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Rule Title: DEFINITIONS
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Department: LABOR AND INDUSTRY
Chapter: BOARD OF PHARMACY
Subchapter: Definitions
 
Latest version of the adopted rule presented in Administrative Rules of Montana (ARM):

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24.174.301    DEFINITIONS

(1) "Airborne particulate cleanliness classification" means the level of cleanliness defined by the maximum allowable number of particles per cubic meter of air as specified in the International Organization of Standardization (ISO) "Classification of Air Cleanliness" (ISO 14644-1) for Class 5, Class 7, and Class 8.

(a) ISO Class 5 is an atmospheric environment that contains less than 3,520 particles 0.5 microns in diameter per cubic meter of air;

(b) ISO Class 7 is an atmospheric environment that contains less than 352,000 particles 0.5 microns in diameter per cubic meter of air; and

(c) ISO Class 8 is an atmospheric environment that contains less than 3,520,000 particles 0.5 microns in diameter per cubic meter of air.

(2) "Beyond use date" (BUD) means the date after which the preparation may not be dispensed or administered to a patient. BUD also means expiration date.

(3) "Biological safety cabinet" means a ventilated cabinet with an inward airflow for personnel protection; a downward, High Efficiency Particulate Arresting (HEPA) filtered, laminar airflow for product protection; and HEPA filtered exhaust system for environmental protection.

(4) "Class 100 environment" means an atmospheric environment which contains fewer than 100 particles 0.5 microns in diameter per cubic foot of air, according to Federal Standard 209E.

(5) "Clean room" means a room in which the concentration of airborne particles is controlled.

(6) "Compounded sterile preparation" (CSP) means:

(a) a preparation prepared according to the manufacturer's labeled instructions and other manipulations when preparing sterile products that expose the original contents to potential contamination, and includes all preparations compounded in a sterile environment; or

(b) a preparation containing nonsterile ingredients or employing nonsterile components and devices that must be sterilized before administration.

(7) "Contingency kit" means a secured kit containing those drugs which may be required to meet the short-term therapeutic need of patients within an institution not having an in-house pharmacy or 24-hour access to dispensing services, and which would not be available from any other authorized source in sufficient time, and without which would compromise the quality of care of the patient.

(8) "Cytotoxic" means a pharmaceutical agent capable of killing living cells.

(9) "DEA" means the Drug Enforcement Administration of the United States Department of Justice.

(10) "Deliver" or "delivery" means the actual, constructive, or attempted transfer of a drug or device from one person to another, whether or not for a consideration.

(11) "Device" is defined in 37-2-101, MCA, and is required under federal law to bear the label "Caution: Federal law requires dispensing by or on the order of a physician" or "Rx only."

(12) "Drug order" means a written or electronic order issued by an authorized practitioner, or a verbal order promptly transcribed, for the compounding and dispensing of a drug or device to be administered to patients within the facility.

(13) "Drug room" means a secure, lockable temperature-controlled location within a facility that does not have an institutional pharmacy and which contains drugs and devices for administration to patients within the facility pursuant to a valid drug order.

(14) "Electronic signature" means a confidential personalized method of affixing a signature to an electronic document that will guarantee the identity of the prescriber.

(15) "Emergency drug cart" or "crash cart" means a secure lockable cart containing drugs and devices necessary to meet the immediate therapeutic needs of inpatients or outpatients and which cannot be obtained from any other authorized source in sufficient time to prevent risk or harm or death to patients.

(16) "Emergency kits" are sealed kits containing those drugs which may be required to meet the immediate therapeutic needs of patients within an institution not having an in-house pharmacy, and which would not be available from any other authorized source in sufficient time to prevent risk or harm or death to patients.

(17) "Facility" means an outpatient center for surgical services, a hospital and/or long-term care facility, or a home infusion facility.

(18) "Floor stock" means prescription drugs not labeled for a specific patient, which are maintained at a nursing station or other hospital department other than the pharmacy, and which are administered to patients within the facility pursuant to a valid drug order. Floor stock shall be maintained in a secure manner pursuant to written policies and procedures, which shall include, but not be limited to, automated dispensing devices.

(19) "Formulary" means a current compilation of pharmaceuticals authorized for use within the institution by representatives of the medical staff and pharmacy department.

(20) "Home infusion facility" means a facility where parenteral solutions are compounded and distributed to outpatients for home infusion pursuant to a valid prescription or drug order.

(21) "Immediate use" means a preparation compounded pursuant to the conditions in ARM 24.174.1121 and whose administration must begin within one hour of preparation.

(22) "Institutional pharmacy" means that physical portion of an institutional facility where drugs, devices, and other material used in the diagnosis and treatment of injury, illness, and disease are dispensed, compounded, and distributed to other healthcare professionals for administration to patients within or outside the facility, and pharmaceutical care is provided.

