In addition to the terms defined in 37-7-101, MCA, the following definitions apply to the rules in this chapter.

(1) "Biological safety cabinet" means a contained unit suitable for the preparation of low to moderate risk agents and where there is a need for protection of the product, personnel, and environment according to National Sanitation Foundation Standard 49.

(2) "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.

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

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

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

(6) "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.

(7) "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."

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

(9) "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.

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

(11) "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.

(12) "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.

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

(14) "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.

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

(16) "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.

(17) "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 health care professionals for administration to patients within or outside the facility, and pharmaceutical care is provided.

(18) "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.

(19) "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.

(20) "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.

(21) "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.

(22) "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.

(23) "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.

(24) "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.

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

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

(27) "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.

(28) "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.

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

(30) "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.

(31) "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.

(32) "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.

(33) "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.

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

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

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