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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 one or more physicians authorized under Chapter 4731. of the Revised Code to practice medicine and surgery or osteopathic medicine and surgery, if an agreement has been established;
(9) Engaging in the administration of immunizations to the extent authorized by section 4729.41 of the Revised Code.
(10) Engaging in the administration of drugs to the extent authorized by section 4729.45 of the Revised Code.
(C) "Compounding" means the preparation, mixing, assembling, packaging, and labeling of one or more drugs in any of the following circumstances:
(1) Pursuant to a prescription issued by a licensed health professional authorized to prescribe drugs;
(2) Pursuant to the modification of a prescription made in accordance with a consult agreement;
(3) As an incident to research, teaching activities, or chemical analysis;
(4) In anticipation of orders for drugs pursuant to prescriptions, based on routine, regularly observed dispensing patterns;
(5) Pursuant to a request made by a licensed health professional authorized to prescribe drugs for a drug that is to be used by the professional for the purpose of direct administration to patients in the course of the professional's practice, if all of the following apply:
(a) At the time the request is made, the drug is not commercially available regardless of the reason that the drug is not available, including the absence of a manufacturer for the drug or the lack of a readily available supply of the drug from a manufacturer.
(b) A limited quantity of the drug is compounded and provided to the professional.
(c) The drug is compounded and provided to the professional as an occasional exception to the normal practice of dispensing drugs pursuant to patient-specific prescriptions.
(D) "Consult agreement" means an agreement that has been entered into under section 4729.39 of the Revised Code.
(E) "Drug" means:
(1) Any article recognized in the United States pharmacopoeia and national formulary, or any supplement to them, intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or animals;
(2) Any other article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or animals;
(3) Any article, other than food, intended to affect the structure or any function of the body of humans or animals;
(4) Any article intended for use as a component of any article specified in division (E)(1), (2), or (3) of this section; but does not include devices or their components, parts, or accessories.
(F) "Dangerous drug" means any of the following:
(1) Any drug to which either of the following applies:
(a) Under the "Federal Food, Drug, and Cosmetic Act," 52 Stat. 1040 (1938), 21 U.S.C.A. 301, as amended, the drug is required to bear a label containing the legend "Caution: Federal law prohibits dispensing without prescription" or "Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian" or any similar restrictive statement, or the drug may be dispensed only upon a prescription;
(b) Under Chapter 3715. or 3719. of the Revised Code, the drug may be dispensed only upon a prescription.
(2) Any drug that contains a schedule V controlled substance and that is exempt from Chapter 3719. of the Revised Code or to which that chapter does not apply;
(3) Any drug intended for administration by injection into the human body other than through a natural orifice of the human body;
(4) Any drug that is a biological product, as defined in section 3715.01 of the Revised Code.
(G) "Federal drug abuse control laws" has the same meaning as in section 3719.01 of the Revised Code.
(H) "Prescription" means all of the following:
(1) A written, electronic, or oral order for drugs or combinations or mixtures of drugs to be used by a particular individual or for treating a particular animal, issued by a licensed health professional authorized to prescribe drugs;
(2) For purposes of sections 2925.61, 4723.488, 4729.44, 4730.431, and 4731.94 of the Revised Code, a written, electronic, or oral order for naloxone issued to and in the name of a family member, friend, or other individual in a position to assist an individual who there is reason to believe is at risk of experiencing an opioid-related overdose.
(3) For purposes of sections 4723.4810, 4729.282, 4730.432, and 4731.93 of the Revised Code, a written, electronic, or oral order for a drug to treat chlamydia, gonorrhea, or trichomoniasis issued to and in the name of a patient who is not the intended user of the drug but is the sexual partner of the intended user;
(4) For purposes of sections 3313.7110, 3313.7111, 3314.143, 3326.28, 3328.29, 4723.483, 4729.88, 4730.433, 4731.96, and 5101.76 of the Revised Code, a written, electronic, or oral order for an epinephrine autoinjector issued to and in the name of a school, school district, or camp;
(5) For purposes of Chapter 3728. and sections 4723.483, 4729.88, 4730.433, and 4731.96 of the Revised Code, a written, electronic, or oral order for an epinephrine autoinjector issued to and in the name of a qualified entity, as defined in section 3728.01 of the Revised Code.
(I) "Licensed health professional authorized to prescribe drugs" or "prescriber" means an individual who is authorized by law to prescribe drugs or dangerous drugs or drug therapy related devices in the course of the individual's professional practice, including only the following:
(1) A dentist licensed under Chapter 4715. of the Revised Code;
(2) A clinical nurse specialist, certified nurse-midwife, or certified nurse practitioner who holds a current, valid license to practice nursing as an advanced practice registered nurse issued under Chapter 4723. 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 license to practice as a physician assistant issued under Chapter 4730. of the Revised Code, holds a valid prescriber number issued by the state medical board, and has been granted physician-delegated prescriptive authority;
(6) A veterinarian licensed under Chapter 4741. of the Revised Code.
(J) "Sale" or "sell" includes any transaction made by any person, whether as principal proprietor, agent, or employee, to do or offer to do any of the following: deliver, distribute, broker, exchange, gift or otherwise give away, or transfer, whether the transfer is by passage of title, physical movement, or both.
(K) "Wholesale sale" and "sale at wholesale" mean any sale in which the purpose of the purchaser is to resell the article purchased or received by the purchaser.
(L) "Retail sale" and "sale at retail" mean any sale other than a wholesale sale or sale at wholesale.
(M) "Retail seller" means any person that sells any dangerous drug to consumers without assuming control over and responsibility for its administration. Mere advice or instructions regarding administration do not constitute control or establish responsibility.
(N) "Price information" means the price charged for a prescription for a particular drug product and, in an easily understandable manner, all of the following:
(1) The proprietary name of the drug product;
(2) The established (generic) name of the drug product;
(3) The strength of the drug product if the product contains a single active ingredient or if the drug product contains more than one active ingredient and a relevant strength can be associated with the product without indicating each active ingredient. The established name and quantity of each active ingredient are required if such a relevant strength cannot be so associated with a drug product containing more than one ingredient.
(4) The dosage form;
(5) The price charged for a specific quantity of the drug product. The stated price shall include all charges to the consumer, including, but not limited to, the cost of the drug product, professional fees, handling fees, if any, and a statement identifying professional services routinely furnished by the pharmacy. Any mailing fees and delivery fees may be stated separately without repetition. The information shall not be false or misleading.
(O) "Wholesale distributor of dangerous drugs" or "wholesale distributor" means a person engaged in the sale of dangerous drugs at wholesale and includes any agent or employee of such a person authorized by the person to engage in the sale of dangerous drugs at wholesale.
(P) "Manufacturer of dangerous drugs" or "manufacturer" means a person, other than a pharmacist or prescriber, who manufactures dangerous drugs and who is engaged in the sale of those dangerous drugs .
(Q) "Terminal distributor of dangerous drugs" or "terminal distributor" means a person who is engaged in the sale of dangerous drugs at retail, or any person, other than a manufacturer, repackager, outsourcing facility, third-party logistics provider, wholesale distributor, or pharmacist, who has possession, custody, or control of dangerous drugs for any purpose other than for that person's own use and consumption. "Terminal distributor" includes pharmacies, hospitals, nursing homes, and laboratories and all other persons who procure dangerous drugs for sale or other distribution by or under the supervision of a pharmacist 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) " Animal shelter" means a facility operated by a humane society or any society organized under Chapter 1717. of the Revised Code or a dog pound operated pursuant to Chapter 955. of the Revised Code.
(U) "Food" has the same meaning as in section 3715.01 of the Revised Code.
(V) "Pain management clinic" has the same meaning as in section 4731.054 of the Revised Code.
(Y) [Added by 131st General Assembly File No. TBD, HB 290] "Investigational drug or product" means a drug or product that has successfully completed phase one of the United States food and drug administration clinical trials and remains under clinical trial, but has not been approved for general use by the United States food and drug administration. "Investigational drug or product" does not include controlled substances in schedule I, as established pursuant to section 3719.41 of the Revised Code, and as amended.
(Y) [Added by 132nd General Assembly File No. TBD, HB 49] "Third-party logistics provider" means a person that provides or coordinates warehousing or other logistics services pertaining to dangerous drugs including distribution, on behalf of a manufacturer, wholesale distributor, or terminal distributor of dangerous drugs, but does not take ownership of the drugs or have responsibility to direct the sale or disposition of the drugs.
(Z) [Added by 131st General Assembly File No. TBD, HB 290] "Product," when used in reference to an investigational drug or product, means a biological product, other than a drug, that is made from a natural human, animal, or microorganism source and is intended to treat a disease or medical condition.
(Z) [Added by 132nd General Assembly File No. TBD, HB 49] "Repackager of dangerous drugs" or "repackager" means a person that repacks and relabels dangerous drugs for sale or distribution.
(AA) "Outsourcing facility" means a facility that is engaged in the compounding and sale of sterile drugs and is registered as an outsourcing facility with the United States food and drug administration.
Amended by 132nd General Assembly File No. TBD, HB 49, §101.01, eff. 9/29/2017.
Amended by 131st General Assembly File No. TBD, HB 216, §1, eff. 4/6/2017.
Amended by 131st General Assembly File No. TBD, SB 332, §1, eff. 4/6/2017.
Amended by 131st General Assembly File No. TBD, HB 290, §1, eff. 4/6/2017.
Amended by 131st General Assembly File No. TBD, HB 505, §1, eff. 3/20/2017.
Amended by 131st General Assembly File No. TBD, HB 200, §1, eff. 9/8/2016.
Amended by 131st General Assembly File No. TBD, HB 188, §1, eff. 3/23/2016.
Amended by 131st General Assembly File No. TBD, HB 124, §1, eff. 3/23/2016.
Amended by 131st General Assembly File No. TBD, SB 110, §1, eff. 10/15/2015.
Amended by 131st General Assembly File No. TBD, HB 4, §1, eff. 7/16/2015.
Amended by 129th General AssemblyFile No.19, HB 93, §1, eff. 5/20/2011.
Effective Date: 06-26-2003; 04-07-2005; 08-19-2005; 05-17-2006; 2007 SB58 08-30-2007 .
There shall be a state board of pharmacy, consisting of nine members, eight of whom shall be pharmacists licensed under this chapter, representing to the extent practicable various phases of the practice of pharmacy, and one of whom shall be a public member at least sixty years of age. Members shall be appointed by the governor with the advice and consent of the senate. Terms of office shall be for four years, commencing on the first day of July and ending on the thirtieth day of June. The Ohio pharmacists association may annually submit to the governor the names of not less than five pharmacists licensed under this chapter, and from the names submitted or from others, at the governor's discretion, the governor each year shall make appointments to the board. Each member shall hold office from the date of appointment until the end of the term for which the member was appointed. Any member appointed to fill a vacancy occurring prior to the expiration of the term for which the predecessor was appointed shall hold office for the remainder of such term. Any member shall continue in office subsequent to the expiration date of the member's term until a successor takes office, or until a period of sixty days has elapsed, whichever occurs first. No member of the board shall be reappointed to the board more than once.
Effective Date: 07-22-1998 .
The state board of pharmacy shall license and register home medical equipment services providers under Chapter 4752. of the Revised Code and shall administer and enforce that chapter.
Added by 132nd General Assembly File No. TBD, HB 49, §130.11, eff. 1/21/2018.
The state board of pharmacy shall organize by electing a president and a vice-president who are members of the board. The president shall preside over the meetings of the board, but shall not vote upon matters determined by the board, except in the event of a tie vote, in which case the president shall vote. The board shall also employ an executive director . The person employed shall not be a member of the board. Each of the officers elected shall serve for a term of one year. The members of the board shall receive an amount fixed pursuant to division (J) of section 124.15 of the Revised Code for each day employed in the discharge of their official duties and their necessary expenses while engaged therein.
Amended by 130th General Assembly File No. TBD, SB 230, §1, eff. 9/17/2014.
Effective Date: 07-22-1998 .
(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 licenses and registrations that have been granted, together with each renewal and suspension or revocation of a license or registration. The books and registers of the board shall be prima-facie evidence of the matters therein recorded. The books and registers may be in electronic format.
The president and executive director of the board may administer oaths.
A statement signed by the executive director to which is affixed the official seal of the board to the effect that it appears from the records of the board that the board has not issued a license or registration to the person specified in the statement, or that a license or registration, if issued, has been revoked or suspended, or the holder has been subjected to disciplinary action by the board shall be received as prima-facie evidence of the record of the board in any court or before any officer of this state.
Amended by 132nd General Assembly File No. TBD, HB 49, §101.01, eff. 9/29/2017.
Amended by 131st General Assembly File No. TBD, SB 319, §1, eff. 4/6/2017.
Effective Date: 07-22-1998 .
An individual desiring to be licensed as a pharmacist shall file with the executive director of the state board of pharmacy a verified application giving such information as the board requires. An application filed under this section may not be withdrawn without the approval of the board. Each applicant shall take an examination to determine fitness to practice pharmacy. Examinations of those applying for licensure as pharmacists shall be held at such times, during each year, and at such places as the board determines. The board may use all or any part of the licensure examination of the national association of boards of pharmacy or any other national standardized pharmacy examination that it considers appropriate. The board may require applicants to purchase the examination and any related materials from the organization providing it.
Effective Date: 02-12-2001 .
(A) As used in this section, "license" and "applicant for an initial license" have the same meanings as in section 4776.01 of the Revised Code, except that "license" as used in both of those terms refers to the types of authorizations otherwise issued or conferred under this chapter.
(B) In addition to any other eligibility requirement set forth in this chapter, each applicant for an initial license shall comply with sections 4776.01 to 4776.04 of the Revised Code. The state board of pharmacy shall not grant a license to an applicant for an initial license unless the applicant complies with sections 4776.01 to 4776.04 of the Revised Code and the board, in its discretion, decides that the results of the criminal records check do not make the applicant ineligible for a license issued pursuant to section 4729.08, 4729.09, 4729.11, 4729.552, or 4729.553 of the Revised Code.
Amended by 131st General Assembly File No. TBD, SB 319, §1, eff. 4/6/2017.
Amended by 129th General AssemblyFile No.19, HB 93, §1, eff. 5/20/2011.
Effective Date: 2007 HB104 03-24-2008
Every applicant for examination and licensure as a pharmacist shall:
(A) Be at least eighteen years of age;
(B) Be of good moral character , as defined in rules adopted by the state board of pharmacy under section 4729.26 of the Revised Code;
(C) Have obtained a degree in pharmacy from a program that has been recognized and approved by the state board of pharmacy, except that graduates of schools or colleges of pharmacy that are located outside the United States and have not demonstrated that the standards of their programs are at least equivalent to programs recognized and approved by the board shall be required to pass an equivalency examination recognized and approved by the board and to establish written and oral proficiency in English.
(D) Have satisfactorily completed at least the minimum requirements for pharmacy internship as outlined by the board.
If the board is satisfied that the applicant meets the foregoing requirements and if the applicant passes the examination required under section 4729.07 of the Revised Code, the board shall issue to the applicant a license authorizing the individual to practice pharmacy.
Amended by 132nd General Assembly File No. TBD, HB 49, §101.01, eff. 9/29/2017.
Effective Date: 07-22-1998 .
The state board of pharmacy may license an individual as a pharmacist without examination if the individual:
(A) Holds a license in good standing to practice pharmacy under the laws of another state, has successfully completed an examination for licensure in the other state, and in the opinion of the board, the examination was at least as thorough as that required by the board at the time the individual took the examination;
(B) Is of good moral character , as defined in rules adopted by the board under section 4729.26 of the Revised Code;
(C) Has filed with the licensing body of the other state at least the credentials or the equivalent that were required by this state at the time the other state licensed the individual as a pharmacist.
The board shall not issue a license to practice pharmacy to an individual licensed in another state if the state in which the individual is licensed does not reciprocate by granting licenses to practice pharmacy to individuals holding valid licenses received through examination by the state board of pharmacy.
Amended by 132nd General Assembly File No. TBD, HB 49, §101.01, eff. 9/29/2017.
Effective Date: 07-22-1998 .
The state board of pharmacy may adopt rules under section 4729.26 of the Revised Code requiring a licensee or registrant under this chapter to report to the board a violation of state or federal law, including any rule adopted under this chapter.
In the absence of fraud or bad faith, a person who reports under this section or testifies in any adjudication conducted under Chapter 119. of the Revised Code is not liable to any person for damages in a civil action as a result of the report or testimony.
Added by 131st General Assembly File No. TBD, SB 319, §1, eff. 4/6/2017.
The state board of pharmacy shall establish a pharmacy internship program for the purpose of providing the practical experience necessary to practice as a pharmacist. Any individual who desires to become a pharmacy intern shall apply for licensure to the board. An application filed under this section may not be withdrawn without the approval of the board.
Each applicant shall be issued a license as a pharmacy intern if the board determines that the applicant is actively pursuing an educational program in preparation for licensure as a pharmacist and meets the other requirements as determined by the board. A license shall be valid until the next renewal date and shall be renewed only if the intern is meeting the requirements and rules of the board.
Amended by 132nd General Assembly File No. TBD, HB 49, §101.01, eff. 9/29/2017.
Effective Date: 02-12-2001 .
A license issued by the state board of pharmacy under section 4729.08 or 4729.11 of the Revised Code entitles the individual to whom it is issued to practice as a pharmacist or as a pharmacy intern in this state until the next renewal date.
Licenses shall be renewed according to the standard renewal procedure of Chapter 4745. of the Revised Code and rules adopted by the board under section 4729.26 of the Revised Code. Licenses are valid for the period specified in the rules, unless earlier revoked or suspended by the board. The period shall not exceed twenty-four months unless the board extends the period in the rules to adjust license renewal schedules.
A pharmacist or pharmacy intern who desires to continue in the practice of pharmacy shall file with the board an application in such form and containing such data as the board may require for renewal of a license. In the case of a pharmacist who dispenses or plans to dispense controlled substances in this state, the pharmacist shall certify, as part of the application, that the pharmacist has been granted access to the drug database established and maintained by the board pursuant to section 4729.75 of the Revised Code, unless the board has restricted the pharmacist from obtaining further information from the database or the board no longer maintains the database. If the pharmacist certifies to the board that the applicant has been granted access to the drug database and the board finds through an audit or other means that the pharmacist has not been granted access, the board may take action under section 4729.16 of the Revised Code.
An application filed under this section for renewal of a license may not be withdrawn without the approval of the board.
If the board finds that an applicant's license has not been revoked or placed under suspension and that the applicant has paid the renewal fee, has continued pharmacy education in accordance with the rules of the board, and is entitled to continue in the practice of pharmacy, the board shall renew the applicant's license.
When a license has expired but an application is made within three years after the expiration of the license, the applicant's license shall be renewed without further examination if the applicant meets the requirements of this section and pays the fee designated under division (A)(5) of section 4729.15 of the Revised Code.
A pharmacist or pharmacy intern who fails to renew the pharmacist's or intern's license by the renewal date prescribed by the board shall not engage in the practice of pharmacy until a valid license is issued by the board.
Amended by 132nd General Assembly File No. TBD, HB 49, §101.01, eff. 9/29/2017.
Amended by 130th General Assembly File No. TBD, SB 276, §1, eff. 3/19/2015.
Amended by 130th General Assembly File No. TBD, HB 394, §1, eff. 3/19/2015.
Amended by 130th General Assembly File No. TBD, HB 341, §1, eff. 1/1/2015.
Amended by 130th General Assembly File No. TBD, HB 483, §101.01, eff. 1/1/2015.
Amended by 130th General Assembly File No. TBD, HB 488, §1, eff. 9/16/2014.
Effective Date: 02-12-2001 .
A pharmacist who fails to make application to the state board of pharmacy for a license renewal within a period of three years from the expiration of the license must pass an examination for licensure and comply with sections 4776.01 to 4776.04 of the Revised Code; except that a pharmacist whose license has expired, but who has continually practiced pharmacy in another state under a license issued by the authority of that state, may obtain a renewed license upon payment to the executive director of the board the fee designated under division (A)(6) of section 4729.15 of the Revised Code.
Amended by 132nd General Assembly File No. TBD, HB 49, §101.01, eff. 9/29/2017.
Amended by 130th General Assembly File No. TBD, HB 488, §1, eff. 9/16/2014.
Effective Date: 07-22-1998 .
Effective Date: 12-31-1971 .
Repealed by 132nd General Assembly File No. TBD, HB 49, §105.01, eff. 9/29/2017.
Effective Date: 07-22-1998 .
(A) Except as provided in division (B) of this section, the state board of pharmacy shall charge the following fees:
(1) For applying for a license to practice as a pharmacist, an amount adequate to cover all expenses of the board related to examination except the expenses of procuring and grading the examination, which fee shall not be returned if the applicant fails to pass the examination;
(2) For the examination of an applicant for licensure as a pharmacist, an amount adequate to cover any expenses to the board of procuring and grading the examination or any part thereof, which fee shall not be returned if the applicant fails to pass the examination;
(3) For issuing a license to an individual who passes the examination described in section 4729.07 of the Revised Code, an amount that is adequate to cover the expense;
(4) For a pharmacist applying for renewal of a license before the expiration date, two hundred fifty dollars , which fee shall not be returned if the applicant fails to qualify for renewal;
(5) For a pharmacist applying for renewal of a license that has been expired for less than three years, the renewal fee identified in division (A)(4) of this section plus a penalty of thirty-seven dollars and fifty cents, which fee shall not be returned if the applicant fails to qualify for renewal;
(6) For a pharmacist applying for renewal of a license that has been expired for more than three years, three hundred thirty-seven dollars and fifty cents, which fee shall not be returned if the applicant fails to qualify for renewal;
(7) For a pharmacist applying for a license on presentation of a pharmacist license granted by another state, three hundred thirty-seven dollars and fifty cents, which fee shall not be returned if the applicant fails to qualify for licensure.
(8) For a license to practice as a pharmacy intern, forty-five dollars , which fee shall not be returned if the applicant fails to qualify for licensure;
(9) For the renewal of a pharmacy intern license, forty-five dollars , which fee shall not be returned if the applicant fails to qualify for renewal;
(10)
For certifying licensure and grades for reciprocal licensure, thirty-five dollars;
(11) For making copies of any application, affidavit, or other document filed in the state board of pharmacy office, an amount fixed by the board that is adequate to cover the expense, except that for copies required by federal or state agencies or law enforcement officers for official purposes, no charge need be made;
(12) For certifying and affixing the seal of the board, an amount fixed by the board that is adequate to cover the expense, except that for certifying and affixing the seal of the board to a document required by federal or state agencies or law enforcement officers for official purposes, no charge need be made;
(13) For each copy of a book or pamphlet that includes laws administered by the state board of pharmacy, rules adopted by the board, and chapters of the Revised Code with which the board is required to comply, an amount fixed by the board that is adequate to cover the expense of publishing and furnishing the book or pamphlet.
(B)
(1) Subject to division (B)(2) of this section, the fees described in divisions (A)(1) to (10) of this section do not apply to an individual who is on active duty in the armed forces of the United States, as defined in section 5903.01 of the Revised Code, to the spouse of an individual who is on active duty in the armed forces of the United States, or to an individual who served in the armed forces of the United States and presents documentation that the individual has been discharged under honorable conditions from the armed forces or has been transferred to the reserve with evidence of satisfactory service.
(2) The state board of pharmacy may establish limits with respect to the individuals for whom fees are not applicable under division (B)(1) of this section.
Amended by 132nd General Assembly File No. TBD, HB 49, §101.01, eff. 9/29/2017.
Amended by 130th General Assembly File No. TBD, HB 488, §1, eff. 9/16/2014.
Effective Date: 07-22-1998 .
(A)
(1) The state board of pharmacy, after notice and hearing in accordance with Chapter 119. of the Revised Code, may impose any one or more of the following sanctions on a pharmacist or pharmacy intern if the board finds the individual engaged in any of the conduct set forth in division (A)(2) of this section:
(a) Revoke, suspend, restrict, limit, or refuse to grant or renew a license;
(b) Reprimand or place the license holder on probation;
(c) Impose a monetary penalty or forfeiture not to exceed in severity any fine designated under the Revised Code for a similar offense, or in the case of a violation of a section of the Revised Code that does not bear a penalty, a monetary penalty or forfeiture of not more than five hundred dollars.
(2) The board may impose the sanctions listed in division (A)(1) of this section if the board finds a pharmacist or pharmacy intern:
(a) Has been convicted of a felony, or a crime of moral turpitude, as defined in section 4776.10 of the Revised Code;
(b) Engaged in dishonesty or unprofessional conduct in the practice of pharmacy;
(c) Is addicted to or abusing alcohol or drugs or is impaired physically or mentally to such a degree as to render the pharmacist or pharmacy intern unfit to practice pharmacy;
(d) Has been convicted of a misdemeanor related to, or committed in, the practice of pharmacy;
(e) Violated, conspired to violate, attempted to violate, or aided and abetted the violation of any of the provisions of this chapter, sections 3715.52 to 3715.72 of the Revised Code, Chapter 2925. or 3719. of the Revised Code, or any rule adopted by the board under those provisions;
(f) Permitted someone other than a pharmacist or pharmacy intern to practice pharmacy;
(g) Knowingly lent the pharmacist's or pharmacy intern's name to an illegal practitioner of pharmacy or had a professional connection with an illegal practitioner of pharmacy;
(h) Divided or agreed to divide remuneration made in the practice of pharmacy with any other individual, including, but not limited to, any licensed health professional authorized to prescribe drugs or any owner, manager, or employee of a health care facility, residential care facility, or nursing home;
(i) Violated the terms of a consult agreement entered into pursuant to section 4729.39 of the Revised Code;
(j) Committed fraud, misrepresentation, or deception in applying for or securing a license issued by the board under this chapter or under Chapter 3715. or 3719. of the Revised Code;
(k) Failed to comply with an order of the board or a settlement agreement;
(l) Engaged in any other conduct for which the board may impose discipline as set forth in rules adopted under section 4729.26 of the Revised Code.