(23) "Labeling" means the process of preparing and affixing a label to any drug container exclusive, however, of the labeling by a manufacturer, packer, or distributor of a nonprescription drug or commercially packaged legend drug or device. Any such label shall include all information required by federal and Montana law or rule.

(24) "Laminar airflow hood" (LAF) means a workspace where the work surface is subjected to a constant HEPA filtered airflow that is directed towards the user.

(25) "Long-term care facility" has the same meaning as provided in 50-5-101, MCA, and means a facility or part of a facility that provides skilled nursing care, residential care, intermediate nursing care, or intermediate developmental disability care to a total of two or more individuals, or that provides personal care.

(26) "Medical gas" means any gaseous substance that meets medical purity standards and has application in a medical environment. Examples of medical gases include, but are not limited to, oxygen, carbon dioxide, nitrous oxide, cyclopropane, helium, nitrogen, and air.

(27) "Medical gas distributor" is a person engaged in the manufacture, processing, packaging, labeling, or distribution of a medical gas to a person other than a consumer or patient.

(28) "Medical gas supplier" is a person engaged in selling, transferring, or delivering to a patient or a patient's agent one or more doses of medical gas in the manufacturer's or distributor's original container for subsequent use by the patient.

(29) "Multi-dose vial" means a vial of liquid medication intended for parenteral administration, whether by injection or infusion, that contains more than one dose of medication; is labeled as containing more than one dose of medication by the manufacturer; and typically contains an antimicrobial preservative to help prevent the growth of bacteria.

(30) "Night cabinet" means a secure locked cabinet or other enclosure located outside the pharmacy, containing drugs which authorized personnel may access in the absence of a pharmacist.

(31) "Nonprescription drug" means a drug which may be sold without a prescription and which is labeled for consumer use in accordance with the requirements of the laws and rules of Montana and the federal government.

(32) "Outpatient center for surgical services" is as defined at 50-5-101, MCA.

(33) "Parenteral" means a sterile preparation of drugs for injection through one or more layers of skin.

(34) "Pharmacist-in-charge" means a pharmacist licensed in Montana who accepts responsibility for the operation of a pharmacy in conformance with all laws and rules pertinent to the practice of pharmacy, who assures that the pharmacy and all pharmacy personnel working in the pharmacy have current and appropriate licensure and certification, and who is personally in full and actual charge of such pharmacy. The pharmacist-in-charge at an out-of-state mail service pharmacy does not have to be licensed in Montana.

(35) "Provisional pharmacy" means a pharmacy licensed by the Montana Board of Pharmacy and includes, but is not limited to, federally qualified health centers as defined in 42 CFR 405.2401, where prescription drugs are dispensed to appropriately screened, qualified patients.

(36) "Qualified patients" mean patients who are uninsured, indigent, or have insufficient funds to obtain needed prescription drugs.

(37) "Remote pharmacy" means a licensed pharmacy at which prescriptions may be filled or transmitted to a central hub pharmacy for filling and subsequent delivery to the remote site or the patient's home. Patient counseling by a pharmacist may occur at this site.

(38) "Remote telepharmacy dispensing machine site" means a licensed site containing prescription inventory which is secured in an automated dispensing device and which has access to its parent pharmacy and registered pharmacists via computer, video, and audio link at all times during business hours.

(39) "Remote telepharmacy site" means a licensed site staffed by a registered pharmacy technician with access to its parent pharmacy and registered pharmacists via computer, video, and audio link at all times during business hours.

(40) "Risk levels for sterile preparations" means the three risk levels of CSP recognized by the United States Pharmacopeia (USP) in USP Chapter 797 "Pharmaceutical Compounding - Sterile Preparations" that are based on the probability of contamination by microbial, chemical, or physical agents. Pursuant to the conditions set forth in ARM 24.174.1121, the three risk levels are low-risk, medium-risk, and high-risk.

(41) "Same-day use" means that the administration of the preparation shall commence within 24 hours from the time of preparation.

(42) "Satellite pharmacy" means a specialized inpatient pharmacy staffed by a pharmacist which is adjacent to or near the department served and is connected via computer to the central institutional pharmacy.

(43) "Security" or "secure system" means a system to maintain the confidentiality and integrity of patient records, which are being sent electronically.

(44) "Single-dose vial" means a sterile medication in a vial without preservatives.

(45) "Sterile pharmaceutical" means any dosage form containing no viable microorganisms including, but not limited to, parenterals and ophthalmics.

(46) "Verification audit" means a comparison and verification of written patient orders with medications removed for that patient.

