Nevada Administrative Code
Chapter 639 - Pharmacists and Pharmacy
COMPOUNDING AND DISPENSING DRUG PRODUCTS
Standards for Compounding and Dispensing Sterile Products
Section 639.67051 - 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:

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:

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:

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

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.