4729-17-02 Responsible person for an institutional pharmacy.

Each institutional pharmacy shall be directed by a pharmacist who holds a current identification card to practice pharmacy in Ohio pursuant to the provisions of section 4729.12 of the Revised Code.

(A) The institutional pharmacy director or designated pharmacist shall be the pharmacist-in-charge pursuant to section 4729.27 of the Revised Code, the responsible person pursuant to rule 4729-5-11 of the Administrative Code, and the pharmacist responsible for maintaining supervision and control over the possession and custody of all dangerous drugs acquired by the institutional facility pursuant to division (B) of section 4729.55 of the Revised Code.

(B) A pharmacist shall be the responsible person for no more than one pharmacy except with written permission from the state board of pharmacy. A written request shall be submitted outlining the circumstances requiring a pharmacist to be responsible for more than one pharmacy and the period of time during which the circumstances will exist. A pharmacist shall not be designated the responsible person for a pharmacy unless he/she will be physically present in the pharmacy a sufficient amount of time to provide supervision and control.

(C) The terminal distributor of dangerous drugs license issued to the institutional facility shall be signed by the responsible person and maintained in a readily available place in the pharmacy.

(D) The responsible person shall:

(1) Be responsible for the practice of pharmacy performed within the institution;

(2) Develop, implement, supervise, and coordinate all services provided by the pharmacy;

(3) In conjunction with the appropriate interdisciplinary committees, be responsible for the development of written policies and procedures which are consistent with this chapter of the Administrative Code and other applicable federal and state laws and rules governing the legal distribution of drugs, assure adherence to these policies and procedures in order to provide for the safe and efficient distribution of drugs in all areas of the institution, and make available a current copy of these written policies and procedures for inspection and/or copying by an employee of the state board of pharmacy;

(4) Be responsible for the security and control of all drugs within the institution;

(5) Be responsible for the maintenance of all records, required by state or federal law to be kept at the licensed location, of the acquisition, use, distribution, and disposition of all drugs.

(E) An institutional pharmacy director or designated pharmacist, who becomes the responsible person shall:

(1) File a written notice to the state board of pharmacy by regular mail, or by verified facsimile transmission within thirty days. This notice shall include:

(a) The name, address, and dangerous drug distributor license number(s) of the institutional pharmacy;

(b) His/her name and pharmacist registration identification number; and

(c) The date on which he/she became the responsible person.

(2) Take a complete inventory, pursuant to federal regulations, of the controlled substances on hand at the pharmacy with the old or previous responsible person at the time he/she ceases to be the responsible person.

(a) The original copy of the inventory shall be maintained in the pharmacy with all other required controlled substance records;

(b) This inventory shall serve as the inventory of controlled substances for which the new or acting responsible person is responsible.

Effective: 01/01/2011
R.C. 119.032 review dates: 09/30/2010 and 12/01/2015
Promulgated Under: 119.03
Statutory Authority: 3719.28, 4729.26
Rule Amplifies: 3719.05, 3719.07, 4729.27, 4729.55
Prior Effective Dates: 9/10/76, 11/1/85, 7/1/90, 7/1/91, 1/10/96, 3/1/99, 1/1/09