History: 37-1-131, 37-7-201, 50-32-314, MCA; IMP, 37-7-102, 37-7-201, 37-7-301, 37-7-321, 37-7-406, 37-7-603, 37-7-604, 37-7-605, 50-32-314, MCA; Eff. 6/9/61; AMD, Eff. 2/27/72; AMD, 1980 MAR p. 126, Eff. 1/18/80; TRANS, from Dept. of Prof. & Occup. Lic., Ch. 274, L. 1981, Eff. 7/1/81; AMD, 1993 MAR p. 293, Eff. 2/26/93; AMD, 1998 MAR p. 3103, Eff. 11/20/98; AMD, 2002 MAR p. 178, Eff. 2/1/02; TRANS, from Commerce, 2002 MAR p. 904; AMD, 2002 MAR p. 3605, Eff. 12/27/02; AMD, 2006 MAR p. 1615, Eff. 6/23/06; AMD, 2007 MAR p. 1936, Eff. 11/22/07; AMD, 2008 MAR p. 1151, Eff. 6/13/08; AMD, 2010 MAR p. 74, Eff. 1/15/10; AMD, 2012 MAR p. 506, Eff. 3/9/12; AMD, 2012 MAR p. 896, Eff. 4/27/12; AMD, 2015 MAR p. 302, Eff. 3/27/15.


 

