legitimate medical purpose within the course of prescriber’s legitimate practice and including orders derived from collaborative pharmacy practice. (80) engineering or means a device, ‘Primary control’ ‘PEC’ such as a laminar airflow workbench or an isolator, or a room that provides an ISO 5 environment. (81) and means the process: ‘Process verification validation’ (a) used to evaluate whether a product, service, or system meets specifications and fulfills its intended purpose; and (b) of establishing evidence that provides a high degree of assurance that a product, service, or system accomplishes its intended requirements. (82) means a commercially manufactured drug or ‘Product’ nutrient that has been evaluated for safety and efficacy by the FDA. A product is accompanied by FDA approved manufacturer labeling or a product package insert. (4883) drug use means a review of the ‘Prospective review’ drug therapy and prescription drug order before patient’s dispensing the drug as part of a drug regimen review. (84) means a substance or agent that tends to cause a ‘Pyrogen’ rise in body temperature or fever. (85) means the cancellation or withdrawal of a ‘Revocation’ license, permit, or other authorization issued by the board either permanently or for a period specified by the board before the person shall be eligible to apply anew. A person whose license, permit, or other authorization has been permanently revoked by the board shall never again be eligible for a license or permit of any kind from the board. (86) engineering means a buffer area and an ‘Secondary control’ ante area that meet the designated ISO classification. (87) compounding area for compounding sterile ‘Segregated means a designated space: products’ (a) confined to a room or a demarcated area; (b) restricted to preparing lowrisk CSPs with a twelve hour or less beyonduse time; (c) containing a device that provides unidirectional air flow of ISO 5 air quality; (d) free of materials extraneous to sterile compounding; and (e) not used for other activities or purposes. (4988) adverse drug means a drugrelated ‘Significant reaction’ incident that may result in serious harm, injury, or death to the patient.
legitimate medical purpose within the prescriber’s course of legitimate practice and including orders derived from collaborative pharmacy practice. (80) ‘Primary engineering control’ or ‘PEC’ means a device, such as a laminar airflow workbench or an isolator, or a room that provides an ISO 5 environment. (81) ‘Process verification and validation’ means the process: (a) used to evaluate whether a product, service, or system meets specifications and fulfills its intended purpose; and (b) of establishing evidence that provides a high degree of assurance that a product, service, or system accomplishes its intended requirements. (82) ‘Product’ means a commercially manufactured drug or nutrient that has been evaluated for safety and efficacy by the FDA. A product is accompanied by FDA approved manufacturer labeling or a product package insert. (4883) ‘Prospective drug use review’ means a review of the patient’s drug therapy and prescription drug order before dispensing the drug as part of a drug regimen review. (84) ‘Pyrogen’ means a substance or agent that tends to cause a rise in body temperature or fever. (85) ‘Revocation’ means the cancellation or withdrawal of a license, permit, or other authorization issued by the board either permanently or for a period specified by the board before the person shall be eligible to apply anew. A person whose license, permit, or other authorization has been permanently revoked by the board shall never again be eligible for a license or permit of any kind from the board. (86) ‘Secondary engineering control’ means a buffer area and an ante area that meet the designated ISO classification. (87) ‘Segregated compounding area for compounding sterile products’ means a designated space: (a) confined to a room or a demarcated area; (b) restricted to preparing lowrisk CSPs with a twelve hour or less beyonduse time; (c) containing a device that provides unidirectional air flow of ISO 5 air quality; (d) free of materials extraneous to sterile compounding; and (e) not used for other activities or purposes. (4988) ‘Significant adverse drug reaction’ means a drugrelated incident that may result in serious harm, injury, or death to the patient.
3161_20130220.docx