Chapter 4729:5-4 | Discipline

Rule 4729:5-4-01 | Disciplinary actions.

• Effective: April 25, 2022
• Promulgated Under: 119.03

(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 terminal 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 4729.57 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 a license or renewal of a license as a terminal distributor of dangerous drugs.

(2) Violating any rule of the board.

(3) Violating any provision of Chapter 4729. of the Revised Code.

(4) Except as provided in section 4729.89 of the Revised Code, violating any provision of the "Federal Food, Drug, and Cosmetic Act," 52 Stat. 1040 (1938), 21 U.S.C.A. 301, or Chapter 3715. of the Revised Code.

(5) Violating any provision of the federal drug abuse control laws or Chapter 2925. or 3719. of the Revised Code.

(6) Falsely or fraudulently promoting to the public a dangerous drug, except that nothing in this rule prohibits a terminal distributor of dangerous drugs from furnishing information concerning a dangerous drug to a health care provider or another licensed terminal distributor.

(7) Ceasing to satisfy the qualifications of a terminal distributor of dangerous drugs set forth in section 4729.55 of the Revised Code.

(8) Except as provided in division (C) of section 4729.57 of the Revised Code:

(a) Waiving the payment of all or any part of a deductible or copayment that an individual, pursuant to a health insurance or health care policy, contract, or plan that covers the services provided by a terminal distributor of dangerous drugs, would otherwise be required to pay for the services if the waiver is used as an enticement to a patient or group of patients to receive pharmacy services from that terminal distributor;

(b) Advertising that the terminal distributor will waive the payment of all or any part of a deductible or copayment that an individual, pursuant to a health insurance or health care policy, contract, or plan that covers the pharmaceutical services, would otherwise be required to pay for the services.

(9) Conviction of a felony.

(10) 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.

(11) Exclusion from participation in medicare or a state health care program.

(12) Being denied a license or registration by the drug enforcement administration or appropriate issuing body of any state or jurisdiction.

(13) 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.

(14) Commission of an act that constitutes a disqualifying offense, regardless of the jurisdiction in which the act was committed.

(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 4729:5-2-01 of the Administrative Code.

(20) 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 professional licensing agency to a spouse or other family member.

(21) 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 professional licensing 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.

(22) Except as provided in Chapter 3719. of the Revised Code, dispensing a sample drug as defined in rule 4729:6-3-08 of the Administrative Code.

(23) The method used by the terminal distributor to store, possess or distribute dangerous drugs poses serious harm to others.

(24) The furnishing of false or fraudulent information or omitting information on due diligence questionnaires and/or attestation documents regarding the purchase or receipt of dangerous drugs from manufacturers, repackagers, third-party logistics providers, outsourcing facilities, wholesale distributors or other terminal distributors.

(25) 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.

(26) Unless otherwise approved by the board, a terminal 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 excluded from participation in medicare or a state health care program.

(i) Has been denied a license or registration by the drug enforcement administration or appropriate issuing body of any state or jurisdiction.

(j) 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.

(k) Has committed an act that constitutes a misdemeanor that is related to, or committed in, the employee's professional practice.

Last updated April 25, 2022 at 8:29 AM

Supplemental Information

Authorized By: 4729.26, 3719.28, 9.79
Amplifies: 4729.57, 4729.89, 4729.55
Five Year Review Date: 4/25/2027
Prior Effective Dates: 3/1/2019

Rule 4729:5-4-02 | Duty to Report.

• Effective: March 1, 2025
• Promulgated Under: 119.03

(A) As used in this rule:

(1) "Dishonesty" means any action by a licensee, registrant or applicant to include, but is not limited to, making any statement that deceives, misrepresents or misleads, or be a party to or an accessory to any fraudulent or deceitful practice or transaction in the practice of pharmacy or in the operation or conduct of a pharmacy.

(2) "Dispensing error" or "error in dispensing" has the same meaning as rule 4729:5-3-22 of the Administrative Code.

