NAC639.67051. Air quality testing and certification.

     1. Except as otherwise provided in NAC 639.67059, a pharmacy engaged in the practice of compounding sterile compounded drug products shall test the air in each of its controlled environments to ensure that the environments attain the air quality required by the provisions of NAC 639.661 to 639.690, inclusive, for an ISO Class 5, ISO Class 7 or ISO Class 8 environment, as applicable.

     2. The air quality testing required by subsection 1 must be performed randomly with regard to:

     (a) The time of day the air samples are collected;

     (b) The staff who is on duty when the samples are gathered; and

     (c) The locations within the pharmacy from which the samples are collected.

     3. A pharmacy engaged in the practice of compounding sterile compounded drug products shall have its ISO Class 5 environment certified pursuant to subsection 4:

     (a) At least twice each year; and

     (b) Before compounding a sterile compounded drug product after:

          (1) A substantial change or renovation is made in the room that contains the laminar airflow hood or barrier isolator cabinet;

          (2) Sizeable equipment is placed in the room that contains the laminar airflow hood or barrier isolator cabinet;

          (3) The laminar airflow hood or barrier isolator cabinet is moved from the location at which the laminar airflow hood or barrier isolator cabinet was most recently tested; or

          (4) The laminar airflow hood or barrier isolator cabinet is repaired.

     4. The certification required by subsection 3 must be completed by a person who is independent of the pharmacy requesting the certification and who is capable of certifying that the ISO Class 5 environment can satisfy and maintain the minimum requirements set forth in NAC 639.6641 for air quality under normal conditions of use.

     5. A pharmacy engaged in the practice of compounding sterile compounded drug products shall have each of its ISO Class 7 and ISO Class 8 environments tested or certified pursuant to subsection 7 for particulates:

     (a) At least twice each year; and

     (b) Before compounding a sterile compounded drug product after:

          (1) A substantial change or renovation is made in the room that contains the laminar airflow hood or barrier isolator cabinet;

          (2) Sizeable equipment is placed in the room that contains the laminar airflow hood or barrier isolator cabinet;

          (3) The laminar airflow hood or barrier isolator cabinet is moved from the location at which the laminar airflow hood or barrier isolator cabinet was most recently tested; or

          (4) A laminar airflow hood or barrier isolator cabinet is added to or removed from the room that contains the laminar airflow hood or barrier isolator cabinet.

     6. The air quality testing required by subsection 5 must be performed randomly with regard to:

     (a) The time of day the air samples are collected;

     (b) The staff who are on duty when the samples are gathered; and

     (c) The locations within the pharmacy from which the samples are collected.

     7. The testing or certification required by subsection 5 must be completed by the pharmacy or by a person who is independent of the pharmacy requesting the certification and who is capable of testing or certifying that the ISO Class 7 or ISO Class 8 environment can satisfy and maintain the minimum requirements set forth in NAC 639.6643 and 639.6645, respectively, for air quality under normal conditions of use.

     8. If the pharmacy performs the testing or certification required by subsection 5, the testing or certification process of the pharmacy must be validated semiannually by the managing pharmacist.

     9. If any of the results of the air quality testing or certification required by this section exceed the tolerances set forth in NAC 639.6641, 639.6643 and 639.6645, for the particular controlled environment, the pharmacy shall take whatever action is necessary to remediate the deficiency and retest the environment until the environment produces results within the tolerances for the particular controlled environment.

     10. The pharmacy shall make and maintain records concerning the air quality testing and certification and any corrections and retesting that were conducted pursuant to this section.

     (Added to NAC by Bd. of Pharmacy by R035-06, eff. 9-18-2008)