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hb462_05_EN
(136th General Assembly)
(Substitute
House Bill Number 462)
AN
ACT
To amend sections 3301.135,
3313.718, 3313.719, 3313.7110, 3313.7111, 3314.141, 3314.143,
3326.28, 3328.24, 3328.29, 3728.01, 4723.483, 4729.01, 4729.51,
4729.513, 4729.541, 4729.88, 4730.433, 4731.96, 4731.961, and 5180.26
and to enact section 4729.262 of the Revised Code to authorize the
procurement and emergency use of additional types of epinephrine
delivery systems by schools, school districts, and camps.
Be
it enacted by the General Assembly of the State of Ohio:
Section
1.
That
sections
3301.135,
3313.718
,
3313.719,
3313.7110, 3313.7111,
3314.141
,
3314.143, 3326.28, 3328.24, 3328.29, 3728.01, 4723.483, 4729.01,
4729.51, 4729.513, 4729.541, 4729.88, 4730.433, 4731.96, 4731.961,
and 5180.26 be amended and section 4729.262
of the Revised Code be
enacted
to
read as follows:
Sec.
3301.135.
(A)
As used in this section:
(1)
"Epinephrine delivery system" has the same meaning as in
section 3313.718 of the Revised Code.
(2)
"Other public school" has the same meaning as in section
3301.0711 of the Revised Code.
(B)
The
department of education and workforce annually shall compile a list
of organizations and companies that offer free and reduced cost
epinephrine
autoinjectors
delivery
systems
to
qualifying school districts, other public schools, and chartered
nonpublic schools. The department shall make this information readily
available on
their
its
web
site and send a copy of the list by mail or electronically to each
school district, other public school, and chartered nonpublic school.
As
used in this section, "other public school" has the same
meaning as in section 3301.0711 of the Revised Code.
Sec.
3313.718.
(A)
As used in this section
,
"prescriber"
:
(1)
"Epinephrine delivery system" means any device or other
product that contains a premeasured dose of epinephrine and enables
the dose to be administered through any route of administration into
the human body to prevent or treat a life-threatening allergic
reaction. "Epinephrine delivery system" includes all of the
following:
(a)
Autoinjectors;
(b)
Intranasal sprays;
(c)
Any device or other product designated by the state board of pharmacy
in rules adopted under section 4729.262 of the Revised Code.
(2)
"Prescriber"
has the same meaning as in section 4729.01 of the Revised Code.
(B)
Notwithstanding section 3313.713 of the Revised Code or any policy
adopted under that section, a student of a school operated by a city,
local, exempted village, or joint vocational school district or a
student of a chartered nonpublic school may possess and use an
epinephrine
autoinjector
delivery
system
to
treat anaphylaxis, if all of the following conditions are satisfied:
(1)
The student has the written approval of the prescriber of the
autoinjector
delivery
system
and,
if the student is a minor, the written approval of the parent,
guardian, or other person having care or charge of the student. The
prescriber's written approval shall include at least all of the
following information:
(a)
The student's name and address;
(b)
The names and dose of the
medication
epinephrine
contained
in the
autoinjector
delivery
system
;
(c)
The date
the
that
administration
of
the
medication
epinephrine
through the delivery system
is
authorized
to
begin;
(d)
The date, if known, that
the
administration of the medication
authority
to administer epinephrine through the delivery system
is
to cease;
(e)
Acknowledgment that the prescriber has determined that the student is
capable of possessing and using the
autoinjector
delivery
system
appropriately
and has provided the student with training in the proper use of the
autoinjector
delivery
system
;
(f)
Circumstances in which the
autoinjector
delivery
system
should
be used;
(g)
Written instructions that outline procedures school employees should
follow in the event that the student is unable to administer
the
anaphylaxis medication
epinephrine
through the delivery system
or
the medication does not produce the expected relief from the
student's anaphylaxis;
(h)
Any severe adverse reactions that may occur to the
child
student
using
the
autoinjector
epinephrine
delivery system
that
should be reported to the prescriber;
(i)
Any severe adverse reactions that may occur to another
child
student
,
for whom the
autoinjector
epinephrine
delivery system
is
not prescribed, should such a
child
student
receive
a dose of
the
medication
epinephrine
;
(j)
At least one emergency telephone number for contacting the prescriber
in an emergency;
(k)
At least one emergency telephone number for contacting the parent,
guardian, or other person having care or charge of the student in an
emergency;
(l)
Any other special instructions from the prescriber.
(2)
The school principal and, if a school nurse is assigned to the
student's school building, the school nurse has received copies of
the written approvals required by division (B)(1) of this section.
(3)
The school principal or, if a school nurse is assigned to the
student's school building, the school nurse has received a backup
dose
of the anaphylaxis medication
epinephrine
delivery system
from
the parent, guardian, or other person having care or charge of the
student or, if the student is not a minor, from the student.
If
these conditions are satisfied, the student may possess and use the
autoinjector
epinephrine
delivery system
at
school or at any activity, event, or program sponsored by or in which
the student's school is a participant.
(C)
Whenever a student uses an
autoinjector
epinephrine
delivery system
at
school or at any activity, event, or program sponsored by or in which
the student's school is a participant or whenever a school employee
administers
anaphylaxis
medication
epinephrine
to
a student
through
an epinephrine delivery system
that
was possessed by the student pursuant to the written approvals
described in division (B)(1) of this section, a school employee shall
immediately request assistance from an emergency medical service
provider.
(D)(1)
A school district, member of a school district board of education, or
school district employee is not liable in damages in a civil action
for injury, death, or loss to person or property allegedly arising
from a district employee's prohibiting a student from using an
autoinjector
epinephrine
delivery system
because
of the employee's good faith belief that the conditions of division
(B) of this section had not been satisfied. A school district, member
of a school district board of education, or school district employee
is not liable in damages in a civil action for injury, death, or loss
to person or property allegedly arising from a district employee's
permitting a student to use an
autoinjector
epinephrine
delivery system
because
of the employee's good faith belief that the conditions of division
(B) of this section had been satisfied. Furthermore, when a school
district is required by this section to permit a student to possess
and use an
autoinjector
epinephrine
delivery system
because
the conditions of division (B) of this section have been satisfied,
the school district, any member of the school district board of
education, or any school district employee is not liable in damages
in a civil action for injury, death, or loss to person or property
allegedly arising from the use of the
autoinjector
epinephrine
delivery system
by
a student for whom it was not prescribed.
This
section does not eliminate, limit, or reduce any other immunity or
defense that a school district, member of a school district board of
education, or school district employee may be entitled to under
Chapter 2744. or any other provision of the Revised Code or under the
common law of this state.
(2)
A chartered nonpublic school or any officer, director, or employee of
the school is not liable in damages in a civil action for injury,
death, or loss to person or property allegedly arising from a school
employee's prohibiting a student from using an
autoinjector
epinephrine
delivery system
because
of the employee's good faith belief that the conditions of division
(B) of this section had not been satisfied. A chartered nonpublic
school or any officer, director, or employee of the school is not
liable in damages in a civil action for injury, death, or loss to
person or property allegedly arising from a school employee's
permitting a student to use an
autoinjector
epinephrine
delivery system
because
of the employee's good faith belief that the conditions of division
(B) of this section had been satisfied. Furthermore, when a chartered
nonpublic school is required by this section to permit a student to
possess and use an
autoinjector
epinephrine
delivery system
because
the conditions of division (B) of this section have been satisfied,
the chartered nonpublic school or any officer, director, or employee
of the school is not liable in damages in a civil action for injury,
death, or loss to person or property allegedly arising from the use
of the
autoinjector
epinephrine
delivery system
by
a student for whom it was not prescribed.
Sec.
3313.719.
(A)
As
used in this section:
(1)
"Epinephrine delivery system" has the same meaning as in
section 3313.718 of the Revised Code.
(2)
"Licensed health professional authorized to prescribe drugs"
has the same meaning as in section 4729.01 of the Revised Code.
(B)
The
board of education of each city, local, exempted village, and joint
vocational school district and the governing authority of each
chartered nonpublic school shall establish a written policy with
respect to protecting students with food allergies. The policy shall
be developed in consultation with parents, school nurses and other
school employees, school volunteers, students, and community members.
(B)
(C)
Each school district board may create training for all staff members
and age-appropriate instruction for students in grades kindergarten
through twelve on food allergies and ways in which to assist an
individual experiencing an allergic reaction.
(C)
Training completed under division (B) of this section
The training
may include instruction in food allergies, signs and symptoms of
anaphylaxis, prevention of allergic reactions, management and
administration of epinephrine, and follow-up and reporting
procedures.
