1. A participant shall retain separate records detailing the receipt, distribution, and dispensing of legend drugs, devices, and supplies under this program.
2. The records of receipt must include:
a. The name and address of the donor;
b. The drug name and strength;
c. The manufacturer of the legend drugs, devices, or supplies;
d. The manufacturer lot number;
e. The drug expiration date;
f. The date received; and g. The quantity received.
3. Records of distribution and dispensing must include:
a. The name and address of the participant;
b. The drug or device name;
c. The drug strength;
d. The quantity distributed;
e. The identity of the manufacturer of the legend drugs, devices, or supplies;
f. The manufacturer lot number;
g. The expiration date;
h. The date of distribution or dispensing; and i. The name and address of the individual to whom the donated item was distributed.
4. Records of dispensing must include:
a. The requirements for a prescription label; and b. The manufacturer's lot number.