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Sub. H. B. No. 283 As Reported by the Senate Health, Human Services and Aging CommitteeAs Reported by the Senate Health, Human Services and Aging Committee Corrected Version
127th General Assembly | Regular Session | 2007-2008 |
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Cosponsors:
Representatives Setzer, Stebelton, Wagner, Williams, S., Schindel, McGregor, J., Fessler, Evans, Seitz, Latta, Yuko, Koziura, Coley, Combs, Collier, Fende, Peterson, Heard, Ujvagi, Hughes, Reinhard, Letson, Otterman, Williams, B., Uecker, Aslanides, Bacon, Batchelder, Brown, Budish, Chandler, Daniels, DeBose, Dodd, Domenick, Dyer, Flowers, Gibbs, Goodwin, Hagan, J., Huffman, Luckie, Patton, Schlichter, Schneider, Wachtmann, Wagoner, Yates, Zehringer Senators Schuring, Seitz, Wagoner, Miller, D., Morano
A BILL
To amend sections 2947.23, 3715.521, 3715.55,
3715.63, 4729.41, 4729.51, and 4729.54 and
to
enact
sections 2947.231, 3715.88, 3715.89,
3715.90,
3715.91, 3715.92, and 4729.541 of the
Revised Code
to permit
pharmacy schools to
accept for
instructional
purposes donations of
certain
dangerous drugs,
including expired
drugs, to
eliminate
the requirement that certain
professional business
entities be
licensed as a
terminal distributor of dangerous drugs, and to
permit the Board of Pharmacy to recover
investigation costs in
certain cases.
BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF OHIO:
Section 1. That sections 2947.23, 3715.521, 3715.55, 3715.63,
4729.41,
4729.51, and 4729.54 be
amended and sections 2947.231,
3715.88,
3715.89, 3715.90, 3715.91, 3715.92, and 4729.541 of the
Revised
Code be enacted to read as follows:
Sec. 2947.23.
(A)(1) In all criminal cases, including
violations of ordinances, the
judge or magistrate shall include in
the sentence the costs of prosecution, including any costs under
section 2947.231 of the Revised Code, and
render a judgment
against the defendant for such costs.
At the time the judge or
magistrate imposes sentence, the judge or magistrate shall notify
the defendant of both of the following:
(a) If the defendant fails to pay that judgment
or
fails to
timely make payments towards that judgment under a
payment
schedule approved by the court, the court may order the
defendant
to perform community service in an amount of not more
than forty
hours per month until the judgment is paid or until the
court is
satisfied that the defendant is in compliance with the
approved
payment schedule.
(b) If the court orders the defendant to perform the
community service, the defendant will receive credit upon the
judgment at the specified hourly credit rate per hour of community
service performed, and each hour of community service performed
will reduce the judgment by that amount.
(2) The following shall apply in all criminal cases:
(a) If a jury has been
sworn at
the trial of a case, the fees
of
the jurors shall be included in
the
costs, which shall be paid
to
the public treasury from which
the jurors were
paid.
(b) If a jury has not been sworn at the trial of a case
because of a defendant's failure to appear without good cause, the
costs incurred in summoning jurors for that particular trial may
be included in the costs of prosecution. If the costs incurred in
summoning jurors are assessed against the defendant, those costs
shall be paid to the public treasury from which the jurors were
paid.
(B) If a judge or magistrate has reason to believe that a
defendant has failed to pay the judgment described in
division (A)
of this section or has failed to timely make payments
towards that
judgment under a payment schedule approved by the
judge or
magistrate, the judge or magistrate shall hold a hearing to
determine whether to order the offender to perform community
service for that failure. The judge or magistrate shall notify
both the defendant and the prosecuting attorney of the place,
time, and date of the hearing and shall give each an opportunity
to present evidence. If, after the hearing, the judge or
magistrate determines that the defendant has failed to pay the
judgment or to timely make payments under the payment schedule and
that imposition of community service for the
failure is
appropriate, the judge or magistrate may order the
offender to
perform community
service in an amount of not more
than forty
hours per month until
the judgment is paid or until the
judge or
magistrate is satisfied that the
offender is in
compliance with
the approved payment schedule.
If the judge or magistrate orders
the defendant to perform community service under this division,
the defendant shall receive credit upon the judgment at the
specified hourly credit rate per hour of community service
performed, and each hour of community service performed shall
reduce the judgment by that amount. Except for the credit and
reduction provided in this division, ordering an
offender to
perform community service under this
division does not
lessen the
amount of the judgment and does not
preclude the state
from taking
any other action to execute the
judgment.
