Ohio Admin. Code 4729:5-2-01 - Responsible person - terminal distributor
(A) Except as provided in paragraph (B) of
this rule, 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
or campus unless granted permission in accordance with paragraph (G) of this
rule.
(2) The responsible person
shall be responsible for the practice of the profession of pharmacy, including,
but not limited to, the 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 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 governing the distribution of drugs and
the practice of pharmacy.
(B) For an institutional pharmacy licensed as
a terminal distributor of dangerous drugs:
(1) Only a pharmacist licensed under section
4729. of the Revised Code may be the responsible person whose name appears on
the terminal distributor of dangerous drugs license for an institutional
pharmacy. A pharmacist shall be the responsible person for no more than one
such pharmacy or campus unless granted permission in accordance with paragraph
(G) of this rule.
(2) The
responsible person shall be responsible for all of the following:
(a) The practice of the profession of
pharmacy performed within the institutional facility, including, but not
limited to, the 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 and maintaining all drug records
otherwise required.
(b) The
development, implementation, supervision, and coordination of all services
provided by the institutional pharmacy.
(c) In conjunction with the appropriate
interdisciplinary committees, the development of written policies and
procedures which are consistent with this division of the Administrative Code
and other applicable federal and state laws, regulations and rules governing
the legal distribution of drugs, adherence to these policies and procedures in
order to provide for the safe distribution of drugs in all areas of the
institutional facility, and making readily retrievable a current copy of these
written policies and procedures.
(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 governing the distribution of drugs and the practice of
pharmacy.
(C) 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 (G) 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 the physician will be physically present at
the location for a sufficient amount of time to provide adequate
supervision.
(2) 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;
(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;
(c) Hold
current board certification by the American board of pain medicine;
(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) The person to whom the category III
terminal distributor of dangerous drugs license with a pain management clinic
classification has been issued, the responsible person and all licensed health
professionals practicing at that location are responsible for compliance with
all state and federal laws, regulations, and rules governing the operation of a
pain management clinic and prescribing of controlled substances.
(D) For locations licensed as a
category III terminal distributor of dangerous drugs with an office-based
opioid treatment classification under section
4729.553 of the Revised Code:
(1) Only a physician or certified nurse
practitioner who meets the following may be the responsible person whose name
appears on the category III terminal distributor of dangerous drugs with an
office-based opioid treatment classification license as defined in section
4729.553 of the Revised Code:
(a) The physician is authorized under Chapter
4731. of the Revised Code to practice medicine and surgery or osteopathic
medicine and surgery or the certified nurse practitioner is designated as a
certified nurse practitioner in accordance with section
4723.42 of the Revised Code and
rules adopted by the board of nursing; and
(b) The physician or certified nurse
practitioner possesses a waiver to prescribe or personally furnish
buprenorphine under the Drug Addiction Treatment Act of 2000 (DATA 2000)
(2/20/2017).
(2) The
responsible person shall submit to a criminal records check in accordance with
section 4776.02 of the Revised
Code.
(3) A physician or certified
nurse practitioner shall not be designated the responsible person for a
location licensed as a category III terminal distributor of dangerous drugs
with an office-based opioid treatment classification unless the physician or
certified nurse practitioner will be physically present at the location for at
least fifteen hours per week. If the facility is not open more than fifteen
hours per week, the minimum amount of on-site supervision shall be at least
fifty per cent of the total hours the facility is open, as reported to the
board by the licensee on the application. Any changes to the licensee's hours
of operation shall be reported to the board, in a manner determined by the
board, within three business days.
(a) The
hour requirements of this paragraph do not apply if either:
(i) The responsible person is unable to meet
the requirements due to a documented illness or emergency and there is another
physician or certified nurse practitoner
practitioner on-site who meets the requirements of
paragraph (C)(1) of this rule who can provide onsite supervision in accordance
with the requirements described in this paragraph. The physician or certified
nurse practitioner shall assume all responsibilities for compliance with this
rule in the absence of the responsible person.
(ii) The location is closed for a state or
federal holiday or other documented reason.
