The Fiscal Estimate and Economic Impact Analysis are attached.
Effect on small business:
These proposed rules do have an economic impact on small businesses, as defined in s. 227.114 (1), Stats. and were submitted to the Small Business Regulatory Review Board for a determination on whether the rules will have a significant economic impact on a substantial number of small businesses. The Department’s Regulatory Review Coordinator may be contacted by email at Daniel.Hereth@wisconsin.gov, or by calling (608) 267-2435. Agency contact person:
Nilajah Hardin, Administrative Rules Coordinator, Department of Safety and Professional Services, Division of Policy Development, 4822 Madison Yards Way, P.O. Box 8366, Madison, Wisconsin 53708; telephone 608-267-7139; email at DSPSAdminRules@wisconsin.gov. Place where comments are to be submitted and deadline for submission:
Comments may be submitted to Nilajah Hardin, Administrative Rules Coordinator, Department of Safety and Professional Services, Division of Policy Development, 4822 Madison Yards Way, P.O. Box 8366, Madison, WI 53708-8366, or by email to DSPSAdminRules@wisconsin.gov. Comments must be received on or before the public hearing on February 14, 2022 at 11:00 a.m., to be included in the record of rule-making proceedings. -----------------------------------------------------------------------------------------------------------
TEXT OF RULE
Section 1 Phar 15.30 (10m), (14g), and (14r) are created to read:
Phar 15.30 (10m) “High-risk level compounded sterile preparations” means preparations compounded from non-sterile ingredients or from ingredients that are incorporated using non-sterile equipment before terminal sterilization, or from commercially manufactured sterile products that lack effective antimicrobial preservatives and whose preparation, transfer, sterilization, and packaging is performed in air quality worse than ISO class 5 for more than one hour. Water containing preparations that are stored for more than six hours before terminal sterilization are also classified as high-risk level compounded sterile preparations.
(14g) “Low-risk level compounded sterile preparations” means preparations compounded with aseptic manipulations entirely within ISO class 5 or better air quality using only sterile ingredients, products, components, and devices. The compounding process involves only transfer, measuring, and mixing, using no more than three commercially manufactured sterile products, and not more than two entries into one sterile container or package to make the compounded sterile preparations. The compounding process is limited to aseptically opening ampules, penetrating sterile stoppers on vials with sterile needles and syringes, and transferring sterile liquids in sterile syringes to sterile administration devices, package containers of other sterile products, and containers for storage and dispensing.
(14r) “Medium-risk level compounded sterile preparations” means preparations compounded under low-risk level conditions but which require multiple individual or small doses of sterile products to be combined or pooled to prepare compounded sterile preparations that will be administered either to multiple patients or to one patient on multiple occasions. The compounding process includes complex aseptic manipulations other than single volume transfer, and requires an unusually long duration, such as that required to complete dissolution or homogeneous mixing.
Section 2 Phar 15.33 (10) is amended to read:
Phar 15.33 (10) Entry points on bags and vials shall be wiped with small sterile 70% isopropyl alcohol swabs or comparable method for disinfecting, allowing the isopropyl alcohol to dry before piercing stoppers with sterile needles and breaking necks of ampuls ampules. The surface of the sterile 70% isopropyl alcohol swabs used for disinfecting entry points of sterile package and devices may not contact any other object before contacting the surface of the entry point. Particle generating material may not be used to disinfect the sterile entry points of packages and devices.
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.
