Chapter 4729:5-2 | Licensure

Rule 4729:5-2-01 | Responsible person - terminal distributor.

• Effective: April 25, 2022
• Promulgated Under: 119.03

(A) Except as provided in paragraph (B) of this rule, for a pharmacy licensed as a terminal distributor of dangerous drugs:

(1) Only a pharmacist may be the responsible person whose name appears on the terminal distributor of dangerous drugs license for a pharmacy as defined in division (A) of section 4729.01 of the Revised Code. A pharmacist shall be the responsible person for no more than one such pharmacy or campus unless granted permission in accordance with paragraph (G) of this rule.

(2) The responsible person shall be responsible for the practice of the profession of pharmacy, including, but not limited to, 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.

(3) The person to whom the terminal distributor of dangerous drugs license has been issued and all pharmacists on duty are responsible for compliance with all state and federal laws, regulations, and rules governing the distribution of drugs and the practice of pharmacy.

(B) For an institutional pharmacy licensed as a terminal distributor of dangerous drugs:

(1) Only a pharmacist licensed under section 4729. of the Revised Code may be the responsible person whose name appears on the terminal distributor of dangerous drugs license for an institutional pharmacy. A pharmacist shall be the responsible person for no more than one such pharmacy or campus unless granted permission in accordance with paragraph (G) of this rule.

(2) The responsible person shall be responsible for all of the following:

(a) The practice of the profession of pharmacy performed within the institutional facility, including, but not limited to, 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.

(b) The development, implementation, supervision, and coordination of all services provided by the institutional pharmacy.

(c) In conjunction with the appropriate interdisciplinary committees, the development of written policies and procedures which are consistent with this division of the Administrative Code and other applicable federal and state laws, regulations and rules governing the legal distribution of drugs, adherence to these policies and procedures in order to provide for the safe distribution of drugs in all areas of the institutional facility, and making readily retrievable a current copy of these written policies and procedures.

(3) The person to whom the terminal distributor of dangerous drugs license has been issued and all pharmacists on duty are responsible for compliance with all state and federal laws, regulations, and rules governing the distribution of drugs and the practice of pharmacy.

(C) For locations licensed as a category III terminal distributor of dangerous drugs with a pain management classification under section 4729.552 of the Revised Code:

(1) Only a physician authorized under Chapter 4731. of the Revised Code to practice medicine and surgery or osteopathic medicine and surgery may be the responsible person whose name appears on the category III terminal distributor of dangerous drugs with a pain management classification license as defined in section 4729.552 of the Revised Code. A physician shall be the responsible person for no more than one such location unless granted permission in accordance with paragraph (G) of this rule. A physician shall not be designated the responsible person for a location licensed as a category III terminal distributor of dangerous drugs with a pain management classification unless the physician will be physically present at the location for a sufficient amount of time to provide adequate supervision.

(2) The responsible person shall submit to a criminal records check in accordance with section 4776.02 of the Revised Code.

(3) The responsible person for locations licensed as a category III terminal distributor of dangerous drugs with a pain management classification under section 4729.552 of the Revised Code must meet one of the following requirements:

(a) Hold current subspecialty certification in pain management by the American board of medical specialties, or hold a current certificate of added qualification in pain management by the American osteopathic association bureau of osteopathic specialists;

(b) Hold current subspecialty certification in hospice and palliative medicine by the American board of medical specialties, or hold a current certificate of added qualification in hospice and palliative medicine by the American osteopathic association bureau of osteopathic specialists;

(c) Hold current board certification by the American board of pain medicine;

(d) Hold current board certification by the American board of interventional pain physicians; or

(e) Hold current board certification in anesthesiology, psychiatry, neurology, physical medicine and rehabilitation, occupational medicine, or rheumatology by the American board of medical specialties or hold current primary certification in anesthesiology, psychiatry, neurology, physical medicine and rehabilitation, occupational medicine, or rheumatology by the American osteopathic association bureau of osteopathic specialists.

(4) The person to whom the category III terminal distributor of dangerous drugs license with a pain management clinic classification has been issued, the responsible person and all licensed health professionals practicing at that location are responsible for compliance with all state and federal laws, regulations, and rules governing the operation of a pain management clinic and prescribing of controlled substances.