(B) Any individual whose license is revoked, suspended, or refused, shall return the license to the offices of the state board of pharmacy within ten days after receipt of notice of such action.
(C) As used in this section:
Unprofessional conduct in the practice of pharmacy" includes any of the following:
(1) Advertising or displaying signs that promote dangerous drugs to the public in a manner that is false or misleading;
(2) Except as provided in section 4729.281 or 4729.44 of the Revised Code, the dispensing or sale of any drug for which a prescription is required, without having received a prescription for the drug;
(3) Knowingly dispensing medication pursuant to false or forged prescriptions;
(4) Knowingly failing to maintain complete and accurate records of all dangerous drugs received or dispensed in compliance with federal laws and regulations and state laws and rules;
(5) Obtaining any remuneration by fraud, misrepresentation, or deception;
(6) Failing to conform to prevailing standards of care of similar pharmacists or pharmacy interns under the same or similar circumstances, whether or not actual injury to a patient is established;
(7) Engaging in any other conduct that the board specifies as unprofessional conduct in the practice of pharmacy in rules adopted under section 4729.26 of the Revised Code.
(D) The board may suspend a license under division (B) of section 3719.121 of the Revised Code by utilizing a telephone conference call to review the allegations and take a vote.
(E) For purposes of this division, an individual authorized to practice as a pharmacist or pharmacy intern accepts the privilege of practicing in this state subject to supervision by the board. By filing an application for or holding a license to practice as a pharmacist or pharmacy intern, an individual gives consent to submit to a mental or physical examination when ordered to do so by the board in writing and waives all objections to the admissibility of testimony or examination reports that constitute privileged communications.
If the board has reasonable cause to believe that an individual who is a pharmacist or pharmacy intern is physically or mentally impaired, the board may require the individual to submit to a physical or mental examination, or both. The expense of the examination is the responsibility of the individual required to be examined.
Failure of an individual who is a pharmacist or pharmacy intern to submit to a physical or mental examination ordered by the board, unless the failure is due to circumstances beyond the individual's control, constitutes an admission of the allegations and a suspension order shall be entered without the taking of testimony or presentation of evidence. Any subsequent adjudication hearing under Chapter 119. of the Revised Code concerning failure to submit to an examination is limited to consideration of whether the failure was beyond the individual's control.
If, based on the results of an examination ordered under this division, the board determines that the individual's ability to practice is impaired, the board shall suspend the individual's license or deny the individual's application and shall require the individual, as a condition for an initial, continued, reinstated, or renewed license to practice, to submit to a physical or mental examination and treatment.
An order of suspension issued under this division shall not be subject to suspension by a court during pendency of any appeal filed under section 119.12 of the Revised Code.
(F) If the board is required under Chapter 119. of the Revised Code to give notice of an opportunity for a hearing and the applicant or licensee does not make a timely request for a hearing in accordance with section 119.07 of the Revised Code, the board is not required to hold a hearing, but may adopt a final order that contains the board's findings. In the final order, the board may impose any of the sanctions listed in division (A) of this section.
(G) Notwithstanding the provision of division (C)(2) of section 2953.32 of the Revised Code specifying that if records pertaining to a criminal case are sealed under that section the proceedings in the case must be deemed not to have occurred, sealing of the following records on which the board has based an action under this section shall have no effect on the board's action or any sanction imposed by the board under this section: records of any conviction, guilty plea, judicial finding of guilt resulting from a plea of no contest, or a judicial finding of eligibility for a pretrial diversion program or intervention in lieu of conviction. The board shall not be required to seal, destroy, redact, or otherwise modify its records to reflect the court's sealing of conviction records.
(H) No pharmacist or pharmacy intern shall knowingly engage in any conduct described in divisions (A)(2)(b) or (A)(2)(e) to (l) of this section.
Amended by 132nd General Assembly File No. TBD, HB 49, §101.01, eff. 9/29/2017.
Amended by 131st General Assembly File No. TBD, SB 319, §1, eff. 4/6/2017.
Amended by 131st General Assembly File No. TBD, HB 4, §1, eff. 7/16/2015.
Amended by 130th General Assembly File No. TBD, SB 276, §1, eff. 3/19/2015.
Amended by 130th General Assembly File No. TBD, HB 394, §1, eff. 3/19/2015.
Effective Date: 02-12-2001 .
(A) An individual registered with the state board of pharmacy to engage in the practice of pharmacy may render the professional services of a pharmacist within this state through a corporation formed under division (B) of section 1701.03 of the Revised Code, a limited liability company formed under Chapter 1705. of the Revised Code, a partnership, or a professional association formed under Chapter 1785. of the Revised Code. This division does not preclude an individual of that nature from rendering professional services as a pharmacist through another form of business entity, including, but not limited to, a nonprofit corporation or foundation, or in another manner that is authorized by or in accordance with this chapter, another chapter of the Revised Code, or rules of the state board of pharmacy adopted pursuant to this chapter.
(B) A corporation, limited liability company, partnership, or professional association described in division (A) of this section may be formed for the purpose of providing a combination of the professional services of the following individuals who are licensed, certificated, or otherwise legally authorized to practice their respective professions:
(1) Optometrists who are authorized to practice optometry under Chapter 4725. of the Revised Code;
(2) Chiropractors who are authorized to practice chiropractic or acupuncture under Chapter 4734. of the Revised Code;
(3) Psychologists who are authorized to practice psychology under Chapter 4732. of the Revised Code;
(4) Registered or licensed practical nurses who are authorized to practice nursing as registered nurses or as licensed practical nurses under Chapter 4723. of the Revised Code;
(5) Pharmacists who are authorized to practice pharmacy under Chapter 4729. of the Revised Code;
(6) Physical therapists who are authorized to practice physical therapy under sections 4755.40 to 4755.56 of the Revised Code;
(7) Occupational therapists who are authorized to practice occupational therapy under sections 4755.04 to 4755.13 of the Revised Code;
(8) Mechanotherapists who are authorized to practice mechanotherapy under section 4731.151 of the Revised Code;
(9) Doctors of medicine and surgery, osteopathic medicine and surgery, or podiatric medicine and surgery who are authorized for their respective practices under Chapter 4731. of the Revised Code;
(10) Licensed professional clinical counselors, licensed professional counselors, independent social workers, social workers, independent marriage and family therapists, or marriage and family therapists who are authorized for their respective practices under Chapter 4757. of the Revised Code.
This division shall apply notwithstanding a provision of a code of ethics applicable to a pharmacist that prohibits a pharmacist from engaging in the practice of pharmacy in combination with a person who is licensed, certificated, or otherwise legally authorized to practice optometry, chiropractic, acupuncture through the state chiropractic board, psychology, nursing, physical therapy, occupational therapy, mechanotherapy, medicine and surgery, osteopathic medicine and surgery, podiatric medicine and surgery, professional counseling, social work, or marriage and family therapy, but who is not also licensed, certificated, or otherwise legally authorized to engage in the practice of pharmacy.
Amended by 130th General Assembly File No. TBD, HB 232, §1, eff. 7/10/2014.
Effective Date: 03-22-1999; 04-06-2007; 2007 HB119 08-22-2007 .
(A) As used in this section, "drug database" means the database established and maintained by the state board of pharmacy pursuant to section 4729.75 of the Revised Code.
(B) The state board of pharmacy shall adopt rules in accordance with Chapter 119. of the Revised Code that establish standards and procedures to be followed by a pharmacist regarding the review of patient information available through the drug database under division (A)(6) of section 4729.80 of the Revised Code.
(C) This section and the rules adopted under it do not apply if the board no longer maintains the drug database.
Amended by 129th General AssemblyFile No.156, SB 301, §1, eff. 3/13/2013.
Added by 129th General AssemblyFile No.19, HB 93, §1, eff. 5/20/2011.
Any investigation, inquiry, or hearing, which the state board of pharmacy is empowered to hold or undertake may be held or undertaken by or before any member or members of the board and the finding or order of such member or members shall be deemed to be the order of said board when approved and confirmed by a majority of the board members present and voting at a meeting of the board at which there is a quorum.
Effective Date: 12-31-1971; 2007 SB58 08-30-2007 .
(A)
(1)
(a) The state board of pharmacy may designate one or more attorneys at law who have been admitted to the practice of law, and who are classified as either administrative law attorney examiners or as administrative law attorney examiner administrators under the state job classification plan adopted under section 124.14 of the Revised Code, as hearing examiners, subject to Chapter 119. of the Revised Code, to conduct any hearing the board is empowered to hold or undertake pursuant to Chapter 119. of the Revised Code.
(b) Notwithstanding the requirement of division (A)(1)(a) of this section that the board designate as a hearing examiner an attorney who is classified as either an administrative law attorney examiner or an administrative law attorney examiner administrator, the board may, subject to section 127.16 of the Revised Code, enter into a personal service contract with an attorney admitted to the practice of law in this state to serve as a hearing examiner.
(2) The hearing examiner shall hear and consider the oral and documented evidence introduced by the parties and issue in writing proposed findings of fact and conclusions of law to the board for their consideration within thirty days following the close of the hearing.
(B) The board shall be given copies of the transcript of the hearing record and all exhibits and documents presented by the parties at the hearing.
(C) The board shall render a decision and take action within ninety days following the receipt of the hearing examiner's proposed findings of fact and conclusions of law.
(D) The final decision of the board in any hearing shall be in writing and contain findings of fact and conclusions of law. Copies of the decision shall be delivered to the parties personally or by certified mail. The decision is final on delivery or mailing, but may be appealed as provided by Chapter 119. of the Revised Code.
Added by 131st General Assembly File No. TBD, SB 319, §1, eff. 4/6/2017.
The state board of pharmacy shall adopt rules in accordance with Chapter 119. of the Revised Code establishing standards for approving and designating physicians and facilities as treatment providers for pharmacists with substance abuse problems and shall approve and designate treatment providers in accordance with the rules. The rules shall include standards for both inpatient and outpatient treatment. The rules shall provide that to be approved, a treatment provider must be capable of making an initial examination to determine the type of treatment required for a pharmacist with substance abuse problems. Subject to the rules, the board shall review and approve treatment providers on a regular basis and may, at its discretion, withdraw or deny approval.
An approved treatment provider shall:
(A) Report to the board the name of any pharmacist suffering or showing evidence of suffering impairment by reason of being addicted to or abusing alcohol or drugs as described in division (A)(2)(c) of section 4729.16 of the Revised Code who fails to comply within one week with a referral for examination;
(B) Report to the board the name of any impaired pharmacist who fails to enter treatment within forty-eight hours following the provider's determination that the pharmacist needs treatment;
(C) Require every pharmacist who enters treatment to agree to a treatment contract establishing the terms of treatment and aftercare, including any required supervision or restrictions of practice during treatment or aftercare;
(D) Require a pharmacist to suspend practice on entering any required inpatient treatment;
(E) Report to the board any failure by an impaired pharmacist to comply with the terms of the treatment contract during inpatient or outpatient treatment or aftercare;
(F) Report to the board the resumption of practice of any impaired pharmacist before the treatment provider has made a clear determination that the pharmacist is capable of practicing according to acceptable and prevailing standards;
(G) Require a pharmacist who resumes practice after completion of treatment to comply with an aftercare contract that meets the requirements of rules adopted by the board for approval of treatment providers;
(H) Report to the board any pharmacist who suffers a relapse at any time during or following aftercare.
Any pharmacist who enters into treatment by an approved treatment provider shall be deemed to have waived any confidentiality requirements that would otherwise prevent the treatment provider from making reports required under this section.
In the absence of fraud or bad faith, no professional association of pharmacists licensed under this chapter that sponsors a committee or program to provide peer assistance to pharmacists with substance abuse problems, no representative or agent of such a committee or program, and no member of the state board of pharmacy shall be liable to any person for damages in a civil action by reason of actions taken to refer a pharmacist to a treatment provider designated by the board or actions or omissions of the provider in treating a pharmacist.
In the absence of fraud or bad faith, no person who reports to the board a pharmacist with a suspected substance abuse problem shall be liable to any person for damages in a civil action as a result of the report.
Amended by 131st General Assembly File No. TBD, SB 319, §1, eff. 4/6/2017.
Amended by 130th General Assembly File No. TBD, SB 276, §1, eff. 3/19/2015.
Amended by 130th General Assembly File No. TBD, HB 394, §1, eff. 3/19/2015.
Effective Date: 03-27-1991 .
Notwithstanding division (B)(4) of section 2317.02 of the Revised Code, a pharmacist , pharmacy intern, pharmacy technician trainee, registered pharmacy technician, certified pharmacy technician, licensed terminal distributor of dangerous drugs, or registered wholesale distributor of dangerous drugs shall cooperate with federal, state, and local government investigations and shall divulge all relevant information when requested by a government agency.
Amended by 131st General Assembly File No. TBD, SB 319, §1, eff. 4/6/2017.
Effective Date: 02-12-2001 .
As used in this section, "medication synchronization" means a pharmacy service that synchronizes the filling or refilling of prescriptions in a manner that allows the dispensed drugs to be obtained on the same date each month.
A pharmacist may dispense a drug in a manner that varies from the prescription for the drug by dispensing a quantity or amount of the drug that is less than a thirty-day supply, if the pharmacist's action is taken solely for the purpose of medication synchronization pursuant to section 1751.68. 3923.602. 5164.7511. or 5167.12 of the Revised Code.
Added by 131st General Assembly File No. TBD, HB 116, §1, eff. 8/31/2016.
(A) Except as provided in division (B) of this section, information received by the state board of pharmacy pursuant to an investigation is confidential and is not subject to discovery in any civil action. Any record that identifies a patient, confidential informant, or individual who files a complaint with the board or may reasonably lead to the identification of the patient, informant, or complainant is not a public record for purposes of section 149.43 of the Revised Code and is not subject to inspection or copying under section 1347.08 of the Revised Code.
(B) The board shall conduct all investigations or inspections and proceedings in a manner that protects the confidentiality of patients, confidential informants, and individuals who file complaints with the board. The board shall not make public the names or any other identifying information of patients, confidential informants, or complainants unless proper consent is given or, in the case of a patient, a waiver of the patient privilege exists under division (B) of section 2317.02 of the Revised Code. The consent or waiver is not required if the board possesses reliable and substantial evidence that no bona fide physician-patient relationship exists.
On request, the board may share any information it receives pursuant to an investigation or inspection, including patient records and patient record information, with law enforcement agencies, other licensing boards, and other state or federal governmental agencies that are prosecuting, adjudicating, or investigating alleged violations of statutes or administrative rules. An agency or board that receives the information shall comply with the same requirements regarding confidentiality as those with which the state board of pharmacy must comply, notwithstanding any conflicting provision of the Revised Code or agency procedure that applies when the agency is dealing with other information in its possession.
Any information the board receives from a state or federal agency is subject to the same confidentiality requirements as the agency from which it was received and shall not be released by the board without prior authorization from that agency.
The board may, for good cause shown, disclose or authorize disclosure of information gathered pursuant to an investigation.
(C) Any board activity that involves continued monitoring of an individual for treatment or recovery purposes as part of or following any disciplinary action taken under section 4729.16, 4729.56, or 4729.57 of the Revised Code shall be conducted in a manner that maintains an individual's confidentiality with respect to the individual's treatment or recovery program. Information received or maintained by the board with respect to the board's monitoring activities is not subject to discovery in any civil action and is confidential, except that the board may disclose information to law enforcement officers and government entities for purposes of an investigation of a license or certificate holder.
Added by 132nd General Assembly File No. TBD, HB 49, §101.01, eff. 9/29/2017.
(A) Subject to division (B) of this section, in addition to the actions the state board of pharmacy may take under Chapter 119. of the Revised Code, the board may order the taking of depositions; examine and copy any books, accounts, papers, records, documents, and other tangible objects; issue subpoenas; and compel the attendance of witnesses and production of books, accounts, papers, records, documents, and other tangible objects.
On failure of a person to comply with a subpoena issued by the board and after reasonable notice to that person, the board may apply to the court of common pleas of Franklin county for an order compelling the production of persons or records pursuant to the Ohio Rules of Civil Procedure.
A subpoena issued by the board may be served by a sheriff, sheriff's deputy, or board employee designated by the board. Service of a subpoena may be made by delivering a copy of the subpoena to the person named in the subpoena or by leaving it at the person's usual place of residence.
(B) A subpoena for patient record information may be issued only on approval by the board's executive director and the president or another board member designated by the president, in consultation with the office of the attorney general. Before issuing the subpoena, the executive director and the office of the attorney general shall determine whether probable cause exists to believe that the complaint filed alleges, or an investigation has revealed, a violation of this chapter or Chapters 2925., 3715., 3719., or 3796. of the Revised Code or any rule adopted by the board, that the records sought are relevant to the alleged violation and material to the investigation, and that the records cover a reasonable period of time surrounding the alleged violation.
(C) The board may adopt rules in accordance with Chapter 119. of the Revised Code establishing procedures to be followed in taking the actions authorized by this section, including procedures regarding payment for and service of subpoenas.
Added by 132nd General Assembly File No. TBD, HB 49, §101.01, eff. 9/29/2017.
(A) The state board of pharmacy shall enforce, or cause to be enforced, this chapter. If it has information that any provision of this chapter has been violated, it shall investigate the matter, and take such action as it considers appropriate .
(B) Nothing in this chapter shall be construed to require the state board of pharmacy to enforce minor violations of this chapter if the board determines that the public interest is adequately served by a notice or warning to the alleged offender.
Effective Date: 07-22-1998; 05-18-2005 .
The state board of pharmacy may adopt rules in accordance with Chapter 119. of the Revised Code, not inconsistent with the law, as may be necessary to carry out the purposes of and to enforce the provisions of this chapter . The rules shall be published and made available by the board to each pharmacist licensed under this chapter.
Effective Date: 07-22-1998; 05-18-2005 .
Effective Date: 07-22-1998 .
A person not a pharmacist, who owns, manages, or conducts a pharmacy, shall employ a pharmacist to be in full and actual charge of such pharmacy. Any pharmacist who owns, manages, or conducts a pharmacy shall be personally in full and actual charge of the pharmacy, or shall employ another pharmacist to be in full and actual charge of the pharmacy.
Effective Date: 07-22-1998 .
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)
(a) Except as provided in division (A)(4)(b) of this section, the amount of the drug that is dispensed or sold under this section does not exceed a seventy-two-hour supply as provided in the prescription.
(b)
(i) Subject to division (A)(4)(b)(ii) of this section, if the drug dispensed or sold under this section is not a controlled substance and the patient has been on a consistent drug therapy as demonstrated by records maintained by a pharmacy, the amount of the drug dispensed or sold does not exceed a thirty-day supply as provided in the prescription or, if the standard unit of dispensing for the drug exceeds a thirty-day supply, the amount of the drug dispensed or sold does not exceed the standard unit of dispensing. The pharmacist shall exercise professional judgment in determining the amount of the drug to be dispensed or sold.
(ii) A pharmacist shall not dispense or sell a particular drug to the same patient in an amount described in division (A)(4)(b)(i) of this section more than once in any twelve-month period.
(B) A pharmacist who dispenses or sells a drug under this section shall do all of the following:
(1) For one year after the date of dispensing or sale, maintain a record in accordance with this chapter of the drug dispensed or sold, including the name and address of the patient and the individual receiving the drug, if the individual receiving the drug is not the patient, the amount dispensed or sold, and the original prescription number;
(2) Notify the health professional who issued the prescription described in division (A)(1) of this section or another health professional responsible for the patient's care not later than seventy-two hours after the drug is sold or dispensed;
(3) If applicable, obtain authorization for additional dispensing from one of the health professionals described in division (B)(2) of this section.
(C) A pharmacist who dispenses or sells a drug under this section may do so once for each prescription described in division (A)(1) of this section.
Amended by 131st General Assembly File No. TBD, HB 116, §1, eff. 8/31/2016.
Amended by 131st General Assembly File No. TBD, HB 188, §1, eff. 3/23/2016.
Effective Date: 07-22-1998 .
(A) Notwithstanding any conflicting provision of this chapter or rule adopted by the state board of pharmacy, a pharmacist may do both of the following with respect to a prescription issued under section 4723.4810. 4730.432. or 4731.93 of the Revised Code:
(1) Dispense a drug pursuant to the prescription;
(2) Label a drug dispensed pursuant to the prescription without the name of the individual for whom the drug is intended if the prescription contains the words "expedited partner therapy" or the letters "EPT."
(B) For each drug dispensed under this section, the pharmacist shall provide all of the following information:
(1) Directions for use of the drug;
(2) Any side effects, adverse reactions, or known contraindications associated with the drug.
(C) A pharmacist who in good faith dispenses a drug under this section is not liable for or subject to any of the following:
(1) Damages in any civil action;
(2) Prosecution in any criminal proceeding;
(3) Professional disciplinary action.
(D) This section does not affect the authority of a pharmacist to distribute information concerning a drug as required by federal law.
Added by 131st General Assembly File No. TBD, HB 124, §1, eff. 3/23/2016.
Divisions (A) and (B) of section 4729.01 and section 4729.28 of the Revised Code do not do any of the following:
(A) Apply to a licensed health professional authorized to prescribe drugs who is acting within the prescriber's scope of professional practice;
(B) Prevent a prescriber from personally furnishing the prescriber's patients with drugs, within the prescriber's scope of professional practice, that seem proper to the prescriber, as long as the drugs are furnished in accordance with section 4729.291 of the Revised Code;
(C) Apply to an individual who personally furnishes a supply of naloxone under authority conferred by a physician under section 4731.941 of the Revised Code or prevent that individual from personally furnishing the supply of naloxone in accordance with a protocol established by the physician under section 4731.941 of the Revised Code;
(D) Apply to the sale of oxygen, the sale of peritoneal dialysis solutions, or the sale of drugs that are not dangerous drugs by a retail dealer, in original packages when labeled as required by the "Federal Food, Drug, and Cosmetic Act," 52 Stat. 1040 (1938), 21 U.S.C.A. 301, as amended.
Amended by 131st General Assembly File No. TBD, HB 4, §1, eff. 7/16/2015.
Amended by 129th General AssemblyFile No.19, HB 93, §1, eff. 5/20/2011.
Effective Date: 03-09-1999; 09-23-2004
(A) Except when provided under section 4731.97 of the Revised Code, when a licensed health professional authorized to prescribe drugs personally furnishes drugs to a patient pursuant to division (B) of section 4729.29 of the Revised Code, the prescriber shall ensure that the drugs are labeled and packaged in accordance with state and federal drug laws and any rules and regulations adopted pursuant to those laws. Records of purchase and disposition of all drugs personally furnished to patients shall be maintained by the prescriber in accordance with state and federal drug statutes and any rules adopted pursuant to those statutes.
(B) When personally furnishing to a patient RU-486 (mifepristone), a prescriber is subject to section 2919.123 of the Revised Code. A prescription for RU-486 (mifepristone) shall be in writing and in accordance with section 2919.123 of the Revised Code.
(C)
(1) Except as provided in divisions (D) and (E) of this section, no prescriber shall do either of the following:
(a) In any thirty-day period, personally furnish to or for patients, taken as a whole, controlled substances in an amount that exceeds a total of two thousand five hundred dosage units;
(b) In any seventy-two-hour period, personally furnish to or for a patient an amount of a controlled substance that exceeds the amount necessary for the patient's use in a seventy-two-hour period.
(2) The state board of pharmacy may impose a fine of not more than five thousand dollars on a prescriber who fails to comply with the limits established under division (C)(1) of this section. A separate fine may be imposed for each instance of failing to comply with the limits. In imposing the fine, the board's actions shall be taken in accordance with Chapter 119. of the Revised Code.
(D) None of the following shall be counted in determining whether the amounts specified in division (C)(1) of this section have been exceeded:
(1) Methadone personally furnished to patients for the purpose of treating drug dependence or addiction, if the prescriber meets the conditions specified in 21 C.F.R. 1306.07;
(2) Buprenorphine personally furnished to patients for the purpose of treating drug dependence or addiction as part of an opioid treatment program that possesses a terminal distributor of dangerous drugs license issued under section 4729.54 of the Revised Code, is the subject of a current, valid certification from the substance abuse and mental health services administration of the United States department of health and human services pursuant to 42 C.F.R. 8.11, and meets either of the following criteria:
(a) Buprenorphine and methadone are personally furnished by physicians treating patients participating in the program.
