Ohio Admin. Code 4729:11-3-03 - [Effective 6/30/2025] Inspections and corrective actions

(A) An entity licensed or registered by the state board of pharmacy pursuant to Chapter 4752. of the Revised Code is subject to an on-site inspection by the board. An authorized board agent employee may, without notice, carry out an on-site inspection or investigation of an entity licensed or registered by the board. Upon verification of the board agent's employee's credentials, the agent employee shall be permitted to enter the licensed or registered entity.

(B) Submission of an application for a license or registration as a HME services provider with the state board of pharmacy constitutes permission for entry and on-site inspection by an authorized board agent.

(C) If an agent of the state board of pharmacy identifies a violation specified in paragraph (D) of this rule, the agent may provide written notice, in a manner determined by the board, of the nature of the observed violations to the designated representative on the license, registration or application. The licensee, registrant or applicant may also be subject to disciplinary actions pursuant to Chapter 4752. of the Revised Code and this division of the Administrative Code.

(D) Violations may include any of the following:

(1) Violating any rule of the board;

(2) Violating any provision of Chapter 4752. of the Revised Code;

(3) Violating any federal, state and local law, rule, or regulation regarding the provision of HME services.

(E) The licensee, registrant, or applicant shall submit to the board within thirty days of a written notice provided in accordance with paragraph (C) of this rule, in a manner determined by the board, either of the following:

(1) The action(s) the licensee, registrant or applicant has taken to correct the violation(s) and the date of implementation of the corrective action(s); or

(2) An explanation disputing the observed violations.

(F) The designated representative of a HME services provider shall comply with investigations and inspections conducted by the board or accrediting body recognized in accordance with rule 4729:11-2-04 of the Administrative Code and shall instruct their staff members to comply with all requests made by the board or accrediting body.

Notes

Ohio Admin. Code 4729:11-3-03

Effective: 6/30/2025
Five Year Review (FYR) Dates: 2/21/2025 and 06/30/2030
Promulgated Under: 119.03
Statutory Authority: 4752.17
Rule Amplifies: 4752.17
Prior Effective Dates: 12/15/2019