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Ohio Laws and Rules
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;
(3) Compounding drugs;
(4) Counseling individuals with regard to their drug therapy, recommending drug therapy related devices, and assisting in the selection of drugs and appliances for treatment of common diseases and injuries and providing instruction in the proper use of the drugs and appliances;
(5) Performing drug regimen reviews with individuals by discussing all of the drugs that the individual is taking and explaining the interactions of the drugs;
(6) Performing drug utilization reviews with licensed health professionals authorized to prescribe drugs when the pharmacist determines that an individual with a prescription has a drug regimen that warrants additional discussion with the prescriber;
(7) Advising an individual and the health care professionals treating an individual with regard to the individual's drug therapy;
(8) Acting pursuant to a consult agreement with a physician authorized under Chapter 4731. of the Revised Code to practice medicine and surgery or osteopathic medicine and surgery, if an agreement has been established with the physician;
(9) Engaging in the administration of immunizations to the extent authorized by section 4729.41 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 to manage an individual's drug therapy that has been entered into by a pharmacist and a physician authorized under Chapter 4731. of the Revised Code to practice medicine and surgery or osteopathic medicine and surgery.
(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.
(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.
(G) "Federal drug abuse control laws" has the same meaning as in section 3719.01 of the Revised Code.
(H) "Prescription" means 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.
(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 certificate to prescribe issued under section 4723.48 of the Revised Code;
(3) An optometrist licensed under Chapter 4725. of the Revised Code to practice optometry under a therapeutic pharmaceutical agents certificate;
(4) A physician authorized under Chapter 4731. of the Revised Code to practice medicine and surgery, osteopathic medicine and surgery, or podiatric medicine and surgery;
(5) A physician assistant who holds a certificate to prescribe issued under Chapter 4730. of the Revised Code;
(6) A veterinarian licensed under Chapter 4741. of the Revised Code.
(J) "Sale" and "sell" include delivery, transfer, barter, exchange, or gift, or offer therefor, and each such transaction made by any person, whether as principal proprietor, agent, or employee.
(K) "Wholesale sale" and "sale at wholesale" mean any sale in which the purpose of the purchaser is to resell the article purchased or received by the purchaser.
(L) "Retail sale" and "sale at retail" mean any sale other than a wholesale sale or sale at wholesale.
(M) "Retail seller" means any person that sells any dangerous drug to consumers without assuming control over and responsibility for its administration. Mere advice or instructions regarding administration do not constitute control or establish responsibility.
(N) "Price information" means the price charged for a prescription for a particular drug product and, in an easily understandable manner, all of the following:
(1) The proprietary name of the drug product;
(2) The established (generic) name of the drug product;
(3) The strength of the drug product if the product contains a single active ingredient or if the drug product contains more than one active ingredient and a relevant strength can be associated with the product without indicating each active ingredient. The established name and quantity of each active ingredient are required if such a relevant strength cannot be so associated with a drug product containing more than one ingredient.
(4) The dosage form;
(5) The price charged for a specific quantity of the drug product. The stated price shall include all charges to the consumer, including, but not limited to, the cost of the drug product, professional fees, handling fees, if any, and a statement identifying professional services routinely furnished by the pharmacy. Any mailing fees and delivery fees may be stated separately without repetition. The information shall not be false or misleading.
(O) "Wholesale distributor of dangerous drugs" 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" means a person, other than a pharmacist, who manufactures dangerous drugs and who is engaged in the sale of those dangerous drugs within this state.
(Q) "Terminal distributor of dangerous drugs" means a person who is engaged in the sale of dangerous drugs at retail, or any person, other than a wholesale distributor or a pharmacist, who has possession, custody, or control of dangerous drugs for any purpose other than for that person's own use and consumption, and 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 or licensed health professional authorized to prescribe drugs.
(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) "Finished dosage form" has the same meaning as in section 3715.01 of the Revised Code.
(U) "Generically equivalent drug" has the same meaning as in section 3715.01 of the Revised Code.
(V) "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.
(W) "Food" has the same meaning as in section 3715.01 of the Revised Code.
(X) "Pain management clinic" has the same meaning as in section 4731.054 of the Revised Code.
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
Effective Date: 07-22-1998
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 who is
a licensed pharmacist in good standing in the practice of pharmacy in this
state. 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. Effective Date: 07-22-1998
(A)
The executive
director of the state board of pharmacy 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. (1)
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.
(2)
The executive director shall carry out
his duties as an appointing authority subject to internal management rules
adopted by the board.
(3)
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.
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 persons to whom identification cards and
licenses have been granted as pharmacists or pharmacy interns, together with
each renewal and suspension or revocation of an identification card and
license. The books and registers of the board shall be prima-facie evidence of
the matters therein recorded. 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 an identification card and
license to practice pharmacy, or any of its branches, to the person specified
in the statement, or that an identification card and license, if issued, has
been revoked or suspended, shall be received as prima-facie evidence of the
record of the board in any court or before any officer of this state.
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, or
4729.552 of the Revised Code.
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 and habits;
(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 and an identification card
authorizing the individual to practice pharmacy.
Effective Date: 07-22-1998
The state board of pharmacy may license an individual as a
pharmacist without examination and issue an identification card to the
pharmacist 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 and habit;
(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 individual was
licensed a pharmacist. The board shall not issue any identification card or
license 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 persons holding valid licenses received through examination by the
state board of pharmacy.
Effective Date: 07-22-1998
Effective Date: 07-26-1991
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 an identification card and license as a pharmacy
intern if in the opinion of the board 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. An identification card and
license shall be valid until the next annual renewal date and shall be renewed
only if the intern is meeting the requirements and rules of the board. The
state board of pharmacy may appoint a director of pharmacy internship who is a
licensed pharmacist and who is not directly or indirectly connected with a
school or college of pharmacy or department of pharmacy of a university. The
director of pharmacy internship shall be responsible to the board for the
operation and direction of the pharmacy internship program established by the
board under this section, and for such other duties as the board may assign.
Effective Date: 02-12-2001
An identification card issued by the state board of pharmacy
under section
4729.08 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 annual renewal date.
Identification cards shall be renewed annually on the fifteenth day of
September, according to the standard renewal procedure of Chapter 4745. of the
Revised Code. Each pharmacist and pharmacy intern shall carry the
identification card or renewal identification card while engaged in the
practice of pharmacy. The license shall be conspicuously exposed at the
principal place where the pharmacist or pharmacy intern practices pharmacy. 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 an identification card. An
application filed under this section may not be withdrawn without the approval
of the board. If the board finds that the applicant's card 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 issue a
renewal identification card to the applicant. When an identification card has
lapsed for more than sixty days but application is made within three years
after the expiration of the card, the applicant shall be issued a renewal
identification card without further examination if the applicant meets the
requirements of this section and pays the fee designated under division (E) of
section 4729.15 of the Revised Code.
Effective Date: 02-12-2001
A pharmacist who fails to make application to the state board
of pharmacy for a renewal identification card within a period of three years
from the expiration of the identification card must pass an examination for
registration; except that a pharmacist whose registration has expired, but who
has continually practiced pharmacy in another state under a license issued by
the authority of that state, may obtain a renewal identification card upon
payment to the executive director of the board the fee designated under
division (F) of section
4729.15 of the Revised Code.
Effective Date: 07-22-1998
Effective Date: 12-31-1971
A replacement license or identification card may be issued a
person registered with the state board of pharmacy as a pharmacist or as a
pharmacy intern whose license or identification card has been lost or
destroyed, upon condition that the applicant by affidavit sets forth the facts
concerning the loss or destruction of the previously issued license or
identification card. Effective Date: 07-22-1998
The state board of pharmacy shall charge the following fees:
(A)
For applying for a license to
practice as a pharmacist, an amount adequate to cover all rentals, compensation
for proctors, and other 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;
(B)
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;
(C)
For issuing a license and an
identification card 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;
(D)
For a pharmacist applying for renewal of
an identification card within sixty days after the expiration date,
ninety-seven dollars and fifty cents, which fee shall not be returned if the
applicant fails to qualify for renewal;
(E)
For a pharmacist applying for renewal of
an identification card that has lapsed for more than sixty days, but for less
than three years, one hundred thirty-five dollars, which fee shall not be
returned if the applicant fails to qualify for renewal;
(F)
For a pharmacist applying for renewal of
an identification card that has lapsed 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;
(G)
For a pharmacist applying for a license
and identification card, 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.