(b) Buprenorphine, but not methadone, is personally furnished by physicians treating patients participating in the program, the program is accredited by a national accrediting organization approved by the substance abuse and mental health services administration, the service of personally furnishing buprenorphine has, notwithstanding section 5119.361 of the Revised Code, been certified by the department of mental health and addiction services under section 5119.36 of the Revised Code, and the program maintains in the record of a patient to whom buprenorphine has been administered or personally furnished a copy of the physician's signed and dated written order for that act.
(c) Controlled substances personally furnished to research subjects by a facility conducting clinical research in studies approved by a hospital-based institutional review board or an institutional review board accredited by the association for the accreditation of human research protection programs.
(E) Division (C)(1) of this section does not apply to a prescriber who is a veterinarian.
Amended by 131st General Assembly File No. TBD, SB 319, §1, eff. 7/1/2017.
Amended by 131st General Assembly File No. TBD, HB 290, §1, eff. 4/6/2017.
Amended by 131st General Assembly File No. TBD, HB 4, §1, eff. 7/16/2015.
Amended by 130th General Assembly File No. TBD, HB 367, §1, eff. 3/23/2015.
Amended by 129th General AssemblyFile No.156, SB 301, §1, eff. 3/13/2013.
Added by 129th General AssemblyFile No.19, HB 93, §1, eff. 5/20/2011.
(A) Except when provided under section 4731.97 of the Revised Code, when a licensed health professional authorized to prescribe drugs personally furnishes drugs to a patient pursuant to division (B) of section 4729.29 of the Revised Code, the prescriber shall ensure that the drugs are labeled and packaged in accordance with state and federal drug laws and any rules and regulations adopted pursuant to those laws. Records of purchase and disposition of all drugs personally furnished to patients shall be maintained by the prescriber in accordance with state and federal drug statutes and any rules adopted pursuant to those statutes.
(B) When personally furnishing to a patient RU-486 (mifepristone), a prescriber is subject to section 2919.123 of the Revised Code. A prescription for RU-486 (mifepristone) shall be in writing and in accordance with section 2919.123 of the Revised Code.
(C)
(1) Except as provided in divisions (D) and (E) of this section, no prescriber shall do either of the following:
(a) In any thirty-day period, personally furnish to or for patients, taken as a whole, controlled substances in an amount that exceeds a total of two thousand five hundred dosage units;
(b) In any seventy-two-hour period, personally furnish to or for a patient an amount of a controlled substance that exceeds the amount necessary for the patient's use in a seventy-two-hour period.
(2) The state board of pharmacy may impose a fine of not more than five thousand dollars on a prescriber who fails to comply with the limits established under division (C)(1) of this section. A separate fine may be imposed for each instance of failing to comply with the limits. In imposing the fine, the board's actions shall be taken in accordance with Chapter 119. of the Revised Code.
(D) None of the following shall be counted in determining whether the amounts specified in division (C)(1) of this section have been exceeded:
(1) Methadone personally furnished to patients for the purpose of treating drug dependence or addiction, if the prescriber meets the conditions specified in 21 C.F.R. 1306.07;
(2) Buprenorphine personally furnished to patients for the purpose of treating drug dependence or addiction as part of an opioid treatment program licensed under section 5119.37 of the Revised Code.
(3) Controlled substances personally furnished to research subjects by a facility conducting clinical research in studies approved by a hospital-based institutional review board or an institutional review board accredited by the association for the accreditation of human research protection programs.
(E) Division (C)(1) of this section does not apply to a prescriber who is a veterinarian.
Amended by 132nd General Assembly File No. TBD, HB 111, §1, eff. 6/29/2019.
Amended by 131st General Assembly File No. TBD, SB 319, §1, eff. 7/1/2017.
Amended by 131st General Assembly File No. TBD, HB 290, §1, eff. 4/6/2017.
Amended by 131st General Assembly File No. TBD, HB 4, §1, eff. 7/16/2015.
Amended by 130th General Assembly File No. TBD, HB 367, §1, eff. 3/23/2015.
Amended by 129th General AssemblyFile No.156, SB 301, §1, eff. 3/13/2013.
Added by 129th General AssemblyFile No.19, HB 93, §1, eff. 5/20/2011.
The state board of pharmacy shall annually conduct an on-site inspection of a community mental health services provider or community addiction services provider that is an opioid treatment program described in division (D)(2)(b) of section 4729.291 of the Revised Code.
Added by 131st General Assembly File No. TBD, HB 4, §1, eff. 7/16/2015.
The state board of pharmacy shall annually conduct an on-site inspection of each opioid treatment program licensed under section 5119.37 of the Revised Code.
Amended by 132nd General Assembly File No. TBD, HB 111, §1, eff. 6/29/2019.
Added by 131st General Assembly File No. TBD, HB 4, §1, eff. 7/16/2015.
Sections 4729.27 and 4729.28 of the Revised Code shall not prohibit a person from selling Paris green and other materials or compounds used exclusively for spraying and disinfecting when put up in bottles or boxes, bearing the name of a licensed pharmacist or wholesale dealer, and labeled as required by section 3719.33 of the Revised Code or apply to or interfere with the exclusively wholesale business of a dealer.
Effective Date: 07-22-1998 .
Sections 4729.27 and 4729.28 of the Revised Code shall not apply to, interfere with, or prohibit any person, firm, or corporation from selling completely denatured alcohol or wood alcohol.
Effective Date: 10-01-1953 .
No person shall have in his possession, or dispense or sell packages or containers of completely denatured alcohol or wood alcohol containing five wine gallons or more without having marked or stenciled thereon the name and address of the seller, the degree of proof of such alcohol, the formula number, and, in letters of not less than one inch in height, the words, "Completely Denatured Alcohol" or "Wood Alcohol," as the case may be, and the names of two or more antidotes for the same. This section, and sections 4729.33 and 3719.33 of the Revised Code shall not interfere with the transfer of such alcohol from storage tanks to other packages or containers, nor require the placing of such mark or stencil upon transportation tanks, nor the registration or placing of mark or stencil upon fuel tanks, automobile radiators, or similar containers for the final use or consumption of such alcohol and from which no further distribution thereof is made.
Effective Date: 10-01-1953 .
No person shall dispense or sell completely denatured alcohol or wood alcohol in packages containing less than five wine gallons without having affixed thereto a label on which is printed or stenciled in plain, legible, red letters of equal prominence on a white background the words, "Completely Denatured Alcohol" or "Wood Alcohol," as the case may be, and in addition on the same label in red ink, under the skull and crossbones symbol, the word "POISON" together with the following statement: "Completely denatured alcohol, or wood alcohol is a violent poison. It cannot be applied externally to human or animal tissue without serious injurious results. It cannot be taken internally without inducing blindness and general physical decay ultimately resulting in death," and without having stamped, stenciled, or printed upon such label the name and address of the seller, the degree of proof, and the formula number thereof. Neither the word "pure" nor the single word "alcohol" alone shall appear on any label of completely denatured alcohol or wood alcohol.
Effective Date: 10-01-1953 .
No person shall dispense, sell, or offer for sale completely denatured alcohol or wood alcohol, or shall display a sign or use a label or advertise such alcohol having the word "pure" or the single word "alcohol" alone thereon, or shall fail to state the degree of proof of such alcohol, or to have the letters displaying or advertising "Completely Denatured Alcohol" or "Wood Alcohol" plain, legible, and of equal prominence.
Effective Date: 10-01-1953 .
The violation by a pharmacist or other person of any laws of Ohio or of the United States of America or of any rule of the board of pharmacy controlling the distribution of a drug of abuse as defined in section 3719.011 of the Revised Code or the commission of any act set forth in division (A) of section 4729.16 of the Revised Code, is hereby declared to be inimical, harmful, and adverse to the public welfare of the citizens of Ohio and to constitute a public nuisance. The attorney general, the prosecuting attorney of any county in which the offense was committed or in which the person committing the offense resides, or the state board of pharmacy may maintain an action in the name of the state to enjoin such person from engaging in such violation. Any action under this section shall be brought in the common pleas court of the county where the offense occurred or the county where the alleged offender resides.
Effective Date: 09-20-1984 .
(A) No place except a pharmacy licensed as a terminal distributor of dangerous drugs and no person except a licensed pharmacist shall display any sign or advertise in any fashion, using the words "pharmacy," "drugs," "drug store," "drug store supplies," "pharmacist," "druggist," "pharmaceutical chemist," "apothecary," "drug sundries," "medicine," or any of these words or their equivalent, in any manner.
(B) A pharmacy making retail sales may advertise by name or therapeutic class the availability for sale or dispensing of any dangerous drug provided that the advertising includes the price information specified in the definition of that term in section 4729.01 of the Revised Code.
Effective Date: 07-22-1998 .
(A) A retail seller of dangerous drugs shall disclose price information regarding dangerous drugs to any person requesting such information.
(B) Pursuant to division (A) of this section, a retail seller of dangerous drugs shall disclose price information in the following ways:
(1) By means of verbal disclosure on the premises of the retail seller to all persons requesting such information;
(2) By means of telephone to any person having a valid prescription, who identifies himself and requests such information.
(C) Price disclosure shall not be required for those schedule II controlled substances where lives or property could be endangered by such disclosure.
Effective Date: 10-01-1976 .
A copy of an original prescription may only be filled in accordance with the rules and regulations adopted by the state board of pharmacy. Prescriptions received electronically or by word of mouth, telephone, telegraph, or other means of communication shall be recorded in writing by the pharmacist and the record so made by the pharmacist shall constitute the original prescription to be filled by the pharmacist. All prescriptions shall be preserved on file at the pharmacy for a period of three years, subject to inspection by the proper officers of the law.
Effective Date: 07-22-1998 .
(A) As used in this section, "biological product." "finished dosage form." "generically equivalent drug." and "interchangeable biological product" have the same meanings as in section 3715.01 of the Revised Code.
(B) Unless instructed otherwise by the person receiving the drug pursuant to the prescription, a pharmacist filling a prescription for a drug prescribed by its brand name may, subject to the following conditions, select a generically equivalent drug, or. in the case of a drug that is a biological product, select an interchangeable biological product:
(1) The pharmacist shall not select a generically equivalent drug or interchangeable biological product if either of the following applies:
(a) In the case of a written or electronic prescription, including a computer-generated prescription, the prescriber handwrites or actively causes to display on the prescription "dispense as written," "D.A.W," "do not substitute." "brand medically necessary." or any other statement or numerical code that indicates the preserver's intent to prevent substitution. Such a designation shall not be preprinted or stamped on the prescription, but a reminder to the prescriber of the designation procedure may be preprinted or displayed on the prescription form or electronic system the prescriber uses to issue the prescription.
(b) In the case of an oral prescription, the prescriber specifies that the drug as prescribed is medically necessary or otherwise indicates the preserver's intent to prevent substitution.
(2) The pharmacist shall not select a generically equivalent drug or interchangeable biological product unless its price to the patient is less than or equal to the price of the drug as prescribed.
(3) The pharmacist or the pharmacist's agent, assistant, or employee shall inform the patient or the patient's agent if a generically equivalent drug or interchangeable biological product is available at a lower or equal cost and of the person's right to refuse the drug selected. Division (B)(3) of this section does not apply to any:
(a) Prescription that is billed to any agency, division, or department of this state which will reimburse the pharmacy;
(b) Prescriptions for patients of a hospital, nursing home, or similar patient care facility.
(C)
(1) Unless the prescriber instructs otherwise, the label for every drug dispensed shall include information that meets the following requirements, using abbreviations as necessary:
(a) Except as provided in divisions (C)(1)(b) and (c) of this section, the label shall include the dispensed drug's brand name.
(b) If the drug dispensed has no brand name and is a generically equivalent drug, the label shall include the generic name of the drug and the distributor of the finished dosage form.
(c) If the drug dispensed has no brand name and is an interchangeable biological product, the label shall include the name of the interchangeable biological product, the manufacturer, and if the distributor is not the same as the manufacturer, the distributor of the finished dosage form.
(2) When dispensing at retail a drug that is a generically equivalent drug or interchangeable biological product for a drug prescribed by its brand name, the pharmacist shall indicate on the drug's label or container that a substitution was made.
(3) The labeling requirements established by divisions (C)(1) and (2) of this section are in addition to all other labeling requirements of Chapter 3715. of the Revised Code.
(D) A pharmacist who selects a drug that is a generically equivalent drug or interchangeable biological product pursuant to this section assumes no greater liability for selecting the dispensed drug than would be incurred in filling a prescription for a drug prescribed by its brand name.
(E) The failure of a prescriber to restrict a prescription by indicating an intent to prevent substitution pursuant to division (B)(1) of this section shall not constitute evidence of the prescriber's negligence unless the prescriber had reasonable cause to believe that the health condition of the patient for whom the drug was intended warranted the prescription of a specific brand name drug and no other. No prescriber shall be liable for civil damages or in any criminal prosecution arising from the substitution of a generically equivalent drug or interchangeable biological product for a prescribed brand name drug by a pharmacist, unless the prescribed brand name drug would have reasonably caused the same loss, damage, injury, or death.
(F)
(1)
(a) Except as provided in division (F)(1)(b) of this section, not later than five business days after a pharmacist dispenses a drug for which an interchangeable biological product is available, regardless of whether a substitution is made, the pharmacist or an individual designated by the pharmacist shall communicate to the prescriber information identifying the specific biological product that was dispensed, including the name of the biological product and its manufacturer.
(b) Communication of the information is not required when a biological product is dispensed by refilling a prescription and the product that is dispensed is the same product that was dispensed when the same prescription was last filled or refilled.
(2) When possible, communication of the information shall be conveyed by entering the information into a recordkeeping system that can reasonably be presumed to be electronically accessible to the prescriber. Such a system may include any of the following:
(a) An interoperable electronic medical records system;
(b) An electronic prescribing system;
(c) An electronic pharmacy benefit management system;
(d) An electronic pharmacy record system.
(3) Entering the complete information into one of the recordkeeping systems listed in division (F)(2) of this section is presumed to provide notice to the prescriber.
(4) When it is not possible to communicate the information by using one of the recordkeeping systems listed in division (F)(2) of this section, communication of the information shall be conveyed by telephone, facsimile, another form of electronic communication, or any other prevailing means of communication.
(G) No pharmacist shall knowingly engage in conduct that is prohibited by division (B) or (C) of this section.
Amended by 131st General Assembly File No. TBD, SB 319, §1, eff. 4/6/2017.
Amended by 131st General Assembly File No. TBD, HB 505, §1, eff. 3/20/2017.
Effective Date: 07-22-1998 .
No licensed pharmacist shall be liable for civil damages or in any criminal prosecution arising from the dispensing of a drug based upon a formulary established by a hospital, a health insuring corporation, a long-term care facility, or the department of rehabilitation and corrections and requiring the pharmacist to dispense the particular drug.
Effective Date: 07-22-1998 .
(A) One or more pharmacists may enter into a consult agreement with one or more physicians authorized under Chapter 4731. of the Revised Code to practice medicine and surgery or osteopathic medicine and surgery if all of the following conditions are met:
(1) Each physician has an ongoing physician-patient relationship with each patient whose drug therapy is being managed.
(2) The diagnosis for which each patient has been prescribed drug therapy is within the scope of each physician's practice.
(3) Each pharmacist has training and experience related to the particular diagnosis for which drug therapy is prescribed.
(B) With respect to consult agreements, all of the following apply:
(1) Under a consult agreement, a pharmacist is authorized to do both of the following, but only to the extent specified in the agreement, this section, and the rules adopted under this section:
(a) Manage drug therapy for treatment of specified diagnoses or diseases for each patient who is subject to the agreement, including all of the following:
(i) Changing the duration of treatment for the current drug therapy;
(ii) Adjusting a drug's strength, dose, dosage form, frequency of administration, or route of administration;
(iii) Discontinuing the use of a drug;
(iv) Administering a drug;
(v) Notwithstanding the definition of "licensed health professional authorized to prescribe drugs" in section 4729.01 of the Revised Code, adding a drug to the patient's drug therapy.
(b)
(i) Order blood and urine tests and evaluate results related to the drug therapy being managed.
(ii) A pharmacist's authority to evaluate blood and urine tests under division (B)(l)(b)(i) of this section does not authorize the pharmacist to make a diagnosis.
(2)
(a) A consult agreement, or the portion of the agreement that applies to a particular patient, may be terminated by any of the following:
(i) A pharmacist who entered into the agreement;
(ii) A physician who entered into the agreement;
(iii) A patient whose drug therapy is being managed;
(iv) An individual who consented to the treatment on behalf of a patient or an individual authorized to act on behalf of a patient.
(b) The pharmacist or physician who receives the notice of a patient's termination of the agreement shall provide written notice to every other pharmacist or physician who is a party to the agreement. A pharmacist or physician who terminates a consult agreement with regard to one or more patients shall provide written notice to all other pharmacists and physicians who entered into the agreement and to each individual who consented to treatment under the agreement. The termination of a consult agreement with regard to one or more patients shall be recorded by the pharmacist and physician in the medical records of each patient to whom the termination applies.
(3) A consult agreement shall be made in writing and shall include all of the following:
(a) The diagnoses and diseases being managed under the agreement, including whether each disease is primary or comorbid;
(b) A description of the drugs or drug categories the agreement involves;
(c) A description of the procedures, decision criteria, and plan the pharmacist is to follow in acting under a consult agreement;
(d) A description of how the pharmacist is to comply with divisions (B)(5) and (6) of this section.
(4) The content of a consult agreement shall be communicated to each patient whose drug therapy is managed under the agreement.
(5) A pharmacist acting under a consult agreement shall maintain a record of each action taken for each patient whose drug therapy is managed under the agreement.
(6) Communication between a pharmacist and physician acting under a consult agreement shall take place at regular intervals specified by the primary physician acting under the agreement. The agreement may include a requirement that a pharmacist send a consult report to each consulting physician.
(7) A consult agreement is effective for two years and may be renewed if the conditions specified in division (A) of this section are met.
(8) A consult agreement does not permit a pharmacist to manage drug therapy prescribed by a physician who has not entered into the agreement.
(C) 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 a patient'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.
(D)
(1) Subject to division (D)(2) of this section, both of the following apply:
(a) A pharmacist acting in accordance with a consult agreement regarding a physician's change in a drug for a patient whose drug therapy the pharmacist is managing under the agreement is not liable in damages in a tort or other civil action for injury or loss to person or property allegedly arising from the change .
(b) A physician acting in accordance with a consult agreement regarding a pharmacist's change in a drug for a patient whose drug therapy the pharmacist is managing under a consult agreement is not liable in damages in a tort or other civil action for injury or loss to person or property allegedly arising from the change unless the physician authorized the specific change .
(2) Division (D)(1) of this section does not limit a physician's or pharmacist's liability in damages in a tort or other civil action for injury or loss to person or property allegedly arising from actions that are not related to the physician's or pharmacist's change in a drug for a patient whose drug therapy is being managed under a consult agreement.
Amended by 131st General Assembly File No. TBD, HB 116, §1, eff. 8/31/2016.
Amended by 131st General Assembly File No. TBD, HB 188, §1, eff. 3/23/2016.
Effective Date: 02-12-2001 .
(A) In the case of a prescription that authorizes a drug to be dispensed by refilling the prescription one or more times and the total quantity or amount of the drug that may be dispensed by filling and refilling the prescription does not exceed a ninety-day supply of the drug, a pharmacist who is filling or refilling the prescription may dispense a quantity or amount of the drug that varies from the quantity or amount of the drug that otherwise would be dispensed pursuant to the prescription, but only if all of the following conditions are met:
(1) The action taken by the pharmacist does not result in a quantity or amount of the drug being dispensed that exceeds the total quantity or amount that may be dispensed by filling and refilling the prescription.
(2) The prescription is for one of the following:
(a) A maintenance drug to be taken on a regular, recurring basis to treat a chronic condition ;
(b) A drug to be taken on a regular, recurring basis to prevent disease;
(c) A contraceptive.
(3) If the prescription is for a maintenance drug, the patient has used an initial thirty-day supply of the drug, or a ninety-day supply of the drug has previously been prescribed to the patient, and the pharmacist determines, after consulting with the patient, that the drug has stabilized the patient's condition.
(4) The prescription is not for a controlled substance, as defined in section 3719.01 of the Revised Code.
(5) The prescriber did not include "dispense as written" or another phrase having a similar meaning on the prescription, or, when issuing a prescription electronically or orally, the prescriber did not specify that the quantity or amount of the drug to be dispensed may not vary from the quantity or amount specified in the prescription.
(6) In the exercise of the pharmacist's professional judgment after consulting with the patient, taking the action authorized by this section is appropriate for the patient.
(B) This section does not require a health care insurer, government health care program, pharmacy benefit manager, or other entity that offers health benefit plans to provide coverage for a drug in a manner that is inconsistent with the patient's benefit plan.
Added by 131st General Assembly File No. TBD, HB 285, §1, eff. 4/6/2017.
(A)
(1) A pharmacist licensed under this chapter who meets the requirements of division (B) of this section, and a pharmacy intern licensed under this chapter who meets the requirements of division (B) of this section and is working under the direct supervision of a pharmacist who meets the requirements of that division, may do any of the following:
(a) Administer immunizations for influenza to individuals who are seven years of age or older;
(b) Only pursuant to a prescription, administer to individuals who are seven years of age or older but not more than thirteen years of age any of the
immunizations included in division (A)(2) of this section;
(c) Administer to individuals who are thirteen years of age or older any of the immunizations included in division (A)(2) of this section.
(2) A pharmacist or pharmacy intern may administer in accordance with divisions (A)(1)(b) and (c) of this section either of the following:
(a) Any immunization that on the effective date of this amendment is included in either of the following immunization schedules recommended by the advisory committee on immunization practices of the centers for disease control and prevention in the United States department of health and human services:
(i) The recommended immunization schedule for persons aged zero through eighteen years;
(ii) The recommended adult immunization schedule.
(b) Any other immunization specified in rules adopted under division (E)(1)(d) of this section.
(3) As part of engaging in the administration of immunizations or supervising a pharmacy intern's administration of immunizations, a pharmacist may administer epinephrine or diphenhydramine, or both, to individuals in emergency situations resulting from adverse reactions to the immunizations administered by the pharmacist or pharmacy intern.
(B) For a pharmacist or pharmacy intern to be authorized to engage in the administration of immunizations pursuant to division (A) of this section, the pharmacist or pharmacy intern shall do all of the following:
(1) Successfully complete a course in the administration of immunizations that 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 ;
(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 or pharmacy intern, other than an immunization for influenza administered to an individual eighteen years of age or older, the pharmacist or pharmacy intern shall notify the individual's family physician or, if the individual has no family physician, the board of health of the health district in which the individual resides or the authority having the duties of a board of health for that district under section 3709.05 of the Revised Code. The notice shall be given not later than thirty days after the immunization is administered.
(3) For each immunization administered by a pharmacist or pharmacy intern to an individual younger than eighteen years of age pursuant to division (A)(1) of this section, the pharmacist or a pharmacy intern shall obtain permission from the individual's parent or legal guardian in accordance with the procedures specified in rules adopted under division (E) of this section.
(D)
(1) No pharmacist shall do either of the following:
(a) Engage in the administration of immunizations unless the requirements of division (B) of this section have been met;
(b) Delegate to any person the pharmacist's authority to engage in or supervise the administration of immunizations.
(2) No pharmacy intern shall engage in the administration of immunizations unless the requirements of division (B) of this section have been met.
(E)
(1) The state board of pharmacy shall adopt rules to implement this section. The rules shall be adopted in accordance with Chapter 119. of the Revised Code and shall include the following:
(a) 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 immunizations to an individual younger than eighteen years of age pursuant to division (A)(1) of this section;
(d) Provisions specifying any immunizations that may be administered under division (A)(2)(b) of this section.
(2) Prior to adopting rules regarding 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 rules specifying any immunizations that may be administered under division (A)(2)(b) of this section, the state board of pharmacy shall consult with the state medical board.
(F) In addition to the rules it adopts under division (E) of this section, the board may adopt rules that change the immunizations authorized by division (A)(2)(a) of this section to reflect changes in the recommendations of the advisory committee on immunization practices. The rules shall be adopted in accordance with Chapter 119 of the Revised Code.
Amended by 130th General Assembly File No. TBD, HB 394, §1, eff. 3/19/2015.
Effective Date: 06-26-2003; 2007 SB58 08-30-2007; 2008 HB283 09-12-2008 .
Repealed by 131st General Assembly File No. TBD, SB 319, §2, eff. 4/6/2018.
Amended by 128th General AssemblyFile No.9, HB 1, §101.01, eff. 10/16/2009.
Amended by 128th General Assemblych.9, HB 2, §101.01, eff. 4/1/2009.
Effective Date: 2008 SB203 04-08-2009
(A) As used in this section:
(1) "Home health agency" has the same meaning as in section 3701.881 of the Revised Code.
(2) "Hospice care program" and "hospice patient" have the same meanings as in section 3712.01 of the Revised Code.
