Mont. Admin. r. 24.174.301 - DEFINITIONS
(1) "Airborne
particulate cleanliness classification" means the level of cleanliness defined
by the maximum allowable number of particles per cubic meter of air as
specified in the International Organization of Standardization (ISO)
"Classification of Air Cleanliness" (ISO 14644-1) for Class 5, Class 7, and
Class 8.
(a) ISO Class 5 is an atmospheric
environment that contains less than 3,520 particles 0.5 microns in diameter per
cubic meter of air;
(b) ISO Class 7
is an atmospheric environment that contains less than 352,000 particles 0.5
microns in diameter per cubic meter of air; and
(c) ISO Class 8 is an atmospheric environment
that contains less than 3,520,000 particles 0.5 microns in diameter per cubic
meter of air.
(2) "Beyond
use date" (BUD) means the date after which the preparation may not be dispensed
or administered to a patient. BUD also means expiration date.
(3) "Biological safety cabinet" means a
ventilated cabinet with an inward airflow for personnel protection; a downward,
High Efficiency Particulate Arresting (HEPA) filtered, laminar airflow for
product protection; and HEPA filtered exhaust system for environmental
protection.
(4) "Board of
Pharmaceutical Specialties" (BPS) means an independent nongovernmental
certification body that provides recognition of persons involved in the
advanced practice of pharmacy specialties through development and
administration and a certification process that is consistent with public
policy regarding the credentialing of healthcare professionals.
(5) "Chart order" means a lawful order
entered on the chart or a medical record of a patient or resident of a facility
by a practitioner, or his or her designated agent, for a drug or device and
shall be considered a prescription.
(6) "Class 100 environment" means an
atmospheric environment which contains fewer than 100 particles 0.5 microns in
diameter per cubic foot of air, according to Federal Standard 209E.
(7) "Clean room" means an environment in
which the concentration of airborne particles is controlled and monitored with
parameters including high efficiency particulate air (HEPA) filtered airflow,
pressurization, temperature, and humidity.
(8) "Clinical practice experience," for
purposes of issuing a clinical pharmacist practitioner endorsement, means
working in a pharmacy practice setting which includes at least 50 percent of
time spent in:
(a) communication with
healthcare professionals and patients regarding drug therapy, wellness, and
health promotion;
(b) designing,
implementing, monitoring, evaluating, and modifying or recommending
modifications in drug therapy to optimize patient care;
(c) identifying, assessing, and solving
medication-related problems and providing a clinical judgment as to the
continuing effectiveness of the therapeutic plan;
(d) conducting physical assessment applicable
to the area of practice, evaluating patient problems, and ordering and
monitoring medications, and/or laboratory tests in accordance with established
standards of practice;
(e)
referring patients to other healthcare professionals as appropriate;
(f) integrating relevant diet, exercise, and
other non-drug therapy with pharmaceutical care;
(g) retrieving, evaluating, utilizing, and
managing data and professional resources;
(h) documenting interventions and evaluating
outcomes; and
(i) integrating
national standards for the quality of healthcare.
(9) "Collaborative practice agreement" is
defined as set forth in ARM
24.174.524.
(10) "Compounded sterile preparation" (CSP)
means:
(a) a preparation prepared according
to the manufacturer's labeled instructions and other manipulations when
preparing sterile products that expose the original contents to potential
contamination, and includes all preparations compounded in a sterile
environment; or
(b) a preparation
containing nonsterile ingredients or employing nonsterile components and
devices that must be sterilized before administration.
(11) "Cytotoxic" means a pharmaceutical agent
capable of killing living cells.
(12) "DEA" means the Drug Enforcement
Administration of the United States Department of Justice.
(13) "Deliver" or "delivery" means the
actual, constructive, or attempted transfer of a drug or device from one person
to another, whether or not for a consideration.
(14) "Device" is defined in
37-2-101,
MCA, and is required under federal law to bear the label "Caution: Federal law
requires dispensing by or on the order of a physician" or "Rx only."
(15) " Drug kit" means a secured kit stored
outside of a pharmacy containing those drugs which may be required to meet the
short-term therapeutic need of patients within an institution not having an
in-house pharmacy or 24-hour access to dispensing services, and which would not
be available from any other authorized source in sufficient time, and without
which would compromise the quality of care of the patient.
