New Mexico Administrative Code › Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING › Chapter 2 - ACUPUNCTURE AND ORIENTAL MEDICINE PRACTITIONERS › Part 19 - EXPANDED PRACTICE CERTIFICATIONS › Section 16.2.19.7 - DEFINITIONS

Current through Register Vol. 35, No. 13, July 16, 2024
A. The definitions
				in this section are in addition to those in the act and 16.2.1.7
				NMAC.
B. The following definition
				applies to the rules and the act:
"
educational course
"
is a comprehensive foundation of studies, approved by the board leading
				to demonstration of entry level competence in the specified knowledge and
				skills required for the four respective certifications in expanded practice; an
				educational course is not an educational program as this term is used in the
				act and the rules and as defined in 16.2.1 NMAC.
C. The following definitions are from
				16.19.36 NMAC for clarification of regulations for doctors of oriental
				medicine, certified in expanded practice;
(1)
				"Air changes per hour" (ACPH) means the number of times a volume of air
				equivalent to the room passes through the room each hour.
(2) 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:
(a) provides assurance that pressure
				relationships are constantly maintained so that air flows from clean to dirty
				areas; and
(b) reduces the need for
				the heating, ventilating, and air-conditioning (HVAC) control system to respond
				to large disturbances.
(3) "Aseptic Technique" means proper
				manipulation of preparations to maintain sterility
(4) "ASHP" American Society of Health-Systems
				Pharmacists.
(5) Beyond-use
				date
"
(BUD) means the date, or as appropriate, date and time,
				after which a compounded preparation is not to be used and is determined from
				the date and time the preparation is compounded.
(6) "Biological safety cabinet" (BSC) means a
				ventilated cabinet that provides ISO Class 5 environment for CSP's, provides
				personnel, preparation, and environmental protection having an open front with
				inward airflow for personnel protection, downward high-efficiency particulate
				air (HEPA)-filtered laminar airflow for preparation protection, and
				HEPA-filtered exhausted air for environmental protection.
(7)"Buffer area" means an 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 CSP's.
(8)
				"certification
"
means independent third party documentation
				declaring that the specific requirements have been met.
(9) Cleanroom" means a 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.
(10) "Closed system vial-transfer device"
				means a vial-transfer system that allows no venting or exposure of substances
				to the environment.
(11) Compounded
				sterile preparations"(CSP's) include, but are not limited, to the following
				dosage forms which must be sterile when administered to patients:
(a) parenteral preparations;
(b) aqueous bronchial and nasal
				inhalations;
(c) injections (e.g.
				colloidal dispersions, emulsions, solutions, suspensions);
(d) irrigations for wounds and body
				cavities;
(e) ophthalmic drops and
				ointments; and
(12)
				"Compounding aseptic isolator" (CAI) means an enclosed ISO Class 5 environments
				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 microbial retentive filter (HEPA minimum).
(13) "Critical area" means an ISO Class 5
				environment.
(14) "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 ampules, 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. Risk of microbial particulate contamination of the critical site
				increases with the size of the openings and exposure time.
(15)"Direct compounding area" (DCA) means a
				critical area within the ISO Class 5 primary engineering control (PEC) where
				critical sites are exposed to unidirectional HEPA-filtered air, also known as
				first air.
(16) "Disinfectant"
				means an agent that frees from infection and destroys disease-causing pathogens
				or other harmful microorganisms, but may not kill bacterial and fungal spores.
				It refers to substances applied to inanimate agents, usually a chemical agent,
				but sometimes a physical one.
(17)
				"Home care" means health care provided in the patient's home (not a hospital or
				skilled nursing facility) by either licensed health professionals or trained
				caregivers. May include hospice care.
(18) "Immediate use" means administration
				begins not later than one (1) hour following the start of the compounding
				procedure. Use of Immediate use products is reserved to those events in which
				delay in preparation would subject the patient to additional risk due to delay
				in therapy and meeting USP/NF <797> (Immediate-Use CSP Provision)
				criteria.
(19) "ISO 5" means air
				containing no more than one hundred (100) particles per cubic foot of air of a
				size at least 0.5 micron or larger in diameter (3520 particles per cubic
				meter).
(20) "ISO 7" means air
				containing no more than ten thousand (10,000) particles per cubic foot of air
				of a size at least 0.5 micron or larger in diameter (352,000 particles per
				cubic meter).