(B) With regard to a dangerous drug that is indicated for the treatment of cancer or a cancer-related illness, must be administered intravenously or by subcutaneous injection, and cannot reasonably be self-administered by the patient to whom the drug is prescribed or by an individual assisting the patient with the self-administration, a pharmacist or pharmacy intern shall not dispense the drug by delivering the drug directly to any of the following or causing the drug to be delivered directly to any of the following:
(1) The patient;
(2) The patient's representative, which may include the patient's guardian or a family member or friend of the patient;
(3) The patient's private residence unless any of the following is the case:
(a) The patient's private residence is a nursing home, residential care facility, rehabilitation facility, or similar institutional facility or heath care facility.
(b) If the patient is an adult and a hospice patient or client of a home health agency, the patient, the licensed health professional authorized to prescribe drugs who prescribed the drug to the patient, or an employee or agent of the prescriber has notified the pharmacist or pharmacy intern that the patient is a hospice patient or client of a home health agency and an employee or agent of the hospice care program or home health agency will be administering the drug to the patient.
(c) If the patient is a minor and a hospice patient or client of a home health agency, either of the following has notified the pharmacist or pharmacy intern that the patient is a client of a home health agency and an employee or agent of the hospice care program or home health agency will be administering the drug to the patient:
(i) The licensed health professional authorized to prescribe drugs who prescribed the drug to the patient or an employee or agent of the prescriber;
(ii) The parent, guardian, or other person who has care or charge of the patient and is authorized to consent to medical treatment on behalf of the patient.
Added by â.o">130th General Assembly File No. TBD, SB 230, §1, eff. 9/17/2014.
(A) As used in this section :
(1) "Board of health" means a board of health of a city or general health district or an authority having the duties of a board of health under section 3709.05 of the Revised Code.
(2) "Physician" means an individual authorized under Chapter 4731. of the Revised Code to practice medicine and surgery, osteopathic medicine and surgery, or podiatric medicine and surgery.
(B) If use of the protocol developed pursuant to rules adopted under division (G) of this section has been authorized under section 3707.56 or 4731.942 of the Revised Code, a pharmacist or pharmacy intern may dispense naloxone without a prescription to either of the following in accordance with that protocol :
(1) An individual who there is reason to believe is experiencing or at risk of experiencing an opioid-related overdose;
(2) A family member, friend, or other person in a position to assist an individual who there is reason to believe is at risk of experiencing an opioid-related overdose.
(C) A pharmacist or pharmacy intern who dispenses naloxone under this section shall instruct the individual to whom naloxone is dispensed to summon emergency services as soon as practicable either before or after administering naloxone.
(D) A pharmacist may document the dispensing of naloxone by the pharmacist or a pharmacy intern supervised by the pharmacist on a prescription form. The form may be assigned a number for record-keeping purposes.
(E) This section does not affect the authority of a pharmacist or pharmacy intern to fill or refill a prescription for naloxone.
(F) A board of health that in good faith authorizes a pharmacist or pharmacy intern to dispense naloxone without a prescription in accordance with a protocol developed pursuant to rules adopted under division (G) of this section is not liable for or subject to any of the following for any action or omission of the individual to whom the naloxone is dispensed: damages in any civil action, prosecution in any criminal proceeding, or professional disciplinary action.
A physician who in good faith authorizes a pharmacist or pharmacy intern to dispense naloxone without a prescription in accordance with a protocol developed pursuant to rules adopted under division (G) of this section is not liable for or subject to any of the following for any action or omission of the individual to whom the naloxone is dispensed: damages in any civil action, prosecution in any criminal proceeding, or professional disciplinary action.
A pharmacist or pharmacy intern authorized under this section to dispense naloxone without a prescription who does so in good faith is not liable for or subject to any of the following for any action or omission of the individual to whom the naloxone is dispensed: damages in any civil action, prosecution in any criminal proceeding, or professional disciplinary action.
(G) the state board of pharmacy shall, after consulting with the department of health and state medical board, adopt rules to implement this section. The rules shall specify a protocol under which pharmacists or pharmacy interns may dispense naloxone without a prescription.
All rules adopted under this section shall be adopted in accordance with Chapter 119. of the Revised Code.
Added by 131st General Assembly File No. TBD, HB 4, §1, eff. 7/16/2015.
(A) As used in this section, "physician" means an individual authorized under Chapter 4731. of the Revised Code to practice medicine and surgery or osteopathic medicine and surgery.
(B)
(1) Subject to division (C) of this section, a pharmacist licensed under this chapter may administer by injection any of the following drugs as long as the drug that is to be administered has been prescribed by a physician and the individual to whom the drug was prescribed has an ongoing physician-patient relationship with the physician:
(a) An opioid antagonist used for treatment of drug addiction and administered in a long-acting or extended-release form;
(b) An antipsychotic drug administered in a long-acting or extended-release form;
(c) Hydroxyprogesterone caproate;
(d) Medroxyprogesterone acetate ;
(e) Cobalamin.
(2) As part of engaging in the administration of drugs by injection pursuant to this section, a pharmacist may administer epinephrine or diphenhydramine, or both, to an individual in an emergency situation resulting from an adverse reaction to a drug administered by the pharmacist.
(C) To be authorized to administer drugs pursuant to this section, a pharmacist must do all of the following:
(1) Successfully complete a course in the administration of drugs that satisfies the requirements established by the state board of pharmacy in rules adopted under division (H) (1) (a) of this section;
(2) Receive and maintain certification to perform basic life-support procedures by successfully completing a basic life- support training course certified by the American red cross or American heart association;
(3) Practice in accordance with a protocol that meets the requirements of division (F) of this section.
(D) Each time a pharmacist administers a drug pursuant to this section, the pharmacist shall do all of the following:
(1) Obtain permission in accordance with the procedures specified in rules adopted under division (H) of this section and comply with the following requirements:
(a) Except as provided in division (D)(1)(c) of this section, for each drug administered by a pharmacist to an individual who is eighteen years of age or older, the pharmacist shall obtain permission from the individual.
(b) For each drug administered by a pharmacist to an individual who is under eighteen years of age, the pharmacist shall obtain permission from the individual's parent or other person having care or charge of the individual.
(c) For each drug administered by a pharmacist to an individual who lacks the capacity to make informed health care decisions, the pharmacist shall obtain permission from the person authorized to make such decisions on the individual's behalf.
(2) In the case of an opioid antagonist described in division (B) of this section, obtain in accordance with division (E) of this section test results indicating that it is appropriate to administer the drug to the individual if either of the following is to be administered:
(a) The initial dose of the drug;
(b) Any subsequent dose, if the administration occurs more than thirty days after the previous dose of the drug was administered.
(3) Observe the individual to whom the drug is administered to determine whether the individual has an adverse reaction to the drug;
(4) Notify the physician who prescribed the drug that the drug has been administered to the individual.
(E) A pharmacist may obtain the test results described in division (D)(2) of this section in either of the following ways:
(1) From the physician;
(2) By ordering blood and urine tests for the individual to whom the opioid antagonist is to be administered.
If a pharmacist orders blood and urine tests, the pharmacist shall evaluate the results of the tests to determine whether they indicate that it is appropriate to administer the opioid antagonist. A pharmacist's authority to evaluate test results under this division does not authorize the pharmacist to make a diagnosis.
(F) All of the following apply with respect to the protocol required by division (C)(3) of this section:
(1) The protocol must be established by a physician who has a scope of practice that includes treatment of the condition for which the individual has been prescribed the drug to be administered.
(2) The protocol must satisfy the requirements established in rules adopted under division (H) (1)(b) of this section.
(3) The protocol must do all of the following:
(a) Specify a definitive set of treatment guidelines;
(b) Specify the locations at which a pharmacist may engage in the administration of drugs pursuant to this section;
(c) Include provisions for implementing the requirements of division (D) of this section, including for purposes of division (D)(3) of this section provisions specifying the length of time and location at which a pharmacist must observe an individual who receives a drug to determine whether the individual has an adverse reaction to the drug;
(d) Specify procedures to be followed by a pharmacist when administering epinephrine, diphenhydramine, or both, to an individual who has an adverse reaction to a drug administered by the pharmacist.
(G) A pharmacist shall not do either of the following:
(1) Engage in the administration of drugs pursuant to this section unless the requirements of division (C) of this section have been met;
(2) Delegate to any person the pharmacist's authority to engage in the administration of drugs pursuant to this section.
(H)
(1) The state board of pharmacy shall adopt rules to implement this section. The rules shall be adopted in accordance with Chapter 119. of the Revised Code and include all of the following:
(a) Requirements for courses in administration of drugs;
(b) Requirements for protocols to be followed by pharmacists in administering drugs pursuant to this section;
(c) Procedures to be followed by a pharmacist in obtaining permission to administer a drug to an individual.
(2) The board shall consult with the state medical board before adopting rules regarding requirements for protocols under this section.
Added by 131st General Assembly File No. TBD, SB 332, §1, eff. 4/6/2017.
(A) As used in this section, "opioid analgesic" has the same meaning as in section 3719.01 of the Revised Code.
(B) Except as provided in division (C) of this section or in any rules adopted under division (D) of this section, all of the following apply with respect to a prescription for an opioid analgesic to be used by an individual on an outpatient basis:
(1) A pharmacist, pharmacy intern, or terminal distributor of dangerous drugs shall not dispense or sell the opioid analgesic in an amount that exceeds a ninety-day supply, as determined according to the prescription's directions for use of the drug, regardless of whether the prescription was issued for a greater amount.
(2) Except as provided in division (B)(3) of this section, a pharmacist, pharmacy intern, or terminal distributor of dangerous drugs shall not dispense or sell the opioid analgesic if more than fourteen days have elapsed since the prescription was issued.
(3) A pharmacist, pharmacy intern, or terminal distributor of dangerous drugs may dispense or sell the opioid analgesic after more than fourteen days have elapsed since the prescription was issued if all of the following apply:
(a) The prescription is one of multiple prescriptions for the drug issued by a single prescriber to the patient on a single day.
(b) When combined, the prescriptions do not authorize the patient to receive an amount that exceeds a ninety-day supply of the drug, as determined according to the prescriptions' directions for use of the drug.
(c) The prescriber has provided written instructions on the prescription indicating the earliest date on which the prescription may be filled.
(d) Not more than fourteen days have elapsed since the date described in division (B)(3)(c) of this section.
(C) Division (B) of this section does not apply when a pharmacist, pharmacy intern, or terminal distributor of dangerous drugs dispenses or sells an opioid analgesic to be delivered outside of this state by mail, parcel post, or common carrier to a patient who resides outside of this state.
(D) The state board of pharmacy may adopt rules establishing an amount that is less than the ninety-day supply described in division (B)(1) of this section or a period that is less than the fourteen-day period described in division (B)(2) of this section. The rules shall be adopted in accordance with Chapter 119. of the Revised Code.
Added by 131st General Assembly File No. TBD, SB 319, §1, eff. 4/6/2017.
(A) The state board of pharmacy may enter into contracts with private entities under which the entities process applications and renewal applications for wholesale distributors of dangerous drugs and terminal distributors of dangerous drugs. When entering into these contracts, the board shall give preference to entities that are Ohio-based companies.
Any revenue received by the board from contracts entered into under this section shall be deposited into the state treasury to the credit of the occupational licensing and regulatory fund. The money may be used for any purpose determined by the board to be relevant to its duties, including the establishment and maintenance of a drug database pursuant to section 4729.75 of the Revised Code.
(B) No enforcement or disciplinary authority granted to the board shall be transferred to a private entity through a contract entered into under this section.
Added by 129th General AssemblyFile No.28, HB 153, §101.01, eff. 9/29/2011.
Effective Date: 12-31-1971 .
(A) No person other than a licensed manufacturer of dangerous drugs, outsourcing facility, third-party logistics provider, repackager of dangerous drugs, or wholesale distributor of dangerous drugs shall possess for sale, sell, distribute, or deliver, at wholesale, dangerous drugs or investigational drugs or products, except as follows:
(1) A licensed terminal distributor of dangerous drugs that is a pharmacy may make occasional sales of dangerous drugs or investigational drugs or products at wholesale.
(2) A licensed terminal distributor of dangerous drugs having more than one licensed location may transfer or deliver dangerous drugs from one licensed location to another licensed location owned by the terminal distributor if the license issued for each location is in effect at the time of the transfer or delivery.
(3) A licensed terminal distributor of dangerous drugs that is not a pharmacy may make occasional sales of naloxone at wholesale.
(B) No licensed manufacturer, outsourcing facility, third-party logistics provider, repackager, or wholesale distributor shall possess for sale, sell, or distribute, at wholesale, dangerous drugs or investigational drugs or products to any person other than the following:
(1) Subject to division (D) of this section, a licensed terminal distributor of dangerous drugs;
(2) Subject to division (C) of this section, any person exempt from licensure as a terminal distributor of dangerous drugs under section 4729.541 of the Revised Code;
(3) A licensed manufacturer, outsourcing facility, third-party logistics provider, repackager, or wholesale distributor ;
(4) A terminal distributor, manufacturer, outsourcing facility, third-party logistics provider, repackager, or wholesale distributor that is located in another state, is not engaged in the sale of dangerous drugs within this state, and is actively licensed to engage in the sale of dangerous drugs by the state in which the distributor conducts business.
(C) No licensed manufacturer, outsourcing facility, third-party logistics provider, repackager, or wholesale distributor shall possess for sale, sell, or distribute, at wholesale, dangerous drugs or investigational drugs or products to either of the following:
(1) A prescriber who is employed by either of the following:
(a) A pain management clinic that is not licensed as a terminal distributor of dangerous drugs with a pain management clinic classification issued under section 4729.552 of the Revised Code;
(b) A facility, clinic, or other location that provides office-based opioid treatment but is not licensed as a terminal distributor of dangerous drugs with an office-based opioid treatment classification issued under section 4729.553 of the Revised Code if such a license is required by that section.
(2) A business entity described in division (A)(2) or (3) of section 4729.541 of the Revised Code that is, or is operating, either of the following:
(a) A pain management clinic without a license as a terminal distributor of dangerous drugs with a pain management clinic classification issued under section 4729.552 of the Revised Code;
(b) A facility, clinic, or other location that provides office-based opioid treatment without a license as a terminal distributor of dangerous drugs with an office-based opioid treatment classification issued under section 4729.553 of the Revised Code if such a license is required by that section.
(D) No licensed manufacturer, outsourcing facility, third-party logistics provider, repackager, or wholesale distributor shall possess dangerous drugs or investigational drugs or products for sale at wholesale, or sell or distribute such drugs at wholesale, to a licensed terminal distributor of dangerous drugs, except as follows:
(1)
In the case of a terminal distributor with a category II license, only dangerous drugs in category II, as defined in division (A)(1) of section 4729.54 of the Revised Code;
(2) In the case of a terminal distributor with a category III license, dangerous drugs in category II and category III, as defined in divisions (A)(1) and (2) of section 4729.54 of the Revised Code;
(3) In the case of a terminal distributor with a limited category II or III license, only the dangerous drugs specified in the license.
(E)
(1) Except as provided in division (E)(2) of this section, no person shall do any of the following:
(a) Sell or distribute, at retail, dangerous drugs;
(b) Possess for sale, at retail, dangerous drugs;
(c) Possess dangerous drugs.
(2)
(a) Divisions (E)(1)(a), (b), and (c) of this section do not apply to any of the following:
(i) A licensed terminal distributor of dangerous drugs;
(ii) A person who possesses, or possesses for sale or sells, at retail, a dangerous drug in accordance with Chapters 3719., 4715., 4723., 4725., 4729., 4730., 4731., and 4741. of the Revised Code;
(iii) Any of the persons identified in divisions (A)(1) to (5) and (13) of section 4729.541 of the Revised Code, but only to the extent specified in that section.
(b) Division (E)(1)(c) of this section does not apply to any of the following:
(i) A licensed manufacturer, outsourcing facility, third-party logistics provider, repackager, or wholesale distributor ;
(ii) Any of the persons identified in divisions (A)(6) to (12) of section 4729.541 of the Revised Code, but only to the extent specified in that section.
(F) No licensed terminal distributor of dangerous drugs or person that is exempt from licensure under section 4729.541 of the Revised Code shall purchase dangerous drugs or investigational drugs or products from any person other than a licensed manufacturer, outsourcing facility, third-party logistics provider, repackager, or wholesale distributor , except as follows:
(1) A licensed terminal distributor of dangerous drugs or person that is exempt from licensure under section 4729.541 of the Revised Code may make occasional purchases of dangerous drugs or investigational drugs or products that are sold in accordance with division (A)(1) or (3) of this section.
(2) A licensed terminal distributor of dangerous drugs having more than one licensed location may transfer or deliver dangerous drugs or investigational drugs or products from one licensed location to another licensed location if the license issued for each location is in effect at the time of the transfer or delivery.
(G) No licensed terminal distributor of dangerous drugs shall engage in the retail sale or other distribution of dangerous drugs or investigational drugs or products or maintain possession, custody, or control of dangerous drugs or investigational drugs or products for any purpose other than the distributor's personal use or consumption, at any establishment or place other than that or those described in the license issued by the state board of pharmacy to such terminal distributor.
(H) Nothing in this section shall be construed to interfere with the performance of official duties by any law enforcement official authorized by municipal, county, state, or federal law to collect samples of any drug, regardless of its nature or in whose possession it may be.
(I) Notwithstanding anything to the contrary in this section, the board of education of a city, local, exempted village, or joint vocational school district may distribute epinephrine autoinjectors for use in accordance with section 3313.7110 of the Revised Code and may distribute inhalers for use in accordance with section 3313.7113 of the Revised Code.
Amended by 132nd General Assembly File No. TBD, HB 49, §101.01, eff. 9/29/2017.
Amended by 131st General Assembly File No. TBD, SB 319, §1, eff. 4/6/2017.
Amended by 131st General Assembly File No. TBD, HB 290, §1, eff. 4/6/2017.
Amended by 131st General Assembly File No. TBD, HB 200, §1, eff. 9/8/2016.
Amended by 131st General Assembly File No. TBD, HB 39, §1, eff. 2/1/2016.
Amended by 131st General Assembly File No. TBD, HB 64, §101.01, eff. 9/29/2015.
Amended by 131st General Assembly File No. TBD, HB 4, §1, eff. 7/16/2015.
Amended by 130th General Assembly File No. TBD, HB 483, §101.01, eff. 6/19/2014.
Amended by 130th General Assembly File No. TBD, HB 296, §1, eff. 4/21/2014.
Amended by 129th General AssemblyFile No.156, SB 301, §1, eff. 3/13/2013.
Amended by 129th General AssemblyFile No.9, HB 9, §1, eff. 6/29/2011.
Amended by 129th General AssemblyFile No.19, HB 93, §1, eff. 5/20/2011.
Effective Date: 05-04-2004; 05-17-2006; 2008 HB283 09-12-2008 .
(A) As used in this section, "naloxone distributor" means either of the following:
(1) A wholesale distributor of dangerous drugs;
(2) A terminal distributor of dangerous drugs that supplies naloxone to any entity under division (B)(1) of this section.
(B)
(1) A naloxone distributor shall prioritize the sale, distribution, and delivery of naloxone to all of the following:
(a) A children's hospital, as defined in section 3727.01 of the Revised Code;
(b) A hospital, as defined in section 3727.01 of the Revised Code;
(c) An emergency medical service organization, as defined in section 4765.01 of the Revised Code;
(d) A facility that is operated as an urgent care center.
(2) The order in which the entities are listed in division (B)(1) of this section does not establish levels of priority among the listed entities.
(C) A naloxone distributor who in good faith complies with division (B) of this section is not liable for or subject to any of the following for an act or omission arising from that compliance: damages in any civil action, prosecution in any criminal proceeding, or professional disciplinary action.
Added by 130th General Assembly File No. TBD, HB 170, §1, eff. 3/11/2014.
A manufacturer of dangerous drugs may donate inhalers, as defined in section 3 313.7113 of the Revised Code, and epinephrine autoinjectors to any of the following:
(A) The board of education of a city, local, exempted village, or joint vocational school district;
(B) A community school established under Chapter 3314. of the Revised Code;
(C) A STEM school established under Chapter 3326. of the Revised Code;
(D) A college-preparatory boarding school established under Chapter 3328. of the Revised Code;
(E) A chartered or nonchartered nonpublic school.
Added by 131st General Assembly File No. TBD, SB 319, §1, eff. 4/6/2017.
(A) As used in this section, "service entity" means a public or private entity that provides services to individuals who there is reason to believe may be at risk of experiencing an opioid-related overdose. "Service entity" includes a college or university, school, local health department, community addiction services provider, court, probation department, halfway house, prison, jail, community residential center, homeless shelter, or similar entity.
(B) A service entity may procure naloxone for use in emergency situations.
(C) A service entity or an employee, volunteer, or contractor of a service entity is not liable for or subject to any of the following for injury, death, or loss to person or property that allegedly arises from an act or omission associated with procuring, maintaining, accessing, or using naloxone under this section, unless the act or omission constitutes willful or wanton misconduct: damages in any civil action, prosecution in any criminal proceeding, or professional disciplinary action.
This section does not eliminate, limit, or reduce any other immunity or defense that a service entity or an employee, volunteer, or contractor of a service entity may be entitled to under Chapter 2305. or any other provision of the Revised Code or under the common law of this state.
Added by 131st General Assembly File No. TBD, SB 319, §1, eff. 4/6/2017.
(A) As used in this section:
(1) "Category II" means any dangerous drug that is not included in category III.
(2) "Category III" means any controlled substance that is contained in schedule I, II, III, IV, or V.
(3) "Schedule I, schedule II, schedule III, schedule IV, and schedule V" mean controlled substance schedules I, II, III, IV, and V, respectively, as established pursuant to section 3719.41 of the Revised Code and as amended.
(B)
(1)
(a) The state board of pharmacy shall license the following persons:
(i) Wholesale distributors of dangerous drugs;
(ii) Manufacturers of dangerous drugs;
(iii) Outsourcing facilities;
(iv) Third-party logistics providers;
(v) Repackagers of dangerous drugs.
(b) There shall be two categories for the licenses identified in division (B)(1)(a) of this section. The categories are as follows:
(i) Category II license. A person who obtains this license may possess, have custody or control of, and distribute, only the dangerous drugs described in category II.
(ii) Category III license. A person who obtains this license may possess, have custody or control of, and distribute, the dangerous drugs described in category II and category III.
(c) The board may adopt rules under section 4729.26 of the Revised Code to create classification types of any license issued pursuant to this section. Persons who meet the definitions of the classification types shall comply with all requirements for the specific license classification specified in rule.
(C) A person seeking a license identified in division (B)(1)(a) of this section shall file with the executive director of the board a verified application containing such information as the board requires of the applicant relative to the licensure qualifications set forth in section 4729.53 of the Revised Code and the rules adopted under that section.
The board shall license as a category II or category III manufacturer, outsourcing facility, third-party logistics provider, repackager, or wholesale distributor each applicant who has paid the required license fee, if the board determines that the applicant meets the licensure qualifications set forth in section 4729.53 of the Revised Code and the rules adopted under that section.
(D) The board may issue to a person who does not reside in this state a license identified in division (B)(1)(a) of this section if the person pays the required licensure fee and meets either of the following:
(1) Possesses a current and valid manufacturer, outsourcing facility, third-party logistics provider, repackager, or wholesale distributor license, or its equivalent, issued by another state in which that person is physically located, but only if that state has qualifications for licensure comparable to the licensure requirements in this state ;
(2) Meets the requirements set forth by the board for issuance of a license identified in division (B)(1)(a) of this section, as verified by a state, federal, or other entity recognized by the board to perform such verification.
(E) All licenses issued or renewed pursuant to this section are effective for a period specified by the board in rules adopted under section 4729.26 of the Revised Code. The effective period for an initial or renewed license shall not exceed twenty-four months unless the board extends the period in rules to adjust license renewal schedules. A license shall be renewed by the board pursuant to this section , the standard renewal procedure of Chapter 4745. of the Revised Code, and rules adopted by the board under section 4729.26 of the Revised Code. A person seeking to renew a
license shall submit an application for renewal and pay the required renewal fee before the date specified in the rules adopted by the board.
(F) Each license issued under this section shall describe not more than one establishment or place where the license holder may engage in the activities authorized by the license. No license shall authorize or permit the person named therein to engage in the sale or distribution of drugs at wholesale or to maintain possession, custody, or control of dangerous drugs for any purpose other than for the licensee's own use and consumption at any establishment or place other than that described in the license.
(G)
(1)
(a) The category II license fee is one thousand nine hundred dollars and shall accompany each application for licensure. The license renewal fee is one thousand nine hundred dollars and shall accompany each renewal application.
(b) The category III license fee is two thousand dollars and shall accompany each application for licensure. The license renewal fee is two thousand dollars and shall accompany each renewal application.
(c)
(i) Subject to division (G)(1)(c)(ii) of this section, a license issued pursuant to this section that has not been renewed by the date specified in rules adopted by the board may be reinstated upon payment of the renewal fee and a penalty of three hundred dollars.
(ii) If a complete application for renewal has not been submitted by the sixty-first day after the renewal date specified in rules adopted by the board, the license is considered void and cannot be renewed, but the license holder may reapply for licensure.
