Chapter 4729:5-18 | Office-Based Opioid Treatment Clinics

Rule 4729:5-18-01 | Office-Based Opioid Treatment Clinics - Definitions.

• Effective: March 12, 2020
• Promulgated Under: 119.03

As used in Chapter 4729:5-18 of the Administrative Code:

(A) "Office-based opioid treatment clinic" or "OBOT clinic" means a facility, clinic or other location licensed as a terminal distributor of dangerous drugs in accordance with section 4729.553 of the Revised Code. An OBOT clinic shall comply with all requirements set forth in this chapter.

(1) Persons meeting any of the following identifying criteria shall obtain licensure under section 4729.553 of the Revised Code:

(a) A facility, clinic or other location where any prescriber provides office-based opioid treatment to more than thirty patients;

(b) A facility, clinic or other location that provides office-based opioid treatment and does not accept public or commercial insurance as a form of payment;

(c) A facility, clinic or other location that provides office-based opioid treatment to more than sixty patients in a thirty-day period.

(2) Paragraph (A)(1) of this rule does not apply to any of the following:

(a) A hospital.

(b) A facility for the treatment of opioid dependence or addiction that is operated by a hospital.

(c) A physician practice owned or controlled, in whole or in part, by a hospital or by an entity that owns or controls, in whole or in part, one or more hospitals.

(d) A facility that conducts only clinical research and uses controlled substances in studies approved by a hospital-based institutional review board or an institutional review board that is accredited by the association for the accreditation of human research protection programs, incorporated.

(e) A facility that holds a category III terminal distributor of dangerous drugs license in accordance with section 4729.54 of the Revised Code for the purpose of treating drug dependence or addiction as part of an opioid treatment program and is the subject of a current, valid certification from the substance abuse and mental health services administration of the United States department of health and human services pursuant to 42 CFR 8.11.

(f) A program or facility that holds a license or certification issued by the department of mental health and addiction services under Chapter 5119. of the Revised Code if the license or certification is approved by the state board of pharmacy.

(i) Upon the effective date of this rule, the board may issue a resolution approving a license or certification issued by the department of mental health and addiction services under Chapter 5119. of the Revised Code.

(ii) The board, by resolution, may revoke the approval of a license or certification issued by the department of mental health and addiction services under Chapter 5119. of the Revised Code. If such approval is revoked, any facility that was previously exempted may continue to operate for up to six months from the date of revocation in order to obtain licensure in accordance with section 4729.553 of the Revised Code. The board may extend this timeframe for good cause shown.

(g) A federally qualified health center or federally qualified health center look-alike, as defined in section 3701.047 of the Revised Code.

(h) A board of health of a city or general health district established by section 3709.01 of the Revised Code, or the authority having the duties of a board of health in any city as authorized by section 3709.05 of the Revised Code.

(i) A state or local correctional facility, as defined in section 5163.45 of the Revised Code.

(j) Any other person or facility exempted in section 4729.553 of the Revised Code.

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

(C) "Dangerous drug" has the same meaning as in section 4729.01 of the Revised Code.

(D) "Licensed health professional authorized to prescribe drugs" or "prescriber" has the same meaning as in rule 4729:5-1-02 of the Administrative Code but shall be limited to a prescriber practicing within the prescriber's applicable scope of practice.

(E) "Patient limit" means the maximum number of individual patients that a prescriber may personally furnish, administer or prescribe a schedule III, IV, or V controlled substance narcotic for the treatment of opioid dependence or addiction at any one time in accordance with state and federal laws, rules and regulations. A patient counts towards a prescriber's patient limit until either:

(1) A controlled substance prescription for the treatment of opioid dependence or addiction has expired or the timeframe in which the medication quantity should have been depleted in accordance with prescription instructions has elapsed; or

(2) The minimum number of days between doses of a controlled substance administered for the treatment of opioid dependence or addiction elapses in accordance with the manufacturer's instructions.

