Ohio Administrative Code › Title 4729:6 - Distribution of Dangerous Drugs › Chapter 4729:6-2 - Licensure › Section 4729:6-2-01 - Responsible person - drug distributor

Current through all
			 regulations passed and filed through July 1, 2024
(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.