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Register January 2002 No. 553
Chapter Phar 15
STERILE PHARMACEUTICALS
Phar 15.01 Authority.
Phar 15.02 Definitions.
Phar 15.03 Policy and procedure manual.
Phar 15.04 Physical requirements.
Phar 15.05 Records and reports.
Phar 15.06 Delivery service.
Phar 15.07 Emergency kits.
Phar 15.08 Cytotoxic drugs.
Phar 15.09 Labeling.
Phar 15.10 Patient training.
Phar 15.11 Quality assurance.
Phar 15.01 Phar 15.01 Authority. The rules in this chapter are adopted pursuant to the authority in ss. 15.08 (5) (b), 227.11 (2) and 450.02 (3), Stats.
Phar 15.01 History History: Cr. Register, March, 2000, No. 531, eff. 4-1-00.
Phar 15.02 Phar 15.02 Definitions. In this chapter:
Phar 15.02(1) (1) "Aseptic preparation" means preparation using procedures designed to preclude contamination of drugs, packaging equipment or supplies by microorganisms during processing.
Phar 15.02(2) (2) "Biological safety cabinet" means a containment unit suitable for preparation of low- to moderate- risk agents where there is a need for protection of the product, personnel and environment, according to national sanitation foundations standard 49.
Phar 15.02(3) (3) "Class 100 environment" means an atmospheric environment that contains less than 100 particles 0.5 microns in diameter per cubic foot of air, as described in federal standard 209.
Phar 15.02 Note Note: "Federal Standard 209" refers to Federal standard 209E: airborne particulate cleanliness classes in cleanrooms and clean zones by the Institute of Environmental Sciences published by the Institute of Environmental Sciences in 1992 and used by the United States General Services Administration as the standard required for use by federal agencies utilizing clean room controlled environments.
Phar 15.02(4) (4) "Critical activities" means activities that are different from other activities due to the increased potential opportunity for contamination to occur.
Phar 15.02(5) (5) "Critical objects" means objects that are different from other objects due to the increased potential opportunity for contamination to occur.
Phar 15.02(6) (6) "Cytotoxic drug" means a pharmaceutical used therapeutically as a toxin to alter biochemical activities of phases of cellular division which uniquely contribute to normal cell growth.
Phar 15.02(7) (7) "OSHA" means the federal occupational safety and health administration.
Phar 15.02(8) (8) "Parenteral" means a preparation of drugs for injection through one or more layers of skin.
Phar 15.02(9) (9) "Practice of pharmacy" has the meaning given in s. 450.01 (16), Stats.
Phar 15.02(10) (10) "Sterile pharmaceutical" means any dosage form devoid of viable microorganisms, including but not limited to parenterals, injectables and ophthalmics.
Phar 15.02 History History: Cr. Register, March, 2000, No. 531, eff. 4-1-00.
Phar 15.03 Phar 15.03 Policy and procedure manual.
Phar 15.03(1) (1) A pharmacy shall prepare and maintain a policy and procedure manual for compounding, dispensing, delivery, administration, storage and use of sterile pharmaceuticals.
Phar 15.03(2) (2) The policy and procedure manual shall include a quality assurance program for the purpose of monitoring personnel qualifications, training and performance, product integrity, equipment, and facilities and include guidelines regarding patient education and the provision of pharmaceutical services. In addition, the manual shall include up-to-date information on the preparation of sterile pharmaceuticals.
Phar 15.03(3) (3) The policy and procedure manual shall be available to all personnel and updated annually or as needed to reflect current practice.
Phar 15.03(4) (4) The policy and procedure manual shall be current and available for inspection by the board or its designee.
Phar 15.03 History History: Cr. Register, March, 2000, No. 531, eff. 4-1-00.
Phar 15.04 Phar 15.04 Physical requirements.
Phar 15.04(1) (1) A pharmacy shall have a designated area for preparing sterile pharmaceuticals. This area shall be a room structurally isolated from other areas, with entry and access restricted to designated personnel and shall be designed to avoid unnecessary traffic and airflow disturbances. The designated area shall only be used for preparation and documentation of sterile pharmaceuticals. The designated area shall be of sufficient size to accommodate a laminar airflow hood and to provide for proper storage of drugs and supplies under appropriate conditions of temperature, light, moisture, sanitation, ventilation and security. Additional drug inventory and bulk supplies shall be stored in an area separate from the designated area for preparing sterile pharmaceuticals.
Phar 15.04(2) (2) A pharmacy shall maintain an environment in the designated area suitable for aseptic preparation of sterile pharmaceuticals and shall have all of the following:
Phar 15.04(2)(a) (a) Appropriate environment control devices that are capable of maintaining at least a class 100 environment during normal activity in the workplace where critical objects are exposed and critical activities are performed.
Phar 15.04(2)(b) (b) Appropriate disposal containers as required by OSHA in 29 CFR PART 1910 for used needles and syringes, and for disposal of other items in compounding and, if applicable, for cytotoxic waste from the preparation of chemotherapy agents and infectious wastes. This should be disposed of in a timely manner.
Phar 15.04(2)(c) (c) Appropriate environmental controls including class II biological safety cabinetry in pharmacies where cytotoxic drug products are prepared.
Phar 15.04(2)(d) (d) Temperature-controlled delivery containers as necessary.
Phar 15.04(2)(e) (e) For hand washing, a sink with hot and cold running water in close proximity.
Phar 15.04(2)(f) (f) Administration devices as necessary.
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.
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