(F) "Personally furnish" or "personally furnishing" means the final association of a drug with a patient by a prescriber prior to the distribution to a patient for use outside the prescriber's practice setting. A prescriber at a OBOT clinic who personally furnishes a dangerous drug shall comply with the requirements of rule 4729:5-19-02 of the Administrative Code.

(G)

(1) "Positive identification" means a method of identifying a person that does not rely on the use of a private personal identifier such as a password, but must use a secure means of identification that includes any of the following:

(a) A manual signature on a hard copy record;

(b) A magnetic card reader;

(c) A bar code reader;

(d) A biometric method;

(e) A proximity badge reader;

(f) A board approved system of randomly generated personal questions;

(g) A printout of every transaction that is verified and manually signed within a reasonable period of time by the individual who performed the action requiring positive identification. The printout must be maintained for three years and made readily retrievable; or

(h) Other effective methods for identifying individuals that have been approved by the board.

(2) A method relying on a magnetic card reader, a bar code reader, a proximity badge reader, or randomly generated questions for identification must also include a private personal identifier, such as a password, for entry into a secure mechanical or electronic system.

(H) "Office-based opioid treatment" means the treatment of opioid dependence or addiction using a controlled substance.

(I) "Personal supervision" means the person specified in rule shall be physically present at the licensed location to deter and detect the diversion of dangerous drugs.

(J) "Readily retrievable" means that records maintained in accordance with this chapter shall be kept in such a manner that, upon request, they can be produced for review no later than three business days to an agent, officer or inspector of the board.

(K) "Responsible person" has the same meaning as defined in rule 4729:5-2-01 of the Administrative Code and is responsible for the supervision and control of dangerous drugs as required in division (B) of section 4729.55 of the Revised Code, adequate safeguards as required in division (C) of section 4729.55 of the Revised Code, security and control of dangerous drugs, and maintaining all drug records otherwise required.

Last updated March 18, 2024 at 2:01 PM

Supplemental Information

Authorized By: 4729.553, 4729.26
Amplifies: 4729.51, 4729.541, 4729.55, 4729.54
Five Year Review Date: 3/12/2025
Prior Effective Dates: 5/12/2017

Rule 4729:5-18-02 | Ownership.

• Effective: March 1, 2020
• Promulgated Under: 119.03

(A) The holder of a category III terminal distributor of dangerous drugs license with an office-based opioid treatment classification shall be in control of a clinic that is owned and operated solely by one or more physicians authorized under Chapter 4731. of the Revised Code to practice medicine and surgery or osteopathic medicine and surgery.

(B) A waiver of the requirement in paragraph (A) of this rule may be granted by the board upon request of an applicant.

(1) A waiver request shall be included as part of the clinic's initial licensure application for a terminal distributor of dangerous drugs license with an office-based opioid treatment classification. The request shall include all information, as deemed necessary by the board, to determine if it is in the public interest to issue a license to a clinic that does not meet the requirement in paragraph (A) of this rule. The board reserves the right to request additional information from the applicant and conduct an inspection of the clinic pursuant to rule 4729:5-3-03 of the Administrative Code prior to rendering its decision.

(2) If the board approves a waiver, the clinic shall retain the waiver unless there is a change of ownership. Upon any change of ownership, the clinic shall submit a new application pursuant to rule 4729:5-2-03 of the Administrative Code.

(3) An applicant whose waiver is denied by the board will be provided with a written explanation of the denial and allowed one opportunity to resubmit its request to address the identified concerns. The resubmission of the request shall occur within sixty days of receiving the board's written explanation or the application will be deemed abandoned.

(4) In determining whether to grant a waiver request, the board shall consider, at a minimum, all the following:

(a) The results of criminal records checks conducted in accordance with rule 4729:5-18-03 of the Administrative Code;

(b) The results of a pre-inspection authorized in accordance with rule 4729:5-3-03 of the Administrative Code:

(c) A review of any past disciplinary actions taken against any owner that are based, in whole or in part, on the owner's inappropriate prescribing, personally furnishing, diverting, administering, storing, compounding, supplying or selling a controlled substance or other dangerous drug; and

(d) Commission of an act by any owner that constitutes a misdemeanor or felony in this state, regardless of the jurisdiction in which the act was committed.

