Ohio Admin. Code 4729-35-08 - [Rescinded] Record keeping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.
Notes
Promulgated Under: 119.03
Statutory Authority: 3715.873
Rule Amplifies: 3715.87, 3715.871, 3715.872, 3715.873
Prior Effective Dates: 01/01/2004, 02/01/2005, 01/01/2009
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