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History: 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 15.15Labeling. The label of a compounded preparation shall include all of the following:
(1)Labeling requirements in s. Phar 7.02 and 8.08.
(2)Storage conditions if other than controlled room temperature.
(3)BUD.
(4)Special handling instructions, when applicable.
(5)Indication that the preparation is compounded unless administered by health care personnel.
History: CR 16-085: cr. Register April 2018 No. 748 eff. 11-1-18.
Phar 15.16Component Selection.
(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.
(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.
(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.
(4)A pharmacist compounding for human use may not use components that have been withdrawn or removed from the market for safety or efficacy reasons by the FDA.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.
History: CR 16-085: cr. Register April 2018 No. 748 eff. 11-1-18.
Phar 15.17Non-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:
(1)The order shall include the name and address of the practitioner, drug, strength, quantity, and the purpose of the compounded preparation.
(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.”
(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.
History: CR 16-085: cr. Register April 2018 No. 748 eff. 11-1-18.
Subchapter II — Non-sterile Compounding
Phar 15.20Component Selection.
(1)Components with an expiration date from the manufacturer or distributor may be used before the expiration date provided all of the following:
(a) The component is stored in its original container under conditions to avoid decomposition.
(b) There is minimal exposure of the remaining component each time component is withdrawn from the container.
(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.
(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:
(a) Component name.
(b) Original supplier.
(c) Lot or control number.
(d) Transfer date.
(e) Expiration date.
History: CR 16-085: cr. Register April 2018 No. 748 eff. 11-1-18.
Phar 15.21Assigning BUD.
(1)The BUD shall not be later than the expiration date on the container of any component.
(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:
(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.
(b) For water-containing oral formulations, the BUD shall not be later than 14 days when stored in a refrigerator.
(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.
(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.
History: CR 16-085: cr. Register April 2018 No. 748 eff. 11-1-18.
Subchapter III — Sterile Compounding
Phar 15.30Definitions. In this subchapter:
(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.
(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.
(3)“Category 1” means a compounded sterile preparation compounded with a primary engineering control in a segregated compounding area.
(4)“Category 2” means a compounded sterile preparation compounded with a primary engineering control in a classified area.
(5)“Clean” means to physically remove debris, dirt, dust, and other impurities from surfaces or objects using a cleaning agent with a detergent.
(6)“Compounded sterile preparation” means a compounded final preparation intended to be sterile through the BUD.
(7)“Compounded stock solution” means a compounded solution to be used in the preparation of multiple units of a finished compounded sterile preparation.
(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.
(9)“Disinfect” means the killing of microorganisms when used according to the disinfectant’s label.
(10)“HEPA” means high-efficiency particulate air.
(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.
(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.
(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.
(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.
(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.
(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.
(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.
(15)“Primary engineering control” means a device or zone that provides an ISO Class 5 environment for sterile compounding.
(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.
(17)“Sterility assurance level of 10-6” means an equivalent to a probability that one unit in a million is nonsterile.
(18)“Segregated compounding area” means a designated, unclassified space, area, or room that contains a primary engineering control.
(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.
History: 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 15.31Facility design and environmental controls.
(1)General. Facilities shall meet all of the following requirements:
(a) Be physically designed and environmentally controlled to minimize airborne contamination from contacting critical sites.
(b) Be accessible only to designated personnel.
(c) Have a heating, ventilation, and air conditioning system controlling the temperature and humidity.
(2)Segregated compounding area. A segregated compounding area shall meet all of the following requirements:
(a) Be located in an area away from unsealed windows and doors that connect to the outdoors, or significant traffic flow.
(b) Be located in an area which is not adjacent to construction sites, warehouses, and food preparation areas.
(c) Have a defined perimeter.
(d) Locate the primary engineering control at least one meter from any sink.
(3)Classified area. A classified area shall meet all of the following:
(a) The surfaces of ceilings, walls, floors, fixtures, shelving, counters, and cabinets shall be smooth, impervious, free from cracks and crevices, and nonshedding.
(b) Work surfaces shall be constructed of smooth, impervious materials. All work surfaces shall be resistant to damage from cleaning and sanitizing agents.
(c) Junctures where ceilings meet walls shall be covered, caulked, or sealed to avoid cracks and crevices in which microorganisms and other contaminate can accumulate. All areas in ceilings and walls where the surface has been penetrated shall be sealed.
(d) Ceilings that consist of inlaid panels shall be impregnated with a polymer to render them impervious and hydrophobic and shall either be caulked or weighted and clipped.
(e) Walls shall be constructed of a durable material, panels locked together and sealed or of epoxy-coated gypsum board.
(f) Floors shall have a covering that shall be seamless or have heat-welded seams and coving to the sidewall. There shall be no floor drains.
(h) Ceiling lighting fixtures shall have exterior lens surfaces which are smooth, mounted flush, and sealed.
(i) Carts shall be constructed of stainless steel wire, nonporous plastic or sheet metal with cleanable casters.
(j) Tacky mats may not be used in a classified area.
(k) HEPA filters and unidirectional airflow shall be used to maintain the appropriate airborne particulate classification.
(L) The classified area shall measure not less than 30 air changes per hour of which at least half shall be HEPA-filtered fresh air.
(m) For classified areas physically separated through the use of walls, doors, and pass-throughs, a minimum differential positive pressure of 0.02-inch water column is required to separate each classified area. If a pass-through is used, only one door shall be opened at a time. A pressure gauge or velocity meter shall be used to monitor the pressure differential or airflow between classified areas with results documented at least daily.
(mm) For classified areas not physically separated, no sterile compounded preparation may be compounded using any ingredient that was at any time non-sterile in a classified area not physically separated and all of the following shall be met:
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Published under s. 35.93, Stats. Updated on the first day of each month. Entire code is always current. The Register date on each page is the date the chapter was last published.