WSR 16-16-045 PROPOSED RULES DEPARTMENT OF HEALTH (Veterinary Board of Governors) [Filed July 26, 2016, 3:53 p.m.]
Original Notice.
Preproposal statement of inquiry was filed as WSR 15-11-056.
Title of Rule and Other Identifying Information: WAC 246-933-340 Practice management, the veterinary board of governors (board) is proposing to amend WAC 246-933-340 to include a drug expiration date in the list of labeling requirements for legend drugs dispensed by a veterinarian.
Hearing Location(s): Department of Health, Creekside Two at Center Point, 20425 72nd Avenue South, Room 309, Kent, WA 98032, on September 19, 2016, at 10:00 a.m.
Date of Intended Adoption: September 19, 2016.
Submit Written Comments to: Loralei Walker, Department of Health, Veterinary Board of Governors, P.O. Box 47852, Olympia, WA 98504-7852, e-mail https://fortress.wa.gov/doh/policyreview, fax (360) 236-2901, by August 31, 2016.
Assistance for Persons with Disabilities: Contact Loralei Walker by August 31, 2016, TTY (800) 833-6388 or 711.
Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: The labeling requirements for legend drugs dispensed by veterinarians in WAC 246-933-340(5) do not include a drug expiration date. To protect patient safety and to bring the rule into alignment with the requirements of RCW 18.92.013, the proposed rule adds a drug expiration date to labeling requirements for legend drugs dispensed by a veterinarian.
Reasons Supporting Proposal: For patient safety, the board is proposing to amend the rule to include a drug expiration date. The labeling requirements are consistent with current pharmacy requirements. Amending the rule will result in consistency between the rule and statute and provide clear direction to licensed veterinarians when labeling medications to be dispensed and important information to consumers regarding the expiration date of medications.
Rule is not necessitated by federal law, federal or state court decision.
Name of Proponent: Department of health, veterinary board of governors, governmental.
Name of Agency Personnel Responsible for Drafting: Brett Lorentson, 111 Israel Road S.E., Tumwater, WA 98501, (360) 236-4611; Implementation and Enforcement: Loralei Walker, 111 Israel Road S.E., Tuwmater, WA 98501, (360) 236-4947.
No small business economic impact statement has been prepared under chapter 19.85 RCW. The proposed rule would not impose more than minor costs on businesses in an industry.
A cost-benefit analysis is required under RCW 34.05.328. A preliminary cost-benefit analysis may be obtained by contacting Loralei Walker, Department of Health, P.O. Box 47852, Olympia, WA 98504-7852, phone (360) 236-4947, fax (360) 236-2901, e-mail Loralei.Walker@doh.wa.gov.
July 26, 2016
Kathy Schmitt
Deputy Director
Health Professions and Facilities
AMENDATORY SECTION (Amending WSR 91-24-098, filed 12/4/91, effective 1/4/92)
WAC 246-933-340 Practice management.
All veterinary medical facilities shall maintain a sanitary environment to avoid sources and transmission of infection. This includes the proper sterilization or sanitation of all equipment used in diagnosis or treatment and the proper routine disposal of waste materials.
(1) Surgery: Surgery shall be performed in a manner compatible with current veterinary practice with regard to anesthesia, asepsis or antisepsis, life support and monitoring procedures, and recovery care. The minimum standards for surgery shall be:
(a) Aseptic or antiseptic surgery shall be performed in a room designated and reserved for surgery and directly related noncontaminating activities.
(b) The surgery room shall be clean, orderly, well lighted and maintained in a sanitary condition, free of offensive odors.
(c) Storage in the surgery room shall be limited only to items and equipment related to surgery and surgical procedures.
(d) Instruments and equipment utilized in the surgery room shall be appropriate for the type of surgical service being provided.
(e) The operating table shall be constructed of a smooth and impervious material.
(f) Chemical disinfection ("cold sterilization") may be used only for field conditions or minor surgical procedures. Sterilizing of all appropriate equipment is required. Provisions for sterilization shall include a steam pressure sterilizer (autoclave) or a gas sterilizer (e.g., ethylene oxide).
