Chapter 4729. PHARMACISTS; DANGEROUS DRUGS
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; |
| (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 2925.61,
4723.484,
4730.434, and
4731.94 of the Revised Code, a
written, electronic, or oral order for naloxone issued to and in the name of a
family member, friend, or other individual in a position to assist an
individual who there is reason to believe is at risk of experiencing an
opioid-related overdose. |
| (3) |
For
purposes of section 4729.44 of the Revised Code, a
written, electronic, or oral order for naloxone issued to and in the name of
either of the following:
| (a) |
An
individual who there is reason to believe is at risk of experiencing an
opioid-related overdose; |
| (b) |
A
family member, friend, or other individual in a position to assist an
individual who there is reason to believe is at risk of experiencing an
opioid-related overdose. |
|
| (4) |
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; |
| (5) |
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; |
| (6) |
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. |
|
| (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 the Revised Code; |
| (4) |
An
optometrist licensed under Chapter 4725. of the Revised Code to practice
optometry under a therapeutic pharmaceutical agents certificate; |
| (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. |
|
| (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. |
| (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) |
"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. |
| (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. |
Amended by
133rd General Assembly File No. 166, HB 341, §1,
eff. 12/16/2020.
Amended by
133rd General Assembly File No. TBD, HB 203, §1,
eff. 12/16/2020.
Amended by
133rd General Assembly File No. TBD, HB 197, §1,
eff. 3/27/2020.
Amended by
133rd General Assembly File No. 19, SB 57, §5,
eff. 7/30/2019.
Amended by
133rd General Assembly File No. 19, SB 57, §1,
eff. 7/30/2019.
Amended by
132nd General Assembly File No. TBD, SB 229, §1,
eff. 3/22/2020.
Amended by
132nd General Assembly File No. TBD, SB 119, §1,
eff. 3/20/2019.
Amended by
132nd General Assembly File No. TBD, HB 49, §101.01, eff.
9/29/2017.
Amended by
131st General Assembly File No. TBD, HB 216, §1,
eff. 4/6/2017.
Amended by
131st General Assembly File No. TBD, SB 332, §1,
eff. 4/6/2017.
Amended by
131st General Assembly File No. TBD, HB 290, §1,
eff. 4/6/2017.
Amended by
131st General Assembly File No. TBD, HB 505, §1,
eff. 3/20/2017.
Amended by
131st General Assembly File No. TBD, HB 200, §1,
eff. 9/8/2016.
Amended by
131st General Assembly File No. TBD, HB 188, §1,
eff. 3/23/2016.
Amended by
131st General Assembly File No. TBD, HB 124, §1,
eff. 3/23/2016.
Amended by
131st General Assembly File No. TBD, SB 110, §1,
eff. 10/15/2015.
Amended by
131st General Assembly File No. TBD, HB 4, §1,
eff. 7/16/2015.
Amended by
129th General AssemblyFile No.19, HB 93,
§1, eff.
5/20/2011.
Effective Date:
06-26-2003; 04-07-2005; 08-19-2005; 05-17-2006; 2007 SB58 08-30-2007 .
There shall be a state board of pharmacy, consisting of nine
members, eight of whom shall be pharmacists licensed under this chapter,
representing to the extent practicable various phases of the practice of
pharmacy, and one of whom shall be a public member at least sixty years of age.
Members shall be appointed by the governor with the advice and consent of the
senate. Terms of office shall be for four years, commencing on the first day of
July and ending on the thirtieth day of June. The Ohio pharmacists association
may annually submit to the governor the names of not less than five pharmacists
licensed under this chapter, and from the names submitted or from others, at
the governor's discretion, the governor each year shall make appointments to
the board. Each member shall hold office from the date of appointment until the
end of the term for which the member was appointed. Any member appointed to
fill a vacancy occurring prior to the expiration of the term for which the
predecessor was appointed shall hold office for the remainder of such term. Any
member shall continue in office subsequent to the expiration date of the
member's term until a successor takes office, or until a period of sixty days
has elapsed, whichever occurs first. No member of the board shall be
reappointed to the board more than once.
Effective Date:
07-22-1998 .
The state board of pharmacy shall license and register home
medical equipment services providers under Chapter 4752. of the Revised Code
and shall administer and enforce that chapter.
Added by
132nd General Assembly File No. TBD, HB 49, §130.11, eff.
1/21/2018.
The state board of
pharmacy shall organize by electing a president and a vice-president who are
members of the board. The president shall preside over the meetings of the
board, but shall not vote upon matters determined by the board, except in the
event of a tie vote, in which case the president shall vote. The board shall
also employ an executive director . The person employed shall not be a member of the board. Each
of the officers elected shall serve for a term of one year. The members of the
board shall receive an amount fixed pursuant to division (J) of section 124.15
of the Revised Code for each day employed in the discharge of their official
duties and their necessary expenses while engaged therein.
Amended by
130th General Assembly File No. TBD, SB 230, §1,
eff. 9/17/2014.
Effective Date: 07-22-1998
.
All of the
following apply with respect to the executive director of the state board
of pharmacy:
| (A) |
The executive director is the chief
administrative officer of the board. |
| (B) |
The
executive director is an appointing authority, as defined in section
124.01
of the Revised Code, and may appoint employees necessary to carry out the
board's functions. |
| (C) |
The executive director, with the board's approval,
may prescribe rules for the conduct of board employees, the performance of its
business, and the custody, use, and preservation of its records, papers, books,
documents, and property. |
| (D) |
The executive
director shall carry out official duties as an appointing authority
subject to internal management rules adopted by the board. |
| (E) |
The executive
director shall give a blanket bond to the state covering all employees of the
agency in the sum of twenty-five thousand dollars, conditioned for the faithful
discharge of the duties of their offices. |
| (F) |
For purposes of division (A)(25) of section
109.71
of the Revised Code, the executive director shall designate employees of the
board to investigate violations of Chapters 2925., 3715., 3719., 3796., 4729.,
and 4752. of the Revised Code and rules adopted thereunder. |
Amended by
132nd General Assembly File No. TBD, SB 229, §1,
eff. 3/22/2019.
Effective Date:
09-20-1984 .
The executive director of the state board of pharmacy, as soon
as possible after the necessary and appropriate scientific evidence is
available and with the board's approval, shall adopt rules that do the
following:
| (A) |
Specify the amount of
salvia divinorum and the amount of salvinorin A that constitute concentrations
of salvia divinorum and salvinorin A in a person's urine, in a person's whole
blood, or in a person's blood serum or plasma at or above which the person is
impaired for purposes of operating or being in physical control of any vessel
underway or manipulating any water skis, aquaplane, or similar device on the
waters of this state; |
| (B) |
Specify
the amount of salvia divinorum and the amount of salvinorin A that constitute
concentrations of salvia divinorum and salvinorin A in a person's urine, in a
person's whole blood, or in a person's blood serum or plasma at or above which
the person is impaired for purposes of operating any vehicle, streetcar, or
trackless trolley within this state. |
Effective Date: 2008 HB215
04-07-2009 .
Five of the voting members of the state board of pharmacy shall
constitute a quorum. The board shall meet at least once during each quarter of
the fiscal year and at such other times and places as the board may direct. The
board shall have a seal and prescribe such rules for its own government as it
deems proper.
Effective Date:
07-24-1990 .
The state board of
pharmacy shall keep a record of its proceedings and a register of all
licenses and registrations that have been granted,
together with each renewal and suspension or revocation of
a license
or registration. The books and registers of the board shall be prima-facie
evidence of the matters therein recorded. The books and registers may be in
electronic format.
The president and
executive director of the board may administer oaths.
A statement signed by
the executive director to which is affixed the official seal of the board to
the effect that it appears from the records of the board that the board has not
issued a license
or registration to the person specified in the statement, or that
a license
or registration, if issued, has been revoked or suspended, or the holder has
been subjected to disciplinary action by the board shall be received as
prima-facie evidence of the record of the board in any court or before any
officer of this state.
Amended by
132nd General Assembly File No. TBD, HB 49, §101.01, eff.
9/29/2017.
Amended by
131st General Assembly File No. TBD, SB 319, §1,
eff. 4/6/2017.
Effective Date:
07-22-1998 .
An individual desiring to be licensed as a pharmacist shall
file with the executive director of the state board of pharmacy a verified
application giving such information as the board requires. An application filed
under this section may not be withdrawn without the approval of the board. Each
applicant shall take an examination to determine fitness to practice pharmacy.
Examinations of those applying for licensure as pharmacists shall be held at
such times, during each year, and at such places as the board determines. The
board may use all or any part of the licensure examination of the national
association of boards of pharmacy or any other national standardized pharmacy
examination that it considers appropriate. The board may require applicants to
purchase the examination and any related materials from the organization
providing it.
Effective Date:
02-12-2001 .
| (A) |
As used in this section, "license" and "applicant
for an initial license" have the same meanings as in section
4776.01 of the Revised Code,
except that "license" as used in both of those terms refers to the types of
authorizations otherwise issued or conferred under this chapter. |
| (B) |
In
addition to any other eligibility requirement set forth in this chapter, each
applicant for an initial license shall comply with sections
4776.01 to
4776.04 of the Revised Code. The
state board of pharmacy shall not grant a license to an applicant for an
initial license unless the applicant complies with sections
4776.01 to
4776.04 of the Revised Code and
the board, in its discretion, decides that the results of the criminal records
check do not make the applicant ineligible for a license issued pursuant to
section 4729.08,
4729.09,
4729.11,
4729.552, or 4729.553 of the Revised Code. |
Amended by
131st General Assembly File No. TBD, SB 319, §1,
eff. 4/6/2017.
Amended by
129th General AssemblyFile No.19, HB 93,
§1, eff.
5/20/2011.
Effective Date: 2007 HB104
03-24-2008
Every applicant for
examination and licensure as a pharmacist shall:
| (A) |
Be at least eighteen years of age; |
| (B) |
Be of good moral character , as defined in rules adopted by the state board of pharmacy
under section 4729.26 of the Revised
Code; |
| (C) |
Have
obtained a degree in pharmacy from a program that has been recognized and
approved by the state board of pharmacy, except that graduates of schools or
colleges of pharmacy that are located outside the United States and have not
demonstrated that the standards of their programs are at least equivalent to
programs recognized and approved by the board shall be required to pass an
equivalency examination recognized and approved by the board and to establish
written and oral proficiency in English. |
| (D) |
Have satisfactorily completed at least the minimum requirements for pharmacy
internship as outlined by the board. If the board is
satisfied that the applicant meets the foregoing requirements and if the
applicant passes the examination required under section
4729.07 of the Revised Code, the
board shall issue to the applicant a license authorizing the individual to practice
pharmacy.
|
Amended by
132nd General Assembly File No. TBD, HB 49, §101.01, eff.
9/29/2017.
Effective Date:
07-22-1998 .
The state board of
pharmacy may license an individual as a pharmacist without examination
if the individual:
| (A) |
Holds a license in good standing to practice pharmacy under the laws of another
state, has successfully completed an examination for licensure in the other
state, and in the opinion of the board, the examination was at least as
thorough as that required by the board at the time the individual took the
examination; |
| (B) |
Is of
good moral character , as defined in rules adopted by the board under section
4729.26 of the Revised
Code; |
| (C) |
Has
filed with the licensing body of the other state at least the credentials or
the equivalent that were required by this state at the time
the other state licensed the individual
as a pharmacist. The board shall not
issue a license to practice
pharmacy to an individual licensed in another state if the state in which
the individual is licensed does not reciprocate by granting licenses to
practice pharmacy to individuals holding valid licenses received
through examination by the state board of pharmacy.
|
Amended by
132nd General Assembly File No. TBD, HB 49, §101.01, eff.
9/29/2017.
Effective Date:
07-22-1998 .
The state board of pharmacy may adopt rules under section
4729.26 of the Revised Code
requiring a licensee or registrant under this chapter to report to the board a
violation of state or federal law, including any rule adopted under this
chapter.
In the absence of fraud or bad faith, a person who reports
under this section or testifies in any adjudication conducted under Chapter
119. of the Revised Code is not liable to any person for damages in a civil
action as a result of the report or testimony.
Added by
131st General Assembly File No. TBD, SB 319, §1,
eff. 4/6/2017.
The state board of
pharmacy shall establish a pharmacy internship program for the purpose of
providing the practical experience necessary to practice as a pharmacist. Any
individual who desires to become a pharmacy intern shall apply for licensure to
the board. An application filed under this section may not be withdrawn without
the approval of the board.
Each applicant shall
be issued a license as a pharmacy intern if
the board
determines that the applicant is actively
pursuing an educational program in preparation for licensure as a pharmacist
and meets the other requirements as determined by the board.
A license shall be valid until the next
renewal date and shall be renewed
only if the intern is meeting the requirements and rules of the board.
Amended by
132nd General Assembly File No. TBD, HB 49, §101.01, eff.
9/29/2017.
Effective Date:
02-12-2001 .
A
license issued by the state board of pharmacy under section
4729.08 or
4729.11 of the Revised
Code entitles the individual to whom it is issued to practice as a pharmacist
or as a pharmacy intern in this state until the next renewal date.
Licenses shall be renewed
according to 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.
Licenses are valid for the period specified in the rules, unless earlier
revoked or suspended by the board. The period shall not exceed twenty-four
months unless the board extends the period in the rules to adjust license
renewal schedules.
A pharmacist or
pharmacy intern who desires to continue in the practice of pharmacy shall file
with the board an application in such form and containing such data as the
board may require for renewal of a license. In the case of a
pharmacist who dispenses or plans to dispense controlled substances in this
state, the pharmacist shall certify, as part of the application, that the
pharmacist has been granted access to the drug database established and
maintained by the board pursuant to section
4729.75 of the Revised Code,
unless the board has restricted the pharmacist from obtaining further
information from the database or the board no longer maintains the database. If
the pharmacist certifies to the board that the applicant has been granted
access to the drug database and the board finds through an audit or other means
that the pharmacist has not been granted access, the board may take action
under section 4729.16 of the Revised
Code.
An application filed
under this section for renewal of a license may not be withdrawn
without the approval of the board.
If the board finds
that an applicant's license has not been revoked or placed under
suspension and that the applicant has paid the renewal fee, has continued
pharmacy education in accordance with the rules of the board, and is entitled
to continue in the practice of pharmacy, the board shall
renew the applicant's
license.
When
a license has expired but
an application is made within three years after
the expiration of the license, the applicant's
license shall be renewed without
further examination if the applicant meets the requirements of this section and
pays the fee designated under division (A)(5) of section
4729.15 of the Revised
Code.
A pharmacist or pharmacy intern who fails to renew the
pharmacist's or intern's license by the renewal date prescribed by the board
shall not engage in the practice of pharmacy until a valid license is issued by
the board.
Amended by
132nd General Assembly File No. TBD, HB 49, §101.01, eff.
9/29/2017.
Amended by
130th General Assembly File No. TBD, SB 276, §1,
eff. 3/19/2015.
Amended by
130th General Assembly File No. TBD, HB 394, §1,
eff. 3/19/2015.
Amended by
130th General Assembly File No. TBD, HB 341, §1,
eff. 1/1/2015.
Amended by
130th General Assembly File No. TBD, HB 483, §101.01, eff.
1/1/2015.
Amended by
130th General Assembly File No. TBD, HB 488, §1,
eff. 9/16/2014.
Effective Date: 02-12-2001
.
A pharmacist who
fails to make application to the state board of pharmacy for a
license renewal within a period of three years
from the expiration of the license must pass an examination
for licensure and comply with sections
4776.01 to
4776.04 of the Revised
Code; except that a pharmacist whose license has expired, but who has continually practiced
pharmacy in another state under a license issued by the authority of that
state, may obtain a renewed license upon payment to
the executive director of the board the fee designated under division (A)(6) of
section 4729.15 of the Revised
Code.
Amended by
132nd General Assembly File No. TBD, HB 49, §101.01, eff.
9/29/2017.
Amended by
130th General Assembly File No. TBD, HB 488, §1,
eff. 9/16/2014.
Effective Date: 07-22-1998
.
Effective Date:
12-31-1971 .
Repealed by
132nd General Assembly File No. TBD, HB 49, §105.01, eff.
9/29/2017.
Effective Date:
07-22-1998 .
| (A) |
Except as provided in division (B) of this section, the state board of pharmacy
shall charge the following fees:
| (1) |
For applying for a license to practice as a pharmacist, an amount adequate to
cover all expenses of the board related to examination except the
expenses of procuring and grading the examination, which fee shall not be
returned if the applicant fails to pass the examination; |
| (2) |
For the examination of an applicant for licensure as a pharmacist, an amount
adequate to cover any expenses to the board of procuring and grading the
examination or any part thereof, which fee shall not be returned if the
applicant fails to pass the examination; |
| (3) |
For issuing a license to an individual who passes the examination described in section
4729.07 of the Revised Code, an
amount that is adequate to cover the expense; |
| (4) |
For a pharmacist applying for renewal of a
license before the expiration date, two hundred
fifty dollars ,
which fee shall not be returned if the applicant fails to qualify for
renewal; |
| (5) |
For a
pharmacist applying for renewal of a license that has
been
expired for less than three years, the renewal fee
identified in division (A)(4) of this section plus a penalty of thirty-seven
dollars and fifty cents, which fee shall not be returned if the applicant
fails to qualify for renewal; |
| (6) |
For a pharmacist applying for renewal of a license that has
been
expired for more than three years, three hundred thirty-seven dollars and
fifty cents, which fee shall not be returned if the applicant fails to qualify
for renewal; |
| (7) |
For a
pharmacist applying for a license on presentation of a pharmacist license granted
by another state, three hundred thirty-seven dollars and fifty cents, which fee
shall not be returned if the applicant fails to qualify for
licensure. |
| (8) |
For a
license to
practice as a pharmacy intern, forty-five dollars , which fee shall not be returned
if the applicant fails to qualify for licensure; |
| (9) |
For the renewal of a pharmacy intern license,
forty-five dollars , which fee shall not be returned if the applicant fails
to qualify for renewal; |
| (10) |
For certifying licensure and grades for
reciprocal licensure, thirty-five dollars;
|
| (11) |
For making
copies of any application, affidavit, or other document filed in the state
board of pharmacy office, an amount fixed by the board that is adequate to
cover the expense, except that for copies required by federal or state agencies
or law enforcement officers for official purposes, no charge need be
made; |
| (12) |
For certifying
and affixing the seal of the board, an amount fixed by the board that is
adequate to cover the expense, except that for certifying and affixing the seal
of the board to a document required by federal or state agencies or law
enforcement officers for official purposes, no charge need be made; |
| (13) |
For each copy
of a book or pamphlet that includes laws administered by the state board of
pharmacy, rules adopted by the board, and chapters of the Revised Code with
which the board is required to comply, an amount fixed by the board that is
adequate to cover the expense of publishing and furnishing the book or
pamphlet. |
|
| (B) |
| (1) |
Subject to division (B)(2) of this section, the fees described in divisions
(A)(1) to (10) of this section do not apply to an individual who
is on active duty in the armed forces of the United States, as defined in section
5903.01 of the Revised Code, to
the spouse of an individual who is on active duty in the armed forces of the
United States, or to an individual who served in the armed forces of the
United States and presents documentation that the individual has
been discharged under honorable conditions from the armed forces or has been
transferred to the reserve with evidence of satisfactory
service. |
| (2) |
The
state board of pharmacy may establish limits with respect to the individuals
for whom fees are not applicable under division (B)(1) of this
section. |
|
Amended by
132nd General Assembly File No. TBD, HB 49, §101.01, eff.
9/29/2017.
Amended by
130th General Assembly File No. TBD, HB 488, §1,
eff. 9/16/2014.
Effective Date: 07-22-1998
.
| (A) |
| (1) |
The
state board of pharmacy, after notice and hearing in accordance with Chapter
119. of the Revised Code, may impose any one or more of the following sanctions
on a pharmacist or pharmacy intern if the board finds the individual engaged in
any of the conduct set forth in division (A)(2) of this section:
| (a) |
Revoke, suspend, restrict, limit, or refuse to grant or renew a
license; |
| (b) |
Reprimand or
place the license holder on probation; |
| (c) |
Impose a monetary penalty or forfeiture not to exceed in severity any fine
designated under the Revised Code for a similar offense, or in the case of a
violation of a section of the Revised Code that does not bear a penalty, a
monetary penalty or forfeiture of not more than five hundred dollars. |
|
| (2) |
The board
may impose the sanctions listed in division (A)(1) of this section if the board
finds a pharmacist or pharmacy intern:
| (a) |
Has
been convicted of a felony, or a crime of moral turpitude, as defined in
section
4776.10
of the Revised Code; |
| (b) |
Engaged in
dishonesty or unprofessional conduct in the practice of pharmacy; |
| (c) |
Is
addicted to or abusing alcohol or drugs or is impaired physically or mentally
to such a degree as to render the pharmacist or pharmacy intern unfit to
practice pharmacy; |
| (d) |
Has been
convicted of a misdemeanor related to, or committed in, the practice of
pharmacy; |
| (e) |
Violated,
conspired to violate, attempted to violate, or aided and abetted the violation
of any of the provisions of this chapter, sections
3715.52 to
3715.72
of the Revised Code, Chapter 2925. or 3719. of the Revised Code, or any rule
adopted by the board under those provisions; |
| (f) |
Permitted someone other than a pharmacist or pharmacy intern to practice
pharmacy; |
| (g) |
Knowingly
lent the pharmacist's or pharmacy intern's name to an illegal practitioner of
pharmacy or had a professional connection with an illegal practitioner of
pharmacy; |
| (h) |
Divided or
agreed to divide remuneration made in the practice of pharmacy with any other
individual, including, but not limited to, any licensed health professional
authorized to prescribe drugs or any owner, manager, or employee of a health
care facility, residential care facility, or nursing home; |
| (i) |
Violated the terms of a consult agreement entered into pursuant to section
4729.39
of the Revised Code; |
| (j) |
Committed
fraud, misrepresentation, or deception in applying for or securing a license
issued by the board under this chapter or under Chapter 3715. or 3719. of the
Revised Code; |
| (k) |
Failed to
comply with an order of the board or a settlement agreement; |
| (l) |
Engaged in any other conduct for which the board may impose discipline as set
forth in rules adopted under section
4729.26 of
the Revised Code. |
|
|
| (B) |
Any
individual whose license is revoked, suspended, or refused, shall return the
license to the offices of the state board of pharmacy within ten days after
receipt of notice of such action. |
| (C) |
As
used in this section: "Unprofessional conduct
in the practice of pharmacy" includes any of the following:
| (1) |
Advertising or displaying signs that promote dangerous drugs to the public in a
manner that is false or misleading; |
| (2) |
Except as provided in section
4729.281 , 4729.44, or 4729.47 of the Revised Code, the dispensing or
sale of any drug for which a prescription is required, without having received
a prescription for the drug; |
| (3) |
Knowingly dispensing medication pursuant to false or forged
prescriptions; |
| (4) |
Knowingly
failing to maintain complete and accurate records of all dangerous drugs
received or dispensed in compliance with federal laws and regulations and state
laws and rules; |
| (5) |
Obtaining
any remuneration by fraud, misrepresentation, or deception; |
| (6) |
Failing to conform to prevailing standards of care of similar pharmacists or
pharmacy interns under the same or similar circumstances, whether or not actual
injury to a patient is established; |
| (7) |
Engaging in any other conduct that the board specifies as unprofessional
conduct in the practice of pharmacy in rules adopted under section
4729.26 of
the Revised Code. |
|
| (D) |
The
board may suspend a license under division (B) of section
3719.121
of the Revised Code by utilizing a telephone conference call to review the
allegations and take a vote. |
| (E) |
For
purposes of this division, an individual authorized to practice as a pharmacist
or pharmacy intern accepts the privilege of practicing in this state subject to
supervision by the board. By filing an application for or holding a license to
practice as a pharmacist or pharmacy intern, an individual gives consent to
submit to a mental or physical examination when ordered to do so by the board
in writing and waives all objections to the admissibility of testimony or
examination reports that constitute privileged communications. If the board has
reasonable cause to believe that an individual who is a pharmacist or pharmacy
intern is physically or mentally impaired, the board may require the individual
to submit to a physical or mental examination, or both. The expense of the
examination is the responsibility of the individual required to be
examined. Failure of an individual
who is a pharmacist or pharmacy intern to submit to a physical or mental
examination ordered by the board, unless the failure is due to circumstances
beyond the individual's control, constitutes an admission of the allegations
and a suspension order shall be entered without the taking of testimony or
presentation of evidence. Any subsequent adjudication hearing under Chapter
119. of the Revised Code concerning failure to submit to an examination is
limited to consideration of whether the failure was beyond the individual's
control. If, based on the results
of an examination ordered under this division, the board determines that the
individual's ability to practice is impaired, the board shall suspend the
individual's license or deny the individual's application and shall require the
individual, as a condition for an initial, continued, reinstated, or renewed
license to practice, to submit to a physical or mental examination and
treatment. An order of suspension
issued under this division shall not be subject to suspension by a court during
pendency of any appeal filed under section
119.12
of the Revised Code.
|
| (F) |
If
the board is required under Chapter 119. of the Revised Code to give notice of
an opportunity for a hearing and the applicant or licensee does not make a
timely request for a hearing in accordance with section
119.07
of the Revised Code, the board is not required to hold a hearing, but may adopt
a final order that contains the board's findings. In the final order, the board
may impose any of the sanctions listed in division (A) of this
section. |
| (G) |
Notwithstanding the provision of division (C)(2) of section
2953.32
of the Revised Code specifying that if records pertaining to a criminal case
are sealed under that section the proceedings in the case must be deemed not to
have occurred, sealing of the following records on which the board has based an
action under this section shall have no effect on the board's action or any
sanction imposed by the board under this section: records of any conviction,
guilty plea, judicial finding of guilt resulting from a plea of no contest, or
a judicial finding of eligibility for a pretrial diversion program or
intervention in lieu of conviction. The board shall not be required to seal,
destroy, redact, or otherwise modify its records to reflect the court's sealing
of conviction records. |
| (H) |
No
pharmacist or pharmacy intern shall knowingly engage in any conduct described
in divisions (A)(2)(b) or (A)(2)(e) to (l) of this section. |
Amended by
132nd General Assembly File No. TBD, HB 101, §1,
eff. 4/8/2019.
Amended by
132nd General Assembly File No. TBD, HB 49, §101.01, eff.
9/29/2017.
Amended by
131st General Assembly File No. TBD, SB 319, §1,
eff. 4/6/2017.
Amended by
131st General Assembly File No. TBD, HB 4, §1,
eff. 7/16/2015.
Amended by
130th General Assembly File No. TBD, SB 276, §1,
eff. 3/19/2015.
Amended by
130th General Assembly File No. TBD, HB 394, §1,
eff. 3/19/2015.
