3. Prepared with preservative added and no sterility testing performed, one of the following:
a. Within 28 days when the preparation is stored at controlled room temperature.
b. Within 42 days when the preparation is stored in a refrigerator.
c. Within 45 days when the preparation is stored in a freezer.
4. Prepared with preservative added and sterility testing performed, one of the following:
a. Within 42 days when the preparation is stored at controlled room temperature.
b. Within 42 days when the preparation is stored in a refrigerator.
c. Within 45 days when the preparation is stored in a freezer.
Section 5 Phar 15.37 (5), (6), and (7) are created to read:
Phar 15.37 (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 at cold temperatures between 2 and 8 degrees Celsius.
(c) Within 45 days when the preparation is stored in a solid frozen state at -20 degrees Celsius.
(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 nine days when the preparation is stored at cold temperatures between 2 and 8 degrees Celsius.
(c) within 45 days when the preparation is stored in a solid frozen state at -20 degrees Celsius.
(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 three days when the preparation is stored at cold temperatures.
(c) Within 45 days when the preparation is stored in a solid frozen state.
Section 6 EFFECTIVE DATE. The rules adopted in this order shall take effect on the first day of the month following publication in the Wisconsin Administrative Register, pursuant to s. 227.22 (2) (intro.), Stats. ------------------------------------------------------------------------------------------------------------
(END OF TEXT OF RULE)
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