NAC639.67071. High-risk sterile compounding: Testing of certain drug products.

     1. A pharmacy engaged in the practice of compounding and dispensing high-risk sterile compounded drug products for injection into the vascular system or central nervous system shall test a quantity of the high-risk sterile compounded drug product for:

     (a) Sterility using a membrane filtration method or an equivalent method, as determined by the Board, before any of the compounded drug product may be administered or dispensed to a patient; and

     (b) Excessive bacterial endotoxins using an appropriate test, as determined by the Board, for the particular product at issue before any of the compounded drug product may be administered or dispensed to a patient.

     2. A pharmacy engaged in the practice of compounding and dispensing high-risk sterile compounded drug products for inhalation or ophthalmic use shall test a quantity of each such high-risk sterile compounded drug product for sterility.

     3. The provisions of subsections 1 and 2 apply only to high-risk sterile compounded drug products:

     (a) Compounded in groups of more than 25 identical individual single-dose packages;

     (b) Compounded in multiple-dose vials for administration to multiple patients; or

     (c) That will be exposed for a period of more than:

          (1) Twelve hours to temperatures of at least 2 degrees Celsius (36 degrees Fahrenheit) but not more than 8 degrees Celsius (46 degrees Fahrenheit); or

          (2) Six hours to temperatures exceeding 8 degrees Celsius (46 degrees Fahrenheit) before the compounded drug product is sterilized.

     4. If any high-risk sterile compounded drug product tested pursuant to this section tests positive for antimicrobial growth or endotoxin production, the high-risk sterile compounded drug product must not be administered or dispensed to a patient.

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