 
MAR Notices Effective From Effective To History Notes
24-174-65 3/27/2015 Current History: 37-1-131, 37-7-201, 50-32-314, MCA; IMP, 37-7-102, 37-7-201, 37-7-301, 37-7-321, 37-7-406, 37-7-603, 37-7-604, 37-7-605, 50-32-314, MCA; Eff. 6/9/61; AMD, Eff. 2/27/72; AMD, 1980 MAR p. 126, Eff. 1/18/80; TRANS, from Dept. of Prof. & Occup. Lic., Ch. 274, L. 1981, Eff. 7/1/81; AMD, 1993 MAR p. 293, Eff. 2/26/93; AMD, 1998 MAR p. 3103, Eff. 11/20/98; AMD, 2002 MAR p. 178, Eff. 2/1/02; TRANS, from Commerce, 2002 MAR p. 904; AMD, 2002 MAR p. 3605, Eff. 12/27/02; AMD, 2006 MAR p. 1615, Eff. 6/23/06; AMD, 2007 MAR p. 1936, Eff. 11/22/07; AMD, 2008 MAR p. 1151, Eff. 6/13/08; AMD, 2010 MAR p. 74, Eff. 1/15/10; AMD, 2012 MAR p. 506, Eff. 3/9/12; AMD, 2012 MAR p. 896, Eff. 4/27/12; AMD, 2015 MAR p. 302, Eff. 3/27/15.
24-174-62 4/27/2012 3/27/2015 History: 37-1-131, 37-7-201, 50-32-314, MCA; IMP, 37-7-102, 37-7-201, 37-7-301, 37-7-321, 37-7-406, 37-7-603, 37-7-604, 37-7-605, 50-32-314, MCA; Eff. 6/9/61; AMD, Eff. 2/27/72; AMD, 1980 MAR p. 126, Eff. 1/18/80; TRANS, from Dept. of Prof. & Occup. Lic., Ch. 274, L. 1981, Eff. 7/1/81; AMD, 1993 MAR p. 293, Eff. 2/26/93; AMD, 1998 MAR p. 3103, Eff. 11/20/98; AMD, 2002 MAR p. 178, Eff. 2/1/02; TRANS, from Commerce, 2002 MAR p. 904; AMD, 2002 MAR p. 3605, Eff. 12/27/02; AMD, 2006 MAR p. 1615, Eff. 6/23/06; AMD, 2007 MAR p. 1936, Eff. 11/22/07; AMD, 2008 MAR p. 1151, Eff. 6/13/08; AMD, 2010 MAR p. 74, Eff. 1/15/10; AMD, 2012 MAR p. 506, Eff. 3/9/12; AMD, 2012 MAR p. 896, Eff. 4/27/12.
24-174-63 3/9/2012 4/27/2012 History: 37-1-131, 37-7-201, 50-32-314, MCA; IMP, 37-7-102, 37-7-201, 37-7-301, 37-7-321, 37-7-406, 37-7-603, 37-7-604, 37-7-605, 50-32-314, MCA; Eff. 6/9/61; AMD, Eff. 2/27/72; AMD, 1980 MAR p. 126, Eff. 1/18/80; TRANS, from Dept. of Prof. & Occup. Lic., Ch. 274, L. 1981, Eff. 7/1/81; AMD, 1993 MAR p. 293, Eff. 2/26/93; AMD, 1998 MAR p. 3103, Eff. 11/20/98; AMD, 2002 MAR p. 178, Eff. 2/1/02; TRANS, from Commerce, 2002 MAR p. 904; AMD, 2002 MAR p. 3605, Eff. 12/27/02; AMD, 2006 MAR p. 1615, Eff. 6/23/06; AMD, 2007 MAR p. 1936, Eff. 11/22/07; AMD, 2008 MAR p. 1151, Eff. 6/13/08; AMD, 2010 MAR p. 74, Eff. 1/15/10; AMD, 2012 MAR p. 506, Eff. 3/9/12.
24-174-59 1/15/2010 3/9/2012 History: 37-1-131, 37-7-201, 50-32-314, MCA; IMP, 37-7-102, 37-7-201, 37-7-301, 37-7-321, 37-7-406, 37-7-603, 37-7-604, 37-7-605, 50-32-314, MCA; Eff. 6/9/61; AMD, Eff. 2/27/72; AMD, 1980 MAR p. 126, Eff. 1/18/80; TRANS, from Dept. of Prof. & Occup. Lic., Ch. 274, L. 1981, Eff. 7/1/81; AMD, 1993 MAR p. 293, Eff. 2/26/93; AMD, 1998 MAR p. 3103, Eff. 11/20/98; AMD, 2002 MAR p. 178, Eff. 2/1/02; TRANS, from Commerce, 2002 MAR p. 904; AMD, 2002 MAR p. 3605, Eff. 12/27/02; AMD, 2006 MAR p. 1615, Eff. 6/23/06; AMD, 2007 MAR p. 1936, Eff. 11/22/07; AMD, 2008 MAR p. 1151, Eff. 6/13/08; AMD, 2010 MAR p. 74, Eff. 1/15/10.
24-174-58 6/13/2008 1/15/2010 History: 37-1-131, 37-7-201, 50-32-314, MCA; IMP, 37-7-102, 37-7-201, 37-7-301, 37-7-321, 37-7-406, 37-7-603, 37-7-604, 37-7-605, 50-32-314, MCA; Eff. 6/9/61; AMD, Eff. 2/27/72; AMD, 1980 MAR p. 126, Eff. 1/18/80; TRANS, from Dept. of Prof. & Occup. Lic., Ch. 274, L. 1981, Eff. 7/1/81; AMD, 1993 MAR p. 293, Eff. 2/26/93; AMD, 1998 MAR p. 3103, Eff. 11/20/98; AMD, 2002 MAR p. 178, Eff. 2/1/02; TRANS, from Commerce, 2002 MAR p. 904; AMD, 2002 MAR p. 3605, Eff. 12/27/02; AMD, 2006 MAR p. 1615, Eff. 6/23/06; AMD, 2007 MAR p. 1936, Eff. 11/22/07; AMD, 2008 MAR p. 1151, Eff. 6/13/08.
24-174-56 11/22/2007 6/13/2008 History: 37-1-131, 37-7-201, 50-32-314, MCA; IMP, 37-7-102, 37-7-201, 37-7-301, 37-7-321, 37-7-406, 37-7-603, 37-7-604, 37-7-605, 50-32-314, MCA; Eff. 6/9/61; AMD, Eff. 2/27/72; AMD, 1980 MAR p. 126, Eff. 1/18/80; TRANS, from Dept. of Prof. & Occup. Lic., Ch. 274, L. 1981, Eff. 7/1/81; AMD, 1993 MAR p. 293, Eff. 2/26/93; AMD, 1998 MAR p. 3103, Eff. 11/20/98; AMD, 2002 MAR p. 178, Eff. 2/1/02; TRANS, from Commerce, 2002 MAR p. 904; AMD, 2002 MAR p. 3605, Eff. 12/27/02; AMD, 2006 MAR p. 1615, Eff. 6/23/06; AMD, 2007 MAR p. 1936, Eff. 11/22/07.
6/23/2006 11/22/2007 History: 37-7-201, MCA; IMP, 37-7-102, 37-7-201, 37-7-301, 37-7-321, 37-7-406, 50-32-314, MCA; Eff. 6/9/61; AMD, Eff. 2/27/72; AMD, 1980 MAR p. 126, Eff. 1/18/80; TRANS, from Dept. of Prof. & Occup. Lic. , Ch. 274, L. 1981, Eff. 7/1/81; AMD, 1993 MAR p. 293, Eff. 2/26/93; AMD, 1998 MAR p. 3103, Eff. 11/20/98; AMD, 2002 MAR p. 178, Eff. 2/1/02; TRANS, from Commerce, 2002 MAR p. 904; AMD, 2002 MAR p. 3605, Eff. 12/27/02; AMD, 2006 MAR p. 1615, Eff. 6/23/06.
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