Ohio Admin. Code 4729:8-5-01

Current through all regulations passed and filed through October 28, 2024

Section 4729:8-5-01 - Dispensary reporting into the prescription monitoring program

(A) Pursuant to section 4729.771 of the Revised Code, a dispensary licensed in accordance with Chapter 3796. of the Revised Code shall transmit electronically to the state board of pharmacy, in a format suitable to the board, the information set forth in this rule within five minutes of the dispensing of any and all medical marijuana:

(1) State license number, which shall be populated by a number provided by the department of commerce;

(2) Dispensary name;

(3) Dispensary address;

(4) Dispensary telephone number;

(5) Patient full name;

(6) Patient registry identification number;

(7) Patient residential address;

(8) Patient telephone number;

(9) Patient date of birth;

(10) Patient gender;

(11) Recommending physician's full name (first name and last name);

(12) Drug enforcement administration physician identification number;

(13) Date recommendation was issued by the recommending physician;

(14) Indication whether the recommendation is new or a refill;

(15) Number of the refill being dispensed;

(16) Date order filled, which shall be the date medical marijuana is dispensed;

(17) Order number, which shall be the serial number assigned to each medical marijuana product dispensed to a patient;

(18) Quantity;

(19) Days supply;

(20) Product identifier, which shall be assigned by the department of commerce;

(21) Date order written, which shall be the date the written recommendation was issued;

(22) Payment code for either cash or third-party provider; and

(23) Drug name, which shall be the brand name of the medical marijuana.

(B) If a dispensary has no drug dispensing information required to be submitted to the board of pharmacy over any twenty-four-hour period, it must submit a "zero report."

(C) The dispensing report 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 thirty-six hours after the last time reported on a previous report.

(D) Any dispensary whose normal business hours are not seven days per week shall electronically indicate its normal business hours to the board and a "zero report" will be automatically submitted on the dispensary's behalf on non-business days.

(E) If a dispensary ceases to possess medical marijuana for dispensing, the designated representative shall notify the board of pharmacy electronically or in writing. The board shall be notified if the dispensary resumes dispensing.

(F) All dispensing information required to be submitted to the board of pharmacy pursuant to paragraph (A) of this rule, must be transmitted in the format specified by the American society for automation in pharmacy ("ASAP"), for prescription monitoring systems.

(G) If a dispensary cannot electronically transmit the required information pursuant to paragraph (A) of this rule, they must immediately contact the board of pharmacy to determine a mutually acceptable method of reporting. The dispensary must document in writing to the board of pharmacy the reasons for their inability to submit the required information.

(H) A dispensary shall transmit the information required pursuant to this section in such a manner as to ensure the confidentiality of the information in compliance with all federal and state laws, including the federal Health Insurance Portability and Accountability Act of 1996, Public Law 104-191.

(I) All medical marijuana dispensing information submitted to the drug database pursuant to this rule must be reported in an accurate and timely manner.

(J) If the omission of dispensing information is discovered, the corrected information must be submitted to the board of pharmacy during the next reporting period after the discovery.

(K) If the omission of data or erroneous data is the result of a computer programming error, the dispensary 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 dispensing information. The board will review the written documentation to ensure compliance with paragraph (A) of this rule.

(L) Except as noted in paragraph (E) of this rule, all data must be submitted or corrected electronically unless prior permission for an alternate method is approved by the board of pharmacy.

Ohio Admin. Code 4729:8-5-01

Effective: 6/7/2024
Five Year Review (FYR) Dates: 06/07/2029
Promulgated Under: 119.03
Statutory Authority: 4729.84
Rule Amplifies: 3796.20, 4729.771, 4729.80, 4729.84