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

 
 
 
Rule
Rule 4729:5-18-01 | Definitions - remote dispensing pharmacies.
 

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

(A) "Remote dispensing pharmacy" means a pharmacy where the dispensing of drugs, patient counseling, and other pharmacist care is provided through a telepharmacy system. The dispensing of drugs at a remote dispensing pharmacy may include the dispensing of drug therapy-related devices.

(B) "Telepharmacy system" means a system that monitors the dispensing of drugs and provides for related drug utilization review and patient counseling services by an electronic method that complies with the requirements of rule 4729:5-18-06 of the Administrative Code. The telepharmacy system shall include the following technologies:

(1) Audio and video;

(2) Still image capture; and

(3) Store and forward.

(C) "Surveillance system" means a system providing continuous video footage of the remote dispensing pharmacy that is recorded and stored for at least sixty days and complies with the requirements of rule 4729:5-18-07 of the Administrative Code.

(D) "Supervising pharmacy" means a pharmacy licensed as a terminal distributor of dangerous drugs that exclusively oversees the operations of a remote dispensing pharmacy.

(E) "Supervising pharmacist" means a pharmacist holding a current Ohio license to practice pharmacy who has met the requirements to supervise a remote dispensing pharmacy as described in this chapter.

(F) "Responsible person" means the same as in rule 4729:5-2-01 of the Administrative Code.

(G) "Social vulnerability" means the demographic and socioeconomic factors that contribute to communities being more adversely affected by external hazards and stressors that cause disease and injury.

(H) "Social vulnerability index" or "SVI" means a risk score assigned to communities using U.S. census data. These data are grouped into four themes that cover four major areas of social vulnerability (household characteristics, house type and transportation, racial and ethnic minority status, and socioeconomic status) and then combined into a single measure of overall social vulnerability. The overall SVI score ranges from zero (least vulnerable) to one (most vulnerable).

Last updated April 7, 2026 at 7:52 AM

Supplemental Information

Authorized By: 4729.26, 4729.554
Amplifies: 3719.28
Five Year Review Date: 4/6/2031
Rule 4729:5-18-02 | Licensure of remote dispensing pharmacies.
 

(A) A remote dispensing pharmacy shall apply for and obtain a terminal distributor of dangerous drugs license with a remote dispensing classification.

(B) The remote dispensing pharmacy shall comply with the licensing requirements of Chapter 4729:5-2 of the Administrative Code.

(C) Remote dispensing pharmacies shall have a pharmacist designated as the responsible person in accordance with rule 4729:5-2-01 of the Administrative Code.

(D) The responsible person designated for a remote dispensing pharmacy shall be the same responsible person designated for the supervising pharmacy. The responsible person may, but is not required to, act as a supervising pharmacist.

(E) If the supervising pharmacy and remote dispensing pharmacy are not under common ownership and control, the supervising pharmacy and remote dispensing pharmacy shall enter into a contract that specifies the services to be provided and the responsibilities and accountabilities of each party to the contract or agreement in compliance with federal and state statutes, rules, and regulations. The contract shall be maintained in a readily retrievable format.

Last updated April 7, 2026 at 7:50 AM

Supplemental Information

Authorized By: 4729.26, 4729.554
Amplifies: 3719.28
Five Year Review Date: 4/6/2031
Rule 4729:5-18-03 | Demonstration of need.
 

(A) Except as provided in this rule, a remote dispensing pharmacy shall not be located within a ten-mile radius of a pharmacy that serves the public as an outpatient pharmacy as defined in Chapter 4729:5-5 of the Administrative Code.

(B) A remote dispensing pharmacy may be located within the ten-mile radius of an outpatient pharmacy if either of the following apply:

(1) The remote dispensing pharmacy is part of a federally qualified health center or federally qualified health center look-alike, as defined in section 3701.047 of the Revised Code, and the remote dispensing pharmacy is located on the same property as, or on a campus contiguous to, the health center or look-alike.

(2) The board approves a request, based on a demonstration of need, that meets the standards established in paragraph (C) of this rule.

