Ohio Adm.Code 4729:8 | Ohio Administrative Code 4729:8 — State Board of Pharmacy | Drug Database

Chapter 4729:8-1 Definitions

Ohio Adm.Code 4729:8-1-01 Ohio automated Rx reporting system - definitions.

As used in division 4729:8 of the Administrative Code:

(A) "Controlled substance" has the same meaning as in section 3719.01 of the Revised Code and Chapter 4729:9-1 of the Administrative Code.

(B) "Central fill pharmacy" has the same meaning as in rule 4729:5-5-19 of the Administrative Code.

(C) "Distributor of dangerous drugs" or "drug distributor" means the following persons licensed in accordance with section 4729.52 of the Revised Code and division 4729:6 of the Administrative Code:

(1) Wholesale distributors of dangerous drugs, including virtual wholesalers.

(2) Manufacturers of dangerous drugs.

(3) Outsourcing facilities.

(D) "Designated representative" means the dispensary key employee responsible for acting in compliance with agency 3796 of the Administrative Code.

(E) "Dispense" means the final association of a drug with a particular patient pursuant to a prescription, drug order, or other lawful order of a prescriber and the professional judgment of and the responsibility for interpreting, preparing, compounding, labeling, and packaging a specific drug.

(F) "Dispensary" means a holder of a valid retail dispensary license in accordance with Chapter 3796. of the Revised Code.

(G) "Originating pharmacy" has the same meaning as in rule 4729:5-5-19 of the Administrative Code.

(H) "Opioid treatment program" has the same meaning as in Chapter 4729:5-21 of the Administrative Code.

(I) "Outpatient" means any person who receives drugs for use outside of an institutional facility as defined in agency 4729 of the Administrative Code.

(J) "Peer review committee" has the same meaning as in section 2305.25 of the Revised Code, except that it includes only a peer review committee of a hospital or a peer review committee of a nonprofit health care corporation that is a member of the hospital or of which the hospital is a member.

(K) "Personally furnish" means the distribution of drugs by a prescriber to the prescriber's patients for use outside the prescriber's practice setting.

(L) "Pharmacy" has the same meaning as in section 4729.01 of the Revised Code.

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

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

(O) "Sale" and "sell" has the same meaning as in section 4729.01 of the Revised Code.

(P) "Wholesale sale" and "sale at wholesale" have the same meaning as in section 4729.01 of the Revised Code. Wholesale sale also includes the following:

(1) An occasional sale conducted in accordance with section 4729.51 of the Revised Code;

(2) The sale of a sample or complimentary supply, as defined in rule 4729:6-3-08 of the Administrative Code, to a prescriber or terminal distributor;

(3) The transfer or sale of a non-patient specific dangerous drug to a prescriber or terminal distributor.

(Q) "Zero report" means either:

(1) A report documenting that none of the drugs listed in Chapter 4729:8-2 of the Administrative Code were sold, dispensed, or personally furnished during the required reporting period; or

(2) For a dispensary, a report documenting that no medical marijuana was sold or dispensed.

Last updated August 4, 2025 at 7:45 AM

History

Effective: August 1, 2025
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-5-19

(A) As used in this chapter:

(1) "Central fill pharmacy" means a pharmacy licensed as a terminal distributor of dangerous drugs acting as an agent of an originating pharmacy to fill or refill a prescription. A central fill pharmacy may also be the originating pharmacy pursuant to paragraph (D) of this rule.

(2) "Originating pharmacy" means an outpatient pharmacy licensed as a terminal distributor of dangerous drugs that uses a central fill pharmacy to fill or refill a prescription.

(B) A central fill pharmacy and originating pharmacy may process a request for the filling or refilling of a prescription received by an originating pharmacy only pursuant to the following requirements:

(1) The central fill pharmacy either has the same owner as the originating pharmacy or has a written contract with the originating pharmacy outlining the services to be provided and the responsibilities of each pharmacy in fulfilling the terms of the contract in compliance with federal and state law. The contract shall expressly state who is responsible for performing the patient counseling requirements in accordance with rule 4729:5-5-09 of the Administrative Code.

(2) The central fill pharmacy shall maintain a record of all originating pharmacies, including name, address, terminal distributor of dangerous drugs license number, and, if applicable, drug enforcement administration registration number, for which it processes a request for the filling or refilling of a prescription received by the originating pharmacy. The record shall be made readily retrievable and maintained for a period of three years.

