SENATE BILL NO. 478
INTRODUCED BY C. CHRISTIAENS, C. TUSS, A. BISHOP, P. CLARK, E. FRANKLIN, D. HARGROVE,
B. LAWSON, K. MESAROS, G. MATTHEWS, B. WILSON, D. WYATT
AN ACT REQUIRING THE BOARD OF PHARMACY TO ADOPT RULES PROVIDING FOR THE REGISTRATION OF AMBULATORY SURGICAL FACILITIES AS ENTITIES ALLOWED TO POSSESS DANGEROUS DRUGS PURSUANT TO TITLE 50, CHAPTER 32, PART 3, MCA; AND PROVIDING AN IMMEDIATE EFFECTIVE DATE.
WHEREAS, Title 50, chapter 32, MCA, requires the Department of Commerce to administer a program under rules adopted by the Board of Pharmacy providing for the registration of persons and institutions that may manufacture, distribute, or administer dangerous drugs; and
WHEREAS, it is the registration system under Title 50, chapter 32, part 3, MCA, that allows hospitals, physicians, and other persons and health care institutions that have legitimate uses for dangerous drugs to possess or administer those drugs; and
WHEREAS, section 50-32-101(12), MCA, provides for a category of a possessor of dangerous drugs known as a "distributor", who is a person or facility that receives dangerous drugs from one registered source and makes them available to another person who is also registered under the law; and
WHEREAS, institutions, such as hospitals and other health care facilities, that do not themselves prescribe or administer dangerous drugs but do receive those drugs from one source and make them available to a physician to administer to a patient are registered pursuant to Title 50, chapter 32, part 3, MCA, as a "distributor", as defined in section 50-32-101(12), MCA; and
WHEREAS, Montana is seeing the development of new and expanding types of health care facilities intended to fill the growing needs of a category of patients who require surgery but do not require hospitalization and who may therefore have surgery performed at an ambulatory surgical facility, soon to be called an "outpatient center for surgical services" pursuant to the terms of Senate Bill No. 116; and
WHEREAS, few if any of the existing ambulatory surgical facilities have themselves been registered for the possession of dangerous drugs because most existing facilities are operationally connected to hospitals or physicians who already have a registration issued by the Department of Commerce; and
WHEREAS, the rules adopted by the Board of Pharmacy pursuant to section 50-32-103(2), MCA, and administered by the Department of Commerce do not provide for the registration of ambulatory surgical facilities or outpatient centers for surgical services as distributors or any other class of registered entity; and
WHEREAS, the registration of ambulatory surgical facilities or outpatient centers for surgical services to allow the facilities or centers to make drugs available for preoperation, operation, and postoperation surgical purposes will provide health care consumers with greater options for the performance of outpatient surgery; and
WHEREAS, the registration of ambulatory surgical facilities or outpatient centers for surgical services will not increase the possibility that dangerous drugs will be used by unauthorized persons because an ambulatory surgical facility or outpatient center for surgical services must still receive those drugs from a registered distributor and because physicians or other persons registered to administer or prescribe drugs will still need to administer or prescribe the drugs possessed by an ambulatory surgical facility or outpatient facility for surgical services.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MONTANA:
Section 1. Board to adopt rules for registration of ambulatory surgical facilities. (1) The board shall, by October 1, 1999, adopt rules to provide for the registration of ambulatory surgical facilities pursuant to Title 50, chapter 32, part 3. The rules must categorize ambulatory surgical facilities as a "distributor" pursuant to 50-32-101(12) or other category of registrant as determined by the board.
(2) If the board determines that ambulatory surgical facilities require the services of a pharmacist in order to be registered, the board shall allow those facilities to use the services of a consulting pharmacist to satisfy the obligation imposed by the board.
(3) This section does not affect any existing requirement that persons providing dangerous drugs to an ambulatory surgical facility or persons administering dangerous drugs within or as the result of procedures performed at an ambulatory surgical facility be registered pursuant to Title 50, chapter 32, part 3.
Section 2. Codification instruction. [Section 1] is intended to be codified as an integral part of Title 50, chapter 32, and the provisions of Title 50, chapter 32, apply to [section 1].
Section 3. Effective date. [This act] is effective on passage and approval.
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