50-12-104. Patient requirements. A patient is eligible for treatment with an investigational drug, biological product, or device if the patient has:

Terms Used In Montana Code 50-12-104

  • Health care provider: means any of the following individuals licensed pursuant to Title 37:

    (a)a physician;

    (b)an advanced practice registered nurse authorized by the board of nursing to prescribe medicine; and

    (c)a physician assistant. See Montana Code 50-12-102

  • United States: includes the District of Columbia and the territories. See Montana Code 1-1-201
  • Written informed consent: means a written document that meets the requirements of 50-12-105. See Montana Code 50-12-102

(1)considered all other treatment options currently approved by the United States food and drug administration;

(2)received a recommendation from the patient’s treating health care provider for an investigational drug, biological product, or device;

(3)given written informed consent for the use of the investigational drug, biological product, or device; and

(4)documentation from the treating health care provider that the patient meets the requirements of this section.