Okla. Admin. Code § 535:15-10-51
The following words or terms, when used in this Subchapter, shall have the following meaning, unless the context clearly indicates otherwise:
"ACPH"means "air changes per hour".
"ALARA"means "as low as reasonably achievable".
"Ante-Area"means an ISO Class 8 or better area where personnel hand hygiene and garbing procedures, staging of components, order entry, CSP labeling, and other high-particulate generating activities are performed. It is also a transition area that (1) provides assurance that pressure relationships are constantly maintained so that air flows from clean to dirty areas and (2) reduces the need for the heating, ventilating, and air-conditioning (HVAC) control system to respond to large disturbances.
"Beyond-use date (BUD)"means the date and time, as appropriate, after which administration is not to begin of a compounded preparation; and such date is determined from the date the preparation is compounded.
"Biological Safety Cabinet (BSC)"means a ventilated cabinet for CSPs, personnel, product, and environmental protection having an open front with inward airflow for personnel protection, downward high-efficiency particulate air (HEPA)-filtered laminar airflow for product protection, and HEPA-filtered exhausted air for environmental protection.
"Buffer Area"means an ISO Class 7 or better area where the primary engineering control (PEC) is physically located. Activities that occur in this area include the staging of components and supplies used when compounding CSPs.
"Clean Room"means an ISO Class 5 or better room in which the concentration of airborne particles is controlled to meet a specified airborne particulate cleanliness class. Microorganisms in the environment are monitored so that a microbial level for air, surface, and personnel gear are not exceeded for a specified cleanliness class.
"Component"means any ingredient used in the compounding of a drug, including those that may not appear on the labeling of such a product.
"Compounder"is a pharmacist or anyone compounding under the direct supervision of a pharmacist pursuant to a prescription order by a licensed prescriber.
"Compounding"means Compounding as defined in 59 O.S. Section 353.1
"Compounding Aseptic Containment Isolator (CACI)"means a compounding aseptic isolator (CAI) designed to provide worker protection from exposure to undesirable levels of airborne drug throughout the compounding and material transfer processes and to provide an aseptic environment for compounding sterile preparations. Air exchange with the surrounding environment should not occur unless the air is first passed through a microbial retentive filter (HEPA minimum) system capable of containing airborne concentrations of the physical size and state of the drug being compounded. Where volatile hazardous drugs are prepared, the exhaust air from the isolator should be appropriately removed by properly designed building ventilation.
"Compounding Aseptic Isolator (CAI)"means a form of isolator specifically designed for compounding pharmaceutical ingredients or preparations. It is designed to maintain an aseptic compounding environment within the isolator throughout the compounding and material transfer processes. Air exchange into the isolator from the surrounding environment should not occur unless the air has first passed through a microbially retentive filter (HEPA minimum).
"Critical Site"means a location that includes any component or fluid pathway surfaces (e.g., vial septa, injection ports, beakers) or openings (e.g., opened ampuls, needle hubs) exposed and at risk of direct contact with air (e.g., ambient room or HEPA filtered), moisture (e.g., oral and mucosal secretions), or touch contamination.
"CSP"means "Compounded Sterile Preparation".
"CSTD"means "Closed-System Vial-Transfer Device".
"FDA"means the federal "Food and Drug Administration".
"Hazardous drug"means any drug listed as such by NIOSH and/or any drug identified by at least one of the following six criteria: carcinogenicity, teratogenicity or developmental toxicity, reproductive toxicity in humans, organ toxicity at low doses in humans or animals, genotoxicity, or new drugs that mimic existing hazardous drugs in structure or toxicity.
"HEPA"means "High Efficiency Particulate Air".
"Immediate Use"means "administration begins not later than 1 hour following the start of the compounding procedure".
"Inordinate Amount"means an amount of compounded drug that exceeds the amount a pharmacy anticipates may be used or dispensed before the BUD of the compounded drug and is unreasonable considering the intended use of the compounded drug.
"ISO"means "International Organization for Standardization"
"ISO 5"means air containing no more than 100 P/ft of air of a size at least 0.5 micron or larger in diameter (3520 P/m 3 ), formerly FS209e Class 100.