(D)
Training completed under division
(B)
(C)
of this section shall qualify as a professional development activity
for the renewal of educator licenses, in addition to activities
approved by local professional development committees under division
(F) of section 3319.22 of the Revised Code.
(E)(1)
The following are not liable in damages in a civil action for injury,
death, or loss to person or property that allegedly arise from an act
or omission associated with any training under
divisions
(B) and
division
(C)
of this section, unless the act or omission constitutes willful or
wanton misconduct:
(a)
A school or school district;
(b)
A member of a district board of education;
(c)
A district or school employee or contractor;
(d)
A licensed health professional authorized to prescribe drugs who
personally furnishes or prescribes epinephrine
autoinjectors
delivery
systems
,
who
consults with a superintendent, or
who
issues
a protocol pursuant to section 3313.7110 of the Revised Code;
(e)
An anaphylaxis training organization and its personnel where
leadership includes a physician authorized under Chapter 4731. of the
Revised Code to practice medicine and surgery or osteopathic medicine
and surgery who is board-certified in allergy and immunology as that
designation is issued by a medical specialty certifying board
recognized by the American board of medical specialties or American
osteopathic association.
(2)
This section does not eliminate, limit, or reduce any other immunity
or defense that a school or school district, member of a district
board of education, district or school employee or contractor, or
licensed health professional may be entitled to under Chapter 2744.
or any other provision of the Revised Code or under the common law of
this state.
Sec.
3313.7110.
(A)
The board of education of each city, local, exempted village, or
joint vocational school district may procure epinephrine
autoinjectors
delivery
systems
for
each school operated by the district to have on the school premises
for use in emergency situations identified under division (C)(5) of
this section by doing one of the following:
(1)
Having a licensed health professional authorized to prescribe drugs,
acting in accordance with section 4723.483, 4730.433, or 4731.96 of
the Revised Code, personally furnish the epinephrine
autoinjectors
delivery
systems
to
the school or school district or issue a prescription for them in the
name of the school or district;
(2)
Having the district's superintendent obtain a prescriber-issued
protocol that includes definitive orders for epinephrine
autoinjectors
delivery
systems
and
the dosages of epinephrine to be administered through them.
A
district board that elects to procure epinephrine
autoinjectors
delivery
systems
under
this section is encouraged to maintain, at all times, at least two
epinephrine
autoinjectors
delivery
systems
at
each school operated by the district.
(B)
A district board that elects to procure epinephrine
autoinjectors
delivery
systems
under
this section shall require the district's superintendent to adopt a
policy governing their maintenance and use. Before adopting the
policy, the superintendent shall consult with a licensed health
professional authorized to prescribe drugs.
(C)
The policy adopted under division (B) of this section shall do all of
the following:
(1)
Identify the one or more locations in each school operated by the
district in which an epinephrine
autoinjector
delivery
system
must
be stored;
(2)
Specify the conditions under which an epinephrine
autoinjector
delivery
system
must
be stored, replaced, and disposed;
(3)
Specify the individuals employed by or under contract with the
district board, in addition to a school nurse or an athletic trainer
,
licensed under Chapter 4755. of the Revised Code, who may access and
use an epinephrine
autoinjector
delivery
system
to
provide a dosage of epinephrine to an individual in an emergency
situation identified under division (C)(5) of this section;
(4)
Specify any training that employees or contractors specified under
division (C)(3) of this section, other than a school nurse or
athletic trainer, must complete before being authorized to access and
use an epinephrine
autoinjector
delivery
system
;
(5)
Identify the emergency situations, including when an individual
exhibits signs and symptoms of anaphylaxis, in which a school nurse,
athletic trainer, or other employees or contractors specified under
division (C)(3) of this section may access and use an epinephrine
autoinjector
delivery
system
;
(6)
Specify that assistance from an emergency medical service provider
must be requested immediately after an epinephrine
autoinjector
delivery
system
is
used;
(7)
Specify the individuals, in addition to students, school employees or
contractors, and school visitors, to whom a dosage of epinephrine may
be administered through an epinephrine
autoinjector
delivery
system
in
an emergency situation specified under division (C)(5) of this
section.
(D)(1)
The following are not liable in damages in a civil action for injury,
death, or loss to person or property that allegedly arises from an
act or omission associated with procuring, maintaining, accessing, or
using an epinephrine
autoinjector
delivery
system
under
this section, unless the act or omission constitutes willful or
wanton misconduct:
(a)
A school or school district;
(b)
A member of a district board of education;
(c)
A district or school employee or contractor;
(d)
A licensed health professional authorized to prescribe drugs who
personally furnishes or prescribes epinephrine
autoinjectors
delivery
systems
,
consults with a superintendent, or issues a protocol pursuant to this
section.
(2)
This section does not eliminate, limit, or reduce any other immunity
or defense that a school or school district, member of a district
board of education, district or school employee or contractor, or
licensed health professional may be entitled to under Chapter 2744.
or any other provision of the Revised Code or under the common law of
this state.
(E)
A school district board of education may accept donations of
epinephrine
autoinjectors
delivery
systems
from
a wholesale distributor of dangerous drugs or a manufacturer of
dangerous drugs
,
as defined in section 4729.01 of the Revised Code,
and may accept donations of money from any person to purchase
epinephrine
autoinjectors
delivery
systems
.
(F)
A district board that elects to procure epinephrine
autoinjectors
delivery
systems
under
this section shall report to the department of education and
workforce each procurement and occurrence in which an epinephrine
autoinjector
delivery
system
is
used from a school's supply of epinephrine
autoinjectors
delivery
systems
.
(G)
As used in this section
,
"licensed
:
(1)
"Epinephrine delivery system" has the same meaning as in
section 3313.718 of the Revised Code.
(2)
"Licensed
health
professional authorized to prescribe drugs
,
"
and
"prescriber"
"prescriber,"
"manufacturer of dangerous drugs," and "wholesale
distributor of dangerous drugs"
have
the same meanings as in section 4729.01 of the Revised Code.
Sec.
3313.7111.
(A)
As
used in this section:
(1)
"Epinephrine delivery system" has the same meaning as in
section 3313.718 of the Revised Code.
(2)
"Licensed health professional authorized to prescribe drugs,"
"manufacturer of dangerous drugs," and "wholesale
distributor of dangerous drugs" have the same meanings as in
section 4729.01 of the Revised Code.
(B)
With
the approval of its governing authority, a chartered or nonchartered
nonpublic school may procure epinephrine
autoinjectors
delivery
systems
in
the manner prescribed by section 3313.7110 of the Revised Code. A
chartered or nonchartered nonpublic school that elects to do so shall
comply with all provisions of that section as if it were a school
district.
(B)(1)
(C)(1)
The following are not liable in damages in a civil action for injury,
death, or loss to person or property that allegedly arises from an
act or omission associated with procuring, maintaining, accessing, or
using an epinephrine
autoinjector
delivery
system
under
this section, unless the act or omission constitutes willful or
wanton misconduct:
(a)
A chartered or nonchartered nonpublic school;
(b)
A member of a chartered or nonchartered nonpublic school governing
authority;
(c)
An employee or contractor of the school;
(d)
A licensed health professional authorized to prescribe drugs who
personally furnishes or prescribes epinephrine
autoinjectors
delivery
systems
,
provides a consultation, or issues a protocol pursuant to this
section.
(2)
This division does not eliminate, limit, or reduce any other immunity
or defense that a chartered or nonchartered nonpublic school or
governing authority, member of a chartered or nonchartered nonpublic
school governing authority, chartered or nonchartered nonpublic
school employee or contractor, or licensed health professional may be
entitled to under any other provision of the Revised Code or the
common law of this state.
(C)
(D)
A chartered or nonchartered nonpublic school may accept donations of
epinephrine
autoinjectors
delivery
systems
from
a wholesale distributor of dangerous drugs or a manufacturer of
dangerous drugs
,
as defined in section 4729.01 of the Revised Code,
and
may accept donations of money from any person to purchase epinephrine
autoinjectors
delivery
systems
.
(D)
(E)
A chartered or nonchartered nonpublic school that elects to procure
epinephrine
autoinjectors
delivery
systems
under
this section shall report to the department of education and
workforce each procurement and occurrence in which an epinephrine
autoinjector
delivery
system
is
used from the school's supply of epinephrine
autoinjectors
delivery
systems
.
Sec.
3314.141.
(A)
As used in this section, "epinephrine delivery system" has
the same meaning as in section 3313.718 of the Revised Code.
