Read the full stored bill text
(136th General Assembly)
(Amended
Senate Bill Number 152)
AN
ACT
To amend sections 4729.01,
4729.36, 4729.531, 4729.532, 4729.54, and 4729.55 of the Revised Code
to allow wild animal rehabilitation facilities to receive a limited
license to administer euthanasia drugs and to modify the law
regarding the use of terms that are limited to pharmacies and
pharmacists.
Be
it enacted by the General Assembly of the State of Ohio:
Section
1.
That
sections 4729.01
,
4729.36
,
4729.531, 4729.532, 4729.54, and 4729.55 of the Revised Code be
amended to read as follows:
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" or a "hemp product" as
those terms are 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 5101.76 of the
Revised Code, a written, electronic, or oral order for an epinephrine
autoinjector 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 5101.78 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.
Sec.
4729.36.
(A)
No place except a pharmacy licensed as a terminal distributor of
dangerous drugs and no person except a licensed pharmacist shall
knowingly
display
any sign or advertise in any fashion
,
using the words "pharmacy," "drugs," "drug
store," "drug store supplies," "pharmacist,"
"druggist," "pharmaceutical chemist,"
"apothecary,"
"drug
sundries,"
or
"medicine
,
"
or
knowingly
use
any
of
these words or their
equivalent
,
of
those words
in any manner
that
would lead or tend to lead the public to believe that the place is a
pharmacy or the person is a pharmacist
.
(B)
A pharmacy making retail sales may advertise by name or therapeutic
class the availability for sale or dispensing of any dangerous drug
provided that the advertising includes the price information
specified in the definition of that term in section 4729.01 of the
Revised Code.
Sec.
4729.531.
(A)
The state board of pharmacy may issue a limited license to an animal
shelter
,
a wild animal rehabilitation facility,
or county dog warden solely for the purpose of purchasing,
possessing, and administering drugs that are distributed in a
manufactured dosage form as described in section 4729.532 of the
Revised Code. Unless otherwise approved by the board, no such license
shall authorize or permit the distribution of these drugs to any
person other than the originating wholesale distributor of the drugs.
An application for licensure shall include the information the board
requires by rule under this section. If the application meets the
requirements of the rules adopted under this section, the board shall
issue the license.
(B)
The board, in accordance with Chapter 119. of the Revised Code, shall
adopt any rules necessary to administer and enforce this section. The
rules shall do all of the following:
(1)
Require as a condition of licensure that an agent or employee of an
animal shelter
or
wild animal rehabilitation facility
or
an agent or employee of a county dog warden, other than a registered
veterinary technician as defined in section 4741.01 of the Revised
Code, has successfully completed a euthanasia technician
certification course described in section 4729.532 of the Revised
Code;
(2)
Specify the information the animal shelter
,
wild animal rehabilitation facility,
or county dog warden must provide the board for issuance or renewal
of a license;
(3)
Address any other matters the board considers necessary or
appropriate for the administration and enforcement of this section.
Sec.
4729.532.
(A)
No agent or employee of an animal shelter
,
no agent or employee of a wild animal rehabilitation facility,
and no county dog warden or agent or employee of a county dog warden
shall perform euthanasia by means of lethal injection on an animal by
use of any substance other than a substance in a manufactured dosage
form that the state veterinary medical licensing board, in
consultation with the state board of pharmacy, approves by rule
adopted in accordance with Chapter 119. of the Revised Code.
The
agent or employee of an animal shelter
or
wild animal rehabilitation facility
,
county dog warden, or agent or employee of a county dog warden when
using a lethal solution to perform euthanasia on an animal shall use
the solution in accordance with the following methods:
(1)
Intravenous injection by hypodermic needle;
(2)
Intraperitoneal injection by hypodermic needle;
(3)
Intracardial injection by hypodermic needle, but only on an animal
verified to be unconscious;
(4)
Oral administration of solution or powder.