(C) As used in this section, "specified hourly credit rate"
means the wage rate that is specified in 26 U.S.C.A. 206(a)(1)
under the federal Fair Labor Standards Act of 1938, that then is
in effect, and that an employer subject to that provision must pay
per hour to each of the employer's employees who is subject to
that provision.
Sec. 2947.231. If a business entity described in division
(B)(1)(j) or (k) of section 4729.51 of the Revised Code pleads
guilty or no contest to or is found guilty of any criminal
offense, the judge or magistrate shall include in the sentence any
costs incurred by the state board of pharmacy in an investigation
leading to the plea or conviction. Investigative costs include
staff salaries, administrative costs, travel expenses, attorney's
fees, and any other reasonable expense incurred by the board. The
board shall set forth the costs the entity is required to pay in
an itemized statement provided to the judge or magistrate.
Sec. 3715.521. No person shall sell, offer for sale, or
deliver at retail
or to the consumer, any of the following:
(A) Any drug after the expiration date required by 21
C.F.R.
211.137 except pursuant to sections 3715.88 to 3715.92 of the
Revised Code;
(B) Any infant formula after the "use by" date required by 21
C.F.R. 107.20;
(C) Any baby food after any expiration date, "use by" date,
or
sale date required by state or federal law or marked on the
container by the
manufacturer, processor, or packager.
Sec. 3715.55. (A) As used in this section, "expired" means:
(1) In the case of a drug, that the expiration date required
by 21
C.F.R. 211.137 has passed;
(2) In the case of infant formula, the "use by" date
required
by 21
C.F.R.
107.20 has passed;
(3) In the case of baby food, that any expiration date,
"use
by" date, or sale date established by state or federal law
or
marked on the container by the manufacturer, processor, or
packager has passed.
(B) Whenever Except as otherwise provided in this division,
whenever the director of agriculture or
the state board of
pharmacy finds or has cause to believe, that any
food, drug,
device, or cosmetic is adulterated, or so misbranded
as to be
dangerous or fraudulent, within the meaning of sections
3715.01
and 3715.52 to 3715.72 of the Revised Code,
or that a drug, infant
formula, or baby food is expired, the
director or board shall
affix
to the article a tag or other appropriate
marking, giving
notice that the article is, or is suspected
of
being, adulterated,
misbranded, or expired and
has been detained or
embargoed, and
warning all persons not to remove or dispose of
the article by
sale or otherwise until permission for
removal or
disposal is
given by the director or the board or the
court. No person may
remove or dispose of a detained or
embargoed article by sale or
otherwise without such permission. This division does not apply to
expired drugs donated pursuant to sections 3715.88 to 3715.92 of
the Revised Code.
(C) When an article detained or embargoed has been found
by
the director or board to be adulterated,
misbranded, or expired,
the director or board shall petition
the municipal or county court
in
whose jurisdiction the article is detained or embargoed for an
order for condemnation of the article. When the director
or the
board has not found within ten days that an article
so detained or
embargoed is adulterated, misbranded,
or expired, the director or
board shall
remove the tag or other marking.
(D) If the court finds that a detained or embargoed
article
is adulterated, misbranded, or expired,
the article shall, after
entry of the decree, be destroyed at the expense of the claimant
thereof, under the supervision of the director or the board, and
all court
costs, fees, storage, and other proper
expenses shall be
taxed against the claimant of the article
or
the claimant's agent;
provided, that when the adulteration
or
misbranding
can be
corrected by proper labeling or processing of the article,
the
court, after entry of the decree and after such costs, fees,
and
expenses have been paid and a good and sufficient bond,
conditioned that the article shall be so labeled or
processed,
has
been executed, may by order direct that the article be
delivered
to the claimant thereof for labeling or processing
under the
supervision of the director or the board. The
expense of
supervision shall be paid by the claimant.
The bond shall be
returned to the claimant of the article on
representation to the
court by the director or the board that the article is
no
longer
in violation of sections
3715.01 and 3715.52 to 3715.72 of the
Revised Code,
and that the expenses of supervision have been paid.