(16) "Drug order" means a written or
electronic order issued by an authorized practitioner, or a verbal order
promptly transcribed, for the compounding and dispensing of a drug or device to
be administered to patients within a facility and shall be considered a
prescription.
(17) "Drug room"
means a secure, lockable temperature-controlled location within a facility that
does not have an institutional pharmacy and which contains drugs and devices
for administration to patients within the facility pursuant to a valid drug
order.
(18) "Electronic
prescription" means a prescription that is generated on an electronic
application and is transmitted to a pharmacy as an electronic data file.
Controlled substance prescriptions for Schedules II through V shall be
transmitted in accordance with DEA requirements as outlined in 21 CFR Part
1300.
(19) "Electronic signature"
means a confidential personalized method of affixing a signature to an
electronic document that will guarantee the identity of the
prescriber.
(20) "Emergency drug
cart" or "crash cart" means a secure lockable cart or container in an inpatient
setting that stores drugs and devices necessary to meet the immediate
therapeutic needs of a patient and which cannot be obtained from any other
authorized source in sufficient time to prevent harm.
(21) "Facility" means an outpatient center
for surgical services, a hospital and/or long-term care facility, or a home
infusion facility.
(22) "Floor
stock" means prescription drugs not labeled for a specific patient, which are
maintained at a nursing station or other hospital department other than the
pharmacy, and which are administered to patients within the facility pursuant
to a valid drug order. Floor stock shall be maintained in a secure manner
pursuant to written policies and procedures, which shall include, but not be
limited to, automated dispensing devices.
(23) "Formulary" means a current compilation
of pharmaceuticals authorized for use within the institution by representatives
of the medical staff and pharmacy department.
(24) "Home infusion facility" means a
facility where parenteral solutions are compounded and distributed to
outpatients for home infusion pursuant to a valid prescription or drug
order.
(25) "Immediate use" means a
preparation compounded pursuant to the conditions in ARM
24.174.1121
and whose administration must begin within one hour of preparation.
(26) "Institutional pharmacy" means that
physical portion of an institutional facility where drugs, devices, and other
material used in the diagnosis and treatment of injury, illness, and disease
are dispensed, compounded, and distributed to other healthcare professionals
for administration to patients within or outside the facility, and
pharmaceutical care is provided.
(27) "Internship" means the practical
experiences required to provide an intern, as defined in
37-7-101, MCA, with the knowledge
and practical experience necessary for professional licensure as a
pharmacist.
(28) "Internship
period" means 300 Introductory Pharmacy Practice Experience (IPPE) hours, and
1,440 Advanced Pharmacy Practice Experience (APPE) hours of practical
experience in an approved pharmacy, hospital, or other facility or location
relevant to the pharmacy profession. The intern may acquire the internship
hours concurrently with school attendance in approved courses, introductory
pharmacy practice experience, and advanced pharmacy practice experience, or
demonstration projects in the Pharm.D. program. The intern may acquire a
maximum of 48 hours experience per calendar week.
(29) Labeling" means the process of preparing
and affixing a label to any drug container exclusive, however, of the labeling
by a manufacturer, packer, or distributor of a nonprescription drug or
commercially packaged legend drug or device. Any such label shall include all
information required by federal and Montana law or rule.
(30) "Laminar airflow hood" (LAF) means a
workspace where the work surface is subjected to a constant HEPA filtered
airflow that is directed towards the user.
(31) "Long-term care facility" has the same
meaning as provided in
50-5-101,
MCA, and means a facility or part of a facility that provides skilled nursing
care, residential care, intermediate nursing care, or intermediate
developmental disability care to a total of two or more individuals, or that
provides personal care.
(32)
"Medical gas" means any gaseous substance that meets medical purity standards
and has application in a medical environment. Examples of medical gases
include, but are not limited to, oxygen, carbon dioxide, nitrous oxide,
cyclopropane, helium, nitrogen, and air.
(33) "Medical gas distributor" is a person
engaged in the manufacture, processing, packaging, labeling, or distribution of
a medical gas to a person other than a consumer or patient.
(34) "Medical gas supplier" is a person
engaged in selling, transferring, or delivering to a patient or a patient's
agent one or more doses of medical gas in the manufacturer's or distributor's
original container for subsequent use by the patient.