(C) A person may submit a request to the board, in a manner determined by board, to allow a remote dispensing pharmacy located within a ten-mile radius of an outpatient pharmacy if the proposed remote dispensing pharmacy is located in census block that is medium-high (0.5-0.75) or high (greater than 0.75) based upon the social vulnerability index (SVI) as designated by the board's Ohio pharmacy access dashboard (accessible via www.pharmacy.ohio.gov).

(D) Persons may register to receive notice from the board (accessible via www.pharmacy.ohio.gov) of requests received pursuant to paragraph (C) of this rule. The board shall notify any person who has registered to be notified and allow for the submission of public comments on the proposed request.

(E) During the sixty-day period that begins on the date that the board sends the electronic notice, a pharmacy currently operating in the state may submit a request to the board for approval to operate a remote dispensing pharmacy.

(F) At the board's next regularly scheduled meeting that occurs on or after the date that is ninety days after the electronic notices are sent, the board shall review all the requests received and make its determination of whether any should be approved. As part of the board's determination, it shall consider the following:

(1) Any comments received from the public;

(2) The geographic proximity of the supervising pharmacy to the proposed remote dispensing pharmacy;

(3) The supervising pharmacy has not been disciplined for a violation of rule 4729:5-5-02 of the Administrative Code and all subsequent rules thereunder within the preceding twelve months;

(4) The supervising pharmacy has not been disciplined for any theft or significant loss of dangerous drugs within the preceding twelve months; and

(5) The supervising pharmacy is not currently on probation or has other restrictions placed upon its terminal distributor of dangerous drugs license pursuant to a settlement agreement or order of the board.

Last updated April 7, 2026 at 7:52 AM

Supplemental Information

Authorized By: 4729.26
Amplifies: 4729.554, 3719.28
Five Year Review Date: 4/6/2031
Rule 4729:5-18-04 | Operation of a remote dispensing pharmacy.
 

(A) A remote dispensing pharmacy shall be located within this state in a building that is zoned for commercial or industrial use. A remote dispensing pharmacy shall not operate out of a personal residence.

(B) Remote dispensing pharmacies shall display a sign at the point of sale indicating that the facility is a remote dispensing pharmacy under continuous video surveillance and that the video is recorded and retained.

(C) The supervising pharmacy shall be exclusively responsible for the operation of a remote dispensing pharmacy and its employees.

(D) There shall be one supervising pharmacist at all times when the remote dispensing pharmacy is operational. The supervising pharmacist shall be located in this state when serving as a supervising pharmacist.

(E) The supervising pharmacist shall not be located more than fifty miles from a remote dispensing pharmacy under the pharmacist's supervision.

(F) To avoid disruption in pharmacy services, the supervising pharmacy shall have a process in place to ensure there is a pharmacist who meets the training requirements of this chapter if the regularly scheduled supervising pharmacist is unable to provide supervision.

(G) The remote dispensing pharmacy shall be physically staffed by at least two certified pharmacy technicians and/or pharmacy interns for the pharmacy to be open to the public.

(H) Unless a pharmacist is located on-site, there shall be no more than a total of three certified pharmacy technicians and/or pharmacy interns working within a remote dispensing pharmacy.

(I) Unless approved by the board, a supervising pharmacist shall not simultaneously oversee the activities of more than one remote dispensing pharmacy. The board may consider expanding this limit to two remote dispensing pharmacies per one supervising pharmacist. For the board to consider a waiver of this limitation, the supervising pharmacy shall submit documentation, in a manner determined by the board, that sufficiently demonstrates the following:

(1) The prescription volume and workload at the supervising pharmacy allows the supervising pharmacist to safely and effectively oversee more than one remote dispensing pharmacy;

(2) The prescription volume and workload at the remote dispensing pharmacies allows the supervising pharmacist to safely and effectively oversee more than one remote dispensing pharmacy; and

(3) Failure to grant this waiver may negatively impact patient health and access to pharmacy services.

