4729-9-30 Wholesale Distributor with a Broker Classification.

(A) "Broker" means any person engaged in the marketing, offering, or contracting for wholesale distribution and sale of a dangerous drug in or into Ohio who does not take physical possession of dangerous drugs.

(B) Brokers shall be licensed by the state board of pharmacy as a wholesale distributor pursuant to section 4729.52 of the Revised Code with a broker classification.

(C) Brokers shall be registered as a business entity with the appropriate state or local authority(s) and must operate out of a location that is zoned for commercial use and not out of a residence or personal dwelling.

(D) 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 wholesale distributor of dangerous drugs with a broker classification:

(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 wholesale distributor permitted to purchase drugs in the state.

(3) Addresses, telephone numbers, and the full names of contact persons for all facilities used by the licensee for the storage of records relating to the distribution of dangerous drugs;

(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 wholesale distributor with a broker classification:

(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, date of birth, of the corporation's president, vice-president, secretary, treasurer and chief executive officer, or any equivalent position;

(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; and

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

(c) For a sole proprietorship:

(i) The full name, business address, social security number, and date of birth of the sole proprietor; and

(ii) If applicable, the federal employer identification number of the business entity.

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

(6) A copy of any existing licensure the entity has from the state in which it is located or a letter from a state entity where it is located that indicates that the state does not license such entities;

(7) A copy of any applicable federal licensure or registration;

(8) If the entity making application for a wholesale distributor of dangerous drugs license with a broker classification is located outside the boundaries of the state of Ohio, part of the licensing process shall be an inquiry to the licensing authority of the state in which that entity is located. This inquiry will determine whether the entity possesses a current and valid license to broker dangerous drugs in that state and the experience the licensing authority has had with the entity. This information will be used as part of the consideration in licensing the entity by the board of pharmacy. The board will respond to inquiries of a similar nature from other states regarding Ohio licensed entities.

(9) Pursuant to section 4729.53 of the Revised Code, a new wholesale distributor of dangerous drug license with a broker classification will not be issued until the following submit fingerprints to the Ohio bureau of criminal identification and investigation (BCI&I) for a criminal records check:

(a) The responsible person on the application for licensure of a wholesale distributor pursuant to rule 4729-5-11 of the Administrative Code; and

(b) The following persons based upon the wholesale distributor's business type:

(i) All partners of a partnership;

(ii) The sole proprietor of a sole proprietorship;

(iii) 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;

(iv) The agency director of a government agency.

(c) The persons listed in paragraph (D)(9)(b) 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 the criminal records check in accordance with this rule.

(10) If there is a change in any of the following persons listed in paragraph (D)(9) of this rule, the new persons shall submit to a criminal records check within thirty days of the change.

(11) All criminal records check 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). The results of the criminal records check must be sent directly to the state board of pharmacy from BCI&I. To be considered valid, the criminal records check must have been performed within the past twelve months. After the board receives the results of all of the required criminal records checks the license licensing process will proceed. The persons listed in paragraph (D)(9) of this rule may submit electronic fingerprint impressions as described in rule 4729-5-12 of the Administrative Code, or, if located outside of Ohio, they may submit fingerprint impressions in a manner approved by the board.

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

(13) Any follow-up information as deemed necessary upon receipt of the application materials.

(E) Prior to the end of the licensing period, a renewal application requesting such information as the state board of pharmacy may require will be sent to the attention of the responsible person. Such a renewal application shall be completed and returned with the applicable fee on or before the established deadline. Failure to do so may result in a refusal by the board to renew the license.

(F) Brokers shall establish and maintain inventories and records of all transactions regarding the transfer or other disposition of dangerous drugs.

(1) These records shall include but not be limited to the following information:

(a) The source of the drugs, including the all of the following:

(i) Name and principle address of the seller or transferor;

(ii) The address of the location from which the drugs were shipped; and

(iii) Verification that the seller and purchaser is appropriately licensed to sell or transfer dangerous drugs at wholesale pursuant to rule 4729-9-12 of the Administrative Code.

(b) The identity and quantity of the drugs transferred and distributed.

(c) The dates of receipt and distribution of the drugs.

(2) Records shall be made available for inspection and copying by properly identified and authorized state board of pharmacy designated agents, federal, state, or local law enforcement agency officials for a period of three years following transfer of the drugs.

(3) Records described in this rule that are kept at the inspection site or that can be immediately retrieved by computer or other electronic means shall be readily available for authorized inspection during the retention period.

(a) Records kept at a central location apart from the inspection site and not electronically retrievable shall be made available for inspection within three business days of a request by properly identified and authorized state board of pharmacy designated agents, federal, state, or local law enforcement agency officials.

(b) Brokers intending to maintain records, described in this rule, at a location other than the place licensed by the state board of pharmacy must obtain approval from the board. A broker maintaining records relating to the distribution and transfer of dangerous drugs at a location other than the place licensed with the state board of pharmacy or via a computerized recordkeeping system shall maintain an executed agreement with the company possessing or storing the records authorizing an agent of the board access to the records maintained in accordance with this rule within three business days, excluding weekends and holidays.

(G) Brokers shall only engage in the marketing, offering, or contracting for wholesale distribution and sale of dangerous drugs that are unopened and packaged in the manufacturer's original container.

(H) Brokers shall operate in compliance with all applicable federal, state, and local laws and regulations.

(I) Brokers shall permit properly identified and authorized state board of pharmacy designated agents, federal, state, and local law enforcement officials to enter and inspect their premises and delivery vehicles, and to audit their records and written operating procedures at reasonable times and in a reasonable manner, to the extent authorized by law.

(J) A broker wishing to engage in wholesale distribution pursuant to rules 4729-9-16, 4729-9-28, 4729-9-29 and 4729-16-02 of the Administrative Code shall comply with the requirements specified in those rules and shall obtain additional licensure for the operations conducted pursuant to those rules.

(K) Brokers shall verify that the seller and buyer are appropriately licensed to prevent the sale or other distribution of dangerous drugs to any person not authorized pursuant to section 4729.51 of the Revised Code.

(L) Brokers shall not engage in the marketing, offering, or contracting for wholesale distribution and sale of dangerous drugs that are controlled substances.

Cite as Ohio Admin. Code 4729-9-30

Effective: 5/12/2017
Five Year Review (FYR) Dates: 05/10/2022
Promulgated Under: 119.03
Statutory Authority: 4729.26
Rule Amplifies: 4729.53, 4729.52