Lawriter - OAC - 4729:6-2-01 Responsible person - drug distributor.

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 employee's 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.


Effective: 3/1/2019
Five Year Review (FYR) Dates: 03/01/2023
Promulgated Under: 119.03
Statutory Authority: 4729.26, 3719.28
Rule Amplifies: 4729.52