Montana Code 37-7-1405. Participants — duties — fee authorized
37-7-1405. Participants — duties — fee authorized. (1) A participant shall comply with all applicable provisions of state and federal law relating to the storage, distribution, and dispensing of a donated cancer drug or device and shall inspect all donated drugs and devices before dispensing them to determine if they are adulterated or misbranded.
Terms Used In Montana Code 37-7-1405
- 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
- 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
- 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
- Person: includes an individual, partnership, corporation, association, or other legal entity. See Montana Code 37-7-101
- 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
(2)A cancer drug or device may be:
(a)dispensed only pursuant to a prescription issued by a prescriber authorized to prescribe cancer drugs or devices; or
(b)distributed to another participant for dispensing.
(3)A cancer drug or device donated to the cancer drug repository program may not be resold.
(4)A participant may charge a handling fee for distributing or dispensing a cancer drug or device.
(5)A participant shall maintain records of donated drugs and devices and the distribution of the drugs and devices.
(6)(a) For cancer drugs or devices that are donated to the participant, records maintained pursuant to subsection (5) must include but are not limited to the following information:
(i)the date the participant received the cancer drug or device;
(ii)the drug name, strength, and amount;
(iii)the prescription number;
(iv)the expiration date of the drug;
(v)the manufacturer’s name and lot number; and
(vi)the name and address of the person or entity donating the drug.
(b)For cancer drugs or devices that are distributed or dispensed by the participant, records maintained pursuant to subsection (5) must include but are not limited to the following information:
(i)the name and address of the receiving person or entity;
(ii)the name, strength, and quantity of the drug;
(iii)the dosage form, if applicable;
(iv)the name and address of the participant who distributed or dispensed the drug or device;
(v)the date the participant distributed or dispensed the drug or device;
(vi)the manufacturer’s name and lot number; and
(vii)the expiration date of the drug.