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This website publishes administrative rules on their effective dates, as designated by the adopting state agencies, colleges, and universities.

Chapter 4729:8-3 | Requirements for Drug Databases

 
 
 
Rule
Rule 4729:8-3-01 | Entities required to submit information.
 

The following entities are required to submit the specified dispensing, personal furnishing, or wholesale sale information in accordance with this chapter of the Administrative Code to the state board of pharmacy for the operation of the drug database:

(A) All pharmacies located within this state and licensed as a terminal distributor of dangerous drugs shall report all drugs listed in Chapter 4729:8-2 of the Administrative Code that are dispensed to outpatients.

(B) All pharmacies located outside this state and licensed as a terminal distributor of dangerous drugs shall report all drugs listed in Chapter 4729:8-2 of the Administrative Code that are dispensed to outpatients residing in this state.

(C) Except as provided in rule 4729:8-2-02 of the Administrative Code, all licensed drug distributors and terminal distributors of dangerous drugs located within this state that sell at wholesale drugs listed in Chapter 4729:8-2 of the Administrative Code to prescribers or terminal distributors of dangerous drugs shall report those drug transactions in accordance with the wholesale reporting requirements of this chapter.

(D) Except as provided in rule 4729:8-2-02 of the Administrative Code, all licensed drug distributors and terminal distributors of dangerous drugs located outside this state that sell at wholesale drugs listed in Chapter 4729:8-2 of the Administrative Code to prescribers or terminal distributors of dangerous drugs located within this state shall report those drug transactions in accordance with the wholesale reporting requirements of this chapter.

(E) Except as provided in rule 4729:8-2-02 of the Administrative Code, all prescribers, except veterinarians, located within this state shall report all drugs listed in Chapter 4729:8-2 of the Administrative Code that are personally furnished to patients.

Supplemental Information

Authorized By: 4729.84, 4729.26, 3719.28
Amplifies: 4729.75, 4729.84, 4729.83, 4729.82, 4729.81, 4729.80, 4729.79, 4729.78, 4729.77, 4729.76
Five Year Review Date: 3/15/2024
Prior Effective Dates: 10/27/2011, 12/1/2016
Rule 4729:8-3-02 | Information required for submission.
 

(A) Pharmacies pursuant to paragraphs (A) and (B) of rule 4729:8-3-01 of the Administrative Code that dispense drugs listed in Chapter 4729:8-2 of the Administrative Code to outpatients shall report the following dispensing information to the board of pharmacy in accordance with rule 4729:8-3-03 of the Administrative Code:

(1) Pharmacy drug enforcement administration registration number. If not applicable, another mutually acceptable identifier;

(2) Pharmacy name;

(3) Pharmacy address;

(4) Pharmacy telephone number;

(5) Patient full name;

(6) Patient residential address;

(7) Patient telephone number;

(8) Patient date of birth;

(9) Patient gender;

(10) Prescriber's full name (first name and last name);

(11) Prescriber's drug enforcement administration registration number. If not applicable, another mutually acceptable identifier;

(12) Date prescription was issued by the prescriber;

(13) Date the prescription was dispensed or sold by the pharmacy;

(14) Indication of whether the prescription dispensed is new or a refill;

(15) Number of the refill being dispensed;

(16) National drug code of the drug dispensed;

(17) Quantity of the drug prescribed;

(18) Quantity of drug dispensed;

(19) Number of days' supply of the drug dispensed as indicated by the prescriber pursuant to agency 4729 of the Administrative Code, except as follows:

(a) If a days' supply is not indicated by the prescriber, the pharmacy shall calculate and report the number of days' supply of the drug dispensed;

(b) If the quantity of drug dispensed is different from the quantity indicated on the prescription, the pharmacy shall calculate and report the number of days' supply of the drug dispensed.

(20) Serial or prescription number assigned to the prescription order;

(21) Source of payment for the prescription that indicates one of the following: private pay (cash), medicaid, medicare, commercial insurance, or workers' compensation;

(22) Pharmacy national provider identification (NPI) number;

(23) Prescriber's national provider identification (NPI) number, if prescriber does not have an NPI, then another mutually acceptable identifier;

(24) Any of the following as indicated by the prescriber pursuant to agency 4729 of the Administrative Code:

(a) The ICD-10-CM medical diagnosis code of the primary disease or condition that the controlled substance drug is being used to treat. The code shall, at a minimum, include the first four alpha-numeric characters of the ICD-10-CM medical diagnosis code, sometimes referred to as the category and the etiology (ex. M 16.5);

(b) For dentists licensed pursuant to Chapter 4715. of the Revised Code, the "Code on Dental Procedures and Nomenclature" (CDT code), as published by the American dental association, of the dental treatment requiring the controlled substance prescription;

(c) If no such code is indicated on the prescription, the pharmacy shall indicate "NC" in the diagnosis data field.