"ISO 7"means air containing no more than 10,000 P/ft of air of a size at least 0.5 micron or larger in diameter (352,000 P/m 3 ), formerly FS209e Class 10,000.
"ISO 8"means air containing no more than 100,000 P/ft of air of a size at least 0.5 micron or larger in diameter (3,520,000 P/m 3 ), formerly FS209e Class 100,000.
"Isolator"means a device that is sealed or is supplied with air through a microbially retentive filtration system (HEPA minimum) and may be reproducibly decontaminated.
"Labeling"means a term that designates all labels and other written, printed, or graphic matter on an immediate container of an article or preparation or on, or in, any package or wrapper in which it is enclosed, except any outer shipping container. The term 'label' designates that part of the labeling on the immediate container.
"LAFW"means "Laminar Airflow Workbench".
"Manufacturing"means manufacturing as defined in 59 O.S. Section 353.1.
"MDV"means 'Multiple Dose Vial'.
"Media-Fill Test"means a test used to qualify aseptic technique of compounding personnel or processes and to ensure that the processes used are able to produce sterile preparation without microbial contamination. During this test, a microbiological growth medium such as Soybean-Casein Digest Medium is substituted for the actual drug product to simulate admixture compounding. The issues to consider in the development of a media-fill test are media-fill procedures, media selection, fill volume, incubation, time and temperature, inspection of filled units, documentation, interpretation of results, and possible corrective actions required.
"Multiple-Dose Container"means a multiple-unit container for articles or preparations intended for sterile compounded preparations administration only and usually containing antimicrobial preservatives.
"Negative Pressure Room"means a room that is at a lower pressure than the adjacent spaces and therefore, the net flow of air is into the room.
"National Safety Foundation"or "NSF"means the foundation that certifies that Biological or Class II safety cabinets meet NSF Standard 49.
"NIOSH"means "National Institute for Occupational Safety and Health"
"PEC"means "Primary Engineering Control".
"PET"means "Positron Emission Tomography".
"Personal Protective Equipment (PPE)"means items such as gloves, gowns, respirators, goggles, face shields, and others that protect individual workers from hazardous physical or chemical exposures.
"Primary Engineering Control (PEC)"means a device or room that provides an ISO Class 5 environment for the exposure of critical sites when compounding CSPs. Such devices include, but may not be limited to, laminar airflow workbenches (LAFWs), biological safety cabinets (BSCs), compounding aseptic isolators (CAIs), and compounding aseptic containment isolators (CACIs).
"Preparation"means an article compounded in a licensed pharmacy pursuant to the order of a licensed prescriber; the article may or may not contain sterile products.
"Product"means a commercially manufactured drug or nutrient that has been evaluated for safety and efficacy by the FDA. Products are accompanied by full prescribing information, which is commonly known as the FDA-approved manufacturer's labeling or product package insert.
"Positive Pressure Room"means a room that is at a higher pressure than the adjacent spaces and, therefore, the net airflow is out of the room.
"Single-dose container"means a single-dose, or a single-unit, container for articles or preparations intended for sterile compounded preparations administration only. It is intended for a single use. A single-dose container is labeled as such. Examples of single-dose containers include prefilled syringes, cartridges, fusion-sealed containers, and closure-sealed containers when so labeled.
"Segregated Compounding Area"means a designated space, either a demarcated area or room, that is restricted to preparing low-risk level CSPs with 12-hour or less BUD. Such area shall contain a device that provides unidirectional airflow of ISO Class 5 air quality for preparation of CSPs and shall be void of activities and materials that are extraneous to sterile compounding.
"Terminal Sterilization"means the application of a lethal process (e.g., steam under pressure or autoclaving) to sealed containers for the purpose of achieving a predetermined sterility assurance level of usually less than 10 -6 , or a probability of less than one in one million of a non-sterile unit.
"Unidirectional Flow"means airflow moving in a single direction in a robust and uniform manner and at sufficient speed to reproducibly sweep particles away from the critical processing or testing area.
"USP"means "United States Pharmacopeia".
Okla. Admin. Code § 535:15-10-51