(3) The central fill pharmacy and originating pharmacy shall have access to common electronic files as part of a real time, online database or have appropriate technology to allow secure access to sufficient information necessary or required to dispense or process the prescription.

(4) The originating pharmacy shall comply with the minimum required information for a patient profile pursuant to rule 4729:5-5-07 of the Administration Code prior to sending a prescription to the central fill pharmacy.

(5) The originating pharmacy shall remain responsible for compliance with the dangerous drug dispensing requirements of this chapter and the compounding requirements of Chapter 4729:7-2 of the Administrative Code that are not assumed in writing by the central fill pharmacy.

(6) The prescription label attached to the container shall contain the name and address of the originating pharmacy. The date on which the prescription was dispensed shall be the date on which the central fill pharmacy filled the prescription.

(a) If the originating pharmacy and the central fill pharmacy are not under common ownership, either of the following shall apply:

(i) The name of the central fill pharmacy shall be included on the prescription label or an auxiliary label; or

(ii) A statement is included on the prescription information accompanying the dangerous drug that indicates a central fill pharmacy was used to fill the prescription and includes the name of the central fill pharmacy.

(7) The originating pharmacy shall provide, upon the request of a patient or caregiver, the name and address of the central fill pharmacy and a contact phone number where the patient or caregiver can receive further assistance regarding prescriptions filled by a central fill pharmacy.

(8) The originating pharmacy shall maintain the original of all prescription orders received for purposes of filing and recordkeeping as required by state and federal law, rules, and regulations.

(9) The central fill pharmacy shall maintain all original fill and refill requests received from the originating pharmacy and shall treat them as original and refill prescription orders for purposes of filing and recordkeeping as required by state and federal law, rules, and regulations.

(10) The central fill pharmacy and originating pharmacy shall each maintain records to capture the positive identification of the licensed or registered individuals responsible for performing respective activities in accordance with paragraph (A) of rule 4729:5-5-04 of the Administrative Code.

(11) The central fill pharmacy and originating pharmacy shall adopt a written quality assurance program for pharmacy services designed to objectively and systematically monitor and evaluate the quality and appropriateness of patient care, pursue opportunities to improve patient care, resolve identified problems and ensure compliance with this rule. The quality assurance plan shall be reviewed and updated annually.

(C) Dangerous drugs may be returned by the originating pharmacy to the central fill pharmacy that originally filled the prescription for the express purpose of being returned to the central fill pharmacy's stock shelves in accordance with the following:

(1) The central fill pharmacy complies with the requirements of rule 4729:5-3-16 of the Administrative Code; and

(2) The originating and central fill pharmacy are under common ownership and control.

(D) An originating pharmacy may return dangerous drugs received by a central fill pharmacy to stock shelves in accordance with rule 4729:5-3-16 of the Administrative Code.

(E) A central fill pharmacy may dispense a prescription directly to a patient pursuant to the following requirements:

(1) A prospective drug utilization review is conducted pursuant to a written contract or agreement in accordance with rule 4729:5-5-08 of the Administrative Code;

(2) Patient counseling is provided pursuant to a written contract or agreement in accordance with rule 4729:5-5-09 of the Administrative Code;

(3) The dispensing is conducted in accordance with all other applicable state and federal laws, regulations and rules, including those specified in 68 CFR 37405 (7/24/2003).

(F) All written documentation required by this rule shall be maintained for three years from the date of execution or review and shall be made readily retrievable.

(G) Drugs that are repackaged or relabeled by a central fill pharmacy shall comply with the requirements of rule 4729:5-5-17 of the Administrative Code.

Last updated February 1, 2022 at 9:15 AM

History

Effective: February 1, 2022
Promulgated Under: 119.03

Chapter 4729:8-2 Drugs Required to be Reported to Ohio Automated Rx Reporting System (OARRS)

Ohio Adm.Code 4729:8-2-01 List of drugs to be reported.

Pursuant to section 4729.75 of the Revised Code, the required information for the following drugs pursuant to an outpatient prescription, personally furnished by a prescriber, or sold at wholesale to a terminal distributor of dangerous drugs shall be submitted to the state board of pharmacy pursuant to sections 4729.77, 4729.78 and 4729.79 of the Revised Code and this division of the Administrative Code:

(A) All schedule II controlled substances;

(B) All schedule III controlled substances;

(D) All schedule V controlled substances.