(2) Renewal fees and penalties assessed under division (G)(1) of this section shall not be returned if the applicant fails to qualify for renewal.
(3) A person licensed pursuant to this section that fails to renew licensure in accordance with this section and rules adopted by the board is prohibited from engaging in manufacturing, repackaging, compounding, or distributing as a third-party logistics provider or wholesale distributor until a valid license is issued by the board.
(H) Holding a license issued pursuant to this section subjects the holder and the holder's agents and employees to the jurisdiction of the board and to the laws of this state for the purpose of the enforcement of this chapter and the rules of the board. However, the filing of an application for licensure under this section by or on behalf of any person, or the issuance of a license pursuant to this section to or on behalf of any person , shall not of itself constitute evidence that the person is doing business within this state.
(I) The board may enter into agreements with other states, federal agencies, and other entities to exchange information concerning licensing and inspection of any manufacturer, outsourcing facility, third-party logistics provider, repackager, or wholesale distributor located within or outside this state and to investigate alleged violations of the laws and rules governing distribution of drugs by such persons. Any information received pursuant to such an agreement is subject to the same confidentiality requirements applicable to the agency or entity from which it was received and shall not be released without prior authorization from that agency or entity. Any information received is also subject to section 4729.23 of the Revised Code.
Amended by 132nd General Assembly File No. TBD, HB 49, §101.01, eff. 9/29/2017.
Amended by 129th General AssemblyFile No.28, HB 153, §101.01, eff. 9/29/2011.
Effective Date: 07-22-1998 .
(A) The state board of pharmacy shall not license any person as a manufacturer of dangerous drugs, outsourcing facility, third-party logistics provider, repackager of dangerous drugs, or wholesale distributor of dangerous drugs unless the applicant for licensure furnishes satisfactory proof to the board that the applicant meets all of the following:
(1) If the applicant has committed acts that the board finds violate any federal, state, or local law, regulation, or rule relating to drug samples, manufacturing, compounding, repackaging, wholesale or retail drug distribution, or distribution of dangerous drugs, including controlled substances, or constitute a felony, or if a federal, state, or local governmental entity has suspended or revoked any current or prior license of the applicant for the manufacture, compounding, repackaging, distribution, or sale of any dangerous drugs, including controlled substances, the applicant, to the satisfaction of the board, assures that the applicant has in place adequate safeguards to prevent the recurrence of any such violations.
(2) The applicant's past experience in the manufacture, compounding, repackaging, or distribution of dangerous drugs, including controlled substances, is acceptable to the board.
(3) The applicant is properly equipped as to land, buildings, equipment, and personnel to properly carry on its business , including providing adequate security for and proper storage conditions and handling for dangerous drugs, and is complying with the requirements under this chapter and the rules adopted pursuant thereto for maintaining and making available records to properly identified board officials and federal, state, and local law enforcement agencies.
(4) Personnel employed by the applicant have the appropriate education or experience, as determined by the board, to assume responsibility for positions related to compliance with this chapter and the rules adopted pursuant thereto.
(5) The applicant has designated the name and address of a person to whom communications from the board may be directed and upon whom the notices and citations provided for in section 4729.56 of the Revised Code may be served.
(6) Adequate safeguards are assured to prevent the sale of dangerous drugs other than in accordance with section 4729.51 of the Revised Code.
(7) 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) In addition to the causes described in section 4729.56 of the Revised Code for refusing to grant or renew a license, the board may refuse to grant or renew a license if the board determines that the granting of the license or its renewal is not in the public interest.
Amended by 132nd General Assembly File No. TBD, HB 49, §101.01, eff. 9/29/2017.
Amended by 131st General Assembly File No. TBD, HB 64, §101.01, eff. 9/29/2015.
Effective Date: 07-01-1992 .
(A) The state board of pharmacy may issue a limited license to animal shelters solely for the purpose of purchasing, possessing, and administering combination drugs that contain pentobarbital and at least one noncontrolled substance ingredient, in a manufactured dosage form, whose only indication is for euthanizing animals, or other substances described in section 4729.532 of the Revised Code. No such license shall authorize or permit the distribution of these drugs to any person other than the originating wholesale distributor of the drugs. An application for licensure shall include the information the board requires by rule under this section. If the application meets the requirements of the rules adopted under this section, the board shall issue the license.
(B) The board, in accordance with Chapter 119. of the Revised Code, shall adopt any rules necessary to administer and enforce this section. The rules shall do all of the following:
(1) Require as a condition of licensure of the facility that an agent or employee of an animal shelter, other than a registered veterinary technician as defined in section 4741.01 of the Revised Code, has successfully completed a euthanasia technician certification course described in section 4729.532 of the Revised Code;
(2) Specify the information the animal shelter must provide the board for issuance or renewal of a license;
(3) Establish criteria for the board to use in determining whether to refuse to issue or renew, suspend, or revoke a license issued under this section;
(4) Address any other matters the board considers necessary or appropriate for the administration and enforcement of this section.
Effective Date: 06-29-1994 .
(A) No agent or employee of an animal shelter shall perform euthanasia by means of lethal injection on an animal by use of any substance other than combination drugs that contain pentobarbital and at least one noncontrolled substance active ingredient, in a manufactured dosage form, whose only indication is for euthanizing animals, or other substance that the state veterinary medical licensing board and the state board of pharmacy both approve by rule adopted in accordance with Chapter 119. of the Revised Code. The agent or employee of an animal shelter when using a lethal solution to perform euthanasia on an animal shall use such solution in accordance with the following methods and in the following order of preference:
(1) Intravenous injection by hypodermic needle;
(2) Intraperitoneal injection by hypodermic needle;
(3) Intracardial injection by hypodermic needle, but only on a sedated or unconscious animal;
(4) Solution or powder added to food.
(B) Except as provided in division (D) of this section, no agent or employee of an animal shelter, other than a registered veterinary technician as defined in section 4741.01 of the Revised Code, shall perform euthanasia by means of lethal injection on an animal unless he has received certification after successfully completing a euthanasia technician certification course as described in this division. The curriculum for a euthanasia technician certification course shall be one that has been approved by the state veterinary medical licensing board, shall be at least sixteen hours in length, and shall include information in at least all of the following areas:
(1) The pharmacology, proper administration, and storage of euthanasia solutions;
(2) Federal and state laws regulating the storage and accountability of euthanasia solutions;
(3) Euthanasia technician stress management;
(4) Proper disposal of euthanized animals.
(C)
(1) Except as provided in division (D) of this section, no agent or employee of an animal shelter shall perform euthanasia by means of lethal injection on animals under this section unless the facility in which he works or is employed is licensed with the state board of pharmacy under section 4729.531 of the Revised Code.
(2) Any agent or employee of an animal shelter performing euthanasia by means of lethal injection shall do so only in a humane and proficient manner that is in conformity with the methods described in division (A) of this section and not in violation of Chapter 959. of the Revised Code.
(D) An agent or employee of an animal shelter who is performing euthanasia by means of lethal injection on animals on or before the effective date of this section may continue to perform such euthanasia and is not required to be certified in compliance with division (B) of this section until ninety days after the effective date of the rules adopted in compliance with Section 3 of House Bill No. 88 of the 120th general assembly.
Effective Date: 06-29-1994 .
(A) As used in this section:
(1)
"Category II" means any dangerous drug that is not included in category III.
(2) "Category III" means any controlled substance that is contained in schedule I, II, III, IV, or V.
(3) "Emergency medical service organization" has the same meaning as in section 4765.01 of the Revised Code.
(4) "Person" includes an emergency medical service organization.
(5) "Schedule I, schedule II, schedule III, schedule IV, and schedule V" mean controlled substance schedules I, II, III, IV, and V, respectively, as established pursuant to section 3719.41 of the Revised Code and as amended.
(B)
(1) A person seeking to be licensed as a terminal distributor of dangerous drugs shall file with the executive director of the state board of pharmacy a verified application. After it is filed, the application may not be withdrawn without approval of the board.
(2) An application shall contain all the following that apply in the applicant's case:
(a) Information that the board requires relative to the qualifications of a terminal distributor of dangerous drugs set forth in section 4729.55 of the Revised Code;
(b) A statement as to whether the person is seeking to be licensed as a category II, category III, limited category II, or limited category III terminal distributor of dangerous drugs;
(c) If the person is seeking to be licensed as a limited category II or limited category III terminal distributor of dangerous drugs, a list of the dangerous drugs that the person is seeking to possess, have custody or control of, and distribute, which list shall also specify the purpose for which those drugs will be used and their source;
(d) If the person is an emergency medical service organization, the information that is specified in 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;
(g) If the application pertains to a facility, clinic, or other location described in division (B) of section 4729.553 of the Revised Code that must hold a category III terminal distributor of dangerous drugs license with an office-based opioid treatment classification, information that demonstrates, to the satisfaction of the board, compliance with division (C) of that section.
(C)
(1) An emergency medical service organization seeking to be licensed as a terminal distributor of dangerous drugs shall list in its application for licensure the following additional information:
(a) The units under its control that the organization determines will possess dangerous drugs for the purpose of administering emergency medical services in accordance with Chapter 4765. of the Revised Code;
(b) With respect to each such unit, whether the dangerous drugs that the organization determines the unit will possess are in category II or III.
(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 copy of its standing orders or protocol, which orders or protocol shall be signed by a physician ;
(2) A list of the dangerous drugs that its units may carry, expressed in standard dose units, which shall be signed by a physician;
(3) A list of the personnel employed or used by the organization to provide emergency medical services in accordance with Chapter 4765. of the Revised Code.
In accordance with Chapter 119. of the Revised Code, the board shall adopt rules specifying when an emergency medical service organization that is licensed as a terminal distributor must notify the board of any changes in its documentation submitted pursuant to division (D) of this section.
(E) There shall be four categories of terminal distributor of dangerous drugs licenses. The categories are as follows:
(1)
Category II license. A person who obtains this license may possess, have custody or control of, and distribute only the dangerous drugs described in category II.
(2) Limited category II license. A person who obtains this license may possess, have custody or control of, and distribute only the dangerous drugs described in category II that were listed in the application for licensure.
(3) Category III license, which may include a pain management clinic classification issued under section 4729.552 of the Revised Code. A person who obtains this license may possess, have custody or control of, and distribute the dangerous drugs described in category II and category III. If the license includes a pain management clinic classification, the person may operate a pain management clinic.
(4) Limited category III license. A person who obtains this license may possess, have custody or control of, and distribute only the dangerous drugs described in category II or category III that were listed in the application for licensure.
(F) Except for an application made on behalf of an animal shelter, if an applicant for a limited category II license or limited category III license intends to administer dangerous drugs to a person or animal, the applicant shall submit, with the application, a copy of its protocol or standing orders. The protocol or orders shall be signed by a licensed health professional authorized to prescribe drugs, specify the dangerous drugs to be administered, and list personnel who are authorized to administer the dangerous drugs in accordance with federal law or the law of this state. An application made on behalf of an animal shelter shall include a list of the dangerous drugs to be administered to animals and the personnel who are authorized to administer the drugs to animals in accordance with section 4729.532 of the Revised Code.
In accordance with Chapter 119. of the Revised Code, the board shall adopt rules specifying when a licensee must notify the board of any changes in its documentation submitted pursuant to this division.
(G)
(1) 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 II or limited category II license, the fee is three hundred twenty dollars .
(b) 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, four hundred forty dollars.
(2)
(a) Except as provided in division (G)(2)(b) of this section, for a person who is required to hold a license as a terminal distributor of dangerous drugs pursuant to division (D) of section 4729.541 of the Revised Code, the fee is one hundred twenty dollars.
(b) For a professional association, corporation, partnership, or limited liability company organized for the purpose of practicing veterinary medicine, the fee is one hundred twenty dollars.
(3) Fees assessed under divisions (G)(1) and (2) of this section shall not be returned if the applicant fails to qualify for the license.
(H)
(1) The board shall issue a terminal distributor of dangerous drugs license to each person who submits an application for such licensure in accordance with this section, pays the required license fee, is determined by the board to meet the requirements set forth in section 4729.55 of the Revised Code, and satisfies any other applicable requirements of this section.
(2) The license of a person other than an emergency medical service organization shall describe the one establishment or place at which the licensee may engage in the sale or other distribution of dangerous drugs at retail and maintain possession, custody, or control of dangerous drugs for purposes other than the licensee's own use or consumption. The one establishment or place shall be that which is identified in the application for licensure.
No such license shall authorize or permit the terminal distributor of dangerous drugs named in it to engage in the sale or other distribution of dangerous drugs at retail or to maintain possession, custody, or control of dangerous drugs for any purpose other than the distributor's own use or consumption, at any establishment or place other than that described in the license, except that an agent or employee of an animal shelter may possess and use dangerous drugs in the course of business as provided in division (D) of section 4729.532 of the Revised Code.
(3) The license of an emergency medical service organization shall cover and describe all the units of the organization listed in its application for licensure.
(I)
(1) All licenses issued or renewed pursuant to this section shall be effective for a period specified by the board in rules adopted under section 4729.26 of the Revised Code. The effective period for an initial or renewed license shall not exceed twenty-four months unless the board extends the period in rules to adjust license renewal schedules. A license shall be renewed by the board according to the provisions of this section, the standard renewal procedure of Chapter 4745. of the Revised Code, and rules adopted by the board under section 4729.26 of the Revised Code. A person seeking to renew a license shall submit an application for renewal and pay the required fee on or before the date specified in the rules adopted by the board. The fee required for the renewal of a license shall be the same as the license fee paid under division (G) of this section.
(2)
(a) Subject to division (I)(2)(b) of this section, a license that has not been renewed by the date specified in rules adopted by the board may be reinstated only upon payment of the required renewal fee and a penalty fee of one hundred ten dollars.
(b) If an application for renewal has not been submitted by the sixty-first day after the renewal date specified in rules adopted by the board, the license is considered void and cannot be renewed, but the license holder may reapply for licensure.
(3) A terminal distributor of dangerous drugs that fails to renew licensure in accordance with this section and rules adopted by the board is prohibited from engaging in the retail sale, possession, or distribution of dangerous drugs until a valid license is issued by the board.
(J)
(1) No emergency medical service organization that is licensed as a terminal distributor of dangerous drugs shall fail to comply with division (C)(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.
(K) The board may enter into agreements with other states, federal agencies, and other entities to exchange information concerning licensing and inspection of terminal distributors of dangerous drugs located within or outside this state and to investigate alleged violations of the laws and rules governing distribution of drugs by terminal distributors. Any information received pursuant to such an agreement is subject to the same confidentiality requirements applicable to the agency or entity from which it was received and shall not be released without prior authorization from that agency or entity.
Amended by 132nd General Assembly File No. TBD, HB 49, §101.01, eff. 9/29/2017.
Amended by 131st General Assembly File No. TBD, SB 319, §1, eff. 4/6/2017.
Amended by 130th General Assembly File No. TBD, HB 483, §101.01, eff. 9/15/2014.
Amended by 129th General AssemblyFile No.19, HB 93, §1, eff. 5/20/2011.
Effective Date: 06-30-1999; 2008 HB283 09-12-2008
(A) Except as provided in divisions (B) to (D) of this section, all of the following are exempt from licensure as a terminal distributor of dangerous drugs:
(1) A licensed health professional authorized to prescribe drugs;
(2) A business entity that is a corporation formed under division (B) of section 1701.03 of the Revised Code, a limited liability company formed under Chapter 1705. of the Revised Code, or a professional association formed under Chapter 1785. of the Revised Code if the entity has a sole shareholder who is a prescriber and is authorized to provide the professional services being offered by the entity;
(3) A business entity that is a corporation formed under division (B) of section 1701.03 of the Revised Code, a limited liability company formed under Chapter 1705. of the Revised Code, a partnership or a limited liability partnership formed under Chapter 1775. of the Revised Code, or a professional association formed under Chapter 1785. of the Revised Code, if, to be a shareholder, member, or partner, an individual is required to be licensed, certified, or otherwise legally authorized under Title XLVII of the Revised Code to perform the professional service provided by the entity and each such individual is a prescriber;
(4) An individual who holds a current license, certificate, or registration issued under Title X LVII of the Revised Code and has been certified to conduct diabetes education by a national certifying body specified in rules adopted by the state board of pharmacy under section 4729.68 of the Revised Code, but only with respect to insulin that will be used for the purpose of diabetes education and only if diabetes education is within the individual's scope of practice under statutes and rules regulating the individual's profession;
(5) An individual who holds a valid certificate issued by a nationally recognized S.C.U.B.A. diving certifying organization approved by the state board of pharmacy under rules adopted by the board, but only with respect to medical oxygen that will be used for the purpose of emergency care or treatment at the scene of a diving emergency;
(6) With respect to epinephrine autoinjectors that may be possessed under section 3313.7110, 3313.7111, 3314.143, 3326.28, or 3328.29 of the Revised Code, any of the following: the board of education of a city, local, exempted village, or joint vocational school district; a chartered or nonchartered nonpublic school; a community school established under Chapter 3314. of the Revised Code; a STEM school established under Chapter 3326. of the Revised Code; or a college-preparatory boarding school established under Chapter 3328. of the Revised Code;
(7) With respect to epinephrine autoinjectors that may be possessed under section 5101.76 of the Revised Code, any of the following: a residential camp, as defined in section 2151.011 of the Revised Code; a child day camp, as defined in section 5 104.01 of the Revised Code; or a child day camp operated by any county, township, municipal corporation, township park district created under section 511.18 of the Revised Code, park district created under section 1545.04 of the Revised Code, or joint recreation district established under section 755.14 of the Revised Code;
(8) With respect to epinephrine autoinjectors that may be possessed under Chapter 3728. of the Revised Code, a qualified entity, as defined in section 3728.01 of the Revised Code;
(9) With respect to inhalers that may be possessed under section 3313.7113, 3313.7114, 3314.144, 3326.30, or 3328.30 of the Revised Code, any of the following: the board of education of a city, local, exempted village, or joint vocational school district; a chartered or nonchartered nonpublic school; a community school established under Chapter 3314. of the Revised Code; a STEM school established under Chapter 3326. of the Revised Code; or a college-preparatory boarding school established under Chapter 3328. of the Revised Code;
(10) With respect to inhalers that may be possessed under section 5101.77 of the Revised Code, any of the following: a residential camp, as defined in section 2151.011 of the Revised Code; a child day camp, as defined in section 5104.01 of the Revised Code; or a child day camp operated by any county, township, municipal corporation, township park district created under section 511.18 of the Revised Code, park district created under section 1545.04 of the Revised Code, or joint recreation district established under section 755.14 of the Revised Code;
(11) With respect to naloxone that may be possessed under section 2925.61 of the Revised Code, a law enforcement agency and its peace officers;
(12) With respect to naloxone that may be possessed under section 4729.514 of the Revised Code, a service entity, as defined in that section;
(13) A facility that is owned and operated by the United States department of defense, the United States department of veterans affairs, or any other federal agency.
(B) If a person described in division (A) of this section is a pain management clinic or is operating a pain management clinic, the person shall hold a license as a terminal distributor of dangerous drugs with a pain management clinic classification issued under section 4729.552 of the Revised Code.
(C) If a person described in division (A) of this section is operating a facility, clinic, or other location described in division (B) of section 4729.553 of the Revised Code that must hold a category III terminal distributor of dangerous drugs license with an office-based opioid treatment classification, the person shall hold a license with that classification.
(D) Any of the persons described in divisions (A) (1) to (12) of this section shall hold a license as a terminal distributor of dangerous drugs in order to possess, have custody or control of, and distribute any of the following:
(1) Dangerous drugs that are compounded or used for the purpose of compounding;
(2) A schedule I, II, III, I V, or V controlled substance, as defined in section 3719.01 of the Revised Code.
Amended by 131st General Assembly File No. TBD, SB 319, §1, eff. 4/6/2017.
Amended by 131st General Assembly File No. TBD, HB 64, §101.01, eff. 9/29/2015.
Amended by 130th General Assembly File No. TBD, HB 367, §1, eff. 3/23/2015.
Amended by 130th General Assembly File No. TBD, HB 483, §101.01, eff. 9/15/2014.
Amended by 129th General AssemblyFile No.19, HB 93, §1, eff. 5/20/2011.
Effective Date: 2008 HB283 09-12-2008
No license shall be issued to an applicant for licensure as a terminal distributor of dangerous drugs unless the applicant has furnished satisfactory proof to the state board of pharmacy that:
(A) The applicant is equipped as to land, buildings, and equipment to properly carry on the business of a terminal distributor of dangerous drugs within the category of licensure approved by the board.
(B) A pharmacist, licensed health professional authorized to prescribe drugs, 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.
(K) In the case of an applicant who is operating a facility, clinic, or other location described in division (B) of section 4729.553 of the Revised Code that must hold a category III terminal distributor of dangerous drugs license with an office-based opioid treatment classification, the applicant meets the requirements to receive that license with that classification.
Amended by 131st General Assembly File No. TBD, SB 319, §1, eff. 4/6/2017.
Amended by 129th General AssemblyFile No.19, HB 93, §1, eff. 5/20/2011.
Effective Date: 02-12-2001 .
Each person, whether located within or outside this state, who sells dangerous drugs at retail for delivery or distribution to persons residing in this state, shall be licensed as a terminal distributor of dangerous drugs pursuant to sections 4729.54 and 4729.55 of the Revised Code. The board of pharmacy may enter into agreements with other states, federal agencies, and other entities to exchange information concerning the licensing and inspection of terminal distributors of dangerous drugs who are located within or outside this state and to investigate any alleged violations of the laws and rules governing the legal distribution of drugs by such persons.
Effective Date: 07-21-1994 .
(A) To be eligible to receive a license as a category III terminal distributor of dangerous drugs with a pain management clinic classification, an applicant shall submit evidence satisfactory to the state board of pharmacy that the applicant's pain management clinic will be operated in accordance with the requirements specified in division (B) of this section and that the applicant meets any other applicable requirements of this chapter.
If the board determines that an applicant meets all of the requirements, the board shall issue to the applicant a license as a category III terminal distributor of dangerous drugs and specify on the license that the terminal distributor is classified as a pain management clinic.
(B) The holder of a terminal distributor license with a pain management clinic classification shall do all of the following:
(1) Be in control of a facility that is owned and operated solely by one or more physicians authorized under Chapter 4731. of the Revised Code to practice medicine and surgery or osteopathic medicine and surgery;
(2) Comply with the requirements for the operation of a pain management clinic, as established by the state medical board in rules adopted under section 4731.054 of the Revised Code;
(3) Ensure that any person employed by the facility complies with the requirements for the operation of a pain management clinic established by the state medical board in rules adopted under section 4731.054 of the Revised Code;
(4) Require any person with ownership of the facility to submit to a criminal records check in accordance with section 4776.02 of the Revised Code and send the results of the criminal records check directly to the state board of pharmacy for review and decision under section 4729.071 of the Revised Code;
(5) Require all employees of the facility to submit to a criminal records check in accordance with section 4776.02 of the Revised Code and ensure that no person is employed who has previously been convicted of, or pleaded guilty to, either of the following:
(a) A theft offense, described in division (K)(3) of section 2913.01 of the Revised Code, that would constitute a felony under the laws of this state, any other state, or the United States;
(b) A felony drug abuse offense, as defined in section 2925.01 of the Revised Code.
(6) Maintain a list of each person with ownership of the facility and notify the state board of pharmacy of any change to that list.
(C) No person shall operate a facility that under this chapter is subject to licensure as a category III terminal distributor of dangerous drugs with a pain management clinic classification without obtaining and maintaining the license with the classification.
No person who holds a category III license with a pain management clinic classification shall fail to remain in compliance with the requirements of division (B) of this section and any other applicable requirements of this chapter.
(D) The state board of pharmacy may impose a fine of not more than five thousand dollars on a person who violates division (C) of this section. A separate fine may be imposed for each day the violation continues. In imposing the fine, the board's actions shall be taken in accordance with Chapter 119. of the Revised Code.
(E) The state board of pharmacy shall adopt rules as it considers necessary to implement and administer this section. The rules shall be adopted in accordance with Chapter 119. of the Revised Code.
Amended by 132nd General Assembly File No. TBD, HB 49, §101.01, eff. 9/29/2017.
Amended by 129th General AssemblyFile No.156, SB 301, §1, eff. 3/13/2013.
Amended by 129th General AssemblyFile No.28, HB 153, §101.01, eff. 9/29/2011.
Added by 129th General AssemblyFile No.19, HB 93, §1, eff. 5/20/2011 and 6/19/2011.
(A) As used in this section:
(1) "Controlled substance" has the same meaning as in section 3719.01 of the Revised Code.
(2) "Hospital" means a hospital registered with the department of health under section 3701.07 of the Revised Code.
(3) "Office-based opioid treatment" means the treatment of opioid dependence or addiction using a controlled substance.
(B)
(1) Except as provided in division (B)(2) of this section, no person shall knowingly operate a facility, clinic, or other location where a prescriber provides office-based opioid treatment to more than thirty patients or that meets any other identifying criteria established in rules adopted under division (G) of this section without holding a category III terminal distributor of dangerous drugs license with an office-based opioid treatment classification.
