Terms Used In Montana Code > Title 37 > Chapter 7 - Pharmacy

• Administer: means the direct application of a drug to the body of a patient by injection, inhalation, ingestion, or any other means. See Montana Code 37-7-101
• Answer: The formal written statement by a defendant responding to a civil complaint and setting forth the grounds for defense.
• Bioavailability: means the extent and rate of absorption from a dosage form as reflected by the time-concentration curve of the administered drug in the systemic circulation. See Montana Code 37-7-502
• Bioequivalent: means a chemical equivalent that, when administered to the same individual in the same dosage regimen, will result in comparable bioavailability. See Montana Code 37-7-502
• Biological product: has the meaning provided in 42 U. See Montana Code 37-7-502
• Board: means the board of pharmacy provided for in 2-15-1733. See Montana Code 37-7-101
• Cancer drug: means a prescription drug used to treat:

  (a)cancer or its side effects; or

  (b)the side effects of a prescription drug used to treat cancer or its side effects. See Montana Code 37-7-101

• Chemical: means medicinal or industrial substances, whether simple, compound, or obtained through the process of the science and art of chemistry, whether of organic or inorganic origin. See Montana Code 37-7-101
• Clinical pharmacist practitioner: means a licensed pharmacist in good standing who meets the requirements specified in 37-7-306. See Montana Code 37-7-101
• Collaborative pharmacy practice: means the practice of pharmacy by a pharmacist who has agreed to work in conjunction with one or more prescribers, on a voluntary basis and under protocol, and who may perform certain patient care functions under certain specified conditions or limitations authorized by the prescriber. See Montana Code 37-7-101
• Commercial purposes: means the ordinary purposes of trade, agriculture, industry, and commerce, exclusive of the practices of medicine and pharmacy. See Montana Code 37-7-101
• Compounding: means the preparation, mixing, assembling, packaging, or labeling of a drug or device based on:

  (a)a practitioner's prescription drug order;

  (b)a professional practice relationship between a practitioner, pharmacist, and patient;

  (c)research, instruction, or chemical analysis, but not for sale or dispensing; or

  (d)the preparation of drugs or devices based on routine, regularly observed prescribing patterns. See Montana Code 37-7-101

• Confidential patient information: means privileged information accessed by, maintained by, or transmitted to a pharmacist in patient records or that is communicated to the patient as part of patient counseling. See Montana Code 37-7-101
• Contract: A legal written agreement that becomes binding when signed.
• Controlled substance: means a substance designated in Schedules II through V of Title 50, chapter 32, part 2. See Montana Code 37-7-101
• Corporation: A legal entity owned by the holders of shares of stock that have been issued, and that can own, receive, and transfer property, and carry on business in its own name.
• Damages: Money paid by defendants to successful plaintiffs in civil cases to compensate the plaintiffs for their injuries.
• Department: means the department of labor and industry provided for in Title 2, chapter 15, part 17. See Montana Code 37-7-101
• Dispenser: means a retail pharmacy, a hospital pharmacy, a group of chain pharmacies under common ownership and control that do not act as a wholesale distributor, or any other person authorized by law to dispense or administer prescription drugs, and the affiliated warehouses or distribution centers of the entities listed in this subsection (1)(a), if they are under common ownership and control and do not act as a wholesale distributor. See Montana Code 37-7-602
• dispensing: means the interpretation, evaluation, and implementation of a prescription drug order, including the preparation and delivery of a drug or device to a patient or patient's agent in a suitable container appropriately labeled for administration to or use by a patient. See Montana Code 37-7-101
• distribution: means the sale, purchase, trade, delivery, handling, storage, or receipt of a drug or device and does not include administering or dispensing a prescription drug, pursuant to section 353(b)(1), or a new animal drug, pursuant to section 360b(b) of the Federal Food, Drug, and Cosmetic Act, 21 U. See Montana Code 37-7-101
• Drug: means a substance:

  (a)recognized as a drug in any official compendium or supplement;

  (b)intended for use in diagnosis, cure, mitigation, treatment, or prevention of disease in humans or animals;

  (c)other than food, intended to affect the structure or function of the body of humans or animals; and

  (d)intended for use as a component of a substance specified in subsection (16)(a), (16)(b), or (16)(c). See Montana Code 37-7-101