Last updated May 1, 2025 at 1:32 PM

History

Effective: March 15, 2019
Promulgated Under: 119.03

Ohio Adm.Code 4729:8-2-02 Additional drugs to be reported.

(A) Pursuant to section 4729.75 of the Revised Code, the required information for the following drugs pursuant to an outpatient prescription, personally furnished by a prescriber, or sold at wholesale to a prescriber or terminal distributor of dangerous drugs shall be submitted to the state board of pharmacy in accordance with sections 4729.77, 4729.78 and 4729.79 of the Revised Code and this division of the Administrative Code:

All dangerous drug products containing gabapentin.

(B) Pursuant to section 4729.75 of the Revised Code, the required information for the following drugs pursuant to an outpatient prescription shall be submitted to the state board of pharmacy in accordance with section 4729.77 of the Revised Code and this division of the Administrative Code:

All dangerous drug products containing naltrexone that are indicated for the treatment of alcohol dependence or the prevention of relapse to opioid dependence.

Last updated May 1, 2025 at 1:32 PM

History

Effective: March 15, 2019
Promulgated Under: 119.03

Chapter 4729:8-3 Reporting Requirements

Ohio Adm.Code 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.

(F) A retail dispensary licensed under Chapter 3796. of the Revised Code in accordance with section 4729.771 of the Revised Code.

(G) An opioid treatment program licensed as a terminal distributor of dangerous drugs is exempted from the reporting requirements of this division.

(1) An opioid treatment program shall report patient information via the central registry established in rule 5122-40-08 of the Administrative Code.

(2) Reporting of patient information pursuant to paragraph (G)(1) of this rule shall be made in compliance with Title 42 CFR Part 2 (4/1/2025).

Last updated August 4, 2025 at 7:46 AM

History

Effective: August 1, 2025
Promulgated Under: 119.03

Ohio Adm.Code 4729:8-2-02

All dangerous drug products containing gabapentin.

All dangerous drug products containing naltrexone that are indicated for the treatment of alcohol dependence or the prevention of relapse to opioid dependence.

Last updated May 1, 2025 at 1:32 PM

History

Effective: March 15, 2019
Promulgated Under: 119.03

Ohio Adm.Code 5122-40-08

(A) Each opioid treatment program is to review the drug database established and maintained by the state of Ohio board of pharmacy under section 4729.75 of the Revised Code (Ohio's prescription drug monitoring program).

(1) Program physicians, or their designees as allowed by the state of Ohio board of pharmacy, are to review a patient's information in the database:

(a) At the patient's intake;

(b) At the initiation of treatment;

(d) When the number of take home doses is increased;

(e) Every ninety days;

(f) When a patient refuses to participate in a drug screen; and

(g) After any positive drug test indicating any drug screen inconsistent with the patient's treatment plan.

(2) The physician, or the physician's designee as allowed by the state of Ohio board of pharmacy, is to review information in the drug database to ensure that the patient is not seeking prescription medication from multiple sources. The results obtained from the database are to be maintained with the patient records in accordance with section 4729.86 of the Revised Code.

(B) All opioid treatment programs are to participate in the central registry for dual enrollment, guest dosing, disaster planning, and administrative efforts.

(1) The central registry will be administered by the state authority.

(2) The central registry will be paid for by the opioid treatment programs through an annual licensing fee that is to be no more than the cost of the central registry. The amount of the fee will be set by the department on a state fiscal year basis and will be announced on or before July first of each year.

(3) To facilitate timely access to information in the central registry for dual enrollment verification purposes, opioid treatment programs will ensure that contact information for program staff is available to the extent necessary to reasonably facilitate direct communication between providers.

(4) Within twenty-four hours of patient admission or discharge, the program is to report to the central registry patient admission data which is to include:

(a) Provider identification, including program name, county, and address;

(b) Patient identification, including:

(i) Patient name or initials;

(ii) Sex;

(iii) Month, day, and year of birth; and,

(iv) Race,

(d) The month, day, and year of discharge, if applicable;

(e) The type of admission (e.g. initial admission, transfer from another program, change in treatment service, etc.);

(f) The type of treatment provided (e.g. withdrawal management or maintenance);

(g) The type of medication prescribed;

(h) The dose of medication;

(i) Medicaid identification, if available; and

(j) Patient home address.