(B)
A
community school, community school governing authority, or community
school employee is not liable in damages in a civil action for harm
allegedly arising from a community school employee's prohibiting a
student from using an
autoinjector
epinephrine
delivery system
described
in section 3313.718 of the Revised Code because of the employee's
good faith belief that the conditions of division (B) of that section
had not been satisfied. A community school, community school
governing authority, or community school employee is not liable in
damages in a civil action for harm allegedly arising from a community
school employee's permitting a student to use an
autoinjector
epinephrine
delivery system
described
in that section because of the employee's good faith belief that the
conditions of division (B) of that section had been satisfied.
Furthermore, when a community school is required in accordance with
that section to permit a student to possess and use an
autoinjector
epinephrine
delivery system
because
the conditions of division (B) of that section have been satisfied,
the community school, any member of the community school governing
authority, or any community school employee is not liable in damages
in a civil action for injury, death, or loss to person or property
allegedly arising from the use of the
autoinjector
epinephrine
delivery system
by
a student for whom it was not prescribed.
(C)
This
section does not eliminate, limit, or reduce any other immunity or
defense that a community school, community school governing
authority, or community school employee may be entitled to under
Chapter 2744. or any other provision of the Revised Code or under the
common law of this state.
Sec.
3314.143.
(A)
As
used in this section:
(1)
"Epinephrine delivery system" has the same meaning as in
section 3313.718 of the Revised Code.
(2)
"Licensed health professional authorized to prescribe drugs,"
"manufacturer of dangerous drugs," and "wholesale
distributor of dangerous drugs" have the same meanings as in
section 4729.01 of the Revised Code.
(B)
With
the approval of its governing authority, a community school
established under this chapter may procure epinephrine
autoinjectors
delivery
systems
in
the manner prescribed by section 3313.7110 of the Revised Code. A
community school that elects to do so shall comply with all
provisions of that section as if it were a school district.
(B)(1)
(C)(1)
The following are not liable in damages in a civil action for injury,
death, or loss to person or property that allegedly arises from an
act or omission associated with procuring, maintaining, accessing, or
using an epinephrine
autoinjector
delivery
system
under
this section, unless the act or omission constitutes willful or
wanton misconduct:
(a)
A community school;
(b)
A member of a community school governing authority;
(c)
A community school employee or contractor;
(d)
A licensed health professional authorized to prescribe drugs who
personally furnishes or prescribes epinephrine
autoinjectors
delivery
systems
,
provides a consultation, or issues a protocol pursuant to this
section.
(2)
This division does not eliminate, limit, or reduce any other immunity
or defense that a community school or governing authority, member of
a community school governing authority, community school employee or
contractor, or licensed health professional may be entitled to under
Chapter 2744. or any other provision of the Revised Code or under the
common law of this state.
(C)
(D)
A community school may accept donations of epinephrine
autoinjectors
delivery
systems
from
a wholesale distributor of dangerous drugs or a manufacturer of
dangerous drugs
,
as defined in section 4729.01 of the Revised Code,
and may accept donations of money from any person to purchase
epinephrine
autoinjectors
delivery
systems
.
(D)
(E)
A community school that elects to procure epinephrine
autoinjectors
delivery
systems
under
this section shall report to the department of education and
workforce each procurement and occurrence in which an epinephrine
autoinjector
delivery
system
is
used from the school's supply of epinephrine
autoinjectors
delivery
systems
.
Sec.
3326.28.
(A)
As
used in this section:
(1)
"Epinephrine delivery system" has the same meaning as in
section 3313.718 of the Revised Code.
(2)
"Licensed health professional authorized to prescribe drugs,"
"manufacturer of dangerous drugs," and "wholesale
distributor of dangerous drugs" have the same meanings as in
section 4729.01 of the Revised Code.
(B)
With
the approval of its governing body, a STEM school established under
this chapter may procure epinephrine
autoinjectors
delivery
systems
in
the manner prescribed by section 3313.7110 of the Revised Code. A
STEM school that elects to do so shall comply with all provisions of
that section as if it were a school district.
(B)(1)
(C)(1)
The following are not liable in damages in a civil action for injury,
death, or loss to person or property that allegedly arises from an
act or omission associated with procuring, maintaining, accessing, or
using an epinephrine
autoinjector
delivery
system
under
this section, unless the act or omission constitutes willful or
wanton misconduct:
(a)
A STEM school;
(b)
A member of a STEM school governing body;
(c)
A STEM school employee or contractor;
(d)
A licensed health professional authorized to prescribe drugs who
personally furnishes or prescribes epinephrine
autoinjectors
delivery
systems
,
provides a consultation, or issues a protocol pursuant to this
section.
(2)
This division does not eliminate, limit, or reduce any other immunity
or defense that a STEM school or governing body, member of a STEM
school governing body, STEM school employee or contractor, or
licensed health professional may be entitled to under Chapter 2744.
or any other provision of the Revised Code or under the common law of
this state.
(C)
(D)
A STEM school may accept donations of epinephrine
autoinjectors
delivery
systems
from
a wholesale distributor of dangerous drugs or a manufacturer of
dangerous drugs
,
as defined in section 4729.01 of the Revised Code,
and may accept donations of money from any person to purchase
epinephrine
autoinjectors
delivery
systems
.
(D)
(E)
A STEM school that elects to procure epinephrine
autoinjectors
delivery
systems
under
this section shall report to the department of education and
workforce each procurement and occurrence in which an epinephrine
autoinjector
delivery
system
is
used from the school's supply of epinephrine
autoinjectors
delivery
systems
.
Sec.
3328.24.
A
college-preparatory boarding school established under this chapter
and its board of trustees shall comply with sections 102.02,
3301.0710, 3301.0711, 3301.0712, 3301.0714, 3301.0729, 3301.948,
3302.037, 3313.474, 3313.5318, 3313.5319, 3313.6013, 3313.6021,
3313.6023, 3313.6024, 3313.6026, 3313.6029, 3313.6031, 3313.617,
3313.618, 3313.6114, 3313.6411, 3313.6413, 3313.668, 3313.669,
3313.6610, 3313.717,
3313.718,
3313.7112,
3313.7117, 3313.721, 3313.753, 3313.8110, 3313.89, 3319.073,
3319.077, 3319.078, 3319.318, 3319.324, 3319.39, 3319.391, 3319.393,
3319.46, 3320.01, 3320.02, 3320.03, 3320.04, 3323.251, and 5502.262,
and Chapter 3365. of the Revised Code as if the school were a school
district and the school's board of trustees were a district board of
education.
Sec.
3328.29.
(A)
As
used in this section:
(1)
"Epinephrine delivery system" has the same meaning as in
section 3313.718 of the Revised Code.
(2)
"Licensed health professional authorized to prescribe drugs,"
"manufacturer of dangerous drugs," and "wholesale
distributor of dangerous drugs" have the same meanings as in
section 4729.01 of the Revised Code.
(B)
With
the approval of its board of trustees, a college-preparatory boarding
school established under this chapter may procure epinephrine
autoinjectors
delivery
systems
in
the manner prescribed by section 3313.7110 of the Revised Code. A
college-preparatory boarding school that elects to do so shall comply
with all provisions of that section as if it were a school district.
(B)(1)
(C)(1)
The following are not liable in damages in a civil action for injury,
death, or loss to person or property that allegedly arises from an
act or omission associated with procuring, maintaining, accessing, or
using an epinephrine
autoinjector
delivery
system
under
this section, unless the act or omission constitutes willful or
wanton misconduct:
(a)
A college-preparatory boarding school;
(b)
A member of a college-preparatory boarding school board of trustees;
(c)
A college-preparatory boarding school employee or contractor;
(d)
A licensed health professional authorized to prescribe drugs who
personally furnishes or prescribes epinephrine
autoinjectors
delivery
systems
,
provides a consultation, or issues a protocol pursuant to this
section.
(2)
This division does not eliminate, limit, or reduce any other immunity
or defense that a college-preparatory boarding school or board of
trustees, member of a college-preparatory boarding school board of
trustees, college-preparatory boarding school employee or contractor,
or licensed health professional may be entitled to under Chapter
2744. or any other provision of the Revised Code or under the common
law of this state.
(C)
(D)
A college-preparatory boarding school may accept donations of
epinephrine
autoinjectors
delivery
systems
from
a wholesale distributor of dangerous drugs or a manufacturer of
dangerous drugs
,
as defined in section 4729.01 of the Revised Code,
and may accept donations of money from any person to purchase
epinephrine
autoinjectors
delivery
systems
.
(D)
(E)
A college-preparatory boarding school that elects to procure
epinephrine
autoinjectors
delivery
systems
under
this section shall report to the department of education and
workforce each procurement and occurrence in which an epinephrine
autoinjector
delivery
system
is
used from a school's supply of epinephrine
autoinjectors
delivery
systems
.
