(1) The following categories of drugs are not acceptable for dispensing or distribution under the program, because the effectiveness and safety of the cancer drug cannot be ensured or is otherwise prohibited:

(a) a cancer drug that is adulterated or misbranded;

(b) a cancer drug in packaging that has been opened, unsealed, or tampered with, or that is no longer in its original container;

(c) a cancer drug packaged in single unit doses if the outside packaging is opened and the single unit dose packaging is also opened;

(d) a cancer drug that requires refrigeration, freezing, or other special temperature requirements beyond controlled room temperature;

(e) controlled substances; and

(f) a cancer drug that has expired before dispensing to the patient.

History: 37-7-1401, MCA; IMP, 37-7-1401, 37-7-1404, 37-7-1405, MCA; NEW, 2010 MAR p. 2968, Eff. 12/24/10.