1. (1) The following categories of cancer drugs are acceptable for dispensing or distribution under the program, if in compliance with 37-7-1404, MCA, the cancer drug:

   1. (a) is in its original, unopened, sealed, and tamper-evident packaging;
   2. (b) is packaged in single unit doses if the outside packaging is opened, but the single unit dose packaging is unopened; and
   3. (c) does not have temperature or storage requirements other than controlled room temperature.
2. (2) Any cancer drug donated to the program cannot be used past its expiration date.

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

   1. (a) are adulterated or misbranded;
   2. (b) do not comply with the requirements in (1);
   3. (c) are controlled substances; and
   4. (d) have expired before dispensing to the patient.

Authorizing statute(s): 37-7-1401, MCA

Implementing statute(s): 37-7-1401, 37-7-1404, 37-7-1405, MCA

History: NEW, 2010 MAR p. 2968, Eff. 12/24/10; AMD, 2012 MAR p. 896, Eff. 4/27/12; AMD, 2024 MAR p. 2219, Eff. 9/21/24.