(J) Certified pharmacy technicians, pharmacy interns, and pharmacists shall complete a training program to ensure that the telepharmacy system can be operated in a safe and effective manner. Training documentation shall be maintained at, or accessible by, the remote dispensing pharmacy and be produced for review immediately upon request of agent, officer, or inspector of the board. Remote dispensing pharmacies shall conduct additional training for their employees if any of the following occurs:

(1) The telepharmacy system used by the remote dispensing pharmacy has changed;

(2) The existing telepharmacy system used by the remote dispensing pharmacy has undergone significant updates.

(K) Unless approved by the board, a remote dispensing pharmacy shall not dispense more than an average of one hundred fifty prescriptions per day during a ninety-day period. For the board to consider a waiver of this limitation, a remote dispensing pharmacy shall submit documentation, in a manner determined by the board, that sufficiently demonstrates the following:

(1) The remote dispensing pharmacy is located in a census block that is medium-high (0.5-0.75) or high (greater than 0.75) based upon the social vulnerability index (SVI) as designated by the board's Ohio pharmacy access dashboard (accessible via www.pharmacy.ohio.gov); and

(2) It is not economically feasible for the remote dispensing pharmacy to convert to an outpatient pharmacy as defined by Chapter 4729:5-5 of the Administrative Code.

(L) The responsible person shall perform on-site visits of the remote dispensing pharmacy at least once per quarter. The on-site visit shall be documented by the responsible person and such documentation shall be immediately retrievable at the location licensed as a remote dispensing pharmacy for three years from the date of the visit by the responsible person. As part of this site visit, the responsible person shall conduct a controlled substance inventory in accordance with rule 4729:5-3-07 of the Administrative Code.

(M) In the event that the telepharmacy system is not in operation, the supervising pharmacist shall be physically located on-site to dispense prescriptions.

(N) A remote dispensing pharmacy shall implement a continuous quality improvement program in accordance with rule 4729:5-3-22 of the Administrative Code.

(O) A remote dispensing pharmacy shall comply with all applicable requirements for the operation of an outpatient pharmacy in accordance with Chapter 4729:5-5 of the Administrative Code.

(P) A remote dispensing pharmacy that holds a category III terminal distributor of dangerous drugs license shall maintain a perpetual controlled substance inventory for all controlled substances stocked by the remote dispensing pharmacy. The inventory shall be established in a manner that will provide total accountability in all aspects of controlled substance distribution.

Last updated April 7, 2026 at 7:52 AM

Supplemental Information

Authorized By: 4729.26, 4729.554
Amplifies: 3719.28
Five Year Review Date: 4/6/2031
Rule 4729:5-18-05 | Personnel requirements.
 

(A) The supervising pharmacy is solely responsible for ensuring that the requirements of this rule are met.

(B) Before a pharmacist may act as the supervising pharmacist for a remote dispensing pharmacy, a pharmacist shall:

(1) Be licensed as a pharmacist under Chapter 4729. of the Revised Code;

(2) Be physically located in this state when acting as the supervising pharmacist; and

(3) Be employed by or under contract with the supervising pharmacy.

(C) The supervising pharmacist shall do all of the following:

(1) Supervise no more than three certified pharmacy technicians and/or pharmacy interns per remote dispensing pharmacy.

(2) Be in full and actual charge of the remote dispensing pharmacy by using the pharmacy's telepharmacy and surveillance system.

(3) Through the telepharmacy system and surveillance system, oversee the pharmacy interns and/or certified pharmacy technicians who are staffing the remote dispensing pharmacy.

(4) Verify each prescription and drug dispensed pursuant to the prescription and provide verification through visual review, barcoding, and any other technology as specified in rule 4729:5-18-06 of the Administrative Code.

(a) All barcodes used shall be scanned, and not manually typed, into the system.

(b) Documentation of verification shall capture the positive identification of the supervising pharmacist.

(5) Offer to provide the service of counseling for each drug dispensed pursuant to a new or refill prescription in accordance with rule 4729:5-5-09 of the Administrative Code.

