| (a) Purpose. Pharmacies compounding sterile preparations,
prepackaging pharmaceutical products, and distributing those products
shall comply with all requirements for their specific license classification
and this section. The purpose of this section is to provide standards
for the:
(1) compounding of sterile preparations pursuant to
a prescription or medication order for a patient from a practitioner
in Class A-S, Class B, Class C-S, and Class E-S pharmacies;
(2) compounding, dispensing, and delivery of a reasonable
quantity of a compounded sterile preparation in Class A-S, Class B,
Class C-S, and Class E-S pharmacies to a practitioner's office for
office use by the practitioner;
(3) compounding and distribution of compounded sterile
preparations by a Class A-S pharmacy for a Class C-S pharmacy; and
(4) compounding of sterile preparations by a Class
C-S pharmacy and the distribution of the compounded preparations to
other Class C or Class C-S pharmacies under common ownership.
(b) Definitions. In addition to the definitions for
specific license 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 Education.
(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
diameter 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 atmospheric
environment that contains less than 352,000 particles 0.5 microns
in diameter per cubic meter of air (formerly stated as 10,000 particles
0.5 microns in diameter per cubic foot of air); and
(C) ISO Class 8 (formerly Class 100,000) is an atmospheric
environment that contains less than 3,520,000 particles 0.5 microns
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
preparation and administration of compounded sterile preparations.
(4) Ante-area--An ISO Class 8 or better area where
personnel may perform hand hygiene and garbing procedures, staging
of components, order entry, labeling, and other high-particulate generating
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--A mode of processing pharmaceutical
and medical preparations that involves the separate sterilization
of the preparation and of the package (containers-closures or packaging
material for medical devices) and the transfer of the preparation
into the container and its closure under at least ISO Class 5 conditions.
(6) Automated compounding device--An automated device
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
compounded 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
cabinet for personnel, product or preparation, and environmental protection
having an open front with inward airflow for personnel protection,
downward HEPA filtered laminar airflow for product protection, and
HEPA filtered exhausted air for environmental protection.
(11) Buffer Area--An ISO Class 7 or, if a Class B pharmacy,
ISO Class 8 or better, area where the primary engineering control
area is physically located. Activities that occur in this area include
the preparation and staging of components and supplies used when compounding
sterile preparations.
(12) Clean room--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.
(13) Component--Any ingredient intended for use in
the compounding of a drug preparation, including those that may not
appear 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
relationship 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
chemical 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
isolator specifically designed 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 shall not occur unless it has first passed through a microbial
retentive filter (HEPA minimum).
(16) Compounding Aseptic Containment Isolator--A compounding
aseptic isolator designed to provide worker protection from exposure
to undesirable levels of airborne drug throughout the compounding
and material transfer processes and to provide an aseptic environment
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) Compounding Personnel--A pharmacist, pharmacy
technician, or pharmacy technician trainee who performs the actual
compounding; a pharmacist who supervises pharmacy technicians or pharmacy
technician trainees compounding sterile preparations, and a pharmacist
who performs an intermediate or final verification of a compounded
sterile preparation.
(18) Critical Area--An ISO Class 5 environment.
(19) Critical Sites--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.
(20) Device--An instrument, apparatus, implement, machine,
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
exposed to unidirectional HEPA-filtered air, also known as first air.
(22) Disinfectant--An agent that frees from infection,
usually a chemical agent but sometimes a physical one, and that destroys
disease-causing pathogens or other harmful microorganisms but may
not kill bacterial and fungal spores. It refers to substances applied
to inanimate objects.
Cont'd... |