(5) A patient's medication and dosage is to be updated within the central registry system at least once a week for disaster planning efforts.

(C) Opioid treatment programs are to check the central registry at least once a day during normal business hours. Opioid treatment programs are to verify that new patients are not enrolled in another program through use of the central registry and by directly checking with other opioid treatment programs located within a radius of one hundred statute miles who do not participate in the central registry.

(1) Before a program admits a patient for treatment, the program is to:

(a) Notify the patient that it cannot provide medication assisted treatment to a patient who is simultaneously receiving medication assisted treatment from another program;

(b) Require the patient to sign a written statement documenting whether they are currently receiving medication assisted treatment from another program and retain the statement in the patient record. If the patient refuses to sign this statement, the program shall not admit the patient for treatment;

(i) Full name and any aliases;

(ii) Month, day, and year of birth;

(iii) Mother's maiden name;

(iv) Sex;

(v) Race;

(vi) Height;

(vii) Weight;

(viii) Color of hair;

(ix) Color of eyes; and

(x) Distinguishing markings, such as scars or tattoos.

(d) Obtain a current patient photo.

(e) Request the patient to voluntarily provide their social security number;

(f) Require the patient to sign an authorization for disclosure of confidential information, pursuant to 42 C.F.R. 2.34, for the limited purpose of authorizing the program to contact each opioid treatment program within a central registry system and within a radius of one hundred statute miles to determine if the patient is simultaneously receiving opioid agonist or partial opioid agonist therapy from another program; and

(g) Document in the patient record all information provided and authorizations of release of information signed pursuant to this rule.

(2) If the program receives the consent in paragraph (C)(1)(e) of this rule, it is to disclose to the central registry or any requesting opioid treatment program within two hundred miles of the program the information provided by the patient in paragraph (C)(1)(c) of this rule upon:

(a) Accepting the patient for treatment;

(b) Changing the dosage being administered or dispensed to the patient; or

(3) If the patient states that they are currently receiving medication assisted treatment from another program and the patient is not approved to receive services on a temporary basis before admitting the patient for treatment, the program is to:

(a) Require the patient to sign an authorization of disclosure of confidential information, pursuant to 42 C.F.R. 2.34, for the limited purpose of authorizing the program to contact the previous program to notify it that the patient has applied for admission for medication assisted treatment;

(b) Provide patient education materials about the transfer process, including but not limited to, the length of time associated with the transfer process, responsibilities of the patient, responsibilities of each agency, and client rights to be re-admitted to the transferring agency if space if available;

(c) Contact the previous program by telephone and notify the program that the individual has applied for admission for medication assisted treatment;

(d) Request information to be transferred from the previous program to the admitting program within seventy-two hours that includes medication type; medication dosage; length of time in treatment; current take home regimen or phase level; and most recent urine drug screen results;

(e) Request the program to cease providing medication assisted treatment if it has not already done so, and only if the admitting program has documentation to verify medication type and dosage;

(f) Request the previous program to provide the new program with written documentation (letter or discharge summary) that it has discharged the patient; and the previous program shall provide such information within seventy-two hours of receiving the request. If the previous program states that it has already discharged the patient, the new program may admit the patient for treatment; and

(g) Document the following information in writing in the patient's record:

(i) The name of the program contacted;

(ii) The date and time of the contact;

(iii) The name of the program staff member contacted; and,

(iv) The results of the contact.

(4) If the patient states that they are a visiting patient approved to receive services on a temporary basis, before providing medication assisted treatment to the patient the program is to:

(a) Contact the other program to determine that it has not already provided the patient with medication assisted treatment therapy for the same time period and that it will not do so; and

(b) Document the following information in writing in the patient's medication orders:

(i) The name of the program contacted;

(ii) The date and time of the contact;

(iii) The name of the program staff member contacted; and

(iv) The results of the contact.

(5) If the patient states that they are not currently receiving medication assisted therapy from another program, the program is to proceed with patient admission procedures.

(6) When a program determines that it is providing medication assisted treatment to a patient who is simultaneously receiving this therapy from one or more other programs, all of the involved programs are to immediately:

(a) Confer to determine which program will accept sole responsibility for the patient;

(b) Revoke the patient's take-home medication privileges; and

(7) The program which agrees to accept sole responsibility for a patient with multiple enrollments shall continue to provide medication assisted treatment. Each of the other programs involved are to:

(a) Immediately discharge the patient from the program;

(b) Document in the patient's record why the patient was discharged from the program;

(c) Provide to the new program, within seventy-two hours of the discharge, written documentation (letter or discharge summary) that it has discharged the patient; and

(d) Send written notification of the discharge to the state authority within seventy-two hours of the discharge.

