Section 3 Phar 15.34 is repealed and recreated to read:
Phar 15.34 Immediate use compounded sterile preparations. Immediate-use compounded sterile preparations are exempt from the requirements described for low-risk level, Category 1, and Category 2 compounding sterile preparations only when all the following criteria are met:
(1) The compounding process involves simple transfer of not more than three commercially manufactured packages of sterile nonhazardous products or diagnostic radiopharmaceutical products from the manufacturers' original containers and not more than two entries into any one container or package of sterile infusion solution or administration container or device.
(2) Unless required for the preparation, the compounding procedure is a continuous process not to exceed 1 hour.
(3) During preparation, aseptic technique is followed and, if not immediately administered, the finished compound sterile preparation is under continuous supervision to minimize the potential for contact with nonsterile surfaces, introduction of particulate matter or biological fluids, mix-ups with other compound sterile preparations, and direct contact of outside surfaces.
(4) Administration begins not later than 4 hours following the start of the preparation.
(5) Unless immediately and completely administered by the person who prepared it or immediate and complete administration is witnessed by the preparer, the compounded sterile preparation shall bear a label listing patient identification information, the names and amounts of all ingredients, the name or initials of the person who prepared it, and the exact 4-hour BUD and time.
(6) If administration of the compounded sterile preparation has not begun within 4 hours following the start of preparation, it shall be promptly, properly, and safely discarded.
Section 4 Phar 15.37 (1) is amended to read:
Phar 15.37 (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 compounded processed sterile preparations, one of the following:
1. No sterility testing performed or sterility testing not passed, and Prepared prepared with one or more nonsterile ingredients starting components, which are sterilized with a validated sterilization procedure prior to compounding no preservative added and no sterility testing performed one of the following:
a. Within 14 days when the preparation is stored at controlled room temperature.
b. Within 7 4 days when the preparation is stored in a refrigerator.
c. Within 45 days when the preparation is stored in a freezer.
2. Prepared only with sterile ingredients, no preservative added and no No sterility testing performed or sterility testing not passed, and prepared with only sterile starting components, one of the following:
a. Within 6 4 days when the preparation is stored at controlled room temperature.
b. Within 9 10 days when the preparation is stored in a refrigerator.
c. Within 45 days when the preparation is stored in a freezer.
3. Prepared only with sterile ingredients, preservative added and no sterility Sterility testing performed and passed, one of the following:
a. Within 28 30 days when the preparation is stored at controlled room temperature.
b. Within 42 45 days when the preparation is stored in a refrigerator.
c. Within 45 60 days when the preparation is stored in a freezer.
4. Prepared only with sterile ingredients, no preservative added and sterility testing, 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.
5. Prepared only with sterile ingredients, preservative added and sterility testing, 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.
(d) For Category 2 compounded sterile preparations, terminally sterilized by a validated procedure, one of the following:
1. Prepared with no preservative and no 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. Prepared with no preservative added and sterility Sterility testing performed and passed, one of the following:
a. Within 28 45 days when the preparation is stored at controlled room temperature.
b. Within 42 60 days when the preparation is stored in a refrigerator.
c. Within 45 90 days when the preparation is stored in a freezer.
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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