Sec.
3728.01.
As
used in this chapter:
(A)
"Administer epinephrine" means to inject an individual with
epinephrine using an autoinjector in a manufactured dosage form.
(B)
"Peace officer" has the same meaning as in section 109.71
of the Revised Code and also includes a sheriff.
(C)
"Prescriber" means an individual who is authorized by law
to prescribe drugs or dangerous drugs or drug therapy related devices
in the course of the individual's professional practice, including
only the following:
(1)
A clinical nurse specialist, certified nurse-midwife, or certified
nurse practitioner
who holds a certificate to prescribe issued under section 4723.48 of
the Revised Code
;
(2)
A physician authorized under Chapter 4731. of the Revised Code to
practice medicine and surgery, osteopathic medicine and surgery, or
podiatric medicine and surgery;
(3)
A physician assistant who is licensed under Chapter 4730. of the
Revised Code, holds a valid prescriber number issued by the state
medical board, and has been granted physician-delegated prescriptive
authority.
(D)
(D)(1)
"Qualified entity" means either of the following:
(1)
(a)
Any public or private entity that is associated with a location where
allergens capable of causing anaphylaxis may be present, including
child care centers, colleges and universities, places of employment,
restaurants, amusement parks, recreation camps, sports playing fields
and arenas, and other similar locations
,
except that "qualified
;
(b)
Either of the following served by a peace officer: a law enforcement
agency or other entity described in division (A) of section 109.71 of
the Revised Code.
(2)
"Qualified
entity"
does not include either of the following:
(a)
A chartered or nonchartered nonpublic school; community school;
science, technology, engineering, and mathematics school;
college-preparatory boarding school; or a school operated by the
board of education of a city, local, exempted village, or joint
vocational school district, as those entities are otherwise
authorized to procure epinephrine
autoinjectors
delivery
systems
pursuant
to sections 3313.7110, 3313.7111, 3314.143, 3326.28, or 3328.29 of
the Revised Code;
(b)
A camp described in section 5180.26 of the Revised Code that is
authorized to procure epinephrine
autoinjectors
delivery
systems
pursuant
to that section
;
(2)
Either of the following served by a peace officer: a law enforcement
agency or other entity described in division (A) of section 109.71 of
the Revised Code
.
Sec.
4723.483.
(A)(1)
(A)
As used in this section, "epinephrine delivery system" has
the same meaning as in section 3313.718 of the Revised Code.
(B)(1)
Subject to division
(A)(2)
(B)(2)
of this section, and notwithstanding any
conflicting
provision
of this chapter or rule adopted by the board of nursing, a clinical
nurse specialist, certified nurse-midwife, or certified nurse
practitioner
who
holds a certificate to prescribe issued under section 4723.48 of the
Revised Code
may
do
either
any
of
the following without having examined an individual to whom
epinephrine may be administered:
(a)
Personally furnish a supply of epinephrine autoinjectors for use in
accordance with
sections
3313.7110, 3313.7111, 3314.143, 3326.28, 3328.29, 3728.03 to 3728.05,
and 5180.26
Chapter
3728.
of
the Revised Code;
(b)
Personally
furnish a supply of epinephrine delivery systems for use in
accordance with sections 3313.7110, 3313.7111, 3314.143, 3326.28,
3328.29, and 5180.26 of the Revised Code;
(c)
Issue
a prescription for epinephrine autoinjectors for use in accordance
with
sections
3313.7110, 3313.7111, 3314.143, 3326.28, 3328.29, 3728.03 to 3728.05,
and 5180.26
Chapter
3728.
of
the Revised Code
;
(d)
Issue a prescription for epinephrine delivery systems for use in
accordance with sections 3313.7110, 3313.7111, 3314.143, 3326.28,
3328.29, and 5180.26 of the Revised Code
.
(2)
An epinephrine autoinjector personally furnished or prescribed under
division
(A)(1)
(B)(1)(a)
or (c)
of this section must be furnished or prescribed in such a manner that
it may be administered only in a manufactured dosage form.
(B)
(C)
A nurse who acts in good faith in accordance with this section is not
liable for or subject to any of the following for any action or
omission of an entity to which an epinephrine
delivery
system, including an
autoinjector
,
is furnished or a prescription is issued: damages in any civil
action, prosecution in any criminal proceeding, or professional
disciplinary action.
Sec.
4729.01.
As
used in this chapter:
(A)
"Pharmacy," except when used in a context that refers to
the practice of pharmacy, means any area, room, rooms, place of
business, department, or portion of any of the foregoing where the
practice of pharmacy is conducted.
(B)
"Practice of pharmacy" means providing pharmacist care
requiring specialized knowledge, judgment, and skill derived from the
principles of biological, chemical, behavioral, social,
pharmaceutical, and clinical sciences. As used in this division,
"pharmacist care" includes the following:
(1)
Interpreting prescriptions;
(2)
Dispensing drugs and drug therapy related devices;
(3)
Compounding drugs;
(4)
Counseling individuals with regard to their drug therapy,
recommending drug therapy related devices, and assisting in the
selection of drugs and appliances for treatment of common diseases
and injuries and providing instruction in the proper use of the drugs
and appliances;
(5)
Performing drug regimen reviews with individuals by discussing all of
the drugs that the individual is taking and explaining the
interactions of the drugs;
(6)
Performing drug utilization reviews with licensed health
professionals authorized to prescribe drugs when the pharmacist
determines that an individual with a prescription has a drug regimen
that warrants additional discussion with the prescriber;
(7)
Advising an individual and the health care professionals treating an
individual with regard to the individual's drug therapy;
(8)
Acting pursuant to a consult agreement, if an agreement has been
established;
(9)
Engaging in the administration of immunizations to the extent
authorized by section 4729.41 of the Revised Code;
(10)
Engaging in the administration of drugs to the extent authorized by
section 4729.45 of the Revised Code.
(C)
"Compounding" means the preparation, mixing, assembling,
packaging, and labeling of one or more drugs in any of the following
circumstances:
(1)
Pursuant to a prescription issued by a licensed health professional
authorized to prescribe drugs;
(2)
Pursuant to the modification of a prescription made in accordance
with a consult agreement;
(3)
As an incident to research, teaching activities, or chemical
analysis;
(4)
In anticipation of orders for drugs pursuant to prescriptions, based
on routine, regularly observed dispensing patterns;
(5)
Pursuant to a request made by a licensed health professional
authorized to prescribe drugs for a drug that is to be used by the
professional for the purpose of direct administration to patients in
the course of the professional's practice, if all of the following
apply:
(a)
At the time the request is made, the drug is not commercially
available regardless of the reason that the drug is not available,
including the absence of a manufacturer for the drug or the lack of a
readily available supply of the drug from a manufacturer.
(b)
A limited quantity of the drug is compounded and provided to the
professional.
(c)
The drug is compounded and provided to the professional as an
occasional exception to the normal practice of dispensing drugs
pursuant to patient-specific prescriptions.
(D)
"Consult agreement" means an agreement that has been
entered into under section 4729.39 of the Revised Code.
(E)
"Drug" means:
(1)
Any article recognized in the United States pharmacopoeia and
national formulary, or any supplement to them, intended for use in
the diagnosis, cure, mitigation, treatment, or prevention of disease
in humans or animals;
(2)
Any other article intended for use in the diagnosis, cure,
mitigation, treatment, or prevention of disease in humans or animals;
(3)
Any article, other than food, intended to affect the structure or any
function of the body of humans or animals;
(4)
Any article intended for use as a component of any article specified
in division (E)(1), (2), or (3) of this section; but does not include
devices or their components, parts, or accessories.
"Drug"
does not include "hemp" as that term is defined in section
928.01 of the Revised Code.
(F)
"Dangerous drug" means any of the following:
(1)
Any drug to which either of the following applies:
(a)
Under the "Federal Food, Drug, and Cosmetic Act," 52 Stat.
1040 (1938), 21 U.S.C.A. 301, as amended, the drug is required to
bear a label containing the legend "Caution: Federal law
prohibits dispensing without prescription" or "Caution:
Federal law restricts this drug to use by or on the order of a
licensed veterinarian" or any similar restrictive statement, or
the drug may be dispensed only upon a prescription;
(b)
Under Chapter 3715. or 3719. of the Revised Code, the drug may be
dispensed only upon a prescription.