(B)
Before euthanasia, a euthanasia technician may administer a solution
of one or more drugs exclusively for the purpose of inducing
anesthesia, sedation, or unconsciousness prior to euthanasia. Only
those drugs that have been approved by rule adopted in accordance
with Chapter 119. of the Revised Code by the state board of pharmacy,
in consultation with the state veterinary medical licensing board,
may be used.
(C)
No agent or employee of an animal shelter
or
wild animal rehabilitation facility
and no county dog warden or agent or employee of a county dog warden,
other than a registered veterinary technician as defined in section
4741.01 of the Revised Code, shall perform euthanasia by means of
lethal injection on an animal or administer pre-euthanasia drugs that
induce anesthesia, sedation, or unconsciousness unless the agent or
employee or county dog warden has received certification after
successfully completing a euthanasia technician certification course
as described in this division.
The
curriculum for a euthanasia technician certification course shall be
one that has been approved by the state veterinary medical licensing
board, shall be at least sixteen hours in length, and shall include
information in at least all of the following areas:
(1)
The pharmacology, proper administration, and storage of euthanasia,
sedation, and anesthesia solutions;
(2)
Federal and state laws regulating the storage and accountability of
euthanasia, sedation, and anesthesia solutions;
(3)
Euthanasia technician stress management;
(4)
Proper disposal of euthanized animals.
(D)(1)
No agent or employee of an animal shelter
or
wild animal rehabilitation facility
shall
perform euthanasia by means of lethal injection on animals or
administer pre-euthanasia drugs that induce anesthesia, sedation, or
unconsciousness under this section unless the facility in which the
agent or employee works or is employed is licensed with the state
board of pharmacy under section 4729.531 of the Revised Code. No
agent or employee of a county dog warden shall perform euthanasia by
means of lethal injection on animals or administer pre-euthanasia
drugs that induce anesthesia, sedation, or unconsciousness under this
section unless the county dog warden is licensed under section
4729.531 of the Revised Code.
(2)
Any agent or employee of an animal shelter
or
wild animal rehabilitation
facility
or
county dog warden performing euthanasia by means of lethal injection
or administering pre-euthanasia drugs that induce anesthesia,
sedation, or unconsciousness shall do so only in a humane and
proficient manner that is in conformity with the methods described in
divisions (A) and (B) of this section and not in violation of Chapter
959. of the Revised Code.
(E)
Nothing in this section precludes a licensed veterinarian or
registered veterinary technician as defined in section 4741.01 of the
Revised Code from engaging in the practice of veterinary medicine as
authorized in Chapter 4741. of the Revised Code.
Sec.
4729.54.
(A)
As used in this section:
(1)
"Category II" means any dangerous drug that is not included
in category III.
(2)
"Category III" means any controlled substance that is
contained in schedule I, II, III, IV, or V.
(3)
"Emergency medical service organization" has the same
meaning as in section 4765.01 of the Revised Code.
(4)
"Emergency medical service organization satellite" means a
location where dangerous drugs are stored that is separate from, but
associated with, the headquarters of an emergency medical service
organization. "Emergency medical service organization satellite"
does not include the units under the control of the emergency medical
service organization.
(5)
"Person" includes an emergency medical service organization
or an emergency medical service organization satellite.
(6)
"Schedule I," "schedule II," "schedule III,"
"schedule IV," and "schedule V" have the same
meanings as in section 3719.01 of the Revised Code.
(B)(1)
A person seeking to be licensed as a terminal distributor of
dangerous drugs shall file with the executive director of the state
board of pharmacy a verified application. After it is filed, the
application may not be withdrawn without approval of the board.
(2)
An application shall contain all the following that apply in the
applicant's case:
(a)
Information that the board requires relative to the qualifications of
a terminal distributor of dangerous drugs set forth in section
4729.55 of the Revised Code;
(b)
A statement as to whether the person is seeking to be licensed as a
category II, category III, limited category II, or limited category
III terminal distributor of dangerous drugs;
(c)
If the person is seeking to be licensed as a limited category II or
limited category III terminal distributor of dangerous drugs, a list
of the dangerous drugs that the person is seeking to possess, have
custody or control of, and distribute, which list shall also specify
the purpose for which those drugs will be used and their source;
(d)
If the person is an emergency medical service organization, the
information that is specified in divisions (C)(1) and (2) of this
section, and if the person is an emergency medical service
organization satellite, the information required under division (D)
of this section;
(e)
Except with respect to the units under the control of an emergency
medical service organization, the identity of the one establishment
or place at which the person intends to engage in the sale or other
distribution of dangerous drugs at retail, and maintain possession,
custody, or control of dangerous drugs for purposes other than the
person's own use or consumption;
(f)
If the application pertains to a pain management clinic, information
that demonstrates, to the satisfaction of the board, compliance with
division (A) of section 4729.552 of the Revised Code.