(6) Have completed a training program on the proper use of the telepharmacy system used at the remote dispensing pharmacy.

(7) Have completed a training program on the proper use of the surveillance system used at the remote dispensing pharmacy.

(D) Before a certified pharmacy technician may work in a remote dispensing pharmacy, the certified pharmacy technician shall:

(1) Hold an active registration as a certified pharmacy technician under Chapter 4729. of the Revised Code;

(2) Hold a national certification as a pharmacy technician from an organization recognized by the board as defined in rule 4729:3-1-01 of the Administrative Code.

(3) Have completed a training program on the proper use of the telepharmacy system used at the remote dispensing pharmacy.

(4) Have at least one thousand hours of practical experience working as a certified pharmacy technician in a pharmacy setting under the direct supervision of a pharmacist.

(5) Have worked at least one year in a pharmacy setting during the three years preceding the date the certified pharmacy technician begins working at the remote dispensing pharmacy.

(E) The supervising pharmacy shall attest that all certified pharmacy technicians meet the requirements of paragraph (D) of this rule. A record of such attestation shall be maintained at, or accessible by, the remote dispensing pharmacy and be produced for review immediately upon request of agent, officer, or inspector of the board.

(F) Before a pharmacy intern may work in a remote dispensing pharmacy, the pharmacy intern shall:

(1) Hold an active license as a pharmacy intern under Chapter 4729. of the Revised Code;

(2) Have at least one thousand hours of experience working as a certified pharmacy technician or pharmacy intern under the direct supervision of a pharmacist;

(3) Only five hundred hours of experience earned as part of the intern's introductory pharmacy practice experience or advanced pharmacy practice experience may count towards the hourly requirements described in paragraph (F)(2) of this rule.

(4) Have worked at least one thousand hours in a pharmacy setting during the three years preceding the date the pharmacy intern begins working at the remote dispensing pharmacy;

(5) Have completed a training program on the proper use of the telepharmacy system used at the remote dispensing pharmacy.

(G) The supervising pharmacy shall attest that all working pharmacy interns meet the requirements of paragraph (F) of this rule. A record of such attestation shall be maintained at, or accessible by, the remote dispensing pharmacy and be produced for review immediately upon request of agent, officer, or inspector of the board.

(H) Certified pharmacy technicians or pharmacy interns are not permitted to do any of the following while working at a remote dispensing pharmacy:

(1) Counsel an individual regarding drugs that are dispensed, recommend drugs and drug therapy-related devices or otherwise provide advice regarding drug therapy, or assist with selecting drugs and drug therapy related devices for treatment of common diseases and injuries or assist with providing instruction on their use;

(2) Perform compounding of sterile or nonsterile drugs, except for the reconstitution of prepackaged dangerous drugs;

(3) Engage in the repackaging of dangerous drugs;

(4) Administer immunizations or perform diagnostic testing, unless a pharmacist is physically onsite to provide direct supervision.

(I) Technicians-in-training, registered pharmacy technicians, or any other pharmacy personnel who do not meet the requirements of this chapter shall not engage in the practice of pharmacy or work at a remote dispensing pharmacy.

Last updated April 7, 2026 at 7:50 AM

Supplemental Information

Authorized By: 4729.26, 4729.554
Amplifies: 3719.28
Five Year Review Date: 4/6/2031
Rule 4729:5-18-06 | Technology requirements for a telepharmacy system.
 

(A) There shall be a fully functioning telepharmacy system in the remote dispensing pharmacy. The system shall always be operational when pharmacy personnel are working in the pharmacy.

(1) The telepharmacy system shall utilize positive identification and comply with the record keeping requirements for outpatient pharmacies in accordance with Chapter 4729:5-5 of the Administrative Code.

(2) In the event that the telepharmacy system is not functional for more than one-business day, the supervising pharmacist or another pharmacist employed by the supervising pharmacy shall be required to be physically on-site to allow for prescriptions to be dispensed during the normal business hours of the remote dispensing pharmacy.

(3) The supervising pharmacy shall have backup procedures to ensure prescriptions may be dispensed in the event of a telepharmacy system outage that is greater than one business day.

