| (23) First Air--The air exiting the HEPA filter in
a unidirectional air stream that is essentially particle free.
(24) Hazardous Drugs--Drugs that, studies in animals
or humans indicate exposure to the drugs, have a potential for causing
cancer, development or reproductive toxicity, or harm to organs. For
the purposes of this chapter, radiopharmaceuticals are not considered
hazardous drugs.
(25) Hot water--The temperature of water from the pharmacy's
sink maintained at a minimum of 105 degrees F (41 degrees C).
(26) HVAC--Heating, ventilation, and air conditioning.
(27) Immediate use--A sterile preparation that is not
prepared 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.
(28) IPA--Isopropyl alcohol (2-propanol).
(29) Labeling--All labels and other written, printed,
or graphic matter on an immediate container of an article or preparation
or on, or in, any package or wrapper in which it is enclosed, except
any outer shipping container. The term "label" designates that part
of the labeling on the immediate container.
(30) Media-Fill Test--A test 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 preparation to simulate admixture compounding. The issues
to consider in the development of a media-fill test are the following:
media-fill procedures, media selection, fill volume, incubation, time
and temperature, inspection of filled units, documentation, interpretation
of results, and possible corrective actions required.
(31) Multiple-Dose Container--A multiple-unit container
for articles or preparations intended for potential administration
only and usually contains antimicrobial preservatives. The beyond-use
date for an opened or entered (e.g., needle-punctured) multiple-dose
container with antimicrobial preservatives is 28 days, unless otherwise
specified by the manufacturer.
(32) 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.
(33) Office use--The administration of a compounded
drug to a patient by a practitioner in the practitioner's office or
by the practitioner 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.
(34) 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
measured 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).
(35) 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.
(36) Preparation or Compounded Sterile Preparation--A
sterile admixture compounded in a licensed pharmacy or other healthcare-related
facility pursuant to the order of a licensed prescriber. The components
of the preparation may or may not be sterile products.
(37) 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 cabinets, compounding aseptic isolators, and compounding aseptic
containment isolators.
(38) Product--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 accompanied
by full prescribing information, which is commonly known as the FDA-approved
manufacturer's labeling or product package insert.
(39) Positive Control--A quality assurance sample prepared
to test positive for microbial growth.
(40) 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.
(41) 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
requirements with respect to identity, purity, non-pyrogenicity, and
sterility.
(42) Reasonable quantity--An amount of a compounded
drug that:
(A) does not exceed the amount a practitioner anticipates
may be used in the practitioner's office or facility before the beyond
use date of the drug;
(B) is reasonable considering the intended use of the
compounded drug and the nature of the practitioner's practice; and
(C) for any practitioner and all practitioners as a
whole, is not greater than an amount the pharmacy is capable of compounding
in compliance with pharmaceutical standards for identity, strength,
quality, and purity of the compounded drug that are consistent with
United States Pharmacopoeia guidelines and accreditation practices.
(43) Segregated Compounding Area--A designated space,
either a demarcated area or room, that is restricted to preparing
low-risk level compounded sterile preparations with 12-hour or less
beyond-use date. Such area shall contain a device that provides unidirectional
airflow of ISO Class 5 air quality for preparation of compounded sterile
preparations and shall be void of activities and materials that are
extraneous to sterile compounding.
(44) Single-dose container--A single-unit container
for articles or preparations intended for parenteral administration
only. It is intended for a single use. A single-dose container is
labeled as such. Examples of single-dose containers include pre-filled
syringes, cartridges, fusion-sealed containers, and closure-sealed
containers when so labeled.
(45) SOPs--Standard operating procedures.
(46) Sterilizing Grade Membranes--Membranes that are
documented to retain 100% of a culture of 107 microorganisms of a
strain of Brevundimonas (Pseudomonas) diminuta per square centimeter
of membrane surface under a pressure of not less than 30 psi (2.0
bar). Such filter membranes are nominally at 0.22-micrometer or 0.2-micrometer
nominal pore size, depending on the manufacturer's practice.
(47) Sterilization by Filtration--Passage of a fluid
or solution through a sterilizing grade membrane to produce a sterile
effluent.
(48) Terminal Sterilization--The application of a lethal
process, e.g., steam under pressure or autoclaving, to sealed final
preparation containers for the purpose of achieving a predetermined
sterility assurance level of usually less than 10-6 or a probability
of less than one in one million of a non-sterile unit.
(49) Unidirectional Flow--An airflow moving in a single
direction in a robust and uniform manner and at sufficient speed to
reproducibly sweep particles away from the critical processing or
testing area.
(50) USP/NF--The current edition of the United States
Pharmacopeia/National Formulary.
(c) Personnel.
(1) Pharmacist-in-charge.
(A) General. The pharmacy shall have a pharmacist-in-charge
in compliance with the specific license classification of the pharmacy.
(B) Responsibilities. In addition to the responsibilities
for the specific class of pharmacy, the pharmacist-in-charge shall
have the responsibility for, at a minimum, the following concerning
the compounding of sterile preparations:
(i) developing a system to ensure that all pharmacy
personnel responsible for compounding and/or supervising the compounding
of sterile preparations within the pharmacy receive appropriate education
and training and competency evaluation;
(ii) determining that all personnel involved in compounding
sterile preparations obtain continuing education appropriate for the
type of compounding done by the personnel;
Cont'd... |