(2) Division (B)(1) of this section does not apply to any of the following:
(a) A hospital;
(b) A facility for the treatment of opioid dependence or addiction that is operated by a hospital;
(c) A physician practice owned or controlled, in whole or in part, by a hospital or by an entity that owns or controls, in whole or in part, one or more hospitals;
(d) A facility that conducts only clinical research and uses controlled substances in studies approved by a hospital-based institutional review board or an institutional review board that is accredited by the association for the accreditation of human research protection programs, inc.;
(e) A facility that holds a category III terminal distributor of dangerous drugs license in accordance with section 4729.54 of the Revised Code for the purpose of treating drug dependence or addiction as part of an opioid treatment program and is the subject of a current, valid certification from the substance abuse and mental health services administration of the United States department of health and human services pursuant to 42 C.F.R. 8.11;
(f) A program or facility that is licensed or certified by the department of mental health and addiction services under Chapter 5119. of the Revised Code.
(C) To be eligible to receive a license as a category III terminal distributor of dangerous drugs with an office-based opioid treatment classification, an applicant shall submit evidence satisfactory to the state board of pharmacy that the applicant's office-based opioid treatment will be operated in accordance with the requirements specified in division (D) of this section and that the applicant meets any other applicable requirements of this chapter.
If the board determines that an applicant meets all of the requirements, the board shall issue to the applicant a license as a category III terminal distributor of dangerous drugs with an office-based opioid treatment classification.
(D) The holder of a category III terminal distributor license with an office-based opioid treatment classification shall do all of the following:
(1) Be in control of a facility that is owned and operated solely by one or more physicians authorized under Chapter 4731. of the Revised Code to practice medicine and surgery or osteopathic medicine and surgery, unless the state board of pharmacy has exempted the holder from this requirement;
(2) Comply with the requirements for conducting office-based opioid treatment, as established by the state medical board in rules adopted under section 4731.056 of the Revised Code;
(3) Require any person with ownership of the facility to submit to a criminal records check in accordance with section 4776.02 of the Revised Code and send the results of the criminal records check directly to the state board of pharmacy for review and decision under section 4729.071 of the Revised Code;
(4) Require 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 offense, as defined in section 2925.01 of the Revised Code.
(5) Maintain a list of each person with ownership of the facility and notify the state board of pharmacy of any change to that list.
(E) No person subject to licensure as a category III terminal distributor of dangerous drugs with an office-based opioid treatment classification shall knowingly fail to remain in compliance with the requirements of division (D) of this section and any other applicable requirements of this chapter.
(F) The state board of pharmacy may impose a fine of not m ore than five thousand dollars on a person who violates division (B) or (E) of this section. A separate fine may be imposed for each day the violation continues. In imposing the fine, the board's actions shall be taken in accordance with Chapter 119. of the Revised Code.
(G) The state board of pharmacy shall adopt rules as it considers necessary to implement and administer this section. the rules shall be adopted in accordance with Chapter 119. of the Revised Code.
Added by 131st General Assembly File No. TBD, SB 319, §1, eff. 8/4/2017.
(A)
(1) The state board of pharmacy, in accordance with Chapter 119. of the Revised Code, may impose any one or more of the following sanctions on a person licensed under division (B)(1)(a) of section 4729.52 of the Revised Code for any of the causes set forth in division (A)(2) of this section:
(a) Suspend, revoke, restrict, limit, or refuse to grant or renew a license;
(b) Reprimand or place the license holder on probation;
(c) Impose a monetary penalty or forfeiture not to exceed in severity any fine designated under the Revised Code for a similar offense or two thousand five hundred dollars if the acts committed are not classified as an offense by the Revised Code ;
(2) The board may impose the sanctions set forth in division (A)(1) of this section for any of the following:
(a) Making any false material statements in an application for licensure under section 4729.52 of the Revised Code;
(b) Violating any federal, state, or local drug law; any provision of this chapter or Chapter 2925., 3715., or 3719. of the Revised Code; or any rule of the board;
(c) A conviction of a felony;
(d) Failing to satisfy the qualifications for licensure under section 4729.53 of the Revised Code or the rules of the board or ceasing to satisfy the qualifications after the registration is granted or renewed;
(e) Falsely or fraudulently promoting to the public a drug that is a controlled substance included in schedule I, II, III, IV, or V, except that nothing in this division prohibits a manufacturer, outsourcing facility, third-party logistics provider, repackager, or wholesale distributor of dangerous drugs from furnishing information concerning a controlled substance to a health care provider or licensed terminal distributor;
(f) Violating any provision of the "Federal Food, Drug, and Cosmetic Act," 52 Stat. 1040 (1938), 21 U.S.C. 301, or Chapter 3715. of the Revised Code;
(g) Any other cause for which the board may impose sanctions as set forth in rules adopted under section 4729.26 of the Revised Code.
(B) Upon the suspension or revocation of any license identified in division (B)(1)(a) of section 4729.52 of the Revised Code, the licensee shall immediately surrender the license to the board.
(C) If the board suspends, revokes, or refuses to renew any license identified in division (B)(1)(a) of section 4729.52 of the Revised Code and determines that there is clear and convincing evidence of a danger of immediate and serious harm to any person, the board may place under seal all dangerous drugs owned by or in the possession, custody, or control of the affected licensee. Except as provided in this division, the board shall not dispose of the dangerous drugs sealed under this division until the licensee exhausts all of the licensee's appeal rights under Chapter 119. of the Revised Code. The court involved in such an appeal may order the board, during the pendency of the appeal, to sell sealed dangerous drugs that are perishable. The board shall deposit the proceeds of the sale with the court.
(D) If the board is required under Chapter 119. of the Revised Code to give notice of an opportunity for a hearing and the license holder does not make a timely request for a hearing in accordance with section 119.07 of the Revised Code, the board is not required to hold a hearing, but may adopt a final order that contains the board's findings. In the final order, the board may impose any of the sanctions listed in division (A) of this section.
(E) Notwithstanding division (C)(2) of section 2953.32 of the Revised Code specifying that if records pertaining to a criminal case are sealed under that section the proceedings in the case must be deemed not to have occurred, sealing of the following records on which the board has based an action under this section shall have no effect on the board's action or any sanction imposed by the board under this section: records of any conviction, guilty plea, judicial finding of guilt resulting from a plea of no contest, or a judicial finding of eligibility for a pretrial diversion program or intervention in lieu of conviction. The board is not required to seal, destroy, redact, or otherwise modify its records to reflect the court's sealing of conviction records.
Amended by 132nd General Assembly File No. TBD, HB 49, §101.01, eff. 9/29/2017.
Amended by 131st General Assembly File No. TBD, HB 64, §101.01, eff. 9/29/2015.
Effective Date: 07-01-1992 .
If the state board of pharmacy determines that there is clear and convincing evidence that the method used by a licensed manufacturer of dangerous drugs, outsourcing facility, third-party logistics provider, repackager of dangerous drugs, or wholesale distributor of dangerous drugs to possess or distribute dangerous drugs presents a danger of immediate and serious harm to others, the board may suspend without a hearing the license issued pursuant to section 4729.52 of the Revised Code. The board shall follow the procedure for suspension without a prior hearing in section 119.07 of the Revised Code. The suspension shall remain in effect, unless removed by the board, until the board's final adjudication order becomes effective, except that if the board does not issue its final adjudication order within one hundred twenty days after the suspension, the suspension shall be void on the one hundred twenty-first day after the suspension.
Amended by 132nd General Assembly File No. TBD, HB 49, §101.01, eff. 9/29/2017.
Added by 131st General Assembly File No. TBD, HB 116, §1, eff. 8/31/2016.
(A) The state board of pharmacy may after notice and a hearing in accordance with Chapter 119. of the Revised Code, impose any one or more of the following sanctions on a terminal distributor of dangerous drugs for any of the causes set forth in division (B) of this section:
(1) Suspend, revoke, restrict, limit, or refuse to grant or renew any license ;
(2) Reprimand or place the license holder on probation;
(3) Impose a monetary penalty or forfeiture not to exceed in severity any fine designated under the Revised Code for a similar offense or one thousand dollars if the acts committed have not been classified as an offense by the Revised Code.
(B) The board may impose the sanctions listed in division (A) of this section for any of the following:
(1) Making any false material statements in an application for a license as a terminal distributor of dangerous drugs;
(2) Violating any rule of the board;
(3) Violating any provision of this chapter;
(4) Except as provided in section 4729.89 of the Revised Code, violating any provision of the "Federal Food, Drug, and Cosmetic Act," 52 Stat. 1040 (1938), 21 U.S.C.A. 301, or Chapter 3715. of the Revised Code;
(5) Violating any provision of the federal drug abuse control laws or Chapter 2925. or 3719. of the Revised Code;
(6) Falsely or fraudulently promoting to the public a dangerous drug, except that nothing in this division prohibits a terminal distributor of dangerous drugs from furnishing information concerning a dangerous drug to a health care provider or another licensed terminal distributor;
(7) Ceasing to satisfy the qualifications of a terminal distributor of dangerous drugs set forth in section 4729.55 of the Revised Code;
(8) Except as provided in division (C) of this section:
(a) Waiving the payment of all or any part of a deductible or copayment that an individual, pursuant to a health insurance or health care policy, contract, or plan that covers the services provided by a terminal distributor of dangerous drugs, would otherwise be required to pay for the services if the waiver is used as an enticement to a patient or group of patients to receive pharmacy services from that terminal distributor;
(b) Advertising that the terminal distributor will waive the payment of all or any part of a deductible or copayment that an individual, pursuant to a health insurance or health care policy, contract, or plan that covers the pharmaceutical services, would otherwise be required to pay for the services.
(9) Conviction of a felony;
(10) Any other cause for which the board may impose discipline as set forth in rules adopted under section 4729.26 of the Revised Code.
(C) Sanctions shall not be imposed under division (B)(8) of this section against any terminal distributor of dangerous drugs that waives deductibles and copayments as follows:
(1) In compliance with a health benefit plan that expressly allows such a practice. Waiver of the deductibles or copayments shall be made only with the full knowledge and consent of the plan purchaser, payer, and third-party administrator. Documentation of the consent shall be made available to the board on request.
(2) For professional services rendered to any other person licensed pursuant to this chapter to the extent allowed by this chapter and the rules of the board.
(D)
(1) Upon the suspension or revocation of a license issued to a terminal distributor of dangerous drugs or the refusal by the board to renew such a license, the distributor shall immediately surrender the license to the board.
(2)
(a) The board may place under seal all dangerous drugs that are owned by or in the possession, custody, or control of a terminal distributor at the time the license is suspended or revoked or at the time the board refuses to renew the license. Except as provided in division (D)(2)(b) of this section, dangerous drugs so sealed shall not be disposed of until appeal rights under Chapter 119. of the Revised Code have expired or an appeal filed pursuant to that chapter has been determined.
(b) The court involved in an appeal filed pursuant to Chapter 119. of the Revised Code may order the board, during the pendency of the appeal, to sell sealed dangerous drugs that are perishable. The proceeds of such a sale shall be deposited with that court.
(E) If the board is required under Chapter 119. of the Revised Code to give notice of an opportunity for a hearing and the license holder does not make a timely request for a hearing in accordance with section 119.07 of the Revised Code, the board is not required to hold a hearing, but may adopt a final order that contains the board's findings. In the final order, the board may impose any of the sanctions listed in division (A) of this section.
(F) Notwithstanding division (C)(2) of section 2953.32 of the Revised Code specifying that if records pertaining to a criminal case are sealed under that section the proceedings in the case must be deemed not to have occurred, sealing of the following records on which the board has based an action under this section shall have no effect on the board's action or any sanction imposed by the board under this section: records of any conviction, guilty plea, judicial finding of guilt resulting from a plea of no contest, or a judicial finding of eligibility for a pretrial diversion program or intervention in lieu of conviction. The board is not required to seal, destroy, redact, or otherwise modify its records to reflect the court's sealing of conviction records.
Amended by 132nd General Assembly File No. TBD, HB 49, §101.01, eff. 9/29/2017.
Amended by 131st General Assembly File No. TBD, HB 290, §1, eff. 4/6/2017.
Amended by 129th General AssemblyFile No.156, SB 301, §1, eff. 3/13/2013.
Effective Date: 07-22-1998 .
(A) The state board of pharmacy may suspend without a hearing the license of a terminal distributor of dangerous drugs if the board determines that there is clear and convincing evidence of a danger of immediate and serious harm to others due to either of the following:
(1) The method used by the terminal distributor to possess or distribute dangerous drugs;
(2) The method of prescribing dangerous drugs used by a licensed health professional authorized to prescribe drugs who holds a terminal distributor license or practices in the employ of or under contract with a terminal distributor.
(B) The board shall follow the procedure for suspension without a prior hearing in section 119.07 of the Revised Code. The suspension shall remain in effect, unless removed by the board, until the board's final adjudication order becomes effective, except that if the board does not issue its final adjudication order within one hundred twenty days after the suspension, the suspension shall be void on the one hundred twenty-first day after the suspension.
If the terminal distributor holds a license with a pain management clinic classification issued under section 4729.552 of the Revised Code or a license with an office-based opioid treatment classification issued under section 4729.553 of the Revised Code and the person holding the license also holds a 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.
Amended by 132nd General Assembly File No. TBD, HB 49, §101.01, eff. 9/29/2017.
Amended by 131st General Assembly File No. TBD, SB 319, §1, eff. 4/6/2017.
Amended by 131st General Assembly File No. TBD, HB 116, §1, eff. 8/31/2016.
Added by 129th General AssemblyFile No.19, HB 93, §1, eff. 5/20/2011.
The state board of pharmacy, within thirty days after receipt of a complete application filed in the form and manner set forth in section 4729.52 or 4729.54 of the Revised Code for the issuance of a license or the renewal of a license , shall notify the applicant therefor whether or not such license will be issued or renewed. If the board determines that such license will not be issued or renewed, such notice to the applicant shall set forth, in a manner determined by the board, the reason or reasons that such license will not be issued or renewed.
Amended by 132nd General Assembly File No. TBD, HB 49, §101.01, eff. 9/29/2017.
Effective Date: 01-01-1962 .
The executive director of the state board of pharmacy shall maintain a register of the names, addresses, and the date of licensure of those persons to whom licenses have been issued pursuant to sections 4729.52 and 4729.54 of the Revised Code.
The board shall make available a roster of those persons . The roster shall indicate those persons whose licenses have been suspended, revoked, or surrendered, and those persons whose licenses have not been renewed.
A written statement signed and verified by the executive director of the board or the director's designee in which it is stated that after diligent search of the register no record or entry of the issuance of a license to a person is found is admissible in evidence and constitutes presumptive evidence of the fact that the person is not licensed pursuant to section 4729.52 or 4729.54 of the Revised Code.
Amended by 132nd General Assembly File No. TBD, HB 49, §101.01, eff. 9/29/2017.
Effective Date: 07-22-1998 .
(A)
(1) Before a licensee identified in division (B)(1)(a) of section 4729.52 of the Revised Code may sell or distribute dangerous drugs at wholesale to any person, except as provided in division (A)(2) of this section, the licensee shall query the roster established pursuant to section 4729.59 of the Revised Code to determine whether the purchaser is a licensed terminal distributor of dangerous drugs.
If no documented query is conducted before a sale is made, it shall be presumed that the sale of dangerous drugs by the licensee is in violation of division (B) of section 4729.51 of the Revised Code and the purchase of dangerous drugs by the purchaser is in violation of division (E) of section 4729.51 of the Revised Code. If a licensee conducts a documented query and relies on the results of the query in selling or distributing dangerous drugs at wholesale to the terminal distributor of dangerous drugs, the licensee shall be deemed not to have violated division (B) of section 4729.51 of the Revised Code in making the sale.
(2) Division (A)(1) of this section does not apply when a licensee identified in division (B)(1)(a) of section 4729.52 of the Revised Code sells or distributes dangerous drugs at wholesale to any of the following:
(a) A person specified in division (B)(4) of section 4729.51 of the Revised Code;
(b) Any of the persons described in divisions (A)(1) to (13) of section 4729.541 of the Revised Code, but only if the purchaser is not required to obtain licensure as provided in divisions (B) to (D) of that section.
(B) Before a licensed terminal distributor of dangerous drugs may purchase dangerous drugs at wholesale, the terminal distributor shall query the roster established pursuant to section 4729.59 of the Revised Code to confirm the seller is licensed to engage in the sale or distribution of dangerous drugs at wholesale.
If no documented query is conducted before a purchase is made, it shall be presumed that the purchase of dangerous drugs by the terminal distributor is in violation of division (F) of section 4729.51 of the Revised Code and the sale of dangerous drugs by the seller is in violation of division (A) of section 4729.51 of the Revised Code. If a licensed terminal distributor of dangerous drugs conducts a documented query at least annually and relies on the results of the query in purchasing dangerous drugs at wholesale , the terminal distributor shall be deemed not to have violated division (F) of section 4729.51 of the Revised Code in making the purchase.
Amended by 132nd General Assembly File No. TBD, HB 49, §101.01, eff. 9/29/2017.
Amended by 131st General Assembly File No. TBD, SB 319, §1, eff. 4/6/2017.
Amended by 131st General Assembly File No. TBD, HB 200, §1, eff. 9/8/2016.
Amended by 131st General Assembly File No. TBD, HB 39, §1, eff. 2/1/2016.
Amended by 131st General Assembly File No. TBD, HB 4, §1, eff. 7/16/2015.
Amended by 130th General Assembly File No. TBD, HB 296, §1, eff. 4/21/2014.
Effective Date: 03-09-1999 .
No person shall make or cause to be made a false or fraudulent license of a terminal distributor of dangerous drugs or a manufacturer, outsourcing facility, third-party logistics provider, repackager, or wholesale distributor of dangerous drugs.
Amended by 132nd General Assembly File No. TBD, HB 49, §101.01, eff. 9/29/2017.
Effective Date: 07-01-1996 .
If a person licensed under section 4729.52 or 4729.54 of the Revised Code ceases to engage in the activities for which the license was issued, the person shall notify the state board of pharmacy of such fact and shall surrender such license to the board within a time frame specified by the board in rules adopted under section 4729.26 of the Revised Code; provided, that on dissolution of a partnership by death, the surviving partner may operate under a license issued to the partnership until expiration, revocation, or suspension of such license , and the heirs or legal representatives of deceased persons, and receivers and trustees in bankruptcy appointed by any competent authority, may operate under the license issued to the persons succeeded in possession by such heir, representative, receiver, or trustee in bankruptcy until expiration, revocation, or suspension of such license .
Amended by 132nd General Assembly File No. TBD, HB 49, §101.01, eff. 9/29/2017.
Effective Date: 01-01-1962 .
Effective Date: 05-18-2005 .
In addition to the remedies provided and irrespective of whether or not there exists an adequate remedy at law, the board of pharmacy may apply to the court of common pleas in the county where any of the provisions of sections 4729.51 to 4729.62 of the Revised Code are being violated or where any violation described in section 4729.35 of the Revised Code is occurring for a temporary or permanent injunction restraining any person from such violation.
Effective Date: 03-14-1985 .
(A) Except as provided in division (B) of this section, all receipts of the state board of pharmacy, from any source, shall be deposited into the state treasury to the credit of the occupational licensing and regulatory fund. All vouchers of the board shall be approved by the president or executive director of the board, or both, as authorized by the board. All initial issuance fees and renewal fees required by sections 4729.01 to 4729.54 of the Revised Code shall be payable by the applicant at the time of making application.
(B)
(1) There is hereby created in the state treasury the board of pharmacy drug law enforcement fund. All moneys that are derived from any fines, mandatory fines, or forfeited bail to which the board may be entitled under Chapter 2925., division (C) of section 2923.42, or division (B) of section 2925.42 of the Revised Code and all moneys that are derived from forfeitures of property to which the board may be entitled pursuant to Chapter 2925. or 2981. of the Revised Code, any other provision of the Revised Code, or federal law shall be deposited into the fund. Subject to division (B)(2) of this section, division (B) of section 2923.44, and divisions (B), (C), and (D) of section 2981.13 of the Revised Code, the moneys in the fund shall be used solely to subsidize the drug law enforcement efforts of the board.
(2) 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.
(D)
(1) Except as provided in divisions (D)(2) and (3) of this section, the board, subject to the approval of the controlling board , may establish fees in excess of the amounts provided by this chapter, provided that such fees do not exceed the amounts permitted by this chapter by more than fifty per cent.
(2) Division (D)(1) of this section does not apply to fees required by this chapter to be established at amounts adequate to cover designated expenses.
(3) Fees established under division (D)(1) of this section or described in division (D)(2) of this section are subject to the limitation on fee increases specified in division (A) of section 4729.83 of the Revised Code.
Amended by 130th General Assembly File No. TBD, HB 483, §101.01, eff. 9/15/2014.
Effective Date: 01-01-1999; 07-01-2007
Effective Date: 05-18-2005 .
On receipt of a notice pursuant to section 3123.43 of the Revised Code, the state board of pharmacy shall comply with sections 3123.41 to 3123.50 of the Revised Code and any applicable rules adopted under section 3123.63 of the Revised Code with respect to a license or certificate of registration issued pursuant to this chapter.
Amended by 132nd General Assembly File No. TBD, HB 49, §101.01, eff. 9/29/2017.
Effective Date: 03-22-2001 .
The state board of pharmacy shall adopt rules pursuant to Chapter 119. of the Revised Code specifying for the purposes of sections 3719.172 and 4729.541 of the Revised Code the national bodies recognized by the board that certify persons who successfully complete diabetes education programs.
Amended by 131st General Assembly File No. TBD, SB 319, §1, eff. 4/6/2017.
Effective Date: 11-06-1996 .
(A) 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 the following: controlled substances, as defined in section 3719.01 of the Revised Code; medical marijuana, as authorized under Chapter 3796. of the Revised Code; and other dangerous drugs the board includes in the database pursuant to rules adopted under section 4729.84 of the Revised Code. In establishing and maintaining the database, the board shall electronically collect information pursuant to sections 4729.77, 4729.771, 4729.772, 4729.78, and 4729.79 of the Revised Code and shall disseminate information as authorized or required by sections 4729.80 and 4729.81 of the Revised Code. The board's collection and dissemination of information shall be conducted in accordance with rules adopted under section 4729.84 of the Revised Code.
Amended by 132nd General Assembly File No. TBD, HB 49, §101.01, eff. 9/29/2017.
Amended by 131st General Assembly File No. TBD, HB 523, §1, eff. 9/8/2016.
Amended by 129th General AssemblyFile No.19, HB 93, §1, eff. 5/20/2011.
Effective Date: 05-18-2005 .
If the state board of pharmacy establishes and maintains a drug database pursuant to section 4729.75 of the Revised Code, the executive director of the board shall do all of the following:
(A) Employ an administrator to manage and direct the duties of staff employed to operate the drug database. The administrator shall be a person who has had training and experience in areas related to the duties of the database.
(B) Employ such professional, technical, and clerical employees as are necessary, and employ or hire on a consulting basis other technical services required for the operation of the database;
(C) Fix the compensation of the administrator and all other staff employed to operate the database.
Effective Date: 05-18-2005 .
(A) If the state board of pharmacy establishes and maintains a drug database pursuant to section 4729.75 of the Revised Code, each pharmacy licensed as a terminal distributor of dangerous drugs that dispenses drugs to patients in this state and is included in the types of pharmacies specified in rules adopted under section 4729.84 of the Revised Code shall submit to the board the following prescription information:
(1) Terminal distributor identification;
(2) Patient identification;
(3) Prescriber identification;
(4) Date prescription was issued by prescriber;
(5) Date drug was dispensed;
(6) Indication of whether the drug dispensed is new or a refill;
(7) Name, strength, and national drug code of the drug dispensed;
(8) Quantity of drug dispensed;
(9) Number of days' supply of drug dispensed;
(10) Serial or prescription number assigned by the terminal distributor;
(11) Source of payment for the drug dispensed;
(12) Any other data fields recognized by the American society for automation in pharmacy and specified in rules adopted under section 4729.84 of the Revised Code.
(B)
(1) The information shall be transmitted as specified by the board in rules adopted under section 4729.84 of the Revised Code.
(2) The information shall be submitted electronically in the format specified by the board, except that the board may grant a waiver allowing the distributor to submit the information in another format.
(3) The information shall be submitted in accordance with any time limits specified by the board, except that the board may grant an extension if either of the following occurs:
(a) The distributor suffers a mechanical or electronic failure, or cannot meet the deadline for other reasons beyond the distributor's control.
(b) The board is unable to receive electronic submissions.
(C) This section does not apply to a prescriber personally furnishing or administering dangerous drugs to the prescriber's patient.
Amended by 132nd General Assembly File No. TBD, HB 49, §101.01, eff. 9/29/2017.
Amended by 129th General AssemblyFile No.19, HB 93, §1, eff. 5/20/2011.
Effective Date: 05-18-2005 .
(A) If the state board of pharmacy establishes and maintains a drug database pursuant to section 4729.75 of the Revised Code, each retail dispensary licensed under Chapter 3796. of the Revised Code by the board shall submit to the board the information regarding medical marijuana dispensed to a patient as specified by the board in rules adopted under section 4729.84 of the Revised Code.