Effective Date: 02-12-2001
.
| (A) |
An individual registered with the state board of
pharmacy to engage in the practice of pharmacy may render the professional
services of a pharmacist within this state through 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
professional association formed under Chapter 1785. of the Revised Code. This
division does not preclude an individual of that nature from rendering
professional services as a pharmacist through another form of business entity,
including, but not limited to, a nonprofit corporation or foundation, or in
another manner that is authorized by or in accordance with this chapter,
another chapter of the Revised Code, or rules of the state board of pharmacy
adopted pursuant to this chapter. |
| (B) |
A
corporation, limited liability company, partnership, or professional
association described in division (A) of this section may be formed for the
purpose of providing a combination of the professional services of the
following individuals who are licensed, certificated, or otherwise legally
authorized to practice their respective professions:
| (1) |
Optometrists who are authorized to practice optometry under Chapter 4725. of
the Revised Code; |
| (2) |
Chiropractors who are authorized to practice chiropractic or acupuncture under
Chapter 4734. of the Revised Code; |
| (3) |
Psychologists who are authorized to practice psychology under Chapter 4732. of
the Revised Code; |
| (4) |
Registered
or licensed practical nurses who are authorized to practice nursing as
registered nurses or as licensed practical nurses under Chapter 4723. of the
Revised Code; |
| (5) |
Pharmacists
who are authorized to practice pharmacy under Chapter 4729. of the Revised
Code; |
| (6) |
Physical
therapists who are authorized to practice physical therapy under sections
4755.40 to 4755.56 of the Revised Code; |
| (7) |
Occupational therapists who are authorized to practice occupational therapy
under sections 4755.04 to 4755.13 of the Revised Code; |
| (8) |
Mechanotherapists who are authorized to practice mechanotherapy under section
4731.151 of the Revised Code; |
| (9) |
Doctors of medicine and surgery, osteopathic medicine and surgery, or podiatric
medicine and surgery who are authorized for their respective practices under
Chapter 4731. of the Revised Code; |
| (10) |
Licensed professional clinical counselors, licensed
professional counselors, independent social workers, social workers,
independent marriage and family therapists, or marriage and family therapists
who are authorized for their respective practices under Chapter 4757. of the
Revised Code. This division shall apply
notwithstanding a provision of a code of ethics applicable to a pharmacist that
prohibits a pharmacist from engaging in the practice of pharmacy in combination
with a person who is licensed, certificated, or otherwise legally authorized to
practice optometry, chiropractic, acupuncture through the state chiropractic
board, psychology, nursing, physical therapy, occupational therapy,
mechanotherapy, medicine and surgery, osteopathic medicine and surgery,
podiatric medicine and surgery, professional counseling, social work, or marriage and
family therapy, but who is not also licensed, certificated, or otherwise
legally authorized to engage in the practice of
pharmacy.
|
|
Amended by
130th General Assembly File No. TBD, HB 232, §1,
eff. 7/10/2014.
Effective Date:
03-22-1999; 04-06-2007; 2007 HB119 08-22-2007 .
| (A) |
As used in this section, "drug database" means the
database established and maintained by the state board of pharmacy pursuant to
section 4729.75 of the Revised
Code. |
| (B) |
The state board of pharmacy shall adopt rules in
accordance with Chapter 119. of the Revised Code that establish standards and
procedures to be followed by a pharmacist regarding the review of patient
information available through the drug database under
division (A)(6) of section
4729.80 of the Revised
Code. |
| (C) |
This section and the rules adopted under it do not
apply if the board no longer maintains the drug database. |
Amended by
129th General AssemblyFile No.156, SB 301,
§1, eff.
3/13/2013.
Added by
129th General AssemblyFile No.19, HB 93,
§1, eff.
5/20/2011.
Any investigation, inquiry, or hearing, which the state board
of pharmacy is empowered to hold or undertake may be held or undertaken by or
before any member or members of the board and the finding or order of such
member or members shall be deemed to be the order of said board when approved
and confirmed by a majority of the board members present and voting at a
meeting of the board at which there is a quorum.
Effective Date:
12-31-1971; 2007
SB58 08-30-2007
.
| (A) |
| (1) |
| (a) |
The state board of
pharmacy may designate one or more attorneys at law who have been admitted to
the practice of law, and who are classified as either administrative law
attorney examiners or as administrative law attorney examiner administrators
under the state job classification plan adopted under section
124.14 of the Revised Code, as
hearing examiners, subject to Chapter 119. of the Revised Code, to conduct any
hearing the board is empowered to hold or undertake pursuant to Chapter 119. of
the Revised Code. |
| (b) |
Notwithstanding the requirement of division (A)(1)(a)
of this section that the board designate as a hearing examiner an attorney who
is classified as either an administrative law attorney examiner or an
administrative law attorney examiner administrator, the board may, subject to
section 127.16 of the Revised Code, enter into a personal service contract with
an attorney admitted to the practice of law in this state to serve as a hearing
examiner. |
|
| (2) |
The hearing examiner shall hear and consider the oral
and documented evidence introduced by the parties and issue in writing proposed
findings of fact and conclusions of law to the board for their consideration
within thirty days following the close of the hearing. |
|
| (B) |
The board shall be given
copies of the transcript of the hearing record and all exhibits and documents
presented by the parties at the hearing. |
| (C) |
The board shall render a decision and take action
within ninety days following the receipt of the hearing examiner's proposed
findings of fact and conclusions of law. |
| (D) |
The final decision of the board in any hearing shall
be in writing and contain findings of fact and conclusions of law. Copies of
the decision shall be delivered to the parties personally or by certified mail.
The decision is final on delivery or mailing, but may be appealed as provided
by Chapter 119. of the Revised Code. |
Added by
131st General Assembly File No. TBD, SB 319, §1,
eff. 4/6/2017.
The state board of
pharmacy shall adopt rules in accordance with Chapter 119. of the Revised Code
establishing standards for approving and designating physicians and facilities
as treatment providers for pharmacists with substance abuse problems and shall
approve and designate treatment providers in accordance with the rules. The
rules shall include standards for both inpatient and outpatient treatment. The
rules shall provide that to be approved, a treatment provider must be capable
of making an initial examination to determine the type of treatment required
for a pharmacist with substance abuse problems. Subject to the rules, the board
shall review and approve treatment providers on a regular basis and may, at its
discretion, withdraw or deny approval.
An approved treatment
provider shall:
| (A) |
Report to the board the name of any pharmacist
suffering or showing evidence of suffering impairment by reason of being
addicted to or abusing alcohol or drugs as described in division (A)(2)(c) of
section 4729.16 of the Revised Code who
fails to comply within one week with a referral for examination; |
| (B) |
Report to the board the name of any impaired pharmacist who fails to enter
treatment within forty-eight hours following the provider's determination that
the pharmacist needs treatment; |
| (C) |
Require every pharmacist who enters treatment to agree to a treatment contract
establishing the terms of treatment and aftercare, including any required
supervision or restrictions of practice during treatment or
aftercare; |
| (D) |
Require a pharmacist to suspend practice on
entering any required inpatient treatment; |
| (E) |
Report to the board any failure by an impaired pharmacist to comply with the
terms of the treatment contract during inpatient or outpatient treatment or
aftercare; |
| (F) |
Report to the board the resumption of practice of
any impaired pharmacist before the treatment provider has made a clear
determination that the pharmacist is capable of practicing according to
acceptable and prevailing standards; |
| (G) |
Require a pharmacist who resumes practice after completion of treatment to
comply with an aftercare contract that meets the requirements of rules adopted
by the board for approval of treatment providers; |
| (H) |
Report to the board any pharmacist who suffers a relapse at any time during or
following aftercare. Any pharmacist who enters
into treatment by an approved treatment provider shall be deemed to have waived
any confidentiality requirements that would otherwise prevent the treatment
provider from making reports required under this section. In the absence of fraud
or bad faith, no professional association of pharmacists licensed under this
chapter that sponsors a committee or program to provide peer assistance to
pharmacists with substance abuse problems, no representative or agent of such a
committee or program, and no member of the state board of pharmacy shall be
liable to any person for damages in a civil action by reason of actions taken
to refer a pharmacist to a treatment provider designated by the board or
actions or omissions of the provider in treating a pharmacist. In the absence of fraud
or bad faith, no person who reports to the board a pharmacist with a suspected
substance abuse problem shall be liable to any person for damages in a civil
action as a result of the report.
|
Amended by
131st General Assembly File No. TBD, SB 319, §1,
eff. 4/6/2017.
Amended by
130th General Assembly File No. TBD, SB 276, §1,
eff. 3/19/2015.
Amended by
130th General Assembly File No. TBD, HB 394, §1,
eff. 3/19/2015.
Effective Date: 03-27-1991
.
Notwithstanding division
(B)(4) of section
2317.02
of the Revised Code, a pharmacist, pharmacy intern, pharmacy technician
trainee, registered pharmacy technician, certified pharmacy technician,
terminal distributor of
dangerous drugs, manufacturer of dangerous drugs, outsourcing facility,
third-party logistics provider, repackager of dangerous drugs, or
wholesale distributor of dangerous drugs shall cooperate with federal, state,
and local government investigations and shall divulge all relevant information
when requested by a government agency.
Amended by
132nd General Assembly File No. TBD, SB 229, §1,
eff. 3/22/2019.
Amended by
131st General Assembly File No. TBD, SB 319, §1,
eff. 4/6/2017.
Effective Date:
02-12-2001 .
As used in this section, "medication synchronization" means
a pharmacy service that synchronizes the filling or refilling of prescriptions
in a manner that allows the dispensed drugs to be obtained on the same date
each month.
A pharmacist may dispense a drug in a manner that varies
from the prescription for the drug by dispensing a quantity or amount of the
drug that is less than a thirty-day supply, if the pharmacist's action is taken
solely for the purpose of medication synchronization pursuant to section
1751.68. 3923.602. 5164.7511. or
5167.12 of the Revised
Code.
Added by
131st General Assembly File No. TBD, HB 116, §1,
eff. 8/31/2016.
| (A) |
Except as provided in division (B) of this section, information received by the
state board of pharmacy pursuant to an investigation is confidential, is not a public record, and is not subject to
discovery in any civil action. |
| (B) |
The
board shall conduct all investigations or inspections and proceedings in a
manner that protects the confidentiality of patients, confidential informants,
and individuals who file complaints with the board. The board shall not make
public the names or any other identifying information of patients, confidential
informants, or complainants unless proper consent is given or, in the case of a
patient, a waiver of the patient privilege exists under division (B) of section
2317.02
of the Revised Code. The consent or waiver is not required if the board
possesses reliable and substantial evidence that no bona fide physician-patient
relationship exists. On request, the board may
share any information it receives pursuant to an investigation or inspection,
including patient records and patient record information, with law enforcement
agencies, other licensing boards, and other state or federal governmental
agencies that are prosecuting, adjudicating, or investigating alleged
violations of statutes or administrative rules. An agency or board that
receives the information shall comply with the same requirements regarding
confidentiality as those with which the state board of pharmacy must comply,
notwithstanding any conflicting provision of the Revised Code or agency
procedure that applies when the agency is dealing with other information in its
possession. Any information the board
receives from a state or federal agency is subject to the same confidentiality
requirements as the agency from which it was received and shall not be released
by the board without prior authorization from that agency. The board may, for good
cause shown, disclose or authorize disclosure of information gathered pursuant
to an investigation.
|
| (C) |
Any
board activity that involves continued monitoring of an individual for
treatment or recovery purposes as part of or following any disciplinary action
taken under this chapter shall
be conducted in a manner that maintains an individual's confidentiality with
respect to the individual's treatment or recovery program. Information received
or maintained by the board with respect to the board's monitoring activities is
not subject to discovery in any civil action, is not a
public record, and is confidential, except that the board may disclose
information to law enforcement officers and government entities for purposes of
an investigation of a license or certificate holder. |
Amended by
132nd General Assembly File No. TBD, HB 101, §1,
eff. 4/8/2019.
Added by
132nd General Assembly File No. TBD, HB 49, §101.01, eff.
9/29/2017.
| (A) |
Subject to division (B) of this section, in addition
to the actions the state board of pharmacy may take under Chapter 119. of the
Revised Code, the board may order the taking of depositions; examine and copy
any books, accounts, papers, records, documents, and other tangible objects;
issue subpoenas; and compel the attendance of witnesses and production of
books, accounts, papers, records, documents, and other tangible objects. On failure of a person to comply with a subpoena issued by
the board and after reasonable notice to that person, the board may apply to
the court of common pleas of Franklin county for an order compelling the
production of persons or records pursuant to the Ohio Rules of Civil
Procedure. A subpoena issued by the board may be served by a sheriff,
sheriff's deputy, or board employee designated by the board. Service of a
subpoena may be made by delivering a copy of the subpoena to the person named
in the subpoena or by leaving it at the person's usual place of
residence.
|
| (B) |
A subpoena for patient record information may be
issued only on approval by the board's executive director and the president or
another board member designated by the president, in consultation with the
office of the attorney general. Before issuing the subpoena, the executive
director and the office of the attorney general shall determine whether
probable cause exists to believe that the complaint filed alleges, or an
investigation has revealed, a violation of this chapter or Chapters 2925.,
3715., 3719., or 3796. of the Revised Code or any rule adopted by the board,
that the records sought are relevant to the alleged violation and material to
the investigation, and that the records cover a reasonable period of time
surrounding the alleged violation. |
| (C) |
The board may adopt rules in accordance with Chapter
119. of the Revised Code establishing procedures to be followed in taking the
actions authorized by this section, including procedures regarding payment for
and service of subpoenas. |
Added by
132nd General Assembly File No. TBD, HB 49, §101.01, eff.
9/29/2017.
| (A) |
The state
board of pharmacy shall enforce, or cause to be enforced, this chapter. If it
has information that any provision of this chapter has been violated, it shall
investigate the matter, and take such action as it considers appropriate .
|
| (B) |
Nothing in this chapter shall
be construed to require the state board of pharmacy to enforce minor violations
of this chapter if the board determines that the public interest is adequately
served by a notice or warning to the alleged offender. |
Effective Date:
07-22-1998;
05-18-2005 .
The state board of pharmacy may adopt rules in accordance with
Chapter 119. of the Revised Code, not inconsistent with the law, as may be
necessary to carry out the purposes of and to enforce the provisions of this
chapter . The rules shall be published and made available by the board to each
pharmacist licensed under this chapter.
Effective Date:
07-22-1998;
05-18-2005 .
Effective Date:
07-22-1998 .
A person not a pharmacist, who owns, manages, or conducts a
pharmacy, shall employ a pharmacist to be in full and actual charge of such
pharmacy. Any pharmacist who owns, manages, or conducts a pharmacy shall be
personally in full and actual charge of the pharmacy, or shall employ another
pharmacist to be in full and actual charge of the pharmacy.
Effective Date:
07-22-1998 .
| (A) |
As used in this section,
"dispense" has the meaning specified by the state board of pharmacy in rules
adopted under section
4729.26 of
the Revised Code. |
| (B) |
| (1) |
Except as provided in division (B)(2) of this section,
no person who is not a pharmacist or a pharmacy intern under the personal
supervision of a pharmacist shall compound
or sell dangerous drugs or otherwise engage in the practice of
pharmacy. |
| (2) |
Except as provided in sections
3701.048,
4729.44, and 4729.47 of the
Revised Code or rules adopted by the board under section
4729.26 of
the Revised Code, no person who is not a pharmacist shall dispense dangerous
drugs. |
|
Amended by
132nd General Assembly File No. TBD, HB 101, §1,
eff. 4/8/2019.
Effective Date:
07-22-1998 .
| (A) |
A pharmacist may dispense or sell a dangerous
drug, other than a schedule II controlled substance as defined in section
3719.01 of the Revised Code,
without a written or oral prescription from a licensed health professional
authorized to prescribe drugs if all of the following conditions are met:
| (1) |
The
pharmacy at which the pharmacist works has a record of a prescription for the
drug in the name of the patient who is requesting it, but the prescription does
not provide for a refill or the time permitted by rules adopted by the state
board of pharmacy for providing refills has elapsed. |
| (2) |
The
pharmacist is unable to obtain authorization to refill the prescription from
the health care professional who issued the prescription or another health
professional responsible for the patient's care. |
| (3) |
In
the exercise of the pharmacist's professional judgment:
| (a) |
The
drug is essential to sustain the life of the patient or continue therapy for a
chronic condition of the patient. |
| (b) |
Failure to dispense or sell the drug to the patient could result in harm to the
health of the patient. |
|
| (4) |
| (a) |
Except as provided in division (A)(4)(b) of this section, the amount of the
drug that is dispensed or sold under this section does not exceed a
seventy-two-hour supply as provided in the prescription. |
| (b) |
| (i) |
Subject to division (A)(4)(b)(ii) of this section, if the drug
dispensed or sold under this section is not a controlled substance and the
patient has been on a consistent drug therapy as demonstrated by records
maintained by a pharmacy, the amount of the drug dispensed or sold does not
exceed a thirty-day supply as provided in the prescription or, if the standard
unit of dispensing for the drug exceeds a thirty-day supply, the amount of the
drug dispensed or sold does not exceed the standard unit of dispensing.
The pharmacist shall exercise professional judgment in
determining the amount of the drug to be dispensed or sold. |
| (ii) |
A
pharmacist shall not dispense or sell a particular drug to the same patient in
an amount described in division (A)(4)(b)(i) of this section more than once in
any twelve-month period. |
|
|
|
| (B) |
A
pharmacist who dispenses or sells a drug under this section shall do all of the
following:
| (1) |
For one year
after the date of dispensing or sale, maintain a record in accordance with this
chapter of the drug dispensed or sold, including the name and address of the
patient and the individual receiving the drug, if the individual receiving the
drug is not the patient, the amount dispensed or sold, and the original
prescription number; |
| (2) |
Notify the
health professional who issued the prescription described in division (A)(1) of
this section or another health professional responsible for the patient's care
not later than seventy-two hours after the drug is sold or dispensed; |
| (3) |
If
applicable, obtain authorization for additional dispensing from one of the
health professionals described in division (B)(2) of this
section. |
|
| (C) |
A pharmacist who dispenses or sells a drug under
this section may do so once for each prescription described in division (A)(1)
of this section. |
Amended by
131st General Assembly File No. TBD, HB 116, §1,
eff. 8/31/2016.
Amended by
131st General Assembly File No. TBD, HB 188, §1,
eff. 3/23/2016.
Effective Date: 07-22-1998
.
| (A) |
Notwithstanding any
conflicting provision of this chapter or rule adopted by the state board of
pharmacy, a pharmacist may do both of the following with respect to a
prescription issued under section 4723.4810. 4730.432. or 4731.93 of the
Revised Code:
| (1) |
Dispense a drug pursuant
to the prescription; |
| (2) |
Label a drug dispensed pursuant to the prescription
without the name of the individual for whom the drug is intended if the
prescription contains the words "expedited partner therapy" or the letters
"EPT." |
|
| (B) |
For each drug dispensed under this section, the
pharmacist shall provide all of the following information:
| (1) |
Directions for use of the drug; |
| (2) |
Any side effects, adverse reactions, or known
contraindications associated with the drug. |
|
| (C) |
A pharmacist who in good faith dispenses a drug under
this section is not liable for or subject to any of the following:
| (1) |
Damages in any civil action; |
| (2) |
Prosecution in any criminal proceeding; |
| (3) |
Professional disciplinary
action. |
|
| (D) |
This section does not affect the authority of a
pharmacist to distribute information concerning a drug as required by federal
law. |
Added by
131st General Assembly File No. TBD, HB 124, §1,
eff. 3/23/2016.
| (A) |
A pharmacist may dispense naltrexone without a written
or oral prescription from a licensed health professional authorized to
prescribe drugs if all of the following conditions are met:
| (1) |
The pharmacist is able to verify a record of a
prescription for the injectable long-acting or extended-release form of
naltrexone in the name of the patient who is requesting the drug, but the
prescription does not provide for a refill or the time permitted by rules
adopted by the state board of pharmacy for providing refills has
elapsed. |
| (2) |
The pharmacist is unable to obtain authorization to
refill the prescription from the prescriber who issued it or another prescriber
responsible for the patient's care. |
| (3) |
In the exercise of the pharmacist's professional
judgment:
| (a) |
The drug is necessary to continue the patient's
therapy for substance use disorder. |
| (b) |
Failure to dispense the drug to the patient could
result in harm to the health of the patient. |
|
|
| (B) |
Before dispensing naltrexone under this section, the
pharmacist shall offer the patient the choice of receiving either the oral form
or injectable long-acting or extended-release form, but only if both forms of
the drug are available for dispensing at the time of the patient's request or
within one day after the request. |
| (C) |
| (1) |
With respect to naltrexone dispensed in an oral form
under this section, the pharmacist shall not dispense an amount that exceeds a
five-day supply. |
| (2) |
With respect to naltrexone dispensed in an injectable
long-acting or extended-release form under this section, both of the following
apply:
| (a) |
The pharmacist shall exercise professional judgment in
determining the amount of the drug dispensed. |
| (b) |
The pharmacist may administer the drug by injection to
the patient but only in accordance with section 4729.45 of the Revised
Code. |
|
|
| (D) |
A pharmacist who dispenses naltrexone under this
section shall do all of the following:
| (1) |
For one year after the date of dispensing, maintain a
record in accordance with this chapter of the drug dispensed, including the
amount and form dispensed, the original prescription number, the name and
address of the patient and, if the individual receiving the drug is not the
patient, the name and address of that individual; |
| (2) |
Notify the prescriber who issued the prescription
described in division (A)(1) of this section or another prescriber responsible
for the patient's care not later than five days after the drug is
dispensed; |
| (3) |
If applicable, obtain authorization for additional
dispensing from one of the prescribers described in division (D)(2) of this
section. |
|
| (E) |
A pharmacist shall exercise professional judgment in
determining the number of times naltrexone may be dispensed under this section
to the same patient. |
| (F) |
This section does not limit the authority of a
pharmacist to dispense a dangerous drug under section
4729.281
of the Revised Code. |
Added by
132nd General Assembly File No. TBD, SB 119, §1,
eff.
3/20/2019.
Divisions (A) and (B) of
section 4729.01 and section
4729.28 of the Revised Code do
not do any of the following:
| (A) |
Apply to a licensed health professional authorized to prescribe drugs who is
acting within the prescriber's scope of professional practice; |
| (B) |
Prevent a prescriber from personally furnishing the prescriber's patients with
drugs, within the prescriber's scope of professional practice, that seem proper
to the prescriber, as long as the drugs are furnished in accordance with
section 4729.291 of the Revised
Code; |
| (C) |
Apply to an
individual who personally furnishes a supply of naloxone under authority
conferred under section
4723.485,
4730.435, or 4731.941 of the Revised Code or
prevent that individual from personally furnishing the supply of naloxone in
accordance with a protocol established under section 4723.485,
4730.435, or 4731.941 of the Revised
Code; |
| (D) |
Apply to the
sale of oxygen, the sale of peritoneal dialysis solutions, or the sale of drugs
that are not dangerous drugs by a retail dealer, in original packages when
labeled as required by the "Federal Food, Drug, and Cosmetic Act," 52 Stat.
1040 (1938), 21 U.S.C.A. 301, as amended. |
Amended by
133rd General Assembly File No. 166, HB 341, §1,
eff. 12/16/2020.
Amended by
131st General Assembly File No. TBD, HB 4, §1,
eff. 7/16/2015.
Amended by
129th General AssemblyFile No.19, HB 93,
§1, eff.
5/20/2011.
Effective Date:
03-09-1999; 09-23-2004
| (A) |
Except when
provided under section
4731.97 of the Revised Code,
when a licensed health professional authorized to prescribe drugs personally
furnishes drugs to a patient pursuant to division (B) of section
4729.29 of the Revised
Code, the prescriber shall ensure that the drugs are labeled and packaged in
accordance with state and federal drug laws and any rules and regulations
adopted pursuant to those laws. Records of purchase and disposition of all
drugs personally furnished to patients shall be maintained by the prescriber in
accordance with state and federal drug statutes and any rules adopted pursuant
to those statutes. |
| (B) |
When
personally furnishing to a patient RU-486 (mifepristone), a prescriber is
subject to section
2919.123
of the Revised Code. A prescription for RU-486 (mifepristone) shall be in
writing and in accordance with section
2919.123
of the Revised Code. |
| (C) |
| (1) |
Except as provided in divisions (D) and (E) of this section, no prescriber
shall do either of the following:
| (a) |
In any
thirty-day period, personally furnish to or for patients, taken as a whole,
controlled substances in an amount that exceeds a total of two thousand five
hundred dosage units; |
| (b) |
In any
seventy-two-hour period, personally furnish to or for a patient an amount of a
controlled substance that exceeds the amount necessary for the patient's use in
a seventy-two-hour period. |
|
| (2) |
The
state board of pharmacy may impose a fine of not more than five thousand
dollars on a prescriber who fails to comply with the limits established under
division (C)(1) of this section. A separate fine may be imposed for each
instance of failing to comply with the limits. In imposing the fine, the
board's actions shall be taken in accordance with Chapter 119. of the Revised
Code. |
|
| (D) |
None of the
following shall be counted in determining whether the amounts specified in
division (C)(1) of this section have been exceeded:
| (1) |
Methadone personally furnished to patients for the purpose of treating drug
dependence or addiction, if the prescriber meets the conditions specified in
21 C.F.R. 1306.07; |
| (2) |
Buprenorphine personally furnished to patients for the purpose of treating drug
dependence or addiction as part of an opioid treatment program
licensed under section
5119.37 of
the Revised Code. |
| (3) |
Controlled
substances personally furnished to research subjects by a facility conducting
clinical research in studies approved by a hospital-based institutional review
board or an institutional review board accredited by the association for the
accreditation of human research protection programs. |
|
| (E) |
Division (C)(1) of this section does not apply to a prescriber who is a
veterinarian. |
Amended by
132nd General Assembly File No. TBD, HB 111, §1,
eff. 6/29/2019.
Amended by
131st General Assembly File No. TBD, SB 319, §1,
eff. 7/1/2017.
Amended by
131st General Assembly File No. TBD, HB 290, §1,
eff. 4/6/2017.
Amended by
131st General Assembly File No. TBD, HB 4, §1,
eff. 7/16/2015.
Amended by
130th General Assembly File No. TBD, HB 367, §1,
eff. 3/23/2015.
Amended by
129th General AssemblyFile No.156, SB 301,
§1, eff.
3/13/2013.
Added by
129th General AssemblyFile No.19, HB 93,
§1, eff.
5/20/2011.
The state board of
pharmacy shall annually conduct an on-site inspection of
each opioid treatment program
licensed under section 5119.37 of the Revised Code.
Amended by
132nd General Assembly File No. TBD, HB 111, §1,
eff. 6/29/2019.
Added by
131st General Assembly File No. TBD, HB 4, §1,
eff. 7/16/2015.
Sections
4729.27 and
4729.28 of the Revised Code shall
not prohibit a person from selling Paris green and other materials or compounds
used exclusively for spraying and disinfecting when put up in bottles or boxes,
bearing the name of a licensed pharmacist or wholesale dealer, and labeled as
required by section
3719.33 of the Revised Code or
apply to or interfere with the exclusively wholesale business of a dealer.
Effective Date:
07-22-1998 .
Sections
4729.27 and
4729.28 of the Revised Code shall
not apply to, interfere with, or prohibit any person, firm, or corporation from
selling completely denatured alcohol or wood alcohol.
Effective Date:
10-01-1953 .
No person shall have in his possession, or dispense or sell
packages or containers of completely denatured alcohol or wood alcohol
containing five wine gallons or more without having marked or stenciled thereon
the name and address of the seller, the degree of proof of such alcohol, the
formula number, and, in letters of not less than one inch in height, the words,
"Completely Denatured Alcohol" or "Wood Alcohol," as the case may be, and the
names of two or more antidotes for the same. This section, and sections
4729.33 and
3719.33 of the Revised Code shall
not interfere with the transfer of such alcohol from storage tanks to other
packages or containers, nor require the placing of such mark or stencil upon
transportation tanks, nor the registration or placing of mark or stencil upon
fuel tanks, automobile radiators, or similar containers for the final use or
consumption of such alcohol and from which no further distribution thereof is
made.
Effective Date:
10-01-1953 .
No person shall dispense or sell completely denatured alcohol
or wood alcohol in packages containing less than five wine gallons without
having affixed thereto a label on which is printed or stenciled in plain,
legible, red letters of equal prominence on a white background the words,
"Completely Denatured Alcohol" or "Wood Alcohol," as the case may be, and in
addition on the same label in red ink, under the skull and crossbones symbol,
the word "POISON" together with the following statement: "Completely denatured
alcohol, or wood alcohol is a violent poison. It cannot be applied externally
to human or animal tissue without serious injurious results. It cannot be taken
internally without inducing blindness and general physical decay ultimately
resulting in death," and without having stamped, stenciled, or printed upon
such label the name and address of the seller, the degree of proof, and the
formula number thereof. Neither the word "pure" nor the single word "alcohol"
alone shall appear on any label of completely denatured alcohol or wood
alcohol.