(E) Whenever the director finds in any room, building,
vehicle of transportation, or other structure, any meat, sea
food
seafood, poultry, vegetable, fruit, or other perishable articles
that are unsound, or contain any filthy, decomposed, or
putrid
substance, or that may be poisonous or deleterious to
health or
otherwise unsafe, the articles are declared to be a
nuisance,
and
the director shall forthwith condemn or destroy the
articles, or
in any other manner render the articles unsalable as human
food.
Sec. 3715.63. (A) A drug or device is adulterated within the
meaning of sections
3715.01 and 3715.52 to 3715.72 of the Revised
Code, if
any of the following apply:
(A)(1) It consists, in whole or in part, of any filthy,
putrid, or decomposed
substance.
(B)(2) It has been produced, processed, prepared, packed, or
held under
unsanitary conditions whereby it may have been
contaminated with filth, or
whereby it may have been rendered
injurious to health.
(C)(3) It is a drug and its container is composed, in whole
or in part, of any
poisonous or deleterious substance that may
render the
contents injurious to
health.
(D)(4) It is a drug and it bears or contains, for purposes of
coloring only, a
coal-tar color other than one from a batch
certified under
authority of
the "Federal Food, Drug, and Cosmetic
Act," 52 Stat. 1040 (1938), 21 U.S.C.A. 301,
as amended.
(E)(5) It purports to be or is represented as a drug the name
of which is
recognized in
the United States pharmacopoeia and
national formulary,
or
any supplement to them, and its strength
differs from or its
quality or purity falls below the standard set
forth in
those compendiums. A
determination as to strength,
quality, or purity shall be made in accordance
with the tests or
methods of assay set forth in the
compendiums, or in the
absence
or inadequacy of such tests or methods of assay, those prescribed
under the authority of the "Federal
Food, Drug, and Cosmetic Act."
A drug recognized in the compendiums is not
adulterated under this
division
because it differs from the
standard of strength,
quality, or purity set forth for that
drug in the compendiums, if
the difference in
strength, quality,
or purity is plainly stated
on its label. Whenever a drug is recognized in
both the
homoeopathic pharmacopoeia
of the
United States and in the United
States
pharmacopoeia and national formulary, including their
supplements, it
shall be subject to the
requirements of the United
States pharmacopoeia and
national formulary unless it is labeled
and offered for sale as a
homoeopathic
drug, in which case it
shall be subject to the provisions of the homoeopathic
pharmacopoeia of the United States and not to those of the
United
States pharmacopoeia and national formulary.
(F)(6) It is not subject to the provisions of division
(E)(A)(5) of this section, and
its strength differs from or its
purity or quality falls below that
which it
purports or is
represented to possess.
(G)(7) It is a drug and any substance has been:
(1)(a) Mixed or packed with the drug so as to reduce
the
drug's quality or strength;
(2)(b) Substituted wholly or in part for the drug.
(B) An expired drug is not adulterated within the meaning of
sections 3715.01 and 3715.52 to 3715.72 of the Revised Code if the
drug is donated pursuant to sections 3715.88 to 3715.92 of the
Revised Code.
Sec. 3715.88. As used in this section and in sections 3715.89
to 3715.92 of the Revised Code:
(A) "Expired" has the same meaning as in section 3715.55 of
the Revised Code.
(B) "National drug code number" means the number registered
for a drug pursuant to the listing system established by the
United States food and drug administration under the "Drug Listing
Act of 1972," 86 Stat. 559, 21 U.S.C. 360, as amended.
(C) "Pharmacy school" means a school, college, university, or
other educational institution that operates a pharmacy program
recognized and approved by the state board of pharmacy.
(D) "Controlled substance" has the same meaning as in section
3719.01 of the Revised Code.
(E) "Manufacturer of dangerous drugs," "terminal distributor
of dangerous drugs," and "wholesale distributor of dangerous
drugs" have the same meanings as in section 4729.01 of the Revised
Code.
Sec. 3715.89. (A) Subject to divisions (B) and (C) of this
section, any manufacturer of dangerous drugs, terminal distributor
of dangerous drugs, or wholesale distributor of dangerous drugs
may donate a dangerous drug,
including a dangerous drug that has
expired, to a pharmacy school.
(B) A dangerous drug donation to a pharmacy school shall meet
all of the following requirements:
(1) The dangerous drug is not a controlled substance.
(2) Each container in which a dangerous drug is donated
contains a single national drug code number of that drug and no
other drugs.
(3) If the dangerous drug is of a type that deteriorates with
time, the container in which the drug is contained is plainly
marked with the drug's expiration date.
