4729-35-08 Record keeping.

(A) Donor forms must be maintained for a minimum of three years by a terminal distributor of dangerous drugs, a wholesale distributor of dangerous drugs, or an institutional facility.

(B) Recipient forms must be maintained for a minimum of three years by a pharmacy, hospital, or nonprofit clinic.

(C) An invoice must be created by the donor location, which includes a terminal distributor of dangerous drugs, a wholesale distributor of dangerous drugs, or an institutional facility where the donor resides. The invoice must include at least the following information:

(1) The name and address of the donor location.

(2) The brand name of the drug donated, or the generic name and list either the name of the manufacturer or the national drug code number (NDC#).

(3) The strength of the drug.

(4) The quantity of the drug.

(5) The date the drug was sent to a pharmacy, hospital, or nonprofit clinic.

(6) The name and address of the recipient pharmacy, hospital, or nonprofit clinic.

(D) A prescriber must document the distribution of a donated repository program drug to his/her patient pursuant to rule 4729-9-22 of the Administrative Code and a pharmacy must document the dispensing of a donated repository program drug pursuant to rule 4729-5-27 of the Administrative Code. Both records must indicate that the drug distributed to a patient was from the repository program. If recipient forms are used with each dispensing, this information may be documented on the recipient form.

(E) A copy of the invoice must be maintained for a minimum of three years by both the donor location, which includes a terminal distributor of dangerous drugs, a wholesale distributor of dangerous drugs, or an institutional facility, and the recipient location, which includes a pharmacy, hospital, or nonprofit clinic.

Effective: 01/01/2009
R.C. 119.032 review dates: 09/26/2008 and 12/01/2013
Promulgated Under: 119.03
Statutory Authority: 3715.873
Rule Amplifies: 3715.87 , 3715.871 , 3715.872 , 3715.873
Prior Effective Dates: 1/1/2004, 2/1/2005