NAC639.67067. High-risk sterile compounding: Process and storage.

     1. A compounded drug product is a high-risk sterile compounded drug product if:

     (a) The compounded drug product is required to be sterile for its effective administration;

     (b) The sterile compounded drug product is contaminated with or at a high risk of becoming contaminated with infectious microorganisms; and

     (c) One or more of the following conditions are present:

          (1) One or more of the ingredients or devices used in the compounding process are nonsterile; or

          (2) One or more of the ingredients or devices used in the compounding process were sterile but were exposed or are suspected of having been exposed for more than 1 hour to an air quality inferior to an ISO Class 5 environment.

     2. Unless sterility testing or potency limitations allow for a different period, the period of storage before administration of a high-risk sterile compounded product must not exceed:

     (a) Twenty-four hours at a controlled room temperature that is at least 20 degrees Celsius (68 degrees Fahrenheit) but not more than 25 degrees Celsius (77 degrees Fahrenheit);

     (b) Three days at a temperature that is at least 2 degrees Celsius (36 degrees Fahrenheit) but not more than 8 degrees Celsius (46 degrees Fahrenheit); or

     (c) Forty-five days in a solid frozen state that is -10 degrees Celsius (14 degrees Fahrenheit) or colder.

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