Lawriter - OAC - 4729:8-3-04 Frequency requirements for submitting drug database.

4729:8-3-04 Frequency requirements for submitting drug database.

(A) A terminal distributor or prescriber that has been in possession of a drug listed in Chapter 4729:8-2 of the Administrative Code for dispensing or personally furnishing within the previous three years shall submit to the board of pharmacy, at least daily, either of the following:

(1) All information required to be submitted to the board of pharmacy pursuant to this division of the Administrative Code.

(2) A zero report, if a terminal distributor has no drug dispensing information or a prescriber has no personally furnishing information required to be submitted to the board of pharmacy pursuant to this division of the Administrative Code.

(B) The information required to be reported pursuant to paragraph (A) of this rule shall be consecutive and inclusive from the last date and time the information was submitted to the board of pharmacy and shall be reported no later than thirty-six hours after the last time reported.

(C) Any record of a dispensed or personally furnished drug listed in Chapter 4729:8-2 of the Administrative Code shall be reported to the board of pharmacy within twenty-four hours of being dispensed or personally furnished.

(D) Any terminal distributor or prescriber whose normal business hours are not seven days per week shall electronically indicate their normal business hours to the board and no zero report will be required for the terminal distributor or prescriber's non-business days.

(E) If a terminal distributor or prescriber ceases to dispense or personally furnish a drug listed in Chapter 4729:8-2 of the Administrative Code, the responsible person on the terminal distributor of dangerous drugs license or the prescriber shall notify the board of pharmacy in writing and request an exemption to reporting.

If at any time a terminal distributor or prescriber begins dispensing or personally furnishing drugs listed in Chapter 4729:8-2 of the Administrative Code, the exemption to reporting shall no longer be valid and the terminal distributor or prescriber shall start reporting in accordance with this rule.

(F) A drug distributor that has been in possession of a drug listed in Chapter 4729:8-2 of the Administrative Code for sale at wholesale within the previous three years shall submit to the board of pharmacy, at least monthly, either of the following:

(1) All information required to be submitted to the board pursuant to this division of the Administrative Code.

(2) A zero report, if a drug distributor has no drug sale information required to be submitted to the board of pharmacy pursuant to this division of the Administrative Code.

(G) All wholesale sale information required to be submitted to the board of pharmacy pursuant to this division of the Administrative Code shall be submitted at least monthly. The information shall be consecutive and inclusive from the last date and time the information was submitted and shall be reported no later than forty-five days after the date of the wholesale sale.

(H) If a drug distributor, prescriber, or terminal distributor cannot submit the required information at the required intervals specified in this rule, the drug distributor, terminal distributor or prescriber may request an extension from the board's executive director or the director's designee to submit the required information in a mutually acceptable time frame.

Replaces: 4729-37-07


Effective: 3/15/2019
Five Year Review (FYR) Dates: 03/15/2024
Promulgated Under: 119.03
Statutory Authority: 4729.26, 3719.28, 4729.84
Rule Amplifies: 4729.84 , 4729.83, 4729.82, 4729.81, 4729.80, 4729.79, 4729.78, 4729.77, 4729.76, 4729.75
Prior Effective Dates: 01/01/2006, 10/19/2007, 01/01/2009, 06/21/2009, 01/01/2011, 10/27/2011, 05/22/2014, 01/15/2016