(2)
Any drug that contains a schedule V controlled substance and that is
exempt from Chapter 3719. of the Revised Code or to which that
chapter does not apply;
(3)
Any drug intended for administration by injection into the human body
other than through a natural orifice of the human body;
(4)
Any drug that is a biological product, as defined in section 3715.01
of the Revised Code.
(G)
"Federal drug abuse control laws" has the same meaning as
in section 3719.01 of the Revised Code.
(H)
"Prescription" means all of the following:
(1)
A written, electronic, or oral order for drugs or combinations or
mixtures of drugs to be used by a particular individual or for
treating a particular animal, issued by a licensed health
professional authorized to prescribe drugs;
(2)
For purposes of sections 4723.4810, 4729.282, 4730.432, and 4731.93
of the Revised Code, a written, electronic, or oral order for a drug
to treat chlamydia, gonorrhea, or trichomoniasis issued to and in the
name of a patient who is not the intended user of the drug but is the
sexual partner of the intended user;
(3)
For purposes of sections 3313.7110, 3313.7111, 3314.143, 3326.28,
3328.29, 4723.483, 4729.88, 4730.433, 4731.96, and 5180.26 of the
Revised Code, a written, electronic, or oral order for an epinephrine
autoinjector
delivery
system
issued
to and in the name of a school, school district, or camp;
(4)
For purposes of Chapter 3728. and sections 4723.483, 4729.88,
4730.433, and 4731.96 of the Revised Code, a written, electronic, or
oral order for an epinephrine autoinjector issued to and in the name
of a qualified entity, as defined in section 3728.01 of the Revised
Code;
(5)
For purposes of sections 3313.7115, 3313.7116, 3314.147, 3326.60,
3328.38, 4723.4811, 4730.437, 4731.92, and 5180.262 of the Revised
Code, a written, electronic, or oral order for injectable or nasally
administered glucagon in the name of a school, school district, or
camp.
(I)
"Licensed health professional authorized to prescribe drugs"
or "prescriber" means an individual who is authorized by
law to prescribe drugs or dangerous drugs or drug therapy related
devices in the course of the individual's professional practice,
including only the following:
(1)
A dentist licensed under Chapter 4715. of the Revised Code;
(2)
A clinical nurse specialist, certified nurse-midwife, or certified
nurse practitioner who holds a current, valid license issued under
Chapter 4723. of the Revised Code to practice nursing as an advanced
practice registered nurse;
(3)
A certified registered nurse anesthetist who holds a current, valid
license issued under Chapter 4723. of the Revised Code to practice
nursing as an advanced practice registered nurse, but only to the
extent of the nurse's authority under sections 4723.43 and 4723.434
of the Revised Code;
(4)
An optometrist licensed under Chapter 4725. of the Revised Code to
practice optometry;
(5)
A physician authorized under Chapter 4731. of the Revised Code to
practice medicine and surgery, osteopathic medicine and surgery, or
podiatric medicine and surgery;
(6)
A physician assistant who holds a license to practice as a physician
assistant issued under Chapter 4730. of the Revised Code, holds a
valid prescriber number issued by the state medical board, and has
been granted physician-delegated prescriptive authority;
(7)
A veterinarian licensed under Chapter 4741. of the Revised Code;
(8)
A certified mental health assistant licensed under Chapter 4772. of
the Revised Code who has been granted physician-delegated
prescriptive authority by the physician supervising the certified
mental health assistant.
(J)
"Sale" or "sell" includes any transaction made by
any person, whether as principal proprietor, agent, or employee, to
do or offer to do any of the following: deliver, distribute, broker,
exchange, gift or otherwise give away, or transfer, whether the
transfer is by passage of title, physical movement, or both.
(K)
"Wholesale sale" and "sale at wholesale" mean any
sale in which the purpose of the purchaser is to resell the article
purchased or received by the purchaser.
(L)
"Retail sale" and "sale at retail" mean any sale
other than a wholesale sale or sale at wholesale.
(M)
"Retail seller" means any person that sells any dangerous
drug to consumers without assuming control over and responsibility
for its administration. Mere advice or instructions regarding
administration do not constitute control or establish responsibility.
(N)
"Price information" means the price charged for a
prescription for a particular drug product and, in an easily
understandable manner, all of the following:
(1)
The proprietary name of the drug product;
(2)
The established (generic) name of the drug product;
(3)
The strength of the drug product if the product contains a single
active ingredient or if the drug product contains more than one
active ingredient and a relevant strength can be associated with the
product without indicating each active ingredient. The established
name and quantity of each active ingredient are required if such a
relevant strength cannot be so associated with a drug product
containing more than one ingredient.
(4)
The dosage form;
(5)
The price charged for a specific quantity of the drug product. The
stated price shall include all charges to the consumer, including,
but not limited to, the cost of the drug product, professional fees,
handling fees, if any, and a statement identifying professional
services routinely furnished by the pharmacy. Any mailing fees and
delivery fees may be stated separately without repetition. The
information shall not be false or misleading.
(O)
"Wholesale distributor of dangerous drugs" or "wholesale
distributor" means a person engaged in the sale of dangerous
drugs at wholesale and includes any agent or employee of such a
person authorized by the person to engage in the sale of dangerous
drugs at wholesale.
(P)
"Manufacturer of dangerous drugs" or "manufacturer"
means a person, other than a pharmacist or prescriber, who
manufactures dangerous drugs and who is engaged in the sale of those
dangerous drugs.
(Q)
"Terminal distributor of dangerous drugs" or "terminal
distributor" means a person who is engaged in the sale of
dangerous drugs at retail, or any person, other than a manufacturer,
repackager, outsourcing facility, third-party logistics provider,
wholesale distributor, or pharmacist, who has possession, custody, or
control of dangerous drugs for any purpose other than for that
person's own use and consumption. "Terminal distributor"
includes pharmacies, hospitals, nursing homes, and laboratories and
all other persons who procure dangerous drugs for sale or other
distribution by or under the supervision of a pharmacist, licensed
health professional authorized to prescribe drugs, or other person
authorized by the state board of pharmacy.
(R)
"Promote to the public" means disseminating a
representation to the public in any manner or by any means, other
than by labeling, for the purpose of inducing, or that is likely to
induce, directly or indirectly, the purchase of a dangerous drug at
retail.
(S)
"Person" includes any individual, partnership, association,
limited liability company, or corporation, the state, any political
subdivision of the state, and any district, department, or agency of
the state or its political subdivisions.
(T)(1)
"Animal shelter" means a facility operated by a humane
society or any society organized under Chapter 1717. of the Revised
Code or a dog pound operated pursuant to Chapter 955. of the Revised
Code.
(2)
"County dog warden" means a dog warden or deputy dog warden
appointed or employed under section 955.12 of the Revised Code.
(3)
"Wild animal rehabilitation facility" means a facility that
holds a permit issued by the chief of the division of wildlife for
rehabilitation purposes in accordance with section 1533.08 of the
Revised Code or rules adopted by the chief.
(U)
"Food" has the same meaning as in section 3715.01 of the
Revised Code.
(V)
"Pain management clinic" has the same meaning as in section
4731.054 of the Revised Code.
(W)
"Investigational drug or product" means a drug or product
that has successfully completed phase one of the United States food
and drug administration clinical trials and remains under clinical
trial, but has not been approved for general use by the United States
food and drug administration. "Investigational drug or product"
does not include controlled substances in schedule I, as defined in
section 3719.01 of the Revised Code.
(X)
"Product," when used in reference to an investigational
drug or product, means a biological product, other than a drug, that
is made from a natural human, animal, or microorganism source and is
intended to treat a disease or medical condition.
(Y)
"Third-party logistics provider" means a person that
provides or coordinates warehousing or other logistics services
pertaining to dangerous drugs including distribution, on behalf of a
manufacturer, wholesale distributor, or terminal distributor of
dangerous drugs, but does not take ownership of the drugs or have
responsibility to direct the sale or disposition of the drugs.
(Z)
"Repackager of dangerous drugs" or "repackager"
means a person that repacks and relabels dangerous drugs for sale or
distribution.
(AA)
"Outsourcing facility" means a facility that is engaged in
the compounding and sale of sterile drugs and is registered as an
outsourcing facility with the United States food and drug
administration.
(BB)
"Laboratory" means a laboratory licensed under this chapter
as a terminal distributor of dangerous drugs and entrusted to have
custody of any of the following drugs and to use the drugs for
scientific and clinical purposes and for purposes of instruction:
dangerous drugs that are not controlled substances, as defined in
section 3719.01 of the Revised Code; dangerous drugs that are
controlled substances, as defined in that section; and controlled
substances in schedule I, as defined in that section.