(D) For locations licensed as a category III terminal distributor of dangerous drugs with an office-based opioid treatment classification under section 4729.553 of the Revised Code:

(1) Only a physician or certified nurse practitioner who meets the following may be the responsible person whose name appears on the category III terminal distributor of dangerous drugs with an office-based opioid treatment classification license as defined in section 4729.553 of the Revised Code:

(a) The physician is authorized under Chapter 4731. of the Revised Code to practice medicine and surgery or osteopathic medicine and surgery or the certified nurse practitioner is designated as a certified nurse practitioner in accordance with section 4723.42 of the Revised Code and rules adopted by the board of nursing; and

(b) The physician or certified nurse practitioner possesses a waiver to prescribe or personally furnish buprenorphine under the Drug Addiction Treatment Act of 2000 (DATA 2000) (2/20/2017).

(2) The responsible person shall submit to a criminal records check in accordance with section 4776.02 of the Revised Code.

(3) A physician or certified nurse practitioner shall not be designated the responsible person for a location licensed as a category III terminal distributor of dangerous drugs with an office-based opioid treatment classification unless the physician or certified nurse practitioner will be physically present at the location for at least fifteen hours per week. If the facility is not open more than fifteen hours per week, the minimum amount of on-site supervision shall be at least fifty per cent of the total hours the facility is open, as reported to the board by the licensee on the application. Any changes to the licensee's hours of operation shall be reported to the board, in a manner determined by the board, within three business days.

(a) The hour requirements of this paragraph do not apply if either:

(i) The responsible person is unable to meet the requirements due to a documented illness or emergency and there is another physician or certified nurse practitioner on-site who meets the requirements of paragraph (C)(1) of this rule who can provide on-site supervision in accordance with the requirements described in this paragraph. The physician or certified nurse practitioner shall assume all responsibilities for compliance with this rule in the absence of the responsible person.

(ii) The location is closed for a state or federal holiday or other documented reason.

(4) The person to whom the category III terminal distributor of dangerous drugs license with an office-based opioid treatment classification has been issued, the responsible person and all licensed health professionals practicing at that location are responsible for compliance with all state and federal laws, regulations, and rules regulating the operation of an office-based opioid treatment facility and prescribing of controlled substances.

(E) For all locations licensed as a terminal distributor of dangerous drugs:

(1) A location licensed as a terminal distributor of dangerous drugs must have a responsible person at all times.

(2) When there is a change of responsible person, the state board of pharmacy shall be notified within ten days of the effective date of the appointment of the new responsible person in a manner determined by the board. For a limited terminal distributor of dangerous drugs license, the notification shall include a drug list required in accordance with agency 4729 of the Administrative Code.

(3) A complete inventory, pursuant to 21 CFR 1304.11 of the Code of Federal Regulations (9/9/2014) and rule 4729:5-3-07 of the Administrative Code, shall be taken of the controlled substances on hand by the new responsible person on the effective date of the change of responsible person. The new responsible person shall be responsible for completing and maintaining this inventory record at the location licensed as a terminal distributor of dangerous drugs.

(4) The responsible person to whom the terminal distributor of dangerous drugs license has been issued and all licensed health professionals on duty are responsible for compliance with all state and federal laws, regulations, and rules governing the distribution of dangerous drugs.

(5) A responsible person must be physically present at the location for a sufficient amount of time to provide supervision and control of dangerous drugs on-site.

(6) The responsible person shall be responsible for ensuring the terminal distributor of dangerous drugs requirements are met, including, but not limited to, 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.

(7) The board of pharmacy shall issue a resolution providing the credential types required for the responsible person of each classification/business type of terminal distributor of dangerous drugs license. Only individuals that meet the credentials specified may be the responsible person for that classification/business type. The resolution shall be updated as necessary and shall be made available on the board's web site (www.pharmacy.ohio.gov).

(F) Unless otherwise approved by the board, a terminal distributor shall not have a responsible person who:

(1) Has been denied the right to work in any facility by the state board of pharmacy as part of an official order of the board.

(2) Has been denied the right to work in such a facility by another professional licensing board/agency as part of an official order of that board/agency.

(3) Has committed an act that constitutes a disqualifying offense, regardless of the jurisdiction in which the act was committed.