Effective Date:
10-01-1953 .
No person shall dispense, sell, or offer for sale completely
denatured alcohol or wood alcohol, or shall display a sign or use a label or
advertise such alcohol having the word "pure" or the single word "alcohol"
alone thereon, or shall fail to state the degree of proof of such alcohol, or
to have the letters displaying or advertising "Completely Denatured Alcohol" or
"Wood Alcohol" plain, legible, and of equal prominence.
Effective Date:
10-01-1953 .
The violation by a pharmacist or other person of any laws of
Ohio or of the United States of America or of any rule of the board of pharmacy
controlling the distribution of a drug of abuse as defined in section
3719.011 of the Revised Code or
the commission of any act set forth in division (A) of section
4729.16 of the Revised Code, is
hereby declared to be inimical, harmful, and adverse to the public welfare of
the citizens of Ohio and to constitute a public nuisance. The attorney general,
the prosecuting attorney of any county in which the offense was committed or in
which the person committing the offense resides, or the state board of pharmacy
may maintain an action in the name of the state to enjoin such person from
engaging in such violation. Any action under this section shall be brought in
the common pleas court of the county where the offense occurred or the county
where the alleged offender resides.
Effective Date:
09-20-1984 .
| (A) |
No place
except a pharmacy licensed as a terminal distributor of dangerous drugs and no
person except a licensed pharmacist shall 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," "medicine," or any of these words or their equivalent, in any
manner. |
| (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.
|
Effective Date:
07-22-1998 .
| (A) |
A retail
seller of dangerous drugs shall disclose price information regarding dangerous
drugs to any person requesting such information. |
| (B) |
Pursuant to division (A) of this section, a retail
seller of dangerous drugs shall disclose price information in the following
ways:
| (1) |
By means of verbal disclosure on
the premises of the retail seller to all persons requesting such information;
|
| (2) |
By means of telephone to any
person having a valid prescription, who identifies himself and requests such
information. |
|
| (C) |
Price
disclosure shall not be required for those schedule II controlled substances
where lives or property could be endangered by such disclosure. |
Effective Date:
10-01-1976 .
A copy of an original prescription may only be filled in
accordance with the rules and regulations adopted by the state board of
pharmacy. Prescriptions received electronically or by word of mouth, telephone,
telegraph, or other means of communication shall be recorded in writing by the
pharmacist and the record so made by the pharmacist shall constitute the
original prescription to be filled by the pharmacist. All prescriptions shall
be preserved on file at the pharmacy for a period of three years, subject to
inspection by the proper officers of the law.
Effective Date:
07-22-1998 .
| (A) |
As used in this section,
"biological product." "finished dosage form." "generically equivalent drug."
and "interchangeable biological product" have the same meanings as in section
3715.01 of the Revised
Code. |
| (B) |
Unless instructed otherwise by the person
receiving the drug pursuant to the prescription, a pharmacist filling a
prescription for a drug prescribed by its brand name may, subject to the following conditions, select a
generically equivalent drug, or. in the
case of a drug that is a biological product, select an interchangeable
biological product:
| (1) |
The
pharmacist shall not select a generically equivalent drug
or interchangeable biological product if
either of the following applies:
| (a) |
In the case of a written or electronic prescription,
including a computer-generated prescription, the prescriber handwrites
or actively causes to display on the prescription
"dispense as written," "D.A.W,"
"do
not substitute." "brand medically necessary." or any other statement or
numerical code that indicates the preserver's intent to prevent substitution.
Such a designation shall not be preprinted or stamped on the prescription, but
a reminder to the prescriber of the designation procedure may be preprinted or
displayed on the prescription form or electronic system the prescriber uses to
issue the prescription. |
| (b) |
In the case of an oral prescription, the prescriber
specifies that the drug
as prescribed is medically necessary
or otherwise indicates the preserver's intent to
prevent substitution. |
|
| (2) |
The
pharmacist shall not select a generically equivalent drug
or interchangeable biological product unless its
price to the patient is less than or equal to the price of the
drug as prescribed. |
| (3) |
The
pharmacist or the pharmacist's agent, assistant, or employee shall inform the
patient or the patient's agent if a generically equivalent drug
or interchangeable biological product is
available at a lower or equal cost and of the person's right to refuse the drug
selected. Division (B)(3) of this section does not apply to any:
| (a) |
Prescription that is billed to any agency, division, or department of this
state which will reimburse the pharmacy; |
| (b) |
Prescriptions for patients of a hospital, nursing home, or similar patient care
facility. |
|
|
| (C) |
| (1) |
Unless the prescriber instructs otherwise, the label for every drug dispensed
shall include information that meets the
following requirements, using abbreviations as
necessary:
| (a) |
Except as provided in divisions (C)(1)(b) and (c) of this
section, the label shall include the dispensed drug's brand name. |
| (b) |
If the drug dispensed has no brand name and is a
generically equivalent drug, the label shall include the generic name of the
drug and the distributor of the finished dosage
form. |
| (c) |
If the drug dispensed has no brand name and is an
interchangeable biological product, the label shall include the name of the
interchangeable biological product, the manufacturer, and if the distributor is
not the same as the manufacturer, the distributor of the finished dosage
form. |
|
| (2) |
When dispensing at retail a
drug that is a generically equivalent drug
or interchangeable biological product for
a drug prescribed by its brand
name, the pharmacist shall indicate on the drug's label or container that
a substitution was made.
|
| (3) |
The labeling requirements established by
divisions (C)(1) and (2) of this section are in
addition to all other labeling requirements of Chapter 3715. of the Revised
Code. |
|
| (D) |
A
pharmacist who selects a drug that is a
generically equivalent drug or interchangeable
biological product pursuant to this section assumes no greater liability
for selecting the dispensed drug than would be incurred in filling a
prescription for a drug prescribed by its brand name. |
| (E) |
The failure of a
prescriber to restrict a prescription by indicating
an intent to prevent substitution pursuant to division
(B)(1)
of this section shall not constitute evidence of the prescriber's negligence
unless the prescriber had reasonable cause to believe that the health condition
of the patient for whom the drug was intended warranted the prescription of a
specific brand name drug and no other. No prescriber shall be liable for civil
damages or in any criminal prosecution arising from the
substitution of a generically equivalent drug
or interchangeable biological product for a
prescribed brand name drug by a pharmacist, unless the prescribed brand name
drug would have reasonably caused the same loss, damage, injury, or
death. |
| (F) |
| (1) |
| (a) |
Except as provided in
division (F)(1)(b) of this section, not later than five business days after a
pharmacist dispenses a drug for which an interchangeable biological product is
available, regardless of whether a substitution is made, the pharmacist or an
individual designated by the pharmacist shall communicate to the prescriber
information identifying the specific biological product that was dispensed,
including the name of the biological product and its manufacturer. |
| (b) |
Communication of the
information is not required when a biological product is dispensed by refilling
a prescription and the product that is dispensed is the same product that was
dispensed when the same prescription was last filled or refilled. |
|
| (2) |
When possible,
communication of the information shall be conveyed by entering the information
into a recordkeeping system that can reasonably be presumed to be
electronically accessible to the prescriber. Such a system may include any of
the following:
| (a) |
An interoperable
electronic medical records system; |
| (b) |
An electronic prescribing system; |
| (c) |
An electronic pharmacy benefit management
system; |
| (d) |
An electronic pharmacy
record system. |
|
| (3) |
Entering the complete information into one of the
recordkeeping systems listed in division (F)(2) of this section is presumed to
provide notice to the prescriber. |
| (4) |
When it is not possible to communicate the information
by using one of the recordkeeping systems listed in division (F)(2) of this
section, communication of the information shall be conveyed by telephone,
facsimile, another form of electronic communication, or any other prevailing
means of communication. |
|
| (G) |
No pharmacist shall knowingly engage in conduct that
is prohibited by division (B) or (C) of this section. |
Amended by
131st General Assembly File No. TBD, SB 319, §1,
eff. 4/6/2017.
Amended by
131st General Assembly File No. TBD, HB 505, §1,
eff. 3/20/2017.
Effective Date:
07-22-1998 .
No licensed pharmacist shall be liable for civil damages or in
any criminal prosecution arising from the dispensing of a drug based upon a
formulary established by a hospital, a health insuring corporation, a long-term
care facility, or the department of rehabilitation and corrections and
requiring the pharmacist to dispense the particular drug.
Effective Date:
07-22-1998 .
| (A) |
As used in this section, "epinephrine autoinjector"
means a device used to administer epinephrine only in a manufactured dosage
form. |
| (B) |
Subject to division (C) of this section, a pharmacist
dispensing an epinephrine autoinjector pursuant to a prescription that
identifies a specific type of epinephrine autoinjector may substitute the
prescribed autoinjector with another epinephrine autoinjector, but only if the
form of epinephrine contained in the autoinjector to be dispensed by
substitution meets either of the following conditions:
| (1) |
It is identical to the form of epinephrine in the type
of autoinjector that was prescribed. |
| (2) |
It is a pharmaceutical equivalent of the form of
epinephrine in the type of autoinjector that was prescribed in that it contains
identical amounts of the identical active ingredients, but not necessarily the
same inactive ingredients; it has been approved by the United States food and
drug administration; and it has not been excluded from recognition as a
pharmaceutical equivalent form of epinephrine by rules adopted under division
(H) of this section. |
|
| (C) |
All of the following conditions apply with respect to
a pharmacist's authority to dispense an epinephrine autoinjector by
substitution:
| (1) |
The pharmacist shall not make the substitution if the
person receiving the autoinjector pursuant to the prescription instructs
otherwise. |
| (2) |
The pharmacist shall not make the substitution if
either of the following applies to the prescription:
| (a) |
In the case of a written or electronic prescription,
including a computer-generated prescription, the prescriber handwrites or
actively causes to display on the prescription "dispense as written," "D.A.W.,"
"do not substitute," "medically necessary as prescribed," or any other
statement or numerical code that indicates the prescriber's intent to prevent
substitution. Such a designation shall not be preprinted or stamped on the
prescription, but a reminder to the prescriber of the designation procedure may
be preprinted or displayed on the prescription form or electronic system the
prescriber uses to issue the prescription. |
| (b) |
In the case of an oral prescription, the prescriber
specifies that the epinephrine autoinjector as prescribed is medically
necessary or otherwise indicates the prescriber's intent to prevent
substitution. |
|
| (3) |
The pharmacist shall not make the substitution unless
its price to the patient is less than or equal to the price of the prescribed
epinephrine autoinjector, except that a pharmacist may substitute an
epinephrine autoinjector with a price to the patient that is greater than the
prescribed autoinjector if the patient specifically requests the more expensive
autoinjector. |
| (4) |
The pharmacist, or a pharmacy intern or agent of the
pharmacist, shall make a reasonable attempt to inform the patient or the
patient's representative if a type of epinephrine autoinjector is available at
a lower or equal cost. |
| (5) |
The pharmacist, or a pharmacy intern or agent of the
pharmacist, shall inform the patient or the patient's representative of the
person's right to refuse substitution of the prescribed epinephrine
autoinjector. |
|
| (D) |
| (1) |
Unless the prescriber instructs otherwise, the label
for every epinephrine autoinjector dispensed shall include the epinephrine
autoinjector's name, if any, and the distributor of the autoinjector.
Abbreviations may be used as necessary. |
| (2) |
When dispensing at retail an epinephrine autoinjector
by substitution, the pharmacist shall indicate on the autoinjector's label or
container that a substitution was made. |
| (3) |
The labeling requirements established by divisions
(D)(1) and (2) of this section are in addition to all other labeling
requirements as required in rules adopted by the state board of
pharmacy. |
|
| (E) |
When a pharmacist dispenses an epinephrine
autoinjector by substitution, the pharmacist or a pharmacy intern shall provide
to the person receiving the device instruction on the proper method of
administering epinephrine with the device, except that the instruction does not
have to be provided if the person is receiving the same device that was
dispensed when the person last received the device by having a prescription
filled or refilled. |
| (F) |
A pharmacist who dispenses an epinephrine autoinjector
pursuant to this section assumes no greater liability for dispensing the
autoinjector by substitution than would be incurred for dispensing the
autoinjector identified on the prescription. |
| (G) |
The failure of a prescriber to restrict a prescription
by indicating an intent to prevent substitution pursuant to this section shall
not constitute evidence of the prescriber's negligence unless the prescriber
had reasonable cause to believe that the health condition of the patient for
whom the epinephrine autoinjector was intended warranted the prescription of a
specific type of epinephrine autoinjector and no other. No prescriber shall be
liable for civil damages or in any criminal prosecution arising from a
pharmacist dispensing an epinephrine autoinjector by substitution, unless the
type of autoinjector prescribed would have reasonably caused the same loss,
damage, injury, or death. |
| (H) |
The state board of pharmacy may adopt rules in
accordance with Chapter 119. of the Revised Code to implement this section. The
rules may specify forms of epinephrine that are not to be recognized as
pharmaceutical equivalents of other forms of epinephrine for purposes of this
section. |
| (I) |
No pharmacist shall knowingly engage in conduct that
is prohibited by division (C) or (D) of this section. |
Added by
132nd General Assembly File No. TBD, HB 101, §1,
eff. 4/8/2019.
| (A) |
As used in
this section:
| (1) |
"Certified nurse practitioner," "certified
nurse-midwife," "clinical nurse specialist," and "standard care arrangement"
have the same meanings as in section
4723.01 of the Revised
Code. |
| (2) |
"Collaborating physician" means a physician who has
entered into a standard care arrangement with a clinical nurse specialist,
certified nurse-midwife, or certified nurse practitioner. |
| (3) |
"Physician" means an individual authorized under
Chapter 4731. of the Revised Code to practice medicine and surgery or
osteopathic medicine and surgery. |
| (4) |
"Physician assistant" means an individual who is
licensed to practice as a physician assistant 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. |
| (5) |
"Supervising physician" means a physician who has
entered into a supervision agreement with a physician assistant under section
4730.19 of the Revised
Code. |
|
| (B) |
Subject to division (C) of this section, one or
more pharmacists may enter into a consult agreement with one or more
of the following
practitioners:
| (2) |
Physician assistants, if entering into a consult
agreement is authorized by one or more supervising physicians; |
| (3) |
Clinical nurse specialists, certified nurse-midwives,
or certified nurse practitioners, if entering into a consult agreement is
authorized by one or more collaborating physicians. |
|
| (C) |
Before entering into a consult agreement, all of
the following conditions must be met:
| (1) |
Each practitioner must have an ongoing
practitioner-patient relationship with each patient
whose drug therapy is to be managed. |
| (2) |
The
diagnosis for which each patient has been prescribed drug therapy
must be
within the scope of each practitioner's practice. |
| (3) |
Each pharmacist must have training and experience related to the
particular diagnosis for which drug therapy is to
be prescribed. |
|
| (D) |
With respect to
consult agreements, all of the following apply:
| (1) |
Under a consult agreement, a pharmacist is authorized to do both of the
following, but only to the extent specified in the agreement, this section, and
the rules adopted under this section:
| (a) |
Manage drug therapy for treatment of specified diagnoses or diseases for each
patient who is subject to the agreement, including all of the following:
| (i) |
Changing the duration of treatment for the current drug therapy; |
| (ii) |
Adjusting a drug's strength, dose, dosage form, frequency of administration, or
route of administration; |
| (iii) |
Discontinuing the use of a drug; |
| (iv) |
Administering a drug; |
| (v) |
Notwithstanding the definition of "licensed health professional authorized to
prescribe drugs" in section
4729.01 of the Revised Code,
adding a drug to the patient's drug therapy. |
|
| (b) |
| (i) |
Order laboratory and diagnostic tests, including
blood and urine tests , that are related to the drug
therapy being managed, and evaluate the results of the
tests that are ordered. |
| (ii) |
A
pharmacist's authority to evaluate test results under division
(D)(1)(b)(i) of this section does not authorize the
pharmacist to make a diagnosis. |
|
|
| (2) |
| (a) |
A
consult agreement, or the portion of the agreement that applies to a particular
patient, may be terminated by any of the following:
| (i) |
A
pharmacist who entered into the agreement; |
| (ii) |
A
practitioner who entered into the agreement; |
| (iii) |
A
patient whose drug therapy is being managed; |
| (iv) |
An
individual who consented to the treatment on behalf of a patient or an
individual authorized to act on behalf of a patient. |
|
| (b) |
The
pharmacist or practitioner who receives the notice of a
patient's termination of the agreement shall provide written notice to every
other pharmacist or practitioner who is a party to the agreement. A
pharmacist or practitioner who terminates a consult agreement
with regard to one or more patients shall provide written notice to all other
pharmacists and practitioners who entered into the agreement and
to each individual who consented to treatment under the agreement. The
termination of a consult agreement with regard to one or more patients shall be
recorded by the pharmacist and practitioner in the medical records of each
patient to whom the termination applies. |
|
| (3) |
A
consult agreement shall be made in writing and shall include all of the
following:
| (a) |
The
diagnoses and diseases being managed under the agreement, including whether
each disease is primary or comorbid; |
| (b) |
A
description of the drugs or drug categories the agreement involves; |
| (c) |
A
description of the procedures, decision criteria, and plan the pharmacist is to
follow in acting under a consult agreement; |
| (d) |
A
description of how the pharmacist is to comply with divisions
(D)(5) and (6) of this section. |
|
| (4) |
The
content of a consult agreement shall be communicated to each patient whose drug
therapy is managed under the agreement. |
| (5) |
A
pharmacist acting under a consult agreement shall maintain a record of each
action taken for each patient whose drug therapy is managed under the
agreement. |
| (6) |
Communication between a pharmacist and practitioner acting under a consult agreement shall
take place at regular intervals specified by the primary
practitioner acting under the agreement. The agreement
may include a requirement that a pharmacist send a consult report to each
consulting practitioner. |
| (7) |
A
consult agreement is effective for two years and may be renewed if the
conditions specified in division (C) of this section continue to be
met. |
| (8) |
A consult
agreement does not permit a pharmacist to manage drug therapy prescribed by a
practitioner who has not entered into the
agreement. |
|
| (E) |
The state board of pharmacy, state medical board, and
board of nursing shall each adopt rules as follows for its license holders
establishing standards and procedures for entering into a consult
agreement and managing a patient's drug therapy under a consult agreement:
| (1) |
The state board of pharmacy, in consultation with the
state medical board and board of nursing, shall adopt rules to be followed by
pharmacists. |
| (2) |
The state medical board, in consultation with the
state board of pharmacy, shall adopt rules to be followed by physicians and
rules to be followed by physician assistants. |
| (3) |
The board of nursing, in consultation with the state
board of pharmacy and state medical board, shall adopt rules to be followed by
clinical nurse specialists, certified nurse-midwives, and certified nurse
practitioners. The boards shall specify in the rules any categories
of drugs or types of diseases for which a consult agreement may not be
established. Each board may adopt any other rules it considers
necessary for the implementation and administration of this section. All rules
adopted under this section shall be adopted in accordance with
Chapter 119. of the Revised Code.
|
|
| (F) |
| (1) |
Subject to division (F)(2) of this section, both of the following
apply:
| (a) |
A pharmacist
acting in accordance with a consult agreement regarding a
practitioner's change in a drug for a patient whose
drug therapy the pharmacist is managing under the agreement is not liable in
damages in a tort or other civil action for injury or loss to person or
property allegedly arising from the change. |
| (b) |
A
practitioner acting in accordance with a consult
agreement regarding a pharmacist's change in a drug for a patient whose drug
therapy the pharmacist is managing under a consult agreement is not liable in
damages in a tort or other civil action for injury or loss to person or
property allegedly arising from the change unless the
practitioner authorized the specific change. |
|
| (2) |
Division
(F)(1) of this section does not limit a
practitioner's or pharmacist's liability in damages in
a tort or other civil action for injury or loss to person or property allegedly
arising from actions that are not related to the practitioner's or pharmacist's change in a drug for a
patient whose drug therapy is being managed under a consult
agreement. |
|
Amended by
133rd General Assembly File No. TBD, HB 203, §1,
eff. 12/16/2020.
Amended by
131st General Assembly File No. TBD, HB 116, §1,
eff. 8/31/2016.
Amended by
131st General Assembly File No. TBD, HB 188, §1,
eff. 3/23/2016.
Effective Date: 02-12-2001
.
| (A) |
In the case of a
prescription that authorizes a drug to be dispensed by refilling the
prescription one or more times and the total quantity or amount of the drug
that may be dispensed by filling and refilling the prescription does not exceed
a ninety-day supply of the drug, a pharmacist who is filling or refilling the
prescription may dispense a quantity or amount of the drug that varies from the
quantity or amount of the drug that otherwise would be dispensed pursuant to
the prescription, but only if all of the following conditions are met:
| (1) |
The action taken by the pharmacist does not result in
a quantity or amount of the drug being dispensed that exceeds the total
quantity or amount that may be dispensed by filling and refilling the
prescription. |
| (2) |
The prescription is for
one of the following:
| (a) |
A maintenance drug to be
taken on a regular, recurring basis to treat a chronic condition ; |
| (b) |
A drug to be taken on a
regular, recurring basis to prevent disease; |
|
| (3) |
If the prescription is for a maintenance drug, the
patient has used an initial thirty-day supply of the drug, or a ninety-day
supply of the drug has previously been prescribed to the patient, and the
pharmacist determines, after consulting with the patient, that the drug has
stabilized the patient's condition. |
| (4) |
The prescription is not for a controlled substance, as
defined in section 3719.01 of the Revised
Code. |
| (5) |
The prescriber did not
include "dispense as written" or another phrase having a similar meaning on the
prescription, or, when issuing a prescription electronically or orally, the
prescriber did not specify that the quantity or amount of the drug to be
dispensed may not vary from the quantity or amount specified in the
prescription. |
| (6) |
In the exercise of the
pharmacist's professional judgment after consulting with the patient, taking
the action authorized by this section is appropriate for the patient. |
|
| (B) |
This section does not
require a health care insurer, government health care program, pharmacy benefit
manager, or other entity that offers health benefit plans to provide coverage
for a drug in a manner that is inconsistent with the patient's benefit
plan. |
Added by
131st General Assembly File No. TBD, HB 285, §1,
eff. 4/6/2017.
| (A) |
| (1) |
A
pharmacist licensed under this chapter who meets the requirements of division
(B) of this section, and 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 do any of the following:
| (a) |
Administer
immunizations for influenza to individuals who are seven years of age or
older; |
| (b) |
Only
pursuant to a prescription, administer to individuals who are seven years of
age or older but not more than thirteen years of age any of the immunizations
included in division (A)(2) of this section; |
| (c) |
Administer to individuals who are thirteen years of age or older any of the
immunizations included in division (A)(2) of this section. |
|
| (2) |
A
pharmacist or pharmacy intern may administer in accordance with divisions
(A)(1)(b) and (c) of this section either of the following:
| (a) |
Any
immunization that on March 19, 2015, is included
in either of the following immunization schedules recommended by the advisory
committee on immunization practices of the centers for disease control and
prevention in the United States department of health and human services:
| (i) |
The
recommended immunization schedule for persons aged zero through eighteen
years; |
| (ii) |
The
recommended adult immunization schedule. |
|
| (b) |
Any
other immunization specified in rules adopted under division (E)(1)(d) of this
section. |
|
| (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 pursuant to 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
meets the
requirements established in rules adopted under this section for such
courses ; |
| (2) |
Receive and
maintain certification to perform basic life-support procedures by successfully
completing a basic life-support training course that
is certified by the American red cross or American heart association
or approved by the state board of
pharmacy; |
| (3) |
Practice in
accordance with a protocol that meets the requirements of
division (C) of this section. |
|
| (C) |
All of the
following apply with respect to the protocol required by division (B)(3)
of this section:
| (1) |
The protocol shall be established by a physician
authorized under Chapter 4731. of the Revised Code to practice medicine and
surgery or osteopathic medicine and surgery. |
| (2) |
The protocol shall specify a definitive set of
treatment guidelines and the locations at which a pharmacist or pharmacy intern
may engage in the administration of immunizations. |
| (3) |
The protocol shall satisfy the requirements
established in rules adopted under this section for protocols. |
| (4) |
The protocol shall include provisions for
implementation of the following requirements:
| (a) |
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 rules adopted under this section establishing
requirements for 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. |
| (b) |
For each
immunization administered to an individual by a pharmacist or pharmacy intern,
other than an immunization for influenza administered to an individual eighteen
years of age or older, the pharmacist or pharmacy intern 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. |
| (c) |
For each
immunization administered by a pharmacist or pharmacy intern to an individual
younger than eighteen years of age pursuant to division (A)(1) of this section,
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 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 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 the following:
| (a) |
Requirements for courses in administration of
immunizations, including requirements that are
consistent with any standards established for such courses by the centers for
disease control and prevention; |
| (b) |
Requirements for protocols to be followed by
pharmacists and pharmacy interns in engaging 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
immunizations to an individual younger than eighteen years of age pursuant to
division (A)(1) of this section; |
| (d) |
Provisions specifying any immunizations that may be administered under division
(A)(2)(b) of this section. |
|
| (2) |
Prior to adopting rules regarding requirements for 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 rules specifying any immunizations that may be administered
under division (A)(2)(b) of this section, the state board of pharmacy shall
consult with the state medical board. |
|
| (F) |
In
addition to the rules it adopts under division (E) of this section, the
state board of
pharmacy may adopt rules that change the immunizations authorized by
division (A)(2)(a) of this section to reflect changes in the recommendations of
the advisory committee on immunization practices. The rules shall be adopted in
accordance with Chapter 119. of the Revised
Code. |
Amended by
132nd General Assembly File No. TBD, HB 101, §1,
eff. 4/8/2019.
Amended by
132nd General Assembly File No. TBD, HB 541, §1,
eff. 3/22/2019.
Amended by
130th General Assembly File No. TBD, HB 394, §1,
eff. 3/19/2015.
Effective Date:
06-26-2003; 2007 SB58 08-30-2007; 2008 HB283 09-12-2008 .
Repealed by
131st General Assembly File No. TBD, SB 319, §2,
eff. 4/6/2018.
Amended by
128th General AssemblyFile No.9, HB 1,
§101.01, eff.
10/16/2009.
Amended by
128th General Assemblych.9, HB 2,
§101.01, eff.
4/1/2009.
Effective Date: 2008 SB203
04-08-2009
| (A) |
As used in
this section:
| (1) |
"Home health
agency" has the same meaning as in section
3701.881
of the Revised Code. |
| (2) |
"Hospice
care program" and "hospice patient" have the same meanings as in section
3712.01
of the Revised Code. |
|
| (B) |
With regard to a dangerous drug that is indicated for the treatment of cancer
or a cancer-related illness, must be administered intravenously or by
subcutaneous injection, and cannot reasonably be self-administered by the
patient to whom the drug is prescribed or by an individual assisting the
patient with the self-administration, a pharmacist shall not dispense the drug by
delivering the drug directly to any of the following or causing the drug to be
delivered directly to any of the following:
| (2) |
The
patient's representative, which may include the patient's guardian or a family
member or friend of the patient; |
| (3) |
The
patient's private residence unless any of the following is the case:
| (a) |
The
patient's private residence is a nursing home, residential care facility,
rehabilitation facility, or similar institutional facility or heath care
facility. |
| (b) |
If the
patient is an adult and a hospice patient or client of a home health agency,
the patient, the licensed health professional authorized to prescribe drugs who
prescribed the drug to the patient, or an employee or agent of the prescriber
has notified the pharmacist that the patient is a hospice patient or client of a home
health agency and an employee or agent of the hospice care program or home
health agency will be administering the drug to the patient. |
| (c) |
If
the patient is a minor and a hospice patient or client of a home health agency,
either of the following has notified the pharmacist that the patient is a client
of a home health agency and an employee or agent of the hospice care program or
home health agency will be administering the drug to the patient:
| (i) |
The
licensed health professional authorized to prescribe drugs who prescribed the
drug to the patient or an employee or agent of the prescriber; |
| (ii) |
The parent, guardian, or other person who has care or charge of the patient and
is authorized to consent to medical treatment on behalf of the
patient. |
|
|
|
Amended by
132nd General Assembly File No. TBD, HB 101, §1,
eff. 4/8/2019.
