Chapter 4729:6-2 | Licensure

Rule 4729:6-2-01 | Responsible person - drug distributor.

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

(A) A location licensed as a distributor of dangerous drugs, in accordance with section 4729.52 of the Revised Code, shall have a responsible person at all times.

(B) When there is a change of responsible person, the state board of pharmacy shall be notified by the new responsible person within ten days of the effective date of the appointment of the new responsible person in a manner determined by the board. The new responsible person shall submit to a criminal records check in accordance with rule 4729:6-2-03 of the Administrative Code.

(C) For all category III drug distributor licenses, a complete inventory, pursuant to rule 4729:6-3-06 of the Administrative Code shall be taken of the controlled substances on site by the new responsible person no later than thirty days from the separation date of the responsible person. The new responsible person shall be responsible for completing and maintaining this inventory record at the location licensed as a drug distributor.

(D) The responsible person for a location licensed as a distributor of dangerous drugs shall be responsible for compliance with all applicable state and federal laws, regulations, and rules governing the manufacture, sale and distribution of dangerous drugs.

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

(F) The board of pharmacy shall issue a resolution providing the credential types or qualifications required for the responsible person of each license/classification/business type of a distributor of dangerous drugs licensed in accordance with section 4729.52 of the Revised Code. Only individuals that meet the credentials specified may be the responsible person for that license/classification/business type. The resolution shall be updated as necessary and made available on the board's web site, www.pharmacy.ohio.gov.

(G) Unless otherwise approved by the board, a drug 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 agency as part of an official order of that 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 disciplined by the state board of pharmacy pursuant to Chapter 4729. of the Revised Code, except for a disciplinary action related to the failure to timely obtain continuing education required pursuant to agency 4729 of the Administrative Code.

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

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

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

(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.

(12) Has committed an act that constitutes a misdemeanor that is related to, or committed in, the employee's professional practice.

Last updated April 25, 2022 at 8:30 AM

Supplemental Information

Authorized By: 4729.26, 3719.28, 9.79
Amplifies: 4729.52
Five Year Review Date: 4/25/2027
Prior Effective Dates: 3/1/2019

Rule 4729:6-2-02 | Distributor of dangerous drugs licensing and renewal.

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

(A) All drug distributor licenses issued pursuant to Chapter 4729. of the Revised Code shall expire on the thirtieth day of June of every odd-numbered year. A license shall be renewed biennially according to the provisions of sections 4729.52 and 4729.53 of the Revised Code and the standard renewal procedure of Chapter 4745. of the Revised Code.

(B) An initial drug distributor license issued on or after the first day of May of every odd-numbered year shall receive an expiration date of the thirtieth day of June of the next odd-numbered year.

(C) A drug distributor who seeks to renew a license shall submit an application for renewal and pay the required fee in accordance with section 4729.52 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 drug distributor who has experienced a change in responsible person pursuant to section 4729:6-2-01 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 drug distributor who has experienced a change in description pursuant to rule 4729:6-2-05 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 4729:6-2-05 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 distributor of dangerous drug license shall be in accordance with sections 4729.52 and 125.18 of the Revised Code.

(G) Licensure pursuant to section 4729.52 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 drug distributor licensed pursuant section 4729.52 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 drug distributor until a valid license is issued by the board.

(I) A drug distributor 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 4729.55 and 125.18 of the Revised Code.

(J) A drug distributor 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 section 4729.55 and 125.18 of the Revised Code. A drug distributor filing a reinstatement application must meet the requirements of this chapter and section 4729.52 of the Revised Code.

(K) Paragraphs (D) and (E) of this rule do not limit the board from taking disciplinary action pursuant to rule 4729:6-4-01 of the Administrative Code against a licensee for failure to comply with the requirements of Chapter 4729:6-2 of the Administrative Code.

Last updated March 7, 2024 at 1:00 PM

Supplemental Information

Authorized By: 4729.26, 3719.28
Amplifies: 4729.52
Five Year Review Date: 3/7/2029
Prior Effective Dates: 3/1/2019

Rule 4729:6-2-03 | Criminal records checks.