(CC)
"Overdose reversal drug" means both of the following:
(1)
Naloxone;
(2)
Any other drug that the state board of pharmacy, through rules
adopted in accordance with Chapter 119. of the Revised Code,
designates as a drug that is approved by the federal food and drug
administration for the reversal of a known or suspected
opioid-related overdose.
(DD)
"Epinephrine delivery system" has the same meaning as in
section 3313.718 of the Revised Code.
Sec.
4729.262.
The
state board of pharmacy shall adopt rules designating the devices or
other products that are approved by the United States food and drug
administration for use in administering a premeasured dose of
epinephrine through any route of administration into the human body.
The rules shall be adopted in accordance with Chapter 119. of the
Revised Code.
Sec.
4729.51.
(A)
No person other than a licensed manufacturer of dangerous drugs,
outsourcing facility, third-party logistics provider, repackager of
dangerous drugs, or wholesale distributor of dangerous drugs shall
possess for sale, sell, distribute, or deliver, at wholesale,
dangerous drugs or investigational drugs or products, except as
follows:
(1)
A licensed terminal distributor of dangerous drugs that is a pharmacy
may make occasional sales of dangerous drugs or investigational drugs
or products at wholesale.
(2)
A licensed terminal distributor of dangerous drugs having more than
one licensed location may transfer or deliver dangerous drugs from
one licensed location to another licensed location owned by the
terminal distributor if the license issued for each location is in
effect at the time of the transfer or delivery.
(3)
A licensed terminal distributor of dangerous drugs that is not a
pharmacy may make occasional sales of the following at wholesale:
(a)
Overdose reversal drugs;
(b)
Dangerous drugs if the drugs being sold are in shortage, as defined
in rules adopted under section 4729.26 of the Revised Code;
(c)
Dangerous drugs other than those described in divisions (A)(3)(a) and
(b) of this section or investigational drugs or products if
authorized by rules adopted under section 4729.26 of the Revised
Code.
(B)
No licensed manufacturer, outsourcing facility, third-party logistics
provider, repackager, or wholesale distributor shall possess for
sale, sell, or distribute, at wholesale, dangerous drugs or
investigational drugs or products to any person other than the
following:
(1)
Subject to division (D) of this section, a licensed terminal
distributor of dangerous drugs;
(2)
Subject to division (C) of this section, any person exempt from
licensure as a terminal distributor of dangerous drugs under section
4729.541 of the Revised Code;
(3)
A licensed manufacturer, outsourcing facility, third-party logistics
provider, repackager, or wholesale distributor;
(4)
A terminal distributor, manufacturer, outsourcing facility,
third-party logistics provider, repackager, or wholesale distributor
that is located in another state, is not engaged in the sale of
dangerous drugs within this state, and is actively licensed to engage
in the sale of dangerous drugs by the state in which the distributor
conducts business.
(C)
No licensed manufacturer, outsourcing facility, third-party logistics
provider, repackager, or wholesale distributor shall possess for
sale, sell, or distribute, at wholesale, dangerous drugs or
investigational drugs or products to either of the following:
(1)
A prescriber who is employed by a pain management clinic that is not
licensed as a terminal distributor of dangerous drugs with a pain
management clinic classification issued under section 4729.552 of the
Revised Code;
(2)
A business entity described in division (A)(2) or (3) of section
4729.541 of the Revised Code that is, or is operating, a pain
management clinic without a license as a terminal distributor of
dangerous drugs with a pain management clinic classification issued
under section 4729.552 of the Revised Code.
(D)
No licensed manufacturer, outsourcing facility, third-party logistics
provider, repackager, or wholesale distributor shall possess
dangerous drugs or investigational drugs or products for sale at
wholesale, or sell or distribute such drugs at wholesale, to a
licensed terminal distributor of dangerous drugs, except as follows:
(1)
In the case of a terminal distributor with a category II license,
only dangerous drugs in category II, as defined in division (A)(1) of
section 4729.54 of the Revised Code;
(2)
In the case of a terminal distributor with a category III license,
dangerous drugs in category II and category III, as defined in
divisions (A)(1) and (2) of section 4729.54 of the Revised Code;
(3)
In the case of a terminal distributor with a limited category II or
III license, only the dangerous drugs specified in the license.
(E)(1)
Except as provided in division (E)(2) of this section, no person
shall do any of the following:
(a)
Sell or distribute, at retail, dangerous drugs;
(b)
Possess for sale, at retail, dangerous drugs;
(c)
Possess dangerous drugs.
(2)(a)
Divisions (E)(1)(a), (b), and (c) of this section do not apply to any
of the following:
(i)
A licensed terminal distributor of dangerous drugs;
(ii)
A person who possesses, or possesses for sale or sells, at retail, a
dangerous drug in accordance with Chapters 3719., 4715., 4723.,
4725., 4729., 4730., 4731., 4741., and 4772. of the Revised Code;
(iii)
Any of the persons identified in divisions (A)(1) to (5) and
(18)
(17)
of section 4729.541 of the Revised Code, but only to the extent
specified in that section.
(b)
Division (E)(1)(c) of this section does not apply to any of the
following:
(i)
A licensed manufacturer, outsourcing facility, third-party logistics
provider, repackager, or wholesale distributor;
(ii)
Any of the persons identified in divisions (A)(6) to (16) of section
4729.541 of the Revised Code, but only to the extent specified in
that section.
(F)
No licensed terminal distributor of dangerous drugs or person that is
exempt from licensure under section 4729.541 of the Revised Code
shall purchase dangerous drugs or investigational drugs or products
from any person other than a licensed manufacturer, outsourcing
facility, third-party logistics provider, repackager, or wholesale
distributor, except as follows:
(1)
A licensed terminal distributor of dangerous drugs or person that is
exempt from licensure under section 4729.541 of the Revised Code may
make occasional purchases of dangerous drugs or investigational drugs
or products that are sold in accordance with division (A)(1) or (3)
of this section.
(2)
A licensed terminal distributor of dangerous drugs having more than
one licensed location may transfer or deliver dangerous drugs or
investigational drugs or products from one licensed location to
another licensed location if the license issued for each location is
in effect at the time of the transfer or delivery.
(G)
No licensed terminal distributor of dangerous drugs shall engage in
the retail sale or other distribution of dangerous drugs or
investigational drugs or products or maintain possession, custody, or
control of dangerous drugs or investigational drugs or products for
any purpose other than the distributor's personal use or consumption,
at any establishment or place other than that or those described in
the license issued by the state board of pharmacy to such terminal
distributor.
(H)
Nothing in this section shall be construed to interfere with the
performance of official duties by any law enforcement official
authorized by municipal, county, state, or federal law to collect
samples of any drug, regardless of its nature or in whose possession
it may be.
(I)
Notwithstanding anything to the contrary in this section, the board
of education of a city, local, exempted village, or joint vocational
school district may distribute epinephrine
autoinjectors
delivery
systems
for
use in accordance with section 3313.7110 of the Revised Code, may
distribute inhalers for use in accordance with section 3313.7113 of
the Revised Code, and may distribute injectable or nasally
administered glucagon for use in accordance with section 3313.7115 of
the Revised Code.
Sec.
4729.513.
A
manufacturer of dangerous drugs may donate inhalers, as defined in
section 3313.7113 of the Revised Code, epinephrine
autoinjectors
delivery
systems
,
as
defined in section 3313.718 of the Revised Code,
or
injectable or nasally administered glucagon to any of the following:
(A)
The board of education of a city, local, exempted village, or joint
vocational school district;
(B)
A community school established under Chapter 3314. of the Revised
Code;
(C)
A STEM school established under Chapter 3326. of the Revised Code;
(D)
A college-preparatory boarding school established under Chapter 3328.
of the Revised Code;
(E)
A chartered or nonchartered nonpublic school;
(F)
A residential camp, as defined in section 2151.011 of the Revised
Code;
(G)
A child day camp, as defined in section 5104.01 of the Revised Code;
(H)
A child day camp operated by any county, township, municipal
corporation, township park district created under section 511.18 of
the Revised Code, park district created under section 1545.04 of the
Revised Code, or joint recreation district established under section
755.14 of the Revised Code.
Sec.
4729.541.