(8) If the state authority determines that there is patient who is enrolled in multiple programs, and none of the programs has accepted sole responsibility for the patient, the state authority is to:

(a) Designate one program which is to accept sole responsibility for the patient; and

(b) Order the remaining programs to proceed in accordance with paragraph (C)(7) of this rule.

(D) An opioid treatment program that has followed the requirements of paragraph (C) of this rule has complied with the requirement to check for patient dual enrollment, regardless of whether or not the patient is actually dually enrolled in another program.

Last updated January 31, 2025 at 7:40 AM

History

Effective: January 31, 2025
Promulgated Under: 119.03

Ohio Adm.Code 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) Pharmacy dispensing software vendor or proprietary software;

(6) Pharmacy license number, if both the drug enforcement administration registration and national provider identifier are not provided;

(7) Type of pharmacy or dispenser;

(8) Indication if entity is a mail order pharmacy;

(9) Patient full name;

(10) Patient residential address;

(11) Patient telephone number;

(12) Patient date of birth;

(13) Patient gender;

(14) Species code;

(15) Owner's name for veterinary patients;

(16) Name of animal;

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

(18) Transmission form of prescription (e.g., written, verbal, electronic, etc.);

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

(20) Date prescription was issued by the prescriber;

(21) Date the prescription was filled ;

(22) Date the prescription was sold, if available;

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

(24) Number of the refill being dispensed;

(25) National drug code of the drug dispensed;

(26) Indication if the product is compounded in accordance with division 4729:7 of the Administrative Code;

(27) Quantity of the drug prescribed;

(28) Quantity of drug dispensed;

(29) 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.

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

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

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

(33) Prescriber's national provider identification (NPI) number, if prescriber does not have an NPI, then the prescriber's state license number or another mutually acceptable identifier;

(34) 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;

(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);

(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.

Last updated May 11, 2026 at 7:53 AM

History

Effective: May 10, 2026
Promulgated Under: 119.03

Ohio Adm.Code 4729:8-3-03

(A) All prescription dispensing information or prescriber personally furnishing information required to be submitted to the board 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:

(1) ASAP version 5.0 "Standard for Prescription Drug Monitoring Programs (4/1/2025)"; or

(2) Until July 1, 2026, "ASAP version 4.2A Standard for Prescription Drug Monitoring Programs" (3/15/2017).

(B) The board's executive director or the director's designee may authorize up to a six-month extension to the implementation of ASAP version 5.0 beyond July 1, 2026. Such extensions may only be considered if the pharmacy or prescriber has made all reasonable and prudent attempts to meet the deadline.

(C) 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 board's executive director or the director's designee to submit drug sales information in a mutually acceptable format.

(D) 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.

(E) In the event that a drug distributor or terminal distributor cannot electronically transmit the required information pursuant to paragraph (D) 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.

Last updated July 1, 2026 at 9:05 AM

History

Effective: July 1, 2026
Promulgated Under: 119.03

Ohio Adm.Code 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 board's executive director or the director's designee to submit the required information in a mutually acceptable time frame.

(I) A dispensary licensed in accordance with Chapter 3796. of the Revised Code shall submit information in accordance with rule 4729:8-5-01 of the Administrative Code.

Last updated August 4, 2025 at 7:46 AM

History

Effective: August 1, 2025
Promulgated Under: 119.03

Ohio Adm.Code 4729:8-5-01

(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.

Last updated June 7, 2024 at 7:50 AM

History

Effective: June 7, 2024
Promulgated Under: 119.03

Ohio Adm.Code 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 board's executive director or the director's designee.

(F) If utilizing a central fill pharmacy to report to the drug database in accordance with this division of the Administrative Code, the central fill pharmacy and the originating pharmacy shall implement a process to submit a correction if the drug is returned to stock pursuant to rule 4729:5-5-22 of the Administrative Code. It shall be the responsibility of the reporting pharmacy to ensure this process is completed in accordance with this rule.