(4) Has been subject to any of the following:

(a) A finding by a court of the person's eligibility for intervention in lieu of conviction; or

(b) A finding by a court of the person's eligibility for treatment or intervention in lieu of conviction in another jurisdiction.

(5) Has been granted entry into a diversion program, deferred prosecution program, or the equivalent thereof.

(6) Cannot practice according to acceptable and prevailing standards of care by reason of mental illness or physical illness, including, but not limited to, physical deterioration that adversely affects cognitive, motor, or perceptive skills.

(7) Is addicted to or abusing alcohol or drugs.

(8) Has been excluded from participation in medicare or a state health care program.

(9) Has been denied a license or registration by the drug enforcement administration or appropriate issuing body of any state or jurisdiction.

(10) Has been the subject of any of the following by the drug enforcement administration or licensing agency of any state or jurisdiction:

(a) A disciplinary action that resulted in the suspension, probation, surrender or revocation of the person's license or registration; or

(b) A disciplinary action that was based, in whole or in part, on the person's inappropriate prescribing, dispensing, diverting, administering, storing, securing, personally furnishing, compounding, supplying or selling a controlled substance or other dangerous drug.

(G) Written requests for being a responsible person at more than one location pursuant to this rule must be submitted to the state board of pharmacy in a manner determined by the board. The executive director or the director's designee shall have the authority to temporarily approve or deny a request for being a responsible person at more than one location for a period not to exceed sixty days. The full board will review requests the executive director or the director's designee has temporarily approved at the next scheduled board meeting. A terminal distributor of dangerous drugs whose request has been denied either by the executive director, the director's designee or the board will be provided with a written explanation of denial and allowed one opportunity to resubmit its request to address the identified concerns. The board may impose conditions on all approved requests, including requirements that requests be submitted for reapproval at intervals determined by the board.

Last updated April 25, 2022 at 8:29 AM

Supplemental Information

Authorized By: 4729.26, 3719.28, 9.79
Amplifies: 4729.54
Five Year Review Date: 4/25/2027
Prior Effective Dates: 3/1/2019

Rule 4729:5-2-02 | Terminal distributor of dangerous drugs licensing and renewal.

• Effective: March 7, 2024
• Promulgated Under: 119.03

(A) All terminal distributor of dangerous drugs licenses issued pursuant to Chapter 4729. of the Revised Code shall expire on the thirty-first day of March of every odd-numbered year. A license shall be renewed biennially according to the provisions of sections 4729.54 and 4729.55 of the Revised Code and the standard renewal procedure of Chapter 4745. of the Revised Code.

(B) An initial terminal distributor of dangerous drugs license issued on or after the thirtieth day of January of every odd-numbered year shall receive an expiration date of the thirty-first day of March of the next odd-numbered year.

(C) A terminal distributor of dangerous drugs who seeks to renew a license shall submit an application for renewal and pay the required fee in accordance with section 4729.54 of the Revised Code, including any transaction fee as required by section 125.18 of the Revised Code, on or before the license expiration date.

(D) A terminal distributor of dangerous drugs who has experienced a change in responsible person pursuant to rule 4729:5-2-01 of the Administrative Code and has not yet reported such change to the board, shall submit the required notification prior to submitting a renewal application.

(E) A terminal distributor of dangerous drugs who has experienced a change in description pursuant to rule 4729:5-2-03 of the Administrative Code and has not yet reported such change to the board, shall submit the required application and fee in lieu of a renewal application.

An application and fee submitted pursuant to rule 4729:5-2-03 of the Administrative Code during the renewal period will qualify as a renewal application and be awarded an expiration date in accordance with paragraph (A) of this rule.

(F) The required fees for initial licensure and biennial renewal of a terminal distributor of dangerous drugs license shall be in accordance with sections 4729.55 and 125.18 of the Revised Code.

(G) Licensure pursuant to section 4729.54 of the Revised Code is not applicable to any facility owned or operated by the following:

(1) The United States department of defense;

(2) The United States department of veterans affairs; or

(3) Any other federal agency.

(H) A terminal distributor of dangerous drugs licensed pursuant section 4729.54 of the Revised Code that fails to renew its license in accordance with this division of the Administrative Code is prohibited from engaging in any authorized activity of a terminal distributor of dangerous drugs until a valid license is issued by the board.