(C)(1)
Each emergency medical service organization that applies for a
terminal distributor of dangerous drugs license shall submit with its
application all of the following:
(a)
A copy of its standing orders or protocol, which orders or protocol
shall be signed by a physician;
(b)
A list of the dangerous drugs that the units under its control may
carry, expressed in standard dose units, which shall be signed by a
physician;
(c)
A list of the personnel employed or used by the organization to
provide emergency medical services in accordance with Chapter 4765.
of the Revised Code.
In
accordance with Chapter 119. of the Revised Code, the board shall
adopt rules specifying when an emergency medical service organization
that is licensed as a terminal distributor must notify the board of
any changes in its documentation submitted pursuant to division
(C)(1) of this section.
(2)
An emergency medical service organization seeking to be licensed as a
terminal distributor of dangerous drugs shall list in its application
for licensure the following additional information:
(a)
The units under its control that the organization determines will
possess dangerous drugs for the purpose of administering emergency
medical services in accordance with Chapter 4765. of the Revised
Code;
(b)
With respect to each such unit, whether the dangerous drugs that the
organization determines the unit will possess are in category II or
III.
(3)
An emergency medical service organization that is licensed as a
terminal distributor of dangerous drugs shall file a new application
for such licensure if there is any change in the number or location
of any of its units or if there is any change in the category of the
dangerous drugs that any unit will possess.
(4)
A unit listed in an application for licensure pursuant to division
(C)(2) of this section may obtain the dangerous drugs it is
authorized to possess from its emergency medical service organization
or, on a replacement basis, from a hospital pharmacy. If units will
obtain dangerous drugs from a hospital pharmacy, the organization
shall file, and maintain in current form, the following items with
the pharmacist who is responsible for the hospital's terminal
distributor of dangerous drugs license:
(a)
A copy of its standing orders or protocol;
(b)
A list of the personnel employed or used by the organization to
provide emergency medical services in accordance with Chapter 4765.
of the Revised Code, who are authorized to possess the drugs, which
list also shall indicate the personnel who are authorized to
administer the drugs.
(D)
Each emergency medical service organization satellite that applies
for a terminal distributor of dangerous drugs license shall submit
with its application all of the information that the board requires
to be submitted with the application, as specified in rules the board
shall adopt in accordance with Chapter 119. of the Revised Code.
(E)
There shall be four categories of terminal distributor of dangerous
drugs licenses. The categories are as follows:
(1)
Category II license. A person who obtains this license may possess,
have custody or control of, and distribute only the dangerous drugs
described in category II.
(2)
Limited category II license. A person who obtains this license may
possess, have custody or control of, and distribute only the
dangerous drugs described in category II that were listed in the
application for licensure.
(3)
Category III license, which may include a pain management clinic
classification issued under section 4729.552 of the Revised Code. A
person who obtains this license may possess, have custody or control
of, and distribute the dangerous drugs described in category II and
category III. If the license includes a pain management clinic
classification, the person may operate a pain management clinic.
(4)
Limited category III license. A person who obtains this license may
possess, have custody or control of, and distribute only the
dangerous drugs described in category II or category III that were
listed in the application for licensure.
(F)
Except for an application made by a county dog warden or on behalf of
an animal shelter
or
wild animal rehabilitation facility
,
if an applicant for a limited category II license or limited category
III license intends to administer dangerous drugs to a person or
animal, the applicant shall submit, with the application, a copy of
its protocol or standing orders. The protocol or orders shall be
signed by a licensed health professional authorized to prescribe
drugs, specify the dangerous drugs to be administered, and list
personnel who are authorized to administer the dangerous drugs in
accordance with federal law or the law of this state.
