Section Phar 15.36 - Inspection, sterility testing and antimicrobial effectiveness(1) PHYSICAL INSPECTION. (a) At the completion of compounding, the compounded sterile preparation shall be inspected by performing all of the following:1. Visually inspect the container closure for leakage, cracks in the container, or improper seals.2. Visually check the compounded sterile preparation for phase separation.3. Each individual injectable unit shall be inspected against a lighted white background and a black background for evidence of visible particulates or other foreign matter or discoloration.(b) For compounded sterile preparations which will not be dispensed promptly after preparation, an inspection shall be conducted immediately before it is dispensed for any defects, including precipitation, cloudiness, or leakage, which may develop during storage.(c) Compounded sterile preparations with any observed defects shall be immediately discarded or marked and segregated from acceptable units in a manner that prevents them from being dispensed.(2) STERILITY TESTING. (a) The membrane filtration method shall be used for sterility testing unless it is not possible due to the compounded sterile preparation formulation. The direct inoculation of the culture method shall be used when the membrane filtration method is not possible.(b) If a preparation may be needed before the results of sterility testing have been received, the pharmacy shall daily observe the incubating test specimens and immediately recall the dispensed preparations when there is any evidence of microbial growth in the test specimens. The patient and the prescriber to whom a potentially contaminated compounded sterile preparation was administered shall be notified immediately of the potential risk.(c) Positive sterility test results shall prompt a rapid and systematic investigation into the causes of the sterility failure, including identification of the contaminating organism and any aspects of the facility, process or personnel that may have contributed to the sterility failure. The investigation and resulting corrective actions shall be documented.(d) All Category 2 compounded sterile preparations made from one or more nonsterile ingredients, except those for inhalation and ophthalmic administration, shall be tested to ensure that they do not contain excessive bacterial endotoxins.(e) Notwithstanding par. (d), a compounded sterile preparation does not need to be tested for bacterial endotoxins if the material is stored under cool and dry conditions and one of the following: 1. The certificate of analysis for the nonsterile ingredient lists the endotoxins burden, and that burden is found acceptable.2. The pharmacy has predetermined the endotoxins burden of the nonsterile ingredient and that burden is found acceptable.(3) ANTIMICROBIAL EFFECTIVENESS. Compounded sterile preparations containing a preservative added by the compounder shall pass an antimicrobial effectiveness testing with the results obtained on the specific formulation before any of the compounded sterile preparation is dispensed. The test may be conducted only once on each formulation in the particular container-closure system in which it will be stored or dispensed. The antimicrobial effectiveness test shall occur at one of the following times: (a) At the completion of the sterility test.(b) At the time of preparation for compounded sterile preparations which have not undergone a sterility testing.Wis. Admin. Code Pharmacy Examining Board Phar 15.36
Adopted by, CR 16-085: cr. Register April 2018 No. 748, eff. 11/1/2018