§ 37-7-501 Short title
§ 37-7-502 Definitions
§ 37-7-503 Rulemaking
§ 37-7-504 General prohibition of drug product substitution
§ 37-7-505 Product selection permitted — limitation
§ 37-7-506 Notice to purchaser
§ 37-7-507 Savings passed on
§ 37-7-508 Product selection not practice of medicine
§ 37-7-509 Limitations on liability
§ 37-7-510 Repealed

Terms Used In Montana Code > Title 37 > Chapter 7 > Part 5 - Drug Product Selection

  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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

  • 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
  • Person: has the meaning provided in 37-7-101. See Montana Code 37-7-502
  • 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
  • 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
  • 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
  • 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
  • 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