Montana Code 37-7-505. Product selection permitted — limitation
37-7-505. Product selection permitted — limitation. (1) Except as limited by subsection (2) and unless instructed otherwise by the purchaser:
Terms Used In Montana Code 37-7-505
- 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
- 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
- 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
- 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
(a)a pharmacist who receives a prescription for a specific drug product by brand or proprietary name may select a less expensive drug product with the same generic name, strength, quantity, dose, and dosage form as the prescribed drug that is, in the pharmacist’s professional opinion, therapeutically equivalent, bioequivalent, and bioavailable; and
(b)a pharmacist who receives a prescription for a specific biological product may select a less expensive interchangeable biological product.
(2)If, in the professional opinion of the prescriber, it is medically necessary that an equivalent drug product or interchangeable biological product not be selected, the prescriber may so indicate by certifying that the specific brand-name drug product prescribed or the specific brand-name biological product prescribed is medically necessary for that particular patient. In the case of a prescription transmitted orally, the prescriber must expressly indicate to the pharmacist that the specific brand-name drug product prescribed or the specific biological product prescribed is medically necessary.
(3)(a) Within 5 business days following the dispensing of a biological product, the dispensing pharmacist or the pharmacist’s designee shall communicate the specific product provided to the patient, including the name of the product and the manufacturer, to the prescriber through any of the following electric records systems:
(i)an interoperable electronic medical records system;
(ii)an electronic prescribing technology;
(iii)a pharmacy benefit management system; or
(iv)a pharmacy record.
(b)Communication through an electronic records system as described in subsection (3)(a) is presumed to provide notice to the prescriber.
(c)If the pharmacist is unable to communicate pursuant to an electronic records system as provided in subsection (3)(a), the pharmacist shall communicate to the prescriber which biological product was dispensed to the patient using facsimile, telephone, electronic transmission, or other prevailing means.
(d)Communication is not required under this subsection (3) when:
(i)there is no federal food and drug administration approved interchangeable biological product for the product prescribed; or
(ii)a refill prescription is not changed from the product dispensed on the prior filling of the prescription.
(4)The pharmacist shall maintain a record of the biological product dispensed for at least 2 years.