Rule 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) "Board of Pharmaceutical Specialties" (BPS) means an independent nongovernmental certification body that provides recognition of persons involved in the advanced practice of pharmacy specialties through development and administration and a certification process that is consistent with public policy regarding the credentialing of healthcare professionals.(5) "Chart order" means a lawful order entered on the chart or a medical record of a patient or resident of a facility by a practitioner, or his or her designated agent, for a drug or device and shall be considered a prescription.(6) "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.(7) "Clean room" means an environment in which the concentration of airborne particles is controlled and monitored with parameters including high efficiency particulate air (HEPA) filtered airflow, pressurization, temperature, and humidity.(8) "Clinical practice experience," for purposes of issuing a clinical pharmacist practitioner endorsement, means working in a pharmacy practice setting which includes at least 50 percent of time spent in: (a) communication with healthcare professionals and patients regarding drug therapy, wellness, and health promotion;(b) designing, implementing, monitoring, evaluating, and modifying or recommending modifications in drug therapy to optimize patient care;(c) identifying, assessing, and solving medication-related problems and providing a clinical judgment as to the continuing effectiveness of the therapeutic plan;(d) conducting physical assessment applicable to the area of practice, evaluating patient problems, and ordering and monitoring medications, and/or laboratory tests in accordance with established standards of practice;(e) referring patients to other healthcare professionals as appropriate;(f) integrating relevant diet, exercise, and other non-drug therapy with pharmaceutical care;(g) retrieving, evaluating, utilizing, and managing data and professional resources;(h) documenting interventions and evaluating outcomes; and(i) integrating national standards for the quality of healthcare.(9) "Collaborative practice agreement" is defined as set forth in ARM 24.174.524.(10) "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.(11) "Cytotoxic" means a pharmaceutical agent capable of killing living cells.(12) "DEA" means the Drug Enforcement Administration of the United States Department of Justice.(13) "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.(14) "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."(15) " Drug kit" means a secured kit stored outside of a pharmacy 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.(16) "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 a facility and shall be considered a prescription.(17) "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.(18) "Electronic prescription" means a prescription that is generated on an electronic application and is transmitted to a pharmacy as an electronic data file. Controlled substance prescriptions for Schedules II through V shall be transmitted in accordance with DEA requirements as outlined in 21 CFR Part 1300.(19) "Electronic signature" means a confidential personalized method of affixing a signature to an electronic document that will guarantee the identity of the prescriber.(20) "Emergency drug cart" or "crash cart" means a secure lockable cart or container in an inpatient setting that stores drugs and devices necessary to meet the immediate therapeutic needs of a patient and which cannot be obtained from any other authorized source in sufficient time to prevent harm.(21) "Facility" means an outpatient center for surgical services, a hospital and/or long-term care facility, or a home infusion facility.(22) "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.(23) "Formulary" means a current compilation of pharmaceuticals authorized for use within the institution by representatives of the medical staff and pharmacy department.(24) "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.(25) "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.(26) "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. (27) "Internship" means the practical experiences required to provide an intern, as defined in 37-7-101, MCA, with the knowledge and practical experience necessary for professional licensure as a pharmacist.(28) "Internship period" means 300 Introductory Pharmacy Practice Experience (IPPE) hours, and 1,440 Advanced Pharmacy Practice Experience (APPE) hours of practical experience in an approved pharmacy, hospital, or other facility or location relevant to the pharmacy profession. The intern may acquire the internship hours concurrently with school attendance in approved courses, introductory pharmacy practice experience, and advanced pharmacy practice experience, or demonstration projects in the Pharm.D. program. The intern may acquire a maximum of 48 hours experience per calendar week.(29) 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.(30) "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.(31) "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.(32) "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.(33) "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.(34) "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.(35) "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.(36) "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.(37) "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.(38) "Outpatient center for surgical services" is as defined at 50-5-101, MCA.(39) "Parenteral" means a sterile preparation of drugs for injection through one or more layers of skin.(40) "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.(41) "Preceptor" means a pharmacist or other approved individual who meets those requirements for the supervision and training of an intern. A preceptor shall have overall responsibility for the required training of the intern.(42) "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.(43) "Qualified patients" mean patients who are uninsured, indigent, or have insufficient funds to obtain needed prescription drugs.(44) "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.(45) "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.(46) "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.(47) "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.(48) "Same-day use" means that the administration of the preparation shall commence within 24 hours from the time of preparation. (49) "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.(50) "Security" or "secure system" means a system to maintain the confidentiality and integrity of patient records, which are being sent electronically.(51) "Single-dose vial" means a sterile medication in a vial without preservatives.(52) "Sterile pharmaceutical" means any dosage form containing no viable microorganisms including, but not limited to, parenterals and ophthalmics.(53) "Supervising pharmacist" means the registered pharmacist who is serving as the pharmacist on duty and is in charge of the day-to-day supervision of the pharmacy personnel.(54) "Supervision" means that all drug distribution or dispensing activities, immunizations, or other activities performed by pharmacy personnel are under the direction of a registered pharmacist.(55) "Verification audit" means a comparison and verification of written patient orders with medications removed for that patient.Mont. Admin. r. 24.174.301
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. 3/27/2015; AMD, 2021 MAR p. 1671, Eff. 11/20/2021; AMD, 2024 MAR p. 2219, Eff. 9/21/2024AUTH: 37-7-201, 50-32-314, MCA; IMP: 37-7-102, 37-7-201, 37-7-301, 37-7-306, 37-7-321, 37-7-406, 37-7-603, 37-7-604, 37-7-605, 50-32-314, MCA