| (a) Purpose. Pharmacies compounding non-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 non-sterile preparations pursuant
to a prescription 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 non-sterile preparation in a Class A (Community),
Class C (Institutional), and Class E (Non-resident) pharmacy to a
practitioner's office for office use by the practitioner;
(3) compounding and distribution of compounded non-sterile
preparations by a Class A (Community) pharmacy for a Class C (Institutional)
pharmacy; and
(4) compounding of non-sterile preparations by a Class
C (Institutional) pharmacy and the distribution of the compounded
preparations to other Class C (Institutional) 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) Active pharmaceutical ingredient--Any substance
intended to be used in the compounding of a preparation, thereby becoming
the active ingredient in that preparation and furnishing pharmacological
activity or other direct effect in the diagnosis, cure, mitigation,
treatment, or prevention of disease in humans or animals or affecting
the structure and function of the body.
(2) Beyond-use date--The date or time after which the
compounded non-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 when the preparation was compounded.
(3) Cleaning--The process of removing soil (e.g., organic
and inorganic material) from objects and surfaces, normally accomplished
by manually or mechanically using water with detergents or enzymatic
products.
(4) Component--Any ingredient intended for use in the
compounding of a drug preparation, including those that may not appear
in such preparation.
(5) 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.
(6) Containment primary engineering control--A ventilated
device designed and operated to minimize worker and environmental
exposures to airborne contaminants through the full or partial enclosure
of a potential contaminant source, the use of airflow capture velocities
to trap and remove airborne contaminants near their point of generation,
the use of air pressure relationships that define the direction of
airflow into the cabinet, and the use of high-efficiency particulate
air (HEPA) filtration on all potentially contaminated exhaust streams.
Examples of containment primary engineering control include containment
ventilated enclosures, biological safety cabinets, and compounding
aseptic containment isolators.
(7) Controlled room temperature--The temperature maintained
thermostatically that encompasses the usual and customary working
environment of 20 - 25 degrees C (68 - 77 degrees F).
(8) Designated person(s)--One or more individuals assigned
by the pharmacist-in-charge or the pharmacist-in-charge's designee
to be responsible and accountable for the performance and operation
of the facility and personnel as related to the preparation of compounded
non-sterile preparations.
(9) Hot water--The temperature of water from the pharmacy's
sink maintained at a minimum of 41 degrees C (105 degrees F).
(10) 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.
(11) Refrigerator--A cold place in which the temperature
is controlled between 2 - 8 degrees C (36 - 46 degrees F).
(12) Sanitizing--A process for reducing on inanimate
surfaces the number of all forms of microbial life including fungi,
viruses, and bacteria using an appropriate agent.
(13) SOPs--Standard operating procedures.
(14) USP/NF--The current edition of the United States
Pharmacopeia/National Formulary.
(15) Water activity--A measure of the fraction of total
water that is unbound and freely available to participate in chemical,
biochemical, or physiochemical reactions or provide an environment
that can support microbial growth.
(c) Personnel. All personnel who compound or have direct
oversight of compounding non-sterile preparations shall be initially
trained and qualified by demonstrating knowledge and competency in
the areas outlined in paragraph (5)(C) of this subsection.
(1) Pharmacist-in-charge. 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
non-sterile compounding:
(A) determining that all personnel involved in non-sterile
compounding possess the education, training, and proficiency necessary
to properly and safely perform compounding duties undertaken or supervised;
(B) determining that all personnel involved in non-sterile
compounding obtain continuing education appropriate for the type of
compounding done by the personnel;
(C) assuring that the equipment used in compounding
is properly maintained;
(D) maintaining an appropriate environment in areas
where non-sterile compounding occurs; and
(E) assuring that effective quality control procedures
are developed and followed.
(2) Designated person(s). The pharmacist-in-charge
or the pharmacist-in-charge's designee shall designate one or more
individuals to be responsible and accountable for the performance
and operation of the facility and personnel for the preparation of
compounded non-sterile preparations. The designated person(s) shall
be identified in the facility's SOPs. If the compounding facility
has only one person responsible for all compounding in the facility,
then that person is the designated person.
(3) Pharmacists. Special requirements for non-sterile
compounding.
(A) All pharmacists engaged in compounding shall:
(i) possess the education, training, and proficiency
necessary to properly and safely perform compounding duties undertaken
or supervised; and
(ii) obtain continuing education appropriate for the
type of compounding undertaken or supervised by the pharmacist.
(B) A pharmacist shall inspect and approve all components,
including consideration of all physical and chemical properties of
the components, drug product containers, closures, labeling, and any
other materials involved in the compounding process.
(C) A pharmacist shall review all compounding records
for accuracy and conduct in-process and final checks to ensure that
errors have not occurred in the compounding process.
(D) A pharmacist is responsible for the proper maintenance,
cleanliness, and use of all equipment used in the compounding process.
(4) Pharmacy technicians and pharmacy technician trainees.
All pharmacy technicians and pharmacy technician trainees engaged
in non-sterile compounding shall:
(A) possess the education, training, and proficiency
necessary to properly and safely perform compounding duties undertaken;
Cont'd... |
