USP (United States Pharmacopeia) and the Oregon State Board of Pharmacy. This ensures that compounded sterile products are safe and effective for patient use, making the QA plan an indispensable policy in addition to monitoring BUD.