NAC639.67069. High-risk sterile compounding: Sterilization.

     1. Except as otherwise provided in subsection 5, a pharmacy engaged in the practice of compounding and dispensing high-risk sterile compounded drug products shall ensure that each such compounded drug product is sterilized through filtration, by using steam in an autoclave or by dry heat. Except as otherwise provided in subsection 5, a pharmacist engaged in the practice of compounding high-risk sterile compounded drug products shall choose the method of sterilization that ensures the strength, purity, quality and packaging integrity of the final compounded drug product.

     2. If a pharmacy sterilizes high-risk sterile compounded drug products using the filtration method, the pharmacy shall:

     (a) Use commercially available sterile filters that are:

          (1) Pyrogen-free and have a nominal porosity of 0.2 micron or 0.22 micron; and

          (2) Certified by the manufacturer to retain at least 10⁷ microorganisms of a strain of Brevundimonas (Pseudomonas) diminuta on each square centimeter of upstream filter surface area under conditions similar to the conditions of sterilization of the high-risk compounded drug products;

     (b) Ensure that the filters used have sufficient capacity to permit the sterilization process to be completed rapidly and without compromising the sterility of the filtration process; and

     (c) Subject the filtration units to the manufacturer’s recommended integrity testing, including, without limitation, the bubble point test, after the filtration of the high-risk sterile compounded drug products is completed.

     3. If a pharmacy sterilizes high-risk sterile compounded drug products using steam in an autoclave, the pharmacy shall:

     (a) Expose each high-risk sterile compounded drug product to steam at 121 degrees Celsius (250 degrees Fahrenheit) under a pressure of 15 pounds per square inch for the duration of the sterilization process;

     (b) Before starting the sterilization process, ensure that plastic, glass and metal devices are wrapped in low particle shedding paper or fabric or sealed in envelopes that prevent microbial penetration after the sterilization of the high-risk sterile compounded drug products is completed;

     (c) Ensure that the solutions that will be used to fill the vials which will be steam sterilized are passed through a filter having a porosity of not more than 1.2 microns to remove particulate matter immediately before filling those vials; and

     (d) Verify the mass of the container that will be sterilized using steam in an autoclave to ensure that the container will be sterile after the period of exposure in that autoclave.

     4. If a pharmacy sterilizes high-risk sterile compounded drug products using dry heat, the pharmacy shall ensure that:

     (a) The heated air is filtered and evenly distributed by a blower throughout the chamber or oven used for the sterilization process; and

     (b) The chamber or oven used for the sterilization process is equipped with accurate temperature controls and a timer.

     5. A pharmacy may only use dry heat as a method of sterilization for a high-risk sterile compounded drug product if the final high-risk sterile compounded drug product would be damaged by moisture or is impermeable to moisture.

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