the hood is moved for operational efficiency. Earlier recertification may be required if dictated by federal or state requirements or specifications due to workload. manufacturer’s (J) All waste materials must be disposed of in accordance with federal, state, and local requirements. (K) A policy and procedure manual must be available in the pharmacy. The manual shall include policies and procedures as applicable for the following: (1) quality control; (2) sterile technique; (3) destruction of returned solutions; (4) labeling of injectable solutions; (5) drug recall procedures; (6) investigational drugs; (7) handling and disposal of hazardous waste; (8) cytotoxic agents; (9) maintenance of patient profiles; and (10) material safety data sheets. (L) When sterile pharmaceuticals are provided to home care patients, the dispensing pharmacy may supply a nurse with emergency drugs if a physician has authorized the use of these drugs by a protocol or prescription drug order for use in an emergency situation, e.g., anaphylactic shock. (M) A licensed health care professional may possess noncontrolled prescribed legend drugs or devices such as water for injection, normal saline for IV, and heparin flush used in the administration of sterile pharmaceuticals. (N) If appropriate, the pharmacist shall demonstrate or document the training and competency in managing therapy provided patient’s by the pharmacist to the patient in the home environment. A pharmacist must be involved in the patient training process in any area that relates to drug compounding, labeling, administration, storage, stability, compatibility, or disposal. The pharmacist is responsible for seeing that the competency in the above patient’s areas is reassessed on an ongoing basis. (O) There must be a documented, ongoing, quality assurance control program that monitors patient care and pharmacy care outcomes, including but not limited to: (1) routine performance of prospective drug use review and patient monitoring functions by a pharmacist; (2) patientmonitoring plans that include written outcome measures and systems for routine patient assessment including, but
the hood is moved for operational efficiency. Earlier recertification may be required if dictated by federal or state requirements or manufacturer’s specifications due to workload. (J) All waste materials must be disposed of in accordance with federal, state, and local requirements. (K) A policy and procedure manual must be available in the pharmacy. The manual shall include policies and procedures as applicable for the following: (1) quality control; (2) sterile technique; (3) destruction of returned solutions; (4) labeling of injectable solutions; (5) drug recall procedures; (6) investigational drugs; (7) handling and disposal of hazardous waste; (8) cytotoxic agents; (9) maintenance of patient profiles; and (10) material safety data sheets. (L) When sterile pharmaceuticals are provided to home care patients, the dispensing pharmacy may supply a nurse with emergency drugs if a physician has authorized the use of these drugs by a protocol or prescription drug order for use in an emergency situation, e.g., anaphylactic shock. (M) A licensed health care professional may possess noncontrolled prescribed legend drugs or devices such as water for injection, normal saline for IV, and heparin flush used in the administration of sterile pharmaceuticals. (N) If appropriate, the pharmacist shall demonstrate or document the patient’s training and competency in managing therapy provided by the pharmacist to the patient in the home environment. A pharmacist must be involved in the patient training process in any area that relates to drug compounding, labeling, administration, storage, stability, compatibility, or disposal. The pharmacist is responsible for seeing that the patient’s competency in the above areas is reassessed on an ongoing basis. (O) There must be a documented, ongoing, quality assurance control program that monitors patient care and pharmacy care outcomes, including but not limited to: (1) routine performance of prospective drug use review and patient monitoring functions by a pharmacist; (2) patientmonitoring plans that include written outcome measures and systems for routine patient assessment including, but
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