Providing of CIIs to institutional patients {Ans: - no more than 7 days supply is dispensed at one time -CDS is not in possession of the ultimate user - institution has appropriate safeguards and records - system can identify supplier, product and patient and set forth directions}COMAR 10.34.19.12: Minimum Requirements for Policies and Procedures in Sterile Compounding {Ans: the policy and procedure manual shall include policies and procedures governing: - risk-management program (incident reporting system, adverse drug reaction reporting system, preparation contamination reporting system) - security measures for premises where preparations are stored and prepared - equipment (procedures for use, documentation of appropriate certifications, documentation of appropriate calibration and preventative maintenance) - sanitation standards and procedures including monitoring - reference materials - information concerning drug preparation, storage and handling, dispensing, labeling, BUD, delivery, destruction, recalls, returns - patient record keeping - handling, dispensing, documentation of investigational drugs - a quality assurance program - verification of training and competency guidelines - compounding process media fill verification procedures - description of appropriate garb - conduct guidelines for personnel in the controlled areas - personnel responsibilities - patient education - protocol and procedures to maintain the integrity of the interior work