Chapter 4729-37 Drug Database

4729-37-01 Definitions.

As used in Chapter 4729-37 of the Administrative Code:

(A) "Controlled substance" has the same meaning as in section 3719.01 of the Revised Code.

(B) "Outpatient" has the same meaning as in rule 4729-17-01 of the Administrative Code.

(C) "Prescriber" or "licensed health professional authorized to prescribe drugs" have the same meaning as in section 4729.01 of the Revised Code.

(D) "Terminal distributor of dangerous drugs" has the same meaning as in section 4729.01 of the Revised Code.

(E) "Wholesale distributor of dangerous drugs" has the same meaning as in section 4729.01 of the Revised Code.

R.C. 119.032 review dates: 10/01/2010 and 10/01/2015
Promulgated Under: 119.03
Statutory Authority: 3719.28 , 4729.26 , 4729.83
Rule Amplifies: 4729.75 , 4729.76 , 4729.77 , 4729.78 , 4729.79 , 4729.80 , 4729.81 , 4729.82 , 4729.83 , 4729.84
Prior Effective Dates: 1/1/06

4729-37-02 List of drugs to be reported.

Pursuant to section 4729.75 of the Revised Code required information for the following list of drugs must be submitted to the board of pharmacy pursuant to sections 4729.77 and 4729.78 of the Revised Code:

(A) All schedule II controlled substances;

(B) All schedule III controlled substances;

(C) All schedule IV controlled substances;

(D) All schedule V controlled substances dispensed pursuant to a prescription;

(E) All schedule V controlled substances sold to a prescriber at wholesale;

(F) All dangerous drug products containing carisoprodol;

(G) All dangerous drug products containing tramadol.

R.C. 119.032 review dates: 10/01/2010 and 10/01/2015
Promulgated Under: 119.03
Statutory Authority: 3719.28 , 4729.26 , 4729.83
Rule Amplifies: 4729.75 , 4729.76 , 4729.77 , 4729.78 , 4729.79 , 4729.80 , 4729.81 , 4729.82 , 4729.83 , 4729.84
Prior Effective Dates: 1/1/06

4729-37-03 Entities required to submit information.

The following entities are required to submit the specified dispensing and wholesale sale information to the board of pharmacy for the drug database:

(A) All pharmacies located outside this state and licensed as a terminal distributor of dangerous drugs shall report all drugs identified in rule 4729-37-02 of the Administrative Code that are dispensed to outpatients residing in this state.

(B) All pharmacies located within this state and licensed as a terminal distributor of dangerous drugs shall report all drugs identified in rule 4729-37-02 of the Administrative Code that are dispensed to all outpatients.

(C) All wholesalers licensed as a wholesale distributor of dangerous drugs that sell drugs identified in rule 4729-37-02 of the Administrative Code at wholesaleshall report those drug transactions.

(D) All pharmacies licensed as a terminal distributor of dangerous drugs that sell drugs identified in rule 4729-37-02 of the Administrative Code at wholesale shall report those drug transactions.

(E) All prescribers, except veterinarians, located within this state shall report all drugs identified in rule 4729-37-02 of the Administrative Code that are personally furnished to outpatients.

Effective: 10/27/2011
R.C. 119.032 review dates: 10/01/2015
Promulgated Under: 119.03
Statutory Authority: 3719.28 , 4729.26 , 4729.83
Rule Amplifies: 4729.75 , 4729.76 , 4729.77 , 4729.78 , 4729.79 , 4729.80 , 4729.81 , 4729.82 , 4729.83 , 4729.84
Prior Effective Dates: 1/1/06, 4/27/07, 10/19/07

4729-37-04 Information required for submission.

(A) Pharmacies pursuant to paragraphs (A) and (B) of rule 4729-37-03 of the Administrative Code that dispense drugs identified in rule 4729-37-02 of the Administrative Code to outpatients residing in this state must report the following dispensing information to the board of pharmacy:

(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 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 actual drug dispensed;

(17) Quantity of drug dispensed;

(18) Number of days' supply of drug dispensed;

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

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

(B) Prescribers pursuant to paragraph (E) of rule 4729-37-03 of the Administrative Code that personally furnish drugs identified in rule 4729-37-02 of the Administrative Code to outpatients must report the following dispensing information to the board of pharmacy:

(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 actual drug dispensed;

(12) Quantity of drug dispensed;

(13) Number of days' supply of drug dispensed; and

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

(C) Wholesalers and pharmacies pursuant to paragraphs (C) and (D) of rule 4729-37-03 of the Administrative Code that sell drugs identified in rule 4729-37-02 of the Administrative Code at wholesale mustat least report the following information to the board of pharmacy in the format described in rule 4729-37-06 of the Administrative Code:

(1) Wholesaler or pharmacy 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 actual drug sold;

(4) Quantity of the drug sold;

(5) Date of sale ; and

(6) Transaction identifier or invoice number.

