4729-5-11 Responsible person.

(A) For a pharmacy licensed as a terminal distributor of dangerous drugs:

(1) Only a pharmacist may be the responsible person whose name appears on the terminal distributor of dangerous drugs license for a pharmacy as defined in division (A) of section 4729.01 of the Revised Code. A pharmacist shall be the responsible person for no more than one such 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.

(2) The responsible person shall be responsible for the practice of the profession of pharmacy, including but not limited to "supervision and control" of dangerous drugs as required in division (B) of section 4729.55 of the Revised Code, "adequate safeguards" as required in division (C) of section 4729.55 of the Revised Code, and maintaining all drug records otherwise required.

(3) The person to whom the terminal distributor of dangerous drugs license has been issued and all pharmacists on duty are responsible for compliance with all state and federal laws, regulations, and rules regulating the distribution of drugs and the practice of pharmacy.

(B) For all locations licensed as a terminal distributor of dangerous drugs:

(1) A location licensed as a terminal distributor of dangerous drugs must have a responsible person at all times.

(2) The responsible person whose name appears on the terminal distributor of dangerous drugs license shall sign the license and shall maintain the license in a readily available place in the principal location of the business.

(3) When there is a change of responsible person, the state board of pharmacy shall be notified by the new responsible person within thirty days on a board approved form. This notice to the state board of pharmacy shall be sent by regular mail or by verified facsimile transmission.

(4) A complete inventory, pursuant to federal regulations and rule 4729-9-14 of the Administrative Code, shall be taken of the controlled substances on hand with the new responsible person on the effective date of the change of responsible person. The new responsible person shall be responsible for completing and maintaining this inventory record at the site of the terminal distributor of dangerous drugs.

(5) The responsible person to whom the terminal distributor of dangerous drugs license has been issued is responsible for compliance with all state and federal laws, regulations, and rules regulating the distribution of drugs.

R.C. 119.032 review dates: 10/01/2010 and 10/01/2015
Promulgated Under: 119.03
Statutory Authority: 4729.26
Rule Amplifies: 4729.27 , 4729.28 , 4729.55 , 4729.60
Prior Effective Dates: 3/21/88, 7/1/90, 2/15/95, 3/1/99, 1/1/04, 2/1/05, 1/1/09