NAC639.6705. Environmental standards.

     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)