(C) A dangerous drug donation to a pharmacy school shall be
accompanied by a form signed by a representative of the
manufacturer, terminal distributor, or wholesale distributor
donating the drug. On delivery, a representative of the
pharmacy
school accepting the drug donation shall also sign the
form. The
form shall do both of the following:
(1) Confirm the acceptance of the dangerous drug donation by
the pharmacy school;
(2) Confirm that both the manufacturer, terminal distributor,
or wholesale distributor donating the
dangerous drug and the
pharmacy school accepting the donation
understand the immunity
provisions of section 3719.92 of the
Revised Code.
Sec. 3715.90. (A) A pharmacy school may accept a donation of
a dangerous drug if the donation is made in accordance with
section 3715.89 of the Revised Code.
(B) All of the following apply to a dangerous drug donated to
a pharmacy school:
(1) The dangerous drug shall be used solely for instructional
purposes.
(2) The dangerous drug shall not be sold or transferred for
consideration of any kind.
(3) In accordance with 21 C.F.R. 201.125, the dangerous drug
shall not be used for a clinical use. "Clinical use" includes the
drug being furnished to a human or animal with the intent or
understanding that the human or animal will ingest or otherwise
absorb the drug into the human's or animal's body.
Sec. 3715.91. The state board of pharmacy shall, in
accordance with Chapter 119. of the Revised Code, adopt rules as
necessary to give effect to sections 3715.89 and 3715.90 of the
Revised Code.
Sec. 3715.92. The state board of pharmacy, any manufacturer
of dangerous drugs, terminal distributor of dangerous drugs, or
wholesale distributor of dangerous drugs that in good faith
donates a
dangerous drug under section 3715.89 of the Revised
Code, and any
pharmacy school that accepts a dangerous drug
donation under
section 3715.90 of the Revised Code, shall not, in
the absence of
bad faith, be subject to any of the following for
matters related
to the donation or acceptance of the drug:
criminal prosecution;
liability in tort or other civil action for
injury, death, or loss
to person or property; or professional
liability.
Sec. 4729.41. (A)(1) A pharmacist licensed under this
chapter
who meets the requirements of division (B) of this section
may do either or both any of the following:
(a) Administer immunizations for influenza to individuals
fourteen years of age or older;
(b) Administer immunizations to individuals eighteen years of
age or older for any of the
following:
(c) Administer to individuals eighteen years of age or older
any other immunization listed in the rule adopted under division
(E)(1)(d) of this section.
(2) A pharmacy intern licensed under this chapter who meets
the requirements of division (B) of this section and is working
under the direct supervision of a pharmacist who meets the
requirements of that division may administer immunizations for
influenza to individuals eighteen years of age or older.
(3) As part of engaging in the administration of
immunizations or supervising a pharmacy intern's administration of
immunizations, a pharmacist may administer epinephrine or
diphenhydramine, or both, to individuals in emergency situations
resulting from adverse reactions to the immunizations administered
by the pharmacist or pharmacy intern.
(B) For a pharmacist or pharmacy intern to be authorized to
engage in the administration of immunizations
as specified in
division (A) of this section, the pharmacist or pharmacy intern
shall do
all of the following:
(1) Successfully complete a course in the administration of
immunizations that has been approved by the state board of
pharmacy as meeting the standards established for such courses by
the centers for disease control and prevention in the public
health service of the United States department of health and human
services;
(2) Receive and maintain certification to perform basic
life-support procedures by successfully completing a basic
life-support training course certified by the American red cross
or American heart association;
(3) Practice in accordance with a definitive set of
treatment
guidelines specified in a protocol established by a
physician and
approved by the state board of pharmacy.
(C) The
protocol required by division (B)(3) of this section
shall include provisions for implementation of the following
requirements:
(1) The
pharmacist or pharmacy intern who administers an
immunization shall observe the individual who receives the
immunization to determine whether the individual has an adverse
reaction to the immunization. The length of time and location of
the observation shall comply with the standards specified in rules
adopted by the state
board of pharmacy under division (E) of this
section for the approval of protocols. The protocol shall specify
procedures to be followed by a pharmacist when administering
epinephrine, diphenhydramine, or both, to an individual who has an
adverse reaction to an immunization administered by the pharmacist
or a pharmacy intern.