Last updated August 4, 2025 at 7:47 AM

History

Effective: August 1, 2025
Promulgated Under: 119.03

Ohio Adm.Code 4729:5-5-22

(A) As used in this rule:

(1) "Pharmacy delivery agent" means an employee of the pharmacy, United States postal service, or common or contract carrier who delivers dangerous drugs that have been dispensed.

(2) "Psychiatric outpatient facility" means a facility where psychiatric evaluation and treatment is provided on an outpatient basis.

(B) An outpatient pharmacy may return dangerous drugs to stock shelves that have been dispensed, but have never left the pharmacy (i.e. never picked up by a patient or caregiver) or the control of a pharmacy delivery agent (i.e. never delivered to a patient or caregiver), if the pharmacy complies with all of the following:

(1) The pharmacy has the capability to place the expiration date, as required by this rule, on the prescription label.

(2) The expiration date on the label shall not exceed the expiration date on the manufacturer's container or one year from the date the drug was originally dispensed and placed in the prescription vial, whichever date is earlier. If multiple manufacturer containers are used, the expiration date shall not exceed the expiration date on the manufacturer's container that will expire first or one year from the date the drug was originally dispensed and placed in the prescription vial, whichever date is earlier. If the prescription container is the manufacturer's original sealed packaging, the expiration date is the expiration date listed on the packaging.

(3) The dangerous drug products returned to stock shelves shall be maintained in the container in which they were filled and shall maintain their original prescription label containing the original expiration date assigned. The label on the container shall not be removed, altered, or replaced with another label or have any other label added, except as follows:

(a) Adding to or modifying the existing label, if the drug name, dose, and original expiration date are maintained.

(b) Adding a new label over the existing label on the container. In this instance, the drug shall be verified by a pharmacist or an electronic verification system following the application of the new label. The new label shall include the expiration date assigned on the original label.

(c) A prescription label may be removed if the prescription container is the manufacturer's original sealed packaging and the removal of the label does not remove or otherwise cause to make unreadable the expiration date and lot number on the manufacturer's packaging.

(4) The contents of a prescription vial or container shall not be returned to the manufacturer's stock bottle.

(5) When dispensing a dangerous drug that was previously returned to stock to another patient, a new container shall be used or, in the case of unit dose or unit of use products, all previous patient information shall be removed.

(6) Drugs returned to stock shelves shall be stored in accordance with rule 4729:5-5-02 of the Administrative Code. The pharmacy shall develop and implement a policy to ensure that drugs are maintained by pharmacy delivery agents within temperatures as stipulated by the USP/NF and/or the manufacturer's or distributor's labeling.

(7) In the case of recalls, any drugs returned to stock shelves containing the drug affected by the recall shall be removed from the shelves immediately, unless the lot number can be determined.

(8) A dangerous drug that leaves the prescription department of the pharmacy in the custody of a pharmacy delivery agent may only be returned to stock shelves if the drug meets either of the following prior to initially leaving the prescription department:

(a) Each dangerous drug prescription is dispensed in a tamper evident container or package prior to leaving the pharmacy; or

(b) The dangerous drug prescription is dispensed in the manufacturer's original tamper evident packaging.

(9) A dangerous drug that is dispensed and shows any signs of tampering or adulteration shall not be returned to stock shelves.

(C) A dangerous drug that exceeds its assigned expiration date, as described in paragraph (B) of this rule, shall be removed from the area for the storage of drugs used for dispensing and administration in accordance with rule 4729:5-3-06 of the Administrative Code.

(D) Non-controlled drugs dispensed by a government entity and delivered for outpatients to a psychiatric outpatient facility or to any service provider licensed as a terminal distributor of dangerous drugs may be returned to stock if all the following apply:

(1) The drugs are packaged in unopened, single-dose or tamper-evident containers; and

(2) The drugs have not been in the possession of the ultimate user.

(E) This rule does not apply to drugs dispensed for inpatients pursuant to agency 4729 of the Administrative Code. Drugs dispensed for inpatients may be returned to stock in accordance with the applicable provisions of agency 4729 of the Administrative Code.

(F) A pharmacy may transfer dangerous drugs that are returned to stock shelves that meet the requirements of this rule to another pharmacy if the transfer is conducted in accordance with paragraph (E) of rule 4729:5-3-09 of the Administrative Code.

