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.
to obtain health care services and shall not include those places where physicians, dentists, veterinarians, or other practitioners, who are duly licensed, engage in private practice. (2544) ‘Institutional pharmacy’ means the physical portion of an institutional facility that is engaged in the compounding, dispensing, and distribution of drugs, devices, and other materials, hereinafter referred to as ‘drugs’, used in the diagnosis and treatment of injury, illness, and disease and which is permitted by the State Board of Pharmacy. (2645) ‘Institutional consultant pharmacist’ means a pharmacist licensed in this State who acts as a consultant for institutional facilities. (2746) ‘Intern’ means an individual who is currently registered by certificate in this State to engage in the practice of pharmacy while under the personal supervision of a pharmacist and is satisfactorily progressing toward meeting the requirements for licensure as a pharmacist. (47) ‘ISO’ means the International Organization for Standardization. (48) ‘ISO 5 environment’ means an atmospheric environment that contains fewer than 3,520 particles no greater than 0.5 millimeters in diameter per cubic meter of air. The previous designation of this environment was known as Class 100. (49) ‘ISO 7 environment’ means an atmospheric environment that contains fewer than 352,000 particles no greater than 0.5 millimeters in diameter per cubic meter of air. The previous designation of this environment was known as Class 10,000. (50) ‘ISO 8 environment’ means an atmospheric environment that contains fewer than 3,520,000 particles no greater than 0.5 millimeters in diameter per cubic meter of air. The previous designation of this environment was known as Class 100,000. (51) ‘Isolator’ means a selfcontained primary engineering control defined by having fixed walls, a floor, and a ceiling, and includes barriers such as gloves, sleeves, and air locks that separate transfers of materials into and out of the environment. The use of an isolator can be an alternative to a buffer area for sterile preparations. (2852) ‘Labeling’ means the process of preparing and affixing a label which includes all information required by federal and state law to a drug container exclusive of the labeling by a manufacturer, packer, or distributor of a nonprescription drug or commercially packaged legend drug or device.
(e) Unless immediately and completely administered by the person who prepared it or immediate and complete administration is witnessed by the preparer, the CSP must bear a label listing the patient identification information, the names and amounts of all ingredients, the name or initials of the person who prepared the CSP, and the exact one hour BUD and time. (f) If administration has not begun within one hour following the start of preparing the CSP, the CSP must be discarded. (C) The compounding area of the facility must meet the facility requirements relative to the risk level of products they prepare. (1) Facility design and environmental control must be designed to minimize airborne contamination from contacting critical sites. (a) A PEC must maintain ISO Class 5 or better conditions while compounding. (b) The PEC HEPAfiltered air must be supplied in critical areas at a velocity sufficient to sweep particles away from the compounding area. (2) The buffer area must maintain at least ISO Class 7 conditions under dynamic operating conditions. (a) The room must be segregated from surrounding, unclassified spaces to reduce the risk of contaminants being blown, dragged, or otherwise introduced into the HEPAfiltered airflow environment. (b) For buffer areas not physically separated from the ante areas, the principle of displacement airflow must be employed. The displacement concept shall not be used for high–risk compounding. (c) The PEC must be placed out of the traffic flow in a manner to avoid conditions that could adversely affect their operation. (d) Cleaning materials must be nonshedding and dedicated for use only in the sterile compounding area. (e) Only the furniture, equipment, supplies, and other material required for the compounding activities to be performed may be brought into the buffer area, and they must be nonpermeable, nonshedding, cleanable, and resistant to disinfectants. They must be cleaned, then disinfected before brought into the area. (f) The surfaces of ceilings, walls, floors, fixtures, shelving, counters, and cabinets in the buffer area must be smooth, impervious, and nonshedding in order to promote cleanliness.