• Drug product: means a dosage form containing one or more active therapeutic ingredients along with other substances included during the manufacturing process. See Montana Code 37-7-502
• Drug utilization review: means an evaluation of a prescription drug order and patient records for duplication of therapy, interactions, proper utilization, and optimum therapeutic outcomes. See Montana Code 37-7-101
• Equitable: Pertaining to civil suits in "equity" rather than in "law." In English legal history, the courts of "law" could order the payment of damages and could afford no other remedy. See damages. A separate court of "equity" could order someone to do something or to cease to do something. See, e.g., injunction. In American jurisprudence, the federal courts have both legal and equitable power, but the distinction is still an important one. For example, a trial by jury is normally available in "law" cases but not in "equity" cases. ^{Source: U.S. Courts}
• Equivalent drug product: means a drug product that has the same established name, active ingredient or ingredients, strength or concentration, dosage form, and route of administration and meets the same standards as another drug product as determined by any official compendium or supplement. See Montana Code 37-7-101
• Evidence: Information presented in testimony or in documents that is used to persuade the fact finder (judge or jury) to decide the case for one side or the other.
• FDA: means the United States food and drug administration. See Montana Code 37-7-101
• Generic name: means the chemical or established name of a drug product or drug ingredient published in the latest edition of an official compendium recognized by the board. See Montana Code 37-7-502
• Health care facility: has the meaning provided in 50-5-101. See Montana Code 37-7-101
• Health clinic: means a facility in which advice, counseling, diagnosis, treatment, surgery, care, or services relating to preserving or maintaining health are provided on an outpatient basis for a period of less than 24 consecutive hours to a person not residing at or confined to the facility. See Montana Code 37-7-101
• Health information system: means one of the following systems used to compile and manage patient health care information:

  (a)an electronic health record system;

  (b)a health information exchange approved by the board;

  (c)a pharmacy dispensing system; or

  (d)a system defined by the board by rule. See Montana Code 37-7-101

• Hospital: has the meaning provided in 50-5-101. See Montana Code 37-7-101
• Immunization-certified pharmacist: means a pharmacist who:

  (a)has successfully completed an immunization delivery course of training that is approved by the accreditation council for pharmacy education or by an authority approved by the board and that, at a minimum, includes instruction in hands-on injection technique, clinical evaluation of indications and contraindications of immunizations, storage and handling of immunizations, and documentation and reporting; and

  (b)holds a current basic cardiopulmonary resuscitation certification issued by the American heart association, the American red cross, or another recognized provider. See Montana Code 37-7-101

• Interchangeable biological product: means a biological product that the federal food and drug administration has:

  (a)licensed; and

  (b)(i) determined meets the standards for interchangeability pursuant to 42 U. See Montana Code 37-7-502

• Intern: means :

  (a)a person who is licensed by the state to engage in the practice of pharmacy while under the personal supervision of a preceptor and who is satisfactorily progressing toward meeting the requirements for licensure as a pharmacist;

  (b)a graduate of an accredited college of pharmacy who is licensed by the state for the purpose of obtaining practical experience as a requirement for licensure as a pharmacist;

  (c)a qualified applicant awaiting examination for licensure; or

  (d)a person participating in a residency or fellowship program. See Montana Code 37-7-101

• Jurisdiction: (1) The legal authority of a court to hear and decide a case. Concurrent jurisdiction exists when two courts have simultaneous responsibility for the same case. (2) The geographic area over which the court has authority to decide cases.
• Knowingly: means only a knowledge that the facts exist which bring the act or omission within the provisions of this code. See Montana Code 1-1-204
• Long-term care facility: has the meaning provided in 50-5-101. See Montana Code 37-7-101
• Manufacturer: means :

  (a)a person approved by application to the FDA to manufacture a product as defined in section 360eee of the Drug Supply Chain Security Act, 21 U. See Montana Code 37-7-602

• Manufacturing: means the production, preparation, propagation, conversion, or processing of a drug or device, either directly or indirectly, by extraction from substances of natural origin or independently by means of chemical or biological synthesis. See Montana Code 37-7-101
• Medicine: means a remedial agent that has the property of curing, preventing, treating, or mitigating diseases or which is used for this purpose. See Montana Code 37-7-101
• Outsourcing facility: means a facility at one geographic location or address that:

  (a)engages in compounding of sterile drugs;

  (b)has elected to register as an outsourcing facility with FDA; and

  (c)complies with all the requirements of section 353b of the Federal Food, Drug, and Cosmetic Act, 21 U. See Montana Code 37-7-101

• Participant: means a physician's office, pharmacy, hospital, or health clinic that has elected to voluntarily participate in the cancer drug repository program provided for in 37-7-1403 and that accepts donated cancer drugs or devices under rules adopted by the board. See Montana Code 37-7-101
• Partnership: A voluntary contract between two or more persons to pool some or all of their assets into a business, with the agreement that there will be a proportional sharing of profits and losses.
• Patient counseling: means the communication by the pharmacist of information, as defined by the rules of the board, to the patient or caregiver in order to ensure the proper use of drugs or devices. See Montana Code 37-7-101
• Peace officer: has the meaning as defined in 46-1-202. See Montana Code 1-1-207
• Person: includes a corporation or other entity as well as a natural person. See Montana Code 1-1-201
• Person: includes an individual, partnership, corporation, association, or other legal entity. See Montana Code 37-7-101
• Person: has the meaning provided in 37-7-101. See Montana Code 37-7-502
• Pharmaceutical care: means the provision of drug therapy and other patient care services intended to achieve outcomes related to the cure or prevention of a disease, elimination or reduction of a patient's symptoms, or arresting or slowing of a disease process. See Montana Code 37-7-101
• Pharmacist: means a person licensed by the state to engage in the practice of pharmacy and who may affix to the person's name the term "R. See Montana Code 37-7-101
• Pharmacy: means an established location, either physical or electronic, registered by the board where drugs or devices are dispensed with pharmaceutical care or where pharmaceutical care is provided. See Montana Code 37-7-101
• Pharmacy technician: means an individual who assists a pharmacist in the practice of pharmacy. See Montana Code 37-7-101
• Practice of pharmacy: means :

