Phar 15.14(2)(g)(g) Sterilization and depyrogenation, if pharmacy does sterilization and depyrogenation. Phar 15.14(2)(k)(k) A risk management program, including documentation of incidents, adverse drug reactions and product contamination. Phar 15.14(2)(n)(n) Handling small and large spills of antineoplastic agents and other hazardous substances. Phar 15.14(2)(o)(o) Notification to patients or practitioners of a preparation which is recalled when there is potential for patient harm. Phar 15.14(3)(3) Review of policies and procedures. The policy and procedures shall be reviewed at least once every 36 months and shall be updated, on a continuous basis, to reflect current practice. Documentation of the review shall be made available to the board upon request. Phar 15.14 HistoryHistory: CR 16-085: cr. Register April 2018 No. 748 eff. 11-1-18; correction in (2) (o) made under s. 35.17, Stats., Register April 2018 No. 748. Phar 15.15Phar 15.15 Labeling. The label of a compounded preparation shall include all of the following: Phar 15.15(2)(2) Storage conditions if other than controlled room temperature. Phar 15.15(5)(5) Indication that the preparation is compounded unless administered by health care personnel. Phar 15.15 HistoryHistory: CR 16-085: cr. Register April 2018 No. 748 eff. 11-1-18. Phar 15.16(1)(1) Active pharmaceutical ingredients or added substances used in compounding shall be manufactured by an FDA registered facility or accompanied by a certificate of analysis. Phar 15.16(2)(2) APIs and added substances shall meet USP or NF monograph specifications when monographs are available. A pharmacist shall use professional judgement in selection of APIs if USP or NF grade is not available. Phar 15.16(3)(3) All components shall be stored and handled consistent with the manufacturer’s labeling or USP or NF monographs and in a manner that prevents contamination and deterioration. Phar 15.16(4)(4) A pharmacist compounding for human use may not use components that have been withdrawn or removed from the market for safety or efficacy reasons by the FDA. A pharmacist compounding for food producing animal use may not use components prohibited for use in food producing animals. Phar 15.16 HistoryHistory: CR 16-085: cr. Register April 2018 No. 748 eff. 11-1-18. Phar 15.17Phar 15.17 Non-patient specific compounding. Compounded preparations dispensed or distributed to a practitioner pursuant to a non-patient specific order to be administered by a practitioner or practitioner’s agent shall meet all of the following: Phar 15.17(1)(1) The order shall include the name and address of the practitioner, drug, strength, quantity, and the purpose of the compounded preparation. Phar 15.17(2)(2) The label shall include the practitioner’s name in place of the patient’s name and state “For Practitioner Administration Only — Not for Dispensing or Distribution.” If the sterility or integrity of the compounded preparation is not maintained after the initial opening of the container, the label shall state “Single-Dose Only.” Phar 15.17(3)(3) The pharmacist shall record the name and address of the location the compounded preparation was dispensed or distributed, and the lot number and BUD of all preparations dispensed or distributed to the practitioner. Phar 15.17 HistoryHistory: CR 16-085: cr. Register April 2018 No. 748 eff. 11-1-18. Subchapter II — Non-sterile Compounding
Phar 15.20(1)(1) Components with an expiration date from the manufacturer or distributor may be used before the expiration date provided all of the following: Phar 15.20(1)(a)(a) The component is stored in its original container under conditions to avoid decomposition. Phar 15.20(1)(b)(b) There is minimal exposure of the remaining component each time component is withdrawn from the container. Phar 15.20(2)(2) Components without an expiration date assigned by the manufacturer or supplier shall be labeled with the date of receipt and assigned a conservative expiration date, not to exceed three years after receipt, based upon the nature of the component and its degradation mechanism, the container in which it is packaged and the storage conditions. Phar 15.20(3)(3) Components transferred to another container which shall provide integrity that is minimally equivalent to the original container and shall be identified with all of the following: Phar 15.20 HistoryHistory: CR 16-085: cr. Register April 2018 No. 748 eff. 11-1-18. Phar 15.21(1)(1) The BUD shall not be later than the expiration date on the container of any component. Phar 15.21(2)(2) Only in the absence of stability information that is applicable to a specific drug product and preparation, the maximum BUD for a non-sterile compounded drug preparation that is packaged in a tight, light-resistant container is as follows: Phar 15.21(2)(a)(a) For nonaqueous formulations stored at controlled room temperature, the BUD shall not be later than the time remaining until the earliest expiration date of any active pharmaceutical ingredient or 6 months, whichever is earlier. Phar 15.21(2)(b)(b) For water-containing oral formulations, the BUD shall not be later than 14 days when stored in a refrigerator. Phar 15.21(2)(c)(c) For water-containing semisolid mucosal liquid, topical, or dermal formulations, stored at controlled room temperature, the BUD shall not be later than 30 days. Phar 15.21(3)(3) Assignment of BUD shall include an assessment of the need for antimicrobial agents or storage in a refrigerator to protect against bacteria, yeast, and mold contamination introduced during or after the compounding process. Phar 15.21 HistoryHistory: CR 16-085: cr. Register April 2018 No. 748 eff. 11-1-18. Subchapter III — Sterile Compounding