(g) Surgical packs include towels, drapes, gloves, sponges and proper instrumentation. They shall be properly prepared for sterilization by heat or gas (sufficient to kill spores) for each sterile surgical procedure.
(h) For any major procedure, such as opening the abdominal or thoracic cavity or exposing bones or joints, a separate sterile surgical pack shall be used for each animal. Surgeons and surgical assistants shall use aseptic technique throughout the entire surgical procedure.
(i) Uncomplicated ovariohysterectomy or castration of normal healthy animals, and minor surgical procedures, such as excising small skin lesions or suturing superficial lacerations, may be performed under clean, antiseptic conditions. Surgeons and surgical assistants shall wear clean attire and sterile gloves, and care shall be taken to avoid introducing bacterial contamination.
(j) All animals shall be properly prepared for surgery as follows:
(i) Clipping and shaving of the surgical area for major procedures requiring aseptic technique as in (h) of this subsection shall be performed in a room other than the surgery room. Loose hair shall be removed from the surgical area((.));
(ii) Scrubbing the surgical area with soap and water((.));
(iii) Disinfecting the surgical area((.));
(iv) Draping the surgical area if appropriate((.));
(k) Anesthetic equipment appropriate for the type of patient and surgery performed shall be available at all times((.));
(l) Compressed oxygen or other adequate means shall be available to be used for resuscitation((.));
(m) Emergency drugs shall be available to the surgery area((.));
(n) Grossly contaminated procedures, such as lancing and draining abscesses, shall not be performed in the room designated for aseptic or antiseptic surgery.
(2) Library: A library of appropriate veterinary journals and textbooks shall be available on the premises for ready reference.
(3) Laboratory: Veterinary medical facilities shall have the capability for use of either in-house or consultant laboratory service for blood chemistry, bacterial cultures and antibiotic sensitivity examinations, complete blood counts, histopathologic examinations and complete necropsies. The in-house laboratory facility shall meet the following minimum standards:
(a) The laboratory room shall be clean and orderly with provision for ample storage((.));
(b) Ample refrigeration shall be provided((.));
(c) Any tests performed shall be properly conducted by currently recognized methods to assure reasonable accuracy and reliability of results.
(4) Radiology: Veterinary medical facilities shall have the capability for use of either in-house or consultant services for obtaining radiographs of diagnostic quality. Radiology equipment and use shall be in compliance with federal and Washington state laws, and shall follow the guidelines approved by the American Veterinary Medical Association.
(5) Biologicals and drugs: The minimum standards for drug procedures shall be:
(a) All controlled substances shall be stored, maintained, administered, dispensed and prescribed in compliance with federal and Washington state laws.
(b) Among things otherwise provided by RCW 18.64.246 and 69.41.050, legend drugs dispensed by a veterinarian shall be labeled with the following:
(i) Name of client or identification of animal((.));
(ii) Date dispensed((.));
(iii) Drug expiration date;
(iv) Complete directions for use((.
(iv)));
(v) Name and strength of the drug((.
(v))); and
(vi) Name of prescribing veterinarian.
(c) A record of all drugs administered or dispensed shall be kept in the client's record. In the case of companion animals this record shall be by individual animal.
(6) Limited services: If veterinary medical services are limited to specific aspects of practice((,)):
(a) The public shall be informed of the limitation of services provided((.));
(b) All veterinary services provided in the facility shall conform to the requirements for those services listed in WAC 246-933-330 and this section((.));
(c) The general requirements prescribed in WAC 246-933-320 shall apply to all veterinary medical facilities.
(7) Exceptions:
(a) The standards and requirements prescribed in WAC 246-933-330(3) and subsection (1)(a), (c), (j)(i), (n) of this section, shall not apply to equine or food animal veterinary procedures performed in medical facilities.
(b) The standards and requirements prescribed in WAC 246-933-320 (1), (2), (3), (4), (6), (8), 246-933-330 and subsections (1)(a), (b), (c), (e), (h), (j)(i), (l), (n), (2), (3), (4), (6)(b), (c) of this section, shall not apply to equine or food animal veterinary procedures performed on the owner's premises by a veterinarian.
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