(B)
(1) The information shall be transmitted as specified by the board in rules adopted under section 4729.84 of the Revised Code.
(2) The information shall be submitted in accordance with any time limits specified by the board, except that the board may grant an extension if either of the following occurs:
(a) The retail dispensary's transmission system suffers a mechanical or electronic failure or the retail dispensary cannot meet the deadline for other reasons beyond the dispensary's control.
(b) The board is unable to receive electronic submissions.
(C) The information required to be submitted under division (A) of this section may be submitted on behalf of the retail dispensary by a delegate approved by that dispensary.
Added by 131st General Assembly File No. TBD, HB 523, §1, eff. 9/8/2016.
(A) If the state board of pharmacy establishes and maintains a drug database pursuant to section 4729.75 of the Revised Code, in addition to the information required to be submitted under sections 4729.77, 4729.771, 4729.78, and 4729.79 of the Revised Code, the board may accept information from other sources, including other state agencies, to the extent the information is related to monitoring the misuse and diversion of drugs as set forth in section 4729.75 of the Revised Code.
(B) Any information submitted pursuant to this section shall be transmitted as specified by the board in rules adopted under section 4729.84 of the Revised Code.
Added by 132nd General Assembly File No. TBD, HB 49, §101.01, eff. 9/29/2017.
(A) If the state board of pharmacy establishes and maintains a drug database pursuant to section 4729.75 of the Revised Code, each manufacturer of dangerous drugs, outsourcing facility, repackager of dangerous drugs, or wholesale distributor of dangerous drugs that delivers drugs to prescribers or terminal distributors of dangerous drugs shall submit to the board the following purchase information:
(1) Purchaser identification;
(2) Identification of the drug sold;
(3) Quantity of the drug sold;
(4) Date of sale;
(5) The license number issued by the board.
(B)
(1) The information shall be transmitted as specified by the board in rules adopted under section 4729.84 of the Revised Code.
(2) The information shall be submitted electronically in the format specified by the board, except that the board may grant a waiver allowing submission of the information in another format.
(3) The information shall be submitted in accordance with any time limits specified by the board, except that the board may grant an extension if either of the following occurs:
(a) The manufacturer, outsourcing facility, repackager, or wholesale distributor suffers a mechanical or electronic failure, or cannot meet the deadline for other reasons beyond the person's control.
(b) The board is unable to receive electronic submissions.
Amended by 132nd General Assembly File No. TBD, HB 49, §101.01, eff. 9/29/2017.
Amended by 129th General AssemblyFile No.19, HB 93, §1, eff. 5/20/2011.
Effective Date: 05-18-2005 .
(A) If the state board of pharmacy establishes and maintains a drug database pursuant to section 4729.75 of the Revised Code, each licensed health professional authorized to prescribe drugs, except as provided in division (C) of this section, who personally furnishes to a patient a controlled substance or other dangerous drug the board includes in the database pursuant to rules adopted under section 4729.84 of the Revised Code shall submit to the board the following information:
(1) Prescriber identification;
(2) Patient identification;
(3) Date drug was furnished by the prescriber;
(4) Indication of whether the drug furnished is new or a refill;
(5) Name, strength, and national drug code of drug furnished;
(6) Quantity of drug furnished;
(7) Number of days' supply of drug furnished;
(8) Source of payment for the drug furnished;
(9) Identification of the owner of the drug furnished.
(B)
(1) The information shall be transmitted as specified by the board in rules adopted under section 4729.84 of the Revised Code.
(2) The information shall be submitted electronically in the format specified by the board, except that the board may grant a waiver allowing the prescriber to submit the information in another format.
(3) The information shall be submitted in accordance with any time limits specified by the board, except that the board may grant an extension if either of the following occurs:
(a) The prescriber's transmission system suffers a mechanical or electronic failure, or the prescriber cannot meet the deadline for other reasons beyond the prescriber's control.
(b) The board is unable to receive electronic submissions.
(C)
(1) The information required to be submitted under division (A) of this section may be submitted on behalf of the prescriber by the owner of the drug being personally furnished or by a delegate approved by that owner.
(2) The requirements of this section to submit information to the board do not apply to a prescriber who is a veterinarian.
(D) If the board becomes aware of a prescriber's failure to comply with this section, the board shall notify the government entity responsible for licensing the prescriber.
Amended by 129th General AssemblyFile No.156, SB 301, §1, eff. 3/13/2013.
Added by 129th General AssemblyFile No.19, HB 93, §1, eff. 5/20/2011.
(A) If the state board of pharmacy establishes and maintains a drug database pursuant to section 4729.75 of the Revised Code, the board is authorized or required to provide information from the database only as follows:
(1) On receipt of a request from a designated representative of a government entity responsible for the licensure, regulation, or discipline of health care professionals with authority to prescribe, administer, or dispense drugs, the board may provide to the representative information from the database relating to the professional who is the subject of an active investigation being conducted by the government entity or relating to a professional who is acting as an expert witness for the government entity in such an investigation.
(2) On receipt of a request from a federal officer, or a state or local officer of this or any other state, whose duties include enforcing laws relating to drugs, the board shall provide to the officer information from the database relating to the person who is the subject of an active investigation of a drug abuse offense, as defined in section 2925.01 of the Revised Code, being conducted by the officer's employing government entity.
(3) Pursuant to a subpoena issued by a grand jury, the board shall provide to the grand jury information from the database relating to the person who is the subject of an investigation being conducted by the grand jury.
(4) Pursuant to a subpoena, search warrant, or court order in connection with the investigation or prosecution of a possible or alleged criminal offense, the board shall provide information from the database as necessary to comply with the subpoena, search warrant, or court order.
(5) On receipt of a request from a prescriber or the prescriber's delegate approved by the board, the board shall provide to the prescriber a report of information from the database relating to a patient who is either a current patient of the prescriber or a potential patient of the prescriber based on a referral of the patient to the prescriber, if all of the following conditions are met:
(a) The prescriber certifies in a form specified by the board that it is for the purpose of providing medical treatment to the patient who is the subject of the request;
(b) The prescriber has not been denied access to the database by the board.
(6) On receipt of a request from a pharmacist or the pharmacist's delegate approved by the board, the board shall provide to the pharmacist information from the database relating to a current patient of the pharmacist, if the pharmacist certifies in a form specified by the board that it is for the purpose of the pharmacist's practice of pharmacy involving the patient who is the subject of the request and the pharmacist has not been denied access to the database by the board.
(7) On receipt of a request from an individual seeking the individual's own database information in accordance with the procedure established in rules adopted under section 4729.84 of the Revised Code, the board may provide to the individual the individual's own prescription history.
(8) On receipt of a request from a medical director or a pharmacy director of a managed care organization that has entered into a contract with the department of medicaid under section 5167.10 of the Revised Code and a data security agreement with the board required by section 5167.14 of the Revised Code, the board shall provide to the medical director or the pharmacy director information from the database relating to a medicaid recipient enrolled in the managed care organization, including information in the database related to prescriptions for the recipient that were not covered or reimbursed under a program administered by the department of medicaid.
(9) On receipt of a request from the medicaid director, the board shall provide to the director information from the database relating to a recipient of a program administered by the department of medicaid, including information in the database related to prescriptions for the recipient that were not covered or paid by a program administered by the department.
(10) On receipt of a request from a medical director of a managed care organization that has entered into a contract with the administrator of workers' compensation under division (B)(4) of section 4121.44 of the Revised Code and a data security agreement with the board required by section 4121.447 of the Revised Code, the board shall provide to the medical director information from the database relating to a claimant under Chapter 4121., 4123., 4127., or 4131. of the Revised Code assigned to the managed care organization, including information in the database related to prescriptions for the claimant that were not covered or reimbursed under Chapter 4121., 4123., 4127., or 4131. of the Revised Code, if the administrator of workers' compensation confirms, upon request from the board, that the claimant is assigned to the managed care organization.
(11) On receipt of a request from the administrator of workers' compensation, the board shall provide to the administrator information from the database relating to a claimant under Chapter 4121., 4123., 4127., or 4131. of the Revised Code, including information in the database related to prescriptions for the claimant that were not covered or reimbursed under Chapter 4121., 4123., 4127., or 4131. of the Revised Code.
(12) On receipt of a request from a prescriber or the prescriber's delegate approved by the board, the board shall provide to the prescriber information from the database relating to a patient's mother, if the prescriber certifies in a form specified by the board that it is for the purpose of providing medical treatment to a newborn or infant patient diagnosed as opioid dependent and the prescriber has not been denied access to the database by the board.
(13) On receipt of a request from the director of health, the board shall provide to the director information from the database relating to the duties of the director or the department of health in implementing the Ohio violent death reporting system established under section 3701.93 of the Revised Code.
(14) On receipt of a request from a requestor described in division (A)(1), (2), (5), or (6) of this section who is from or participating with another state's prescription monitoring program, the board may provide to the requestor information from the database, but only if there is a written agreement under which the information is to be used and disseminated according to the laws of this state.
(15) On receipt of a request from a delegate of a retail dispensary licensed under Chapter 3796. of the Revised Code who is approved by the board to serve as the dispensary's delegate, the board shall provide to the delegate a report of information from the database pertaining only to a patient's use of medical marijuana, if both of the following conditions are met:
(a) The delegate certifies in a form specified by the board that it is for the purpose of dispensing medical marijuana for use in accordance with Chapter 3796. of the Revised Code.
(b) The retail dispensary or delegate has not been denied access to the database by the board.
(16) On receipt of a request from a judge of a program certified by the Ohio supreme court as a specialized docket program for drugs, the board shall provide to the judge, or an employee of the program who is designated by the judge to receive the information, information from the database that relates specifically to a current or prospective program participant.
(17) On receipt of a request from a coroner, deputy coroner, or coroner's delegate approved by the board, the board shall provide to the requestor information from the database relating to a deceased person about whom the coroner is conducting or has conducted an autopsy or investigation.
(18) On receipt of a request from a prescriber, the board may provide to the prescriber a summary of the prescriber's prescribing record if such a record is created by the board. Information in the summary is subject to the confidentiality requirements of this chapter.
(19)
(a) On receipt of a request from a pharmacy's responsible person, the board may provide to the responsible person a summary of the pharmacy's dispensing record if such a record is created by the board. Information in the summary is subject to the confidentiality requirements of this chapter.
(b) As used in division (A)(19)(a) of this section, "responsible person" has the same meaning as in rules adopted by the board under section 4729.26 of the Revised Code.
(20) The board may provide information from the database without request to a prescriber or pharmacist who is authorized to use the database pursuant to this chapter.
(21)
(a) On receipt of a request from a prescriber or pharmacist, or the prescriber's or pharmacist's delegate, who is a designated representative of a peer review committee, the board shall provide to the committee information from the database relating to a prescriber who is subject to the committee's evaluation, supervision, or discipline if the information is to be used for one of those purposes. The board shall provide only information that it determines, in accordance with rules adopted under section 4729.84 of the Revised Code, is appropriate to be provided to the committee.
(b) As used in division (A)(21)(a) of this section, "peer review committee" has the same meaning as in section 2305.25 of the Revised Code, except that it includes only a peer review committee of a hospital or a peer review committee of a nonprofit health care corporation that is a member of the hospital or of which the hospital is a member.
(22) Any personal health information submitted to the board pursuant to section 4729.772 of the Revised Code may be provided by the board only as authorized by the submitter of the information and in accordance with rules adopted under section 4729.84 of the Revised Code.
(B) The state board of pharmacy shall maintain a record of each individual or entity that requests information from the database pursuant to this section. In accordance with rules adopted under section 4729.84 of the Revised Code, the board may use the records to document and report statistics and law enforcement outcomes.
The board may provide records of an individual's requests for database information only to the following:
(1) A designated representative of a government entity that is responsible for the licensure, regulation, or discipline of health care professionals with authority to prescribe, administer, or dispense drugs who is involved in an active criminal or disciplinary investigation being conducted by the government entity of the individual who submitted the requests for database information;
(2) A federal officer, or a state or local officer of this or any other state, whose duties include enforcing laws relating to drugs and who is involved in an active investigation being conducted by the officer's employing government entity of the individual who submitted the requests for database information;
(3) A designated representative of the department of medicaid regarding a prescriber who is treating or has treated a recipient of a program administered by the department and who submitted the requests for database information.
(C) Information contained in the database and any information obtained from it is confidential and is not a public record. Information contained in the records of requests for information from the database is confidential and is not a public record. Information contained in the database that does not identify a person, including any licensee or registrant of the board or other entity, may be released in summary, statistical, or aggregate form.
(D)
A pharmacist or prescriber shall not be held liable in damages to any person in any civil action for injury, death, or loss to person or property on the basis that the pharmacist or prescriber did or did not seek or obtain information from the database.
Amended by 132nd General Assembly File No. TBD, HB 49, §101.01, eff. 9/29/2017.
Amended by 131st General Assembly File No. TBD, HB 523, §1, eff. 9/8/2016.
Amended by 131st General Assembly File No. TBD, HB 64, §101.01, eff. 9/29/2015.
Amended by 130th General Assembly File No. TBD, HB 493, §1, eff. 9/17/2014.
Amended by 130th General Assembly File No. TBD, HB 341, §1, eff. 9/16/2014.
Amended by 130th General Assembly File No. TBD, HB 483, §101.01, eff. 9/15/2014.
Amended by 130th General Assembly File No. 25, HB 59, §101.01, eff. 9/29/2013.
Amended by 129th General AssemblyFile No.156, SB 301, §1, eff. 3/13/2013.
Renumbered and amended by 129th General AssemblyFile No.19, HB 93, §1, eff. 5/20/2011.
Effective Date: 05-18-2005 .
If the state board of pharmacy establishes and maintains a drug database pursuant to section 4729.75 of the Revised Code, the board shall review the information in the drug database. If the board determines from the review that a violation of law may have occurred, it shall notify the appropriate law enforcement agency or a government entity responsible for the licensure, regulation, or discipline of licensed health professionals authorized to prescribe drugs and supply information required by the agency or entity for an investigation of the violation of law that may have occurred. The board also shall notify the medicaid director if the board determines that the violation may have been committed by a provider of services under a program administered by the department of medicaid.
Amended by 130th General Assembly File No. 25, HB 59, §101.01, eff. 9/29/2013.
Renumbered and amended by 129th General AssemblyFile No.19, HB 93, §1, eff. 5/20/2011.
Effective Date: 05-18-2005 .
(A) If the state board of pharmacy establishes a drug database pursuant to section 4729.75 of the Revised Code, the information collected for the database shall be retained in the database and accessible to persons listed in division (A) of section 4729.80 of the Revised Code for at least five years.
(B) Except as provided in division (C) of this section, any information that identifies a patient shall be destroyed after it has been retained for five years unless a law enforcement agency or a government entity responsible for the licensure, regulation, or discipline of licensed health professionals authorized to prescribe drugs has submitted a written request to the board for retention of the information in accordance with rules adopted by the board under section 4729.84 of the Revised Code.
(C) The board may retain information that identifies a patient for a period in excess of five years if the board considers retention of the information necessary to serve an investigatory or public health purpose.
Amended by 132nd General Assembly File No. TBD, HB 49, §101.01, eff. 9/29/2017.
Amended by 131st General Assembly File No. TBD, HB 64, §101.01, eff. 9/29/2015.
Renumbered and amended by 129th General AssemblyFile No.19, HB 93, §1, eff. 5/20/2011.
Effective Date: 05-18-2005 .
(A) If the state board of pharmacy establishes and maintains a drug database pursuant to section 4729.75 of the Revised Code, the board may use, for the purpose of establishing or maintaining the database, any portion of the licensure or registration fees collected under this chapter. The board shall not increase the amount of any of those fees solely for the purpose of establishing or maintaining the database.
The board shall not impose any charge on a prescriber for the establishment or maintenance of the database. The board shall not charge any fees for the transmission of data to the database or for the receipt of information from the database, except that the board may charge a fee in accordance with rules adopted under section 4729.84 of the Revised Code to an individual who requests the individual's own database information under section 4729.80 of the Revised Code.
(B) The board may accept grants, gifts, or donations for purposes of the drug database. Any money received shall be deposited into the state treasury to the credit of the drug database fund, which is hereby created. Money in the fund shall be used solely for purposes of the drug database.
Amended by 132nd General Assembly File No. TBD, HB 49, §101.01, eff. 9/29/2017.
Amended by 130th General Assembly File No. TBD, HB 483, §101.01, eff. 9/15/2014.
Renumbered and amended by 129th General AssemblyFile No.19, HB 93, §1, eff. 5/20/2011.
Effective Date: 05-18-2005 .
For purposes of establishing and maintaining a drug database pursuant to section 4729.75 of the Revised Code, the state board of pharmacy shall adopt rules in accordance with Chapter 119. of the Revised Code to carry out and enforce sections 4729.75 to 4729.83 of the Revised Code. The rules shall specify all of the following:
(A) A means of identifying each patient, each terminal distributor of dangerous drugs, each purchase at wholesale of dangerous drugs, and each retail dispensary licensed under Chapter 3796. of the Revised Code about which information is entered into the drug database;
(B) Requirements for the transmission of information from terminal distributors of dangerous drugs, manufacturers of dangerous drugs, outsourcing facilities, repackagers of dangerous drugs, wholesale distributors of dangerous drugs, prescribers, and retail dispensaries;
(C) An electronic format for the submission of information from persons identified in division (B) of this section;
(D) A procedure whereby a person unable to submit information electronically may obtain a waiver to submit information in another format;
(E) A procedure whereby the board may grant a request from a law enforcement agency or a government entity responsible for the licensure, regulation, or discipline of licensed health professionals authorized to prescribe drugs that information that has been stored for three years be retained when the information pertains to an open investigation being conducted by the agency or entity;
(F) A procedure whereby a person identified in division (B) of this section may apply for an extension to the time by which information must be transmitted to the board;
(G) A procedure whereby a person or government entity to which the board is authorized to provide information may submit a request to the board for the information and the board may verify the identity of the requestor;
(H) Standards for determining what information is appropriate to be provided under division (A)(21) of section 4729.80 of the Revised Code;
(I) A procedure whereby the board can use the database request records required by division (B) of section 4729.80 of the Revised Code to document and report statistics and law enforcement outcomes;
(J) A procedure whereby an individual may request the individual's own database information and the board may verify the identity of the requestor;
(K) A reasonable fee that the board may charge under section 4729.83 of the Revised Code for providing an individual with the individual's own database information pursuant to section 4729.80 of the Revised Code;
(L) The other specific dangerous drugs that, in addition to controlled substances, must be included in the database;
(M) The types of pharmacies licensed as terminal distributors of dangerous drugs that are required to submit prescription information to the board pursuant to section 4729.77 of the Revised Code;
(N) Additional data fields, recognized by the American society for automation in pharmacy, that licensed terminal distributors of dangerous drugs must submit to the board pursuant to section 4729.77 of the Revised Code;
(O) The information regarding medical marijuana dispensed to a patient that a retail dispensary is required to submit to the board pursuant to section 4729.771 of the Revised Code;
(P) Requirements for the transmission of information pursuant to section 4729.772 of the Revised Code and requirements for the release of such information by the board.
Amended by 132nd General Assembly File No. TBD, HB 49, §101.01, eff. 9/29/2017.
Amended by 131st General Assembly File No. TBD, HB 523, §1, eff. 9/8/2016.
Amended by 131st General Assembly File No. TBD, HB 64, §101.01, eff. 9/29/2015.
Renumbered and amended by 129th General AssemblyFile No.19, HB 93, §1, eff. 5/20/2011.
Effective Date: 05-18-2005 .
If the state board of pharmacy establishes and maintains a drug database pursuant to section 4729.75 of the Revised Code, the board shall prepare reports regarding the database and present or submit them in accordance with both of the following:
(A) The board shall present a biennial report to the standing committees of the house of representatives and the senate that are primarily responsible for considering health and human services issues. Each report shall include all of the following:
(1) The cost to the state of establishing and maintaining the database;
(2) Information from the board, terminal distributors of dangerous drugs, prescribers, and retail dispensaries licensed under Chapter 3796. of the Revised Code regarding the board's effectiveness in providing information from the database;
(3) The board's timeliness in transmitting information from the database.
(B) The board shall submit a semiannual report to the governor, the president of the senate, the speaker of the house of representatives, the attorney general, the chairpersons of the standing committees of the house of representatives and the senate that are primarily responsible for considering health and human services issues, the department of public safety, the state dental board, the board of nursing, the state vision professionals board, the state medical board, and the state veterinary medical licensing board. The state board of pharmacy shall make the report available to the public on its internet web site. Each report submitted shall include all of the following for the period covered by the report:
(1) An aggregate of the information submitted to the board under section 4729.77 of the Revised Code regarding prescriptions for controlled substances containing opioids, including all of the following:
(a) The number of prescribers who issued the prescriptions;
(b) The number of patients to whom the controlled substances were dispensed;
(c) The average quantity of the controlled substances dispensed per prescription;
(d) The average daily morphine equivalent dose of the controlled substances dispensed per prescription.
(2) An aggregate of the information submitted to the board under section 4729.79 of the Revised Code regarding controlled substances containing opioids that have been personally furnished to a patient by a prescriber, other than a prescriber who is a veterinarian, including all of the following:
(a) The number of prescribers who personally furnished the controlled substances;
(b) The number of patients to whom the controlled substances were personally furnished;
(c) The average quantity of the controlled substances that were furnished at one time;
(d) The average daily morphine equivalent dose of the controlled substances that were furnished at one time.
(3) An aggregate of the information submitted to the board under section 4729.771 of the Revised Code regarding medical marijuana.
Amended by 132nd General Assembly File No. TBD, HB 49, §130.11, eff. 1/21/2018.
Amended by 131st General Assembly File No. TBD, HB 523, §1, eff. 9/8/2016.
Amended by 130th General Assembly File No. TBD, SB 276, §1, eff. 3/19/2015.
Amended by 130th General Assembly File No. TBD, HB 394, §1, eff. 3/19/2015.
Renumbered by 129th General AssemblyFile No.19, HB 93, §1, eff. 5/20/2011.
Effective Date: 05-18-2005 .
If the state board of pharmacy establishes and maintains a drug database pursuant to section 4729.75 of the Revised Code, all of the following apply:
(A)
(1) No person identified in divisions (A)(1) to (13) , (15) to (22), or (B) of section 4729.80 of the Revised Code shall disseminate any written or electronic information the person receives from the drug database or otherwise provide another person access to the information that the person receives from the database, except as follows:
(a) When necessary in the investigation or prosecution of a possible or alleged criminal offense;
(b) When a person provides the information to the prescriber, pharmacist, or retail dispensary licensed under Chapter 3796. of the Revised Code for whom the person is approved by the board to serve as a delegate of the prescriber, pharmacist, or retail dispensary for purposes of requesting and receiving information from the drug database under division (A)(5), (6), or (15) of section 4729.80 of the Revised Code;
(c) When a prescriber, pharmacist, or retail dispensary licensed under Chapter 3796. of the Revised Code provides the information to a person who is approved by the board to serve as such a delegate of the prescriber, pharmacist, or retail dispensary;
(d) When a prescriber or pharmacist includes the information in a medical record, as defined in section 3701.74 of the Revised Code.
(2) No person shall provide false information to the state board of pharmacy with the intent to obtain or alter information contained in the drug database.
(3) No person shall obtain drug database information by any means except as provided under section 4729.80 or 4729.81 of the Revised Code.
(B) A person shall not use information obtained pursuant to division (A) of section 4729.80 of the Revised Code as evidence in any civil or administrative proceeding.
(C)
(1) Except as provided in division (C)(2) of this section, after providing notice and affording an opportunity for a hearing in accordance with Chapter 119. of the Revised Code, the board may restrict a person from obtaining further information from the drug database if any of the following is the case:
(a) The person violates division (A)(1), (2), or (3) of this section;
(b) The person is a requestor identified in division (A)(14) of section 4729.80 of the Revised Code and the board determines that the person's actions in another state would have constituted a violation of division (A)(1), (2), or (3) of this section;
(c) The person fails to comply with division (B) of this section, regardless of the jurisdiction in which the failure to comply occurred;
(d) The person creates, by clear and convincing evidence, a threat to the security of information contained in the database.
(2) If the board determines that allegations regarding a person's actions warrant restricting the person from obtaining further information from the drug database without a prior hearing, the board may summarily impose the restriction. A telephone conference call may be used for reviewing the allegations and taking a vote on the summary restriction. The summary restriction shall remain in effect, unless removed by the board, until the board's final adjudication order becomes effective.
(3) The board shall determine the extent to which the person is restricted from obtaining further information from the database.
Amended by 132nd General Assembly File No. TBD, HB 49, §101.01, eff. 9/29/2017.
Amended by 131st General Assembly File No. TBD, HB 523, §1, eff. 9/8/2016.
Amended by 131st General Assembly File No. TBD, HB 64, §101.01, eff. 9/29/2015.
Amended by 130th General Assembly File No. TBD, SB 276, §1, eff. 3/19/2015.
Amended by 130th General Assembly File No. TBD, HB 394, §1, eff. 3/19/2015.
Amended by 130th General Assembly File No. TBD, HB 493, §1, eff. 9/17/2014.
