Montana Code 37-7-1404. Cancer drugs or devices accepted or dispensed — conditions
37-7-1404. Cancer drugs or devices accepted or dispensed — conditions. (1) (a) Unless otherwise prohibited by law, a cancer drug or device may be accepted or dispensed under the cancer drug repository program established under 37-7-1403 if the drug or device is in its original, unopened, sealed, and tamper-evident unit dose packaging.
Terms Used In Montana Code 37-7-1404
- 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
- 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
- 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
- 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
- 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
(b)A cancer drug packaged in single-unit doses may be accepted and dispensed if the outside packaging is opened but the single-unit dose packaging is unopened.
(2)A cancer drug may not be accepted or dispensed under this section if the drug:
(a)bears an expiration date that is earlier than 6 months after the date the drug was donated;
(b)is considered adulterated or misbranded under the provisions of Title 50, chapter 31, part 3; or
(c)is subject to restricted distribution pursuant to 21 C.F.R. § 314.520.
(3)Subject to the limitations provided in this section, an unused cancer drug or device dispensed under the medicaid program provided for in Title 53, chapter 6, may be accepted and dispensed under the cancer drug repository program.
(4)A cancer drug or device donated under this program must be stored:
(a)separately from other prescription drugs or stock;
(b)according to the manufacturer’s recommended storage conditions; and
(c)in the compounding or dispensing area if stored in a pharmacy.
(5)In dispensing a donated cancer drug or device, a participant shall give first priority to a qualified patient in the participant’s service area. Other cancer patients may receive donated cancer drugs or devices if a qualified patient is not available.
(6)A participant shall notify a patient if the patient is receiving a cancer drug or device that has been donated.