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 unless granted permission in accordance with paragraph (E) of this rule.

(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, security and control of dangerous drugs as required in rule 4729-9-11 of the Administrative 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 Revised 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 in section 4729.552 of the Revised Code. A physician shall be the responsible person for no more than one such location unless granted permission in accordance with paragraph (E) of this rule. 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 Revised 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 Revised Code shall:

(a) Have ever been denied a license to prescribe, dispense, personally furnish, 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, personally furnishing, diverting, 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, personally furnishing, diverting, 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, personally furnishing, diverting,supplying or selling a controlled substance or other dangerous drug.

(5) The person to whom the category III terminal distributor of dangerous drugs license with a pain management classification has been issued, the responsible person and all licensed health professionals on duty are responsible for compliance with all state and federal laws, regulations, and rules regulating the operation of a pain management clinic and prescribing of controlled substances.

(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) When there is a change of responsible person, the state board of pharmacy shall be notified within ten days of the effective date of the appointment of the new responsible person in a manner prescribed by the board. For an animal shelter licensed as a terminal distributor of dangerous drugs, the notification shall include a notarized drug list prepared pursuant to paragraph (D) of rule 4729-14-03 of the Administrative Code.

(3) 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.

(4) The responsible person to whom the terminal distributor of dangerous drugs license has been issued and all licensed health professionals on duty areresponsible for compliance with all state and federal laws, regulations, and rules regulating the distribution of dangerous drugs.

(5) A responsible person must be physically present at the location for a sufficient amount of time to provide supervision and control of dangerous drugs on-site.

(6) The responsible person shall be responsible for ensuring the terminal distributor of dangerous drugs requirements are met, 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, security and control of dangerous drugs as required in rule 4729-9-11 of the Administrative Code and maintaining all records relating to the distribution dangerous drugs.

(7) The board of pharmacy shall issue a resolution providing the credential types required for the responsible person of each classification of terminal distributor of dangerous drugs license. Only individuals that meet the credentials specified may be the responsible person for that classification type. The resolution shall be updated as necessary and available on the board's web site,www.pharmacy.ohio.gov.

(D) For all locations licensed as a wholesale distributor of dangerous drugs:

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

(2) When there is a change of responsible person, the state board of pharmacy shall be notified by the new responsible person within ten days of the effective date of the appointment of the new responsible person in a manner prescribed by the board.

(3) A responsible person shall not be designated the responsible person for more than one location licensed as a wholesale distributor of dangerous drugs unless granted permission in accordance with paragraph (E) of this rule.

(4) A complete inventory pursuant to section 1304.11 of the Code of Federal Regulations (9/1/2015) shall be taken of the controlled substances on site by 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 wholesale distributor of dangerous drugs.

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

(6) The board of pharmacy shall issue a resolution providing the credential types or qualifications required for the responsible person of each classification of wholesale distributor of dangerous drugs license. Only individuals that meet the credentials specified may be the responsible person for that classification type. The resolution shall be updated as necessary and available on the board's web site,www.pharmacy.ohio.gov.

(E) Written requests for being a responsible person at more than one location must be submitted to the state board of pharmacy in a manner prescribed by the board. The executive director or designee shall have the authority to temporarily approve or deny a request for being a responsible person at more than one location for a period not to exceed sixty days. The full board will review requests the executive director or designee has temporarily approved at the next scheduled board meeting. A terminal or wholesale distributor of dangerous drugs whose request has been denied either by the executive director, the executive director's designee or the board will be provided with a written explanation of denial and allowed one opportunity to resubmit its request to address the identified concerns. If the board approves a request for being a responsible person at more than one location, the request will be good for a period of up to one year, unless otherwise indicated by the board.

Effective: 9/1/2016
Five Year Review (FYR) Dates: 01/21/2016 and 09/01/2021
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, 04/01/2015