Added by
â.o">130th General Assembly File No. TBD, SB 230, §1,
eff. 9/17/2014.
| (A) |
As used in
this section:
| (1) |
"Board of
health" means a board of health of a city or general health district or an
authority having the duties of a board of health under section
3709.05 of the Revised
Code. |
| (2) |
"Physician"
means an individual authorized under Chapter 4731. of the Revised Code to
practice medicine and surgery, osteopathic medicine and surgery, or podiatric
medicine and surgery. |
|
| (B) |
If
use of the protocol developed pursuant to rules adopted under division (G) of
this section has been authorized under section
3707.56 or
4731.942 of the Revised Code, a
pharmacist or pharmacy intern may dispense naloxone without a prescription to
either of the following in accordance with that protocol:
| (1) |
An
individual who there is reason to believe is experiencing or at risk of
experiencing an opioid-related overdose; |
| (2) |
A
family member, friend, or other individual in a position to assist an
individual who there is reason to believe is at risk of experiencing an
opioid-related overdose. |
|
| (C) |
A
pharmacist or pharmacy intern who dispenses naloxone under this section shall
instruct the individual to whom naloxone is dispensed to summon emergency
services as soon as practicable either before or after administering
naloxone. |
| (D) |
A pharmacist
may document on a prescription form the dispensing of naloxone by the
pharmacist or a pharmacy intern supervised by the pharmacist. The form may be
assigned a number for record-keeping purposes. |
| (E) |
This section does not affect the authority of a pharmacist or pharmacy intern
to fill or refill a prescription for naloxone. |
| (F) |
A
board of health that in good faith authorizes a pharmacist or pharmacy intern
to dispense naloxone without a prescription in accordance with a protocol
developed pursuant to rules adopted under division (G) of this section is not
liable for or subject to any of the following for any action or omission of the
individual to whom the naloxone is dispensed: damages in any civil action,
prosecution in any criminal proceeding, or professional disciplinary action. A physician who in good
faith authorizes a pharmacist or pharmacy intern to dispense naloxone without a
prescription in accordance with a protocol developed pursuant to rules adopted
under division (G) of this section is not liable for or subject to any of the
following for any action or omission of the individual to whom the naloxone is
dispensed: damages in any civil action, prosecution in any criminal proceeding,
or professional disciplinary action. A pharmacist or pharmacy
intern authorized under this section to dispense naloxone without a
prescription who does so in good faith is not liable for or subject to any of
the following for any action or omission of the individual to whom the naloxone
is dispensed: damages in any civil action, prosecution in any criminal
proceeding, or professional disciplinary action.
|
| (G) |
The
state board of pharmacy shall, after consulting with the department of health
and state medical board, adopt rules to implement this section. The rules shall
specify a protocol under which pharmacists or pharmacy interns may dispense
naloxone without a prescription. All rules adopted under
this section shall be adopted in accordance with Chapter 119. of the Revised
Code.
|
| (H) |
| (1) |
The state board of pharmacy shall develop a program to
educate all of the following about the authority of a pharmacist or pharmacy
intern to dispense naloxone without a prescription:
| (a) |
Holders of licenses issued under this chapter that
engage in the sale or dispensing of naloxone pursuant to this
section; |
| (b) |
Registered pharmacy technicians, certified pharmacy
technicians, and pharmacy technician trainees registered under this chapter who
engage in the sale of naloxone pursuant to this section; |
| (c) |
Individuals who are not licensed or registered under
this chapter but are employed by license holders described in division
(H)(1)(a) of this section. |
|
| (2) |
As part of the program, the board also shall educate
the license holders, pharmacy technicians, and employees described in division
(H)(1) of this section about maintaining an adequate supply of naloxone and
methods for determining a pharmacy's stock of the drug. |
| (3) |
The board may use its web site to share information
under the program. |
|
Amended by
133rd General Assembly File No. 166, HB 341, §1,
eff. 12/16/2020.
Amended by
132nd General Assembly File No. TBD, SB 119, §1,
eff. 3/20/2019.
Added by
131st General Assembly File No. TBD, HB 4, §1,
eff. 7/16/2015.
| (A) |
As used in
this section, "physician" means an individual authorized under Chapter 4731. of
the Revised Code to practice medicine and surgery or osteopathic medicine and
surgery. |
| (B) |
| (1) |
Subject to division (C) of this section, a pharmacist licensed under this
chapter may administer by injection any of the following drugs as long as the
drug that is to be administered has been prescribed by a physician and the
individual to whom the drug was prescribed has an ongoing physician-patient
relationship with the physician:
| (a) |
An addiction treatment
drug administered in a long-acting or extended-release form; |
| (b) |
An
antipsychotic drug administered in a long-acting or extended-release
form; |
| (c) |
Hydroxyprogesterone caproate; |
| (d) |
Medroxyprogesterone acetate; |
|
| (2) |
As part of
engaging in the administration of drugs by injection pursuant to this section,
a pharmacist may administer epinephrine or diphenhydramine, or both, to an
individual in an emergency situation resulting from an adverse reaction to a
drug administered by the pharmacist. |
|
| (C) |
To
be authorized to administer drugs pursuant to this section, a pharmacist must
do all of the following:
| (1) |
Successfully
complete a course in the administration of drugs that satisfies the
requirements established by the state board of pharmacy in rules adopted under
division (H)(1)(a) of this section; |
| (2) |
Receive and maintain certification to perform basic life-support procedures by
successfully completing a basic life-support training course that is certified
by the American red cross or American heart association or approved by the
state board of pharmacy; |
| (3) |
Practice in accordance with a protocol that meets the requirements of division
(F) of this section. |
|
| (D) |
Each time a pharmacist administers a drug pursuant to this section, the
pharmacist shall do all of the following:
| (1) |
Obtain permission in accordance with the procedures specified in rules adopted
under division (H) of this section and comply with the following requirements:
| (a) |
Except as provided in division (D)(1)(c) of this section, for each drug
administered by a pharmacist to an individual who is eighteen years of age or
older, the pharmacist shall obtain permission from the individual. |
| (b) |
For
each drug administered by a pharmacist to an individual who is under eighteen
years of age, the pharmacist shall obtain permission from the individual's
parent or other person having care or charge of the individual. |
| (c) |
For
each drug administered by a pharmacist to an individual who lacks the capacity
to make informed health care decisions, the pharmacist shall obtain permission
from the person authorized to make such decisions on the individual's
behalf. |
|
| (2) |
In the case
of an addiction treatment drug described in division
(B)(1)(a) of this section, obtain in accordance
with division (E) of this section test results indicating that it is
appropriate to administer the drug to the individual if either of the following
is to be administered:
| (a) |
The initial
dose of the drug; |
| (b) |
Any
subsequent dose, if the administration occurs more than thirty days after the
previous dose of the drug was administered. |
|
| (3) |
Observe the individual to whom the drug is administered to determine whether
the individual has an adverse reaction to the drug; |
| (4) |
Notify the physician who prescribed the drug that the drug has been
administered to the individual. |
|
| (E) |
A
pharmacist may obtain the test results described in division (D)(2) of this
section in either of the following ways:
| (2) |
By ordering
blood and urine tests for the individual to whom the drug is to be administered. If a pharmacist orders
blood and urine tests, the pharmacist shall evaluate the results of the tests
to determine whether they indicate that it is appropriate to administer the
drug. A pharmacist's authority to evaluate test
results under this division does not authorize the pharmacist to make a
diagnosis.
|
|
| (F) |
All
of the following apply with respect to the protocol required by division (C)(3)
of this section:
| (1) |
The protocol
must be established by a physician who has a scope of practice that includes
treatment of the condition for which the individual has been prescribed the
drug to be administered. |
| (2) |
The
protocol must satisfy the requirements established in rules adopted under
division (H)(1)(b) of this section. |
| (3) |
The
protocol must do all of the following:
| (a) |
Specify a definitive set of treatment guidelines; |
| (b) |
Specify the locations at which a pharmacist may engage in the administration of
drugs pursuant to this section; |
| (c) |
Include provisions for implementing the requirements of division (D) of this
section, including for purposes of division (D)(3) of this section provisions
specifying the length of time and location at which a pharmacist must observe
an individual who receives a drug to determine whether the individual has an
adverse reaction to the drug; |
| (d) |
Specify procedures to be followed by a pharmacist when administering
epinephrine, diphenhydramine, or both, to an individual who has an adverse
reaction to a drug administered by the pharmacist. |
|
|
| (G) |
A pharmacist
shall not do either of the following:
| (1) |
Engage in the administration of drugs pursuant to this section unless the
requirements of division (C) of this section have been met; |
| (2) |
Delegate to any person the pharmacist's authority to engage in the
administration of drugs pursuant to this section. |
|
| (H) |
| (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
include all of the following:
| (a) |
Requirements
for courses in administration of drugs; |
| (b) |
Requirements for protocols to be followed by pharmacists in administering drugs
pursuant to this section; |
| (c) |
Procedures to be followed by a pharmacist in obtaining permission to administer
a drug to an individual. |
|
| (2) |
The
board shall consult with the state medical board before adopting rules
regarding requirements for protocols under this section. |
|
Amended by
133rd General Assembly File No. 166, HB 341, §1,
eff. 12/16/2020.
Amended by
132nd General Assembly File No. TBD, HB 101, §1,
eff. 4/8/2019.
Added by
131st General Assembly File No. TBD, SB 332, §1,
eff. 4/6/2017.
| (A) |
As used in
this section, "opioid analgesic,"
"schedule
III," "schedule IV," and "schedule V" have the same
meanings as in section
3719.01
of the Revised Code. |
| (B) |
Except as
provided in division (C) of this section or in any rules adopted under
this section, all of the
following apply with respect to a prescription for an opioid analgesic to be
used by an individual on an outpatient basis:
| (1) |
A
pharmacist shall not dispense
the opioid analgesic in an
amount that exceeds a ninety-day supply, as determined according to the
prescription's directions for use of the drug, regardless of whether the
prescription was issued for a greater amount. |
| (2) |
Except as provided in division (B)(3) of this section, a pharmacist shall not dispense the opioid analgesic if more than fourteen days have elapsed
since the prescription was issued. |
| (3) |
| (a) |
A pharmacist may dispense the opioid analgesic after
more than fourteen days have elapsed since the prescription was issued if, on
the date the prescription was issued, the prescriber issued only one
prescription for the drug to the patient and both of the following apply:
| (i) |
The prescriber provided written instructions on the
prescription specifying the earliest date on which the prescription may be
filled. |
| (ii) |
Not more than fourteen days have elapsed since the
date described in division (B)(3)(a)(i) of this section. |
|
| (b) |
A
pharmacist may dispense
the opioid analgesic after more
than fourteen days have elapsed since the prescription was issued if the
prescription is one of multiple prescriptions for the drug issued by a single
prescriber to the patient on a single day and all of the
following apply:
| (i) |
When
combined, the prescriptions do not authorize the patient to receive an amount
that exceeds a ninety-day supply of the drug, as determined according to the
prescriptions' directions for use of the drug. |
| (ii) |
The prescriber
has provided written instructions on the prescription
specifying the earliest date on which the prescription
may be filled. |
| (iii) |
Not more than
fourteen days have elapsed since the date described in division (B)(3)(b)(ii) of this
section. |
|
| (c) |
A pharmacist may dispense the opioid analgesic by
refilling the prescription for the opioid analgesic after more than fourteen
days have elapsed since the prescription was issued if the opioid analgesic is
included in schedule III, IV, or V, as defined in section
3719.01
of the Revised Code. |
| (d) |
If the prescription for the opioid analgesic was
partially filled within the applicable fourteen-day period described in
division (B)(2), (B)(3)(a), or (B)(3)(b) of this section, a pharmacist may
dispense the remaining amount of the opioid analgesic after more than fourteen
days have elapsed since the prescription was issued. |
|
|
| (C) |
Division (B)
of this section does not apply in either of the following
circumstances:
| (1) |
When an opioid analgesic is to be delivered outside this state by mail, parcel post, or common
carrier to a patient who resides outside this state; |
| (2) |
When an opioid analgesic is to be used as part of an
individual's treatment for opioid dependence or addiction. |
|
| (D) |
The state
board of pharmacy may adopt rules establishing an amount that is less than the
ninety-day supply described in division (B)(1) of this section or a period that
is less than the fourteen-day periods described in divisions
(B)(2), (B)(3)(a), and (B)(3)(b) of this section.
The rules shall be adopted in accordance with Chapter 119. of the Revised
Code. |
Amended by
132nd General Assembly File No. TBD, SB 229, §1,
eff. 3/22/2019.
Added by
131st General Assembly File No. TBD, SB 319, §1,
eff. 4/6/2017.
| (A) |
As used in this section:
| (1) |
"Board of health" means a board of health of a city or
general health district or an authority having the duties of a board of health
under section
3709.05
of the Revised Code. |
| (2) |
"Physician" means an individual authorized under
Chapter 4731. of the Revised Code to practice medicine and surgery, osteopathic
medicine and surgery, or podiatric medicine and surgery. |
|
| (B) |
If use of a protocol that has been developed pursuant
to rules adopted under division (G) of this section has been authorized under
section 3707.60 or 4731.961 of the Revised Code, a pharmacist or pharmacy
intern may dispense epinephrine without a prescription in accordance with that
protocol to either of the following individuals so long as the individual is at
least eighteen years of age:
| (1) |
An individual who there is reason to believe is
experiencing or at risk of experiencing anaphylaxis if the pharmacy affiliated
with the pharmacist or intern has a record of previously dispensing epinephrine
to the individual in accordance with a prescription issued by a licensed health
professional authorized to prescribe drugs; |
| (2) |
An individual acting on behalf of a qualified entity,
as defined in section
3728.01 of the Revised
Code. |
|
| (C) |
| (1) |
A pharmacist or pharmacy intern who dispenses
epinephrine under this section shall instruct the individual to whom
epinephrine is dispensed to summon emergency services as soon as practicable
either before or after administering epinephrine. |
| (2) |
A pharmacist or pharmacy intern who dispenses
epinephrine to an individual identified in division (B)(1)(a) of this section
shall provide notice of the dispensing to the individual's primary care
provider, if known, or to the prescriber who issued the individual the initial
prescription for epinephrine. |
|
| (D) |
A pharmacist may document the dispensing of
epinephrine by the pharmacist or a pharmacy intern supervised by the pharmacist
on a prescription form. The form may be assigned a number for record-keeping
purposes. |
| (E) |
This section does not affect the authority of a
pharmacist or pharmacy intern to fill or refill a prescription for
epinephrine. |
| (F) |
A board of health that in good faith authorizes a
pharmacist or pharmacy intern to dispense epinephrine without a prescription in
accordance with a protocol developed pursuant to rules adopted under division
(G) of this section is not liable for or subject to any of the following for
any action or omission of the individual to whom the epinephrine is dispensed:
damages in any civil action, prosecution in any criminal proceeding, or
professional disciplinary action. A
physician who in good faith authorizes a pharmacist or pharmacy intern to
dispense epinephrine without a prescription in accordance with a protocol
developed pursuant to rules adopted under division (G) of this section is not
liable for or subject to any of the following for any action or omission of the
individual to whom the epinephrine is dispensed: damages in any civil action,
prosecution in any criminal proceeding, or professional disciplinary
action. A
pharmacist or pharmacy intern authorized under this section to dispense
epinephrine without a prescription who does so in good faith is not liable for
or subject to any of the following for any action or omission of the individual
to whom the epinephrine is dispensed: damages in any civil action, prosecution
in any criminal proceeding, or professional disciplinary action.
|
| (G) |
Not later than ninety days after the effective date of
this section, the state board of pharmacy shall, after consulting with the
state medical board, adopt rules to implement this section. The rules shall
specify minimum requirements for protocols established by physicians under
which pharmacists or pharmacy interns may dispense epinephrine without a
prescription. All rules adopted under this section shall be adopted in
accordance with Chapter 119. of the Revised Code.
|
Added by
132nd General Assembly File No. TBD, HB 101, §1,
eff. 4/8/2019.
When filling a prescription, if a pharmacist, pharmacy
intern, or terminal distributor of dangerous drugs has information indicating
that the cost-sharing amount required by the patient's health benefit plan
exceeds the amount that may otherwise be charged for the same drug, both of the
following apply:
| (A) |
The pharmacist, pharmacy intern, or terminal
distributor shall provide this information to the patient. |
| (B) |
The patient shall not be charged the higher
amount. |
Added by
133rd General Assembly File No. TBD, HB 166, §101.01, eff.
10/17/2019.
| (A) |
The
state board of pharmacy may enter into contracts with private entities under
which the entities process applications and renewal applications for wholesale
distributors of dangerous drugs and terminal distributors of dangerous drugs.
When entering into these contracts, the board shall give preference to entities
that are Ohio-based companies. Any revenue received by the board from contracts
entered into under this section shall be deposited into the state treasury to
the credit of the occupational licensing and regulatory fund. The money may be
used for any purpose determined by the board to be relevant to its duties,
including the establishment and maintenance of a drug database pursuant to
section 4729.75 of the Revised Code.
|
| (B) |
No enforcement or disciplinary authority granted to
the board shall be transferred to a private entity through a contract entered
into under this section. |
Added by
129th General AssemblyFile No.28, HB 153,
§101.01, eff.
9/29/2011.
Effective Date: 12-31-1971
.
| (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 :
| (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 either of the following:
| (a) |
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; |
| (b) |
A facility,
clinic, or other location that provides office-based opioid treatment but is
not licensed as a terminal distributor of dangerous drugs with an office-based
opioid treatment classification issued under section
4729.553 of the Revised Code if
such a license is required by that section. |
|
| (2) |
A
business entity described in division (A)(2) or (3) of section
4729.541 of the Revised Code
that is, or is operating, either of the following:
| (a) |
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; |
| (b) |
A facility,
clinic, or other location that provides office-based opioid treatment without a
license as a terminal distributor of dangerous drugs with an office-based
opioid treatment classification issued under section
4729.553 of the Revised Code if
such a license is required by that section. |
|
|
| (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., and 4741. of the Revised Code; |
| (iii) |
Any of the persons identified in divisions (A)(1) to (5) and (13) 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 (12) 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 for use in accordance with
section 3313.7110 of the Revised Code
and may distribute inhalers for use in accordance with section
3313.7113 of the Revised
Code. |
Amended by
133rd General Assembly File No. 166, HB 341, §1,
eff. 12/16/2020.
Amended by
132nd General Assembly File No. TBD, SB 229, §1,
eff. 3/22/2019.
Amended by
132nd General Assembly File No. TBD, HB 49, §101.01, eff.
9/29/2017.
Amended by
131st General Assembly File No. TBD, SB 319, §1,
eff. 4/6/2017.
Amended by
131st General Assembly File No. TBD, HB 290, §1,
eff. 4/6/2017.
Amended by
131st General Assembly File No. TBD, HB 200, §1,
eff. 9/8/2016.
Amended by
131st General Assembly File No. TBD, HB 39, §1,
eff. 2/1/2016.
Amended by
131st General Assembly File No. TBD, HB 64, §101.01, eff.
9/29/2015.
Amended by
131st General Assembly File No. TBD, HB 4, §1,
eff. 7/16/2015.
Amended by
130th General Assembly File No. TBD, HB 483, §101.01, eff.
6/19/2014.
Amended by
130th General Assembly File No. TBD, HB 296, §1,
eff. 4/21/2014.
Amended by
129th General AssemblyFile No.156, SB 301,
§1, eff.
3/13/2013.
Amended by
129th General AssemblyFile No.9, HB 9,
§1, eff.
6/29/2011.
Amended by
129th General AssemblyFile No.19, HB 93,
§1, eff.
5/20/2011.
Effective Date:
05-04-2004; 05-17-2006; 2008 HB283 09-12-2008 .
| (A) |
As used in this section,
"naloxone distributor" means either of the following:
| (1) |
A wholesale distributor of dangerous drugs; |
| (2) |
A terminal distributor of
dangerous drugs that supplies naloxone to any entity under division (B)(1) of
this section. |
|
| (B) |
| (1) |
A naloxone distributor shall prioritize the sale,
distribution, and delivery of naloxone to all of the following:
| (a) |
A children's hospital, as defined in section 3727.01
of the Revised Code; |
| (b) |
A hospital, as defined in section 3727.01 of the
Revised Code; |
| (c) |
An emergency medical
service organization, as defined in section 4765.01 of the Revised Code; |
| (d) |
A facility that is
operated as an urgent care center. |
|
| (2) |
The order in which the entities are listed in division
(B)(1) of this section does not establish levels of priority among the listed
entities. |
|
| (C) |
A naloxone distributor who in good faith complies with
division (B) of this section is not liable for or subject to any of the
following for an act or omission arising from that compliance: damages in any
civil action, prosecution in any criminal proceeding, or professional
disciplinary action. |
Added by
130th General Assembly File No. TBD, HB 170, §1,
eff. 3/11/2014.
A manufacturer of dangerous drugs may donate inhalers, as
defined in section 3 313.7113 of the Revised Code, and epinephrine
autoinjectors 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. |
Added by
131st General Assembly File No. TBD, SB 319, §1,
eff. 4/6/2017.
| (A) |
As used in
this section, "service entity" means a public or private entity that may
provide services to or interact with individuals
who there is reason to believe may be at risk of experiencing an opioid-related
overdose. "Service entity" includes a church or other place of worship, college
or university, school, library, health department
operated by the board of health of a city or general
health district, community addiction services provider, court, probation
department, halfway house, prison, jail, community residential center, homeless
shelter, or similar entity. |
| (B) |
A
service entity may procure and maintain naloxone
for either or both of the following purposes:
| (1) |
To use in emergency situations; |
| (2) |
To permit an employee, volunteer, or contractor of the
service entity to personally furnish a supply of naloxone pursuant to a
protocol established under section
3707.561,
4723.485,
4730.435, or
4731.941 of the Revised
Code. |
|
| (C) |
A service
entity or an employee, volunteer, or contractor of a service entity is not
liable for or subject to any of the following for injury, death, or loss to
person or property that allegedly arises from an act or omission associated
with procuring, maintaining, accessing, using, or personally
furnishing naloxone under this section, unless the act or omission
constitutes willful or wanton misconduct: damages in any civil action,
prosecution in any criminal proceeding, or professional disciplinary action. This section does not
eliminate, limit, or reduce any other immunity or defense that a service entity
or an employee, volunteer, or contractor of a service entity may be entitled to
under Chapter 2305. or any other provision of the Revised Code or under the
common law of this state.
|
Amended by
133rd General Assembly File No. 166, HB 341, §1,
eff. 12/16/2020.
Amended by
133rd General Assembly File No. TBD, HB 166, §101.01, eff.
10/17/2019.
Added by
131st General Assembly File No. TBD, SB 319, §1,
eff. 4/6/2017.
| (A) |
In accordance with divisions (B) and (C) of this
section, a terminal distributor of dangerous drugs may acquire and maintain a
supply of naloxone for use in emergency situations and for distribution through
an automated mechanism. The naloxone may be maintained at a location other than
the location licensed as a terminal distributor of dangerous
drugs. |
| (B) |
In the case of naloxone for use in emergency
situations, a terminal distributor of dangerous drugs shall do all of the
following:
| (1) |
Provide instructions regarding the emergency
administration of naloxone to any individual who accesses the naloxone,
including a specific instruction to summon emergency services as set forth in
division (D) of this section; |
| (2) |
Specify a process to be used to notify the terminal
distributor that the naloxone has been accessed within a reasonable time of its
being accessed; |
| (3) |
Maintain the naloxone in accordance with the
manufacturer's or distributor's instructions. |
|
| (C) |
In the case of naloxone for distribution through an
automated mechanism, a terminal distributor of dangerous drugs shall comply
with standards and procedures specified in rules adopted under division (F) of
this section. |
| (D) |
| (1) |
Notwithstanding any conflicting provision of the
Revised Code, both of the following apply:
| (a) |
Any individual may access naloxone maintained as
provided in division (B) of this section and may administer it to an individual
who there is reason to believe is experiencing an opioid-related
overdose. |
| (b) |
Any individual may receive naloxone distributed
through an automated system as provided in division (C) of this section and may
administer it to an individual who there is reason to believe is experiencing
an opioid-related overdose. |
|
| (2) |
An individual who administers naloxone as authorized
by this section shall make a good faith effort to activate or have another
individual activate an emergency medical services system as soon as possible,
except that this requirement does not apply if the individual administering the
naloxone is doing so as part of an emergency medical services system or at a
hospital, as defined in section
3727.01 of the Revised
Code. |
|
| (E) |
An individual is not liable for or subject to any of
the following for injury, death, or loss to person or property that allegedly
arises from an act or omission associated with any action authorized by this
section, unless the act or omission constitutes willful or wanton misconduct:
damages in any civil action, prosecution in any criminal proceeding, or
professional disciplinary action. |
| (F) |
The state board of pharmacy shall adopt rules
establishing standards and procedures applicable to the distribution of
naloxone through an automated mechanism. The rules shall be adopted in
accordance with Chapter 119. of the Revised Code. |
Added by
133rd General Assembly File No. 166, HB 341, §1,
eff.