(3) "Reckless behavior" means a person who acts recklessly or who is reckless. A person acts recklessly when, with heedless indifference to the consequences, the person disregards a substantial and unjustifiable risk that the person's conduct is likely to cause a certain result or is likely to be of a certain nature. A person is reckless with respect to circumstances when, with heedless indifference to the consequences, the person disregards a substantial and unjustifiable risk that such circumstances are likely to exist.

(4) "Unprofessional conduct" means conduct that is detrimental to the best interests of the public, including conduct that endangers the health, safety or welfare of a patient or client. Such conduct shall include, but not be limited to, the following acts: coercion, intimidation, harassment, sexual harassment, improper use of private health information, threats, degradation of character, indecent or obscene conduct, and theft.

(B) A pharmacy licensed as a terminal distributor of dangerous drugs shall be required to report, from direct observation or objective evidence, the following to the board in accordance with paragraph (C) of this rule:

(1) Any error in dispensing when the error is the result of reckless behavior.

(2) Any error in dispensing where the error results in any of the following per the "National Coordinating Council for Medication Error Reporting and Prevention Medication Error Index (Revised 2/20/2001)":

(a) Category G: an error occurred that resulted in permanent patient harm.

(b) Category H: an error occurred that resulted in a near-death event (e.g., anaphylaxis, cardiac arrest).

(c) Category I: an error occurred that resulted in patient death.

(3) The termination or resignation of employment of any individual licensed or registered by the board that was based, in whole or in part, on an error or errors in dispensing.

(4) The termination or resignation of employment of any individual licensed or registered by the board that was based, in whole or in part, on engaging in unprofessional conduct, dishonesty, or reckless behavior.

(5) The termination or resignation of employment of any individual licensed or registered by the board that was based, in whole or in part, on conduct indicating an individual licensed or registered by the board is practicing pharmacy while physically or mentally impaired by alcohol, drugs or other chemical substances or impaired physically or mentally to such a degree as to render the individual unfit to carry out their professional duties.

(C) Reporting required in accordance with this rule shall be made by mail, using the board's online complaint form (available on the board's website: www.pharmacy.ohio.gov), or telephone and shall include the following information:

(1) The name of the employer and the employer's terminal distributor license number;

(2) The full name and license or registration number of the licensee or registrant for which a report is being made;

(3) If applicable, an explanation of the error in dispensing that occurred, including details regarding any patient harm;

(4) If applicable, an explanation of the circumstances that resulted in the individual's termination or resignation from employment; and

(5) The date(s) of and place(s) of occurrence(s), if known.

(D) All reports submitted in accordance with this rule shall protect the confidentiality of patients. The Board may request additional information, including patient information, as part of an investigation conducted in accordance with Chapter 4729. of the Revised Code.

(E) All required reporting shall be submitted to the board no later than:

(1) For an error in dispensing pursuant to paragraphs (B)(1) to (B)(3) of this rule, ten days from the date the quality assurance program review in accordance with rule 4729:5-3-22 of the Administrative Code was completed; and

(2) For the termination or resignation of an employee pursuant to paragraphs (B)(4) and (B)(5) of this rule, ten days from the date the individual is terminated or resigns from employment.

(F) Notwithstanding any provision of agency 4729 of the Administrative Code, a pharmacist, pharmacy intern, certified pharmacy technician, registered pharmacy technician, or pharmacy technician trainee shall not be required to make a report to the board pursuant to the applicable duty to report rules in divisions 4729:1, 4729:2, and 4729:3 of the Administrative Code if the licensee or registrant is employed by or under contract with a pharmacy licensed as a terminal distributor of dangerous drugs and the terminal distributor submits a report in accordance with this rule.

(G) In accordance with section 4729.23 of the Revised Code, information submitted to the board in accordance with this rule shall be deemed confidential, is not a public record, and is not subject to discovery in any civil action.

Last updated March 4, 2025 at 8:00 AM

Supplemental Information

Authorized By: 4729.26, 3719.28, 9.79
Amplifies: 4729.57, 4729.89, 4729.55
Five Year Review Date: 3/1/2030