(A)
Except as provided in divisions (B) and (C) of this section, all of
the following are exempt from licensure as a terminal distributor of
dangerous drugs:
(1)
A licensed health professional authorized to prescribe drugs;
(2)
A business entity that is a corporation formed under division (B) of
section 1701.03 of the Revised Code, a limited liability company
formed under former Chapter 1705. of the Revised Code as that chapter
existed prior to February 11, 2022, or Chapter 1706. of the Revised
Code, or a professional association formed under Chapter 1785. of the
Revised Code if the entity has a sole shareholder who is a prescriber
and is authorized to provide the professional services being offered
by the entity;
(3)
A business entity that is a corporation formed under division (B) of
section 1701.03 of the Revised Code, a limited liability company
formed under former Chapter 1705. of the Revised Code as that chapter
existed prior to February 11, 2022, or Chapter 1706. of the Revised
Code, a partnership or a limited liability partnership formed under
Chapter 1775. of the Revised Code, or a professional association
formed under Chapter 1785. of the Revised Code, if, to be a
shareholder, member, or partner, an individual is required to be
licensed, certified, or otherwise legally authorized under Title
XLVII of the Revised Code to perform the professional service
provided by the entity and each such individual is a prescriber;
(4)
An individual who holds a current license, certificate, or
registration issued under Title XLVII of the Revised Code and has
been certified to conduct diabetes education by a national certifying
body specified in rules adopted by the state board of pharmacy under
section 4729.68 of the Revised Code, but only with respect to insulin
that will be used for the purpose of diabetes education and only if
diabetes education is within the individual's scope of practice under
statutes and rules regulating the individual's profession;
(5)
An individual who holds a valid certificate issued by a nationally
recognized S.C.U.B.A. diving certifying organization approved by the
state board of pharmacy under rules adopted by the board, but only
with respect to medical oxygen that will be used for the purpose of
emergency care or treatment at the scene of a diving emergency;
(6)
With respect to epinephrine
autoinjectors
delivery
systems
that
may be possessed under section 3313.7110, 3313.7111, 3314.143,
3326.28, or 3328.29 of the Revised Code, any of the following: the
board of education of a city, local, exempted village, or joint
vocational school district; a chartered or nonchartered nonpublic
school; a community school established under Chapter 3314. of the
Revised Code; a STEM school established under Chapter 3326. of the
Revised Code; or a college-preparatory boarding school established
under Chapter 3328. of the Revised Code;
(7)
With respect to epinephrine
autoinjectors
delivery
systems
that
may be possessed under section 5180.26 of the Revised Code, any of
the following: a residential camp, as defined in section 2151.011 of
the Revised Code; a child day camp, as defined in section 5104.01 of
the Revised Code; or a child day camp operated by any county,
township, municipal corporation, township park district created under
section 511.18 of the Revised Code, park district created under
section 1545.04 of the Revised Code, or joint recreation district
established under section 755.14 of the Revised Code;
(8)
With respect to epinephrine autoinjectors that may be possessed under
Chapter 3728. of the Revised Code, a qualified entity, as defined in
section 3728.01 of the Revised Code;
(9)
With respect to inhalers that may be possessed under section
3313.7113, 3313.7114, 3314.144, 3326.30, or 3328.30 of the Revised
Code, any of the following: the board of education of a city, local,
exempted village, or joint vocational school district; a chartered or
nonchartered nonpublic school; a community school established under
Chapter 3314. of the Revised Code; a STEM school established under
Chapter 3326. of the Revised Code; or a college-preparatory boarding
school established under Chapter 3328. of the Revised Code;
(10)
With respect to inhalers that may be possessed under section 5180.261
of the Revised Code, any of the following: a residential camp, as
defined in section 2151.011 of the Revised Code; a child day camp, as
defined in section 5104.01 of the Revised Code; or a child day camp
operated by any county, township, municipal corporation, township
park district created under section 511.18 of the Revised Code, park
district created under section 1545.04 of the Revised Code, or joint
recreation district established under section 755.14 of the Revised
Code;
(11)
With respect to overdose reversal drugs that may be possessed for the
purposes described in section 3715.50 of the Revised Code, any person
or government entity exercising the authority conferred by that
section;
(12)
With respect to overdose reversal drugs that may be possessed for use
in personally furnishing supplies of the drug pursuant to a protocol
established under section 3715.503 of the Revised Code, any
individual exercising the authority conferred by that section;
(13)
With respect to injectable or nasally administered glucagon that may
be possessed under sections 3313.7115, 3313.7116, 3314.147, 3326.60,
and 3328.38 of the Revised Code, any of the following: the board of
education of a city, local, exempted village, or joint vocational
school district; a chartered or nonchartered nonpublic school; a
community school established under Chapter 3314. of the Revised Code;
a STEM school established under Chapter 3326. of the Revised Code; or
a college-preparatory boarding school established under Chapter 3328.
of the Revised Code;
(14)
With respect to injectable or nasally administered glucagon that may
be possessed under section 5180.262 of the Revised Code, any of the
following: a residential camp, as defined in section 2151.011 of the
Revised Code; a child day camp, as defined in section 5104.01 of the
Revised Code; or a child day camp operated by any county, township,
municipal corporation, township park district created under section
511.18 of the Revised Code, park district created under section
1545.04 of the Revised Code, or joint recreation district established
under section 755.14 of the Revised Code;
(15)
A person who possesses nitrous oxide for use as a direct ingredient
in food pursuant to 21 C.F.R. 184.1545 or for testing or maintaining
a plumbing or heating, ventilation, and air conditioning system;
(16)
A person who possesses medical oxygen, sterile water, or sterile
saline for direct administration to patients or for the purpose of
installation or maintenance of home medical equipment, as defined in
section 4752.01 of the Revised Code;
(17)
A facility that is owned and operated by the United States department
of defense, the United States department of veterans affairs, or any
other federal agency.
(B)
If a person described in division (A) of this section is a pain
management clinic or is operating a pain management clinic, the
person shall hold a license as a terminal distributor of dangerous
drugs with a pain management clinic classification issued under
section 4729.552 of the Revised Code.
(C)
Any of the persons described in divisions (A)(1) to (16) of this
section shall hold a license as a terminal distributor of dangerous
drugs in order to possess, have custody or control of, and distribute
any of the following:
(1)
Dangerous drugs that are compounded or used for the purpose of
compounding;
(2)
A schedule I, II, III, IV, or V controlled substance, as defined in
section 3719.01 of the Revised Code.
Sec.
4729.88.
(A)
Notwithstanding any
conflicting
provision
of this chapter or rule adopted by the state board of pharmacy, a
pharmacist may dispense
epinephrine
delivery systems, including
epinephrine
autoinjectors
,
pursuant to a prescription issued under section 4723.483, 4730.433,
or 4731.96 of the Revised Code.
A
pharmacist who in good faith dispenses epinephrine
delivery
systems, including
autoinjectors
,
under this division is not liable for or subject to any of the
following for any action or omission of an entity to which an
epinephrine
delivery
system, including an
autoinjector
,
is dispensed: damages in any civil action, prosecution in any
criminal proceeding, or professional disciplinary action.
(B)
Notwithstanding any
conflicting
provision
of this chapter or rule adopted by the state board of pharmacy, a
pharmacist may dispense injectable or nasally administered glucagon
pursuant to a prescription issued under section 4723.4811, 4730.437,
or 4731.92 of the Revised Code.
A
pharmacist who in good faith dispenses injectable or nasally
administered glucagon under this division is not liable for or
subject to any of the following for any action or omission of an
entity to which the drug is dispensed: damages in any civil action,
prosecution in any criminal proceeding, or professional disciplinary
action.
Sec.
4730.433.
(A)(1)
(A)
As used in this section, "epinephrine delivery system" has
the same meaning as in section 3313.718 of the Revised Code.
(B)(1)
Subject
to division
(A)(2)
(B)(2)
of this section, and notwithstanding any
conflicting
provision
of this chapter or rule adopted by the state medical board, a
physician assistant who holds a license issued under this chapter and
a valid prescriber number issued by the state medical board and has
been granted physician-delegated prescriptive authority may do
either
any
of
the following without having examined an individual to whom
epinephrine may be administered:
(a)
Personally furnish a supply of epinephrine autoinjectors for use in
accordance with
sections
3313.7110, 3313.7111, 3314.143, 3326.28, 3328.29, 3728.03 to 3728.05,
and 5180.26
Chapter
3728.
of
the Revised Code;
(b)
Personally
furnish a supply of epinephrine delivery systems for use in
accordance with sections 3313.7110, 3313.7111, 3314.143, 3326.28,
3328.29, and 5180.26 of the Revised Code;
(c)
Issue
a prescription for epinephrine autoinjectors for use in accordance
with
sections
3313.7110, 3313.7111, 3314.143, 3326.28, 3328.29, 3728.03 to 3728.05,
and 5180.26
Chapter
3728.
of
the Revised Code
;
(d)
Issue a prescription for epinephrine delivery systems for use in
accordance with sections 3313.7110, 3313.7111, 3314.143, 3326.28,
3328.29, and 5180.26 of the Revised Code
.
