Current through all regulations passed and filed through November 4, 2024
Section 4729:6-4-01 - Disciplinary actions(A) The state board of pharmacy, in accordance with Chapter 119. of the Revised Code, may impose any one or more of the following sanctions on a person licensed as a distributor of dangerous drugs for any of the causes set forth in paragraph (B) of this rule:(1) Suspend, revoke, restrict, limit, or refuse to grant or renew a license;(2) Reprimand or place the license holder on probation;(3) Impose a monetary penalty or forfeiture as set forth in section 4729.56 of the Revised Code.(B) The board may impose the sanctions set forth in paragraph (A) of this rule for any of the following:(1) Making any false material statements in an application for licensure or licensure renewal under section 4729.52 of the Revised Code.(2) Violating any federal, state, or local drug law; any provision of Chapter 2925., 3715., 3719., or 4729. of the Revised Code; or any rule of the board.(3) A conviction of a felony.(4) Commission of an act that constitutes a disqualifying offense, regardless of the jurisdiction in which the act was committed.(5) Failing to satisfy the qualifications for licensure under section 4729.53 of the Revised Code or the rules of the board or ceasing to satisfy the qualifications after the license is granted or renewed.(6) Falsely or fraudulently promoting to the public a drug that is a controlled substance included in schedule I, II, III, IV, or V, except that nothing in this rule prohibits a drug distributor from furnishing information concerning a controlled substance to a health care provider or licensed terminal distributor.(7) Violating any provision of the "Federal Food, Drug, and Cosmetic Act," 52 Stat. 1040 (1938), United States Code Title 21 (10/22/2017).(8) Failing to comply with the requirements of rule 4729:6-3-05 of the Administrative Code.(9) Conducting the sale of a suspicious order without conducting an independent analysis prior to completing a sale to determine whether the reported drugs are likely to be diverted from legitimate channels in accordance with rule 4729:6-3-05 of the Administrative Code. (10) Commission of a crime of moral turpitude as defined in section 4776.10 of the Revised Code.(11) Violation of any restrictions placed by the state board of pharmacy on a license or violating any terms of a board order issued against the licensee.(12) Exclusion from participation in Medicare or a state health care program.(13) Being denied a license or registration by the drug enforcement administration or appropriate issuing body of any state or jurisdiction.(14) Being the subject of any of the following by the drug enforcement administration or licensing agency of any state or jurisdiction:(a) A disciplinary action that resulted in the suspension 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, personally furnishing, compounding, supplying or selling a controlled substance or other dangerous drug. (15) 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.(16) Has been granted entry into a diversion program, deferred prosecution program, or the equivalent thereof.(17) Is addicted to or abusing alcohol or drugs.(18) Commission of an act that constitutes a misdemeanor that is related to, or committed in, the person's professional practice.(19) Employs a responsible person that does not meet the requirements set forth in rule 4729:6-2-01 of the Administrative Code.(20) Retaliating against or disciplining an employee for filing a complaint with a board of pharmacy or other licensing body or reporting a violation of state or federal statute or any ordinance or regulation of a political subdivision that the employee's employer has authority to correct. As used in this rule, retaliation or discipline of an employee includes, but is not limited to, the following: (a) Removing or suspending the employee from employment;(b) Withholding from the employee salary increases or employee benefits to which the employee is otherwise entitled;(c) Transferring or reassigning the employee;(d) Denying the employee a promotion that otherwise would have been received;(e) Reducing the employee in pay or position.(21) The method used by the drug distributor to store, possess or distribute dangerous drugs poses serious harm to others.(22) The ownership of such entity has been transferred from a person whose license issued in accordance with Chapter 4729. of the Revised Code has been revoked or disciplined by the state board of pharmacy or any other state or federal professional licensing or regulatory agency to a spouse or other family member.(23) The ownership of such facility has been transferred from a licensee whose license has been revoked or disciplined by the state board of pharmacy or any other state or federal professional licensing or regulatory agency to another who employs the former owner or who allows the former owner to be present within the physical confines of the location to be licensed.(24) Unless otherwise approved by the board, a distributor knowingly employs a person with access to drug stock who:(a) 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.(b) 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.(c) Has committed an act that constitutes a disqualifying offense, regardless of the jurisdiction in which the act was committed.(d) Has committed an act that constitutes a misdemeanor or felony drug offense, except for a minor misdemeanor drug offense, regardless of the jurisdiction in which the act was committed. (e) Has been subject to any of the following:(i) A finding by a court of the person's eligibility for intervention in lieu of conviction; or(ii) A finding by a court of the person's eligibility for treatment or intervention in lieu of conviction in another jurisdiction.(f) Has been granted entry into a diversion program, deferred prosecution program, or the equivalent thereof.(g) Is addicted to or abusing alcohol or drugs.(h) 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.(i) Has been excluded from participation in medicare or a state health care program.(j) Has been denied a license or registration by the drug enforcement administration or appropriate issuing body of any state or jurisdiction.(k) Has been the subject of any of the following by the drug enforcement administration or licensing agency of any state or jurisdiction: (i) A disciplinary action that resulted in the suspension, probation, surrender or revocation of the person's license or registration; or(ii) 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.(l) Has committed an act that constitutes a misdemeanor that is related to, or committed in, the employee's professional practice.Ohio Admin. Code 4729:6-4-01
Effective: 4/25/2022
Five Year Review (FYR) Dates: 1/12/2022 and 04/25/2027
Promulgated Under: 119.03
Statutory Authority: 9.79, 4729.26
Rule Amplifies: 4729.51, 4729.53, 4729.55
Prior Effective Dates: 07/01/1991, 01/10/1996, 03/01/1999, 01/01/2011, 10/15/2015, 03/01/2019