Texas Register, Volume 37, Number 35, Pages 6819-7008, August 31, 2012 Page: 6,924
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(4) If a pharmacy fails to initiate a recall, the board may re-
quire a pharmacy to initiate a recall if there is potential for or confirmed
harm to a patient.
291.133. Pharmacies Compounding Sterile Preparations.
(a) Purpose. Pharmacies compounding sterile preparations,
prepackaging pharmaceutical products, and distributing those products
shall comply with all requirements for their specific license classifica-
tion and this section. The purpose of this section is to provide standards
for the:
(1) compounding of sterile preparations pursuant to a pre-
scription or medication order for a patient from a practitioner in Class
A (Community), Class C (Institutional), and Class E (Non-resident)
pharmacies;
(2) compounding, dispensing, and delivery of a reasonable
quantity of a compounded sterile preparation in a Class A (Commu-
nity), Class C (Institutional), and Class E (Non-resident) pharmacies
to a practitioner's office for office use by the practitioner;
(3) compounding and distribution of compounded sterile
preparations by a Class A (Community) pharmacy for a Class C (Insti-
tutional) pharmacy; and
(4) compounding of sterile preparations by a Class C (In-
stitutional) pharmacy and the distribution of the compounded prepara-
tions to other Class C (Institutional) pharmacies under common own-
ership.
(b) Definitions. In addition to the definitions for specific li-
cense classifications, the following words and terms, when used in this
section, shall have the following meanings, unless the context clearly
indicates otherwise.
(1) ACPE--Accreditation Council for Pharmacy Educa-
tion.
(2) Airborne particulate cleanliness class--The level of
cleanliness specified by the maximum allowable number of particles
per cubic meter of air as specified in the International Organization of
Standardization (ISO) Classification Air Cleanliness (ISO 14644-1).
For example:
(A) ISO Class 5 (formerly Class 100) is an atmospheric
environment that contains less than 3,520 particles 0.5 microns in diam-
eter per cubic meter of air (formerly stated as 100 particles 0.5 microns
in diameter per cubic foot of air);
(B) ISO Class 7 (formerly Class 10,000) is an atmo-
spheric environment that contains less than 352,000 particles 0.5 mi-
crons in diameter per cubic meter of air (formerly stated as 10,000 par-
ticles 0.5 microns in diameter per cubic foot of air); and
(C) ISO Class 8 (formerly Class 100,000) is an atmo-
spheric environment that contains less than 3,520,000 particles 0.5 mi-
crons in diameter per cubic meter of air (formerly stated as 100,000
particles 0.5 microns in diameter per cubic foot of air).
(3) Ancillary supplies--Supplies necessary for the prepara-
tion and administration of compounded sterile preparations.
(4) Anteroom--An ISO Class 8 or better area where per-
sonnel may perform hand hygiene and garbing procedures, staging of
components, order entry, labeling, and other high-particulate generat-
ing activities. 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.(5) Aseptic Processing--The technique involving pro-
cedures designed to preclude contamination of drugs, packaging,
equipment, or supplies by microorganisms during preparation.
(6) Automated compounding device--An automated de-
vice that compounds, measures, and/or packages a specified quantity
of individual components in a predetermined sequence for a designated
sterile preparation.
(7) Batch--A specific quantity of a drug or other material
that is intended to have uniform character and quality, within specified
limits, and is produced during a single preparation cycle.
(8) Batch preparation compounding--Compounding of
multiple sterile preparation units, in a single discrete process, by the
same individual(s), carried out during one limited time period. Batch
preparation/compounding does not include the preparation of multiple
sterile preparation units pursuant to patient specific medication orders.
(9) Beyond-use date--The date or time after which the com-
pounded sterile preparation shall not be stored or transported or begin
to be administered to a patient. The beyond-use date is determined
from the date or time the preparation is compounded.
(10) Biological Safety Cabinet, Class II--A ventilated cab-
inet for personnel, product, and environmental protection having an
open front with inward airflow for personnel protection, downward
HEPA filtered laminar airflow for product protection, and HEPA fil-
tered exhausted air for environmental protection.
(11) Buffer Area, Buffer or Core Room, Buffer or Clean
Room Areas, Buffer Room Area, Buffer or Clean Area, or Buffer Zone-
-An ISO Class 7 area where the primary engineering control area is
physically located. Activities that occur in this area include the prepa-
ration and staging of components and supplies used when compound-
ing sterile preparations.
(12) Clean room or controlled area--A room in which the
concentration of airborne particles is controlled to meet a specified air-
borne 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.
(13) Component--Any ingredient intended for use in the
compounding of a drug preparation, including those that may not ap-
pear in such preparation.
(14) Compounding--The preparation, mixing, assembling,
packaging, or labeling of a drug or device:
(A) as the result of a practitioner's prescription drug or
medication order based on the practitioner-patient-pharmacist relation-
ship in the course of professional practice;
(B) for administration to a patient by a practitioner as
the result of a practitioner's initiative based on the practitioner-patient-
pharmacist relationship in the course of professional practice;
(C) in anticipation of prescription drug or medication
orders based on routine, regularly observed prescribing patterns; or
(D) for or as an incident to research, teaching, or chem-
ical analysis and not for sale or dispensing, except as allowed under
562.154 or Chapter 563 of the Occupations Code.
(15) Compounding Aseptic Isolator--A form of barrier iso-
lator specifically designed for compounding pharmaceutical ingredi-
ents or preparations. It is designed to maintain an aseptic compound-
ing environment within the isolator throughout the compounding and
material transfer processes. Air exchange into the isolator from the sur-37 TexReg 6924 August 31, 2012 Texas Register
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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/m1/105/: accessed April 30, 2024), University of North Texas Libraries, The Portal to Texas History, https://texashistory.unt.edu; crediting UNT Libraries Government Documents Department.