(H)
For a license and
identification card to practice as a pharmacy intern, twenty-two dollars and
fifty cents, which fee shall not be returned if the applicant fails to qualify
for licensure;
(I)
For the renewal
of a pharmacy intern identification card, twenty-two dollars and fifty cents,
which fee shall not be returned if the applicant fails to qualify for renewal;
(J)
For issuing a replacement
license to a pharmacist, twenty-two dollars and fifty cents;
(K)
For issuing a replacement license to a
pharmacy intern, seven dollars and fifty cents;
(L)
For issuing a replacement identification
card to a pharmacist, thirty-seven dollars and fifty cents, or pharmacy intern,
seven dollars and fifty cents;
(M)
For certifying licensure and grades for reciprocal licensure, ten dollars;
(N)
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;
(O)
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;
(P)
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.
Effective Date: 07-22-1998
(A)
The state board of
pharmacy, after notice and hearing in accordance with Chapter 119. of the
Revised Code, may revoke, suspend, limit, place on probation, or refuse to
grant or renew an identification card, or may 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, if the board finds a pharmacist or pharmacy
intern: (1)
Guilty of a felony or gross
immorality;
(2)
Guilty of
dishonesty or unprofessional conduct in the practice of pharmacy;
(3)
Addicted to or abusing liquor or drugs or
impaired physically or mentally to such a degree as to render the pharmacist or
pharmacy intern unfit to practice pharmacy;
(4)
Has been convicted of a misdemeanor
related to, or committed in, the practice of pharmacy;
(5)
Guilty of willfully violating, conspiring
to violate, attempting to violate, or aiding and abetting 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;
(6)
Guilty
of permitting anyone other than a pharmacist or pharmacy intern to practice
pharmacy;
(7)
Guilty of knowingly
lending the pharmacist's or pharmacy intern's name to an illegal practitioner
of pharmacy or having professional connection with an illegal practitioner of
pharmacy;
(8)
Guilty of dividing
or agreeing 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;
(9)
Has violated the terms of a
consult agreement entered into pursuant to section
4729.39 of the Revised Code;
(10)
Has committed fraud,
misrepresentation, or deception in applying for or securing a license or
identification card issued by the board under this chapter or under Chapter
3715. or 3719. of the Revised Code.
(B)
Any individual whose identification card
is revoked, suspended, or refused, shall return the identification card and
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 of the Revised Code, the
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.
(D)
The board may suspend a license or
identification card 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)
If, pursuant to an
adjudication under Chapter 119. of the Revised Code, the board has reasonable
cause to believe that a pharmacist or pharmacy intern is physically or mentally
impaired, the board may require the pharmacist or pharmacy intern to submit to
a physical or mental examination, or both.
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. 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, or podiatric medicine and surgery,
but who is not also licensed, certificated, or otherwise legally authorized to
engage in the practice of pharmacy.
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 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 liquor or drugs as described in division (A)(3) 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.
Effective Date: 03-27-1991
Notwithstanding division (B)(4) of section
2317.02 of the Revised Code, a
pharmacist shall cooperate with federal, state, and local government
investigations and shall divulge all relevant information when requested by a
government agency. Effective Date: 02-12-2001
Effective Date: 12-31-1971
(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
No person who is not a pharmacist or a pharmacy intern under
the personal supervision of a pharmacist shall compound, dispense, or sell
dangerous drugs or otherwise engage in the practice of pharmacy.
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)
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)
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.
Effective Date: 07-22-1998
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 the sale of oxygen,
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
129th General AssemblyFile
No.19, HB 93,
§1, eff.
5/20/2011. Effective Date:
03-09-1999; 09-23-2004 (A)
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.
(1)
Except as provided in division
(D)
of this section, a prescriber may not 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.
(1)
None of the
following shall be counted in determining whether the amounts specified in
division (C)(1) of this section have been exceeded: (a)
Methadone
provided to patients for the purpose of treating drug addiction, if the
prescriber meets the conditions specified in
21 C.F.R.
1306.07 ;
(b)
Buprenorphine provided to patients for the purpose of treating drug addiction,
if the prescriber is exempt from separate registration with the United States
drug enforcement administration pursuant to
21 C.F.R.
1301.28 ;
(c)
Controlled
substances provided 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.
(2)
Division
(C)(1) of this section does not apply to a prescriber who is a
veterinarian.
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. 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)
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 select a generically equivalent drug, as defined in section
3715.01 of the Revised Code,
subject to the following conditions: (1)
The
pharmacist shall not select a generically equivalent drug if the prescriber
handwrites "dispense as written," or "D.A.W.," on the written prescription, or,
when ordering a prescription electronically or orally, the prescriber specifies
that the prescribed drug is medically necessary. These designations shall not
be preprinted or stamped on the prescription. Division (A)(1) of this section
does not preclude a reminder of the procedure required to prohibit the
selection of a generically equivalent drug from being preprinted on the
prescription.
(2)
The pharmacist
shall not select a generically equivalent drug unless its price to the patient
is less than or equal to the price of the prescribed drug.
(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 is available at a lower or equal cost, and of
the person's right to refuse the drug selected. Division (A)(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.
(B)
Unless the prescriber instructs
otherwise, the label for every drug dispensed shall include the drug's brand
name, if any, or its generic name and the name of the distributor, using
abbreviations if necessary. When dispensing at retail a generically equivalent
drug for the brand name drug prescribed, the pharmacist shall indicate on the
drug's label or container that a generic substitution was made. The labeling
requirements established by this division are in addition to all other labeling
requirements of Chapter 3715. of the Revised Code.
(C)
A pharmacist who selects a generically
equivalent drug 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.
(D)
The failure of a prescriber to restrict a
prescription by specifying "dispense as written," or "D.A.W.," pursuant to
division (A)(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 interchange of a generically equivalent drug 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.
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)
A pharmacist
may enter into a consult agreement with a physician authorized under Chapter
4731. of the Revised Code to practice medicine and surgery or osteopathic
medicine and surgery. Under a consult agreement, a pharmacist is authorized to
manage an individual's drug therapy, but only to the extent specified in the
agreement, this section, and the rules adopted under this section.
(B)
All of the following apply to a consult
agreement that authorizes a pharmacist to manage the drug therapy of an
individual who is not a patient of a hospital, as defined in section
3727.01 of the Revised Code, or a
resident in a long-term care facility, as defined in section
3729.01 of the Revised Code: (1)
A separate consult agreement must be
entered into for each individual whose drug therapy is to be managed by a
pharmacist. A consult agreement applies only to the particular diagnosis for
which a physician prescribed an individual's drug therapy. If a different
diagnosis is made for the individual, the pharmacist and physician must enter
into a new or additional consult agreement.
(2)
Management of an individual's drug
therapy by a pharmacist under a consult agreement may include monitoring and
modifying a prescription that has been issued for the individual. Except as
provided in section
4729.38 of the Revised Code for
the selection of generically equivalent drugs, management of an individual's
drug therapy by a pharmacist under a consult agreement shall not include
dispensing a drug that has not been prescribed by the physician.
(3)
Each consult agreement shall be in
writing, except that a consult agreement may be entered into verbally if it is
immediately reduced to writing.
(4)
A physician entering into a consult
agreement shall specify in the agreement the extent to which the pharmacist is
authorized to manage the drug therapy of the individual specified in the
agreement.
(5)
A physician
entering into a consult agreement may specify one other physician who has
agreed to serve as an alternate physician in the event that the primary
physician is unavailable to consult directly with the pharmacist. The
pharmacist may specify one other pharmacist who has agreed to serve as an
alternate pharmacist in the event that the primary pharmacist is unavailable to
consult directly with the physician.
(6)
A consult agreement may not be
implemented until it has been signed by the primary pharmacist, the primary
physician, and the individual whose drug therapy will be managed or another
person who has the authority to provide consent to treatment on behalf of the
individual. Once the agreement is signed by all required parties, the physician
shall include in the individual's medical record the fact that a consult
agreement has been entered into with a pharmacist.
