N.J. Admin. Code § 13:39-11.2
The following words and terms, when used in this subchapter, shall have the following meanings:
"Ante area" means an ISO class 8 or better area where personnel hand hygiene and garbing procedures, staging of components, order entry, labeling, and other high-particulate-generating activities are performed. The "ante area" 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.
"Biological safety cabinet" means a ventilated cabinet for compounded sterile preparations that has an open front with inward airflow for personnel protection, downward high-efficiency particulate air (HEPA)-filtered laminar airflow for product protection, and HEPA-filtered exhaust air for environmental protection.
"Buffer area" means an ISO class 7 area where the primary engineering control is physically located and where the preparation and staging of components and supplies used in compounding sterile preparations occurs.
"Cleanroom" means a room in which the concentration of airborne particles is controlled to meet a specified airborne particulate cleanliness (ISO) 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. A "cleanroom" includes a buffer area or room and an ante area or room.
"Compounding" means the preparation, mixing, assembling, packaging, or labeling of a drug or device as the result of a practitioner's prescription or medication order or initiative based on the relationship of the practitioner or the patient with the pharmacist in the course of professional practice, or for the purpose of, or incident to, research, teaching, or chemical analysis and not for sale or dispensing. Compounding also includes the preparation of drugs or devices in anticipation of prescriptions or medication orders based on routine, regularly-observed prescribing patterns. Compounding includes mixing, reconstituting, or assembling a drug according to the product's labeling or to the manufacturer's directions.
"Compounding aseptic containment isolator" means a compounding aseptic isolator designed to provide worker protection from exposure to undesirable levels of airborne hazardous drugs 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 (high-efficiency particulate air (HEPA) minimum) system capable of containing airborne concentrations of the physical size and state of the drug being compounded.
"Compounding aseptic isolator" 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 process. Air exchanges into the isolator from the surrounding environment should not occur unless the air has first passed through a microbially retentive filter (high-efficiency particulate air (HEPA) minimum).
"Immediate use compounded sterile preparations" means preparations intended for emergency patient care and involve only simple aseptic measuring and transfer manipulations of no more than three sterile non-hazardous commercial drug and diagnostic radiopharmaceutical drug products, including an infusion or diluent solution. Unless required for the preparation, the compounding process occurs continuously without delays or interruptions and does not exceed one hour. Administration of immediate use compounded sterile preparations shall begin within one hour of preparation or the compounded sterile preparations shall be discarded. Immediate use compounded sterile preparations shall not be compounded and stored for anticipated needs and shall not be compounded as batch preparations. At no time during the compounding process, nor prior to administration, are critical sites and ingredients of the compounded sterile preparation directly exposed to contact contamination, such as human touch, cosmetic flakes, or particulates, blood, human body substances, and non-sterile inanimate sources.
"ISO class 5 air quality conditions" means conditions in which the air particle count is no greater than a total of 3,520 particles of 0.5 micrometers and larger per cubic meter of air (100 particles per cubic foot) that is supplied by high-efficiency particulate air (HEPA) or HEPA-filtered air.
"ISO class 7 air quality conditions" means conditions in which the air particle count is no greater than a total of 352,000 particles of 0.5 micrometers and larger per cubic meter of air (10,000 particles per cubic foot) that is supplied by high-efficiency particulate air (HEPA) or HEPA-filtered air.
"ISO class 8 air quality conditions" means conditions in which the air particle count is no greater than a total of 3,520,000 particles of 0.5 micrometers and larger per cubic meter of air (100,000 particles per cubic foot) that is supplied by high-efficiency particulate air (HEPA) or HEPA-filtered air.
"Negative pressure room" means a room that is at a lower pressure than the adjacent spaces and, therefore, the net airflow is into the room.
"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.
"Primary engineering control" means a device or room that provides an ISO class 5 environment for the exposure of critical sites when compounding sterile preparations. Such devices include laminar airflow workbenches, biological safety cabinets, compounding aseptic isolators, and compounding aseptic containment isolators.
"Risk levels for compounded sterile preparations" means the established classification for compounded sterile preparations based on the potential for microbial, chemical, and physical contamination of the preparations and are defined as follows:
1. "Low-risk level compounded sterile preparations" means preparations compounded with aseptic manipulations entirely within ISO class 5 or better air quality using only sterile ingredients, products, components, and devices. The compounding process involves only assembling, transferring, measuring, and mixing, using no more than three commercially manufactured sterile products, and not more than two entries into one sterile container or package to make the compounded sterile preparations. The compounding process is limited to aseptically opening ampules, penetrating sterile stoppers on vials with sterile needles and syringes, and transferring sterile liquids in sterile syringes to sterile administration devices, package containers of other sterile products, and containers for storage and dispensing.
2. "Medium-risk level compounded sterile preparations" means preparations compounded under low-risk level conditions but which require multiple individual or small doses of sterile products to be combined or pooled to prepare compounded sterile preparations that will be administered either to multiple patients or to one patient on multiple occasions. The compounding process includes complex aseptic manipulations other than single volume transfer, and requires an unusually long duration, such as that required to complete dissolution or homogeneous mixing.
3. "High-risk level compounded sterile preparations" means preparations compounded from non-sterile ingredients or from ingredients that are incorporated using non-sterile equipment before terminal sterilization, or from commercially manufactured sterile products that lack effective antimicrobial preservatives and whose preparation, transfer, sterilization, and packaging is performed in air quality worse than ISO class 5 for more than one hour. Water-containing preparations that are stored for more than six hours before terminal sterilization are also classified as high-risk level compounded sterile preparations.
N.J. Admin. Code § 13:39-11.2
See: 29 N.J.R. 2246(a), 30 N.J.R. 2255(a).
Former N.J.A.C. 13:39-11.2, Training requirements, was recodified to N.J.A.C. 13:39-11.7.
Amended by R.2005 d.25, effective 1/18/2005.
See: 36 N.J.R. 3345(a), 37 N.J.R. 295(a).
Rewrote the section.
Amended by R.2013 d.084, effective 6/3/2013.
See: 45 N.J.R. 439(a), 45 N.J.R. 1400(b).
Added definitions "Ante area", "Biological safety cabinet", "Buffer area", "Cleanroom", "Compounding", "Compounding aseptic containment isolator", "Compounding aseptic isolator", "Immediate use compounded sterile preparations", "ISO class 8 air quality conditions", "Negative pressure room", "Positive pressure room", "Primary engineering control", and "Risk levels for compounded sterile preparations"; in definitions "ISO class 5 air quality conditions" and "ISO class 7 air quality conditions", inserted "that is supplied by high-efficiency particulate air (HEPA) or HEPA-filtered air"; and deleted definition "ISO class 6 air quality conditions".