Nevada Administrative Code
Chapter 639 - Pharmacists and Pharmacy
COMPOUNDING AND DISPENSING DRUG PRODUCTS
Standards for Compounding and Dispensing Sterile Products
Section 639.6705 - Environmental standards
Universal Citation: NV Admin Code 639.6705
Current through September 16, 2024
1. Except as otherwise provided in NAC 639.67059, a pharmacy engaged in the practice of compounding sterile compounded drug products shall provide an ISO Class 5 environment.
2. If a pharmacy uses a laminar airflow hood as its ISO Class 5 environment within which to compound sterile compounded drug products, the pharmacy:
(a) Shall ensure that the laminar airflow
hood is located within a room with a buffer area that maintains an ISO Class 7
environment under normal conditions of use.
(b) Shall maintain an ante-area or space in
close proximity to any entrance to the room containing the laminar airflow hood
that maintains an ISO Class 8 environment under normal conditions of
use.
(c) Shall ensure that the room
that contains the laminar airflow hood maintains a constant temperature and
humidity that:
(1) Ensures the safety and
efficacy of the compounded drug products, components and equipment;
and
(2) Provides an environment in
which the employees of the pharmacy can work comfortably for the duration of
the compounding that will be conducted in the room.
(d) Shall require each employee of the
pharmacy who enters the buffer area containing the laminar airflow hood to:
(1) Remove all jewelry from his or her hands
and arms;
(2) Perform sanitizing
scrubbing; and
(3) Wear fresh
protective clothing, including, without limitation, gowns, shoe covers or
dedicated shoes, and hair covers, in the ante-area or space in close proximity
to an entrance to the room and to remove all such items of protective clothing
whenever the employee leaves the room. A gown may be used more than once within
a 12-hour period if it is removed in the ante-area and is stored in the
ante-area until it is used again.
(e) Shall require an employee to wear
nonpowdered gloves and a face mask and beard cover, as applicable, before the
employee enters the buffer area.
(f) Shall ensure, to the extent practicable,
that all items located in or brought into the room containing the laminar
airflow hood have nonporous, smooth, impermeable surfaces that:
(1) Can withstand being cleaned repeatedly
with a disinfectant; and
(2) Do not
shed particles which may become airborne in the room.
(g) Must have floors, walls and ceilings in
the room containing the laminar airflow hood that are made of materials that
can withstand being cleaned and disinfected repeatedly with solutions and
products.
(h) Shall ensure, before
any compounding can occur within the laminar airflow hood, that the laminar
airflow hood is used according to the manufacturer's directions with regard to
starting and using the laminar airflow hood in a manner which ensures that the
interior of the laminar airflow hood creates and maintains an ISO Class 5
environment.
(i) Shall ensure that:
(1) The ISO Class 5 environment is cleaned:
(I) At the beginning of each work
shift;
(II) Before the compounding
of each batch preparation begins;
(III) At least every 30 minutes after the
compounding of a sterile compounded drug product has begun during a period of
continuous compounding activity;
(IV) After there has been a spill within the
ISO Class 5 environment; and
(V)
Whenever it is known or suspected that surface contamination exists as a result
of a breach in procedure.
(2) The counters and easily cleanable work
surfaces in close proximity to the laminar airflow hood and in, or in close
proximity to, the buffer area are cleaned at least once each day in which the
ISO Class 5 environment is used and whenever a counter or surface may require
cleaning as a result of its use throughout the working day.
(3) The floors are cleaned at least once each
day in which the ISO Class 5 environment is used and whenever the floors may
require cleaning as a result of its use throughout the working day.
(4) The walls, ceilings, storage, shelving
and other surfaces that are not easily cleaned are cleaned at least once each
month.
3. If a pharmacy uses a barrier isolator cabinet that maintains an ISO Class 5 environment at all times when it is in use as its ISO Class 5 environment within which to compound sterile compounded drug products, the pharmacy shall ensure that:
(a) The barrier isolator cabinet
is placed in the pharmacy at a location where:
(1) The compounding may occur without
interruption or inconvenience; and
(2) The barrier isolator cabinet will not be
compromised by its proximity to air vents, doorways or other pharmacy fixtures
or equipment.
(b) Before
any compounding may occur within the barrier isolator cabinet, the barrier
isolator cabinet is used according to the manufacturer's directions with regard
to starting and using the barrier isolator cabinet in a manner which ensures
that the interior of the barrier isolator cabinet creates and maintains an ISO
Class 5 environment.
(c) The
barrier isolator cabinet is cleaned:
(1) At
the beginning of each work shift;
(2) Before the compounding of each batch
preparation begins;
(3) At least
every 30 minutes after the compounding of a sterile compounded drug product has
begun during a period of continuous compounding activity;
(4) After there has been a spill within the
ISO Class 5 environment; and
(5)
Whenever it is known or suspected that surface contamination exists as a result
of a breach in procedure.
(d) The counters and easily cleanable work
surfaces in close proximity to the barrier isolator cabinet are cleaned at
least once each day in which the barrier isolator cabinet is used and whenever
a counter or surface may require cleaning as a result of its use throughout the
working day.
(e) The floors in
close proximity to the barrier isolator cabinet are cleaned at least once each
day in which the barrier isolator cabinet is used and whenever the floors may
require cleaning as a result of its use throughout the working day.
4. A barrier isolator cabinet that cannot maintain an ISO Class 5 environment at all times when it is being used shall be deemed a laminar airflow hood for purposes of satisfying the requirements of this section.
5. As used in this section, "batch preparation" means the compounding of multiple units of sterile compounded drug products, not for immediate use, in a single process by the same person.
Added to NAC by Bd. of Pharmacy by R035-06, eff. 9-18-2008
NRS 639.070
Disclaimer: These regulations may not be the most recent version. Nevada may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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