(7)
Prior to commencing any action to manage
an individual's drug therapy under a consult agreement, the pharmacist shall
make reasonable attempts to contact and confer with the physician who entered
into the consult agreement with the pharmacist. A pharmacist may commence an
action to manage an individual's drug therapy prior to conferring with the
physician or the physician's alternate, but shall immediately cease the action
that was commenced if the pharmacist has not conferred with either physician
within forty-eight hours. A pharmacist acting under a consult agreement shall
maintain a record of each action taken to manage an individual's drug therapy.
The pharmacist shall send to the individual's physician a written report of all
actions taken to manage the individual's drug therapy at intervals the
physician shall specify when entering into the agreement. The physician shall
include the pharmacist's report in the medical records the physician maintains
for the individual.
(8)
A consult
agreement may be terminated by either the pharmacist or physician who entered
into the agreement. By withdrawing consent, the individual whose drug therapy
is being managed or the individual who consented to the treatment on behalf of
the individual may terminate a consult agreement. The pharmacist or physician
who receives the individual's withdrawal of consent shall provide written
notice to the opposite party. A pharmacist or physician who terminates a
consult agreement shall provide written notice to the opposite party and to the
individual who consented to treatment under the agreement. The termination of a
consult agreement shall be recorded by the pharmacist and physician in the
records they maintain on the individual being treated.
(9)
Except as described in division (B)(5) of
this section, the authority of a pharmacist to manage an individual's drug
therapy under a consult agreement does not permit the pharmacist to manage drug
therapy prescribed by any other physician.
(C)
All of the following apply to a consult
agreement that authorizes a pharmacist to manage the drug therapy of an
individual who is a patient of a hospital, as defined in section
3727.01 of the Revised Code, or a
resident in a long-term care facility, as defined in section
3729.01 of the Revised Code: (1)
Before a consult agreement may be entered
into and implemented, a hospital or long-term care facility shall adopt a
policy for consult agreements. For any period of time during which a pharmacist
or physician acting under a consult agreement is not physically present and
available at the hospital or facility, the policy shall require that another
pharmacist and physician be available at the hospital or facility.
(2)
The consult agreement shall be made in
writing and shall comply with the hospital's or facility's policy on consult
agreements.
(3)
The content of the
consult agreement shall be communicated to the individual whose drug therapy
will be managed in a manner consistent with the hospital's or facility's policy
on consult agreements.
(4)
A
pharmacist acting under a consult agreement shall maintain in the individual's
medical record a record of each action taken under the agreement.
(5)
Communication between a pharmacist and
physician acting under the consult agreement shall take place at regular
intervals specified by the primary physician acting under the agreement.
(6)
A consult agreement may be
terminated by the individual, a person authorized to act on behalf of the
individual, the primary physician acting under the agreement, or the primary
pharmacist acting under the agreement. When a consult agreement is terminated,
all parties to the agreement shall be notified and the termination shall be
recorded in the individual's medical record.
(7)
The authority of a pharmacist acting
under a consult agreement does not permit the pharmacist to act under the
agreement in a hospital long-term care facility at which the pharmacist is not
authorized to practice.
(D)
The state board of pharmacy, in
consultation with the state medical board, shall adopt rules to be followed by
pharmacists, and the state medical board, in consultation with the state board
of pharmacy, shall adopt rules to be followed by physicians, that establish
standards and procedures for entering into a consult agreement and managing an
individual's drug therapy under a consult agreement. The boards shall specify
in the rules any categories of drugs or types of diseases for which a consult
agreement may not be established. Either board may adopt any other rules it
considers necessary for the implementation and administration of this section.
All rules adopted under this division shall be adopted in accordance with
Chapter 119. of the Revised Code.
Effective Date: 02-12-2001
(1)
A pharmacist licensed under this chapter
who meets the requirements of division (B) of this section may do any of the
following: (a)
Administer immunizations for
influenza to individuals fourteen years of age or older;
(b)
Administer immunizations to individuals
eighteen years of age or older for any of the following: (i)
Pneumonia;
(ii)
Tetanus;
(iii)
Hepatitis A;
(iv)
Hepatitis B;
(v)
Meningitis;
(vi)
Diphtheria;
(vii)
Pertussis.
(c)
Administer to individuals eighteen years
of age or older any other immunization listed in the rule adopted under
division (E)(1)(d) of this section.
(2)
A pharmacy intern licensed under this
chapter who meets the requirements of division (B) of this section and is
working under the direct supervision of a pharmacist who meets the requirements
of that division may administer immunizations for influenza to individuals
eighteen years of age or older.
(3)
As part of engaging in the administration
of immunizations or supervising a pharmacy intern's administration of
immunizations, a pharmacist may administer epinephrine or diphenhydramine, or
both, to individuals in emergency situations resulting from adverse reactions
to the immunizations administered by the pharmacist or pharmacy intern.
(B)
For a pharmacist or
pharmacy intern to be authorized to engage in the administration of
immunizations as specified in division (A) of this section, the pharmacist or
pharmacy intern shall do all of the following: (1)
Successfully complete a course in the
administration of immunizations that has been approved by the state board of
pharmacy as meeting the standards established for such courses by the centers
for disease control and prevention in the public health service of the United
States department of health and human services;
(2)
Receive and maintain certification to
perform basic life-support procedures by successfully completing a basic
life-support training course certified by the American red cross or American
heart association;
(3)
Practice in
accordance with a definitive set of treatment guidelines specified in a
protocol established by a physician and approved by the state board of
pharmacy.
(C)
The
protocol required by division (B)(3) of this section shall include provisions
for implementation of the following requirements: (1)
The pharmacist or pharmacy intern who
administers an immunization shall observe the individual who receives the
immunization to determine whether the individual has an adverse reaction to the
immunization. The length of time and location of the observation shall comply
with the standards specified in rules adopted by the state board of pharmacy
under division (E) of this section for the approval of protocols. The protocol
shall specify procedures to be followed by a pharmacist when administering
epinephrine, diphenhydramine, or both, to an individual who has an adverse
reaction to an immunization administered by the pharmacist or a pharmacy
intern.
(2)
For each immunization
administered to an individual by a pharmacist, other than an immunization for
influenza administered to an individual eighteen years of age or older, the
pharmacist shall notify the individual's family physician or, if the individual
has no family physician, the board of health of the health district in which
the individual resides or the authority having the duties of a board of health
for that district under section
3709.05 of the Revised Code. The
notice shall be given not later than thirty days after the immunization is
administered.
(3)
For each
immunization for influenza administered by a pharmacist to an individual who is
fourteen years of age or older but younger than eighteen years of age, the
pharmacist or a pharmacy intern shall obtain permission from the individual's
parent or legal guardian in accordance with the procedures specified in rules
adopted under division (E) of this section.
(1)
No
pharmacist shall do either of the following: (a)
Engage in the administration of
immunizations unless the requirements of division (B) of this section have been
met;
(b)
Delegate to any person
the pharmacist's authority to engage in or supervise the administration of
immunizations.
(2)
No
pharmacy intern shall engage in the administration of immunizations for
influenza unless the requirements of division (B) of this section have been
met.
(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)
Provisions for approval of courses in
administration of immunizations;
(b)
Provisions for approval of protocols to
be followed by pharmacists and pharmacy interns in engaging in the
administration of immunizations, including protocols that contain provisions
specifying the locations at which a pharmacist or pharmacy intern may engage in
the administration of immunizations;
(c)
Procedures to be followed by pharmacists
and pharmacy interns in obtaining from the individual's parent or legal
guardian permission to administer influenza immunizations to an individual
younger than eighteen years of age pursuant to division (A)(1)(a) of this
section;
(d)
A list of
immunizations that may be administered under division (A)(1)(c) of this
section.
(2)
Prior to
adopting rules regarding approval of protocols to be followed by pharmacists
and pharmacy interns in engaging in the administration of immunizations, the
state board of pharmacy shall consult with the state medical board and the
board of nursing.