(4) In the event of a temporary telepharmacy system outage of less than the duration of one business day, the supervising pharmacist may direct the certified pharmacy technicians and/or pharmacy interns at the remote dispensing pharmacy to complete activities not requiring pharmacist verification or use of the telepharmacy system. Staff at the remote dispensing pharmacy may continue to sell prescriptions that have already been verified and dispensed by the pharmacist. In this case, patients shall be provided with a phone number where they can obtain patient counseling in accordance with rule 4729:5-5-09 of the Administrative Code.

(5) The telepharmacy system shall comply with all the following:

(a) Chapter 3798. of the Revised Code;

(b) 42 U.S.C. 1320d et. seq. (9/5/2025); and

(c) 45 C.F.R. parts 160, 162, and 164 (9/5/2025) for individually identifiable health information (HIPAA).

(B) The telepharmacy system shall, at a minimum, have high-definition image resolution with variable viewing options to accurately and safely dispense a dangerous drug or drug device and sufficient data retention capabilities to investigate any quality-related events.

(1) The telepharmacy system must produce images that are high definition with image resolution of at least three hundred pixels per inch.

(2) The images shall contain the following to ensure the pharmacist is able to appropriately verify the prescription prior to dispensing.

(a) A clear image of the prescription label affixed to the medication or device;

(b) The full quantity of the filled prescription;

(c) Except as provided in paragraph (B)(3) of this rule, the medication stock bottle or container and label of a drug that has been returned to stock in accordance with rule 4729:5-5-22 of the Administrative Code used to fill the prescription, if applicable; and

(d) Clear markings present on the pill or capsule, if applicable.

(3) The board may waive or modify the requirements listed in paragraph (B)(2)(c) of this rule if the remote dispensing pharmacy can provide an alternative method that accurately captures information from the medication stock bottle and/or container and label of a drug that has been returned to stock in accordance with rule 4729:5-5-22 of the Administrative Code.

(4) Images associated with the verification and dispensing of a prescription or device shall be retained and become part of the patient's profile and maintained for one year.

(C) There shall be a working computer link, video link, and audio link to the supervising pharmacist whenever the remote dispensing pharmacy is open to the public. The required technology must allow the supervising pharmacist to provide the personal assistance, direction, and approval needed to verify and ensure remote tasks are safely and properly performed.

(D) Written prescriptions presented to the remote dispensing pharmacy shall be scanned into the telepharmacy system. The original prescription must be able to be viewed at both the remote dispensing pharmacy and the supervising pharmacy.

(1) All information in the prescription shall be scanned in full color (i.e., retains color information and/or color graphics in the document) via technology designed to capture information in one form and reproduce it in an electronic medium presentable and usable to an end user.

(2) A prescription record or image once created shall be unalterable but may be annotated as necessary so long as the original record or image is still available for review and the individual that made the annotation is noted.

(E) Certified pharmacy technicians and/or pharmacy interns shall use barcoding technology when filling prescriptions at a remote dispensing pharmacy to ensure the accuracy of prescriptions dispensed in accordance with this chapter. Barcodes shall be scanned, and not manually typed, into the system.

The board may waive or modify the barcode technology requirements listed in this paragraph if the remote dispensing pharmacy can provide an alternative method to ensure the accuracy of prescriptions dispensed in accordance with this chapter.

(F) All records of prescriptions dispensed, including the records of the actions performed through the telepharmacy system, shall be maintained at the remote dispensing pharmacy, in a readily retrievable manner, for three years after the dispensation of the prescription.

Last updated April 7, 2026 at 7:53 AM

Supplemental Information

Authorized By: 4729.26, 4729.554
Amplifies: 3719.28
Five Year Review Date: 4/6/2031
Rule 4729:5-18-07 | Security requirements for a remote dispensing pharmacy.
 

(A) There shall be a fully functioning surveillance system in the remote dispensing pharmacy that is operational at all times.

(1) No operations of the remote dispensing pharmacy shall commence if the surveillance system is not functional.