An
application made by a county dog warden or on behalf of an animal
shelter
or
wild animal rehabilitation facility
shall
include a list of the dangerous drugs to be administered to animals
and the personnel who are authorized to administer the drugs to
animals in accordance with section 4729.532 of the Revised Code.
In
accordance with Chapter 119. of the Revised Code, the board shall
adopt rules specifying when a licensee must notify the board of any
changes in its documentation submitted pursuant to this division.
(G)(1)
Except as provided in division (G)(3) of this section, each applicant
for licensure as a terminal distributor of dangerous drugs shall
submit, with the application, a license fee. The amount assessed
shall not be returned to the applicant if the applicant fails to
qualify for the license.
(2)
The following fees apply under division (G)(1) of this section:
(a)
Except as provided in division (G)(2)(b) of this section:
(i)
Three hundred twenty dollars for a category II or limited category II
license;
(ii)
Four hundred forty dollars for a category III license, including a
license with a pain management clinic classification issued under
section 4729.552 of the Revised Code, or a limited category III
license.
(b)
One hundred twenty dollars for all of the following:
(i)
A person who is required to hold a license as a terminal distributor
of dangerous drugs pursuant to division (C) of section 4729.541 of
the Revised Code;
(ii)
A professional association, corporation, partnership, or limited
liability company organized for the purpose of practicing veterinary
medicine that is not included in division (G)(2)(b)(i) of this
section;
(iii)
An emergency medical service organization satellite.
(3)
No fee applies for a license issued to a charitable pharmacy, as
defined in section 3719.811 of the Revised Code, if the charitable
pharmacy is participating in the drug repository program established
under section 3715.87 of the Revised Code.
(H)(1)
The board shall issue a terminal distributor of dangerous drugs
license to each person who submits an application for such licensure
in accordance with this section, pays the required license fee, is
determined by the board to meet the requirements set forth in section
4729.55 of the Revised Code, and satisfies any other applicable
requirements of this section.
(2)
Except for the license of a county dog warden, the license shall
describe the one establishment or place at which the licensee may
engage in the sale or other distribution of dangerous drugs at retail
and maintain possession, custody, or control of dangerous drugs for
purposes other than the licensee's own use or consumption. The one
establishment or place shall be that which is identified in the
application for licensure.
No
such license shall authorize or permit the terminal distributor of
dangerous drugs named in it to engage in the sale or other
distribution of dangerous drugs at retail or to maintain possession,
custody, or control of dangerous drugs for any purpose other than the
distributor's own use or consumption, at any establishment or place
other than that described in the license, except that an agent or
employee of an animal shelter
or
wild animal rehabilitation facility
or
county dog warden may possess and use dangerous drugs in the course
of business as provided in section 4729.532 of the Revised Code.
(3)
The license of an emergency medical service organization shall cover
the organization's headquarters and, in addition, shall cover and
describe all the units of the organization listed in its application
for licensure.
(I)(1)
All licenses issued or renewed pursuant to this section shall be
effective for a period specified by the board in rules adopted under
section 4729.26 of the Revised Code. The effective period for an
initial or renewed license shall not exceed twenty-four months unless
the board extends the period in rules to adjust license renewal
schedules. A license shall be renewed by the board according to the
provisions of this section, the standard renewal procedure of Chapter
4745. of the Revised Code, and rules adopted by the board under
section 4729.26 of the Revised Code. A person seeking to renew a
license shall submit an application for renewal and pay the required
fee on or before the date specified in the rules adopted by the
board. The fee required for the renewal of a license shall be the
same as the license fee that applies under division (G)(2) of this
section.
(2)(a)
Subject to division (I)(2)(b) of this section, a license that has not
been renewed by the date specified in rules adopted by the board may
be reinstated only upon payment of the required renewal fee and a
penalty fee of one hundred ten dollars.
