Texas Register, Volume 37, Number 35, Pages 6819-7008, August 31, 2012 Page: 6,925
6819-7008 p. ; 28 cm.View a full description of this periodical.
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rounding environment shall not occur unless it has first passed through
a microbial retentive filter (HEPA minimum).
(16) Compounding Aseptic Containment Isolator--A com-
pounding aseptic isolator designed to provide worker protection from
exposure to undesirable levels of airborne drug throughout the com-
pounding and material transfer processes and to provide an aseptic en-
vironment for compounding sterile preparations. Air exchange with
the surrounding environment should not occur unless the air is first
passed through a microbial retentive filter (HEPA minimum) system
capable of containing airborne concentrations of the physical size and
state of the drug being compounded. Where volatile hazardous drugs
are prepared, the exhaust air from the isolator should be appropriately
removed by properly designed building ventilation.
(17) Critical Area--A critical area is an ISO Class 5 envi-
ronment.
(18) Critical Sites--Sterile ingredients of compounded ster-
ile preparations and locations on devices and components used to pre-
pare, package, and transfer compounded sterile preparations that pro-
vide opportunity for exposure to contamination.
(19) Cytotoxic--A pharmaceutical that has the capability of
killing living cells.
(20) Device--An instrument, apparatus, implement, ma-
chine, contrivance, implant, in-vitro reagent, or other similar or related
article, including any component part or accessory, that is required
under federal or state law to be ordered or prescribed by a practitioner.
(21) Direct Compounding Area--A critical area within the
ISO Class 5 primary engineering control where critical sites are ex-
posed to unidirectional HEPA-filtered air, also known as first air.
(22) Disinfectant--A disinfectant is an agent that frees from
infection, usually a chemical agent but sometimes a physical one, and
that destroys disease-causing pathogens or other harmful microorgan-
isms but may not kill bacterial spores. It refers to substances applied
to inanimate objects.
(23) First Air--The air exiting the HEPA filter in a unidi-
rectional air stream that is essentially particle free.
(24) Hot water--The temperature of water from the phar-
macy's sink maintained at a minimum of 105 degrees F (41 degrees C).
(25) HVAC--Heating, ventilation, and air conditioning.
(26) Immediate use--A sterile preparation that is not pre-
pared according to USP 797 standards (i.e. outside the pharmacy and
most likely not by pharmacy personnel) which shall be stored for no
longer than one hour after completion of the preparation.
(27) IPA--Isopropyl alcohol (2-propanol).
(28) Media-Fill Test--A media-fill test is 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-fill test are the following: me-
dia-fill procedures, media selection, fill volume, incubation, time and
temperature, inspection of filled units, documentation, interpretation of
results, and possible corrective actions required.
(29) Multiple-Dose Container--A multiple-unit container
for articles or preparations intended for potential administration only
and usually contains antimicrobial preservatives. The beyond-usedate for an opened or entered (e.g., needle-punctured) multiple-dose
container with antimicrobial preservatives is 28 days, unless otherwise
specified by the manufacturer.
(30) Negative Pressure Room--A room that is at a lower
pressure compared to adjacent spaces and, therefore, the net flow of air
is into the room.
(31) Office use--The administration of a compounded drug
to a patient by a practitioner in the practitioner's office or by the practi-
tioner in a health care facility or treatment setting, including a hospital,
ambulatory surgical center, or pharmacy in accordance with Chapter
562 of the Act, or for administration or provision by a veterinarian in
accordance with 563.054 of the Act.
(32) Pharmacy Bulk Package--A container of a sterile
preparation for potential use that contains many single doses. The
contents are intended for use in a pharmacy admixture program and
are restricted to the preparation of admixtures for infusion or, through
a sterile transfer device, for the filling of empty sterile syringes. The
closure shall be penetrated only one time after constitution with a
suitable sterile transfer device or dispensing set, which allows mea-
sured dispensing of the contents. The pharmacy bulk package is to be
used only in a suitable work area such as a laminar flow hood (or an
equivalent clean air compounding area).
(33) Prepackaging--The act of repackaging and relabeling
quantities of drug products from a manufacturer's original container
into unit dose packaging or a multiple dose container for distribution
within a facility licensed as a Class C pharmacy or to other pharmacies
under common ownership for distribution within those facilities. The
term as defined does not prohibit the prepackaging of drug products for
use within other pharmacy classes.
(34) Preparation or Compounded Sterile Preparation--A
sterile admixture compounded in a licensed pharmacy or other health-
care-related facility pursuant to the order of a licensed prescriber.
(35) Primary Engineering Control--A device or room that
provides an ISO Class 5 environment for the exposure of critical sites
when compounding sterile preparations. Such devices include, but may
not be limited to, laminar airflow workbenches, biological safety cabi-
nets, and compounding aseptic isolators and compounding aseptic con-
tainment isolators.
(36) Product--A product is a commercially manufactured
sterile drug or nutrient that has been evaluated for safety and efficacy
by the U.S. Food and Drug Administration (FDA). Products are accom-
panied by full prescribing information, which is commonly known as
the FDA-approved manufacturer's labeling or product package insert.
(37) Positive Control--A quality assurance sample pre-
pared to test positive for microbial growth.
(38) Positive Pressure Room--A room that is at a higher
pressure compared to adjacent spaces and, therefore, the net airflow is
out of the room.
(39) Quality assurance--The set of activities used to ensure
that the process used in the preparation of sterile drug preparations lead
to preparations that meet predetermined standards of quality.
(40) Quality control--The set of testing activities used to
determine that the ingredients, components (e.g., containers), and final
compounded sterile preparations prepared meet predetermined require-
ments with respect to identity, purity, non-pyrogenicity, and sterility.
(41) Reasonable quantity--An amount of a compounded
drug that:ADOPTED RULES August 31, 2012 37 TexReg 6925
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Texas. Secretary of State. Texas Register, Volume 37, Number 35, Pages 6819-7008, August 31, 2012, periodical, August 31, 2012; Austin, Texas. (https://texashistory.unt.edu/ark:/67531/metapth253227/m1/106/: accessed April 30, 2024), University of North Texas Libraries, The Portal to Texas History, https://texashistory.unt.edu; crediting UNT Libraries Government Documents Department.