Effective: 10/27/2011
R.C. 119.032 review dates: 12/01/2015
Promulgated Under: 119.03
Statutory Authority: 3719.28 , 4729.26 , 4729.83
Rule Amplifies: 4729.75 , 4729.76 , 4729.77 , 4729.78 , 4729.79 , 4729.80 , 4729.81 , 4729.82 , 4729.83 , 4729.84
Prior Effective Dates: 1/1/06, 4/27/07, 10/19/07, 1/1/11

4729-37-05 Electronic format required for the transmission of dispensing information.

(A) All pharmacy dispensing information or prescriber personally furnishing information required to be submitted to the board of pharmacy pursuant to rule 4729-37-04 of the Administrative Code must be transmitted in the format specified by the"American Society for Automation in Pharmacy" (ASAP) for prescription monitoring programs.

(B) In the event that a pharmacy or a prescriber cannot electronically transmit the required information pursuant to rule 4729-37-04 of the Administrative Code they must immediately contact the board of pharmacy to determine a mutually acceptable method of reporting. The pharmacyor prescriber must document in writing to the board of pharmacy the reasons for their inability to submit the required information.

Effective: 10/27/2011
R.C. 119.032 review dates: 10/01/2015
Promulgated Under: 119.03
Statutory Authority: 3719.28 , 4729.26 , 4729.83
Rule Amplifies: 4729.75 , 4729.76 , 4729.77 , 4729.78 , 4729.79 , 4729.80 , 4729.81 , 4729.82 , 4729.83 , 4729.84
Prior Effective Dates: 1/1/06

4729-37-06 Electronic format required for the transmission of wholesale drug sales.

(A) All wholesale data required to be submitted to the board of pharmacy pursuant to paragraph (B) of rule 4729-37-04 of the Administrative Code must 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.

(B) In the event that a wholesaler or pharmacy cannot electronically transmit the required information pursuant to paragraph (B) of rule 4729-37-04 of the Administrative Code they must immediately contact the board of pharmacy to determine a mutually acceptable method of reporting. The wholesaler or pharmacy must document in writing to the board of pharmacy the reasons for their inability to submit the required information.

Effective: 10/27/2011
R.C. 119.032 review dates: 10/01/2015
Promulgated Under: 119.03
Statutory Authority: 3719.28 , 4729.26 , 4729.83
Rule Amplifies: 4729.75 , 4729.76 , 4729.77 , 4729.78 , 4729.79 , 4729.80 , 4729.81 , 4729.82 , 4729.83 , 4729.84
Prior Effective Dates: 1/1/06, 10/19/07

4729-37-07 Frequency requirements for submitting drug database information.

(A) A pharmacy or prescriber that has possessed for the purpose of dispensing or personally furnishing a reported drug (including a sample drug) within the previous two years shall submit to the board of pharmacy, at least weekly, either of the following:

(1) All drug dispensing and personally furnishing information required to be submitted to the board of pharmacy pursuant to rules 4729-37-02 and 4729-37-04 of the Administrative Code.

(2) A "Zero Report", if a pharmacy has no drug dispensing information or a prescriber has no personally furnishing information required to be submitted to the board of pharmacy pursuant to rules 4729-37-02 and 4729-37-04 of the Administrative Code.

(B) The dispensing report, the personally furnishing information, or the "Zero Report" shall be consecutive and inclusive from the last date and time that information was submitted and shall be reported no later than eight days after the last date reported on a previous report.

(C) If a pharmacy or prescriber ceases to possess for the purpose of dispensing or personally furnishing any reported drug (including a sample drug), the responsible person may notify the board of pharmacy in writing. If the board is notified of the change, the pharmacy or prescriber is not required to submit a "Zero Report" until the pharmacy or prescriber possesses for the purpose of dispensing or personally furnishing a reported drug (including a sample drug).

(D) All wholesale drug sale information required to be submitted to the board of pharmacy pursuant to rules 4729-37-02 and 4729-37-04 of the Administrative Code must be submitted monthly as follows:

(1) During the first through the fifteenth day of each month; and

(2) The information shall be consecutive and inclusive from the last date and time information was submitted and shall be reported no later than forty-five days after the date of the wholesale sale.

(E) In the event that a wholesaler, prescriber, or pharmacy cannot submit the required information as described in this rule , the responsible person must immediately contact the board of pharmacy to determine a mutually acceptable time for submission of information. The reasons for the inability of the wholesaler, prescriber, or pharmacy to submit the required information must be documented in writing to the board of pharmacy .