(3)
Prior to
adopting a rule listing immunizations that may be administered under division
(A)(1)(c) of this section, the state board of pharmacy shall consult with the
state medical board.
Effective Date:
06-26-2003; 2007 SB58 08-30-2007; 2008 HB283 09-12-2008
(A)
As used in this section, "qualified pharmacy technician" means a person who is
under the personal supervision of a pharmacist and to whom all of the following
apply: (1)
The
person is eighteen years of age or older.
(2)
The person possesses a high school diploma, possesses a certificate of high
school equivalence, or was employed prior to April 8, 2009, as a pharmacy
technician without a high school diploma or a certificate of high school
equivalence.
(3)
The
person has passed an examination approved by the state board of pharmacy to
determine a person's competency to perform services as a pharmacy technician.
(4)
Except
as otherwise provided in this section, the person has submitted to a criminal
records check in accordance with section
4776.02 of the Revised Code as if
the person was an applicant for an initial license who is subject to that
section, and the results of the criminal records check provided as described in
that section and section
4776.04 of the Revised Code do not
show that the person previously has been convicted of or pleaded guilty to any
felony in this state, any other state, or the United States.
(B)
Except
as provided in division (F) of this section, no person who is not a pharmacist,
pharmacy intern, or qualified pharmacy technician shall do any of the following
in a pharmacy or while performing a function of a pharmacy: (1)
Engage in the compounding of any drug;
(2)
Package or label any drug;
(3)
Prepare or mix any intravenous drug to be injected into a human being.
(C)
No
pharmacist shall allow any person employed or otherwise under the control of
the pharmacist to violate division (B) of this section.
(D)
No person who owns, manages, or conducts a pharmacy shall allow any person
employed or otherwise under the control of the person who owns, manages, or
conducts the pharmacy to violate division (B) of this section.
(E)
No person who submits to a criminal records check in accordance with section
4776.02 of the Revised Code for
the purpose of satisfying the criterion set forth in division (A)(4) of this
section and who obtains a report pursuant to section
4776.02 or
4776.04 of the Revised Code
containing the results of the criminal records check and any information
provided by the federal bureau of investigation shall modify or alter, or allow
any other person to modify or alter, any item, record, or information contained
in the report and thereafter use the modified or altered report for the purpose
of satisfying the criterion set forth in division (A)(4) of this section or
otherwise submit or use it for any purpose or in any manner identified in
division (A) of section
2921.13 of the Revised Code.
(1)
Division (B) of this section does not
prohibit a health care professional authorized to engage in the activities
specified in division (B)(1), (2), or (3) of this section while acting in the
course of the professional's practice.
(2)
Division (B) of this section does not prohibit the activities performed by a
student as an integral part of a pharmacy technician training program that is
operated by a vocational school district or joint vocational school district,
certified by the department of education, or approved by the Ohio board of
regents.
(3)
In the
case of a person employed after April 8, 2009, division (B) of this section
does not prohibit the person's activities for the first
twelve months following the initial date of
employment, if both of the following apply: (a)
The person is participating in or has completed a pharmacy technician training
program that meets the board's standards for those programs and is making
substantial progress in preparation to take a pharmacy technician examination
approved by the board.
(b)
The results of the person's criminal records check provided as described in
sections 4776.02 and
4776.04 of the Revised Code show
that the person previously has not been convicted of or has not pleaded guilty
to any felony in this state, any other state, or the United States.
(4)
In the
case of a person who completes a pharmacy technician training program that is
operated by a vocational school district or joint vocational school district,
division (B) of this section does not prohibit the person's activities for the
first twelve months following the date of completing
the program, if both of the following apply: (a)
The person is making substantial progress in preparation to take a pharmacy
technician examination approved by the board.
(b)
The results of the person's criminal records check show that the person
previously has not been convicted of or has not pleaded guilty to any felony in
this state, any other state, or the United States.
(5)
In the case of a person employed on April 8, 2009, in the capacity of a
pharmacy technician, division (B) of this section does not do either of the
following: (a)
Require
the person to undergo a criminal records check if the person has been employed
for five years or longer;
(b)
Prohibit the person's activities until the earlier of either of the following: (i)
If the person has not passed an examination described in division (A)(3) of
this section, eighteen months after April 8, 2009;
(ii)
If a
criminal records check is required because the person has not been employed for
five years or longer, the date on which the person and the employer receive the
results of a criminal records check provided as described in sections
4776.02 and
4776.04 of the Revised Code that
show the person previously has been convicted of or pleaded guilty to any
felony in this state, any other state, or the United States.
(G)
If, pursuant
to rules adopted under section
4729.26 of the Revised Code, the
board requires a person that develops or administers a pharmacy technician
examination to submit examination materials to the board for approval, any
examination materials that are submitted shall not be public records for
purposes of section
149.43 of the Revised Code.
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)
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 registered wholesale distributor of dangerous drugs shall
possess for sale, sell, distribute, or deliver, at wholesale, dangerous drugs,
except as follows: (1)
A pharmacist
who is a licensed terminal distributor of dangerous drugs or who is employed by
a licensed terminal distributor of dangerous drugs may make occasional sales of
dangerous drugs at wholesale;
(2)
A
licensed terminal distributor of dangerous drugs having more than one
establishment or place may transfer or deliver dangerous drugs from one
establishment or place for which a license has been issued to the terminal
distributor to another establishment or place for which a license has been
issued to the terminal distributor if the license issued for each establishment
or place is in effect at the time of the transfer or delivery.
(1)
No registered wholesale distributor of
dangerous drugs shall possess for sale, or sell, at wholesale, dangerous drugs
to any person other than the following: (a)
Except as provided in division (B) (2)(a) of this section, a licensed health professional
authorized to prescribe drugs;
(b)
An
optometrist licensed under Chapter 4725. of the Revised Code who holds a
topical ocular pharmaceutical agents certificate;
(c)
A
registered wholesale distributor of dangerous drugs;
(d)
A
manufacturer of dangerous drugs;
(e)
Subject to division (B)(3) of this section, a licensed terminal distributor of
dangerous drugs;
(f)
Carriers or
warehouses for the purpose of carriage or storage;
(g)
Terminal or wholesale distributors of dangerous drugs who are not engaged in
the sale of dangerous drugs within this state;
(h)
An
individual who holds a current license, certificate, or registration issued
under Title 47 of the Revised Code and has been certified to conduct diabetes
education by a national certifying body specified in rules adopted by the state
board of pharmacy under section
4729.68 of the Revised Code, but
only with respect to insulin that will be used for the purpose of diabetes
education and only if diabetes education is within the individual's scope of
practice under statutes and rules regulating the individual's
profession;
(i)
An
individual who holds a valid certificate issued by a nationally recognized
S.C.U.B.A. diving certifying organization approved by the state board of
pharmacy in rule, but only with respect to medical oxygen that will be used for
the purpose of emergency care or treatment at the scene of a diving
emergency;
(j)
Except as
provided in division (B)(2)(b) of this section, a
business entity that is a corporation formed under division (B) of section
1701.03 of the Revised Code, a
limited liability company formed under Chapter 1705. of the Revised Code, or a
professional association formed under Chapter 1785. of the Revised Code if the
entity has a sole shareholder who is a licensed health professional authorized
to prescribe drugs and is authorized to provide the professional services being
offered by the entity;
(k)
Except as
provided in division (B)(2)(c) of this section, a
business entity that is a corporation formed under division (B) of section
1701.03 of the Revised Code, a
limited liability company formed under Chapter 1705. of the Revised Code, a
partnership or a limited liability partnership formed under Chapter 1775. of
the Revised Code, or a professional association formed under Chapter 1785. of
the Revised Code, if, to be a shareholder, member, or partner, an individual is
required to be licensed, certified, or otherwise legally authorized under Title
XLVII of the Revised Code to perform the professional service provided by the
entity and each such individual is a licensed health professional authorized to
prescribe drugs.
