Kan. Admin. Regs. § 68-13-2 - Definitions
Current through Register Vol. 41, No. 14, April 7, 2022
As used in this article of the board's regulations, each of the following terms shall have the meaning specified in this regulation:
(a) "Active ingredients" means chemicals,
substances, or other components intended for use in the diagnosis, cure,
mitigation, treatment, or prevention of diseases in humans or for use as
nutritional supplements.
(b) "Added
substances" and "inactive ingredients" mean the ingredients necessary to
compound a sterile preparation or nonsterile preparation and not intended or
expected to cause a human pharmacologic response if administered alone in the
amount or concentration contained in a single dose of the drug
product.
(c) "Antearea" means an
area, separate from the buffer area, that meets the requirements of an ISO
class eight environment and in which personal hygiene and garbing procedures,
staging of components, order entry, and labeling are performed.
(d) "Batch" means multiple sterile dosage
units in a quantity greater than 25 that are compounded in a discrete process
by the same individual or individuals during one limited period.
(e) "Beyond-use date" means a date placed on
a prescription label at the time of dispensing, repackaging, or prepackaging
that is intended to indicate to the patient or caregiver a time beyond which
the contents of the prescription are not recommended to be used.
(f) "Biological safety cabinet" and "BSC"
mean a ventilated cabinet for sterile preparations and hazardous drugs to
protect personnel, products, and the environment that has an open front with
inward airflow for protection of personnel, downward-airflow LAFS for product
protection, and HEPA-filtered exhausted air for environmental
protection.
(g) "Buffer area" means
an area that meets the requirements for an ISO class seven environment and in
which the primary engineering control is located.
(h) "Clean room" means a room that meets the
requirements for an ISO class five environment.
(i) "Complex nonsterile compounding" means
making a nonsterile preparation that requires special training, environment,
facilities, equipment, and procedures to ensure appropriate therapeutic
outcomes. Nonsterile preparations made using complex nonsterile compounding
shall include transdermal dosage forms, modified-release forms, and
suppositories for systemic effects.
(j) "Component" means any active ingredient
or added substance intended for use in the compounding of a drug product,
including any ingredient that does not appear in the drug product.
(k) "Compounding" has the meaning specified
in K.S.A. 2017 Supp.
65-1626,
and amendments thereto.
(l)
"Compounding area" means any area in a pharmacy or outsourcing facility where
compounding is performed.
(m)
"Compounding aseptic containment isolator" and "CACI" mean a compounding
aseptic isolator designed to provide worker protection from exposure to
undesirable levels of airborne drugs throughout the compounding and material
transfer process and to provide an aseptic environment for compounding sterile
preparations. Air exchange with the surrounding environment shall not occur
unless the air is first passed through a HEPA filter capable of containing
airborne concentrations of the physical size and state of the drug being
compounded. whenever volatile hazardous drugs are compounded, the exhaust air
from the CACI shall be removed by the building's ventilation system.
(n) "Compounding aseptic isolator" and "CAI"
mean a type of isolator specifically designed for compounding sterile
preparations or nonsterile preparations and designed to maintain an aseptic
compounding environment within the isolator throughout the compounding and
material transfer process. Air exchange into the CAI from the surrounding
environment shall not occur unless the air has first passed through a HEPA
filter and an ISO class five environment is maintained.
(o) "Cytotoxic," when used to describe a
pharmaceutical, means that the pharmaceutical is capable of killing living
cells. This term is also used to describe components classified as cancer
chemotherapeutic, carcinogenic, mutagenic, or antineoplastic.
(p) "Dosage unit" means the amount of a
sterile preparation that would be administered to or taken by one patient at a
time.
(q) "Endotoxin" means a
potentially toxic, natural compound that is a structural component of bacterial
cell walls and that is released mainly when bacteria undergo destruction or
decomposition.
(r) "Essentially a
copy" means any sterile preparation or nonsterile preparation that is
comparable in active ingredients to a commercially available drug product,
unless either of the following conditions is met:
(1) There is a change made for an identified
individual patient that produces a clinically significant difference for the
patient, as determined by the prescribing practitioner, between the comparable
commercially available drug product and either the sterile preparation or the
nonsterile preparation.
(2) The
drug appears on the drug shortage list in section 506E of the federal food,
drug, and cosmetic act,
21 U.S.C.
356e, at the time of compounding,
distribution, and dispensing.
(s) "Excursion" means a deviation from the
range of temperatures specified by the manufacturer for storage or transport of
a pharmaceutical based on stability data.
(t) "Glove fingertip test" means a test in
which a gloved fingertip is pressed to and cultured on a microbiological growth
media plate. Each successful glove fingertip test shall yield no more than
three colony-forming units per contact plate for the annual competency
evaluation and shall yield zero colony-forming units at least three times for
the initial competency evaluation.
(u) "Hazardous drug" means any drug or
compounded drug identified by at least one of the following criteria:
(1) Carcinogenicity;
(2) teratogenicity or developmental
toxicity;
(3) reproductive
toxicity;
(4) organ toxicity at low
doses;
(5) genotoxicity;
or
(6) drug product structure or
toxicity that mimics that of existing hazardous drugs.
(v) "HEPA" means high-efficiency particulate
air.
(w) "ISO class eight
environment" means an atmospheric environment containing less than 3,520,000
airborne particles measuring at least 0.5 micron in diameter per cubic meter of
air.
(x) "ISO class five
environment" means an atmospheric environment containing less than 3,520
airborne particles measuring at least 0.5 micron in diameter per cubic meter of
air.
