§ 485.522 Condition of participation: Pharmaceutical services. The REH must have pharmaceutical services that meet the needs of its patients. The REH must have a pharmacy or a drug storage area that is directed by a registered pharmacist or other qualified individual in accordance with state scope of practice laws. The medical staff is responsible for developing policies and procedures that minimize drug errors. This function may be delegated to the REH's registered pharmacist or other qualified individual. ( a ) *Standard: Pharmacy management and administration.* The pharmacy or drug storage area must be administered in accordance with accepted professional principles and in accordance with state and Federal laws. ( 1 ) A pharmacist or competent individual in accordance with state scope of practice laws must be responsible for developing, supervising, and coordinating all the activities of the pharmacy services. The pharmacist or competent individual in accordance with state law and scope of practice must be available for a sufficient time to provide oversight of the REH's pharmacy services based on the scope and complexity of the services offered at the REH.
( 2 ) The pharmaceutical service must have an adequate number of personnel to ensure quality pharmaceutical services for the provision of all services provided by the REH.
( 3 ) Current and accurate records must be kept of the receipt and disposition of all scheduled drugs.
( b ) *Standard: Delivery of services.* Drugs and biologicals must be controlled and distributed in accordance with applicable standards of practice, consistent with Federal and state law, to ensure patient safety. ( 1 ) All compounding, packaging, and dispensing of drugs must be done by a licensed pharmacist or a licensed physician, or under the supervision of a pharmacist or competent individual in accordance with state law and scope of practice and performed consistent with state and Federal laws.
( 2 ) All drugs and biologicals must be kept in a secure area, and locked when appropriate. ( i ) All drugs listed in Schedules II, III, IV, and V of the Comprehensive Drug Abuse Prevention and Control Act of 1970 (21 U.S.C. 801 *et seq.*) must be kept locked within a secure area.
( ii ) Only authorized personnel may have access to locked areas.
( 3 ) Outdated, mislabeled, or otherwise unusable drugs and biologicals must not be available for patient use.
( 4 ) Drugs and biologicals must be removed from the pharmacy or storage area only by personnel designated in the policies of the medical staff and pharmaceutical service, in accordance with Federal and state law.
( c ) Standard: Administration of drugs . Drugs must be prepared and administered according to established policies and acceptable standards of practice. ( 1 ) Adverse reactions must be reported to the physician responsible for the patient and must be documented in the record.
( 2 ) Blood transfusions, blood products, and intravenous medications must be administered in accordance with state law and approved medical staff policies and procedures.
( 3 ) Orders given orally for drugs and biologicals must be followed by a written order, signed by the prescribing physician or other authorized prescriber.
( 4 ) There must be an REH procedure for reporting transfusion reactions, adverse drug reactions, and errors in administration of drugs.