1. A participant shall retain separate records detailing the receipt, distribution, and dispensing of legend drugs, devices, and supplies under this program.

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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.