12/16/2020.
| (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) |
"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) |
The
state board of pharmacy shall license the following persons:
| (i) |
Wholesale distributors of dangerous drugs; |
| (ii) |
Manufacturers of dangerous drugs; |
| (iii) |
Outsourcing facilities; |
| (iv) |
Third-party logistics providers; |
| (v) |
Repackagers of dangerous drugs. |
|
| (b) |
There shall be two categories for the licenses identified in division (B)(1)(a)
of this section. The categories are as follows:
| (i) |
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. |
| (ii) |
Category
III license. 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. |
|
| (c) |
The
board may adopt rules under section
4729.26 of
the Revised Code to create classification types of any license issued pursuant
to this section. Persons who meet the definitions of the classification types
shall comply with all requirements for the specific license classification
specified in rule. |
|
|
| (C) |
A person
seeking a license identified in division (B)(1)(a) of this section shall file
with the executive director of the board a verified application containing such
information as the board requires of the applicant relative to the licensure
qualifications set forth in section
4729.53
of the Revised Code and the rules adopted under that section. The board shall license
as a category II or category III manufacturer, outsourcing facility,
third-party logistics provider, repackager, or wholesale distributor each
applicant who has paid the required license fee, if the board determines that
the applicant meets the licensure qualifications set forth in section
4729.53
of the Revised Code and the rules adopted under that section.
|
| (D) |
The
board may issue to a person who does not reside in this state a license
identified in division (B)(1)(a) of this section if the person pays the
required licensure fee and meets either of the following:
| (1) |
Possesses a current and valid manufacturer, outsourcing facility, third-party
logistics provider, repackager, or wholesale distributor license, or its
equivalent, issued by another state in which that person is physically located,
but only if that state has qualifications for licensure comparable to the
licensure requirements in this state; |
| (2) |
Meets the requirements set forth by the board for issuance of a license
identified in division (B)(1)(a) of this section, as verified by a state,
federal, or other entity recognized by the board to perform such
verification. |
|
| (E) |
All
licenses issued or renewed pursuant to this section are 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
pursuant to 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 renewal fee before the date
specified in the rules adopted by the board. |
| (F) |
Each license issued under this section shall describe not more than one
establishment or place where the license holder may engage in the activities
authorized by the license. No license shall authorize or permit the person
named therein to engage in the sale or distribution of drugs at wholesale or to
maintain possession, custody, or control of dangerous drugs for any purpose
other than for the licensee's own use and consumption at any establishment or
place other than that described in the license. |
| (G) |
| (1) |
| (a) |
The
category II license fee is one thousand nine hundred dollars and shall
accompany each application for licensure. The license renewal fee is one
thousand nine hundred dollars and shall accompany each renewal
application. |
| (b) |
The category
III license fee is two thousand dollars and shall accompany each application
for licensure. The license renewal fee is two thousand dollars and shall
accompany each renewal application. |
| (c) |
| (i) |
Subject to division (G)(1)(c)(ii) of this section, a license issued pursuant to
this section that has not been renewed by the date specified in rules adopted
by the board may be reinstated upon payment of the renewal fee and a penalty of
three hundred dollars. |
| (ii) |
If a
complete 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. |
|
|
| (2) |
Renewal fees and penalties assessed under division (G)(1) of this section shall
not be returned if the applicant fails to qualify for renewal. |
| (3) |
A
person licensed pursuant to this section that fails to renew licensure in
accordance with this section and rules adopted by the board is prohibited from
engaging in manufacturing, repackaging, compounding, or distributing as a
third-party logistics provider or wholesale distributor until a valid license
is issued by the board. |
|
| (H) |
Holding a license issued pursuant to this section subjects the holder and the
holder's agents and employees to the jurisdiction of the board and to the laws
of this state for the purpose of the enforcement of this chapter and the rules
of the board. However, the filing of an application for licensure under this
section by or on behalf of any person, or the issuance of a license pursuant to
this section to or on behalf of any person, shall not of itself constitute
evidence that the person is doing business within this state. |
| (I) |
The
board may enter into agreements with other states, federal agencies, and other
entities to exchange information concerning licensing and inspection of any
manufacturer, outsourcing facility, third-party logistics provider, repackager,
or wholesale distributor located within or outside this state and to
investigate alleged violations of the laws and rules governing distribution of
drugs by such persons. 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. Any information received is also
subject to section 4729.23 of the Revised
Code. |
Amended by
132nd General Assembly File No. TBD, SB 229, §1,
eff. 3/22/2020.
Amended by
132nd General Assembly File No. TBD, HB 49, §101.01, eff.
9/29/2017.
Amended by
129th General AssemblyFile No.28, HB 153,
§101.01, eff.
9/29/2011.
Effective Date: 07-22-1998
.
| (A) |
The state
board of pharmacy shall not license any person as a manufacturer of dangerous
drugs, outsourcing facility, third-party logistics provider, repackager of
dangerous drugs, or wholesale distributor of dangerous drugs unless the
applicant for licensure furnishes satisfactory proof to the board that
all of the following
conditions are met:
| (1) |
If
the applicant has committed acts that the board finds violate any federal,
state, or local law, regulation, or rule relating to drug samples,
manufacturing, compounding, repackaging, wholesale or retail drug distribution,
or distribution of dangerous drugs, including controlled substances, or
constitute a felony, or if a federal, state, or local governmental entity has
suspended or revoked any current or prior license of the applicant for the
manufacture, compounding, repackaging, distribution, or sale of any dangerous
drugs, including controlled substances, the applicant, to the satisfaction of
the board, assures that the applicant has in place adequate safeguards to
prevent the recurrence of any such violations. |
| (2) |
The
applicant's past experience in the manufacture, compounding, repackaging, or
distribution of dangerous drugs, including controlled substances, is acceptable
to the board. |
| (3) |
The
applicant is properly equipped as to land, buildings, equipment, and personnel
to properly carry on its business, including providing adequate security for
and proper storage conditions and handling for dangerous drugs, and is
complying with the requirements under this chapter and the rules adopted
pursuant thereto for maintaining and making available records to properly
identified board officials and federal, state, and local law enforcement
agencies. |
| (4) |
Personnel
employed by the applicant have the appropriate education or experience, as
determined by the board, to assume responsibility for positions related to
compliance with this chapter and the rules adopted pursuant thereto. |
| (5) |
The
applicant has designated the name and address of a person to whom
communications from the board may be directed and upon whom the notices and
citations provided for in section
4729.56
of the Revised Code may be served. |
| (6) |
Adequate safeguards are assured to prevent the sale of dangerous drugs other
than in accordance with section
4729.51
of the Revised Code. |
| (7) |
With respect
to criminal records checks, the applicant has done both of the following and
the board has decided that the results of the criminal records checks do not
make the applicant ineligible for a license issued pursuant to section
4729.52
of the Revised Code:
| (b) |
Required any person who is seeking to serve as the
responsible person on the license, who has an ownership interest, or who is a
corporate officer, as set forth in rules adopted under division (C) of this
section, to submit to a criminal records check in accordance with section
4776.02
of the Revised Code and send the results of the criminal records check directly
to the board. |
|
| (8) |
The applicant meets any other requirement or
qualification the board, by rule adopted under division (C) of this section, considers
relevant to and consistent with the public safety and health. |
|
| (B) |
In addition
to the causes described in section
4729.56
of the Revised Code for refusing to grant or renew a license, the board may
refuse to grant or renew a license if the board determines that the granting of
the license or its renewal is not in the public interest. |
| (C) |
The board shall adopt rules in accordance with Chapter
119. of the Revised Code that do all of the following:
| (1) |
For purposes of division (A)(7)(b) of this section,
define "responsible person" and specify the persons with ownership interests
and the corporate officers who are required to submit to criminal records
checks; |
| (2) |
For purposes of division (A)(8) of this section,
specify other requirements or qualifications, if any, that an applicant must
meet to receive a license; |
| (3) |
Address any other matter the board considers
appropriate to implement this section. |
|
Amended by
132nd General Assembly File No. TBD, SB 229, §1,
eff. 3/22/2019.
Amended by
132nd General Assembly File No. TBD, HB 49, §101.01, eff.
9/29/2017.
Amended by
131st General Assembly File No. TBD, HB 64, §101.01, eff.
9/29/2015.
Effective Date: 07-01-1992
.
| (A) |
The state
board of pharmacy may issue a limited license to animal shelters solely for the
purpose of purchasing, possessing, and administering combination drugs that
contain pentobarbital and at least one noncontrolled substance ingredient, in a
manufactured dosage form, whose only indication is for euthanizing animals, or
other substances described in section
4729.532 of the Revised Code. 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 of
the facility that an agent or employee of an animal shelter, 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 must provide the board for issuance or renewal of a license;
|
| (3) |
Establish criteria for the
board to use in determining whether to refuse to issue or renew, suspend, or
revoke a license issued under this section; |
| (4) |
Address any other matters the board
considers necessary or appropriate for the administration and enforcement of
this section. |
|
Effective Date:
06-29-1994 .
| (A) |
No agent
or employee of an animal shelter shall perform euthanasia by means of lethal
injection on an animal by use of any substance other than combination drugs
that contain pentobarbital and at least one noncontrolled substance active
ingredient, in a manufactured dosage form, whose only indication is for
euthanizing animals, or other substance that the state veterinary medical
licensing board and the state board of pharmacy both approve by rule adopted in
accordance with Chapter 119. of the Revised Code. The agent or employee of an
animal shelter when using a lethal solution to perform euthanasia on an animal
shall use such solution in accordance with the following methods and in the
following order of preference:
| (1) |
Intravenous injection by hypodermic needle; |
| (2) |
Intraperitoneal injection by hypodermic
needle; |
| (3) |
Intracardial injection
by hypodermic needle, but only on a sedated or unconscious animal; |
| (4) |
Solution or powder added to food.
|
|
| (B) |
Except as provided
in division (D) of this section, no agent or employee of an animal shelter,
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 unless he 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 solutions; |
| (2) |
Federal and state laws regulating the
storage and accountability of euthanasia solutions; |
| (3) |
Euthanasia technician stress management;
|
| (4) |
Proper disposal of euthanized
animals. |
|
| (C) |
| (1) |
Except as provided in division (D) of this
section, no agent or employee of an animal shelter shall perform euthanasia by
means of lethal injection on animals under this section unless the facility in
which he works or is employed is licensed with the state board of pharmacy
under section
4729.531 of the Revised Code.
|
| (2) |
Any agent or employee of an
animal shelter performing euthanasia by means of lethal injection shall do so
only in a humane and proficient manner that is in conformity with the methods
described in division (A) of this section and not in violation of Chapter 959.
of the Revised Code. |
|
| (D) |
An agent or employee of an animal shelter who is
performing euthanasia by means of lethal injection on animals on or before the
effective date of this section may continue to perform such euthanasia and is
not required to be certified in compliance with division (B) of this section
until ninety days after the effective date of the rules adopted in compliance
with Section 3 of House Bill No. 88 of the 120th general assembly. |
Effective Date:
06-29-1994 .
| (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; |
| (g) |
If the
application pertains to a facility, clinic, or other location described in
division (B) of section
4729.553 of the Revised Code
that must hold a category III terminal distributor of dangerous drugs license
with an office-based opioid treatment classification, information that
demonstrates, to the satisfaction of the board, compliance with division (C) of
that section. |
|
|
| (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 on behalf of an animal shelter, 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 on behalf of an
animal shelter 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) |
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 (D) 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.
|
|
|
|
| (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
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 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 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 paid under division (G) 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. |
Amended by
132nd General Assembly File No. TBD, SB 229, §1,
eff. 3/22/2019.
Amended by
132nd General Assembly File No. TBD, HB 49, §101.01, eff.
9/29/2017.
Amended by
131st General Assembly File No. TBD, SB 319, §1,
eff. 4/6/2017.
Amended by
130th General Assembly File No. TBD, HB 483, §101.01, eff.
9/15/2014.
Amended by
129th General AssemblyFile No.19, HB 93,
§1, eff.
5/20/2011.
Effective Date:
06-30-1999; 2008 HB283 09-12-2008
| (A) |
Except as
provided in divisions (B) to (D) 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 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 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 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 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 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 that may be possessed under section
5101.76 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
5101.77 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 naloxone that may be possessed under section
2925.61 of the Revised Code, a
law enforcement agency and its peace officers; |
| (12) |
With respect to naloxone that may be possessed under section
4729.514 of the Revised Code
for use in emergency situations or for personally
furnishing supplies of naloxone, a service entity, as defined in that
section; |
| (13) |
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) |
If a person
described in division (A) of this section is operating a facility, clinic, or
other location described in division (B) of section
4729.553 of the Revised Code
that must hold a category III terminal distributor of dangerous drugs license
with an office-based opioid treatment classification, the person shall hold a
license with that classification. |
| (D) |
Any
of the persons described in divisions (A)(1) to (12) 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. |
|
Amended by
133rd General Assembly File No. 166, HB 341, §1,
eff. 12/16/2020.
Amended by
131st General Assembly File No. TBD, SB 319, §1,
eff. 4/6/2017.
Amended by
131st General Assembly File No. TBD, HB 64, §101.01, eff.
9/29/2015.
Amended by
130th General Assembly File No. TBD, HB 367, §1,
eff. 3/23/2015.
Amended by
130th General Assembly File No. TBD, HB 483, §101.01, eff.
9/15/2014.
Amended by
129th General AssemblyFile No.19, HB 93,
§1, eff.
5/20/2011.
Effective Date: 2008 HB283
09-12-2008
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) |
A
pharmacist, licensed health professional authorized to prescribe drugs,
other person authorized by the board, animal
shelter licensed under section
4729.531
of the Revised Code, or 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) |
In the case
of an applicant who is a food processor or retail seller of food, the applicant
will maintain supervision and control over the possession and custody of
nitrous oxide. |
| (G) |
In the case
of an applicant who is a retail seller of oxygen in original packages labeled
as required by the "Federal Food, Drug, and Cosmetic Act," the applicant will
maintain supervision and control over the possession, custody, and retail sale
of the oxygen. |
| (H) |
If the
application is made on behalf of an animal shelter, at least one of the agents
or employees of the animal shelter is certified in compliance with section
4729.532
of the Revised Code. |
| (I) |
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. |
| (J) |
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. |
| (K) |
In the case
of an applicant who is operating a facility, clinic, or other location
described in division (B) of section
4729.553 of the Revised Code
that must hold a category III terminal distributor of dangerous drugs license
with an office-based opioid treatment classification, the applicant meets the
requirements to receive that license with that classification. |
Amended by
132nd General Assembly File No. TBD, SB 229, §1,
eff. 3/22/2020.
Amended by
131st General Assembly File No. TBD, SB 319, §1,
eff. 4/6/2017.
Amended by
129th General AssemblyFile No.19, HB 93,
§1, eff.
5/20/2011.
Effective Date: 02-12-2001
.
Each person, whether located within or outside this state, who
sells dangerous drugs at retail for delivery or distribution to persons
residing in this state, shall be licensed as a terminal distributor of
dangerous drugs pursuant to sections
4729.54 and
4729.55 of the Revised Code. The
board of pharmacy may enter into agreements with other states, federal
agencies, and other entities to exchange information concerning the licensing
and inspection of terminal distributors of dangerous drugs who are located
within or outside this state and to investigate any alleged violations of the
laws and rules governing the legal distribution of drugs by such persons.
Effective Date:
07-21-1994 .
| (A) |
To be eligible to receive a license as a category III terminal distributor of
dangerous drugs with a pain management clinic classification, an applicant
shall submit evidence satisfactory to the state board of pharmacy that the
applicant's pain management clinic will be operated in accordance with the
requirements specified in division (B) of this section and that the applicant
meets any other applicable requirements of this chapter. If the board
determines that an applicant meets all of the requirements, the board shall
issue to the applicant a license as a category III terminal distributor of
dangerous drugs and specify on the license that the terminal distributor is
classified as a pain management clinic.
|
| (B) |
The holder of a terminal distributor license with a pain management clinic
classification shall do all of the following:
| (1) |
Be in control of a facility that is owned and operated solely by one or more
physicians authorized under Chapter 4731. of the Revised Code to practice
medicine and surgery or osteopathic medicine and surgery; |
| (2) |
Comply with the requirements for the operation of a pain management clinic, as
established by the state medical board in rules adopted under section
4731.054 of the Revised
Code; |
| (3) |
Ensure
that any person employed by the facility complies with the requirements for the
operation of a pain management clinic established by the state medical board in
rules adopted under section
4731.054 of the Revised
Code; |
| (4) |
Require
any person with ownership of the facility to submit to a criminal records check
in accordance with section
4776.02 of the Revised Code and
send the results of the criminal records check directly to the state board of
pharmacy for review and decision under section
4729.071 of the Revised
Code; |
| (5) |
Require
all employees of the facility to submit to a criminal records check in
accordance with section
4776.02 of the Revised Code and
ensure that no person is employed who has previously been convicted of, or
pleaded guilty to, either of the following:
| (a) |
A theft offense, described in division (K)(3) of section
2913.01 of the Revised Code,
that would constitute a felony under the laws of this state, any other state,
or the United States; |
| (b) |
A felony drug abuse offense, as defined in section
2925.01 of the Revised
Code. |
|
| (6) |
Maintain
a list of each person with ownership of the facility and notify the state board
of pharmacy of any change to that list. |
|
| (C) |
No person shall operate a facility that under this chapter is subject to
licensure as a category III terminal distributor of dangerous drugs with a pain
management clinic classification without obtaining and maintaining the license
with the classification. No person who holds a
category III license with a pain management clinic classification shall fail to
remain in compliance with the requirements of division (B) of this section and
any other applicable requirements of this chapter.
|
| (D) |
The state board of pharmacy may impose a fine of not more than five thousand
dollars on a person who
violates division (C) of this section. A separate fine may be imposed for each
day the violation continues. In imposing the fine, the board's actions shall be
taken in accordance with Chapter 119. of the Revised Code. |
| (E) |
The state board of pharmacy shall adopt rules as it considers necessary to
implement and administer this section. The rules shall be adopted in accordance
with Chapter 119. of the Revised Code. |
Amended by
132nd General Assembly File No. TBD, HB 49, §101.01, eff.
9/29/2017.
Amended by
129th General AssemblyFile No.156, SB 301,
§1, eff.
3/13/2013.
Amended by
129th General AssemblyFile No.28, HB 153,
§101.01, eff.
9/29/2011.
Added by
129th General AssemblyFile No.19, HB 93,
§1, eff.
5/20/2011 and 6/19/2011.
| (A) |
As used in
this section:
| (1) |
"Advanced practice registered nurse" has the same
meaning as in section
4723.01 of the Revised
Code. |
| (2) |
"Controlled
substance" has the same meaning as in section
3719.01 of the Revised
Code. |
| (3) |
"Hospital" means
a hospital registered with the department of health under section
3701.07 of the Revised
Code. |
| (4) |
"Office-based
opioid treatment" means the treatment of opioid dependence or addiction using a
controlled substance. |
| (5) |
"Physician" means an individual who is authorized
under Chapter 4731. of the Revised Code to practice medicine and surgery or
osteopathic medicine and surgery. |
| (6) |
"Physician assistant" means an individual who is
licensed under Chapter 4730. of the Revised Code. |
|
| (B) |
| (1) |
Except as provided in divisions (B)(2) and
(3) of this section, no person shall knowingly operate a facility,
clinic, or other location where a prescriber provides office-based opioid
treatment to more than thirty patients or that meets any other identifying
criteria established in rules adopted under this section without holding a
category III terminal distributor of dangerous drugs license with an
office-based opioid treatment classification. |
| (2) |
Division (B)(1) of this section does not apply to any of the following:
| (b) |
A facility
for the treatment of opioid dependence or addiction that is operated by a
hospital; |
| (c) |
A physician
practice owned or controlled, in whole or in part, by a hospital or by an
entity that owns or controls, in whole or in part, one or more
hospitals; |
| (d) |
A facility
that conducts only clinical research and uses controlled substances in studies
approved by a hospital-based institutional review board or an institutional
review board that is accredited by the association for the accreditation of
human research protection programs, inc.; |
| (e) |
A
facility that holds a category III terminal distributor of dangerous drugs
license in accordance with section
4729.54 of the Revised Code for
the purpose of treating drug dependence or addiction as part of an opioid
treatment program and is the subject of a current, valid certification from the
substance abuse and mental health services administration of the United States
department of health and human services pursuant to 42 C.F.R. 8.11; |
| (f) |
A
program or facility that holds a license or certification issued by the
department of mental health and addiction services under Chapter 5119. of the
Revised Code if the license or certification is approved by the state board of
pharmacy; |
| (g) |
A federally
qualified health center or federally qualified health center look-alike, as
defined in section 3701.047 of the Revised
Code; |
| (h) |
A state or
local correctional facility, as defined in section
5163.45 of the Revised
Code; |
| (i) |
A facility in which patients are treated on-site for
opioid dependence or addiction exclusively through direct administration by a
physician, physician assistant, or advanced practice registered nurse of drugs
that are used for treatment of opioid dependence or addiction and are neither
dispensed nor personally furnished to patients for off-site
self-administration; |
| (j) |
Any
other facility specified in rules adopted under this section. |
|
| (3) |
A patient who receives treatment on-site for opioid
dependence or addiction through direct administration of a drug by a physician,
physician assistant, or advanced practice registered nurse shall not be
included in determining whether more than thirty patients are being provided
office-based opioid treatment in a particular facility, clinic, or other
location that is subject to division (B)(1) of this section. |
|
| (C) |
To be
eligible to receive a license as a category III terminal distributor of
dangerous drugs with an office-based opioid treatment classification, an
applicant shall submit evidence satisfactory to the state board of pharmacy
that the applicant's office-based opioid treatment will be operated in
accordance with the requirements specified in division (D) of this section and
that the applicant meets any other applicable requirements of this chapter. If the board determines
that an applicant meets all of the requirements, the board shall issue to the
applicant a license as a category III terminal distributor of dangerous drugs
with an office-based opioid treatment classification.
|
| (D) |
The
holder of a category III terminal distributor license with an office-based
opioid treatment classification shall do all of the following:
| (1) |
Be
in control of a facility that is owned and operated solely by one or more
physicians , unless the state board of pharmacy waives this requirement
for the holder; |
| (2) |
Comply with
the requirements for conducting office-based opioid treatment, as established
by the state medical board in rules adopted under section
4731.056 of the Revised
Code; |
| (3) |
Require any
person with ownership of the facility to submit to a criminal records check in
accordance with section
4776.02 of the Revised Code and
send the results of the criminal records check directly to the state board of
pharmacy for review and decision under section
4729.071 of the Revised
Code; |
| (4) |
Require each
person employed by or seeking employment with the facility to submit to a
criminal records check in accordance with section
4776.02 of the Revised
Code; |
| (5) |
Ensure that
a person is not employed by the facility if the person, within the ten years
immediately preceding the date the person applied for employment, was convicted
of or pleaded guilty to either of the following, unless the state board of
pharmacy permits the person to be employed by waiving this requirement for the
facility:
| (a) |
A theft
offense, described in division (K)(3) of section
2913.01 of the Revised Code,
that would constitute a felony under the laws of this state, any other state,
or the United States; |
| (b) |
A felony
drug offense, as defined in section
2925.01 of the Revised
Code. |
|
| (6) |
Maintain a
list of each person with ownership of the facility and notify the state board
of pharmacy of any change to that list. |
|
| (E) |
No
person subject to licensure as a category III terminal distributor of dangerous
drugs with an office-based opioid treatment classification shall knowingly fail
to remain in compliance with the requirements of division (D) of this section
and any other applicable requirements of this chapter. |
| (F) |
The
state board of pharmacy may impose a fine of not more than five thousand
dollars on a person who violates division (B) or (E) of this section. A
separate fine may be imposed for each day the violation continues. In imposing
the fine, the board's actions shall be taken in accordance with Chapter 119. of
the Revised Code. |
| (G) |
The state
board of pharmacy shall adopt rules as it considers necessary to implement and
administer this section. The rules shall be adopted in accordance with Chapter
119. of the Revised Code. |
Amended by
133rd General Assembly File No. 166, HB 341, §1,
eff. 12/16/2020.
Amended by
132nd General Assembly File No. TBD, HB 101, §1,
eff. 4/8/2019.
Amended by
132nd General Assembly File No. TBD, SB 229, §1,
eff. 3/22/2019.
Added by
131st General Assembly File No. TBD, SB 319, §1,
eff. 8/4/2017.
| (A) |
| (1) |
The state board of pharmacy, in
accordance with Chapter 119. of the Revised Code, may
impose
any one or more of the following sanctions on a person licensed under division
(B)(1)(a) of section 4729.52 of the Revised Code for
any of the causes set forth in division (A)(2) of this section:
| (a) |
Suspend, revoke, restrict, limit, or refuse to grant or renew
a license; |
| (b) |
Reprimand or place the license holder on
probation; |
| (c) |
Impose a monetary penalty or forfeiture not to
exceed in severity any fine designated under the Revised Code for a similar
offense or two thousand five
hundred dollars if the acts committed are not classified as an offense by
the Revised Code ; |
|
| (2) |
The board may impose the sanctions set forth in
division (A)(1) of this section for any of the following:
| (a) |
Making any false
material statements in an application for licensure under section
4729.52 of the Revised
Code; |
| (b) |
Violating any
federal, state, or local drug law; any provision of this chapter or Chapter
2925., 3715., or 3719. of the Revised Code; or any rule of the board; |
| (c) |
A conviction of
a felony; |
| (d) |
Failing to
satisfy the qualifications for licensure under section
4729.53 of the Revised Code or
the rules of the board or ceasing to satisfy the qualifications after the
registration is granted or renewed; |
| (e) |
Falsely or fraudulently promoting to the public a drug
that is a controlled substance included in schedule I, II, III, IV, or V,
except that nothing in this division prohibits a manufacturer, outsourcing
facility, third-party logistics provider, repackager, or wholesale distributor
of dangerous drugs from furnishing information concerning a controlled
substance to a health care provider or licensed terminal
distributor; |
| (f) |
Violating any provision of the "Federal Food, Drug,
and Cosmetic Act," 52 Stat. 1040 (1938),
21 U.S.C. 301, or Chapter 3715. of the Revised
Code; |
| (g) |
Any other cause for which the board may impose
sanctions as set forth in rules adopted under section
4729.26 of the Revised
Code. |
|
|
| (B) |
Upon the suspension or revocation of any license identified in division
(B)(1)(a) of section 4729.52 of the Revised
Code, the licensee shall immediately surrender the
license to the board. |
| (C) |
If the board suspends, revokes, or refuses to renew any
license
identified in division (B)(1)(a) of section
4729.52 of the Revised
Code and determines that there is clear and convincing evidence of a
danger of immediate and serious harm to any person, the board may place under
seal all dangerous drugs owned by or in the possession, custody, or control of
the affected licensee. Except as provided in
this division, the board shall not dispose of the dangerous drugs sealed under
this division until the licensee exhausts all
of the licensee's appeal rights under Chapter 119. of
the Revised Code. The court involved in such an appeal may order the board,
during the pendency of the appeal, to sell sealed dangerous drugs that are
perishable. The board shall deposit the proceeds of the sale with the
court. |
| (D) |
If the board is required under Chapter 119. of the
Revised Code to give notice of an opportunity for a hearing and the license
holder does not make a timely request for a hearing in accordance with section
119.07 of the Revised Code, the
board is not required to hold a hearing, but may adopt a final order that
contains the board's findings. In the final order, the board may impose any of
the sanctions listed in division (A) of this section. |
| (E) |
Notwithstanding division (C)(2) of section
2953.32 of the Revised Code
specifying that if records pertaining to a criminal case are sealed under that
section the proceedings in the case must be deemed not to have occurred,
sealing of the following records on which the board has based an action under
this section shall have no effect on the board's action or any sanction imposed
by the board under this section: records of any conviction, guilty plea,
judicial finding of guilt resulting from a plea of no contest, or a judicial
finding of eligibility for a pretrial diversion program or intervention in lieu
of conviction. The board is not required to seal, destroy, redact, or otherwise
modify its records to reflect the court's sealing of conviction
records. |
Amended by
132nd General Assembly File No. TBD, HB 49, §101.01, eff.
9/29/2017.
Amended by
131st General Assembly File No. TBD, HB 64, §101.01, eff.
9/29/2015.
Effective Date: 07-01-1992
.
If the state board of
pharmacy determines that there is clear and convincing evidence that the method
used by a licensed manufacturer of dangerous drugs, outsourcing
facility, third-party logistics provider, repackager of dangerous drugs,
or wholesale distributor of dangerous drugs to possess or distribute dangerous drugs presents a
danger of immediate and serious harm to others, the board may suspend without a
hearing the license issued pursuant to
section 4729.52 of the Revised Code. The
board shall follow the procedure for suspension without a prior hearing in
section 119.07 of the Revised Code. The
suspension shall remain in effect, unless removed by the board, until the
board's final adjudication order becomes effective, except that if the board
does not issue its final adjudication order within one hundred
twenty days after the suspension, the suspension shall be void on the
one
hundred twenty-first day after the suspension.
Amended by
132nd General Assembly File No. TBD, HB 49, §101.01, eff.
9/29/2017.
