PATIENT MONITORING AND ADVERSE EVENTS REPORTING
Compounding facilities must clinically monitor patients treated with CSPs according to the regulations and guidelines of their respective state health care practitioner licensure boards or of accepted standards of practice. Compounding facilities must provide patients and other recipients of CSPs with a way to address their questions and report any concerns that they may have with CSPs and their administration devices.
The standard operating procedures manuals of compounding facilities must describe specific instructions for receiving, acknowledging, and dating receipts; and for recording, or filing, and evaluating reports of adverse events and of the quality of preparation claimed to be associated with CSPs. Reports of adverse events with CSPs must be reviewed promptly and thoroughly by compounding supervisors to correct and prevent future occurrences. Compounding personnel are encouraged to participate in adverse event reporting and product defects programs of the Food and Drug Administration (FDA) and United States Pharmacopeia (USP).