Oklahoma Administrative Code › Title 535 - Oklahoma State Board of Pharmacy › Chapter 15 - Pharmacies › Subchapter 10 - Good Compounding Practices › Part 3 - GOOD COMPOUNDING PRACTICES FOR STERILE PREPARATIONS › Section 535:15-10-51 - Definitions

Current through Vol. 41, No. 20, July 1, 2024
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".
Added at 26 Ok Reg
					 2276, eff 7-1-09