  (a)interpreting, evaluating, and implementing prescriber orders;

  (b)administering drugs and devices pursuant to a collaborative practice agreement, except as provided in 37-7-105, and compounding, labeling, dispensing, and distributing drugs and devices, including patient counseling;

  (c)properly and safely procuring, storing, distributing, and disposing of drugs and devices and maintaining proper records;

  (d)prescribing drugs and devices in accordance with 37-7-106;

  (e)monitoring drug therapy and use;

  (f)initiating or modifying drug therapy in accordance with collaborative pharmacy practice agreements established and approved by health care facilities or voluntary agreements with prescribers;

  (g)participating in quality assurance and performance improvement activities;

  (h)providing information on drugs, dietary supplements, and devices to patients, the public, and other health care providers; and

  (i)participating in scientific or clinical research as an investigator or in collaboration with other investigators. See Montana Code 37-7-101

• Practice pharmacy by means of telehealth: means to provide pharmaceutical care through the use of information technology to patients at a distance. See Montana Code 37-7-101
• Preceptor: means an individual who is registered by the board and participates in the instructional training of a pharmacy intern. See Montana Code 37-7-101
• Prescriber: means a medical practitioner, as defined in 37-2-101, licensed under the professional laws of the state to administer and prescribe medicine and drugs. See Montana Code 37-7-502
• Prescription drug: means any drug that is required by federal law or regulation to be dispensed only by a prescription subject to section 353(b) of the Federal Food, Drug, and Cosmetic Act, 21 U. See Montana Code 37-7-101
• Prescription drug order: means an order from a prescriber for a drug or device that is communicated directly or indirectly by the prescriber to the furnisher by means of a signed order, by electronic transmission, in person, or by telephone. See Montana Code 37-7-101
• Printing: means the act of reproducing a design on a surface by any process. See Montana Code 1-1-203
• Process: means a writ or summons issued in the course of judicial proceedings. See Montana Code 1-1-202
• Product selection: means to dispense without the prescriber's express authorization a different drug product in place of the drug product prescribed. See Montana Code 37-7-502
• Provisional community pharmacy: means a pharmacy that has been approved by the board, including but not limited to federally qualified health centers, as defined in 42 C. See Montana Code 37-7-101
• Qualified patient: means a person who is uninsured, indigent, or has insufficient funds to obtain needed prescription drugs or cancer drugs. See Montana Code 37-7-101
• Registry: means the prescription drug registry provided for in 37-7-1502. See Montana Code 37-7-101
• Repackager: means a person who owns or operates an establishment that repacks and relabels a product or a package for:

  (a)further sale; or

  (b)distribution without a further transaction. See Montana Code 37-7-602

• State: when applied to the different parts of the United States, includes the District of Columbia and the territories. See Montana Code 1-1-201
• Subpoena: A command to a witness to appear and give testimony.
• Therapeutically equivalent: means those chemical equivalents that, when administered in the same dosage regimen, will provide essentially the same therapeutic effect as measured by the control of a symptom or a disease and/or toxicity. See Montana Code 37-7-502
• United States: includes the District of Columbia and the territories. See Montana Code 1-1-201
• Utilization plan: means a plan under which a pharmacist may use the services of a pharmacy technician in the practice of pharmacy to perform tasks that:

  (a)do not require the exercise of the pharmacist's independent professional judgment; and

  (b)are verified by the pharmacist. See Montana Code 37-7-101

• Wholesale: means a sale for the purpose of resale. See Montana Code 37-7-101
• Wholesale distribution: means distribution of prescription drugs to persons other than a consumer or patient. See Montana Code 37-7-602
• Wholesale distributor: means a person or entity, other than a manufacturer, a manufacturer's colicensed partner, a third-party logistics provider, or a repackager, who is engaged in wholesale distribution of prescription drugs. See Montana Code 37-7-602
• Willfully: when applied to the intent with which an act is done or omitted, means a purpose or willingness to commit the act or make the omission referred to. See Montana Code 1-1-204
• Writing: includes printing. See Montana Code 1-1-203