Ohio § 4729.01

§ 4729.01.

As used in this chapter: (A) “ Pharmacy ,” except when used in a context that refers to the practice of pharmacy, means any

area, room, rooms, place of business, department, or portion of any of the foregoing

where the practice of pharmacy is conducted. (B) “ Practice of pharmacy ” means providing pharmacist care requiring specialized knowledge, judgment, and skill

derived from the principles of biological, chemical, behavioral, social, pharmaceutical,

and clinical sciences.  As used in this division, “ pharmacist care ” includes the following: (1) Interpreting prescriptions; (2) Dispensing drugs and drug therapy related devices; (3) Compounding drugs; (4) Counseling individuals with regard to their drug therapy, recommending drug therapy

related devices, and assisting in the selection of drugs and appliances for treatment

of common diseases and injuries and providing instruction in the proper use of the

drugs and appliances; (5) Performing drug regimen reviews with individuals by discussing all of the drugs that

the individual is taking and explaining the interactions of the drugs; (6) Performing drug utilization reviews with licensed health professionals authorized

to prescribe drugs when the pharmacist determines that an individual with a prescription

has a drug regimen that warrants additional discussion with the prescriber; (7) Advising an individual and the health care professionals treating an individual with

regard to the individual's drug therapy; (8) Acting pursuant to a consult agreement, if an agreement has been established; (9) Engaging in the administration of immunizations to the extent authorized by section 4729.41 of the Revised Code ; (10) Engaging in the administration of drugs to the extent authorized by section 4729.45 of the Revised Code . (C) “ Compounding ” means the preparation, mixing, assembling, packaging, and labeling of one or more

drugs in any of the following circumstances: (1) Pursuant to a prescription issued by a licensed health professional authorized to

prescribe drugs; (2) Pursuant to the modification of a prescription made in accordance with a consult

agreement; (3) As an incident to research, teaching activities, or chemical analysis; (4) In anticipation of orders for drugs pursuant to prescriptions, based on routine,

regularly observed dispensing patterns; (5) Pursuant to a request made by a licensed health professional authorized to prescribe

drugs for a drug that is to be used by the professional for the purpose of direct

administration to patients in the course of the professional's practice, if all of

the following apply: (a) At the time the request is made, the drug is not commercially available regardless

of the reason that the drug is not available, including the absence of a manufacturer

for the drug or the lack of a readily available supply of the drug from a manufacturer. (b) A limited quantity of the drug is compounded and provided to the professional. (c) The drug is compounded and provided to the professional as an occasional exception

to the normal practice of dispensing drugs pursuant to patient-specific prescriptions. (D) “ Consult agreement ” means an agreement that has been entered into under section 4729.39 of the Revised Code . (E) “ Drug ” means: (1) Any article recognized in the United States pharmacopoeia and national formulary,

or any supplement to them, intended for use in the diagnosis, cure, mitigation, treatment,

or prevention of disease in humans or animals; (2) Any other article intended for use in the diagnosis, cure, mitigation, treatment,

or prevention of disease in humans or animals; (3) Any article, other than food, intended to affect the structure or any function of

the body of humans or animals; (4) Any article intended for use as a component of any article specified in division

(E)(1), (2), or (3) of this section;  but does not include devices or their components,

parts, or accessories. “Drug” does not include “hemp” as that term is defined in section 928.01 of the Revised Code . (F) “ Dangerous drug ” means any of the following: (1) Any drug to which either of the following applies: (a) Under the “Federal Food, Drug, and Cosmetic Act,” 52 Stat. 1040 (1938), 21 U.S.C.A. 301 , as amended, the drug is required to bear a label containing the legend “Caution:

 Federal law prohibits dispensing without prescription” or “Caution:  Federal law

restricts this drug to use by or on the order of a licensed veterinarian” or any similar

restrictive statement, or the drug may be dispensed only upon a prescription; (b) Under Chapter 3715. or 3719. of the Revised Code, the drug may be dispensed only

upon a prescription. (2) Any drug that contains a schedule V controlled substance and that is exempt from

Chapter 3719. of the Revised Code or to which that chapter does not apply; (3) Any drug intended for administration by injection into the human body other than

through a natural orifice of the human body; (4) Any drug that is a biological product, as defined in section 3715.01 of the Revised Code . (G) “Federal drug abuse control laws” has the same meaning as in section 3719.01 of the Revised Code . (H) “ Prescription ” means all of the following: (1) A written, electronic, or oral order for drugs or combinations or mixtures of drugs

to be used by a particular individual or for treating a particular animal, issued

by a licensed health professional authorized to prescribe drugs; (2) For purposes of sections 4723.4810 , 4729.282 , 4730.432 , and 4731.93 of the Revised Code , a written, electronic, or oral order for a drug to treat chlamydia, gonorrhea, or

trichomoniasis issued to and in the name of a patient who is not the intended user

of the drug but is the sexual partner of the intended user; (3) For purposes of sections 3313.7110 , 3313.7111 , 3314.143 , 3326.28 , 3328.29 , 4723.483 , 4729.88 , 4730.433 , 4731.96 , and 5180.26 of the Revised Code , a written, electronic, or oral order for an epinephrine autoinjector issued to and

in the name of a school, school district, or camp; (4) For purposes of Chapter 3728. and sections 4723.483 , 4729.88 , 4730.433 , and 4731.96 of the Revised Code , a written, electronic, or oral order for an epinephrine autoinjector issued to and

in the name of a qualified entity, as defined in section 3728.01 of the Revised Code ; (5) For purposes of sections 3313.7115 , 3313.7116 , 3314.147 , 3326.60 , 3328.38 , 4723.4811 , 4730.437 , 4731.92 , and 5180.262 of the Revised Code , a written, electronic, or oral order for injectable or nasally administered glucagon

