Ohio Administrative Code › Title 4729 - State Board of Pharmacy › Chapter 4729-9 - Dangerous Drugs › Section 4729-9-16 - Minimum requirements for wholesalers

Current through all regulations passed and filed through July 1, 2024
The following minimum requirements shall apply to all persons
				distributing dangerous drugs at wholesale in Ohio:
(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 wholesale 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 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, handling, and 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:
(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; and
(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;
(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:
(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) If the entity making application for a
			 wholesale distributor of dangerous drugs license 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 or
			 jurisdiction in which that entity is located. This inquiry will determine
			 whether the entity possesses a current and valid license to distribute
			 dangerous drugs in that state or jurisdiction 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 Ohio state board of pharmacy. The Ohio board will respond to inquiries
			 of a similar nature from other states about licensees in Ohio.
(7)
									Pursuant to
			 section 4729.53 of the Revised Code, a
			 new wholesale distributor of dangerous drug license 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 (A)(7)(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 a background check in accordance with
			 this rule.
(8)
									If there is a change in any of the following persons
			 listed in paragraph (A)(7) of this rule, the new persons shall submit to a
			 criminal records check within thirty days of the change.
(9)
									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). 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 licensing process will proceed. The persons listed in paragraph
			 (A)(7) of this rule may submit electronic fingerprint impressions as described
			 to 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.
(10)
									Any information
			 required on the application as determined by the board.
(11)
									Any follow-up
			 information as deemed necessary upon receipt of the application
			 materials.