Last updated March 18, 2024 at 2:01 PM

Supplemental Information

Authorized By: 4729.553, 4729.26
Amplifies: 4729.51, 4729.541, 4729.55, 4729.54
Five Year Review Date: 3/1/2025
Prior Effective Dates: 5/12/2017

Rule 4729:5-18-03 | Criminal records checks for office-based opioid treatment clinics.

• Effective: March 1, 2020
• Promulgated Under: 119.03

(A) All criminal records checks conducted in accordance with this rule shall consist of both an Ohio bureau of criminal identification and investigation (BCI&I) records check and a federal bureau of investigations (FBI) records check.

(B) Pursuant to section 4729.553 of the Revised Code, a terminal distributor of dangerous drug license with an office-based opioid treatment classification will not be issued until the physician owner(s) or, if incorporated, the physician officers of the office-based opioid treatment clinic submit fingerprints to BCI&I for a criminal records check. The results of the criminal records check must be sent directly to the state board of pharmacy from BCI&I. To be considered valid, the criminal records check must have been performed within the past twelve months.

(C) If a waiver is requested pursuant to paragraph (B) of rule 4729:5-18-02 of the Administrative Code, a terminal distributor of dangerous drug license with an office-based opioid treatment classification will not be issued until the following submit fingerprints to BCI&I for a criminal records check:

(1) Based upon the terminal distributor's business type:

(a) All partners of a partnership;

(b) The sole proprietor of a sole proprietorship;

(c) The president, vice president, secretary, treasurer, and chief executive officer, or any equivalent position of a corporation and, if a corporation is not publicly traded on a major stock exchange, each shareholder owning ten percent or more of the voting stock of the corporation; or

(d) The agency director of a government agency.

(2) The persons listed in paragraph (C)(1) of this rule shall be a natural person that owns and/or operates the business entity applying for licensure. In the event the applicant is not owned by a natural person, each business entity with an ownership interest in the applicant must be disclosed on the application up to and through the entity that is owned by a natural person, who shall be subject to a criminal records check in accordance with this rule.

(3) The results of the criminal records check must be sent directly to the state board of pharmacy from BCI&I. To be considered valid, the criminal records check must have been performed within the past twelve months.

(D) If there is a change in any of the persons listed in paragraphs (B) and (C) of this rule, only the new persons shall submit to a criminal records check as part of the change of ownership requirements pursuant to rule 4729:5-2-03 of the Administrative Code.

(E) Physician owner(s), physician officers or persons listed in paragraph (C)(1) of this rule are required to have all employees submit to a BCI&I and FBI criminal records check to ensure that a person is not employed by the clinic if the person, within the ten years immediately preceding the date the person applied for employment, was convicted of, or pleaded guilty to, a theft offense that would constitute a felony as described in division (K)(3) of section 2913.01 of the Revised Code or a felony drug abuse offense as defined in section 2925.01 of the Revised Code. The board may waive this requirement if a request is submitted in accordance with paragraph (F) of this rule.

(1) BCI&I shall send the results of the BCI&I criminal records check directly to the employer or potential employer. BCI&I shall provide a letter regarding the FBI criminal records check to the employer or potential employer stating that there is either no record of any conviction or a letter stating that the request may not meet the criteria.

(2) When an employer or potential employer receives a letter stating that the request may not meet the criteria, they may share this information with the employee or potential employee.

(3) In order to complete the criminal records check, the employee or potential employee must then complete a "Request for Release-FBI Rapsheet" and send it to BCI&I to request a copy of the FBI criminal records check results be sent directly to the employee or potential employee. The employee or potential employee must provide the results to the employer or potential employer in the original sealed envelope received from BCI&I.

(4) The criminal records check shall be based on electronic fingerprint impressions that are submitted directly to BCI&I from a WebCheck provider agency located in Ohio. The employer may accept the results of a criminal records check based on ink impressions from a WebCheck provider agency only in the event that readable electronic fingerprint impressions cannot be obtained.