Phar 15.30Phar 15.30 Definitions. In this subchapter: Phar 15.30(1)(1) “Ante area” means an ISO Class 8 or better area where personnel hand hygiene and garbing procedures, staging of components, order entry, labeling and other high particulate generating activities are performed. The ante-area is the transition area between the unclassified area of the facility and the buffer area. Phar 15.30(2)(2) “Buffer area” means an ISO Class 7 or ISO Class 8 if using an isolator or cleaner area where the primary engineering control that generates and maintains an ISO Class 5 environment is physically located. Phar 15.30(3)(3) “Category 1” means a compounded sterile preparation compounded with a primary engineering control in a segregated compounding area. Phar 15.30(4)(4) “Category 2” means a compounded sterile preparation compounded with a primary engineering control in a classified area. Phar 15.30(5)(5) “Clean” means to physically remove debris, dirt, dust, and other impurities from surfaces or objects using a cleaning agent with a detergent. Phar 15.30(6)(6) “Compounded sterile preparation” means a compounded final preparation intended to be sterile through the BUD. Phar 15.30(7)(7) “Compounded stock solution” means a compounded solution to be used in the preparation of multiple units of a finished compounded sterile preparation. Phar 15.30(8)(8) “Critical site” means a location that includes any component or fluid pathway surfaces or openings that are exposed and at risk of direct contact with air, moisture, or touch contamination. Phar 15.30(9)(9) “Disinfect” means the killing of microorganisms when used according to the disinfectant’s label. Phar 15.30(10m)(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. High-risk level compounded sterile preparations include water containing preparations that are stored for more than six hours before terminal sterilization. Phar 15.30(11)(11) “ISO Class 5” means conditions in which the air particle count is no greater than a total of 3,520 particles of 0.5 micrometers and larger per cubic meter of air that is supplied by HEPA or HEPA-filtered air. Phar 15.30(12)(12) “ISO Class 7” means conditions in which the air particle count is no greater than a total of 352,000 particles of 0.5 micrometers and larger per cubic meter of air that is supplied by HEPA or HEPA-filtered air. Phar 15.30(13)(13) “ISO Class 8” means conditions in which the air particle count is no greater than a total of 3,520,000 particles of 0.5 micrometers and larger per cubic meter of air that is supplied by HEPA or HEPA-filtered air. Phar 15.30(14)(14) “Isolator” means an enclosure that provides HEPA-filtered ISO Class 5 unidirectional air operated at a continuously higher pressure than its surrounding environment and is decontaminated using an automated system. An isolator uses only decontaminated interfaces or rapid transfer ports for materials transfer. Phar 15.30(14g)(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 low-risk level sterile 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. Phar 15.30(14r)(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 medium-risk level sterile 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. Phar 15.30(15)(15) “Primary engineering control” means a device or zone that provides an ISO Class 5 environment for sterile compounding. Phar 15.30(16)(16) “Restricted access barrier system (RABS)” means an enclosure that provides HEPA-filtered ISO Class 5 unidirectional air that allows for the ingress or egress of materials through defined openings that have been designed and validated to preclude the transfer of contamination, and that generally are not to be opened during operations. RABS include compounding aseptic isolators and compounding aseptic containment isolators. Phar 15.30(17)(17) “Sterility assurance level of 10-6” means an equivalent to a probability that one unit in a million is nonsterile. Phar 15.30(18)(18) “Segregated compounding area” means a designated, unclassified space, area, or room that contains a primary engineering control. Phar 15.30(19)(19) “Urgent use compounded sterile preparation” means a preparation needed urgently for a single patient and preparation of the compounded sterile preparation under Category 1 or Category 2 requirements would subject the patient to additional risk due to delays. Phar 15.30 HistoryHistory: CR 16-085: cr. Register April 2018 No. 748 eff. 11-1-18; CR 22-007: cr. (10m), (14g), (14r) Register July 2022 No. 799, eff. 8-1-22. Phar 15.31Phar 15.31 Facility design and environmental controls. Phar 15.31(1)(1) General. Facilities shall meet all of the following requirements: Phar 15.31(1)(a)(a) Be physically designed and environmentally controlled to minimize airborne contamination from contacting critical sites. Phar 15.31(1)(c)(c) Have a heating, ventilation, and air conditioning system controlling the temperature and humidity. Phar 15.31(2)(2) Segregated compounding area. A segregated compounding area shall meet all of the following requirements: Phar 15.31(2)(a)(a) Be located in an area away from unsealed windows and doors that connect to the outdoors, or significant traffic flow. Phar 15.31(2)(b)(b) Be located in an area which is not adjacent to construction sites, warehouses, and food preparation areas. Phar 15.31(2)(d)(d) Locate the primary engineering control at least one meter from any sink. Phar 15.31(3)(3) Classified area. A classified area shall meet all of the following:
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