• Effective: August 31, 2024
• Promulgated Under: 119.03

(A) Unless otherwise approved by the board, a new distributor of dangerous drug license will not be issued until the following persons submit fingerprints to the Ohio bureau of criminal investigation (BCI) for a criminal records check in accordance with paragraph (C) of this rule:

(1) The responsible person on the application for licensure; and

(2) The following persons based upon the drug distributor's business type:

(a) All partners of a partnership.

(b) The sole proprietor of a sole proprietorship.

(c) All members of a limited liability company.

(i) If the limited liability company has a member which is not a natural person, the limited liability company's president, vice president, secretary, treasurer, and chief executive officer, or any equivalent position.

(ii) If the limited liability company's sole member is a publicly traded corporation, the limited-liability company may seek a waiver pursuant to paragraph (A)(3) of this rule.

(d) Except as provided in paragraph (A)(3) of this rule, 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. If the director or the director's designee determines other person(s) in the organizational structure have substantial control, such as the power to influence management and operational decision-making over the distribution of dangerous drugs, the director or designee may require a criminal records check of those with substantial control in addition to or in place of those persons set forth in this paragraph.

(e) The executive director or any equivalent position of a nonprofit organization.

(3) For publicly traded corporations, the board's executive director or the director's designee may waive the criminal records checks required in paragraph (A)(2)(c) of this rule under the following circumstances:

(a) The publicly traded corporation submits a request to the executive director and includes the organizational structure of the corporation, including all corporate officer positions responsible for directing the distribution of dangerous drugs. The director or the director's designee may request additional information about the corporation's organizational structure.

(b) The executive director or the director's designee approves an alternate list of corporate officers who are required to submit a criminal records check. If approval is not provided, the publicly traded corporation shall comply with paragraph (A)(2)(c) of this rule.

(B) The persons listed in paragraph (A)(2) 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.

(C) All criminal records checks conducted in accordance with this rule shall consist of both a BCI criminal records check and a federal bureau of investigations records check (FBI) and shall comply with the following:

(1) Be based on electronic fingerprint impressions that are submitted directly to BCI from a WebCheck provider agency or ink impressions. The state board of pharmacy may accept the results of a criminal records check based on ink impressions only in the following circumstances:

(a) Readable electronic fingerprint impressions cannot be obtained or are rejected by either BCI or FBI;

(b) The person or persons listed in paragraph (A) of this rule reside outside of the state of Ohio; or

(c) The person or persons listed in paragraph (A) of this rule have a home address that is seventy-five miles or more from the nearest WebCheck location.

(2) Results will only be considered valid if the fingerprint impressions were obtained within one year of the date the application is received by the board.

(3) The results of the criminal records check must be sent directly to the state board of pharmacy from BCI.

(D) Only new persons listed in paragraphs (A)(1) and (A)(2) of this rule shall be required to submit to a criminal records check for a new application resulting from a change in the description of a distributor of dangerous drugs pursuant to rule 4729:6-2-05 of the Administrative Code.

Last updated September 3, 2024 at 8:36 AM

Supplemental Information

Authorized By: 3719.28, 4729.26, 4729.53
Amplifies: 4729.52
Five Year Review Date: 8/31/2029
Prior Effective Dates: 3/1/2019

Rule 4729:6-2-04 | Drug distributor applications.

• Effective: August 31, 2024
• Promulgated Under: 119.03

(A) The following information shall be required on a form supplied by the state board of pharmacy from each person making application for a license as a distributor of dangerous drugs:

(1) The name, full physical business address (not a post office box), and telephone number.

(2) All trade, fictitious, or business names used by the licensee (e.g. "doing business as" or "formerly known as").

(3) Addresses, telephone numbers, and the full names of contact persons for all facilities used by the licensee for the storage, handling, and distribution of dangerous drugs located in this state or used to distribute drugs into this state.

(4) The type of ownership or operation (i.e., sole proprietorship, partnership, limited liability company, corporation, government agency, or nonprofit organization).

(5) The following information for the owner(s) and/or operator(s) of the drug distributor:

(a) For a partnership:

(i) The full name, business address, social security number, and date of birth of each partner. If the partner is not a natural person, each business entity that is a partner having an ownership interest must be disclosed on the application up to and through the entity that is owned by a natural person.

(ii) The name of the partnership.

(iii) The partnership's federal employer identification number.

(b) For a sole proprietorship: the full name, business address, social security number, and date of birth of the sole proprietor.

