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

Current through June 11, 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.