4729-5-11 Responsible person.

 

 

 

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 locations licensed as a category III terminal distributor of dangerous drugs with a pain management classification under section 4729.552 of the Revise Code:

 

(1)Only a physician authorized under Chapter 4731. of the Revised Code  to practice medicine and surgery or osteopathic medicine and surgery may be the responsible person whose name appears on the category III terminal distributor of dangerous drugs with a pain management classification license as defined 4729.552 of the Revised Code. A physician shall be the responsible person for no more than one such location except with written permission from the state board of pharmacy. A written request shall be submitted outlining the circumstances requiring a physician to be responsible for more than one location and the period of time during which the circumstances will exist. A physician shall not be designated the responsible person for a location licensed as a category III terminal distributor of dangerous drugs with a pain management classification unless he/she will be physically present at the location for a sufficient amount of time to provide supervision.

 

(2)All employees of the facility, including the responsible person, shall submit to a criminal records check in accordance with section 4776.02 of the Revised

 

 

Code.

(3) The responsible person for locations licensed as a category III terminal distributor of dangerous drugs with a pain management classification under section 4729.552 of the Revise Code must meet one of the following requirements:

(a) Hold current subspecialty certification in pain management by the American board of medical specialties, or hold a current certificate of added qualification in pain management by the American osteopathic association bureau of osteopathic specialists; or

(b) Hold current subspecialty certification in hospice and palliative medicine by the American board of medical specialties, or hold a current certificate of added qualification in hospice and palliative medicine by the American osteopathic association bureau of osteopathic specialists; or

(c) Hold current board certification by the American board of pain medicine; or

(d)Hold current board certification by the American board of interventional pain physicians; or

(e) Hold current board certification in anesthesiology, psychiatry, neurology, physical medicine and rehabilitation, occupational medicine, or rheumatology by the American board of medical specialties or hold current primary certification in anesthesiology, psychiatry, neurology, physical medicine and rehabilitation, occupational medicine, or rheumatology by the American osteopathic association bureau of osteopathic specialists.

(4) No responsible person for locations licensed as a category III terminal distributor of dangerous drugs with a pain management classification under section 4729.552 of the Revise Code shall:

(a) Have ever been denied a license to prescribe, dispense, administer, supply, or sell a controlled substance by the drug enforcement administration or appropriate issuing body of any state or jurisdiction, based, in whole or in part, on the prescriber's inappropriate prescribing, dispensing, administering, supplying or selling a controlled substance or other dangerous drug.

(b) Have held a license issued by the drug enforcement administration or a state licensing agency in any jurisdiction, under which the person may prescribe, dispense, administer, supply or sell a controlled substance, that  has  ever  been  restricted,  based,  in  whole  or  in  part,  on  the

prescriber's   inappropriate   prescribing,   dispensing,   administering, supplying, or selling a controlled substance or other dangerous drug.

(c) Have been subject to disciplinary action by any licensing entity that was based, in whole or in part, on the prescribers inappropriate prescribing, dispensing, diverting, administering, supplying or selling a controlled substance or other dangerous drug.

(B)(C) 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.

Effective:                                                     04/01/2015

R.C. 119.032 review dates:                         10/01/2015

CERTIFIED ELECTRONICALLY

Certification

08/29/2014

Date

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