(b)
If an application for renewal has not been submitted by the
sixty-first day after the renewal date specified in rules adopted by
the board, the license is considered void and cannot be renewed, but
the license holder may reapply for licensure.
(3)
A terminal distributor of dangerous drugs that fails to renew
licensure in accordance with this section and rules adopted by the
board is prohibited from engaging in the retail sale, possession, or
distribution of dangerous drugs until a valid license is issued by
the board.
(J)(1)
No emergency medical service organization that is licensed as a
terminal distributor of dangerous drugs shall fail to comply with
division (C)(1), (3), or (4) of this section.
(2)
No licensed terminal distributor of dangerous drugs shall possess,
have custody or control of, or distribute dangerous drugs that the
terminal distributor is not entitled to possess, have custody or
control of, or distribute by virtue of its category of licensure.
(3)
No licensee that is required by division (F) of this section to
notify the board of changes in its protocol or standing orders, or in
personnel, shall fail to comply with that division.
(K)
The board may enter into agreements with other states, federal
agencies, and other entities to exchange information concerning
licensing and inspection of terminal distributors of dangerous drugs
located within or outside this state and to investigate alleged
violations of the laws and rules governing distribution of drugs by
terminal distributors. Any information received pursuant to such an
agreement is subject to the same confidentiality requirements
applicable to the agency or entity from which it was received and
shall not be released without prior authorization from that agency or
entity.
Sec.
4729.55.
No
license shall be issued to an applicant for licensure as a terminal
distributor of dangerous drugs unless the applicant has furnished
satisfactory proof to the state board of pharmacy that:
(A)
The applicant is equipped as to land, buildings, and equipment to
properly carry on the business of a terminal distributor of dangerous
drugs within the category of licensure approved by the board.
(B)
One
of the following will maintain supervision and control over the
possession and custody of dangerous drugs and controlled substances
that may be acquired by or on behalf of the applicant:
(1)
A
pharmacist, licensed health professional authorized to prescribe
drugs,
or
other
person authorized by the board
,
;
(2)
An
animal shelter
,
wild animal rehabilitation facility,
or county dog warden licensed under section 4729.531 of the Revised
Code
,
or
;
(3)
A
laboratory
will
maintain supervision and control over the possession and custody of
dangerous drugs and controlled substances that may be acquired by or
on behalf of the applicant
.
(C)
Adequate safeguards are assured to prevent the sale or other
distribution of dangerous drugs by any person other than a pharmacist
or licensed health professional authorized to prescribe drugs.
(D)
Adequate safeguards are assured that the applicant will carry on the
business of a terminal distributor of dangerous drugs in a manner
that allows pharmacists and pharmacy interns employed by the terminal
distributor to practice pharmacy in a safe and effective manner.
(E)
If the applicant, or any agent or employee of the applicant, has been
found guilty of violating section 4729.51 of the Revised Code, the
"Federal Food, Drug, and Cosmetic Act," 52 Stat. 1040
(1938), 21 U.S.C.A. 301, the federal drug abuse control laws, Chapter
2925., 3715., 3719., or 4729. of the Revised Code, or any rule of the
board, adequate safeguards are assured to prevent the recurrence of
the violation.
(F)
If the application is made on behalf of an animal shelter
,
wild animal rehabilitation facility,
or county dog warden, at least one of the agents or employees of the
animal shelter or county dog warden is certified in compliance with
section 4729.532 of the Revised Code.
(G)
In the case of an applicant who is a retail seller of peritoneal
dialysis solutions in original packages labeled as required by the
"Federal Food, Drug, and Cosmetic Act," 52 Stat. 1040
(1938), 21 U.S.C.A. 301, the applicant will maintain supervision and
control over the possession, custody, and retail sale of the
peritoneal dialysis solutions.
(H)
In the case of an applicant who is a pain management clinic, the
applicant meets the requirements to receive a license with a pain
management clinic classification issued under section 4729.552 of the
Revised Code.
Section
2.
That
existing sections 4729.01
,
4729.36
,
4729.531, 4729.532, 4729.54, and 4729.55 of the Revised Code are
hereby repealed.
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 ___________________