(F) A waiver of the employment prohibitions in paragraph (E) of this rule may be granted by the board upon request of an applicant or current licensee.

(1) A waiver request shall be included as part of either:

(a) The clinic's initial licensure application for a terminal distributor of dangerous drugs license with an office-based opioid treatment classification; or

(b) The submission of a separate form, approved by the board, for a currently licensed OBOT clinic.

(2) The waiver request shall include all information, as deemed necessary by the board, to determine if it is in the public interest to waive the employment prohibitions set forth in paragraph (E) of this rule. The board reserves the right to request additional information from the applicant or licensee and the employee prior to rendering its decision.

(3) If the board approves a waiver to paragraph (E) of this rule, the clinic shall retain the waiver until the employee is no longer employed by the clinic or the employment prohibition in paragraph (E) of this rule no longer applies.

(4) An applicant or licensee whose waiver request is denied by the board will be provided with a written explanation of the denial and allowed one opportunity to resubmit its request to address the identified concerns. The resubmission of the request shall occur with sixty days of receiving the board's written explanation.

(5) In determining whether to grant a waiver request, the board shall consider, at a minimum, all the following:

(a) The results of the employee's criminal records check conducted in accordance with this rule;

(b) A review of any past disciplinary actions taken against the employee that are based, in whole or in part, on the employee's inappropriate prescribing, personally furnishing, diverting, administering, storing, compounding, supplying or selling a controlled substance or other dangerous drug; and

(c) Commission of an act by the employee that constitutes a misdemeanor or felony in this state, regardless of the jurisdiction in which the act was committed.

Last updated March 18, 2024 at 2:01 PM

Supplemental Information

Authorized By: 4729.26, 4729.553
Amplifies: 4729.51, 4729.54, 4729.55, 4729.541
Five Year Review Date: 3/1/2025

Rule 4729:5-18-04 | Security, control and storage of dangerous drugs.

• Effective: February 4, 2021
• Promulgated Under: 119.03

(A) The security and control of dangerous drugs is the responsibility of the responsible person on the terminal distributor of dangerous drugs license and the terminal distributor of dangerous drugs.

(B) Except as provided in paragraphs (F) and (G) of this rule, controlled substance dangerous drugs shall be stored in a securely locked, substantially constructed cabinet or safe to deter and detect unauthorized access.

(1) The cabinet or safe shall be placed in an area that is not readily accessible to the public.

(2) The cabinet or safe shall remain locked and secured when not in use.

(3) In the case of a combination lock or access code, the combination or access code shall be changed upon termination of employment of an employee having knowledge of the combination or access code.

(4) In the case of a key lock, all keys shall be maintained in a secure place that is inaccessible to anyone other than a prescriber or pharmacist if not being used by a prescriber, pharmacist or a licensed health care professional in accordance with paragraph (B)(6)(a), (B)(6)(b), or (B)(6)(c) of this rule. All locks shall be kept in good working order with keys removed therefrom.

(5) During non-business hours, the cabinet or safe shall be maintained in an area secured by a physical barrier with suitable locks, which may include a locked room or secure facility.

(6) Except as provided in paragraph (B)(6)(a), (B)(6)(b), or (B)(6)(c) of this rule, only a prescriber or pharmacist shall be able to access the cabinet or safe.

(a) A prescriber or pharmacist may provide a licensed health care professional with a temporary key for the purposes of accessing the cabinet or safe. A licensed health care professional shall return the key provided in accordance with this paragraph to the prescriber or pharmacist or to a secured location with restricted access (such as a lockbox) no later than the end of the provider's shift or if there is no longer a prescriber or pharmacist available to provide personal supervision.

(b) A prescriber or pharmacist may provide a licensed health care professional with a key, combination or access code for the purposes of accessing the cabinet or safe, if all the following conditions apply:

(i) The cabinet or safe is maintained in a room secured by a physical barrier with suitable locks that can only be unlocked by a prescriber or pharmacist; and

(ii) The room is locked during non-business hours or when there is no longer a prescriber or pharmacist available to provide personal supervision.