(2) For each immunization administered to an individual by a
pharmacist, other than an immunization for influenza administered
to an individual eighteen years of age or older, the pharmacist
shall notify the individual's family
physician or, if the
individual has no family physician, the board
of health of the
health district in which the individual resides or the authority
having the duties of a board of health for that district under
section 3709.05 of the Revised Code. The notice shall be given not
later than thirty days after the immunization is administered.
(3) For each immunization for influenza administered by a
pharmacist to an individual who is fourteen years of age or older
but younger than eighteen years of age, the pharmacist or a
pharmacy intern shall obtain permission from the individual's
parent or legal guardian in accordance with the procedures
specified in rules adopted under division (E) of this section.
(D)(1) No pharmacist shall do either of the following:
(a) Engage in the administration of immunizations unless the
requirements of division (B) of this section
have been met;
(b) Delegate to any person the pharmacist's authority to
engage in or supervise the administration of immunizations.
(2) No pharmacy intern shall engage in the administration of
immunizations for influenza unless the requirements of division
(B) of this section have been met.
(E)(1) The state board of pharmacy shall adopt rules to
implement this section. The rules shall be adopted in accordance
with Chapter 119. of the Revised Code and shall include provisions
for the following:
(a) Approval Provisions for approval of courses in
administration of immunizations;
(b) Approval Provisions for approval of protocols to
be
followed by pharmacists and pharmacy interns in engaging in the
administration of immunizations, including protocols that contain
provisions specifying the locations at which a pharmacist or
pharmacy intern may engage in the administration of immunizations;
(c) Procedures to be followed by pharmacists and pharmacy
interns in obtaining from the individual's parent or legal
guardian permission to administer influenza immunizations to an
individual younger than eighteen years of age pursuant to division
(A)(1)(a) of this section;
(d) A list of immunizations that may be administered under
division (A)(1)(c) of this section.
(2) Prior to adopting rules regarding approval of protocols
to be followed by pharmacists and pharmacy interns in engaging in
the administration of immunizations, the
state board of pharmacy
shall consult with the state medical board
and the board of
nursing.
(3) Prior to adopting a rule listing immunizations that may
be administered under division (A)(1)(c) of this section, the
state board of pharmacy shall consult with the state medical
board.
Sec. 4729.51. (A) No person other than a registered
wholesale distributor of dangerous drugs shall possess for sale,
sell, distribute, or deliver, at wholesale, dangerous drugs,
except as follows:
(1) A pharmacist who is a licensed terminal distributor of
dangerous drugs or who is employed by a licensed terminal
distributor of dangerous drugs may make occasional sales of
dangerous drugs at wholesale;
(2) A licensed terminal distributor of dangerous drugs
having
more than one establishment or place may transfer or
deliver
dangerous drugs from one establishment or place for which
a
license has been issued to the terminal distributor to another
establishment or place for which a license has been issued to the
terminal distributor if the license issued for each
establishment
or place is in effect at the time of the transfer or delivery.
(B)(1) No registered wholesale distributor of dangerous
drugs
shall possess for sale, or sell, at wholesale, dangerous
drugs to
any person other than the following:
(a) A licensed health professional authorized to
prescribe
drugs;
(b) An optometrist licensed under Chapter 4725. of the
Revised Code who holds
a
topical ocular pharmaceutical agents
certificate;
(c) A registered wholesale distributor of dangerous
drugs;
(d) A manufacturer of dangerous drugs;
(e) A licensed terminal distributor of dangerous drugs,
subject to division (B)(2) of this section;
(f) Carriers or warehousers for the purpose of
carriage or
storage;
(g) Terminal or wholesale
distributors of dangerous
drugs
who
are not engaged in the sale of dangerous drugs within this
state;
(h) An individual who holds a current license,
certificate,
or
registration issued under Title 47 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;
(i) An individual who holds a valid certificate issued by a
nationally recognized S.C.U.B.A. diving certifying organization
approved by the pharmacy board in rule, 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;
(j) 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 Chapter 1705. 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
licensed health professional authorized to prescribe drugs and is
authorized to provide the professional services being offered by
the entity;
(k) 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 Chapter 1705. 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 licensed
health professional authorized to prescribe drugs.