(I) A terminal distributor of dangerous drugs that fails to renew its license by the expiration date is considered lapsed and may be reinstated upon receipt of a renewal application, fee, and penalty as specified in sections 4729.54 and 125.18 of the Revised Code.

(J) A terminal distributor of dangerous drugs that has lapsed for more than sixty days after its expiration date is considered expired and may be reinstated upon receipt of a reinstatement application and fee as specified in sections 4729.54 and 125.18 of the Revised Code. A terminal distributor filing a reinstatement application must meet the requirements of this chapter and section 4729.55 of the Revised Code.

(K) Paragraphs (D) and (E) of this rule do not limit the board from taking disciplinary action pursuant to rule 4729:5-4-01 of the Administrative Code against a licensee for failure to comply with the requirements of Chapter 4729:5-2 of the Administrative Code.

Last updated March 7, 2024 at 7:45 AM

Supplemental Information

Authorized By: 4729.26
Amplifies: 4729.55, 4729.54
Five Year Review Date: 3/7/2029

Rule 4729:5-2-03 | Change in description of a terminal distributor of dangerous drugs.

• Effective: October 1, 2024
• Promulgated Under: 119.03

(A) Any change in the ownership, business or trade name, category, or address of a terminal distributor of dangerous drugs requires an application and required fee. The application and required fee shall be submitted within thirty days of any change in the ownership, business or trade name, category, or address.

(B) A change of ownership includes any of the following:

(1) For all terminal distributors of dangerous drugs:

(a) Any business entity change from its original form, as licensed, to a sole proprietorship, partnership, limited liability company, corporation, or any other business entity.

(b) Two wholly owned subsidiaries of a parent company are merged.

(c) A currently licensed terminal distributor is purchased or operated by a different business entity than what is listed on the original application, even if the location maintains the original "doing business as" (DBA) and/or responsible person.

(2) For corporations:

(a) Except as provided in paragraph (B)(2)(d) of this rule, a change of controlling interest of ten per cent or more of a licensed corporation's outstanding shares of voting stock.

(b) An existing corporation ceases, and a new corporation or other business entity is formed.

(c) An existing corporation continues and there is a one hundred per cent stock purchase by another corporation or other business entity.

(d) For publicly traded corporations, a routine sale of stock is not a change of ownership.

A publicly traded corporation is a company that has listed itself on at least one public stock exchange or has issued securities and is subject to public reporting requirements.

(3) For partnerships, any partnership change, other than that which was originally licensed.

(a) A partnership change is deemed to have occurred when:

(i) There is an addition of one or more partners in a partnership to which a license is issued.

(ii) The entity is sold, and the sale becomes final.

(b) A transfer of a portion of ownership among existing partners is not a change of ownership, if there is no addition of a partner.

(4) For a limited liability company, any membership change of a limited liability company, other than that which was originally licensed.

(a) A membership change is deemed to have occurred when:

(i) There is an addition of one or more members in a company to which a license is issued.

(ii) The entity is sold, and the sale becomes final.

(b) For limited liability companies, a transfer of a portion of ownership among existing members is not a change of ownership, if there is no addition of a member.

(5) Any other business model change, as determined by the board to be a change of ownership.

(C) If any change of ownership in accordance with paragraph (B) of this rule results in a new or different DBA or a new or different employer identification number (EIN), an application and fee is required.

(D) A change of ownership in accordance with this rule may result in the issuance of a new license.

(E) A change of ownership, as described in paragraph (B) of this rule, of a licensee's parent or holding company which does not exercise direct control of the licensed entity, shall not require an application, fee, or new license number.

(F) A change of address includes the physical relocation of the licensee's operations and location of the drug stock. This shall include a change of suites within an existing building or campus.

(G) A change of address that results from a change within a local government entity or United States postal service (U.S.P.S.) that does not include any physical relocation of the licensee's operations shall not require an application and fee. The licensee shall submit written notification to the board, in a manner determined by the board, indicating the change of address.

Last updated October 1, 2024 at 9:19 AM

Supplemental Information

Authorized By: 4729.26, 3719.28
Amplifies: 4729.55, 4729.54
Five Year Review Date: 10/1/2029
Prior Effective Dates: 8/1/2019

Rule 4729:5-2-04 | Procedure for discontinuing business as a terminal distributor of dangerous drugs.