(2) The video produced by the surveillance system must be stored for sixty days in a readily retrievable manner.

(3) The surveillance system shall be capable of providing not less than four simultaneous camera views of the pharmacy operation at the remote dispensing pharmacy.

(B) The surveillance system must allow the supervising pharmacist to determine who has accessed the pharmacy. A supervising pharmacist shall complete a training program on proper use of the surveillance system and documentation of this completion must be maintained at, or accessible by, the remote dispensing pharmacy and be produced for review immediately upon request of agent, officer, or inspector of the board.

(C) The supervising pharmacist shall supervise the remote dispensing pharmacy via the pharmacy surveillance system to deter and detect theft or diversion.

(D) The supervising pharmacist shall ensure that all dangerous drugs, drug devices, controlled substances, and hypodermics that are delivered onto the premises of the remote dispensing pharmacy are immediately placed and secured in the pharmacy.

(E) Pharmacy technicians and pharmacy interns who meet the qualifications of rule 4729:5- 18-05 of the Administrative Code and are employed by the remote dispensing pharmacy may only access the pharmacy if the supervising pharmacist is providing supervision via the pharmacy's surveillance system.

(F) An unlicensed person is permitted to enter the remote dispensing pharmacy if all the following apply:

(1) The person is performing maintenance or repair of the pharmacy;

(2) The supervising pharmacist provides supervision of the unlicensed person via the pharmacy's surveillance system; and

(3) There are two certified pharmacy technicians or pharmacy interns present in the pharmacy to provide on-site supervision of the unlicensed person.

(G) All schedule II controlled substance dangerous drugs shall be stored in a securely locked, substantially constructed cabinet or safe and shall not be dispersed throughout the stock of dangerous drugs maintained by the pharmacy. The cabinet or safe shall remain locked and secured when not in use. Schedule III through V controlled substance dangerous drugs may be stored with Schedule II controlled substance dangerous drugs.

(H) A remote dispensing pharmacy shall be secured by both:

(1) A physical barrier (i.e., barricade) with suitable locks approved by the board. Except for extraordinary circumstances beyond the pharmacy's control, a pharmacy shall notify the board, in a manner determined by the board, of any installation or modification to a physical barrier prior to implementation.

(2) An alarm system approved by the board that is monitored by a central station for control and can detect unauthorized access to the pharmacy. The alarm system shall be tested on a biannual basis. The pharmacy or the entity that manages security for the pharmacy shall maintain testing records for three years from the date of testing and shall make such records readily retrievable. The pharmacy shall be responsible for obtaining testing records if such records are maintained by a third-party. Except for extraordinary circumstances beyond the pharmacy's control, a pharmacy shall notify the board, in a manner determined by the board, of any installation or modification to an alarm system prior to implementation.

(I) The remote dispensing pharmacy shall contain all dangerous drugs, hypodermics, and D.E.A. controlled substance order forms and every other item or product that requires the supervision or sale by a pharmacist.

(J) Only the supervising pharmacist, certified pharmacy technicians, and pharmacy interns employed by the remote dispensing pharmacy may have access to keys or other methods of gaining access to the pharmacy.

(K) All keys, combinations, or access codes, including alarm codes, shall be changed upon termination of employment of an employee having knowledge of the combination or access code.

(L) No prescription, dangerous drug, hypodermic, nor any other item or product that requires the supervision or sale by a pharmacist may be sold, given away, or disposed of at any time the pharmacy is closed or the surveillance system is inoperable.

(M) New or refill prescriptions may be deposited into a secure area within the building where the pharmacy is located when the pharmacy is closed.

(N) If a remote dispensing pharmacy provides services by means of a drive-through facility, the drive-through facility shall be constructed and maintained in a manner, and with materials, that secures the premises of the pharmacy from unauthorized access.

Last updated April 7, 2026 at 7:51 AM

Supplemental Information

Authorized By: 4729.26, 4729.554
Amplifies: 3719.28
Five Year Review Date: 4/6/2031