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This website publishes administrative rules on their effective dates, as designated by the adopting state agencies, colleges, and universities.

Chapter 4729:6-2 | Distributor of Dangerous Drugs

 
 
 
Rule
Rule 4729:6-2-01 | Responsible Person - Drug Distributor.
 

(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 misdemeanor theft offense, regardless of the jurisdiction in which the act was committed.

(4) Has committed an act that constitutes a misdemeanor drug offense, except for a minor misdemeanor drug offense, regardless of the jurisdiction in which the act was committed.

(5) Has committed an act that constitutes a felony, regardless of the jurisdiction in which the act was committed.

(6) 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.

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

(8) 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.

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

(10) 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.

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

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

(13) 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.

(14) Has committed an act that constitutes a misdemeanor that is related to, or committed in, the employees professional practice.

(15) Has committed an act of moral turpitude that constitutes a felony or misdemeanor in this state, regardless of the jurisdiction in which the act was committed.

Supplemental Information

Authorized By: 4729.26, 3719.28
Amplifies: 4729.52
Five Year Review Date: 3/1/2023
Rule 4729:6-2-02 | Distributor of dangerous drugs licensing and renewal.
 

(A) Upon the effective date of this rule:

(1) All drug distributor licenses issued pursuant to section 4729.52 of the Revise Code shall be effective for a period of twelve months from the first day of July of each year. A license shall be renewed by the board for a like period, annually, 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.

(2) A person 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 on or before the thirtieth day of June each year.

(3) The required fees for initial licensure and annual renewal of a distributor of dangerous drug license are as follows:

(a) For a category II license: nine hundred fifty dollars;

(b) For a category III license: one thousand dollars.

(B) Effective July 1, 2019:

(1) All drug distributor licenses issued pursuant to section 4729.52 of the Revised Code shall be effective for a period of twenty-four months from the first day of July of every odd-numbered year. A license shall be renewed by the board for a like period, 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.

(2) A person 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 on or before the thirtieth day of June of every odd-numbered year.

(3) The required fees for initial licensure and biennial renewal of a distributor of dangerous drug licensure shall be in accordance with section 4729.52 of the Revised Code.

(C) Paragraph (A) of this rule is no longer applicable effective July 1, 2019.

(D) 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.

(E) A person licensed pursuant section 4729.52 of the Revised Code that fails to renew a license in accordance with this section and rules adopted by the board is prohibited from engaging in any authorized activity of a drug distributor until a valid license is issued by the board.

Supplemental Information

Authorized By: 4729.26, 3719.28
Amplifies: 4729.52
Five Year Review Date: 3/1/2023
Rule 4729:6-2-03 | Criminal Records Checks.
 

(A) A new distributor of dangerous drug license will not be issued until the following persons submit fingerprints to the Ohio bureau of criminal identification and investigation (BCI&I) 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) 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.

(d) The agency director of a government agency.

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

(a) The public 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 directors 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 that 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&I 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&I 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&I 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&I.

(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.

Supplemental Information

Authorized By: 3719.28, 4729.26
Amplifies: 4729.52
Five Year Review Date: 3/1/2023
Rule 4729:6-2-04 | Drug Distributor Applications.
 

(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"). Trade or business names shall not be identical to the name used by another, unrelated drug distributor permitted to purchase or sell drugs in this state.

(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, corporation, or government agency).

(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 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 boards executive director or directors 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.

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

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

(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 or jurisdiction to determine if the entity possesses a current and valid license to distribute dangerous drugs in that state or jurisdiction 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 verified-accredited wholesale distributors (VAWD) 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 entitys 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.

Supplemental Information

Authorized By: 3719.28, 4729.26
Amplifies: 4729.52
Five Year Review Date: 3/1/2023
Rule 4729:6-2-05 | Change in description of a distributor of dangerous drugs.
 

(A) Any change in the ownership, business or trade name, category, or address of a distributor of dangerous drugs requires a new application, required fee, and license. The new 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) A change of controlling interest of ten per cent or more of a licensed corporation's outstanding shares of voting stock.

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

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

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

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

(6) 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.

(7) 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 or removal 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) For partnerships, a transfer of a proportion of ownership among existing partners is not a change of ownership, if there is no addition or removal of a partner.

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

(C) For publicly traded corporations, a routine sale of stock is not a change of ownership. A publicly traded corporation is a corporation owned by stockholders who are members of the general public and who trade shares publicly, often through a listing on a stock exchange.

(D) 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), a new application fee is required.

(E) A change of ownership set forth in this rule or as otherwise determined by the board's executive director or the director's designee may require the board to issue a new license number.

(F) A change of ownership as described in paragraph (B) of this rule of a licensee's parent or holding company shall not require a new application, required fee, and license.

(G) A change of credential class shall require notification to the board and may also require a new application. A change of credential class may not require a full application fee and the board may charge a nominal processing fee.

Supplemental Information

Authorized By: 4729.26
Amplifies: 4729.51, 4729.54, 4729.52
Five Year Review Date: 3/1/2023
Prior Effective Dates: 1/1/2009, 10/15/2015, 2/1/2017
Rule 4729:6-2-06 | Procedure for discontinuing business as a distributor of dangerous drugs.
 

(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, at least thirty days in advance of the proposed date of discontinuing business, unless waived by the board's executive director or the director's designee due to extraordinary circumstances beyond the licensee's control. 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 records in accordance with the following:

(1) 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.

(2) 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.

Supplemental Information

Authorized By: 4729.26, 3719.28
Amplifies: 4729.26
Five Year Review Date: 3/1/2023
Prior Effective Dates: 9/10/1976, 1/1/2011