Effective: 10/27/2011
R.C. 119.032 review dates: 12/01/2015
Promulgated Under: 119.03
Statutory Authority: 3719.28 , 4729.26 , 4729.83
Rule Amplifies: 4729.75 , 4729.76 , 4729.77 , 4729.78 , 4729.79 , 4729.80 , 4729.81 , 4729.82 , 4729.83 , 4729.84
Prior Effective Dates: 1/1/06, 10/19/07, 1/1/09, 6/21/09, 1/1/11

4729-37-08 Procedures for obtaining drug database information.

Persons that are permitted pursuant to divisions (A)(1) to (A)(5) of section 4729.79 of the Revised Code to obtain information from the drug database must comply with the following procedures:

(A) A designated representative of a government entity, a prescriber, or a pharmacist must:

(1) Complete a request form giving such information as required by the board of pharmacy;

(2) Submit the completed form to the board of pharmacy in person, by mail, or by other board approved means.

(B) A federal, state, or local officer must:

(1) Complete a request form giving such information as required by the board of pharmacy that will include an active case number assigned by the investigating agency or department and an approval by a supervisor of that agency or department;

(2) Submit the completed form to the board of pharmacy in person, by mail, or by other board approved means.

(C) An individual seeking the individual's own database information must:

(1) Complete a notarized request form giving such information as required by the board of pharmacy;

(2) Submit the completed form in person or by mail;

(3) Receive the information in person at the board of pharmacy office during normal business hours and show proof of identity with a current government issued form of identification that contains a picture such as a current state issued identification card, a current state issued drivers license, or a valid passport;

(4) Pay the cost of printing the document as determined by the board of pharmacy's current per page rate.

R.C. 119.032 review dates: 10/01/2010 and 10/01/2015
Promulgated Under: 119.03
Statutory Authority: 3719.28 , 4729.26 , 4729.83
Rule Amplifies: 4729.75 , 4729.76 , 4729.77 , 4729.78 , 4729.79 , 4729.80 , 4729.81 , 4729.82 , 4729.83 , 4729.84
Prior Effective Dates: 1/1/06, 4/27/07

4729-37-09 Requesting an extension to the information storage requirements.

A government entity or a law enforcement agency pursuant to section 4729.81 of the Revised Code may request that specific information in the database related to an open investigation be retained beyond the two year information retention requirement. The government entity or law enforcement agency must submit a written request on a form giving such information as required by the board of pharmacy.

R.C. 119.032 review dates: 10/01/2010 and 10/01/2015
Promulgated Under: 119.03
Statutory Authority: 3719.28 , 4729.26 , 4729.83
Rule Amplifies: 4729.75 , 4729.76 , 4729.77 , 4729.78 , 4729.79 , 4729.80 , 4729.81 , 4729.82 , 4729.83 , 4729.84
Prior Effective Dates: 1/1/06

4729-37-10 Providing database statistics and law enforcement outcomes.

The board of pharmacy may provide or present database statistics and law enforcement outcomes based on request information pursuant to section 4729.79 of the Revised Code. The information shall not identify a person and will be provided as determined by the board of pharmacy in summary, statistical, or aggregate form.

R.C. 119.032 review dates: 10/01/2010 and 10/01/2015
Promulgated Under: 119.03
Statutory Authority: 3719.28 , 4729.26 , 4729.83
Rule Amplifies: 4729.75 , 4729.76 , 4729.77 , 4729.78 , 4729.79 , 4729.80 , 4729.81 , 4729.82 , 4729.83 , 4729.84
Prior Effective Dates: 1/1/06

4729-37-11 Corrections to the drug database.

(A) Drug dispensing and wholesale drug sale information must be submitted to the drug database in an accurate and timely manner pursuant to rule 4729-37-07 of the Administrative Code.

(B) If the ommission of drug dispensing or wholesale drug sale information is discovered, the omitted information must be submitted to the board of pharmacy by the pharmacy, prescriber, or wholesaler during the next reporting time period after the discovery.

(C) If erroneous drug dispensing or wholesale drug sale information is discovered, the corrected information must be submitted to the board of pharmacy by the pharmacy, prescriber or wholesaler during the next reporting time period after the discovery. If the erroneous information was discovered by the licensee, the licensee must notify the board immediately by telephone of the error and submit written documentation that identifies the erroneous information.

(D) If the omission of data or erroneous data is the result of a computer programming error, the pharmacy, prescriber, or wholesaler must notify the board of pharmacy immediately by telephone and submit written documentation. The documentation shall fully describe the error and propose a date for submitting the corrected drug information. The board will review the written documentation to assure compliance with paragraph (A) of this rule.

Effective: 10/27/2011
R.C. 119.032 review dates: 12/01/2013
Promulgated Under: 119.03
Statutory Authority: 3719.28 , 4729.26 , 4729.83
Rule Amplifies: 4729.75 , 4729.76 , 4729.77 , 4729.78 , 4729.79 , 4729.80 , 4729.81 , 4729.82 , 4729.83 , 4729.84
Prior Effective Dates: 1/1/09