(21) "ISO 8" means
				air containing no more than one hundred thousand (100,000) particles per cubic
				foot of air of a size at least 0.5 micron or larger in diameter (3,520,000
				particles per cubic meter).
(22)
				"Laminar airflow" means a non-turbulent, non-mixing streamline flow of air in
				parallel layers.
(23) "Laminar
				airflow workbench" (LAFW) means a ventilated cabinet for compounding of sterile
				preparations. Provides preparation protection with high-effciency particulate
				air (HEPA) filtered laminar airflow, ISO Class 5. airflow may be horizontal
				(back to front) or vertical (top to bottom) in direction.
(24) "Media-fll 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-fll test are media-fll procedures, media selection, fll volume,
				incubation, time, and temperature, inspection of flled units, documentation,
				interpretation of results, and possible corrective actions required.
(25) "Multiple-dose container
"
means a multiple-unit container for articles or preparations intended
				for parenteral administration only and usually containing antimicrobial
				preservatives. Once opened or entered, a multiple dose container with
				antimicrobial preservative has a BUD of 28 days unless otherwise specified by
				the manufacturer.
(26) "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.
(27) "Parenteral product" means any
				preparation administered by injection through one (1) or more layers of skin
				tissue.
(28) "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.
(29) "Plan of
				care" means an individualized care plan for each patient receiving parenteral
				products in a home setting to include the following:
(a) description of actual or potential drug
				therapy problems and their proposed solutions;
(b) a description of desired outcomes of drug
				therapy provided;
(c) a proposal
				for patient education and counseling; and
(d) a plan specifying proactive objective and
				subjective monitoring (e.g. vital signs, laboratory test, physical findings,
				patient response, toxicity, adverse reactions, and noncompliance) and the
				frequency with which monitoring is to occur.
(30) "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.
(31)
				"Preparation" means a CSP that is a sterile drug or nutrient compounded in a
				licensed pharmacy or other healthcare-related facility pursuant to the order of
				a licensed prescriber; the article may or may not contain sterile
				products.
(32) "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.
(33) "Quality assurance" means a program for
				the systematic monitoring and evaluation of the various aspects of a service or
				facility to ensure that standards of quality are being met.
(34) "Quality control" means a system for
				verifying and maintaining a desired level of quality in a preparations or
				process, as by planning, continued inspection, and corrective action as
				required.
(35) "Single-dose
				container" means a single-dose, or a single-unit, container for articles or
				preparations intended for parenteral administration only. It is intended for a
				single use. Examples of single-dose containers include prefilled syringes,
				cartridges, fusion-sealed containers, and closure-sealed containers when so
				labeled.
(36) "Secondary
				engineering control" means the ante area and buffer area or cleanroom in which
				primary engineering controls are placed.
(37) "Segregated compounding area" means a
				designated space, either a demarcated area or room, that is restricted to
				preparing low-risk level CSP's with twelve (12)-hour or less BUD. Such area
				shall contain a device that provides unidirectional airflow of ISO Class 5 air
				quality for preparation of CSP's and shall be void of activities and materials
				that are extraneous to sterile compounding.
(38) "Standard operating procedure" (SOP)
				means a written protocol detailing the required standards for performance of
				tasks and operations within a facility.
(39) "Sterile" means free from bacteria or
				other living microorganisms.
(40)
				"Sterilization by filtration" means passage of a fluid or solution through a
				sterilizing grade membrane to produce a sterile effluent.
(41)"Sterilizing grade membranes" means
				membranes that are documented to retain one hundred percent (100%) of a culture
				of 107 microorganisms of a strain of Brevundimonas (Pseudomonas) diminuta per
				square centimeter of membrane surface under a pressure of not less than 30 psi.
				Such filter membranes are nominally at 0.22 µm or 0.2 µm porosity,
				depending on the manufacturer's practice.
(42) "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.
(43) "USP 797" United
				States Pharmacopeia Chapter <797> Pharmaceutical Compounding.
(44) Sterile Preparations- This general
				Chapter provides procedures and requirements for compounding sterile
				preparations. General Chapter<797> describes conditions and practices to
				prevent harm to patients that could result from microbial contamination,
				excessive bacterial endotoxins, variability in intended strength, unintended
				chemical and physical contaminants, and ingredients of inappropriate quality in
				compounded sterile preparations.
(45) "USP/ NF standards" means United States
				pharmacopeia/national formulary.