Section Phar 15.37 - Beyond use dating(1) Sterility and stability considerations shall be taken into account when establishing a BUD. Either Category 1 and 2, or low, medium, and high-risk compounding preparation standards may be used, but not a combination of the two within the same pharmacy. The following dates and times for storage and initiation of administration of the compounded sterile preparations shall apply: (a) For compounded sterile preparations including components from conventionally manufactured products, the BUD shall not exceed the shortest expiration of any of the starting components. If the compounded sterile preparation includes non-conventionally manufactured products, the BUD may not exceed the shortest BUD of any of the starting components.(b) For Category 1 compounded sterile preparations, one of the following: 1. May not exceed 12 hours when the preparation is stored at controlled room temperature.2. May not exceed 24 hours when the preparation is stored in a refrigerator.(c) For aseptically processed Category 2 processed sterile preparations, one of the following: 1. No sterility testing performed or sterility testing not passed, and prepared with one or more nonsterile starting components, one of the following:a. Within 1 day when the preparation is stored at controlled room temperature.b. Within 4 days when the preparation is stored in a refrigerator.c. Within 45 days when the preparation is stored in a freezer.2. No sterility testing performed or sterility testing not passed, and prepared with only sterile starting components, one of the following:a. Within 4 days when the preparation is stored at controlled room temperature.b. Within 10 days when the preparation is stored in a refrigerator.c. Within 45 days when the preparation is stored in a freezer.3. Sterility testing performed and passed, one of the following:a. Within 30 days when the preparation is stored at controlled room temperature.b. Within 45 days when the preparation is stored in a refrigerator.c. Within 60 days when the preparation is stored in a freezer.(d) For Category 2 compounded sterile preparations, terminally sterilized by a validated procedure, one of the following:1. No sterility testing performed or sterility testing not passed, one of the following: a. Within 14 days when the preparation is stored at controlled room temperature.b. Within 28 days when the preparation is stored in a refrigerator.c. Within 45 days when the preparation is stored in a freezer.2. Sterility testing performed and passed, one of the following:a. Within 45 days when the preparation is stored at controlled room temperature.b. Within 60 days when the preparation is stored in a refrigerator.c. Within 90 days when the preparation is stored in a freezer.(2) The BUD established in sub. (1) may not be exceeded or extended for compounded sterile preparations without verifiable supporting valid scientific sterility and stability information that is directly applicable to the specific preparation or compound. (3) For compounded sterile preparations which have been assigned a BUD based upon storage in a freezer, the integrity of the container-closure system with the specific compounded sterile preparation in it shall have been demonstrated for 45 days at frozen storage. The container-closure integrity test may be conducted only once on each formulation in the specific container closure-system in which it will be stored or dispensed.(4) When a preservative is added, the compounded sterile formulation shall pass antimicrobial effectiveness testing that shall include inoculation of standardized microorganisms, incubation serial sampling, and calculation of the changes in colony forming unit concentrations in terms of log reduction. The results of antimicrobial effectiveness testing shall be obtained before any of the compounded sterile preparation is dispensed. Preservatives shall not be used as a substitute for good compounding practices.(5) For low-risk level compounded sterile preparations, in the absence of passing a sterility test: (a) Within 48 hours when the preparation is stored at controlled room temperature.(b) Within 14 days when the preparation is stored in a refrigerator.(c) Within 45 days when the preparation is stored in a freezer.(d) For products prepared in an airflow workbench not located in a buffer area, administration shall begin within 12 hours or less of preparation.(6) For medium-risk level compounded sterile preparations, in the absence of passing a sterility test: (a) Within 30 hours when the preparation is stored at controlled room temperature.(b) Within 9 days when the preparation is stored in a refrigerator.(c) Within 45 days when the preparation is stored in a freezer.(7) For high-risk level compounded sterile preparations, in the absence of passing a sterility test: (a) Within 24 hours when the preparation is stored at controlled room temperature.(b) Within 3 days when the preparation is stored in a refrigerator.(c) Within 45 days when the preparation is stored in a freezer.Wis. Admin. Code Pharmacy Examining Board Phar 15.37
Adopted by, CR 16-085: cr. Register April 2018 No. 748, eff. 11/1/2018Amended by, CR 22-007: am. (1) (intro.), (c) (intro.), 1. (intro.), a., b., 2. (intro.), a., b., 3., r. (1) (c) 4., 5., am. (1) (d) 1. (intro.), 2., r. (1) (d) 3., 4., cr. (5) to (7) Register July 2022 No. 799, eff. 8-1-22; correction in (6) (b), (7) (b) made under s. 35.17, Stats. Register July 2022 No. 799, eff. 8/1/2022.