(B) Prescribers pursuant to paragraph (E) of rule 4729:8-3-01 of the Administrative Code that personally furnish drugs listed in Chapter 4729:8-2 of the Administrative Code shall report the following information to the board of pharmacy in accordance with rule 4729:8-3-03 of the Administrative Code:

(1) Prescriber drug enforcement administration registration number. If not applicable, another mutually acceptable identifier;

(2) Prescriber full name (first and last name);

(3) Prescriber address;

(4) Prescriber telephone number;

(5) Patient full name;

(6) Patient residential address;

(7) Patient telephone number;

(8) Patient date of birth;

(9) Patient gender;

(10) Date the drug was personally furnished by the prescriber;

(11) National drug code of the drug personally furnished;

(12) Quantity of drug personally furnished;

(13) Number of intended days' supply of drug personally furnished;

(14) Source of payment for the prescription that indicates one of the following: private pay (cash), medicaid, medicare, commercial insurance, or workers' compensation;

(15) Either of the following:

(a) The ICD-10-CM medical diagnosis code of the primary disease or condition that the controlled substance drug is being used to treat. The code shall, at a minimum, include the first four alpha numeric characters of the ICD-10-CM medical diagnosis code, sometimes referred to as the category and the etiology (ex. M 16.5);

(b) For dentists licensed pursuant to Chapter 4715. of the Revised Code, the "Code on Dental Procedures and Nomenclature" (CDT code), as published by the American dental association, of the dental treatment requiring the controlled substance prescription.

(C) Drug distributors and terminal distributors pursuant to paragraphs (C) and (D) of rule 4729:8-3-01 of the Administrative Code that sell at wholesale drugs listed in Chapter 4729:8-2 of the Administrative Code shall report the following information to the board of pharmacy in accordance with rule 4729:8-3-03 of the Administrative Code:

(1) Drug distributor or terminal distributor drug enforcement administration registration number. If not applicable, then another mutually acceptable identifier;

(2) Purchaser's drug enforcement administration registration number. If not applicable, then another mutually acceptable identifier;

(3) National drug code number of the drug sold;

(4) Quantity of the drug sold;

(5) Date of sale; and

(6) Transaction identifier or invoice number.

(D) Drug distributors shall report suspicious orders and customer information pursuant to rule 4729:6-3-05 of the Administrative Code to the drug database established in section 4729.75 of the Revised Code.

Supplemental Information

Authorized By: 3719.28, 4729.26, 4729.84
Amplifies: 4729.75, 4729.76, 4729.77, 4729.78, 4729.79, 4729.80, 4729.81, 4729.82, 4729.83, 4729.84
Five Year Review Date: 3/15/2024
Prior Effective Dates: 1/1/2006, 1/1/2011, 10/27/2011, 5/22/2014
Rule 4729:8-3-03 | Electronic format required for the transmission of drug sales.
 

(A) All prescription dispensing information or prescriber personally furnishing information required to be submitted to the board of pharmacy pursuant to rule 4729-8-3-02 of the Administrative Code must be transmitted in the following format specified by the "American Society for Automation in Pharmacy" (ASAP) for prescription monitoring programs:

ASAP Version 4.2A Standard for Prescription Drug Monitoring Programs (3/15/2017).

(B) In the event that a pharmacy or a prescriber cannot electronically transmit the required information pursuant to paragraph (A) of this rule, the pharmacy or prescriber may request a variance from the boards executive director or the directors designee to submit drug sales information in a mutually acceptable format.

(C) All wholesale data required to be submitted to the board of pharmacy pursuant to rule 4729-8-3-02 of the Administrative Code shall be transmitted in the report format used when transmitting controlled substance data to the federal drug enforcement administration via the "Automation of Reports and Consolidated Orders System (ARCOS)" or other mutually acceptable format.

(D) In the event that a drug distributor or terminal distributor cannot electronically transmit the required information pursuant to paragraph (C) of this rule, the drug distributor or terminal distributor may request a variance from the board's executive director or the director's designee to submit drug sales information in a mutually acceptable format.

Supplemental Information

Authorized By: 3719.28, 4729.26, 4729.84
Amplifies: 4729.75, 4729.76, 4729.77, 4729.78, 4729.79, 4729.80, 4729.81, 4729.82, 4729.83, 4729.84
Five Year Review Date: 3/15/2024
Prior Effective Dates: 1/1/2006, 1/15/2016
Rule 4729:8-3-04 | Frequency requirements for submitting drug database information.
 

(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 boards executive director or the directors designee to submit the required information in a mutually acceptable time frame.

Supplemental Information

Authorized By: 4729.26, 3719.28, 4729.84
Amplifies: 4729.84, 4729.83, 4729.82, 4729.81, 4729.80, 4729.79, 4729.78, 4729.77, 4729.76, 4729.75
Five Year Review Date: 3/15/2024
Prior Effective Dates: 1/1/2011, 5/22/2014
Rule 4729:8-3-05 | Corrections to the drug database.
 

(A) All information required to be submitted in accordance with this division shall be submitted to the drug database in an accurate and timely manner.

(B) If the omission of drug sale information is discovered, the omitted information shall be submitted to the board of pharmacy by the terminal distributor, prescriber, or drug distributor during the next reporting time period after the discovery.

(C) If erroneous drug sale information is discovered, the terminal distributor, drug distributor or prescriber shall notify the board of pharmacy within twenty-four hours of the discovery. The corrected information must be submitted to the board of pharmacy by the terminal distributor, prescriber or drug distributor within seven days of the discovery.

(D) If the omission of data or erroneous data is the result of a computer programming error, the terminal distributor, prescriber, or drug distributor must notify the board of pharmacy immediately by telephone and submit written or electronic documentation. The documentation shall fully describe the error and propose a mutually agreed upon date for submitting the corrected information.

(E) Except as noted in paragraph (D) of this rule, all data must be submitted or corrected electronically unless prior permission for an alternate method is granted by the boards executive director or the directors designee.

Supplemental Information

Authorized By: 4729.84, 4729.26, 3719.28
Amplifies: 4729.75, 4729.84, 4729.83, 4729.82, 4729.81, 4729.80, 4729.79, 4729.78, 4729.77, 4729.76
Five Year Review Date: 3/15/2024
Prior Effective Dates: 1/1/2009, 10/27/2011