(2) No registered wholesale distributor of dangerous drugs
shall possess dangerous drugs for sale at wholesale, or sell such
drugs at wholesale, to a licensed terminal distributor of
dangerous drugs, except to:
(a) A terminal distributor who has a category I license,
only
dangerous drugs described in category I, as defined in
division
(A)(1) of section 4729.54 of the Revised Code;
(b) A terminal distributor who has a category II license,
only dangerous drugs described in category I and category II, as
defined in divisions (A)(1) and (2) of section 4729.54 of the
Revised Code;
(c) A terminal distributor who has a category III license,
dangerous drugs described in category I, category II, and
category
III, as defined in divisions (A)(1), (2), and (3) of
section
4729.54 of the Revised Code;
(d) A terminal distributor who has a limited category I,
II,
or III license, only the dangerous drugs specified in the
certificate furnished by the terminal distributor in accordance
with section 4729.60 of the Revised Code.
(C)(1) Except as provided in division (C)(4) of this section,
no person shall sell, at retail, dangerous drugs.
(2) Except as provided in division (C)(4) of this section, no
person shall possess for sale, at retail, dangerous drugs.
(3) Except as provided in division (C)(4) of this section, no
person shall possess dangerous drugs.
(4) Divisions (C)(1), (2), and (3) of this section do not
apply
to a registered wholesale distributor of dangerous drugs, a
licensed terminal distributor of dangerous drugs, or 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., and 4741. of the
Revised Code.
Divisions (C)(1), (2), and (3) of
this section do not apply
to 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 to
the extent
that the individual possesses insulin or personally
supplies
insulin solely 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.
Divisions (C)(1), (2), and (3) of this section do not apply
to an individual who holds a valid certificate issued by a
nationally recognized S.C.U.B.A. diving certifying organization
approved by the pharmacy board in rule, but only to the extent
that the individual possesses medical oxygen or personally
supplies medical oxygen for the purpose of emergency care or
treatment at the scene of a diving emergency.
(D) No licensed terminal distributor of dangerous drugs
shall
purchase for the purpose of resale dangerous drugs from
any
person
other than a registered wholesale distributor of
dangerous drugs,
except as follows:
(1) A licensed terminal distributor of dangerous drugs may
make occasional purchases of dangerous drugs for resale from a
pharmacist who is a licensed terminal distributor of dangerous
drugs or who is employed by a licensed terminal distributor of
dangerous drugs;
(2) A licensed terminal distributor of dangerous drugs
having
more than one establishment or place may transfer or
receive
dangerous drugs from one establishment or place for which
a
license has been issued to the terminal distributor to another
establishment or place for which a license has been issued to the
terminal distributor if the license issued for each establishment
or place is in effect at the time of the transfer or receipt.
(E) No licensed terminal distributor of dangerous drugs
shall
engage in the sale or other distribution of dangerous drugs
at
retail or maintain possession, custody, or control of
dangerous
drugs 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 board of pharmacy to
such terminal distributor.
(F) 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.
Sec. 4729.54. (A) As used in this section and section
4729.541 of the Revised Code:
(1) "Category I" means single-dose injections of
intravenous
fluids, including saline, Ringer's lactate, five per
cent dextrose
and distilled water, and other intravenous fluids
or parenteral
solutions included in this category by rule of the
board of
pharmacy, that have a volume of one hundred milliliters
or more
and that contain no added substances, or single-dose
injections of
epinephrine to be administered pursuant to sections
4765.38 and
4765.39 of the Revised Code.
(2) "Category II" means any dangerous drug that is not
included in category I or III.
(3) "Category III" means any controlled substance that is
contained in schedule I, II, III, IV, or V.
(4) "Emergency medical service organization" has the same
meaning as in section 4765.01 of the Revised Code.
(5) "Person" includes an emergency medical service
organization.
(6) "Schedule I, schedule II, schedule III, schedule IV,
and
schedule V" mean controlled substance schedules I, II, III,
IV,
and V, respectively, as established pursuant to section
3719.41 of
the Revised Code and as amended.
(B) A person who desires to be licensed as a terminal
distributor of dangerous drugs shall file with the executive
director of the board of pharmacy a verified application that
contains the following:
(1) 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;
(2) A statement that the person wishes to be licensed as a
category I, category II, category III, limited category I,
limited
category II, or limited category III terminal distributor
of
dangerous drugs;
(3) If the person wishes to be licensed as a limited
category
I, limited category II, or limited category III terminal
distributor of dangerous drugs, a notarized list of the dangerous
drugs that the person wishes 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;
(4) If the person is an emergency medical service
organization, the information that is specified in division
(C)(1)
of this section;
(5) Except for 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.
(C)(1) An emergency medical service organization that
wishes
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 I, II, or III.
(2) 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 any change in the
category of the dangerous drugs that any unit will possess.