(2)
An epinephrine autoinjector personally furnished or prescribed under
division
(A)(1)
(B)(1)(a)
or (c)
of this section must be furnished or prescribed in such a manner that
it may be administered only in a manufactured dosage form.
(B)
(C)
A physician assistant who acts in good faith in accordance with this
section is not liable for or subject to any of the following for any
action or omission of an entity to which an epinephrine
delivery system, including an
autoinjector
,
is furnished or a prescription is issued: damages in any civil
action, prosecution in any criminal proceeding, or professional
disciplinary action.
Sec.
4731.96.
(A)
As used in this section
and section 4731.961 of the Revised Code, "physician"
:
(1)
"Epinephrine delivery system" has the same meaning as in
section 3313.718 of the Revised Code.
(2)
"Physician"
means an individual authorized under this chapter to practice
medicine and surgery, osteopathic medicine and surgery, or podiatric
medicine and surgery.
(B)(1)
Subject to division (B)(2) of this section, and notwithstanding any
conflicting
provision
of this chapter or rule adopted by the state medical board, a
physician may do
either
any
of
the following without having examined an individual to whom
epinephrine may be administered:
(a)
Personally furnish a supply of epinephrine autoinjectors for use in
accordance with
sections
3313.7110, 3313.7111, 3314.143, 3326.28, 3328.29, 3728.03 to 3728.05,
and 5180.26
Chapter
3728.
of
the Revised Code;
(b)
Personally
furnish a supply of epinephrine delivery systems for use in
accordance with sections 3313.7110, 3313.7111, 3314.143, 3326.28,
3328.29, and 5180.26 of the Revised Code;
(c)
Issue
a prescription for epinephrine autoinjectors for use in accordance
with
sections
3313.7110, 3313.7111, 3314.143, 3326.28, 3328.29, 3728.03 to 3728.05,
and 5180.26
Chapter
3728.
of
the Revised Code
;
(d)
Issue a prescription for epinephrine delivery systems for use in
accordance with sections 3313.7110, 3313.7111, 3314.143, 3326.28,
3328.29, and 5180.26 of the Revised Code
.
(2)
An epinephrine autoinjector personally furnished or prescribed under
division
(B)(1)
(B)(1)(a)
or (c)
of this section must be furnished or prescribed in such a manner that
it may be administered only in a manufactured dosage form.
(C)
A physician who acts in good faith in accordance with this section is
not liable for or subject to any of the following for any action or
omission of an entity to which an epinephrine
delivery
system, including an
autoinjector
,
is furnished or a prescription is issued: damages in any civil
action, prosecution in any criminal proceeding, or professional
disciplinary action.
Sec.
4731.961.
A
As
used in this section, "physician" has the same meaning as
in section 4731.96 of the Revised Code.
A
physician
who has established a protocol that meets the requirements specified
by the state board of pharmacy in rules adopted under section 4729.47
of the Revised Code may authorize one or more pharmacists and any of
the pharmacy interns supervised by the pharmacist or pharmacists to
use the protocol for the purpose of dispensing epinephrine under
section 4729.47 of the Revised Code.
Sec.
5180.26.
(A)
A residential camp, as defined in section 2151.011 of the Revised
Code, a child day camp, as defined in section 5104.01 of the Revised
Code, or a child day camp operated by any county, township, municipal
corporation, township park district created under section 511.18 of
the Revised Code, park district created under section 1545.04 of the
Revised Code, or joint recreation district established under section
755.14 of the Revised Code may procure epinephrine
autoinjectors
delivery
systems
for
use in emergency situations identified under division (C)(5) of this
section by doing one of the following:
(1)
Having a licensed health professional authorized to prescribe drugs,
acting in accordance with section 4723.483, 4730.433, or 4731.96 of
the Revised Code, personally furnish the epinephrine
autoinjectors
delivery
systems
to
the camp or issue a prescription for them in the name of the camp;
(2)
Obtaining a prescriber-issued protocol that includes definitive
orders for epinephrine
autoinjectors
delivery
systems
and
the dosages of epinephrine to be administered through them.
A
camp that elects to procure epinephrine
autoinjectors
delivery
systems
under
this section is encouraged to maintain at least two epinephrine
autoinjectors
delivery
systems
at
all times.
(B)
A camp that elects to procure epinephrine
autoinjectors
delivery
systems
under
this section shall adopt a policy governing their maintenance and
use. Before adopting the policy, the camp shall consult with a
licensed health professional authorized to prescribe drugs.
(C)
The policy adopted under division (B) of this section shall do all of
the following:
(1)
Identify the one or more locations in which an epinephrine
autoinjector must be stored;
(2)
Specify the conditions under which an epinephrine autoinjector must
be stored, replaced, and disposed;
(3)
Specify the individuals employed by or under contract with the camp
who may access and use an epinephrine autoinjector to provide a
dosage of epinephrine to an individual in an emergency situation
identified under division (C)(5) of this section;
(4)
Specify any training that employees or contractors specified under
division (C)(3) of this section must complete before being authorized
to access and use an epinephrine autoinjector;
(5)
Identify the emergency situations, including when an individual
exhibits signs and symptoms of anaphylaxis, in which employees or
contractors specified under division (C)(3) of this section may
access and use an epinephrine autoinjector;
(6)
Specify that assistance from an emergency medical service provider
must be requested immediately after an epinephrine autoinjector is
used;
(7)
Specify the individuals to whom a dosage of epinephrine may be
administered through an epinephrine autoinjector in an emergency
situation specified under division (C)(5) of this section.
(D)(1)
The following are not liable in damages in a civil action for injury,
death, or loss to person or property that allegedly arises from an
act or omission associated with procuring, maintaining, accessing, or
using an epinephrine autoinjector under this section, unless the act
or omission constitutes willful or wanton misconduct:
(a)
A camp;
(b)
A camp employee or contractor;
(c)
A licensed health professional authorized to prescribe drugs who
personally furnishes or prescribes epinephrine
autoinjectors
delivery
systems
,
provides a consultation, or issues a protocol pursuant to this
section.
(2)
This section does not eliminate, limit, or reduce any other immunity
or defense that a camp or camp employee or contractor or licensed
health professional may be entitled to under Chapter 2744. or any
other provision of the Revised Code or under the common law of this
state.
(E)
A camp may accept donations of epinephrine
autoinjectors
delivery
systems
from
a wholesale distributor of dangerous drugs, as defined in section
4729.01 of the Revised Code, and may accept donations of money from
any person to purchase epinephrine
autoinjectors
delivery
systems
.
(F)
A camp that elects to procure epinephrine
autoinjectors
delivery
systems
under
this section shall report to the department of children and youth
each procurement and occurrence in which an epinephrine autoinjector
is used from a camp's supply of epinephrine
autoinjectors
delivery
systems
.
(G)
As used in this section
,
"licensed
:
(1)
"Epinephrine delivery system" has the same meaning as in
section 3313.718 of the Revised Code.
(2)
"Licensed
health
professional authorized to prescribe drugs"
and
"prescriber"
"prescriber,"
and "wholesale distributor of dangerous drugs"
have the same meanings as in section 4729.01 of the Revised Code.
Section
2.
That
existing sections
3301.135,
3313.718
,
3313.719,
3313.7110, 3313.7111,
3314.141
,
3314.143, 3326.28, 3328.24, 3328.29, 3728.01, 4723.483, 4729.01,
4729.51, 4729.513, 4729.541, 4729.88, 4730.433, 4731.96, 4731.961,
and 5180.26
of the Revised Code are hereby repealed.
Section
3.
The
General Assembly, applying the principle stated in division (B) of
section 1.52 of the Revised Code that amendments are to be harmonized
if reasonably capable of simultaneous operation, finds that the
following sections, presented in this act as composites of the
sections as amended by the acts indicated, are the resulting versions
of the sections in effect prior to the effective date of the sections
as presented in this act:
Section
3328.24 of the Revised Code as amended by both H.B. 10 and H.B. 96 of
the 136th General Assembly.
Section
4729.01 of the Revised Code as amended by H.B. 96, S.B. 56, and S.B.
152, all of the 136th General Assembly.
Speaker
___________________ of the House of Representatives.
President
___________________ of the Senate.
Passed
________________________, 20____
Approved
________________________, 20____
Governor.
The section numbering of law
of a general and permanent nature is complete and in conformity with
the Revised Code.
Director, Legislative
Service Commission.
Filed
in the office of the Secretary of State at Columbus, Ohio, on the
____ day of ___________, A. D. 20____.
Secretary of State.
File
No. _________ Effective Date ___________________