(c) Any other method approved by the board's executive director or the director's designee that provides effective controls and procedures to guard against theft and diversion.

(C) Except as provided in paragraph (G) of this rule, a licensed health care professional, acting within the scope of the professional's practice, may have access to controlled substances only under the personal supervision of a prescriber or pharmacist.

(D) Only a prescriber shall have access to uncompleted prescription blanks used for writing a prescription. Uncompleted prescription blanks shall be secured when not in use.

(E) Personnel authorized by the responsible person may have access to D.E.A. controlled substance order forms only under the personal supervision of a prescriber or a person delegated power of attorney in accordance with 21 CFR 1305.05 (9/30/2019). D.E.A. controlled substance order forms shall be secured when not in use.

(F) Thiafentanil, carfentanil, etorphine hydrochloride and diprenorphine shall be stored in a separate safe or steel cabinet equivalent to a U.S. government class V security container from all other controlled substances.

(1) There is no minimum size or weight requirement but if the cabinet or safe weighs less than seven hundred fifty pounds, it must be secured to the floor or wall in such a way that it cannot be readily removed.

(2) The cabinet or safe shall be placed in an area that is not readily accessible to the public. During non-business hours, the cabinet or safe shall be stored in an area secured by a physical barrier with suitable locks, which may include a locked room or secured facility.

(3) The cabinet or safe shall remain locked and secured when not in use.

(4) In the case of a combination lock or access code, the combination or access code shall be changed upon termination of employment of an employee having knowledge of the combination or access codes.

(5) In the case of a key lock, all keys shall be maintained in a secure place that is inaccessible to anyone other than a prescriber or pharmacist if not being used by a prescriber or pharmacist. All locks shall be kept in good working order with keys removed therefrom.

(6) During non-business hours, the cabinet or safe shall be maintained in an area secured by a physical barrier with suitable locks, which may include a locked room or secure facility.

(7) Only a prescriber or pharmacist shall be able to access the safe or cabinet.

(G) A registered nurse licensed under Chapter 4723. of the Revised Code may have unsupervised access to controlled substances only under the following conditions:

(1) The drugs have been personally furnished by a prescriber or dispensed by a pharmacy for direct administration to a patient.

(2) The drugs must be stored in a securely locked, substantially constructed cabinet or safe with access that is limited to prescribers, pharmacists, and registered nurses. The cabinet or safe must be separate from those required in paragraphs (B) and (F) of this rule.

(a) The cabinet or safe shall be placed in an area that is not readily accessible to the public.

(b) The cabinet or safe shall remain locked and secured when not in use.

(c) In the case of a combination lock or access code, the combination or access code shall be changed upon termination of employment of an employee having knowledge of the combination or access code.

(d) In the case of a key lock, all keys shall be maintained in a secure place that is inaccessible to anyone other than a prescriber, pharmacist or registered nurse.

(e) During non-business hours, the cabinet or safe shall be maintained in an area secured by a physical barrier with suitable locks, which may include a locked room or secure facility.

(3) A record of drug administration shall be maintained in accordance with paragraph (E) of rule 4729:5-18-05 of the Administrative Code and shall also include the date and time the drugs are accessed from the cabinet or safe.

(4) The responsible person shall report the theft or significant loss of drugs maintained pursuant to this paragraph in accordance with rule 4729:5-3-02 of the Administrative Code.

(H) During non-business hours, hypodermics shall be stored in an area secured by a physical barrier with suitable locks, which may include a substantially constructed cabinet, locked room or secured facility. During normal business hours, hypodermics shall not be stored in areas where members of the public are not supervised by individuals authorized to administer injections.

(I) During non-business hours, non-controlled dangerous drugs shall be stored in an area secured by a physical barrier with suitable locks, which may include a substantially constructed cabinet, locked room, or secured facility. During normal business hours, non-controlled dangerous drugs shall not be stored in areas where members of the public are not supervised by individuals authorized to administer such drugs.