Added by
131st General Assembly File No. TBD, HB 116, §1,
eff. 8/31/2016.
| (A) |
The state board of pharmacy may after notice and a hearing in accordance with Chapter
119. of the Revised Code, impose any one or more of the following sanctions on
a terminal distributor of dangerous drugs for any of the causes set forth in
division (B) of this section:
| (1) |
Suspend, revoke, restrict, limit, or refuse to grant or renew any
license ; |
| (2) |
Reprimand or place the license holder on
probation; |
| (3) |
Impose a monetary penalty or forfeiture not to
exceed in severity any fine designated under the Revised Code for a similar
offense or one thousand dollars if the acts committed have not been classified
as an offense by the Revised Code. |
|
| (B) |
The board may impose the sanctions listed in division
(A) of this section for any of the following:
| (1) |
Making any false material statements in an application for a license as a
terminal distributor of dangerous drugs; |
| (2) |
Violating any rule of the board; |
| (3) |
Violating any provision of this chapter; |
| (4) |
Except as provided in section
4729.89 of the Revised Code,
violating any provision of the "Federal Food, Drug, and Cosmetic Act," 52 Stat.
1040 (1938), 21 U.S.C.A. 301, or Chapter 3715. of the Revised
Code; |
| (5) |
Violating any provision of the federal drug abuse control laws or Chapter 2925.
or 3719. of the Revised Code; |
| (6) |
Falsely or fraudulently promoting to the public a dangerous drug, except that
nothing in this division prohibits a terminal distributor of dangerous drugs
from furnishing information concerning a dangerous drug to a health care
provider or another licensed terminal distributor; |
| (7) |
Ceasing to satisfy the qualifications of a terminal distributor of dangerous
drugs set forth in section
4729.55 of the Revised
Code; |
| (8) |
Except
as provided in division (C) of this section:
| (a) |
Waiving the payment of all or any part of a deductible or copayment that an
individual, pursuant to a health insurance or health care policy, contract, or
plan that covers the services provided by a terminal distributor of dangerous
drugs, would otherwise be required to pay for the services if the waiver is
used as an enticement to a patient or group of patients to receive pharmacy
services from that terminal distributor; |
| (b) |
Advertising that the terminal distributor will waive the payment of all or any
part of a deductible or copayment that an individual, pursuant to a health
insurance or health care policy, contract, or plan that covers the
pharmaceutical services, would otherwise be required to pay for the
services. |
|
| (9) |
Conviction of a felony; |
| (10) |
Any other cause for which the board may impose
discipline as set forth in rules adopted under section
4729.26 of the Revised
Code. |
|
| (C) |
Sanctions shall
not be imposed under division (B)(8) of this section against any terminal
distributor of dangerous drugs that waives deductibles and copayments as
follows:
| (1) |
In
compliance with a health benefit plan that expressly allows such a practice.
Waiver of the deductibles or copayments shall be made only with the full
knowledge and consent of the plan purchaser, payer, and third-party
administrator. Documentation of the consent shall be made available to the
board on request. |
| (2) |
For
professional services rendered to any other person licensed pursuant to this
chapter to the extent allowed by this chapter and the rules of the
board. |
|
| (D) |
| (1) |
Upon the suspension or revocation of a license issued to a terminal distributor
of dangerous drugs or the refusal by the board to renew such a license, the
distributor shall immediately surrender the license to the board. |
| (2) |
| (a) |
The board may place under seal all dangerous drugs that are owned by or in the
possession, custody, or control of a terminal distributor at the time the
license is suspended or revoked or at the time the board refuses to renew the
license. Except as provided in
division (D)(2)(b) of this section, dangerous drugs so sealed
shall not be disposed of until appeal rights under Chapter 119. of the Revised
Code have expired or an appeal filed pursuant to that chapter has been
determined. |
| (b) |
The
court involved in an appeal filed pursuant to Chapter 119. of the Revised Code
may order the board, during the pendency of the appeal, to sell sealed
dangerous drugs that are perishable. The proceeds of such a sale shall be
deposited with that court. |
|
|
| (E) |
If the board is required under Chapter 119. of the
Revised Code to give notice of an opportunity for a hearing and the license
holder does not make a timely request for a hearing in accordance with section
119.07 of the Revised Code, the
board is not required to hold a hearing, but may adopt a final order that
contains the board's findings. In the final order, the board may impose any of
the sanctions listed in division (A) of this section. |
| (F) |
Notwithstanding division (C)(2) of section
2953.32 of the Revised Code
specifying that if records pertaining to a criminal case are sealed under that
section the proceedings in the case must be deemed not to have occurred,
sealing of the following records on which the board has based an action under
this section shall have no effect on the board's action or any sanction imposed
by the board under this section: records of any conviction, guilty plea,
judicial finding of guilt resulting from a plea of no contest, or a judicial
finding of eligibility for a pretrial diversion program or intervention in lieu
of conviction. The board is not required to seal, destroy, redact, or otherwise
modify its records to reflect the court's sealing of conviction
records. |
Amended by
132nd General Assembly File No. TBD, HB 49, §101.01, eff.
9/29/2017.
Amended by
131st General Assembly File No. TBD, HB 290, §1,
eff. 4/6/2017.
Amended by
129th General AssemblyFile No.156, SB 301,
§1, eff.
3/13/2013.
Effective Date: 07-22-1998
.
| (A) |
The
state board of pharmacy may suspend without a hearing the license of a terminal
distributor of dangerous drugs if the board determines that there is clear and
convincing evidence of a danger of immediate and serious harm to others due to
either of the following:
| (1) |
The
method used by the terminal distributor to possess or distribute dangerous
drugs; |
| (2) |
The
method of prescribing dangerous drugs used by a licensed health professional
authorized to prescribe drugs who holds a terminal distributor license or
practices in the employ of or under contract with a terminal
distributor. |
|
| (B) |
The
board shall follow the procedure for suspension without a prior hearing in
section
119.07
of the Revised Code. The suspension shall remain in effect, unless removed by
the board, until the board's final adjudication order becomes effective, except
that if the board does not issue its final adjudication order within one
hundred twenty days after the suspension, the suspension shall be void on the
one hundred twenty-first day after the suspension. If the terminal
distributor holds a license with a pain management clinic classification issued
under section
4729.552
of the Revised Code or a license with an office-based opioid treatment
classification issued under section
4729.553 of the Revised Code and
the person holding the license also holds a license
issued under Chapter 4731. of the Revised Code to practice medicine and surgery
or osteopathic medicine and surgery, prior to suspending the license without a
hearing, the board shall consult with the secretary of the state medical board
or, if the secretary is unavailable, another physician member of the
board.
|
Amended by
133rd General Assembly File No. TBD, HB 166, §101.01, eff.
10/17/2019.
Amended by
132nd General Assembly File No. TBD, HB 49, §101.01, eff.
9/29/2017.
Amended by
131st General Assembly File No. TBD, SB 319, §1,
eff. 4/6/2017.
Amended by
131st General Assembly File No. TBD, HB 116, §1,
eff. 8/31/2016.
Added by
129th General AssemblyFile No.19, HB 93,
§1, eff.
5/20/2011.
The
state board of pharmacy, within thirty days after
receipt of a
complete application filed in the form and manner set forth in section
4729.52 or
4729.54 of the Revised Code for
the issuance of a license
or the
renewal of a license , shall notify the applicant therefor whether or not
such license
will be issued or renewed. If the board determines that such license
will not be
issued or renewed, such notice to the applicant shall set forth,
in a manner determined by the board, the reason or reasons that such
license will
not be issued or renewed.
Amended by
132nd General Assembly File No. TBD, HB 49, §101.01, eff.
9/29/2017.
Effective Date:
01-01-1962 .
The executive
director of the state board of pharmacy shall maintain a register of the names,
addresses, and the date of licensure of those persons to whom
licenses have been issued pursuant to
sections 4729.52 and 4729.54 of the Revised Code.
The board shall
make available
a roster
of
those persons . The roster shall indicate those
persons whose licenses have been suspended, revoked, or surrendered, and those
persons whose licenses have not been renewed.
A written statement
signed and verified by the executive director of the board
or the director's designee in which it is stated
that after diligent search of the register no record or entry of the issuance
of a license
to a person is found is admissible in evidence and constitutes presumptive
evidence of the fact that the person is not licensed pursuant to section
4729.52 or
4729.54 of the Revised
Code.
Amended by
132nd General Assembly File No. TBD, HB 49, §101.01, eff.
9/29/2017.
Effective Date:
07-22-1998 .
| (A) |
| (1) |
Before a licensee identified in
division (B)(1)(a) of section
4729.52 of the Revised
Code may sell or distribute dangerous drugs
at wholesale to any person, except as provided in division (A)(2) of this
section, the licensee shall query the
roster established pursuant to section
4729.59 of the Revised Code to
determine whether the purchaser is a licensed terminal distributor of
dangerous drugs. If no
documented query is conducted before a sale is
made, it shall be presumed that the sale of dangerous drugs by the
licensee is in violation of division (B) of
section 4729.51 of the Revised Code and
the purchase of dangerous drugs by the purchaser is in violation of division
(E) of section 4729.51 of the Revised Code. If
a licensee conducts a
documented query and relies on the results of
the query in selling or distributing
dangerous drugs at wholesale to the terminal distributor of dangerous drugs,
the licensee shall be deemed not to
have violated division (B) of section
4729.51 of the Revised Code in
making the sale.
|
| (2) |
Division (A)(1) of this section does not apply when a
licensee identified in division (B)(1)(a) of section
4729.52 of the Revised
Code sells or distributes dangerous drugs
at wholesale to any of the following:
| (a) |
A person specified in division (B)(4) of section
4729.51 of the Revised
Code; |
| (b) |
Any of
the persons described in divisions (A)(1) to (13) of section
4729.541 of the Revised Code,
but only if the purchaser is not required to obtain licensure as provided in
divisions (B) to (D) of that section. |
|
|
| (B) |
Before a licensed terminal distributor of dangerous drugs may purchase
dangerous drugs at wholesale, the terminal distributor shall
query the roster established pursuant to section
4729.59 of the Revised Code to
confirm the seller is licensed to
engage in the sale or distribution of dangerous
drugs at wholesale. If no
documented query is conducted
before a purchase is made, it shall be presumed that the purchase of dangerous
drugs by the terminal distributor is in violation of division (F) of section
4729.51 of the Revised Code and
the sale of dangerous drugs by the seller is in violation of division (A) of
section 4729.51 of the Revised Code. If
a licensed terminal distributor of dangerous drugs conducts a documented query at least annually and
relies on the results of the query in purchasing dangerous
drugs at wholesale , the terminal distributor shall be deemed not to
have violated division (F) of section
4729.51 of the Revised Code in
making the purchase.
|
Amended by
132nd General Assembly File No. TBD, HB 49, §101.01, eff.
9/29/2017.
Amended by
131st General Assembly File No. TBD, SB 319, §1,
eff. 4/6/2017.
Amended by
131st General Assembly File No. TBD, HB 200, §1,
eff. 9/8/2016.
Amended by
131st General Assembly File No. TBD, HB 39, §1,
eff. 2/1/2016.
Amended by
131st General Assembly File No. TBD, HB 4, §1,
eff. 7/16/2015.
Amended by
130th General Assembly File No. TBD, HB 296, §1,
eff. 4/21/2014.
Effective Date: 03-09-1999
.
No person shall make or cause to be made
a false or fraudulent license of a
terminal distributor of dangerous drugs or a
manufacturer, outsourcing facility, third-party logistics provider, repackager,
or wholesale distributor of dangerous drugs.
Amended by
132nd General Assembly File No. TBD, HB 49, §101.01, eff.
9/29/2017.
Effective Date:
07-01-1996 .
If a
person licensed under section
4729.52 or
4729.54 of the Revised Code
ceases to engage in the activities for which the license was issued, the
person shall notify the state board of
pharmacy of such fact and shall surrender such license
to the board
within a time frame specified by the board in rules
adopted under section
4729.26 of the Revised
Code; provided, that on dissolution of a partnership by death, the
surviving partner may operate under a license issued to the partnership until expiration,
revocation, or suspension of such license , and the heirs or legal representatives of
deceased persons, and receivers and trustees in bankruptcy appointed by any
competent authority, may operate under the license issued to the persons
succeeded in possession by such heir, representative, receiver, or trustee in
bankruptcy until expiration, revocation, or suspension of such license
.
Amended by
132nd General Assembly File No. TBD, HB 49, §101.01, eff.
9/29/2017.
Effective Date:
01-01-1962 .
Effective Date:
05-18-2005 .
In addition to the remedies provided and irrespective of
whether or not there exists an adequate remedy at law, the board of pharmacy
may apply to the court of common pleas in the county where any of the
provisions of sections
4729.51 to
4729.62 of the Revised Code are
being violated or where any violation described in section
4729.35 of the Revised Code is
occurring for a temporary or permanent injunction restraining any person from
such violation.
Effective Date:
03-14-1985 .
| (A) |
Except
as provided in division (B) of this section, all receipts of the state board of
pharmacy, from any source, shall be deposited into the state treasury to the
credit of the occupational licensing and regulatory fund. All vouchers of the
board shall be approved by the president or executive director of the board, or
both, as authorized by the board. All initial issuance fees and renewal fees
required by sections
4729.01
to
4729.54
of the Revised Code shall be payable by the applicant at the time of making
application. |
| (B) |
| (1) |
There
is hereby created in the state treasury the board of pharmacy drug law
enforcement fund. All moneys that are derived from any fines, mandatory fines,
or forfeited bail to which the board may be entitled under Chapter 2925.,
division (C) of section
2923.42,
or division (B) of section
2925.42
of the Revised Code and all moneys that are derived from forfeitures of
property to which the board may be entitled pursuant to Chapter 2925. or 2981.
of the Revised Code, any other provision of the Revised Code, or federal law
shall be deposited into the fund. Subject to division (B)(2) of this section,
division (B) of section
2923.44,
and divisions (B), (C), and (D) of section
2981.13
of the Revised Code, the moneys in the fund shall be used solely to subsidize
the drug law enforcement efforts of the board. |
| (2) |
There is hereby created in the state treasury the board
of pharmacy federal equitable sharing justice fund and the board of pharmacy
federal equitable sharing treasury fund. Notwithstanding any contrary
provision in the Revised Code, moneys that are derived from forfeitures of
property pursuant to federal law shall be deposited into the board
of pharmacy federal equitable sharing justice fund or board of
pharmacy federal equitable sharing treasury fund
as determined by the source of the
money, shall be used and accounted for in accordance with the applicable
federal law, and the board otherwise shall comply with that law in connection
with the moneys. All investment earnings of the board
of pharmacy federal equitable sharing justice fund shall be credited to that
fund. All investment earnings of the board of pharmacy federal equitable
sharing treasury fund shall be credited to that fund. |
|
| (C) |
All
fines and forfeited bonds assessed and collected under prosecution or
prosecution commenced in the enforcement of this chapter shall be paid to the
executive director of the board within thirty days and by the executive
director paid into the state treasury to the credit of the occupational
licensing and regulatory fund. |
| (D) |
| (1) |
Except
as provided in divisions (D)(2) and (3) of this section, the board, subject to
the approval of the controlling board, may establish fees in excess of the
amounts provided by this chapter, provided that such fees do not exceed the
amounts permitted by this chapter by more than fifty per cent. |
| (2) |
Division (D)(1) of this section does not apply to fees required by this chapter
to be established at amounts adequate to cover designated expenses. |
| (3) |
Fees
established under division (D)(1) of this section or described in division
(D)(2) of this section are subject to the limitation on fee increases specified
in division (A) of section
4729.83
of the Revised Code. |
|
Amended by
133rd General Assembly File No. TBD, HB 166, §101.01, eff.
10/17/2019.
Amended by
130th General Assembly File No. TBD, HB 483, §101.01, eff.
9/15/2014.
Effective Date:
01-01-1999; 07-01-2007
Effective Date:
05-18-2005 .
On receipt of a
notice pursuant to section
3123.43 of the Revised Code, the
state board of pharmacy shall comply with sections
3123.41 to
3123.50 of the Revised Code and
any applicable rules adopted under section
3123.63 of the Revised Code with
respect to a license or certificate of registration issued pursuant to this
chapter.
Amended by
132nd General Assembly File No. TBD, HB 49, §101.01, eff.
9/29/2017.
Effective Date:
03-22-2001 .
The state board of
pharmacy shall adopt rules pursuant to Chapter 119. of the Revised Code
specifying for the purposes of sections
3719.172 and
4729.541 of the Revised
Code the national bodies recognized by the board that certify persons who
successfully complete diabetes education programs.
Amended by
131st General Assembly File No. TBD, SB 319, §1,
eff. 4/6/2017.
Effective Date:
11-06-1996 .
| (A) |
| (1) |
The
state board of pharmacy, in collaboration with the director of mental health
and addiction services and attorney general, shall establish and administer a
drug take-back program under which drugs are collected from the community
by participating entities for the purpose of
destruction or disposal of the drugs. |
| (2) |
Each of the following may participate in the
program:
| (a) |
A law enforcement agency; |
| (b) |
Any registrant authorized by the federal drug
enforcement administration to be a collector pursuant to 21 C.F.R.
1317.40; |
| (c) |
Any other entity specified by the board in
rule. |
|
|
| (B) |
The
program shall be established and administered in such a manner that it does
both of the following:
| (1) |
Complies
with any state or federal laws regarding the collection, destruction, or
disposal of drugs; |
| (2) |
Maintains
the confidentiality of individuals who submit or otherwise provide drugs under
the program. |
|
| (C) |
In
consultation with the director of mental health and addiction services and
attorney general, the board shall adopt rules governing the program. The rules
shall be adopted in accordance with Chapter 119. of the Revised Code. In
adopting the rules, the board shall specify all of the following:
| (1) |
The
entities that may participate; |
| (2) |
Guidelines and responsibilities for accepting drugs by participating
entities; |
| (3) |
Drugs that
may be collected; |
| (4) |
Record-keeping requirements; |
| (5) |
Proper methods to destroy unused drugs; |
| (6) |
Privacy protocols and security standards; |
| (7) |
Drug transportation procedures; |
| (8) |
The
schedule, duration, and frequency of the collections of drugs ; |
| (9) |
Any
other standards and procedures the board considers necessary for purposes of
governing the program. |
|
| (D) |
In
accordance with state and federal law, the board may adopt rules to allow an
entity participating in the program to return any unused drugs to the pharmacy
that originally dispensed the drug. The rules shall include procedures to be
followed to maintain the confidentiality of the person for whom the drug was
dispensed. |
| (E) |
Rules
adopted under this section may not do any of the following:
| (1) |
Require any entity to establish, fund, or operate a drug take-back
program; |
| (2) |
Establish
any new licensing requirement or fee to participate in the program; |
| (3) |
Require any entity to compile data on drugs collected; |
| (4) |
Limit the authority of an entity to collect controlled
substances in accordance with federal law. |
|
| (F) |
The
board may compile data on the amount and type of drugs collected under the
program. For purposes of this division, the board may cooperate with a public
or private entity in obtaining assistance in the compilation of data. An entity
providing the assistance shall not be reimbursed under the program for any
costs incurred in providing the assistance. |
| (G) |
If
the board compiles data under division (F) of this section, the board shall
submit a report to the governor and, in accordance with section
101.68
of the Revised Code, the general assembly. The report, to the extent possible,
shall include the total
weight of drugs collected .
|
| (H) |
No
entity is required to participate in a drug take-back program established under
this section, and no entity shall be subject to civil liability or professional
disciplinary action for declining to participate. |
| (I) |
The
board may accept grants, gifts, or donations for purposes of the program. Money
received under this division shall be deposited into the drug take-back program
fund established under section
109.90
of the Revised Code. |
| (J) |
An ordinance, resolution, or other law that is adopted
by a municipal corporation or other political subdivision on or after the
effective date of this amendment and regulates the collection of drugs for
destruction or disposal shall comply with division (E) of this
section. |
Amended by
132nd General Assembly File No. TBD, SB 229, §1,
eff. 3/22/2019.
Amended by
130th General Assembly File No. 25, HB 59, §101.01, eff.
9/29/2013.
Added by
129th General AssemblyFile No.19, HB 93,
§1, eff.
5/20/2011.
| (A) |
The state board of pharmacy shall make available on
its internet web site information regarding the drug take-back program
established under section
4729.69
of the Revised Code. The information shall include all of the following:
| (1) |
A description of the drugs eligible for collection by
participating entities; |
| (2) |
A description of available options for collection,
including take-back events and collection by receptacle or
mail; |
| (3) |
A directory of participating entities, including the
address, telephone number, and hours of operation for each
entity; |
| (4) |
A list of take-back events, including the date, time,
and location for each event. |
|
| (B) |
The board may engage in other activities designed to
promote public awareness of the drug take-back program. |
Added by
132nd General Assembly File No. TBD, SB 229, §1,
eff.
3/22/2019.
| (A) |
As used in
this section, "cryogenic vessel" means an insulated metal container in the form
of a cylinder or other design used to hold gases that have been liquefied by
extreme reductions in temperature. |
| (B) |
The state board of pharmacy shall establish and
implement a medical gases safety program to ensure that cryogenic vessels
containing medical gases meet the requirements of this section and are properly
handled. The program applies only to cryogenic vessels that are portable and
contain medical gases in a volume intended for use in administering direct
treatment to one or more individuals. The program does not apply to cylinders
or containers of other designs that contain medical gases that are only
compressed. |
| (C) |
Each cryogenic
vessel subject to this section shall meet the following requirements:
| (1) |
The vessel shall be properly labeled
according to the medical gas contained in the vessel. |
| (2) |
The vessel shall be color coded as
follows:
| (b) |
Carbon dioxide - gray; |
| (c) |
Cyclopropane - orange; |
| (f) |
Nitrous oxide - blue; |
| (g) |
Oxygen - green. The colors specified in
this division shall not be used for any medical gas other than those specified
in this division. |
|
| (3) |
The
color coding specified in division (C)(2) of this section shall be applied to
the vessel by doing either of the following:
| (a) |
Applying the appropriate color to the top
six inches of the body of the vessel; |
| (b) |
Affixing a wrap to the vessel that
encircles the vessel completely, has the identity of the contained gas printed
completely or continuously around the wrap, and uses the appropriate color as
the print or background for the identity of the gas. |
|
| (4) |
The vessel shall not have previously
contained a gas that is not a medical gas. |
| (5) |
When the vessel is being reused for a
medical gas other than the medical gas it previously contained, new labeling
and color coding shall be applied to the vessel and all old labeling and color
coding shall be completely removed. |
| (6) |
The connector between the vessel and the
valve through which the medical gas is delivered shall be either of the
following:
| (a) |
A threaded or socket
connection that is silver brazed or welded to the valve; |
| (b) |
A permanent and integral part of the
valve. |
|
|
| (D) |
No
person shall remove a connector between a cryogenic vessel subject to this
section and the valve through which the medical gas is delivered from the
vessel, replace the connector with another connector, or attach an adapter to
the vessel or connector unless the person meets standards established by the
board in rules adopted under this section. A person who violates this division
is guilty of tampering with drugs pursuant to section
2925.24 of the Revised Code.
|
| (E) |
All employees who are
responsible for installing or changing the cryogenic vessels subject to this
section shall be trained in the proper handling of medical gases and cryogenic
vessels, including training in understanding the labeling of the vessels and
recognizing the color coding required by this section. |
| (F) |
The board shall adopt rules to implement the
medical gases safety program established pursuant to this section. The rules
shall be adopted in accordance with Chapter 119. of the Revised Code. The
board's rules shall specify standards and procedures to be followed in ensuring
that the individuals who modify existing cryogenic vessels for purposes of
bringing the vessels into compliance with this section are qualified
individuals. The board's standards for being considered qualified shall include
requirements for knowledge in proper safety precautions concerning medical
gases, cryogenic vessels that contain medical gases, and devices through which
medical gases are delivered from cryogenic vessels. |
Effective Date:
03-15-2002 .
The state board of
pharmacy may establish and maintain a drug database. The board shall use the
drug database to monitor the misuse and diversion of the following: controlled
substances, as defined in section
3719.01
of the Revised Code; medical marijuana, as authorized under Chapter 3796. of
the Revised Code; and other dangerous drugs the board includes in the database
pursuant to rules adopted under section
4729.84
of the Revised Code.
The board also shall use the drug database to monitor
naltrexone.
In establishing and maintaining the database, the
board shall electronically collect information pursuant to sections
4729.77,
4729.771, 4729.772,
4729.78,
and
4729.79
of the Revised Code and shall disseminate information as authorized or required
by sections
4729.80
and
4729.81
of the Revised Code. The board's collection and dissemination of information
shall be conducted in accordance with rules adopted under section
4729.84
of the Revised Code.
Amended by
132nd General Assembly File No. TBD, SB 119, §1,
eff. 3/20/2019.
Amended by
132nd General Assembly File No. TBD, HB 49, §101.01, eff.
9/29/2017.
Amended by
131st General Assembly File No. TBD, HB 523, §1,
eff. 9/8/2016.
Amended by
129th General AssemblyFile No.19, HB 93,
§1, eff.
5/20/2011.
Effective Date: 05-18-2005
.
If the state board of pharmacy establishes and maintains a drug
database pursuant to section
4729.75 of the Revised Code, the
executive director of the board shall do all of the following:
| (A) |
Employ an administrator to manage and
direct the duties of staff employed to operate the drug database. The
administrator shall be a person who has had training and experience in areas
related to the duties of the database. |
| (B) |
Employ such professional, technical, and clerical
employees as are necessary, and employ or hire on a consulting basis other
technical services required for the operation of the database; |
| (C) |
Fix the compensation of the
administrator and all other staff employed to operate the database. |
Effective Date:
05-18-2005 .
| (A) |
If the state board of pharmacy establishes and maintains a drug database
pursuant to section 4729.75 of the Revised Code,
each pharmacy licensed as a terminal distributor of dangerous drugs that
dispenses drugs to patients in this state and is included in the types of
pharmacies specified in rules adopted under section
4729.84 of the Revised Code
shall submit to the board the following prescription information:
| (1) |
Terminal distributor identification; |
| (2) |
Patient identification; |
| (3) |
Prescriber identification; |
| (4) |
Date prescription was issued by prescriber; |
| (5) |
Date drug was dispensed; |
| (6) |
Indication of whether the drug dispensed is new or a refill; |
| (7) |
Name, strength, and national drug code of the drug dispensed; |
| (8) |
Quantity of drug dispensed; |
| (9) |
Number of days' supply of drug dispensed; |
| (10) |
Serial
or prescription number assigned by the terminal distributor; |
| (11) |
Source
of payment for the drug dispensed; |
| (12) |
Any other data fields recognized by the American
society for automation in pharmacy and specified in rules adopted under section
4729.84 of the Revised
Code. |
|
| (B) |
| (1) |
The information shall be transmitted as specified by the board in rules adopted
under section 4729.84 of the Revised
Code. |
| (2) |
The
information shall be submitted electronically in the format specified by the
board, except that the board may grant a waiver allowing the distributor to
submit the information in another format. |
| (3) |
The information shall be submitted in accordance with any time limits specified
by the board, except that the board may grant an extension if either of the
following occurs:
| (a) |
The
distributor suffers a mechanical or electronic failure, or cannot meet the
deadline for other reasons beyond the distributor's control. |
| (b) |
The board is unable to receive electronic submissions. |
|
|
| (C) |
This
section does not apply to a prescriber personally furnishing or administering
dangerous drugs to the prescriber's patient. |
Amended by
132nd General Assembly File No. TBD, HB 49, §101.01, eff.
9/29/2017.
Amended by
129th General AssemblyFile No.19, HB 93,
§1, eff.
5/20/2011.
