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.

(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.

History: En. Sec. 3, Ch. 299, L. 2009.