Montana Code Annotated 2023



Part 14. Donated Drugs and Devices Program

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.

(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 CFR 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.

History: En. Sec. 2, Ch. 299, L. 2009.