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Phar 15.04(3) (3) A pharmacy shall have sufficient reference materials related to sterile pharmaceuticals to meet the needs of the pharmacy staff.
Phar 15.04(4) (4) The designated area shall be closed and disinfected at regular intervals with appropriate agents.
Phar 15.04 History History: Cr. Register, March, 2000, No. 531, eff. 4-1-00.
Phar 15.05 Phar 15.05 Records and reports.
Phar 15.05(1)(1) Specific records and reports shall be maintained describing the preparation of sterile pharmaceuticals in the pharmacy. These records and reports shall include:
Phar 15.05(1)(a) (a) Training and competency evaluations of personnel.
Phar 15.05(1)(b) (b) Documentation of refrigerator and freezer temperatures.
Phar 15.05(1)(c) (c) Certification of laminar airflow hoods.
Phar 15.05(2) (2) The following minimum labeling requirements shall be met for sterile pharmaceuticals prepared for a single patient if the pharmaceuticals are to be completely administered within 28 hours:
Phar 15.05(2)(a) (a) The identity of all solutions and ingredients and their corresponding amounts, concentration or volumes on the final preparation container in such a manner as to allow the locating of problematic final products.
Phar 15.05(2)(b) (b) The identity of personnel involved in preparation.
Phar 15.05(2)(c) (c) The date and time of pharmacy preparation where applicable.
Phar 15.05(2)(d) (d) The final sterile pharmaceuticals expiration date and storage requirements, where applicable.
Phar 15.05 History History: Cr. Register, March, 2000, No. 531, eff. 4-1-00.
Phar 15.06 Phar 15.06 Delivery service. The pharmacist shall assure the appropriate environmental control of all products shipped.
Phar 15.06 History History: Cr. Register, March, 2000, No. 531, eff. 4-1-00.
Phar 15.07 Phar 15.07 Emergency kits.
Phar 15.07(1)(1) When sterile pharmaceuticals are provided to home care patients, the dispensing pharmacy shall supply the patient or the patient's agent with emergency drugs, when authorized by the physician under protocol, if an emergency situation has been anticipated by either the physician, nurse or pharmacist.
Phar 15.07(2) (2) The dispensing pharmacy shall be responsible for providing written instructions on the storage and recordkeeping requirements for the emergency kit.
Phar 15.07 History History: Cr. Register, March, 2000, No. 531, eff. 4-1-00.
Phar 15.08 Phar 15.08 Cytotoxic drugs. In addition to the minimum requirements for a pharmacy established by rule of the board, the following requirements are necessary for those pharmacies that prepare cytotoxic drugs:
Phar 15.08(1) (1) All cytotoxic drugs shall be compounded in a vertical flow, class II, biological safety cabinet. If non-exposed surfaces become contaminated with cytotoxic agents, no products other than cytotoxic drugs may be compounded in this cabinet until such time as the cabinet is decontaminated utilizing appropriate techniques to eradicate the contaminant.
Phar 15.08(2) (2) Personnel shall be protected by a protective barrier or apparel which shall include gloves, gowns and other applicable protective apparel as described in 29 CFR PART 1910 of OSHA regulations.
Phar 15.08(3) (3) Appropriate safety and containment techniques for compounding cytotoxic drugs shall be used in conjunction with the aseptic techniques required for preparing sterile pharmaceuticals.
Phar 15.08(4) (4) Pharmacy disposal and patient and caregiver education regarding disposal of cytotoxic waste shall comply with all applicable local, state and federal requirements.
Phar 15.08(5) (5) Written procedures for the handling of both major and minor spills of cytotoxic agents shall be developed and shall be included in the pharmacy policy and procedure manual.
Phar 15.08(6) (6) Prepared doses of cytotoxic drugs shall be dispensed, labeled with proper precautions on the primary and shipping container and should be shipped in a manner to minimize the risk of accidental rupture of the primary container.
Phar 15.08 History History: Cr. Register, March, 2000, No. 531, eff. 4-1-00.
Phar 15.09 Phar 15.09 Labeling. In addition to the labeling requirements of s. 450.11 (4), Stats., the following shall also be included on the labels of sterile pharmaceuticals:
Phar 15.09(1) (1) Control or lot number.
Phar 15.09(2) (2) Expiration date and time, when applicable.
Phar 15.09(3) (3) Appropriate auxiliary labeling, including precautions.
Phar 15.09(4) (4) Storage requirements.
Phar 15.09(5) (5) Identification of the responsible pharmacist.
Phar 15.09 History History: Cr. Register, March, 2000, No. 531, eff. 4-1-00.
Phar 15.10 Phar 15.10 Patient training. A pharmacist is responsible for documenting the patient's training and competency in managing the type of therapy provided by the pharmacist to the patient if administered by the patient or a caregiver. A pharmacist is responsible for the provision of or supervision of the patient training process in any area that relates to drug compounding, administration, labeling, storage, stability or incompatibility. A pharmacist shall be responsible for seeing that the patient's competency in the above areas is reassessed on an ongoing basis.
Phar 15.10 History History: Cr. Register, March, 2000, No. 531, eff. 4-1-00.
Phar 15.11 Phar 15.11 Quality assurance.
Phar 15.11(1)(1) There shall be a documented, ongoing quality assurance control program that monitors personnel performance, equipment and facilities. Appropriate samples of finished products shall be examined to assure that the pharmacy is capable of consistently preparing sterile pharmaceuticals meeting specifications.
Phar 15.11(2) (2) The area designated for preparing sterile pharmaceuticals and all horizontal and vertical laminar flow hoods shall be certified to be operationally efficient and meet the standards of a class 100 environment by an independent contractor. All biological safety cabinets shall be certified according to national sanitation foundations standard 49 or manufacturer's specifications. Certification shall take place before initial use or after relocation and at least annually. Certification records shall be maintained.
Phar 15.11 Note Note: "National Sanitation Foundations Standard 49" refers to National Sanitation Foundation standard no 49 for class II (laminar flow) biohazard cabinetry / as prepared by the NSF Advisory Committee on Biohazard Cabinetry; and recommended for adoption by the NSF Council of Public Health Consultants by the National Sanitation Foundation (U.S.) published in 1983 by the National Sanitation Foundation of Ann Arbor, Michigan.
Phar 15.11(3) (3) A pharmacy shall have written procedures requiring sampling for microbial contamination through a validation procedure, simulation of actual aseptic preparation, and by using bacterial growth medium to culture environmental samples.
Phar 15.11(4) (4) If compounding of parenteral solutions is performed using non-sterile chemicals, extensive end-product sterility testing shall be documented. If any parenteral solution fails the testing, procedures shall be in place to quarantine future products for sterility testing to assure end-product sterility prior to release of the products from quarantine. The compounding process shall utilize components and techniques that assure a sterile and particulate-free product.
Phar 15.11(5) (5) A pharmacy shall have written justification of the assigned expiration date for pharmacy prepared sterile pharmaceuticals.
Phar 15.11(6) (6) A pharmacy shall have documentation of quality assurance audits, including infection control and sterile technique audits at least annually.
Phar 15.11(7) (7) A pharmacy shall have procedures to assure consistent preparation of sterile pharmaceuticals.
Phar 15.11 History History: Cr. Register, March, 2000, No. 531, eff. 4-1-00.
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