(3) A unit listed in an application for licensure pursuant
to
division (C)(1) 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 that
applies
for a terminal distributor of dangerous drugs license
shall submit
with its application the following:
(1) A notarized copy of its standing orders or protocol,
which orders or protocol shall be signed by a physician and
specify the dangerous drugs that its units may carry, expressed
in
standard dose units;
(2) 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.
An emergency medical service organization that is licensed
as
a terminal distributor shall notify the board immediately of
any
changes in its standing orders or protocol.
(E) There shall be six categories of terminal distributor
of
dangerous drugs licenses, which categories shall be as
follows:
(1) Category I license. A person who obtains this license
may
possess, have custody or control of, and distribute only the
dangerous drugs described in category I.
(2) Limited category I license. A person who obtains this
license may possess, have custody or control of, and distribute
only the dangerous drugs described in category I that were listed
in the application for licensure.
(3) 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 I and category II.
(4) 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 I or
category II
that were listed in the application for licensure.
(5) Category III license. A person who obtains this
license
may possess, have custody or control of, and distribute
the
dangerous drugs described in category I, category II, and
category
III.
(6) 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 I,
category II, or
category III that were listed in the application
for licensure.
(F) Except for an application made on behalf of an animal
shelter, if an
applicant for licensure as a limited category I,
II, or III terminal distributor of dangerous drugs intends to
administer dangerous drugs to a person or animal, the applicant
shall submit, with the application, a notarized copy of its
protocol or standing orders, which 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 on behalf of an animal shelter shall include
a
notarized 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. After obtaining a terminal
distributor license, a
licensee shall
notify the board immediately of any changes in its
protocol or
standing orders, or in such personnel.
(G)(1) Except as provided in division
(G)(2) of this section,
each applicant for licensure as
a
terminal distributor
of
dangerous drugs shall submit, with the application, a license
fee
determined as follows:
(a) For a category I or limited category I license,
forty-five dollars;
(b) For a category II or limited category II license,
one
hundred twelve dollars and fifty cents;
(c) For a category III or limited category III license,
one
hundred fifty dollars.
(2) For a professional association, corporation, partnership,
or limited liability company organized for the purpose of
practicing veterinary medicine, the fee shall be forty
dollars.
Fees assessed under divisions (G)(1) and (2) of
this section
shall not be returned if the applicant fails to qualify for
registration.
(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) The license of a person other than an emergency
medical
service organization 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 described 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 may possess
and use dangerous drugs
in the course of business as provided in
division (D) of section 4729.532 of
the Revised Code.
(3) The license of an emergency medical service
organization
shall cover and describe all the
units of
the organization listed
in its application for licensure.
(4) The license of every terminal distributor of dangerous
drugs shall indicate, on its face, the category of licensure. If
the license is a limited category I, II, or III license, it shall
specify, and shall authorize the licensee to possess, have
custody
or control of, and distribute only, the dangerous drugs
that were
listed in the application for licensure.
(I) All licenses issued pursuant to this section shall be
effective for a period of twelve months from the first day of
January of each year. A license shall be renewed by the board
for
a like period, annually, according to the provisions of this
section, and the standard renewal procedure of Chapter 4745. of
the Revised Code. A person who desires to renew a license shall
submit an application for renewal and pay the required fee on or
before the
thirty-first day of December each year.
The fee
required for the
renewal of a license shall be the same as the fee
paid for the
license being renewed, and shall accompany the
application for
renewal.
A license that has not been renewed during December in any
year and by the first day of February of the following year may
be
reinstated only upon payment of the required renewal fee and a
penalty fee of fifty-five dollars.
(J)(1) No emergency medical service organization that is
licensed as a terminal distributor of dangerous drugs shall fail
to comply with division (C)(2) or (3) of this section.
(2) No emergency medical service organization that is
licensed as a terminal distributor of dangerous drugs shall fail
to comply with division (D) of this section.
(3) 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.
(4) 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.
Sec. 4729.541. A person described in division (B)(1)(j) or
(k) of section 4729.51 of the Revised Code may possess, have
custody or control of, and distribute the dangerous drugs in
category I, category II, and category III of section 4729.54 of
the Revised Code without holding a terminal distributor of
dangerous drugs license issued under that section.
Section 2. That existing sections 2947.23, 3715.521, 3715.55,
3715.63, 4729.41, 4729.51, and 4729.54 of the Revised Code are
hereby
repealed.
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