Current through September 16, 2024
1. Except
as otherwise provided in subsection 5, a pharmacy engaged in the practice of
compounding and dispensing high-risk sterile compounded drug products shall
ensure that each such compounded drug product is sterilized through filtration,
by using steam in an autoclave or by dry heat. Except as otherwise provided in
subsection 5, a pharmacist engaged in the practice of compounding high-risk
sterile compounded drug products shall choose the method of sterilization that
ensures the strength, purity, quality and packaging integrity of the final
compounded drug product.
2. If a
pharmacy sterilizes high-risk sterile compounded drug products using the
filtration method, the pharmacy shall:
(a)
Use commercially available sterile filters that are:
(1) Pyrogen-free and have a nominal porosity
of 0.2 micron or 0.22 micron; and
(2) Certified by the manufacturer to retain
at least 107 microorganisms of a strain of
Brevundimonas (Pseudomonas)
diminuta on each square centimeter of upstream filter surface
area under conditions similar to the conditions of sterilization of the
high-risk compounded drug products;
(b) Ensure that the filters used have
sufficient capacity to permit the sterilization process to be completed rapidly
and without compromising the sterility of the filtration process; and
(c) Subject the filtration units to the
manufacturer's recommended integrity testing, including, without limitation,
the bubble point test, after the filtration of the high-risk sterile compounded
drug products is completed.
3. If a pharmacy sterilizes high-risk sterile
compounded drug products using steam in an autoclave, the pharmacy shall:
(a) Expose each high-risk sterile compounded
drug product to steam at 121 degrees Celsius (250 degrees Fahrenheit) under a
pressure of 15 pounds per square inch for the duration of the sterilization
process;
(b) Before starting the
sterilization process, ensure that plastic, glass and metal devices are wrapped
in low particle shedding paper or fabric or sealed in envelopes that prevent
microbial penetration after the sterilization of the high-risk sterile
compounded drug products is completed;
(c) Ensure that the solutions that will be
used to fill the vials which will be steam sterilized are passed through a
filter having a porosity of not more than 1.2 microns to remove particulate
matter immediately before filling those vials; and
(d) Verify the mass of the container that
will be sterilized using steam in an autoclave to ensure that the container
will be sterile after the period of exposure in that autoclave.
4. If a pharmacy sterilizes
high-risk sterile compounded drug products using dry heat, the pharmacy shall
ensure that:
(a) The heated air is filtered
and evenly distributed by a blower throughout the chamber or oven used for the
sterilization process; and
(b) The
chamber or oven used for the sterilization process is equipped with accurate
temperature controls and a timer.
5. A pharmacy may only use dry heat as a
method of sterilization for a high-risk sterile compounded drug product if the
final high-risk sterile compounded drug product would be damaged by moisture or
is impermeable to moisture.
Added to NAC by Bd. of
Pharmacy by R035-06, eff. 9-18-2008
NRS
639.070