(y) "ISO class seven
environment" means an atmospheric environment containing less than 352,000
airborne particles measuring at least 0.5 micron in diameter per cubic meter of
air.
(z) "Laminar airflow system"
and "LAFS" mean an apparatus designed to provide an ISO class five environment
for the compounding of sterile preparations using air circulation in a defined
direction that passes through a HEPA filter.
(aa) "Manufacturing" means manufacture as
defined in
K.S.A.
65-1626, and amendments thereto.
(bb) "Media fill test" means a test in which
a microbiological growth medium, which may consist of a soybean-casein digest
medium, is substituted for an actual drug product to simulate admixture
compounding. The media fill test shall be successful if it produces a sterile
preparation without microbial contamination.
(cc) "Moderate nonsterile compounding" means
making a nonsterile preparation that requires special calculations or
procedures to determine quantities of components per nonsterile preparation or
per dosage unit or making a nonsterile preparation for which stability data is
not available. Nonsterile preparations made using moderate nonsterile
compounding shall include morphine sulfate suppositories, diphenhydramine
troches, and a mixture of two or more manufactured creams if stability of the
mixture is not known.
(dd)
"Multiple-dose container" means a multiple-unit container for any sterile
preparation intended only for parenteral administration, usually containing
antimicrobial preservatives.
(ee)
"Nonsterile preparation" means a pharmaceutical made using simple nonsterile
compounding, moderate nonsterile compounding, or complex nonsterile
compounding.
(ff) "Official
compendium" has the meaning specified in
K.S.A.
65-656, and amendments thereto.
(gg) "Order" means either a prescription
order as defined in
K.S.A.
65-1626, and amendments thereto, or a
medication order as defined in
K.A.R.
68-5-1.
(hh) "Parenteral," when used to refer to a
solution, means that the solution is administered by injection through one or
more layers of skin or by other routes of administration that bypass the
gastrointestinal tract.
(ii)
"Parenteral product" means a sterile preparation administered by injection
through one or more layers of skin or by other routes of administration that
bypass the gastrointestinal tract.
(jj) "Practitioner-patient-pharmacist
relationship" means a relationship that meets all of the following conditions:
(1) The practitioner has assumed the
responsibility for making medical judgments regarding the health of the patient
and the need for medical treatment.
(2) The practitioner has sufficient knowledge
of the patient to initiate at least a general or preliminary diagnosis of the
medical condition, and the practitioner has examined the patient and is
available for follow-up.
(3) The
practitioner has communicated the necessary prescriptions to the pharmacist,
who is able to provide pharmaceutical care to the patient and, if needed,
communicate with the practitioner.
(kk) "Primary engineering control" means a
clean room or an apparatus for compounding sterile preparations, including an
LAFS, a BSC, a CAI, or a CACI, designed to provide an ISO class five
environment for compounding sterile preparations.
(ll) "Purified water" means water that meets
the requirements for ionic and organic chemistry purity and protection from
microbial contamination specified in section 1231 of the official
compendium.
(mm) "Refrigeration"
and "controlled cold temperature" mean a temperature maintained
thermostatically between 2° and 8°C (36° to 46°F) that allows
for excursions between 0° and 15°C (32° to 59°F) that are
experienced during storage, shipping, and distribution, such that the allowable
calculated mean kinetic temperature is not more than 8°C
(46°F).
(nn) "Room temperature"
means a temperature maintained thermostatically that meets the following
criteria:
(1) Encompasses the usual and
customary working environment of 20° to 25°C (68° to
77°F);
(2) results in a mean
kinetic temperature calculated to be not more than 25°C (77°F);
and
(3) allows for excursions
between 15° and 30°C (59° to 86°F) experienced in pharmacies,
hospitals, and storage facilities, such that the allowable calculated mean
kinetic temperature remains in the allowed range.
(oo) "Segregated compounding area" means a
designated, demarcated area or room that is restricted to compounding low-risk
sterile preparations, which shall contain a primary engineering control
providing unidirectional airflow that maintains an ISO class five environment
and shall be void of all activities and materials extraneous to the sterile
compounding process.
(pp) "Simple
nonsterile compounding" means either of the following:
(1) Making a nonsterile preparation that has
a compounding monograph listed in the official compendium or that appears in a
peer-reviewed journal containing specifics on component quantities, compounding
procedure, equipment, and stability data for the formulation and appropriate
beyond-use dates; or
(2)
reconstituting or manipulating commercially available products that require the
addition of one or more ingredients as directed by the manufacturer.
Nonsterile preparations made using simple nonsterile compounding shall include captopril oral solution, indomethacin topical gel, and potassium bromide oral solution.
(qq) "Single-dose container" means a
single-unit container for any sterile preparation intended for parenteral
administration that is accessed once for one patient.
(rr) "Specific medical need" means a medical
reason why a commercially available drug product cannot be used, excluding cost
and convenience.
(ss) "Sterile
preparation" means any dosage form of a drug, including parenteral products
free of viable microorganisms, made using currently accepted aseptic
compounding techniques under acceptable compounding conditions. This term shall
include any commercially compounded sterile drug dosage form that has been
altered in the compounding process.
(tt) "Sufficient documentation" means either
of the following:
(1) A prescription
documenting a specific medical need; or
(2) a notation in a pharmacy's or an
outsourcing facility's records that verbal or other documentation of the
specific medical need was received for each prescription, including the name of
the person verifying the specific medical need, the date, and the specific
medical need.
Notes
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