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
Universal Citation: 16 NM Admin Code 16.2.19.7
Current through Register Vol. 35, No. 18, September 24, 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.
Disclaimer: These regulations may not be the most recent version. New Mexico may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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