(J) All records relating to the receipt, administration, distribution, personal furnishing and sale of dangerous drugs shall be maintained under appropriate supervision and control to restrict unauthorized access.

(K) All areas where dangerous drugs are stored shall be dry, well-lit, well-ventilated, and maintained in a clean and orderly condition. Storage areas shall be maintained at temperatures and conditions which will ensure the integrity of the drugs prior to use as stipulated by the USP/NF and/or the manufacturer's or distributor's labeling. Refrigerators and freezers used for the storage of drugs shall comply with the following:

(1) Maintain either of the following to ensure proper refrigeration and/or freezer temperatures are maintained:

(a) Temperature logs with, at a minimum, daily observations; or

(b) A temperature monitoring system capable of detecting and alerting staff of a temperature excursion.

(2) The terminal distributor shall develop and implement policies and procedures to respond to any out of range individual temperature readings or excursions to ensure the integrity of stored drugs.

(3) The terminal distributor shall develop and implement a policy that no food or beverage products are permitted to be stored in refrigerators or freezers used to store drugs.

(L) Upon the initial puncture of a multiple-dose vial containing a drug, the vial shall be labeled with a beyond-use date or date opened. The beyond-use date for an opened or entered (e.g., needle punctured) multiple-dose container with antimicrobial preservatives is twenty-eight days, unless otherwise specified by the manufacturer. A multiple-dose vial that exceeds its beyond-use date shall be deemed adulterated.

(M) Adulterated drugs, including expired drugs, shall be stored in accordance with rule 4729:5-3-06 of the Administrative Code.

(N) Disposal of controlled substances shall be conducted in accordance with rule 4729:5-3-01 of the Administrative Code.

(O) Disposal of non-controlled dangerous drugs shall be conducted in accordance with rule 4729:5-3-06 of the Administrative Code.

Last updated March 18, 2024 at 2:01 PM

Supplemental Information

Authorized By: 4729.553, 4729.26
Amplifies: 4729.51, 4729.541, 4729.55, 4729.54
Five Year Review Date: 9/20/2027
Prior Effective Dates: 3/1/2020

Rule 4729:5-18-05 | Record keeping.

• Effective: February 4, 2021
• Promulgated Under: 119.03

(A) An OBOT clinic shall keep a record of all dangerous drugs received, administered, personally furnished, disposed, sold or transferred.

(B) Records of receipt shall contain the name, strength, dosage form, and quantity of the dangerous drugs received, the name and address of the seller, the name and address of the recipient, and the date of receipt. An invoice from a drug distributor licensed in accordance with division 4729:6 of the Administrative Code containing the required information may be used to meet this requirement.

(C) Records of temperature control monitoring described in paragraph (K)(1) of rule 4729:5-18-04 of the Administrative Code shall include any of the following:

(1) For temperature logs, either:

(a) The date and time of observation, the full name or the initials of the individual performing the check, and the temperature recorded; or

(b) For systems that provide automated temperature monitoring, maintain a report that provides, at a minimum, the date and time of observation and the temperature recorded.

(2) For temperature monitoring systems capable of detecting and alerting staff of a temperature excursion, maintain reports that provide information on any temperature excursion that includes the date, time, temperature recorded, and length of each excursion.

(D) Records of personally furnishing shall contain the name, strength, dosage form, and quantity of the dangerous drugs personally furnished, the name, address and date of birth of the person to whom or for whose use the dangerous drugs were personally furnished, the positive identification of the prescriber personally furnishing the drug, the date the drug is personally furnished and, if applicable, the date the drug is received by the patient or patient's caregiver.

(E)

(1) Records of administration shall contain the name, strength, dosage form, and quantity of the dangerous drugs administered, the name and date of birth of the person to whom or for whose use the dangerous drugs were administered, the date of administration, and either:

(a) For non-controlled substance dangerous drugs: the identification of the health care professional administering the drug.