Effective Date: 05-18-2005
.
| (A) |
If the state board of
pharmacy establishes and maintains a drug database pursuant to section
4729.75 of the Revised Code,
each retail dispensary licensed under Chapter 3796. of the Revised Code by the
board shall submit to the board the information regarding medical marijuana
dispensed to a patient as specified by the board in rules adopted under section
4729.84 of the Revised
Code. |
| (B) |
| (1) |
The information shall be
transmitted as specified by the board in rules adopted under section
4729.84 of the Revised
Code. |
| (2) |
The information shall be
submitted in accordance with any time limits specified by the board, except
that the board may grant an extension if either of the following occurs:
| (a) |
The retail dispensary's transmission system suffers a
mechanical or electronic failure or the retail dispensary cannot meet the
deadline for other reasons beyond the dispensary's control. |
| (b) |
The board is unable to receive electronic
submissions. |
|
|
| (C) |
The information required to be submitted under
division (A) of this section may be submitted on behalf of the retail
dispensary by a delegate approved by that dispensary. |
Added by
131st General Assembly File No. TBD, HB 523, §1,
eff. 9/8/2016.
| (A) |
If the state board of pharmacy establishes and
maintains a drug database pursuant to section
4729.75 of the Revised Code, in
addition to the information required to be submitted under sections
4729.77,
4729.771,
4729.78, and
4729.79 of the Revised Code, the
board may accept information from other sources, including other state
agencies, to the extent the information is related to monitoring the misuse and
diversion of drugs as set forth in section
4729.75 of the Revised
Code. |
| (B) |
Any information submitted pursuant to this section
shall be transmitted as specified by the board in rules adopted under section
4729.84 of the Revised
Code. |
Added by
132nd General Assembly File No. TBD, HB 49, §101.01, eff.
9/29/2017.
| (A) |
If the state board of pharmacy establishes and maintains a drug database
pursuant to section 4729.75 of the Revised Code,
each manufacturer of dangerous drugs, outsourcing
facility, repackager of dangerous drugs, or wholesale distributor of
dangerous drugs that delivers drugs to prescribers or terminal distributors of dangerous drugs
shall submit to the board the following purchase information:
| (1) |
Purchaser identification; |
| (2) |
Identification of the drug sold; |
| (3) |
Quantity of the drug sold; |
| (5) |
The
license number
issued by the board. |
|
| (B) |
| (1) |
The information shall be transmitted as specified by the board in rules adopted
under section 4729.84 of the Revised
Code. |
| (2) |
The
information shall be submitted electronically in the format specified by the
board, except that the board may grant a waiver allowing
submission of the information in another
format. |
| (3) |
The
information shall be submitted in accordance with any time limits specified by
the board, except that the board may grant an extension if either of the
following occurs:
| (a) |
The
manufacturer, outsourcing facility, repackager, or
wholesale distributor suffers a mechanical or electronic failure, or
cannot meet the deadline for other reasons beyond the
person's control. |
| (b) |
The board is unable to receive electronic submissions. |
|
|
Amended by
132nd General Assembly File No. TBD, HB 49, §101.01, eff.
9/29/2017.
Amended by
129th General AssemblyFile No.19, HB 93,
§1, eff.
5/20/2011.
Effective Date: 05-18-2005
.
| (A) |
If the state
board of pharmacy establishes and maintains a drug database pursuant to section
4729.75
of the Revised Code, each licensed health professional authorized to prescribe
drugs, except as provided in division (C) of this section, who personally
furnishes to a patient a controlled substance,
naltrexone, or other dangerous drug the board includes in the database
pursuant to rules adopted under section
4729.84
of the Revised Code shall submit to the board the following information:
| (1) |
Prescriber identification; |
| (2) |
Patient identification; |
| (3) |
Date drug was furnished by the prescriber; |
| (4) |
Indication of whether the drug furnished is new or a refill; |
| (5) |
Name, strength, and national drug code of drug furnished; |
| (6) |
Quantity of drug furnished; |
| (7) |
Number of days' supply of drug furnished; |
| (8) |
Source of payment for the drug furnished; |
| (9) |
Identification of the owner of the drug furnished. |
|
| (B) |
| (1) |
The
information shall be transmitted as specified by the board in rules adopted
under section
4729.84
of the Revised Code. |
| (2) |
The
information shall be submitted electronically in the format specified by the
board, except that the board may grant a waiver allowing the prescriber to
submit the information in another format. |
| (3) |
The
information shall be submitted in accordance with any time limits specified by
the board, except that the board may grant an extension if either of the
following occurs:
| (a) |
The
prescriber's transmission system suffers a mechanical or electronic failure, or
the prescriber cannot meet the deadline for other reasons beyond the
prescriber's control. |
| (b) |
The board is
unable to receive electronic submissions. |
|
|
| (C) |
| (1) |
The
information required to be submitted under division (A) of this section may be
submitted on behalf of the prescriber by the owner of the drug being personally
furnished or by a delegate approved by that owner. |
| (2) |
The
requirements of this section to submit information to the board do not apply to
a prescriber who is a veterinarian. |
|
| (D) |
If
the board becomes aware of a prescriber's failure to comply with this section,
the board shall notify the government entity responsible for licensing the
prescriber. |
Amended by
132nd General Assembly File No. TBD, SB 119, §1,
eff. 3/20/2019.
Amended by
129th General AssemblyFile No.156, SB 301,
§1, eff.
3/13/2013.
Added by
129th General AssemblyFile No.19, HB 93,
§1, eff.
5/20/2011.
| (A) |
If the state
board of pharmacy establishes and maintains a drug database pursuant to section
4729.75 of the Revised Code, the
board is authorized or required to provide information from the database only
as follows:
| (1) |
On receipt
of a request from a designated representative of a government entity
responsible for the licensure, regulation, or discipline of health care
professionals with authority to prescribe, administer, or dispense drugs, the
board may provide to the representative information from the database relating
to the professional who is the subject of an active investigation being
conducted by the government entity or relating to a professional who is acting
as an expert witness for the government entity in such an
investigation. |
| (2) |
On receipt
of a request from a federal officer, or a state or local officer of this or any
other state, whose duties include enforcing laws relating to drugs, the board
shall provide to the officer information from the database relating to the
person who is the subject of an active investigation of a drug abuse offense,
as defined in section
2925.01 of the Revised Code,
being conducted by the officer's employing government entity. |
| (3) |
Pursuant to a subpoena issued by a grand jury, the board shall provide to the
grand jury information from the database relating to the person who is the
subject of an investigation being conducted by the grand jury. |
| (4) |
Pursuant to a subpoena, search warrant, or court order in connection with the
investigation or prosecution of a possible or alleged criminal offense, the
board shall provide information from the database as necessary to comply with
the subpoena, search warrant, or court order. |
| (5) |
On
receipt of a request from a prescriber or the prescriber's delegate approved by
the board, the board shall provide to the prescriber a report of information
from the database relating to a patient who is either a current patient of the
prescriber or a potential patient of the prescriber based on a referral of the
patient to the prescriber, if all of the following conditions are met:
| (a) |
The
prescriber certifies in a form specified by the board that it is for the
purpose of providing medical treatment to the patient who is the subject of the
request; |
| (b) |
The
prescriber has not been denied access to the database by the board. |
|
| (6) |
On receipt
of a request from a pharmacist or the pharmacist's delegate approved by the
board, the board shall provide to the pharmacist information from the database
relating to a current patient of the pharmacist, if the pharmacist certifies in
a form specified by the board that it is for the purpose of the pharmacist's
practice of pharmacy involving the patient who is the subject of the request
and the pharmacist has not been denied access to the database by the
board. |
| (7) |
On receipt
of a request from an individual seeking the individual's own database
information in accordance with the procedure established in rules adopted under
section 4729.84 of the Revised Code, the
board may provide to the individual the individual's own prescription
history. |
| (8) |
On receipt
of a request from a medical director or a pharmacy director of a managed care
organization that has entered into a contract with the department of medicaid
under section 5167.10 of the Revised Code and
a data security agreement with the board required by section
5167.14 of the Revised Code, the
board shall provide to the medical director or the pharmacy director
information from the database relating to a medicaid recipient enrolled in the
managed care organization, including information in the database related to
prescriptions for the recipient that were not covered or reimbursed under a
program administered by the department of medicaid. |
| (9) |
On
receipt of a request from the medicaid director, the board shall provide to the
director information from the database relating to a recipient of a program
administered by the department of medicaid, including information in the
database related to prescriptions for the recipient that were not covered or
paid by a program administered by the department. |
| (10) |
On
receipt of a request from a medical director of a managed care organization
that has entered into a contract with the administrator of workers'
compensation under division (B)(4) of section
4121.44 of the Revised Code and
a data security agreement with the board required by section
4121.447 of the Revised Code,
the board shall provide to the medical director information from the database
relating to a claimant under Chapter 4121., 4123., 4127., or 4131. of the
Revised Code assigned to the managed care organization, including information
in the database related to prescriptions for the claimant that were not covered
or reimbursed under Chapter 4121., 4123., 4127., or 4131. of the Revised Code,
if the administrator of workers' compensation confirms, upon request from the
board, that the claimant is assigned to the managed care
organization. |
| (11) |
On receipt
of a request from the administrator of workers' compensation, the board shall
provide to the administrator information from the database relating to a
claimant under Chapter 4121., 4123., 4127., or 4131. of the Revised Code,
including information in the database related to prescriptions for the claimant
that were not covered or reimbursed under Chapter 4121., 4123., 4127., or 4131.
of the Revised Code. |
| (12) |
On receipt
of a request from a prescriber or the prescriber's delegate approved by the
board, the board shall provide to the prescriber information from the database
relating to a patient's mother, if the prescriber certifies in a form specified
by the board that it is for the purpose of providing medical treatment to a
newborn or infant patient diagnosed as opioid dependent and the prescriber has
not been denied access to the database by the board. |
| (13) |
On
receipt of a request from the director of health, the board shall provide to
the director information from the database relating to the duties of the
director or the department of health in implementing the Ohio violent death
reporting system established under section
3701.93 of the Revised
Code. |
| (14) |
On receipt
of a request from a requestor described in division (A)(1), (2), (5), or (6) of
this section who is from or participating with another state's prescription
monitoring program, the board may provide to the requestor information from the
database, but only if there is a written agreement under which the information
is to be used and disseminated according to the laws of this state. |
| (15) |
On
receipt of a request from a delegate of a retail dispensary licensed under
Chapter 3796. of the Revised Code who is approved by the board to serve as the
dispensary's delegate, the board shall provide to the delegate a report of
information from the database pertaining only to a patient's use of medical
marijuana, if both of the following conditions are met:
| (a) |
The
delegate certifies in a form specified by the board that it is for the purpose
of dispensing medical marijuana for use in accordance with Chapter 3796. of the
Revised Code. |
| (b) |
The retail
dispensary or delegate has not been denied access to the database by the
board. |
|
| (16) |
On receipt
of a request from a judge of a program certified by the Ohio supreme court as a
specialized docket program for drugs, the board shall provide to the judge, or
an employee of the program who is designated by the judge to receive the
information, information from the database that relates specifically to a
current or prospective program participant. |
| (17) |
On
receipt of a request from a coroner, deputy coroner, or coroner's delegate
approved by the board, the board shall provide to the requestor information
from the database relating to a deceased person about whom the coroner is
conducting or has conducted an autopsy or investigation. |
| (18) |
On
receipt of a request from a prescriber, the board may provide to the prescriber
a summary of the prescriber's prescribing record if such a record is created by
the board. Information in the summary is subject to the confidentiality
requirements of this chapter. |
| (19) |
| (a) |
On
receipt of a request from a pharmacy's responsible person, the board may
provide to the responsible person a summary of the pharmacy's dispensing record
if such a record is created by the board. Information in the summary is subject
to the confidentiality requirements of this chapter. |
| (b) |
As
used in division (A)(19)(a) of this section, "responsible person" has the same
meaning as in rules adopted by the board under section
4729.26 of the Revised
Code. |
|
| (20) |
The board
may provide information from the database without request to a prescriber or
pharmacist who is authorized to use the database pursuant to this
chapter. |
| (21) |
| (a) |
On
receipt of a request from a prescriber or pharmacist, or the prescriber's or
pharmacist's delegate, who is a designated representative of a peer review
committee, the board shall provide to the committee information from the
database relating to a prescriber who is subject to the committee's evaluation,
supervision, or discipline if the information is to be used for one of those
purposes. The board shall provide only information that it determines, in
accordance with rules adopted under section
4729.84 of the Revised Code, is
appropriate to be provided to the committee. |
| (b) |
As
used in division (A)(21)(a) of this section, "peer review committee" has the
same meaning as in section
2305.25 of the Revised Code,
except that it includes only a peer review committee of a hospital or a peer
review committee of a nonprofit health care corporation that is a member of the
hospital or of which the hospital is a member. |
|
| (22) |
On receipt of a request from a requestor described in
division (A)(5) or (6) of this section who is from or participating with a
prescription monitoring program that is operated by a federal agency and
approved by the board, the board may provide to the requestor information from
the database, but only if there is a written agreement under which the
information is to be used and disseminated according to the laws of this
state. |
| (23) |
Any
personal health information submitted to the board pursuant to section
4729.772 of the Revised Code may
be provided by the board only as authorized by the submitter of the information
and in accordance with rules adopted under section
4729.84 of the Revised
Code. |
|
| (B) |
The state
board of pharmacy shall maintain a record of each individual or entity that
requests information from the database pursuant to this section. In accordance
with rules adopted under section
4729.84 of the Revised Code, the
board may use the records to document and report statistics and law enforcement
outcomes. The board may provide
records of an individual's requests for database information only to the
following:
| (1) |
A designated
representative of a government entity that is responsible for the licensure,
regulation, or discipline of health care professionals with authority to
prescribe, administer, or dispense drugs who is involved in an active criminal
or disciplinary investigation being conducted by the government entity of the
individual who submitted the requests for database information; |
| (2) |
A
federal officer, or a state or local officer of this or any other state, whose
duties include enforcing laws relating to drugs and who is involved in an
active investigation being conducted by the officer's employing government
entity of the individual who submitted the requests for database
information; |
| (3) |
A designated
representative of the department of medicaid regarding a prescriber who is
treating or has treated a recipient of a program administered by the department
and who submitted the requests for database information. |
|
| (C) |
Information contained in the database and any information obtained from it is
confidential and is not a public record. Information contained in the records
of requests for information from the database is confidential and is not a
public record. Information contained in the database that does not identify a
person, including any licensee or registrant of the board or other entity, may
be released in summary, statistical, or aggregate form. |
| (D) |
A
pharmacist or prescriber shall not be held liable in damages to any person in
any civil action for injury, death, or loss to person or property on the basis
that the pharmacist or prescriber did or did not seek or obtain information
from the database. |
Amended by
133rd General Assembly File No. 166, HB 341, §1,
eff. 12/16/2020.
Amended by
132nd General Assembly File No. TBD, HB 49, §101.01, eff.
9/29/2017.
Amended by
131st General Assembly File No. TBD, HB 523, §1,
eff. 9/8/2016.
Amended by
131st General Assembly File No. TBD, HB 64, §101.01, eff.
9/29/2015.
Amended by
130th General Assembly File No. TBD, HB 493, §1,
eff. 9/17/2014.
Amended by
130th General Assembly File No. TBD, HB 341, §1,
eff. 9/16/2014.
Amended by
130th General Assembly File No. TBD, HB 483, §101.01, eff.
9/15/2014.
Amended by
130th General Assembly File No. 25, HB 59, §101.01, eff.
9/29/2013.
Amended by
129th General AssemblyFile No.156, SB 301,
§1, eff.
3/13/2013.
Renumbered and amended by
129th General AssemblyFile No.19, HB 93,
§1, eff.
5/20/2011.
Effective Date: 05-18-2005
.
If the state board of
pharmacy establishes and maintains a drug database pursuant to section 4729.75
of the Revised Code, the board shall review the information in the drug
database. If the board determines from the review that a violation of law may
have occurred, it shall notify the appropriate law enforcement agency or a
government entity responsible for the licensure, regulation, or discipline of
licensed health professionals authorized to prescribe drugs and supply
information required by the agency or entity for an investigation of the
violation of law that may have occurred. The board also
shall notify the medicaid director if the board determines that the violation
may have been committed by a provider of services under a program administered
by the department of medicaid.
Amended by
130th General Assembly File No. 25, HB 59, §101.01, eff.
9/29/2013.
Renumbered and amended by
129th General AssemblyFile No.19, HB 93,
§1, eff.
5/20/2011.
Effective Date: 05-18-2005
.
| (A) |
If the state board of pharmacy establishes a drug database pursuant to section
4729.75 of the Revised Code, the
information collected for the database shall be retained in the database
and accessible to persons listed in division (A) of
section 4729.80 of the Revised
Code for at least five years. |
| (B) |
Except as provided in division (C) of this section,
any information that identifies a patient shall be destroyed after it has
been retained for five years unless a law enforcement agency or a
government entity responsible for the licensure, regulation, or discipline of
licensed health professionals authorized to prescribe drugs has submitted a
written request to the board for retention of the information in accordance
with rules adopted by the board under section
4729.84 of the Revised
Code. |
| (C) |
The board may retain information that identifies a
patient for a period in excess of five years if the board considers retention
of the information necessary to serve an investigatory or public health
purpose. |
Amended by
132nd General Assembly File No. TBD, HB 49, §101.01, eff.
9/29/2017.
Amended by
131st General Assembly File No. TBD, HB 64, §101.01, eff.
9/29/2015.
Renumbered and amended by
129th General AssemblyFile No.19, HB 93,
§1, eff.
5/20/2011.
Effective Date: 05-18-2005
.
| (A) |
If the state board of pharmacy establishes and maintains a drug database
pursuant to section 4729.75 of the Revised Code, the
board may use, for the purpose of establishing or maintaining the database, any
portion of the licensure or registration fees
collected under this chapter. The board shall not
increase the amount of any of those fees solely for the purpose of establishing
or maintaining the database. The board shall not
impose any charge on a prescriber for the establishment or maintenance of the
database. The board shall not charge any fees for the transmission of data to
the database or for the receipt of information from the database, except that
the board may charge a fee in accordance with rules adopted under section
4729.84 of the Revised Code to
an individual who requests the individual's own database information under
section 4729.80 of the Revised
Code.
|
| (B) |
The
board may accept grants, gifts, or donations for purposes of the drug database.
Any money received shall be deposited into the state treasury to the credit of
the drug database fund, which is hereby created. Money in the fund shall be
used solely for purposes of the drug database. |
Amended by
132nd General Assembly File No. TBD, HB 49, §101.01, eff.
9/29/2017.
Amended by
130th General Assembly File No. TBD, HB 483, §101.01, eff.
9/15/2014.
Renumbered and amended by
129th General AssemblyFile No.19, HB 93,
§1, eff.
5/20/2011.
Effective Date: 05-18-2005
.
For purposes of
establishing and maintaining a drug database pursuant to section
4729.75 of the Revised Code, the
state board of pharmacy shall adopt rules in accordance with Chapter 119. of
the Revised Code to carry out and enforce sections
4729.75 to
4729.83 of the Revised Code. The
rules shall specify all of the following:
| (A) |
A means of identifying each patient, each terminal distributor of dangerous
drugs, each purchase at wholesale of dangerous drugs, and each retail
dispensary licensed under Chapter 3796. of the Revised Code about which
information is entered into the drug database; |
| (B) |
Requirements for the transmission of information from terminal distributors of
dangerous drugs, manufacturers of dangerous drugs,
outsourcing facilities, repackagers of dangerous drugs, wholesale
distributors of dangerous drugs, prescribers, and retail
dispensaries; |
| (C) |
An
electronic format for the submission of information from
persons
identified in division (B) of this section; |
| (D) |
A procedure whereby a person unable to submit information
electronically may obtain a waiver to submit information in another
format; |
| (E) |
A
procedure whereby the board may grant a request from a law enforcement agency
or a government entity responsible for the licensure, regulation, or discipline
of licensed health professionals authorized to prescribe drugs that information
that has been stored for three years be retained when the information pertains
to an open investigation being conducted by the agency or entity; |
| (F) |
A procedure whereby a person identified in division (B) of this section
may apply for an extension to the time by which information must be transmitted
to the board; |
| (G) |
A
procedure whereby a person or government entity to which the board is
authorized to provide information may submit a request to the board for the
information and the board may verify the identity of the requestor; |
| (H) |
Standards for determining what information is
appropriate to be provided under division (A)(21) of section
4729.80 of the Revised
Code; |
| (I) |
A
procedure whereby the board can use the database request records required by
division (B) of section
4729.80 of the Revised Code to
document and report statistics and law enforcement outcomes; |
| (J) |
A procedure
whereby an individual may request the individual's own database information and
the board may verify the identity of the requestor; |
| (K) |
A reasonable fee
that the board may charge under section
4729.83 of the Revised Code for
providing an individual with the individual's own database information pursuant
to section 4729.80 of the Revised
Code; |
| (L) |
The other
specific dangerous drugs that, in addition to controlled substances, must be
included in the database; |
| (M) |
The types of
pharmacies licensed as terminal distributors of dangerous drugs that are
required to submit prescription information to the board pursuant to section
4729.77 of the Revised
Code; |
| (N) |
Additional data fields, recognized by the American
society for automation in pharmacy, that licensed terminal distributors of
dangerous drugs must submit to the board pursuant to section
4729.77 of the Revised
Code; |
| (O) |
The
information regarding medical marijuana dispensed to a patient that a retail
dispensary is required to submit to the board pursuant to section
4729.771 of the Revised Code; |
| (P) |
Requirements for the transmission of information
pursuant to section 4729.772 of the Revised Code and requirements for the
release of such information by the board. |
Amended by
132nd General Assembly File No. TBD, HB 49, §101.01, eff.
9/29/2017.
Amended by
131st General Assembly File No. TBD, HB 523, §1,
eff. 9/8/2016.
Amended by
131st General Assembly File No. TBD, HB 64, §101.01, eff.
9/29/2015.
Renumbered and amended by
129th General AssemblyFile No.19, HB 93,
§1, eff.
5/20/2011.
Effective Date: 05-18-2005
.
If the state board of
pharmacy establishes and maintains a drug database pursuant to section
4729.75
of the Revised Code, the board shall prepare reports regarding the database and
present or submit them in accordance with both of the following:
| (A) |
The
board shall present a biennial report to the standing committees of the house
of representatives and the senate that are primarily responsible for
considering health and human services issues. Each report shall include all of
the following:
| (1) |
The cost to
the state of establishing and maintaining the database; |
| (2) |
Information from the board, terminal distributors of dangerous drugs,
prescribers, and retail dispensaries licensed under Chapter 3796. of the
Revised Code regarding the board's effectiveness in providing information from
the database; |
| (3) |
The board's
timeliness in transmitting information from the database. |
|
| (B) |
The
board shall submit a semiannual report to the governor, the president of the
senate, the speaker of the house of representatives, the attorney general, the
chairpersons of the standing committees of the house of representatives and the
senate that are primarily responsible for considering health and human services
issues, the department of public safety, the state dental board, the board of
nursing, the state vision professionals board, the state medical board, and the
state veterinary medical licensing board. The state board of pharmacy shall
make the report available to the public on its internet web site. Each report
submitted shall include all of the following for the period covered by the
report:
| (1) |
An aggregate
of the information submitted to the board under section
4729.77
of the Revised Code regarding prescriptions for controlled substances
containing opioids, including all of the following:
| (a) |
The
number of prescribers who issued the prescriptions; |
| (b) |
The
number of patients to whom the controlled substances were dispensed; |
| (c) |
The
average quantity of the controlled substances dispensed per
prescription; |
| (d) |
The average
daily morphine equivalent dose of the controlled substances dispensed per
prescription. |
|
| (2) |
An
aggregate of the information submitted to the board under section
4729.79
of the Revised Code regarding controlled substances containing opioids that
have been personally furnished to a patient by a prescriber, other than a
prescriber who is a veterinarian, including all of the following:
| (a) |
The
number of prescribers who personally furnished the controlled
substances; |
| (b) |
The number
of patients to whom the controlled substances were personally
furnished; |
| (c) |
The average
quantity of the controlled substances that were furnished at one
time; |
| (d) |
The average
daily morphine equivalent dose of the controlled substances that were furnished
at one time. |
|
| (3) |
An
aggregate of the information submitted to the board under section 4729.771 of
the Revised Code regarding medical marijuana; |
| (4) |
An aggregate of the information submitted to the board
under sections
4729.77
and
4729.79
of the Revised Code regarding naltrexone, including all of the following:
| (a) |
The number of prescribers who issued the prescriptions
for or personally furnished the drug; |
| (b) |
The number of patients to whom the drug was dispensed
or personally furnished; |
| (c) |
The average quantity of the drug dispensed per
prescription or furnished at one time. |
|
|
Amended by
132nd General Assembly File No. TBD, SB 119, §1,
eff. 3/20/2019.
Amended by
132nd General Assembly File No. TBD, HB 49, §130.11, eff.
1/21/2018.
Amended by
131st General Assembly File No. TBD, HB 523, §1,
eff. 9/8/2016.
Amended by
130th General Assembly File No. TBD, SB 276, §1,
eff. 3/19/2015.
Amended by
130th General Assembly File No. TBD, HB 394, §1,
eff. 3/19/2015.
Renumbered by
129th General AssemblyFile No.19, HB 93,
§1, eff.
5/20/2011.
Effective Date: 05-18-2005
.
If the state board
of pharmacy establishes and maintains a drug database pursuant to section
4729.75
of the Revised Code, all of the following apply:
| (A) |
| (1) |
No
person identified in divisions (A)(1) to (13), (15) to
(23),
or (B) of section
4729.80
of the Revised Code shall disseminate any written or electronic information the
person receives from the drug database or otherwise provide another person
access to the information that the person receives from the database, except as
follows:
| (a) |
When
necessary in the investigation or prosecution of a possible or alleged criminal
offense; |
| (b) |
When a
person provides the information to the prescriber, pharmacist, or retail
dispensary licensed under Chapter 3796. of the Revised Code for whom the person
is approved by the board to serve as a delegate of the prescriber, pharmacist,
or retail dispensary for purposes of requesting and receiving information from
the drug database under division (A)(5), (6), or (15) of section
4729.80
of the Revised Code; |
| (c) |
When a
prescriber, pharmacist, or retail dispensary licensed under Chapter 3796. of
the Revised Code provides the information to a person who is approved by the
board to serve as such a delegate of the prescriber, pharmacist, or retail
dispensary; |
| (d) |
When a
prescriber or pharmacist includes the information in a medical record, as
defined in section
3701.74
of the Revised Code. |
|
| (2) |
No
person shall provide false information to the state board of pharmacy with the
intent to obtain or alter information contained in the drug database. |
| (3) |
No
person shall obtain drug database information by any means except as provided
under section
4729.80
or
4729.81
of the Revised Code. |
|
| (B) |
A
person shall not use information obtained pursuant to division (A) of section
4729.80
of the Revised Code as evidence in any civil or administrative
proceeding. |
| (C) |
| (1) |
Except
as provided in division (C)(2) of this section, after providing notice and
affording an opportunity for a hearing in accordance with Chapter 119. of the
Revised Code, the board may restrict a person from obtaining further
information from the drug database if any of the following is the case:
| (a) |
The
person violates division (A)(1), (2), or (3) of this section; |
| (b) |
The
person is a requestor identified in division (A)(14) or
(22) of section
4729.80
of the Revised Code and the board determines that the person's actions in
another state would have constituted a violation of division (A)(1), (2), or
(3) of this section; |
| (c) |
The
person fails to comply with division (B) of this section, regardless of the
jurisdiction in which the failure to comply occurred; |
| (d) |
The
person creates, by clear and convincing evidence, a threat to the security of
information contained in the database. |
|
| (2) |
If the
board determines that allegations regarding a person's actions warrant
restricting the person from obtaining further information from the drug
database without a prior hearing, the board may summarily impose the
restriction. A telephone conference call may be used for reviewing the
allegations and taking a vote on the summary restriction. The summary
restriction shall remain in effect, unless removed by the board, until the
board's final adjudication order becomes effective. |
| (3) |
The
board shall determine the extent to which the person is restricted from
obtaining further information from the database. |
|
Amended by
133rd General Assembly File No. TBD, HB 166, §101.01, eff.