(2)
No
registered wholesale distributor of dangerous drugs shall
possess for sale, or sell, at wholesale, dangerous drugs to any of the
following: (a)
A prescriber
who is employed by a pain management clinic that is not licensed as a terminal
distributor of dangerous drugs with a pain management clinic classification
issued under section
4729.552 of the Revised
Code;
(b)
A business
entity described in division (B)(1)(j) of this section that is, or is
operating, a pain management clinic without a license as a terminal distributor
of dangerous drugs with a pain management clinic classification issued under
section 4729.552 of the Revised
Code;
(c)
A business
entity described in division (B)(1)(k) of this section that is, or is
operating, a pain management clinic without a license as a terminal distributor
of dangerous drugs with a pain management clinic classification issued under
section 4729.552 of the Revised
Code.
(3)
No
registered wholesale distributor of dangerous drugs shall possess dangerous
drugs for sale at wholesale, or sell such drugs at wholesale, to a licensed
terminal distributor of dangerous drugs, except as follows: (a)
In
the case of a terminal distributor with a category I license, only dangerous
drugs described in category I, as defined in division (A)(1) of section
4729.54 of the Revised
Code;
(b)
In the case
of a terminal distributor with a category II license, only dangerous drugs
described in category I and category II, as defined in divisions (A)(1) and (2)
of section
4729.54 of the Revised
Code;
(c)
In the case
of a terminal distributor with a category III license, dangerous drugs
described in category I, category II, and category III, as defined in divisions
(A)(1), (2), and (3) of section
4729.54 of the Revised
Code;
(d)
In the case
of a terminal distributor with a limited category I, II, or III license, only
the dangerous drugs specified in the certificate furnished by the terminal
distributor in accordance with section
4729.60 of the Revised
Code.
(1)
Except as provided in division (C)(4) of
this section, no person shall sell, at retail, dangerous drugs.
(2)
Except as provided in division (C)(4) of this section, no person shall possess
for sale, at retail, dangerous drugs.
(3)
Except as provided in division (C)(4) of this section, no person shall possess
dangerous drugs.
(4)
Divisions
(C)(1), (2), and (3) of this section do not apply to a registered wholesale
distributor of dangerous drugs, a licensed terminal distributor of dangerous
drugs, or a person who possesses, or possesses for sale or sells, at retail, a
dangerous drug in accordance with Chapters 3719., 4715., 4723., 4725., 4729.,
4730., 4731., and 4741. of the Revised Code. Divisions (C)(1), (2),
and (3) of this section do not apply to an individual who holds a current
license, certificate, or registration issued under Title XLVII of the Revised
Code and has been certified to conduct diabetes education by a national
certifying body specified in rules adopted by the state board of pharmacy under
section 4729.68 of the Revised Code, but
only to the extent that the individual possesses insulin or personally supplies
insulin solely for the purpose of diabetes education and only if diabetes
education is within the individual's scope of practice under statutes and rules
regulating the individual's profession. Divisions (C)(1), (2),
and (3) of this section do not apply to an individual who holds a valid
certificate issued by a nationally recognized S.C.U.B.A. diving certifying
organization approved by the state board of pharmacy in rule, but only to the
extent that the individual possesses medical oxygen or personally supplies
medical oxygen for the purpose of emergency care or treatment at the scene of a
diving emergency. (D)
No
licensed terminal distributor of dangerous drugs shall purchase for the purpose
of resale dangerous drugs from any person other than a registered wholesale
distributor of dangerous drugs, except as follows: (1)
A
licensed terminal distributor of dangerous drugs may make occasional purchases
of dangerous drugs for resale from a pharmacist who is a licensed terminal
distributor of dangerous drugs or who is employed by a licensed terminal
distributor of dangerous drugs;
(2)
A
licensed terminal distributor of dangerous drugs having more than one
establishment or place may transfer or receive dangerous drugs from one
establishment or place for which a license has been issued to the terminal
distributor to another establishment or place for which a license has been
issued to the terminal distributor if the license issued for each establishment
or place is in effect at the time of the transfer or receipt.
(E)
No licensed
terminal distributor of dangerous drugs shall engage in the sale or other
distribution of dangerous drugs at retail or maintain possession, custody, or
control of dangerous drugs for any purpose other than the distributor's
personal use or consumption, at any establishment or place other than that or
those described in the license issued by the state board of pharmacy to such
terminal distributor.
(F)
Nothing in
this section shall be construed to interfere with the performance of official
duties by any law enforcement official authorized by municipal, county, state,
or federal law to collect samples of any drug, regardless of its nature or in
whose possession it may be.
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.
(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)
A person
desiring to be registered as a wholesale distributor of dangerous drugs shall
file with the executive director of the state board of pharmacy a verified
application containing such information as the board requires of the applicant
relative to the qualifications to be registered as a wholesale distributor of
dangerous drugs set forth in section
4729.53 of the Revised Code and
the rules adopted under that section. The board shall register as a wholesale
distributor of dangerous drugs each applicant who has paid the required
registration fee, if the board determines that the applicant meets the
qualifications to be registered as a wholesale distributor of dangerous drugs
set forth in section
4729.53 of the Revised Code and
the rules adopted under that section.
(B)
The board may register and issue to a person who does not reside in this state
a registration certificate as a wholesale distributor of dangerous drugs if the
person possesses a current and valid wholesale distributor of dangerous drugs
registration certificate or license issued by another state that has
qualifications for licensure or registration comparable to the registration
requirements in this state and pays the required registration fee.
(C)
All registration certificates issued pursuant to this section are effective for
a period of twelve months from the first day of July of each year. A
registration certificate shall be renewed annually by the board for a like
period, pursuant to this section and the standard renewal procedure of Chapter
4745. of the Revised Code. A person desiring to renew a registration
certificate shall submit an application for renewal and pay the required
renewal fee before the first day of July each year.
(D)
Each registration certificate and its application shall describe not more than
one establishment or place where the registrant or applicant may engage in the
sale of dangerous drugs at wholesale. No registration certificate shall
authorize or permit the wholesale distributor of dangerous drugs named therein
to engage in the sale of drugs at wholesale or to maintain possession, custody,
or control of dangerous drugs for any purpose other than for the registrant's
own use and consumption at any establishment or place other than that described
in the certificate.
(1)
The registration fee is
seven
hundred fifty dollars and shall accompany each application for registration.
The registration renewal fee is seven hundred fifty dollars and shall accompany
each renewal application. A registration
certificate that has not been renewed in any year by the first day of August
may be reinstated upon payment of the renewal fee and a penalty of
one
hundred fifty dollars. (2)
Renewal fees and penalties assessed under division (E)(1) of this section shall
not be returned if the applicant fails to qualify for renewal.
(F)
The
registration of any person as a wholesale distributor of dangerous drugs
subjects the person and the person'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 registration as a wholesale distributor of dangerous drugs by,
or on behalf of, any person or the registration of any person as a wholesale
distributor of dangerous drugs shall not, of itself, constitute evidence that
the person is doing business within this state.
Amended by
129th General AssemblyFile
No.28, HB 153,
§101.01, eff.
9/29/2011. Effective Date: 07-22-1998
(A)
The board of
pharmacy shall not register any person as a wholesale distributor of dangerous
drugs unless the applicant for registration furnishes satisfactory proof to the
board of pharmacy that he meets all of the following: (1)
That if the applicant has been convicted
of a violation of any federal, state, or local law relating to drug samples,
wholesale or retail drug distribution, or distribution of controlled substances
or of a felony, or if a federal, state, or local governmental entity has
suspended or revoked any current or prior license or registration of the
applicant for the manufacture or sale of any dangerous drugs, including
controlled substances, the applicant, to the satisfaction of the board, assures
that he has in place adequate safeguards to prevent the recurrence of any such
violations;
(2)
The applicant's
past experience in the manufacture or distribution of dangerous drugs,
including controlled substances, is acceptable to the board.
(3)
The applicant is equipped as to land,
buildings, equipment, and personnel to properly carry on the business of a
wholesale distributor of dangerous drugs, 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 to any person other than
those named in division (B) of section
4729.51 of the Revised Code.
(7)
Any other requirement or
qualification the board, by rule adopted in accordance with Chapter 119. of the
Revised Code, considers relevant to and consistent with the public safety and
health.
(B)
The board
may refuse to register or renew the registration certificate of any person if
the board determines that the granting of the registration certificate or its
renewal is not in the public interest.