Amended by 130th General Assembly File No. TBD, HB 341, §1, eff. 9/16/2014.
Amended by 130th General Assembly File No. TBD, HB 483, §101.01, eff. 9/15/2014.
Amended by 129th General AssemblyFile No.156, SB 301, §1, eff. 3/13/2013.
Added by 129th General AssemblyFile No.19, HB 93, §1, eff. 5/20/2011.
If the state board of pharmacy establishes and maintains a drug database pursuant to section 4729.75 of the Revised Code and if the board restricts a prescriber from obtaining further information from the database pursuant to division (C) of section 4729.86 of the Revised Code, the board shall notify the government entity responsible for licensing the prescriber.
Added by 130th General Assembly File No. TBD, HB 341, §1, eff. 1/1/2015.
Added by 130th General Assembly File No. TBD, HB 483, §101.01, eff. 1/1/2015.
The state board of pharmacy shall comply with section 4776.20 of the Revised Code.
Added by 129th General AssemblyFile No.169, HB 247, §1, eff. 3/22/2013.
Notwithstanding any provision of this chapter or rule adopted by the state board of pharmacy, a pharmacist may dispense epinephrine autoinjectors pursuant to a prescription issued under section 4723.483. 4730.432. or 4731.96 of the Revised Code.
A pharmacist who in good faith dispenses epinephrine autoinjectors under this section is not liable for or subject to any of the following for any action or omission of an entity to which an epinephrine autoinjector is dispensed: damages in any civil action, prosecution in any criminal proceeding, or professional disciplinary action.
Added by 131st General Assembly File No. TBD, HB 200, §1, eff. 9/8/2016.
(A) As used in this section, "eligible patient," "investigational drug, product, or device," "terminal condition," and "treating physician" have the same meanings as in section 4731.97 of the Revised Code.
(B) A manufacturer of dangerous drugs may, in accordance with section 4731.97 of the Revised Code, provide an investigational drug, product, or device for treatment of a terminal condition to an eligible patient or to the treating physician who is treating the eligible patient's terminal condition. In doing so, the manufacturer may do all of the following:
(1) Provide the investigational drug, product, or device to the eligible patient or treating physician directly or through a terminal distributor of dangerous drugs;
(2) Provide the investigational drug, product, or device either with or without charge for the costs associated with manufacturing and providing the investigational drug, product, or device;
(3) Require the eligible patient to participate in data collection relating to use of the investigational drug, product, or device.
(C) Except for actions or omissions constituting willful or wanton misconduct, a manufacturer or terminal distributor of dangerous drugs that provides or distributes an investigational drug, product, or device pursuant to this section and section 4731.97 of the Revised Code is not liable for or subject to damages in any civil action or prosecution in any criminal proceeding for actions or omissions related to providing or distributing the investigational drug, product, or device.
(D) Nothing in this section shall be interpreted as requiring a manufacturer or terminal distributor to provide an investigational drug, product, or device to an eligible patient or the patient's treating physician.
Added by 131st General Assembly File No. TBD, HB 290, §1, eff. 4/6/2017.
(A) As used in this section, "responsible person" has the same meaning as in rules adopted by the state board of pharmacy under section 4729.26 of the Revised Code.
(B)
(1) An applicant for registration as a registered pharmacy technician shall:
(a) Be at least eighteen years of age;
(b) Possess a high school diploma or a certificate of high school equivalence or have been employed continuously since prior to April 8, 2009, as a pharmacy technician without a high school diploma or certificate of high school equivalence;
(c) Be of good moral character, as defined in rules adopted by the state board of pharmacy under section 4729.26 of the Revised Code;
(d) Except as provided in division (D) of this section, comply with sections 4776.01 to 4776.04 of the Revised Code;
(e) Except as provided in division (E)(1) of this section, obtain from a pharmacy's responsible person an attestation that the applicant has successfully completed education and training that meets the requirements established by the board in rules adopted under section 4729.94 of the Revised Code.
(2) An applicant for registration as a certified pharmacy technician shall:
(a) Comply with divisions (B)(1)(a), (c), and (d) of this section;
(b) Possess a high school diploma or a certificate of high school equivalence;
(c) Except as provided in division (E)(2) of this section, obtain from a pharmacy's responsible person an attestation that the applicant has successfully completed education and training that meets the requirements established by the board in rules adopted under section 4729.94 of the Revised Code;
(d) Have a current pharmacy technician certification from an organization that has been recognized by the board.
(C) A pharmacist or pharmacy intern whose license has been denied, revoked, suspended, or otherwise restricted by the board shall not be registered as a registered pharmacy technician or certified pharmacy technician.
(D) Until the date that is two years after the effective date of this section, an applicant for registration as a registered pharmacy technician or certified pharmacy technician who meets the requirements to be a qualified pharmacy technician under section 4729.42 of the Revised Code, as it existed immediately prior to the effective date of section 4729.95 of the Revised Code, may, instead of complying with division (B)(1) (d) of this section, authorize the superintendent of the bureau of criminal identification and investigation to make the results of a criminal records check of the applicant available to the state board of pharmacy. The criminal records check must have been conducted not earlier than twenty-four months before the date of the application for registration.
(E)
(1) Until the date that is two years after the effective date of this section, an applicant for registration as a registered pharmacy technician who meets the requirements to be a qualified pharmacy technician under section 4729.42 of the Revised Code, as it existed immediately prior to the effective date of section 4729.95 of the Revised Code, may, instead of complying with division (B)(1)(e) of this section, submit an attestation from a pharmacy's responsible person that the applicant has completed a pharmacy technician training program that is of appropriate breadth and depth to clearly address the competencies for a technician to safely and effectively work in that particular setting and includes instruction in all of the following:
(a) Packaging and labeling drugs;
(b) Pharmacy terminology;
(c) Basic drug information;
(d) Basic calculations;
(e) Quality control procedures;
(f) State and federal statutes, rules, and regulations regarding pharmacy technician duties, pharmacist duties, pharmacy intern duties, prescription or drug order processing procedures, non-sterile drug compounding, drug record-keeping requirements, patient confidentiality, security requirements, and storage requirements.
(2) Until the date that is two years after the effective date of this section, an applicant for registration as a certified pharmacy technician who meets the requirements to be a qualified pharmacy technician under section 4729.42 of the Revised Code, as it existed immediately prior to the effective date of section 4729.95 of the Revised Code, may, instead of complying with division (B)(2)(c) of this section, submit an attestation from a pharmacy's responsible person that the applicant has completed a pharmacy technician training program that is of appropriate breadth and depth to clearly address the competencies for a technician to safely and effectively work in that particular setting and includes instruction in all of the following:
(a) The topics listed in divisions (E)(1)(a) to (f) of this section;
(b) Sterile drug compounding;
(c) Preparing and mixing intravenous drugs to be injected into a human being.
Added by 131st General Assembly File No. TBD, SB 319, §1, eff. 4/6/2017.
An applicant for registration under section 4729.90 of the Revised Code shall file with the state board of pharmacy an application in the form and manner prescribed in rules adopted under section 4729.94 of the Revised Code. The application shall be accompanied by an application fee of fifty dollars, which shall not be returned if the applicant fails to qualify for registration.
If the board is satisfied that the applicant meets the requirements of section 4729.90 of the Revised Code and any additional requirements established by the board and determines that the results of a criminal records check do not make the applicant ineligible, the board shall register the applicant as a registered pharmacy technician or certified pharmacy technician, as applicable.
Registration under this section is valid for the period specified by the board in rules adopted under section 4729.94 of the Revised Code. The period shall not exceed twenty-four months unless the board extends the period in the rules to adjust license renewal schedules.
Added by 131st General Assembly File No. TBD, SB 319, §1, eff. 4/6/2017.
(A) A registered pharmacy technician or certified pharmacy technician shall file an application for registration renewal in the form and manner prescribed by the state board of pharmacy in rules adopted under section 4729.94 of the Revised Code. Registrations shall be renewed in accordance with the rules and the standard renewal procedure set forth in Chapter 4745. of the Revised Code. The renewal fee is twenty-five dollars per year.
(B)
(1) A registered pharmacy technician or certified pharmacy technician who fails to renew registration in accordance with division (A) of this section is prohibited from engaging in the activities authorized by section 4729.91 of the Revised Code.
(2)
(a) A registration that is not renewed by a date determined under division (A) of this section but has not lapsed for more than ninety days may be reinstated if the applicant does both of the following:
(i) Submits a renewal application in a form prescribed by the board in rules adopted under section 4729.94 of the Revised Code;
(ii) Pays the renewal fee and a late fee of fifty dollars.
(b) A registration that has lapsed for more than ninety days cannot be renewed, but the registration holder may reapply for registration.
Added by 131st General Assembly File No. TBD, SB 319, §1, eff. 4/6/2017.
(A) A registered pharmacy technician may, under the direct supervision of a pharmacist, engage in the following activities at a location licensed as a terminal distributor of dangerous drugs to the extent that the activities do not require the exercise of professional judgment:
(1) Accepting new written or electronic prescription orders from a prescriber or a prescriber's agent;
(2) Entering information into and retrieving information from a database or patient profile;
(3) Preparing and affixing labels;
(4) Stocking dangerous drugs and retrieving those drugs from inventory;
(5) Counting and pouring dangerous drugs into containers;
(6) Placing dangerous drugs into patient storage containers;
(7) Non-sterile drug compounding as authorized by the state board of pharmacy in rules adopted under section 4729.94 of the Revised Code;
(8) Other activities specified by the board in rules adopted under section 4729.94 of the Revised Code.
(B) A certified pharmacy technician may, under the direct supervision of a pharmacist, engage in the following activities at a location licensed as a terminal distributor of dangerous drugs to the extent that the activities do not require the exercise of professional judgment:
(1) Any activity listed in division (A) of this section;
(2) Accepting or requesting refill authorizations for dangerous drugs that are not controlled substances from a prescriber or the prescriber's agent, so long as there is no change from the original prescription;
(3) Sterile and non-sterile drug compounding as authorized by the board in rules adopted under section 4729.94 of the Revised Code;
(4) Other activities specified by the board in rules adopted under section 4729.94 of the Revised Code.
Added by 131st General Assembly File No. TBD, SB 319, §1, eff. 4/6/2017.
(A) An applicant for registration as a pharmacy technician trainee shall:
(1) Comply with divisions (B)(1)(a) to (c) of section 4729.90 of the Revised Code;
(2) Be enrolled in or plan to enroll in education and training that will allow the applicant to meet the requirements established by the state board of pharmacy in rules adopted under section 4729.94 of the Revised Code;
(3) Comply with sections 4776.01 to 4776.04 of the Revised Code.
(B) A pharmacist or pharmacy intern whose license has been denied, revoked, suspended, or otherwise restricted by the board shall not be registered as a pharmacy technician trainee.
Added by 131st General Assembly File No. TBD, SB 319, §1, eff. 4/6/2017.
An applicant for registration as a pharmacy technician trainee shall file with the state board of pharmacy an application in the form and manner prescribed in rules adopted under section 4729.94 of the Revised Code. The application shall by accompanied by an application fee of twenty-five dollars, which shall not be returned if the applicant fails to qualify for registration.
If the board is satisfied that an applicant meets the requirements of section 4729.92 of the Revised Code and any additional requirements established by the board and determines that the results of a criminal records check do not make the applicant ineligible, the board shall register the applicant as a pharmacy technician trainee.
Registration is valid for one year from the date of registration. Registration is not renewable, but an individual may reapply for registration if the individual's previous registration has lapsed for more than five years or the board grants its approval.
Added by 131st General Assembly File No. TBD, SB 319, §1, eff. 4/6/2017.
A pharmacy technician trainee may, under the direct supervision of a pharmacist, engage in the same activities as a registered pharmacy technician, as listed in division (A) of section 4729.91 of the Revised Code.
Added by 131st General Assembly File No. TBD, SB 319, §1, eff. 4/6/2017.
The state board of pharmacy shall adopt rules under section 4729.26 of the Revised Code governing registration of registered pharmacy technicians, certified pharmacy technicians, and pharmacy technician trainees. The rules shall include all of the following:
(A) Application and renewal forms and procedures;
(B) Reapplication forms and procedures for individuals whose registration has lapsed more than ninety days;
(C) Education and training requirements, requirements for employer-administered training programs, and other requirements considered appropriate by the board;
(D) Additional activities permitted by divisions (A)(7) and (B)(4) of section 4729.91 of the Revised Code;
(E) Requirements for sterile and non-sterile drug compounding ;
(F) Continuing education requirements;
(G) Conduct that constitutes dishonesty or unprofessional conduct by a registered pharmacy technician, certified pharmacy technician, or pharmacy technician trainee;
(H) Additional conduct for which the board may impose discipline under section 4729.96 of the Revised Code on a registered pharmacy technician, certified pharmacy technician, or pharmacy technician trainee;
(I) Any other rules the board considers appropriate to implement sections 4729.90 to 4729.96 of the Revised Code.
Added by 131st General Assembly File No. TBD, SB 319, §1, eff. 4/6/2017.
(A) No person who is not a pharmacist, pharmacy intern, registered pharmacy technician, certified pharmacy technician, or pharmacy technician trainee shall knowingly engage in any of the activities listed in section 4729.91 of the Revised Code in a location licensed as a terminal distributor of dangerous drugs or while performing the function of a terminal distributor, except that this division does not prevent a licensed health care professional from engaging in activities that are authorized by law as part of the licensed professional's practice.
(B) No pharmacist shall knowingly allow any person employed or otherwise under the control of the pharmacist to violate division (A) of this section.
(C) No terminal distributor of dangerous drugs shall knowingly allow any person employed or otherwise under the control of the person who owns, manages, or conducts the terminal distributor to violate division (A) of this section.
Added by 131st General Assembly File No. TBD, SB 319, §1, eff. 4/6/2018.
(A)
(1) The state board of pharmacy, after notice and hearing in accordance with Chapter 119. of the Revised Code, may impose one or more of the following sanctions on a pharmacy technician trainee, registered pharmacy technician, or certified pharmacy technician if the board finds the individual engaged in any of the conduct set forth in division (A)(2) of this section:
(a) Revoke, suspend, restrict, limit, or refuse to grant or renew a registration;
(b) Reprimand or place the holder of the registration on probation;
(c) Impose a monetary penalty or forfeiture not to exceed in severity any fine designated under the Revised Code for a similar offense, or in the case of a violation of a section of the Revised Code that does not bear a penalty, a monetary penalty or forfeiture of not more than five hundred dollars.
(2) The board may impose the sanctions listed in division (A)(1) of this section if the board finds a pharmacy technician trainee, registered pharmacy technician, or certified pharmacy technician:
(a) Has been convicted of a felony, or a crime of moral turpitude, as defined in section 4776.10 of the Revised Code;
(b) Engaged in dishonesty or unprofessional conduct, as prescribed in rules adopted by the board under section 4729.94 of the Revised Code;
(c) Is addicted to or abusing alcohol or drugs or impaired physically or mentally to such a degree as to render the individual unable to perform the individual's duties;
(d) Violated, conspired to violate, attempted to violate, or aided and abetted the violation of any of the provisions of this chapter, sections 3715.52 to 3715.72 of the Revised Code, Chapter 2925. or 3719. of the Revised Code, or any rule adopted by the board under those provisions;
(e) Committed fraud, misrepresentation, or deception in applying for or securing a registration issued by the board under this chapter;
(f) Failed to comply with an order of the board or a settlement agreement;
(g) Engaged in any other conduct for which the board may impose discipline as set forth in rules adopted by the board under section 4729.94 of the Revised Code.
(B) The board may suspend a registration under division (B) of section 3719.121 of the Revised Code by utilizing a telephone conference call to review the allegations and take a vote.
(C) For purposes of this division, an individual authorized to practice as a pharmacy technician trainee, registered pharmacy technician, or certified pharmacy technician accepts the privilege of practicing in this state subject to supervision by the board. By filing an application for or holding a registration under this chapter, the individual gives consent to submit to a mental or physical examination when ordered to do so by the board in writing and waives all objections to the admissibility of testimony or examination reports that constitute privileged communications.
If the board has reasonable cause to believe that an individual who is a pharmacy technician trainee, registered pharmacy technician, or certified pharmacy technician is physically or mentally impaired, the board may require the individual to submit to a physical or mental examination, or both. The expense of the examination is the responsibility of the individual required to be examined.
Failure of an individual who is a pharmacy technician trainee, registered pharmacy technician, or certified pharmacy technician to submit to a physical or mental examination ordered by the board, unless the failure is due to circumstances beyond the individual's control, constitutes an admission of the allegations and a suspension order shall be entered without the taking of testimony or presentation of evidence. Any subsequent adjudication hearing under Chapter 119. of the Revised Code concerning failure to submit to an examination is limited to consideration of whether the failure was beyond the individual's control.
If, based on the results of an examination ordered under this division, the board determines that the individual's ability to practice is impaired, the board shall suspend the individual's registration or deny the individual's application and shall require the individual, as a condition for an initial, continued, reinstated, or renewed registration to practice, to submit to a physical or mental examination and treatment.
An order of suspension issued under this division shall not be subject to suspension by a court during pendency of any appeal filed under section 119.12 of the Revised Code.
(D) If the board is required under Chapter 119. of the Revised Code to give notice of an opportunity for a hearing and the applicant or registrant does not make a timely request for a hearing in accordance with section 119.07 of the Revised Code, the board is not required to hold a hearing, but may adopt a final order that contains the board's findings. In the final order, the board may impose any of the sanctions listed in division (A) of this section.
(E) Notwithstanding the provision of division (C)(2) of section 2953.32 of the Revised Code specifying that if records pertaining to a criminal case are sealed under that section the proceedings in the case must be deemed not to have occurred, sealing of the following records on which the board has based an action under this section shall have no effect on the board's action or any sanction imposed by the board under this section: records of any conviction, guilty plea, judicial finding of guilt resulting from a plea of no contest, or a judicial finding of eligibility for a pretrial diversion program or intervention in lieu of conviction. The board shall not be required to seal, destroy, redact, or otherwise modify its records to reflect the court's sealing of conviction records.
(F) No pharmacy technician trainee, registered pharmacy technician, or certified pharmacy technician shall knowingly engage in any conduct described in divisions (A)(2)(b) or (A)(2) (d) to (g) of this section.
Added by 131st General Assembly File No. TBD, SB 319, §1, eff. 4/6/2017.
(A) Whoever violates division (H) of section 4729.16, division (G) of section 4729.38, section 4729.57, or division (F) of section 4729.96 of the Revised Code is guilty of a minor misdemeanor, unless a different penalty is otherwise specified in the Revised Code. Each day's violation constitutes a separate offense.
(B) Whoever violates section 4729.27, 4729.28, or 4729.36 of the Revised Code is guilty of a misdemeanor of the third degree. Each day's violation constitutes a separate offense. If the offender previously has been convicted of or pleaded guilty to a violation of this chapter, that person is guilty of a misdemeanor of the second degree.
(C) Whoever violates section 4729.32, 4729.33, or 4729.34 of the Revised Code is guilty of a misdemeanor.
(D) Whoever violates division (A), (B), (C), (D), (F), or (G) of section 4729.51 of the Revised Code is guilty of a misdemeanor of the first degree.
(E)
(1) Whoever violates section 4729.37, division (E)(1)(b) of section 4729.51, division (J) of section 4729.54, division (B) or (D) of section 4729.553, or section 4729.61 of the Revised Code is guilty of a felony of the fifth degree. If the offender previously has been convicted of or pleaded guilty to a violation of this chapter or a violation of Chapter 2925. or 3719. of the Revised Code, that person is guilty of a felony of the fourth degree.
(2) If an offender is convicted of or pleads guilty to a violation of section 4729.37, division (E) of section 4729.51, division (J) of section 4729.54, or section 4729.61 of the Revised Code, if the violation involves the sale, offer to sell, or possession of a scheduleIor II controlled substance, with the exception of marihuana, and if the court imposing sentence upon the offender finds that the offender as a result of the violation is a major drug offender, as defined in section 2929.01 of the Revised Code, and is guilty of a specification of the type described in division (A) of section 2941.1410 of the Revised Code, the court, in lieu of the prison term authorized or required by division (E)(1) of this section and sections 2929.13 and 2929.14 of the Revised Code and in addition to any other sanction imposed for the offense under sections 2929.11 to 2929.18 of the Revised Code, shall impose upon the offender, in accordance with division (B)(3) of section 2929.14 of the Revised Code, the mandatory prison term specified in that division.
(3) Notwithstanding any contrary provision of section 3719.21 of the Revised Code, the clerk of court shall pay any fine imposed for a violation of section 4729.37, division (E) of section 4729.51, division (J) of section 4729.54, or section 4729.61 of the Revised Code pursuant to division (A) of section 2929.18 of the Revised Code in accordance with and subject to the requirements of division (F) of section 2925.03 of the Revised Code. The agency that receives the fine shall use the fine as specified in division (F) of section 2925.03 of the Revised Code.
(F) Whoever violates section 4729.531 of the Revised Code or any rule adopted thereunder or section 4729.532 of the Revised Code is guilty of a misdemeanor of the first degree.
(G) Whoever violates division (E)(1)(a) of section 4729.51 of the Revised Code is guilty of a felony of the fourth degree. If the offender has previously been convicted of or pleaded guilty to a violation of this chapter, or of a violation of Chapter 2925. or 3719. of the Revised Code, that person is guilty of a felony of the third degree.
(H) Whoever violates division (E)(1)(c) of section 4729.51 of the Revised Code is guilty of a misdemeanor of the first degree. If the offender has previously been convicted of or pleaded guilty to a violation of this chapter, or of a violation of Chapter 2925. or 3719. of the Revised Code, that person is guilty of a felony of the fifth degree.
(I)
(1) Whoever violates division (A) of section 4729.95 of the Revised Code is guilty of unauthorized pharmacy-related drug conduct. Except as otherwise provided in this section, unauthorized pharmacy-related drug conduct is a misdemeanor of the second degree. If the offender previously has been convicted of or pleaded guilty to a violation of division (A), (B), or (C) of that section, unauthorized pharmacy-related drug conduct is a misdemeanor of the first degree on a second offense and a felony of the fifth degree on a third or subsequent offense.
(2) Whoever violates division (B) or (C) of section 4729.95 of the Revised Code is guilty of permitting unauthorized pharmacy-related drug conduct. Except as otherwise provided in this section, permitting unauthorized pharmacy-related drug conduct is a misdemeanor of the second degree. If the offender previously has been convicted of or pleaded guilty to a violation of division (A), (B), or (C) of that section, permitting unauthorized pharmacy-related drug conduct is a misdemeanor of the first degree on a second offense and a felony of the fifth degree on a third or subsequent offense.
(3) Notwithstanding any contrary provision of section 3719.21 of the Revised Code or any other provision of law that governs the distribution of fines, the clerk of the court shall pay any fine imposed pursuant to division (I)(1) or (2) of this section to the state board of pharmacy if the board has adopted a written internal control policy under division (F)(2) of section 2925.03 of the Revised Code that addresses fine moneys that it receives under Chapter 2925. of the Revised Code and if the policy also addresses fine moneys paid under this division. The state board of pharmacy shall use the fines so paid in accordance with the written internal control policy to subsidize the board's law enforcement efforts that pertain to drug offenses.
(J)
(1) Whoever violates division (A)(1) of section 4729.86 of the Revised Code is guilty of a misdemeanor of the third degree. If the offender has previously been convicted of or pleaded guilty to a violation of division (A)(1), (2), or (3) of section 4729.86 of the Revised Code, that person is guilty of a misdemeanor of the first degree.
(2) Whoever violates division (A)(2) of section 4729.86 of the Revised Code is guilty of a misdemeanor of the first degree. If the offender has previously been convicted of or pleaded guilty to a violation of division (A)(1), (2), or (3) of section 4729.86 of the Revised Code, that person is guilty of a felony of the fifth degree.
(3) Whoever violates division (A)(3) of section 4729.86 of the Revised Code is guilty of a felony of the fifth degree. If the offender has previously been convicted of or pleaded guilty to a violation of division (A)(1), (2), or (3) of section 4729.86 of the Revised Code, that person is guilty of a felony of the fourth degree.
(K) A person who violates division (C) of section 4729.552 of the Revised Code is guilty of a misdemeanor of the first degree. If the person previously has been convicted of or pleaded guilty to a violation of division (C) of section 4729.552 of the Revised Code, that person is guilty of a felony of the fifth degree.
Amended by 132nd General Assembly File No. TBD, SB 1, §1, eff. 10/31/2018.
Amended by 131st General Assembly File No. TBD, SB 319, §1, eff. 4/6/2017.
Amended by 131st General Assembly File No. TBD, HB 505, §1, eff. 3/20/2017.
Amended by 129th General AssemblyFile No.29, HB 86, §1, eff. 9/30/2011.
Amended by 129th General AssemblyFile No.19, HB 93, §1, eff. 5/20/2011.
Amended by 128th General AssemblyFile No.9, HB 1, §101.01, eff. 10/16/2009.
Amended by 128th General Assemblych.9, HB 2, §101.01, eff. 4/1/2009.
Effective Date: 03-23-2000; 2008 SB203 04-08-2009