10/17/2019.
Amended by
132nd General Assembly File No. TBD, HB 49, §101.01, eff.
9/29/2017.
Amended by
131st General Assembly File No. TBD, HB 523, §1,
eff. 9/8/2016.
Amended by
131st General Assembly File No. TBD, HB 64, §101.01, eff.
9/29/2015.
Amended by
130th General Assembly File No. TBD, SB 276, §1,
eff. 3/19/2015.
Amended by
130th General Assembly File No. TBD, HB 394, §1,
eff. 3/19/2015.
Amended by
130th General Assembly File No. TBD, HB 493, §1,
eff. 9/17/2014.
Amended by
130th General Assembly File No. TBD, HB 341, §1,
eff. 9/16/2014.
Amended by
130th General Assembly File No. TBD, HB 483, §101.01, eff.
9/15/2014.
Amended by
129th General AssemblyFile No.156, SB 301,
§1, eff.
3/13/2013.
Added by
129th General AssemblyFile No.19, HB 93,
§1, eff.
5/20/2011.
If the state board of pharmacy establishes and
maintains a drug database pursuant to section 4729.75 of the Revised Code and
if the board restricts a prescriber from obtaining further information from the
database pursuant to division (C) of section 4729.86 of the Revised Code, the
board shall notify the government entity responsible for licensing the
prescriber.
Added by
130th General Assembly File No. TBD, HB 341, §1,
eff. 1/1/2015.
Added by
130th General Assembly File No. TBD, HB 483, §101.01, eff.
1/1/2015.
The state board of pharmacy shall comply with section
4776.20 of the Revised Code.
Added by
129th General AssemblyFile No.169, HB 247,
§1, eff.
3/22/2013.
Notwithstanding any provision of this chapter or rule
adopted by the state board of pharmacy, a pharmacist may dispense epinephrine
autoinjectors pursuant to a prescription issued under section
4723.483. 4730.432. or 4731.96
of the Revised Code.
A pharmacist who in good faith dispenses epinephrine
autoinjectors under 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
autoinjector is dispensed: damages in any civil action, prosecution in any
criminal proceeding, or professional disciplinary action.
Added by
131st General Assembly File No. TBD, HB 200, §1,
eff. 9/8/2016.
| (A) |
As used in this section,
"eligible patient," "investigational drug, product, or device," "terminal
condition," and "treating physician" have the same meanings as in section
4731.97 of the Revised Code. |
| (B) |
A manufacturer of dangerous drugs may, in accordance
with section 4731.97 of the Revised Code, provide an investigational drug,
product, or device for treatment of a terminal condition to an eligible patient
or to the treating physician who is treating the eligible patient's terminal
condition. In doing so, the manufacturer may do all of the following:
| (1) |
Provide the investigational drug, product, or device
to the eligible patient or treating physician directly or through a terminal
distributor of dangerous drugs; |
| (2) |
Provide the investigational drug, product, or device
either with or without charge for the costs associated with manufacturing and
providing the investigational drug, product, or device; |
| (3) |
Require the eligible patient to participate in data
collection relating to use of the investigational drug, product, or
device. |
|
| (C) |
Except for actions or omissions constituting willful
or wanton misconduct, a manufacturer or terminal distributor of dangerous drugs
that provides or distributes an investigational drug, product, or device
pursuant to this section and section 4731.97 of the Revised Code is not liable
for or subject to damages in any civil action or prosecution in any criminal
proceeding for actions or omissions related to providing or distributing the
investigational drug, product, or device. |
| (D) |
Nothing in this section shall be interpreted as
requiring a manufacturer or terminal distributor to provide an investigational
drug, product, or device to an eligible patient or the patient's treating
physician. |
Added by
131st General Assembly File No. TBD, HB 290, §1,
eff. 4/6/2017.
| (A) |
As used in
this section, "responsible person" has the same meaning as in rules adopted by
the state board of pharmacy under section
4729.26 of
the Revised Code. |
| (B) |
| (1) |
An
applicant for registration as a registered pharmacy technician shall:
| (a) |
Be
at least eighteen years of age; |
| (b) |
Possess a high school diploma or a certificate of high school equivalence or
have been employed continuously since prior to April 8, 2009, as a pharmacy
technician without a high school diploma or certificate of high school
equivalence; |
| (c) |
Be of good
moral character, as defined in rules adopted by the state board of pharmacy
under section
4729.26 of
the Revised Code; |
| (d) |
Except as
provided in division (D) of this section, comply with sections
4776.01
to
4776.04
of the Revised Code; |
| (e) |
Except as
provided in division (E)(1) of this section, have successfully completed
education and training that meets the requirements established by the board in
rules adopted under section
4729.94 of the Revised
Code. |
|
| (2) |
An applicant
for registration as a certified pharmacy technician shall:
| (a) |
Comply with divisions (B)(1)(a), (c), and (d) of this section; |
| (b) |
Possess a high school diploma or a certificate of high school
equivalence; |
| (c) |
Except as
provided in division (E)(2) of this section, have successfully completed
education and training that meets the requirements established by the board in
rules adopted under section
4729.94 of the Revised
Code; |
| (d) |
Have a
current pharmacy technician certification from an organization that has been
recognized by the board. |
|
|
| (C) |
A
pharmacist or pharmacy intern whose license has been denied, revoked,
suspended, or otherwise restricted by the board shall not be registered as a
registered pharmacy technician or certified pharmacy technician. |
| (D) |
Until the date that is two years after April 6,
2017, an applicant for registration as a registered pharmacy technician
or certified pharmacy technician who meets the requirements to be a qualified
pharmacy technician under section
4729.42
of the Revised Code, as it existed immediately prior to the effective date of
section 4729.95 of the Revised Code,
may, instead of complying with division (B)(1)(d) of this section, authorize
the superintendent of the bureau of criminal identification and investigation
to make the results of a criminal records check of the applicant available to
the state board of pharmacy. The criminal records check must have been
conducted not earlier than twenty-four months before the date of the
application for registration. |
| (E) |
| (1) |
Until the date that is two years after April 6,
2017, an applicant for registration as a registered pharmacy technician
who meets the requirements to be a qualified pharmacy technician under section
4729.42
of the Revised Code, as it existed immediately prior to the effective date of
section 4729.95 of the Revised Code,
may, instead of complying with division (B)(1)(e) of this section, submit an
attestation from a pharmacy's responsible person that the applicant has
completed a pharmacy technician training program that is of appropriate breadth
and depth to clearly address the competencies for a technician to safely and
effectively work in that particular setting and includes instruction in all of
the following:
| (a) |
Packaging
and labeling drugs; |
| (b) |
Pharmacy
terminology; |
| (c) |
Basic drug
information; |
| (e) |
Quality
control procedures; |
| (f) |
State and
federal statutes, rules, and regulations regarding pharmacy technician duties,
pharmacist duties, pharmacy intern duties, prescription or drug order
processing procedures, non-sterile drug compounding, drug record-keeping
requirements, patient confidentiality, security requirements, and storage
requirements. |
|
| (2) |
Until the date that is two years after April 6,
2017, an applicant for registration as a certified pharmacy technician
who meets the requirements to be a qualified pharmacy technician under section
4729.42
of the Revised Code, as it existed immediately prior to the effective date of
section 4729.95 of the Revised Code,
may, instead of complying with division (B)(2)(c) of this section, submit an
attestation from a pharmacy's responsible person that the applicant has
completed a pharmacy technician training program that is of appropriate breadth
and depth to clearly address the competencies for a technician to safely and
effectively work in that particular setting and includes instruction in all of
the following:
| (a) |
The topics
listed in divisions (E)(1)(a) to (f) of this section; |
| (b) |
Sterile drug compounding; |
| (c) |
Preparing and mixing intravenous drugs to be injected into a human
being. |
|
|
Amended by
132nd General Assembly File No. TBD, SB 229, §1,
eff. 3/22/2019.
Added by
131st General Assembly File No. TBD, SB 319, §1,
eff. 4/6/2017.
An applicant for registration under section 4729.90 of the
Revised Code shall file with the state board of pharmacy an application in the
form and manner prescribed in rules adopted under section 4729.94 of the
Revised Code. The application shall be accompanied by an application fee of
fifty dollars, which shall not be returned if the applicant fails to qualify
for registration.
If the board is satisfied that the applicant meets the
requirements of section 4729.90 of the Revised Code and any additional
requirements established by the board and determines that the results of a
criminal records check do not make the applicant ineligible, the board shall
register the applicant as a registered pharmacy technician or certified
pharmacy technician, as applicable.
Registration under this section is valid for the period
specified by the board in rules adopted under section 4729.94 of the Revised
Code. The period shall not exceed twenty-four months unless the board extends
the period in the rules to adjust license renewal schedules.
Added by
131st General Assembly File No. TBD, SB 319, §1,
eff. 4/6/2017.
| (A) |
A registered pharmacy
technician or certified pharmacy technician shall file an application for
registration renewal in the form and manner prescribed by the state board of
pharmacy in rules adopted under section 4729.94 of the Revised Code.
Registrations shall be renewed in accordance with the rules and the standard
renewal procedure set forth in Chapter 4745. of the Revised Code. The renewal
fee is twenty-five dollars per year. |
| (B) |
| (1) |
A registered pharmacy technician or certified pharmacy
technician who fails to renew registration in accordance with division (A) of
this section is prohibited from engaging in the activities authorized by
section 4729.91 of the Revised Code. |
| (2) |
| (a) |
A registration that is not renewed by a date
determined under division (A) of this section but has not lapsed for more than
ninety days may be reinstated if the applicant does both of the
following:
| (i) |
Submits a renewal
application in a form prescribed by the board in rules adopted under section
4729.94 of the Revised Code; |
| (ii) |
Pays the renewal fee and a late fee of fifty
dollars. |
|
| (b) |
A registration that has lapsed for more than ninety
days cannot be renewed, but the registration holder may reapply for
registration. |
|
|
Added by
131st General Assembly File No. TBD, SB 319, §1,
eff. 4/6/2017.
| (A) |
A registered pharmacy
technician may, under the direct supervision of a pharmacist, engage in the
following activities at a location licensed as a terminal distributor of
dangerous drugs to the extent that the activities do not require the exercise
of professional judgment:
| (1) |
Accepting new written or
electronic prescription orders from a prescriber or a prescriber's agent; |
| (2) |
Entering information into
and retrieving information from a database or patient profile; |
| (3) |
Preparing and affixing labels; |
| (4) |
Stocking dangerous drugs and retrieving those drugs
from inventory; |
| (5) |
Counting and pouring dangerous drugs into
containers; |
| (6) |
Placing dangerous drugs
into patient storage containers; |
| (7) |
Non-sterile drug compounding as authorized by the
state board of pharmacy in rules adopted under section 4729.94 of the Revised
Code; |
| (8) |
Other activities
specified by the board in rules adopted under section 4729.94 of the Revised
Code. |
|
| (B) |
A certified pharmacy technician may, under the direct
supervision of a pharmacist, engage in the following activities at a location
licensed as a terminal distributor of dangerous drugs to the extent that the
activities do not require the exercise of professional judgment:
| (1) |
Any activity listed in division (A) of this
section; |
| (2) |
Accepting or requesting
refill authorizations for dangerous drugs that are not controlled substances
from a prescriber or the prescriber's agent, so long as there is no change from
the original prescription; |
| (3) |
Sterile and non-sterile drug compounding as authorized
by the board in rules adopted under section 4729.94 of the Revised Code; |
| (4) |
Other activities
specified by the board in rules adopted under section 4729.94 of the Revised
Code. |
|
Added by
131st General Assembly File No. TBD, SB 319, §1,
eff. 4/6/2017.
| (A) |
An applicant for
registration as a pharmacy technician trainee shall:
| (1) |
Comply with divisions (B)(1)(a) to (c) of section
4729.90 of the Revised Code; |
| (2) |
Be enrolled in or plan to enroll in education and
training that will allow the applicant to meet the requirements established by
the state board of pharmacy in rules adopted under section 4729.94 of the
Revised Code; |
|
| (B) |
A pharmacist or pharmacy intern whose license has been
denied, revoked, suspended, or otherwise restricted by the board shall not be
registered as a pharmacy technician trainee. |
Added by
131st General Assembly File No. TBD, SB 319, §1,
eff. 4/6/2017.
An applicant for registration as a pharmacy technician
trainee shall file with the state board of pharmacy an application in the form
and manner prescribed in rules adopted under section 4729.94 of the Revised
Code. The application shall by accompanied by an application fee of twenty-five
dollars, which shall not be returned if the applicant fails to qualify for
registration.
If the board is satisfied that an applicant meets the
requirements of section 4729.92 of the Revised Code and any additional
requirements established by the board and determines that the results of a
criminal records check do not make the applicant ineligible, the board shall
register the applicant as a pharmacy technician trainee.
Registration is valid for one year from the date of
registration. Registration is not renewable, but an individual may reapply for
registration if the individual's previous registration has lapsed for more than
five years or the board grants its approval.
Added by
131st General Assembly File No. TBD, SB 319, §1,
eff. 4/6/2017.
A pharmacy technician trainee may, under the direct
supervision of a pharmacist, engage in the same activities as a registered
pharmacy technician, as listed in division (A) of section 4729.91 of the
Revised Code.
Added by
131st General Assembly File No. TBD, SB 319, §1,
eff. 4/6/2017.
The state board of pharmacy shall adopt rules under section
4729.26 of the Revised Code
governing registration of registered pharmacy technicians, certified pharmacy
technicians, and pharmacy technician trainees. The rules shall include all of
the following:
| (A) |
Application and renewal
forms and procedures; |
| (B) |
Reapplication forms and procedures for individuals
whose registration has lapsed more than ninety days; |
| (C) |
Education and training requirements, requirements for
employer-administered training programs, and other requirements considered
appropriate by the board; |
| (D) |
Additional activities permitted by divisions (A)(7)
and (B)(4) of section 4729.91 of the Revised Code; |
| (E) |
Requirements for sterile and non-sterile drug
compounding ; |
| (F) |
Continuing education
requirements; |
| (G) |
Conduct that constitutes
dishonesty or unprofessional conduct by a registered pharmacy technician,
certified pharmacy technician, or pharmacy technician trainee; |
| (H) |
Additional conduct for which the board may impose
discipline under section 4729.96 of the Revised Code on a registered pharmacy
technician, certified pharmacy technician, or pharmacy technician
trainee; |
| (I) |
Any other rules the board
considers appropriate to implement sections 4729.90 to 4729.96 of the Revised
Code. |
Added by
131st General Assembly File No. TBD, SB 319, §1,
eff. 4/6/2017.
| (A) |
No person who is not a
pharmacist, pharmacy intern, registered pharmacy technician, certified pharmacy
technician, or pharmacy technician trainee shall knowingly engage in any of the
activities listed in section 4729.91 of the Revised Code in a location licensed
as a terminal distributor of dangerous drugs or while performing the function
of a terminal distributor, except that this division does not prevent a
licensed health care professional from engaging in activities that are
authorized by law as part of the licensed professional's practice. |
| (B) |
No pharmacist shall
knowingly allow any person employed or otherwise under the control of the
pharmacist to violate division (A) of this section. |
| (C) |
No terminal distributor of dangerous drugs shall
knowingly allow any person employed or otherwise under the control of the
person who owns, manages, or conducts the terminal distributor to violate
division (A) of this section. |
Added by
131st General Assembly File No. TBD, SB 319, §1,
eff. 4/6/2018.
| (A) |
| (1) |
The state board of
pharmacy, after notice and hearing in accordance with Chapter 119. of the
Revised Code, may impose one or more of the following sanctions on a pharmacy
technician trainee, registered pharmacy technician, or certified pharmacy
technician if the board finds the individual engaged in any of the conduct set
forth in division (A)(2) of this section:
| (a) |
Revoke, suspend, restrict, limit, or refuse to grant
or renew a registration; |
| (b) |
Reprimand or place the holder of the registration on
probation; |
| (c) |
Impose a monetary penalty
or forfeiture not to exceed in severity any fine designated under the Revised
Code for a similar offense, or in the case of a violation of a section of the
Revised Code that does not bear a penalty, a monetary penalty or forfeiture of
not more than five hundred dollars. |
|
| (2) |
The board may impose the sanctions listed in division
(A)(1) of this section if the board finds a pharmacy technician trainee,
registered pharmacy technician, or certified pharmacy technician:
| (a) |
Has been convicted of a felony, or a crime of moral
turpitude, as defined in section
4776.10 of the Revised
Code; |
| (b) |
Engaged in dishonesty or
unprofessional conduct, as prescribed in rules adopted by the board under
section 4729.94 of the Revised Code; |
| (c) |
Is addicted to or abusing alcohol or drugs or impaired
physically or mentally to such a degree as to render the individual unable to
perform the individual's duties; |
| (d) |
Violated, conspired to violate, attempted to violate,
or aided and abetted the violation of any of the provisions of this chapter,
sections 3715.52 to
3715.72 of the Revised Code,
Chapter 2925. or 3719. of the Revised Code, or any rule adopted by the board
under those provisions; |
| (e) |
Committed fraud, misrepresentation, or deception in
applying for or securing a registration issued by the board under this
chapter; |
| (f) |
Failed to comply with an
order of the board or a settlement agreement; |
| (g) |
Engaged in any other conduct for which the board may
impose discipline as set forth in rules adopted by the board under section
4729.94 of the Revised Code. |
|
|
| (B) |
The board may suspend a registration under division
(B) of section 3719.121 of the Revised Code by
utilizing a telephone conference call to review the allegations and take a
vote. |
| (C) |
For purposes of this
division, an individual authorized to practice as a pharmacy technician
trainee, registered pharmacy technician, or certified pharmacy technician
accepts the privilege of practicing in this state subject to supervision by the
board. By filing an application for or holding a registration under this
chapter, the individual gives consent to submit to a mental or physical
examination when ordered to do so by the board in writing and waives all
objections to the admissibility of testimony or examination reports that
constitute privileged communications. If the board has reasonable cause to believe that an
individual who is a pharmacy technician trainee, registered pharmacy
technician, or certified pharmacy technician is physically or mentally
impaired, the board may require the individual to submit to a physical or
mental examination, or both. The expense of the examination is the
responsibility of the individual required to be examined. Failure of an individual who is a pharmacy technician
trainee, registered pharmacy technician, or certified pharmacy technician to
submit to a physical or mental examination ordered by the board, unless the
failure is due to circumstances beyond the individual's control, constitutes an
admission of the allegations and a suspension order shall be entered without
the taking of testimony or presentation of evidence. Any subsequent
adjudication hearing under Chapter 119. of the Revised Code concerning failure
to submit to an examination is limited to consideration of whether the failure
was beyond the individual's control. If, based on the results of an examination ordered under
this division, the board determines that the individual's ability to practice
is impaired, the board shall suspend the individual's registration or deny the
individual's application and shall require the individual, as a condition for
an initial, continued, reinstated, or renewed registration to practice, to
submit to a physical or mental examination and treatment. An order of suspension issued under this division shall not
be subject to suspension by a court during pendency of any appeal filed under
section 119.12 of the Revised
Code.
|
| (D) |
If the board is required
under Chapter 119. of the Revised Code to give notice of an opportunity for a
hearing and the applicant or registrant does not make a timely request for a
hearing in accordance with section
119.07 of the Revised Code, the
board is not required to hold a hearing, but may adopt a final order that
contains the board's findings. In the final order, the board may impose any of
the sanctions listed in division (A) of this section. |
| (E) |
Notwithstanding the provision of division (C)(2) of
section 2953.32 of the Revised Code
specifying that if records pertaining to a criminal case are sealed under that
section the proceedings in the case must be deemed not to have occurred,
sealing of the following records on which the board has based an action under
this section shall have no effect on the board's action or any sanction imposed
by the board under this section: records of any conviction, guilty plea,
judicial finding of guilt resulting from a plea of no contest, or a judicial
finding of eligibility for a pretrial diversion program or intervention in lieu
of conviction. The board shall not be required to seal, destroy, redact, or
otherwise modify its records to reflect the court's sealing of conviction
records. |
| (F) |
No pharmacy technician
trainee, registered pharmacy technician, or certified pharmacy technician shall
knowingly engage in any conduct described in divisions (A)(2)(b) or (A)(2) (d)
to (g) of this section. |
Added by
131st General Assembly File No. TBD, SB 319, §1,
eff. 4/6/2017.
| (A) |
Whoever
violates division (H) of section
4729.16,
division (G) of section
4729.38,
division (I) of section 4729.382, section
4729.57,
or division (F) of section
4729.96 of the Revised Code is
guilty of a minor misdemeanor, unless a different penalty is otherwise
specified in the Revised Code. Each day's violation constitutes a separate
offense. |
| (B) |
Whoever
violates section
4729.27,
4729.28, or
4729.36 of the
Revised Code is guilty of a misdemeanor of the third degree. Each day's
violation constitutes a separate offense. If the offender previously has been
convicted of or pleaded guilty to a violation of this chapter, that person is
guilty of a misdemeanor of the second degree. |
| (C) |
Whoever violates section
4729.32,
4729.33,
or
4729.34 of the
Revised Code is guilty of a misdemeanor. |
| (D) |
Whoever violates division (A), (B), (C), (D), (F), or (G) of section
4729.51
of the Revised Code is guilty of a misdemeanor of the first degree. |
| (E) |
| (1) |
Whoever violates section
4729.37,
division (E)(1)(b) of section
4729.51,
division (J) of section
4729.54,
division (B) or (D) of section
4729.553, or section
4729.61
of the Revised Code is guilty of a felony of the fifth degree. If the offender
previously has been convicted of or pleaded guilty to a violation of this
chapter or a violation of Chapter 2925. or 3719. of the Revised Code, that
person is guilty of a felony of the fourth degree. |
| (2) |
If
an offender is convicted of or pleads guilty to a violation of section
4729.37,
division (E) of section
4729.51,
division (J) of section
4729.54,
or section
4729.61
of the Revised Code, if the violation involves the sale, offer to sell, or
possession of a schedule I or II controlled substance, with the exception of
marihuana, and if the court imposing sentence upon the offender finds that the
offender as a result of the violation is a major drug offender, as defined in
section
2929.01
of the Revised Code, and is guilty of a specification of the type described in
division (A) of section
2941.1410
of the Revised Code, the court, in lieu of the prison term authorized or
required by division (E)(1) of this section and sections
2929.13
and
2929.14
of the Revised Code and in addition to any other sanction imposed for the
offense under sections
2929.11
to
2929.18
of the Revised Code, shall impose upon the offender, in accordance with
division (B)(3) of section
2929.14
of the Revised Code, the mandatory prison term specified in that
division. |
| (3) |
Notwithstanding any contrary provision of section
3719.21
of the Revised Code, the clerk of court shall pay any fine imposed for a
violation of section
4729.37,
division (E) of section
4729.51,
division (J) of section
4729.54,
or section
4729.61
of the Revised Code pursuant to division (A) of section
2929.18
of the Revised Code in accordance with and subject to the requirements of
division (F) of section
2925.03
of the Revised Code. The agency that receives the fine shall use the fine as
specified in division (F) of section
2925.03
of the Revised Code. |
|
| (F) |
Whoever violates section
4729.531
of the Revised Code or any rule adopted thereunder or section
4729.532
of the Revised Code is guilty of a misdemeanor of the first degree. |
| (G) |
Whoever violates division (E)(1)(a) of section
4729.51
of the Revised Code is guilty of a felony of the fourth degree. If the offender
has previously been convicted of or pleaded guilty to a violation of this
chapter, or of a violation of Chapter 2925. or 3719. of the Revised Code, that
person is guilty of a felony of the third degree. |
| (H) |
Whoever violates division (E)(1)(c) of section
4729.51
of the Revised Code is guilty of a misdemeanor of the first degree. If the
offender has previously been convicted of or pleaded guilty to a violation of
this chapter, or of a violation of Chapter 2925. or 3719. of the Revised Code,
that person is guilty of a felony of the fifth degree. |
| (I) |
| (1) |
Whoever violates division (A) of section
4729.95 of the Revised Code is
guilty of unauthorized pharmacy-related drug conduct. Except as otherwise
provided in this section, unauthorized pharmacy-related drug conduct is a
misdemeanor of the second degree. If the offender previously has been convicted
of or pleaded guilty to a violation of division (A), (B), or (C) of that
section, unauthorized pharmacy-related drug conduct is a misdemeanor of the
first degree on a second offense and a felony of the fifth degree on a third or
subsequent offense. |
| (2) |
Whoever
violates division (B) or (C) of section
4729.95 of the Revised Code is
guilty of permitting unauthorized pharmacy-related drug conduct. Except as
otherwise provided in this section, permitting unauthorized pharmacy-related
drug conduct is a misdemeanor of the second degree. If the offender previously
has been convicted of or pleaded guilty to a violation of division (A), (B), or
(C) of that section, permitting unauthorized pharmacy-related drug conduct is a
misdemeanor of the first degree on a second offense and a felony of the fifth
degree on a third or subsequent offense. |
| (3) |
Notwithstanding any contrary provision of section
3719.21
of the Revised Code or any other provision of law that governs the distribution
of fines, the clerk of the court shall pay any fine imposed pursuant to
division (I)(1) or (2) of this section to the state board of pharmacy if the
board has adopted a written internal control policy under division (F)(2) of
section
2925.03
of the Revised Code that addresses fine moneys that it receives under Chapter
2925. of the Revised Code and if the policy also addresses fine moneys paid
under this division. The state board of pharmacy shall use the fines so paid in
accordance with the written internal control policy to subsidize the board's
law enforcement efforts that pertain to drug offenses. |
|
| (J) |
| (1) |
Whoever violates division (A)(1) of section
4729.86
of the Revised Code is guilty of a misdemeanor of the third degree. If the
offender has previously been convicted of or pleaded guilty to a violation of
division (A)(1), (2), or (3) of section
4729.86
of the Revised Code, that person is guilty of a misdemeanor of the first
degree. |
| (2) |
Whoever
violates division (A)(2) of section
4729.86
of the Revised Code is guilty of a misdemeanor of the first degree. If the
offender has previously been convicted of or pleaded guilty to a violation of
division (A)(1), (2), or (3) of section
4729.86
of the Revised Code, that person is guilty of a felony of the fifth
degree. |
| (3) |
Whoever
violates division (A)(3) of section
4729.86
of the Revised Code is guilty of a felony of the fifth degree. If the offender
has previously been convicted of or pleaded guilty to a violation of division
(A)(1), (2), or (3) of section
4729.86
of the Revised Code, that person is guilty of a felony of the fourth
degree. |
|
| (K) |
A person who
violates division (C) of section
4729.552
of the Revised Code is guilty of a misdemeanor of the first degree. If the
person previously has been convicted of or pleaded guilty to a violation of
division (C) of section
4729.552
of the Revised Code, that person is guilty of a felony of the fifth
degree. |
Amended by
132nd General Assembly File No. TBD, HB 101, §1,
eff. 4/8/2019.
Amended by
132nd General Assembly File No. TBD, SB 1, §1,
eff. 10/31/2018.
Amended by
131st General Assembly File No. TBD, SB 319, §1,
eff. 4/6/2017.
Amended by
131st General Assembly File No. TBD, HB 505, §1,
eff. 3/20/2017.
Amended by
129th General AssemblyFile No.29, HB 86,
§1, eff.
9/30/2011.
Amended by
129th General AssemblyFile No.19, HB 93,
§1, eff.
5/20/2011.
Amended by
128th General AssemblyFile No.9, HB 1,
§101.01, eff.
10/16/2009.
Amended by
128th General Assemblych.9, HB 2,
§101.01, eff.
4/1/2009.
Effective Date:
03-23-2000; 2008 SB203 04-08-2009