(35) "Multi-dose vial" means a vial of liquid
medication intended for parenteral administration, whether by injection or
infusion, that contains more than one dose of medication; is labeled as
containing more than one dose of medication by the manufacturer; and typically
contains an antimicrobial preservative to help prevent the growth of
bacteria.
(36) "Night cabinet"
means a secure locked cabinet or other enclosure located outside the pharmacy,
containing drugs which authorized personnel may access in the absence of a
pharmacist.
(37) "Nonprescription
drug" means a drug which may be sold without a prescription and which is
labeled for consumer use in accordance with the requirements of the laws and
rules of Montana and the federal government.
(38) "Outpatient center for surgical
services" is as defined at
50-5-101,
MCA.
(39) "Parenteral" means a
sterile preparation of drugs for injection through one or more layers of
skin.
(40) "Pharmacist-in-charge"
means a pharmacist licensed in Montana who accepts responsibility for the
operation of a pharmacy in conformance with all laws and rules pertinent to the
practice of pharmacy, who assures that the pharmacy and all pharmacy personnel
working in the pharmacy have current and appropriate licensure and
certification, and who is personally in full and actual charge of such
pharmacy. The pharmacist-in-charge at an out-of-state mail service pharmacy
does not have to be licensed in Montana.
(41) "Preceptor" means a pharmacist or other
approved individual who meets those requirements for the supervision and
training of an intern. A preceptor shall have overall responsibility for the
required training of the intern.
(42) "Provisional pharmacy" means a pharmacy
licensed by the Montana Board of Pharmacy and includes, but is not limited to,
federally qualified health centers as defined in
42 CFR
405.2401, where prescription drugs are
dispensed to appropriately screened, qualified patients.
(43) "Qualified patients" mean patients who
are uninsured, indigent, or have insufficient funds to obtain needed
prescription drugs.
(44) "Remote
pharmacy" means a licensed pharmacy at which prescriptions may be filled or
transmitted to a central hub pharmacy for filling and subsequent delivery to
the remote site or the patient's home. Patient counseling by a pharmacist may
occur at this site.
(45) "Remote
telepharmacy dispensing machine site" means a licensed site containing
prescription inventory which is secured in an automated dispensing device and
which has access to its parent pharmacy and registered pharmacists via
computer, video, and audio link at all times during business hours.
(46) "Remote telepharmacy site" means a
licensed site staffed by a registered pharmacy technician with access to its
parent pharmacy and registered pharmacists via computer, video, and audio link
at all times during business hours.
(47) "Risk levels for sterile preparations"
means the three risk levels of CSP recognized by the United States Pharmacopeia
(USP) in USP Chapter 797 "Pharmaceutical Compounding - Sterile Preparations"
that are based on the probability of contamination by microbial, chemical, or
physical agents. Pursuant to the conditions set forth in ARM 24.174.1121, the
three risk levels are low-risk, medium-risk, and high-risk.
(48) "Same-day use" means that the
administration of the preparation shall commence within 24 hours from the time
of preparation.
(49) "Satellite
pharmacy" means a specialized inpatient pharmacy staffed by a pharmacist which
is adjacent to or near the department served and is connected via computer to
the central institutional pharmacy.
(50) "Security" or "secure system" means a
system to maintain the confidentiality and integrity of patient records, which
are being sent electronically.
(51)
"Single-dose vial" means a sterile medication in a vial without
preservatives.
(52) "Sterile
pharmaceutical" means any dosage form containing no viable microorganisms
including, but not limited to, parenterals and ophthalmics.
(53) "Supervising pharmacist" means the
registered pharmacist who is serving as the pharmacist on duty and is in charge
of the day-to-day supervision of the pharmacy personnel.
(54) "Supervision" means that all drug
distribution or dispensing activities, immunizations, or other activities
performed by pharmacy personnel are under the direction of a registered
pharmacist.
(55) "Verification
audit" means a comparison and verification of written patient orders with
medications removed for that patient.
Notes
AUTH: 37-7-201, 50-32-314, MCA; IMP: 37-7-102, 37-7-201, 37-7-301, 37-7-306, 37-7-321, 37-7-406, 37-7-603, 37-7-604, 37-7-605, 50-32-314, MCA
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