Last updated September 14, 2026 at 2:11 PM

History

Effective: December 1, 2020
Promulgated Under: 119.03

Chapter 4729:8-4 Access and Statistics of Drug Database Information

Ohio Adm.Code 4729:8-4-01 Procedures for obtaining drug database information and access by peer review committees.

(A) Persons that are permitted pursuant to section 4729.80 of the Revised Code to obtain information from the drug database shall comply with all application procedures, requirements and acceptable use policies adopted by the board.

(B) An individual seeking the individual's own database information shall comply with the following:

(1) Complete a 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 driver's license, or a valid passport; and

(4) The person may be required to pay the cost of printing the document as determined by the board of pharmacy's current per page rate.

(C) Pursuant to section 4729.80 of the Revised Code, the board shall provide the following information to a designated representative of a peer review committee relating to a prescriber who is subject to the committee's evaluation, supervision, or discipline:

(1) A summary of the prescriber's prescribing record, if such a record is created by the board;

(2) Information from the database, in a format determined by the board, relating to a current or previous patient of the prescriber who is subject to the committee's evaluation, supervision, or discipline.

(D) An employee of the state board of pharmacy who has been appointed to an overdose fatality review committee or suicide fatality review committee may provide a drug database report to a person described in division (A)(5), (A)(6), or (A)(17) of section 4729.80 of the Revised Code.

(1) The employee may only provide the information for the purposes of the committee's review in accordance with Chapter 307. of the Revised Code.

(2) The employee shall verify that the person receiving the report has signed a written agreement specifying how the information is to be used and disseminated according to the laws of this state.

Last updated August 4, 2025 at 7:47 AM

History

Effective: August 1, 2025
Promulgated Under: 119.03

Ohio Adm.Code 4729:8-4-02 Extension to the information storage requirements and the provision of database statistics.

(A) A government entity or a law enforcement agency pursuant to section 4729.82 of the Revised Code may request that specific information in the database related to an open investigation be retained beyond the five-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.

(B) The board of pharmacy may provide or present database statistics and law enforcement outcomes based on request information pursuant to section 4729.80 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.

Last updated May 1, 2025 at 1:33 PM

History

Effective: March 15, 2019
Promulgated Under: 119.03

Ohio Adm.Code 4729:8-4-03 Access to opioid treatment program data provided by the Ohio department of mental health and addiction services.

(A) Pursuant to section 4729.80 of the Revised Code, the following persons shall be permitted to access opioid treatment program data provided by the Ohio department of behavioral health in accordance with section 4729.772 of the Revised Code:

(1) Prescriber and prescriber delegates as authorized under section 4729.80 of the Revised Code;

(2) Pharmacist and pharmacist delegates as authorized under section 4729.80 of the Revised Code;

(3) The director of health as authorized under section 4729.80 of the Revised Code;

(4) An individual listed in paragraphs (A)(1) and (A)(2) of this rule who is from or participating with another state's prescription monitoring program; and

(5) A coroner, deputy coroner, or coroner's delegate as authorized under section 4729.80 of the Revised Code.

(B) Nothing in this rule shall be construed to limit the state board of pharmacy's access and use of data collected by the drug database to carry out its responsibilities in accordance with section 4729.81 of the Revised Code.

Last updated March 2, 2026 at 11:47 AM

History

Effective: March 2, 2026
Promulgated Under: 119.03

Ohio Adm.Code 4729:8-4-04 Access to overdose data provided by the Ohio department of health.

(A) Pursuant to section 4729.80 of the Revised Code, the following persons shall be permitted to access drug overdose data provided by the Ohio department of health in accordance with section 4729.772 of the Revised Code:

(1) Prescriber and prescriber delegates as authorized under section 4729.80 of the Revised Code;

(2) Pharmacist and pharmacist delegates as authorized under section 4729.80 of the Revised Code;

(3) The director of health as authorized under section 4729.80 of the Revised Code;

(4) An individual listed in paragraphs (A)(1) and (A)(2) of this rule who is from or participating with another state's prescription monitoring program; and

(5) A coroner, deputy coroner, or coroner's delegate as authorized under section 4729.80 of the Revised Code.

Last updated July 25, 2024 at 8:26 AM

History

Effective: July 25, 2024
Promulgated Under: 119.03

Chapter 4729:8-5 Dispensary Reporting into the Prescription Monitoring Program

Ohio Adm.Code 4729:8-5-01 Dispensary reporting into the prescription monitoring program.