(4) The person to whom the category III
terminal distributor of dangerous drugs license with an office-based opioid
treatment classification has been issued, the responsible person and all
licensed health professionals practicing at that location are responsible for
compliance with all state and federal laws, regulations, and rules regulating
the operation of an office-based opioid treatment facility and prescribing of
controlled substances.
(E) 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 determined by the board. For a limited terminal
distributor of dangerous drugs license, the notification shall include a drug
list required in accordance with agency 4729 of the Administrative
Code.
(3) A complete inventory,
pursuant to
21 CFR
1304.11 of the Code of Federal Regulations
(9/9/2014) and rule 4729:5-3-07 of the Administrative Code, shall be taken of
the controlled substances on hand 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 location licensed as a 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 are responsible for compliance with all
state and federal laws, regulations, and rules governing 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, the 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 and maintaining all drug records
otherwise required.
(7) The board
of pharmacy shall issue a resolution providing the credential types required
for the responsible person of each classification/business type of terminal
distributor of dangerous drugs license. Only individuals that meet the
credentials specified may be the responsible person for that classification/
business type. The resolution shall be updated as necessary and shall be made
available on the board's web site (www.pharmacy.ohio.gov).
(F) Unless otherwise approved by
the board, a terminal distributor shall not have a responsible person who:
(6)(4) Has been subject to
any of the following:
(7)(5) Has been granted
entry into a diversion program, deferred prosecution program, or the equivalent
thereof.
(8)(6) Cannot practice
according to acceptable and prevailing standards of care by reason of mental
illness or physical illness, including, but not limited to, physical
deterioration that adversely affects cognitive, motor, or perceptive
skills.
(9)(7) Is addicted to or
abusing alcohol or drugs.
(10)(8) Has been excluded
from participation in medicare or a state health care program.
(11)(9)
Has been denied a license or registration by the drug enforcement
administration or appropriate issuing body of any state or
jurisdiction.
(12)(10) Has been the
subject of any of the following by the drug enforcement administration or
licensing agency of any state or jurisdiction:
(1) Has been denied the right to work in any
facility by the state board of pharmacy as part of an official order of the
board.
(2) Has been denied the
right to work in such a facility by another professional licensing board/agency
as part of an official order of that board/agency.
(3) Has committed an act that constitutes a
misdemeanor theft
disqualifying offense, regardless of the jurisdiction
in which the act was committed.
(4) Has committed an act that
constitutes a misdemeanor drug offense, except for a minor misdemeanor drug
offense, regardless of the jurisdiction in which the act was
committed.
(5) Has committed an act that
constitutes a felony, regardless of the jurisdiction in which the act was
committed.
(a) A finding by a court
of the person's eligibility for intervention in lieu of conviction;
or
(b) A finding by a court of the
person's eligibility for treatment or intervention in lieu of conviction in
another jurisdiction.
(a) A disciplinary action that resulted in
the suspension, probation, surrender or revocation of the person's license or
registration; or
(b) A disciplinary
action that was based, in whole or in part, on the person's inappropriate
prescribing, dispensing, diverting, administering, storing, securing,
personally furnishing, compounding, supplying or selling a controlled substance
or other dangerous drug.
(13) Has committed an act that
constitutes a misdemeanor that is related to, or committed in, the employee's
professional practice.
(14) Has committed an act of moral
turpitude that constitutes a felony or misdemeanor, regardless of the
jurisdiction in which the act was committed.
(G) Written requests
for being a responsible person at more than one location pursuant to this rule
must be submitted to the state board of pharmacy in a manner determined by the
board. The executive director or the director's 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 the director's
designee has temporarily approved at the next scheduled board meeting. A
terminal distributor of dangerous drugs whose request has been denied either by
the executive director, the 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. The board may impose conditions
on all approved requests, including requirements that requests be submitted for
reapproval at intervals determined by the board.
Notes
Promulgated Under: 119.03
Statutory Authority: 4729.26, 3719.28, 9.79
Rule Amplifies: 4729.54
Prior Effective Dates: 03/01/2019
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