Ohio Admin. Code 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, limited liability company, corporation, or 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.

(b)(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 board's executive director or director's 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.

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

(d)(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 or jurisdiction where located to determine if the entity possesses a current and valid license or registration 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 an applicable 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 entity's 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.

Notes

Ohio Admin. Code 4729:6-2-04

Effective: 8/31/2024
Five Year Review (FYR) Dates: 3/19/2024 and 08/31/2029
Promulgated Under: 119.03
Statutory Authority: 3719.28, 4729.26
Rule Amplifies: 4729.52
Prior Effective Dates: 03/01/2019