(b) For controlled substance dangerous drugs: the positive identification of the health care professional administering the drug.

(2) Records of dangerous drugs administered which become a permanent part of the patient's medical record shall be deemed to meet the requirements of this paragraph.

(3) Records of dangerous drugs administered by a health care professional, acting within the professional's scope of practice, who is not a prescriber shall include documentation of an order issued by a prescriber or protocol authorizing the administration of the drug. An order that is a permanent part of the patient's medical record shall be deemed to meet the requirements of this paragraph. Orders for the administration of controlled substances shall be documented using positive identification.

(4) Paragraph (E)(3) of this rule does not apply to the administration of dangerous drugs pursuant to paragraph (G) of rule 4729:5-18-04 of the Administrative Code or non-controlled dangerous drugs for direct administration to a patient that have been dispensed by a pharmacy or personally furnished by a prescriber.

(F) Records of disposal of dangerous drugs from inventory, other than controlled substances, shall contain the name, strength, dosage form, and quantity of the dangerous drug disposed, the date of disposal, the method of disposal, and the identification of the licensed health care professional that performed the disposal.

(G) Records of controlled substance drug disposal shall comply with the requirements of rule 4729:5-3-01 of the Administrative Code.

(1) If the disposal of controlled substance drug inventory is performed on-site, records shall also include the positive identification of two licensed healthcare professionals conducting and witnessing the disposal, one of whom shall be the responsible person or the responsible persons designee.

(2) If conducting the disposal of an unused portion of a controlled substance resulting from administration to a patient, records shall also include the positive identification of two licensed healthcare professionals conducting and witnessing the disposal.

(H) Records of transfer or sale conducted in accordance with rule 4729:5-3-09 of the Administrative Code shall contain the name, strength, dosage form, national drug code, expiration date and quantity of the dangerous drug transferred or sold, the address of the location where the drugs were transferred or sold, and the date of transfer or sale.

(I) Controlled substance inventory records shall be maintained in accordance with rule 4729:5-3-07 of the Administrative Code.

(J) All records maintained in accordance with this rule shall be readily retrievable and shall be kept on-site for a period of three years.

(1) A terminal distributor intending to maintain records at a location other than the location licensed by the state board of pharmacy must notify the board in a manner determined by the board.

(2) Any such alternate location shall be secured and accessible only to authorized representatives or contractors of the terminal distributor of dangerous drugs.

(K) All records maintained pursuant to this rule may be electronically created and maintained, provided that the system that creates and maintains the electronic record does so in accordance with the following:

(1) Complies with the requirements of this rule;

(2) All paper records shall be scanned in full color via technology designed to capture information in one form and reproduce it in an electronic medium presentable and usable to an end user;

(3) Contains security features, such as unique user names and passwords, to prevent unauthorized access; and

(4) Contains daily back-up functionality to protect against record loss.

Last updated March 18, 2024 at 2:01 PM

Supplemental Information

Authorized By: 4729.26, 4729.553
Amplifies: 4729.51, 4729.54, 4729.55, 4729.541
Five Year Review Date: 9/20/2027
Prior Effective Dates: 3/1/2020

Rule 4729:5-18-06 | Compliance.

• Effective: March 1, 2020
• Promulgated Under: 119.03

A clinic licensed as a terminal distributor of dangerous drugs with an office-based opioid treatment classification and all prescribers practicing at the clinic shall comply with the following:

(A) The requirements for conducting office-based opioid treatment pursuant to Chapters 4731-33 and 4730-4 of the Administrative Code;

(B) Patient limits set forth in federal and state laws, rules, and regulations; and

(C) All other state and federal laws, rules, and regulations on the prescribing, personally furnishing, possessing or administration of controlled substances and other dangerous drugs.

Last updated March 18, 2024 at 2:01 PM

Supplemental Information

Authorized By: 4729.26, 4729.553
Amplifies: 4729.51, 4729.54, 4729.55, 4729.541
Five Year Review Date: 3/1/2025
Prior Effective Dates: 5/12/2017