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.
(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 and section
4729.541 of the Revised Code: (1)
"Category I" means single-dose injections of intravenous fluids, including
saline, Ringer's lactate, five per cent dextrose and distilled water, and other
intravenous fluids or parenteral solutions included in this category by rule of
the state board of pharmacy, that have a volume
of one hundred milliliters or more and that contain no added substances, or
single-dose injections of epinephrine to be administered pursuant to sections
4765.38 and
4765.39 of the Revised
Code.
(2)
"Category II"
means any dangerous drug that is not included in category I or III.
(3)
"Category III" means any controlled substance that is contained in schedule I,
II, III, IV, or V.
(4)
"Emergency
medical service organization" has the same meaning as in section
4765.01 of the Revised
Code.
(5)
"Person"
includes an emergency medical service organization.
(6)
"Schedule I, schedule II, schedule III, schedule IV, and schedule V" mean
controlled substance schedules I, II, III, IV, and V, respectively, as
established pursuant to section
3719.41 of the Revised Code and as
amended.
(1)
A person who desires 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 that the person wishes to
be licensed as a category I, category II, category III, limited category I,
limited category II, or limited category III terminal distributor of dangerous
drugs;
(c)
If the person wishes to be licensed
as a limited category I, limited category II, or limited category III terminal
distributor of dangerous drugs, a notarized list of the dangerous drugs that
the person wishes to possess, have custody or control of, and distribute, which
list shall also specify the purpose for which those drugs will be used and
their source;
(d)
If the person is an emergency medical
service organization, the information that is specified in division (C)(1) of
this section;
(e)
Except for an emergency medical
service organization, the identity of the one establishment or place at which
the person intends to engage in the sale or other distribution of dangerous
drugs at retail, and maintain possession, custody, or control of dangerous
drugs for purposes other than the person's own use or consumption;
(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.
4729.03 Organization.
4729.04 Executive director of board - duties.
4729.041 Amount of salvia divinorum or salvinorin A required for impaired operation.
4729.05 Meetings of board.
4729.06 Records - seals.
4729.07 License application - examination.
4729.071 License applicant to comply with RC Chapter 4776.
4729.08 License qualifications.
4729.09 Reciprocity.
4729.10 [Repealed].
4729.11 Establishing pharmacy internship program.
4729.12 Identification card - issuing, carrying, displaying.
4729.13 Failure to renew identification card.
4729.131 [Repealed].
4729.14 Issuing replacement licenses or identification cards.
4729.15 State board of pharmacy - fees.
4729.16 Discplinary actions.
4729.161 Offering services through authorized business entity.
4729.162 Adoption of rules regarding review of patient information available through drug database.
4729.17 Single member may hold hearing.
4729.18 Standards for approving and designating physicians and facilities as treatment providers for pharmacists with substance abuse problems.
4729.19 Cooperation in investigation.
4729.20 to 4729.24 [Repealed].
4729.25 Enforcement.
4729.26 Administrative rules.
4729.261, 4729.262 [Repealed].
4729.27 Pharmacist must be in full and actual charge of pharmacy.
4729.28 Unauthorized practice.
4729.281 Conditions for refill of prescription.
4729.29 Exemptions.
4729.291 Drugs personally furnished by prescriber.
4729.30 Sale of Paris green.
4729.31 Exceptions.
4729.32 Requirements for sale of denatured or wood alcohol in five gallon lots or more.
4729.33 Requirements for sale of denatured or wood alcohol in less than five gallon lots.
4729.34 Advertising.
4729.35 Violations deemed public nuisance.
4729.36 Advertisements.
4729.361 Disclosing price information.
4729.37 Filling prescriptions - records.
4729.38 Selecting generically equivalent drugs.
4729.381 Licensed pharmacist - immunity.
4729.39 Consult agreement with physicians.
4729.41 Adult immunizations.
4729.42 Unauthorized conduct by pharmacy technicians.
4729.50 Contracts with private entities to process applications.
4729.51 Selling, purchasing, distributing, or delivering dangerous drugs.
4729.511 Naloxone distributor; priorities.
4729.52 Registering as wholesale distributor.
4729.53 Registration requirements.
4729.531 Limited license to animal shelters for use of drugs for euthanizing animals.
4729.532 Performing euthanasia by means of lethal injection on animal.
4729.54 Terminal distributor licenses.
(1) An emergency medical service organization that wishes to be licensed as a terminal distributor of dangerous drugs shall list in its application for licensure the following additional information:
(a) The units under its control that the organization determines will possess dangerous drugs for the purpose of administering emergency medical services in accordance with Chapter 4765. of the Revised Code;
(b) With respect to each such unit, whether the dangerous drugs that the organization determines the unit will possess are in category I, II, or III.
(2) An emergency medical service organization that is licensed as a terminal distributor of dangerous drugs shall file a new application for such licensure if there is any change in the number, or location of, any of its units or any change in the category of the dangerous drugs that any unit will possess.
(3) A unit listed in an application for licensure pursuant to division (C)(1) of this section may obtain the dangerous drugs it is authorized to possess from its emergency medical service organization or, on a replacement basis, from a hospital pharmacy. If units will obtain dangerous drugs from a hospital pharmacy, the organization shall file, and maintain in current form, the following items with the pharmacist who is responsible for the hospital's terminal distributor of dangerous drugs license:
(a) A copy of its standing orders or protocol;
(b) A list of the personnel employed or used by the organization to provide emergency medical services in accordance with Chapter 4765. of the Revised Code, who are authorized to possess the drugs, which list also shall indicate the personnel who are authorized to administer the drugs.
(D) Each emergency medical service organization that applies for a terminal distributor of dangerous drugs license shall submit with its application the following:
(1) A notarized copy of its standing orders or protocol, which orders or protocol shall be signed by a physician and specify the dangerous drugs that its units may carry, expressed in standard dose units;
(2) A list of the personnel employed or used by the organization to provide emergency medical services in accordance with Chapter 4765. of the Revised Code.
An emergency medical service organization that is licensed as a terminal distributor shall notify the board immediately of any changes in its standing orders or protocol.
(E) There shall be six categories of terminal distributor of dangerous drugs licenses, which categories shall be as follows:
(1) Category I license. A person who obtains this license may possess, have custody or control of, and distribute only the dangerous drugs described in category I.
(2) Limited category I license. A person who obtains this license may possess, have custody or control of, and distribute only the dangerous drugs described in category I that were listed in the application for licensure.
(3) Category II license. A person who obtains this license may possess, have custody or control of, and distribute only the dangerous drugs described in category I and category II.
(4) Limited category II license. A person who obtains this license may possess, have custody or control of, and distribute only the dangerous drugs described in category I or category II that were listed in the application for licensure.
(5) Category III license, 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 I, category II, and category III. If the license includes a pain management clinic classification, the person may operate a pain management clinic.
(6) Limited category III license. A person who obtains this license may possess, have custody or control of, and distribute only the dangerous drugs described in category I, category II, or category III that were listed in the application for licensure.
(F) Except for an application made on behalf of an animal shelter, if an applicant for licensure as a limited category I, II, or III terminal distributor of dangerous drugs intends to administer dangerous drugs to a person or animal, the applicant shall submit, with the application, a notarized copy of its protocol or standing orders, which protocol or orders shall be signed by a licensed health professional authorized to prescribe drugs, specify the dangerous drugs to be administered, and list personnel who are authorized to administer the dangerous drugs in accordance with federal law or the law of this state. An application made on behalf of an animal shelter shall include a notarized list of the dangerous drugs to be administered to animals and the personnel who are authorized to administer the drugs to animals in accordance with section 4729.532 of the Revised Code. After obtaining a terminal distributor license, a licensee shall notify the board immediately of any changes in its protocol or standing orders, or in such personnel.
(1) Except as provided in division (G)(2) of this section, each applicant for licensure as a terminal distributor of dangerous drugs shall submit, with the application, a license fee determined as follows:
(a) For a category I or limited category I license, forty-five dollars;
(b) For a category II or limited category II license, one hundred twelve dollars and fifty cents;
(c) For a category III 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, one hundred fifty dollars.