(c) For a limited lability company: the full name, business address, social security number, and date of birth of each member. If the member(s) is not a natural person, each business entity that is a member having an ownership interest must be disclosed on the application up to and through the entity that is owned by a natural person.

(d) For a corporation:

(i) The full name, business address, social security number, and date of birth of the corporation's president, vice-president, secretary, treasurer, and chief executive officer, or any equivalent position. For a publicly traded corporation that obtains a criminal records check waiver pursuant to paragraph (A)(3) of rule 4729:6-2-03 of the Administrative Code, the full name, business address, social security number, and date of birth of the corporate officers subject to a criminal records check as determined by the board's executive director or director's designee.

(ii) The name or names of the corporation.

(iii) The state of incorporation.

(iv) The corporation's federal employer identification number.

(v) The name of the parent company, if applicable.

(vi) If the corporation is not publicly traded on a major stock exchange, the full name, business address, and social security number of each shareholder owning ten percent or more of the voting stock of the corporation.

(e) For a government agency: the full name, business address, social security number, and date of birth of the agency director.

(f) For a nonprofit organization: the full name, business address, social security number, and date of birth of the executive director or any equivalent position.

(6) If the entity submitting an application for a distributor of dangerous drugs license is located outside the boundaries of the state of Ohio, the licensing process shall include an inquiry to the licensing authority of the state where located to determine if the entity possesses a current and valid license or registration to distribute dangerous drugs in that state and any disciplinary action, including actions pending, the licensing authority is taking or may have taken against the entity. This information may be used to determine if the business entity should be granted a license by the state board of pharmacy. An entity located outside the boundaries of the state of Ohio that is making application for licensure as a third-party logistics provider or virtual wholesaler shall maintain an applicable accreditation from the national association of boards of pharmacy if the state where the entity resides does not license such entities.

(7) If applicable, proof of the entity's valid registration with the United States food and drug administration and/or the United States drug enforcement administration.

(8) Any information required on the application as determined by the board.

(9) Any follow-up information as deemed necessary by the board's executive director or the director's designee upon receipt of the application materials.

(B) Prior to the end of the licensing period established in rule 4729:6-2-02 of the Administrative Code, a renewal application requesting such information as the state board of pharmacy may require will be sent to the email or physical address of record to the attention of the responsible person. Such renewal application form shall be completed and returned with the applicable fee on or before the date established in rule 4729:6-2-02 of the Administrative Code.

(C) The board shall not license an entity located outside of the United States.

(D) Except as provided in paragraph (D)(1) of this rule, an applicant or licensee engaged in the distribution of dangerous drugs shall obtain all applicable licenses issued in accordance with this division of the Administrative Code.

(1) This provision does not apply to a manufacturer who is also engaged in the wholesale distribution of dangerous drugs.

(2) An applicant or licensee engaged in activities requiring multiple licenses shall ensure that all requirements for each license can be maintained and all applicable drug records are segregated by license type.

Last updated September 3, 2024 at 8:37 AM

Supplemental Information

Authorized By: 3719.28, 4729.26
Amplifies: 4729.52
Five Year Review Date: 8/31/2029
Prior Effective Dates: 3/1/2019

Rule 4729:6-2-05 | Change in description of a 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 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 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 drug 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) 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 9:00 AM

Supplemental Information

Authorized By: 4729.26
Amplifies: 4729.51, 4729.52, 4729.53
Five Year Review Date: 10/1/2029
Prior Effective Dates: 9/10/1976, 2/1/2003, 1/1/2009, 10/15/2015, 3/1/2019

Rule 4729:6-2-06 | Procedure for discontinuing business as a distributor of dangerous drugs.

• Effective: August 31, 2024
• Promulgated Under: 119.03

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

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

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

(3) The name and address of the secured location where the records required to be maintained in accordance with this division will be stored.

(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 drug records.

(C) On the date of discontinuing business, a complete inventory of all controlled substances being transferred, or disposed pursuant to rule 4729:6-3-01 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.

Last updated September 3, 2024 at 8:37 AM

Supplemental Information

Authorized By: 4729.26, 3719.28
Amplifies: 4729.26
Five Year Review Date: 8/31/2029
Prior Effective Dates: 7/1/1992, 1/1/2011, 3/1/2019