• Effective: October 1, 2024
• Promulgated Under: 119.03

(A) A terminal distributor of dangerous drugs who plans to discontinue business activities shall file a notice with the board of pharmacy. The notice shall be submitted, in a manner determined by the board, within thirty days of discontinuation of business as a terminal distributor of dangerous drugs. This notice shall include the following information:

(1) The name, address, and license number of the terminal distributor discontinuing business.

(2) The name, address, and license number of the terminal distributor or other authorized entity where the dangerous drugs will be transferred.

(3) The name and address of the secured location where the records of purchase and sale will be kept in accordance with this division of the Administrative Code.

(4) The proposed date of discontinuing business.

(B) Unless the licensee is informed by the executive director before the proposed date of discontinuing business that the transfer of dangerous drugs and records may not occur, the licensee discontinuing business may transfer the dangerous drugs and patient records.

(C) On the date of discontinuing business, a complete inventory of all controlled substances being transferred, or disposed of, in accordance with rule 4729:5-3-01 of the Administrative Code, shall be made. The inventory shall list the name, strength, dosage form, and quantity of all controlled substances transferred or disposed.

This inventory shall serve as the final inventory of the licensee discontinuing business and the initial inventory of the licensee to whom the controlled substances are being transferred. A copy of the inventory shall be included in the records of each licensee involved in the transfer.

(D) A terminal distributor of dangerous drugs licensed as a pharmacy that is permanently closing shall:

(1) Provide notification, using the information on file with the pharmacy, to each patient who has filled a prescription within the previous six months. This notification must be made a minimum of fifteen calendar days prior to closing and must include:

(a) The last day the pharmacy will be open;

(b) Name, address, and telephone number of the pharmacy that will take possession of the pharmacy records or the person who will serve as the custodian of records;

(c) Instructions on how patients can arrange for transfer of their pharmacy records to a pharmacy of their choice; and

(d) The last day a transfer may be initiated.

(2) The notification shall be made via:

(a) Direct mail, e-mail, or text message; and

(b) Posting a closing notice on each pharmacy entrance, on each telephone greeting, and pharmacy-operated internet (e.g., website, social media, mobile applications).

(3) Provide any new patients filling prescriptions during the fifteen-calendar day period prior to the pharmacy closing with written notification that includes:

(a) The last day the pharmacy will be open;

(b) Name, address and telephone number of the pharmacy to which pharmacy records will be transferred or the person who will serve as the custodian of pharmacy records;

(c) Instructions on how patients can arrange for transfer of their pharmacy records to a pharmacy of their choice; and

(d) The last day a transfer may be initiated.

Last updated October 1, 2024 at 9:19 AM

Supplemental Information

Authorized By: 4729.26, 3719.28
Amplifies: 4729.54, 3719.07, 4729.37, 4729.55
Five Year Review Date: 10/1/2029
Prior Effective Dates: 3/1/2019

Rule 4729:5-2-05 | Notification of Accessible Services.

• Effective: August 23, 2024
• Promulgated Under: 119.03

(A) Every outpatient pharmacy providing pharmacy services in this state shall report to the state board of pharmacy, in a manner determined by the board, the following information on accessible services provided by the pharmacy within ninety days of the effective date of this rule:

(1) The type of language translation services, including translated prescription labels, for patients who are of limited English proficiency;

(2) The type of services available for patients who are hard of hearing; and

(3) The type of services available for patients with low vision.

(B) As part of the licensure and renewal process established in rule 4729:5-2-02 of the Administrative Code, an outpatient pharmacy providing pharmacy services in this state shall submit information on the accessible services listed in paragraph (A) of this rule that are provided by the pharmacy.

(C) An outpatient pharmacy required to submit notification to the board in accordance with this rule shall notify the board within thirty days of any change in the accessible services provided by the pharmacy.

(D) Except as provided in paragraph (E) of this rule, a pharmacy that reports it offers accessible services shall be required to provide those services to patients upon request.

(E) Paragraph (D) of this rule does not apply if the pharmacy experiences a temporary software or equipment failure of the accessible service offered.

Last updated August 23, 2024 at 7:53 AM

Supplemental Information

Authorized By: 3719.28, 4729.26
Amplifies: 4729.55
Five Year Review Date: 8/23/2029