(2) For a professional association, corporation, partnership, or limited liability company organized for the purpose of practicing veterinary medicine, the fee shall be forty dollars.
(3) Fees assessed under divisions (G)(1) and (2) of this section shall not be returned if the applicant fails to qualify for registration.
(1) The board shall issue a terminal distributor of dangerous drugs license to each person who submits an application for such licensure in accordance with this section, pays the required license fee, is determined by the board to meet the requirements set forth in section 4729.55 of the Revised Code, and satisfies any other applicable requirements of this section.
(2) The license of a person other than an emergency medical service organization shall describe the one establishment or place at which the licensee may engage in the sale or other distribution of dangerous drugs at retail and maintain possession, custody, or control of dangerous drugs for purposes other than the licensee's own use or consumption. The one establishment or place shall be that which is described in the application for licensure.
No such license shall authorize or permit the terminal distributor of dangerous drugs named in it to engage in the sale or other distribution of dangerous drugs at retail or to maintain possession, custody, or control of dangerous drugs for any purpose other than the distributor's own use or consumption, at any establishment or place other than that described in the license, except that an agent or employee of an animal shelter may possess and use dangerous drugs in the course of business as provided in division (D) of section 4729.532 of the Revised Code.
(3) The license of an emergency medical service organization shall cover and describe all the units of the organization listed in its application for licensure.
(4) The license of every terminal distributor of dangerous drugs shall indicate, on its face, the category of licensure. If the license is a limited category I, II, or III license, it shall specify, and shall authorize the licensee to possess, have custody or control of, and distribute only, the dangerous drugs that were listed in the application for licensure.
(I) All licenses issued pursuant to this section shall be effective for a period of twelve months from the first day of January of each year. A license shall be renewed by the board for a like period, annually, according to the provisions of this section, and the standard renewal procedure of Chapter 4745. of the Revised Code. A person who desires to renew a license shall submit an application for renewal and pay the required fee on or before the thirty-first day of December each year. The fee required for the renewal of a license shall be the same as the fee paid for the license being renewed, and shall accompany the application for renewal.
A license that has not been renewed during December in any year and by the first day of February of the following year may be reinstated only upon payment of the required renewal fee and a penalty fee of fifty-five dollars.
(1) No emergency medical service organization that is licensed as a terminal distributor of dangerous drugs shall fail to comply with division (C)(2) or (3) of this section.
(2) No emergency medical service organization that is licensed as a terminal distributor of dangerous drugs shall fail to comply with division (D) of this section.
(3) No licensed terminal distributor of dangerous drugs shall possess, have custody or control of, or distribute dangerous drugs that the terminal distributor is not entitled to possess, have custody or control of, or distribute by virtue of its category of licensure.
(4) No licensee that is required by division (F) of this section to notify the board of changes in its protocol or standing orders, or in personnel, shall fail to comply with that division.
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 division (B) of this section, a business entity described in division (B)(1)(j) or (k) of section 4729.51 of the Revised Code may possess, have custody or control of, and distribute the dangerous drugs in category I, category II, and category III of section 4729.54 of the Revised Code without holding a terminal distributor of dangerous drugs license issued under that section.
(B) If a business entity described in division (B)(1)(j) or (k) of section 4729.51 of the Revised Code is a pain management clinic or is operating a pain management clinic, the entity 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.
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, animal shelter licensed with the state board of pharmacy under section 4729.531 of the Revised Code, or a laboratory as defined in section 3719.01 of the Revised Code will maintain supervision and control over the possession and custody of dangerous drugs 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.
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 terminal distributor of dangerous drugs license holder 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 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) In accordance with Chapter 119. of the Revised Code, the board of pharmacy may suspend, revoke, or refuse to renew any registration certificate issued to a wholesale distributor of dangerous drugs pursuant to section 4729.52 of the Revised Code or may 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 are not classified as an offense by the Revised Code for any of the following causes:
(1) Making any false material statements in an application for registration as a wholesale distributor of dangerous drugs;
(2) 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;
(3) A conviction of a felony;
(4) Ceasing to satisfy the qualifications for registration under section 4729.53 of the Revised Code or the rules of the board.
(B) Upon the suspension or revocation of the registration certificate of any wholesale distributor of dangerous drugs, the distributor shall immediately surrender his registration certificate to the board.
(C) If the board suspends, revokes, or refuses to renew any registration certificate issued to a wholesale distributor of dangerous drugs 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 wholesale distributor of dangerous drugs. Except as provided in this division, the board shall not dispose of the dangerous drugs sealed under this division until the wholesale distributor of dangerous drugs exhausts all of his 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.
Effective Date: 07-01-1992
(A) The state board of pharmacy may suspend, revoke, or refuse to grant or renew any license as a terminal distributor of dangerous drugs , or may 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, for any of the following causes:
(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) 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 (B) 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.
(B) Sanctions shall not be imposed under division (A)(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.
(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) 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 otherwise provided in this division, 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.
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.
Amended by 129th General AssemblyFile No.156, SB 301, §1, eff. 3/13/2013.
Effective Date: 07-22-1998
If the state board of pharmacy determines that there is clear and convincing evidence that the method used by a terminal distributor of dangerous drugs to distribute controlled substances presents a danger of immediate and serious harm to others, the board may suspend the terminal distributor's license without a hearing. 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 ninety days after the hearing, the suspension shall be void on the ninety-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 and the person holding the license also holds a certificate 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.
Added by 129th General AssemblyFile No.19, HB 93, §1, eff. 5/20/2011.
The board of pharmacy, within thirty days after receipt of an 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 new license or registration certificate or the renewal of a license or registration certificate previously issued, shall notify the applicant therefor whether or not such license or registration certificate will be issued or renewed. If the board determines that such license or registration certificate will not be issued or renewed, such notice to the applicant shall set forth the reason or reasons that such license or registration certificate will not be issued or renewed.
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 registration of those persons to whom a registration certificate has been issued pursuant to section 4729.52 of the Revised Code and those persons to whom a license has been issued pursuant to section 4729.54 of the Revised Code. The register shall be the property of the board and shall be open for public examination and inspection at all reasonable times, as the board may direct. The board shall publish or make available to registered wholesale distributors and licensed terminal distributors of dangerous drugs, annually, and at such other times and in such manner as the board shall prescribe, a roster setting forth the names and addresses of those persons who have been registered by the board pursuant to section 4729.52 of the Revised Code and those persons who have been licensed pursuant to section 4729.54 of the Revised Code, those persons whose licenses or registration certificates have been suspended, revoked, or surrendered, and those persons whose licenses or registration certificates have not been renewed. A written statement signed and verified by the executive director of the board in which it is stated that after diligent search of the register no record or entry of the issuance of a license or registration certificate to a person is found is admissible in evidence and constitutes presumptive evidence of the fact that the person is not a licensed terminal distributor or is not a registered wholesale distributor of dangerous drugs.
Effective Date: 07-22-1998
(A) Before a registered wholesale distributor of dangerous drugs may sell dangerous drugs at wholesale to any person, other than the persons specified in divisions (B)(1)(a) to (d) and (B)(1)(f) to (h) of section 4729.51 of the Revised Code, such wholesale distributor shall obtain from the purchaser and the purchaser shall furnish to the wholesale distributor a certificate indicating that the purchaser is a licensed terminal distributor of dangerous drugs. The certificate shall be in the form that the state board of pharmacy shall prescribe, and shall set forth the name of the licensee, the number of the license, a description of the place or establishment or each place or establishment for which the license was issued, the category of licensure, and, if the license is a limited category I, II, or III license, the dangerous drugs that the licensee is authorized to possess, have custody or control of, and distribute. If no certificate is obtained or furnished before a sale is made, it shall be presumed that the sale of dangerous drugs by the wholesale distributor 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 (C) of section 4729.51 of the Revised Code. If a registered wholesale distributor of dangerous drugs obtains or is furnished a certificate from a terminal distributor of dangerous drugs and relies on the certificate in selling dangerous drugs at wholesale to the terminal distributor of dangerous drugs, the wholesale distributor of dangerous drugs shall be deemed not to have violated division (B) of section 4729.51 of the Revised Code in making the sale.
(B) Before a licensed terminal distributor of dangerous drugs may purchase dangerous drugs at wholesale, the terminal distributor shall obtain from the seller and the seller shall furnish to the terminal distributor the number of the seller's registration certificate to engage in the sale of dangerous drugs at wholesale. If no registration number is obtained or furnished before a purchase is made, it shall be presumed that the purchase of dangerous drugs by the terminal distributor is in violation of division (D) 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 obtains or is furnished a registration number from a wholesale distributor of dangerous drugs and relies on the registration number in purchasing dangerous drugs at wholesale from the wholesale distributor of dangerous drugs, the terminal distributor shall be deemed not to have violated division (D) of section 4729.51 of the Revised Code in making the purchase.
Effective Date: 03-09-1999
(A) No person shall make or cause to be made, or furnish or cause to be furnished to a wholesale distributor of dangerous drugs, a false certificate required to be furnished to a wholesale distributor of dangerous drugs by section 4729.60 of the Revised Code for the purchase of dangerous drugs at wholesale.
(B) No person shall make or cause to be made a false registration certificate of a wholesale distributor of dangerous drugs or a false or fraudulent license of a terminal distributor of dangerous drugs.
Effective Date: 07-01-1996
If a wholesale distributor of dangerous drugs who has been registered ceases to engage in the sale of dangerous drugs at wholesale, or if a terminal distributor of dangerous drugs to whom a license has been issued ceases to engage in the sale of dangerous drugs at retail, such terminal or wholesale distributor of dangerous drugs shall notify the board of pharmacy of such fact and shall surrender such license or registration certificate to the board; provided, that on dissolution of a partnership by death, the surviving partner may operate under a license or registration certificate issued to the partnership until expiration, revocation, or suspension of such license or registration certificate, 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 or registration certificate issued to the persons succeeded in possession by such heir, representative, receiver, or trustee in bankruptcy until expiration, revocation, or suspension of such license or registration certificate.
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.
(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)
Notwithstanding any contrary provision in the Revised Code, moneys that are
derived from forfeitures of property pursuant to federal law and that are
deposited into the board of pharmacy drug law enforcement fund in accordance
with division (B)(1) of this section 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.
(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. The board, subject to the
approval of the controlling board and except for fees required to be
established by the board at amounts "adequate" to cover designated expenses,
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.
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, identification card, or certificate of registration
issued pursuant to this chapter. 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
4729.51 of the Revised Code the
national bodies recognized by the board that certify persons who successfully
complete diabetes education programs. Effective Date: 11-06-1996
(A)
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 for the purpose of destruction or
disposal of the drugs.
(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, except that
the first collection shall occur not later than one year after
May 20, 2011;
(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.
(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 following information: (1)
Total weight of drugs collected, both with and without packaging;
(2)
The weight of controlled substances;
(3)
The amount of all of the following as a per cent of total drugs collected: (a)
Controlled substances;
(b)
Brand name drugs;
(c)
Generic
drugs;
(d)
Prescription drugs;
(e)
Non-prescription drugs.
(4)
The amount of vitamins, herbal supplements, and personal care products
collected;
(5)
If
provided by the person who submitted or otherwise donated drugs to the program,
the reasons why the drugs were returned or unused.
(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.
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)
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: (a)
Air - yellow;
(b)
Carbon dioxide - gray;
(c)
Cyclopropane - orange;
(d)
Helium - brown;
(e)
Nitrogen - black;
(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 controlled substances, as
defined in section
3719.01 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. In establishing and maintaining the database, the board shall
electronically collect information pursuant to sections
4729.77 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
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.
(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.
4729.64 Injunctions.
4729.65 Depositing receipts.
4729.66 [Repealed].
4729.67 Effect of child support default on license or certificate.
4729.68 Completion of diabetes education program.
4729.69 Establishment and administration of drug take-back program.
4729.70 Establishing and implementing medical gases safety program.
4729.75 Drug database may be established by board of pharmacy.
4729.76 Duties of administrator of drug database.
4729.77 Drug database information to be supplied by terminal distributors.
(C) This section does not apply to a prescriber personally furnishing or administering dangerous drugs to the prescriber's patient.
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 wholesale distributor of dangerous drugs that delivers drugs in this state 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;
(4) Date of sale;
(5) The wholesale distributor's license number issued by the board.
(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.
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 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.
(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.
(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 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 in accordance with the following:
(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.
(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 may provide to the prescriber information from the database relating to a patient who is either of the following, if 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 :
(a) A current patient of the prescriber;
(b) A potential patient of the prescriber based on a referral of the patient to the prescriber.
(6) On receipt of a request from a pharmacist or the pharmacist's delegate approved by the board, the board may 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.
(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 database information.
(8) On receipt of a request from the medical director of a managed care organization that has entered into a data security agreement with the board required by section 5167.14 of the Revised Code, the board shall provide to the medical 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 the administrator of workers' compensation, the board may provide to the administrator information from the database relating to a claimant under Chapter 4121., 4123., 4127., or 4131. of the Revised Code.
(11) 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.
(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 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 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.
(C) Information contained in the database and any information obtained from it is not a public record. Information contained in the records of requests for information from the database is not a public record. Information that does not identify a person 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 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
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 for at least two years. Any information that identifies a patient shall be destroyed after it has been retained for two 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.
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 shall not impose any charge on a terminal distributor of dangerous drugs, pharmacist, or 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.
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, and each purchase at wholesale of dangerous drugs about which information is entered into the drug database;
(B) Requirements for the transmission of information from terminal distributors of dangerous drugs, wholesale distributors of dangerous drugs , and prescribers;
(C) An electronic format for the submission of information from terminal distributors , wholesale distributors , and prescribers;
(D) A procedure whereby a terminal distributor , wholesale distributor , or prescriber 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 two years be retained when the information pertains to an open investigation being conducted by the agency or entity;
(F) A procedure whereby a terminal distributor, wholesale distributor, or prescriber 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) 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;
(I) A procedure whereby an individual may request the individual's own database information and the board may verify the identity of the requestor;
(J) 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;
(K) The other specific dangerous drugs that, in addition to controlled substances , must be included in the database;
(L) 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.
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 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. The initial report shall be presented not later than two years after the database is established.
(B) Each report presented under this section shall include all of the following:
(1) The cost to the state of establishing and maintaining the database;
(2) Information from terminal distributors of dangerous drugs, prescribers, and the board regarding the board's effectiveness in providing information from the database;
(3) The board's timeliness in transmitting information from the database.
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:
(1) No person identified in divisions (A)(1) to (10) 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 or pharmacist for whom the person is approved by the board to serve as a delegate of the prescriber or pharmacist for purposes of requesting and receiving information from the drug database under division (A)(5) or (6) of section 4729.80 of the Revised Code;
(c) When a prescriber or pharmacist provides the information to a person who is approved by the board to serve as such a delegate of the prescriber or pharmacist.
(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.
(1) 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)(11) 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.
(2) The board shall determine the extent to which the person is restricted from obtaining further information from the 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.
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.
(A) Whoever violates section 4729.16 , division (A) or (B) of section 4729.38 , or section 4729.57 of the Revised Code is guilty of a minor misdemeanor. 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), (D), or (E) of section 4729.51 of the Revised Code is guilty of a misdemeanor of the first degree.
(1) Whoever violates section 4729.37 , division (C)(2) of section 4729.51 , division (J) of section 4729.54 , 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 (C) 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 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 (C) 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 (C)(1) 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 (C)(3) 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.
(1) Whoever violates division (B) of section 4729.42 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 (B), (C), (D), or (E) 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 (C) or (D) of section 4729.42 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 (B), (C), (D), or (E) 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) Whoever violates division (E) of section 4729.42 of the Revised Code is guilty of the offense of falsification under section 2921.13 of the Revised Code. In addition to any other sanction imposed for the violation, the offender is forever disqualified from engaging in any activity specified in division (B)(1), (2), or (3) of section 4729.42 of the Revised Code and from performing any function as a health care professional or health care worker. As used in this division, "health care professional" and "health care worker" have the same meanings as in section 2305.234 of the Revised Code.
(4) 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), (2), or (3) 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.
(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 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