in the name of a school, school district, or camp. (I) “ Licensed health professional authorized to prescribe drugs ” or “ prescriber ” means an individual who is authorized by law to prescribe drugs or dangerous drugs

or drug therapy related devices in the course of the individual's professional practice,

including only the following: (1) A dentist licensed under Chapter 4715. of the Revised Code; (2) A clinical nurse specialist, certified nurse-midwife, or certified nurse practitioner

who holds a current, valid license issued under Chapter 4723. of the Revised Code

to practice nursing as an advanced practice registered nurse; (3) A certified registered nurse anesthetist who holds a current, valid license issued

under Chapter 4723. of the Revised Code to practice nursing as an advanced practice

registered nurse, but only to the extent of the nurse's authority under section 4723.43 of the Revised Code ; (4) An optometrist licensed under Chapter 4725. of the Revised Code to practice optometry; (5) A physician authorized under Chapter 4731. of the Revised Code to practice medicine

and surgery, osteopathic medicine and surgery, or podiatric medicine and surgery; (6) A physician assistant who holds a license to practice as a physician assistant issued

under Chapter 4730. of the Revised Code, holds a valid prescriber number issued by

the state medical board, and has been granted physician-delegated prescriptive authority; (7) A veterinarian licensed under Chapter 4741. of the Revised Code; (8) A certified mental health assistant licensed under Chapter 4772. of the Revised Code

who has been granted physician-delegated prescriptive authority by the physician supervising

the certified mental health assistant. (J) “ Sale ” or “ sell ” includes any transaction made by any person, whether as principal proprietor, agent,

or employee, to do or offer to do any of the following:  deliver, distribute, broker,

exchange, gift or otherwise give away, or transfer, whether the transfer is by passage

of title, physical movement, or both. (K) “ Wholesale sale ” and “ sale at wholesale ” mean any sale in which the purpose of the purchaser is to resell the article purchased

or received by the purchaser. (L) “ Retail sale ” and “ sale at retail ” mean any sale other than a wholesale sale or sale at wholesale. (M) “ Retail seller ” means any person that sells any dangerous drug to consumers without assuming control

over and responsibility for its administration.  Mere advice or instructions regarding administration do not constitute control or

establish responsibility. (N) “ Price information ” means the price charged for a prescription for a particular drug product and, in

an easily understandable manner, all of the following: (1) The proprietary name of the drug product; (2) The established (generic) name of the drug product; (3) The strength of the drug product if the product contains a single active ingredient

or if the drug product contains more than one active ingredient and a relevant strength

can be associated with the product without indicating each active ingredient.  The established name and quantity of each active ingredient are required if such

a relevant strength cannot be so associated with a drug product containing more than

one ingredient. (4) The dosage form; (5) The price charged for a specific quantity of the drug product.  The stated price shall include all charges to the consumer, including, but not limited

to, the cost of the drug product, professional fees, handling fees, if any, and a

statement identifying professional services routinely furnished by the pharmacy.  Any mailing fees and delivery fees may be stated separately without repetition.  The information shall not be false or misleading. (O) “ Wholesale distributor of dangerous drugs ” or “ wholesale distributor ” means a person engaged in the sale of dangerous drugs at wholesale and includes

any agent or employee of such a person authorized by the person to engage in the sale

of dangerous drugs at wholesale. (P) “ Manufacturer of dangerous drugs ” or “ manufacturer ” means a person, other than a pharmacist or prescriber, who manufactures dangerous

drugs and who is engaged in the sale of those dangerous drugs. (Q) “ Terminal distributor of dangerous drugs ” or “ terminal distributor ” means a person who is engaged in the sale of dangerous drugs at retail, or any person,

other than a manufacturer, repackager, outsourcing facility, third-party logistics

provider, wholesale distributor, or pharmacist, who has possession, custody, or control

of dangerous drugs for any purpose other than for that person's own use and consumption.  “ Terminal distributor ” includes pharmacies, hospitals, nursing homes, and laboratories and all other persons

who procure dangerous drugs for sale or other distribution by or under the supervision

of a pharmacist, licensed health professional authorized to prescribe drugs, or other

person authorized by the state board of pharmacy. (R) “ Promote to the public ” means disseminating a representation to the public in any manner or by any means,

other than by labeling, for the purpose of inducing, or that is likely to induce,

directly or indirectly, the purchase of a dangerous drug at retail. (S) “ Person ” includes any individual, partnership, association, limited liability company, or

corporation, the state, any political subdivision of the state, and any district,

department, or agency of the state or its political subdivisions. (T)(1) “ Animal shelter ” means a facility operated by a humane society or any society organized under Chapter

1717. of the Revised Code or a dog pound operated pursuant to Chapter 955. of the

Revised Code. (2) “ County dog warden ” means a dog warden or deputy dog warden appointed or employed under section 955.12 of the Revised Code . (3) “ Wild animal rehabilitation facility ” means a facility that holds a permit issued by the chief of the division of wildlife

for rehabilitation purposes in accordance with section 1533.08 of the Revised Code or rules adopted by the chief. (U) “Food” has the same meaning as in section 3715.01 of the Revised Code . (V) “Pain management clinic” has the same meaning as in section 4731.054 of the Revised Code . (W) “ Investigational drug or product ” means a drug or product that has successfully completed phase one of the United

States food and drug administration clinical trials and remains under clinical trial,

but has not been approved for general use by the United States food and drug administration.  “Investigational drug or product” does not include controlled substances in schedule

I, as defined in section 3719.01 of the Revised Code . (X) “ Product ,” when used in reference to an investigational drug or product, means a biological

product, other than a drug, that is made from a natural human, animal, or microorganism

source and is intended to treat a disease or medical condition. (Y) “ Third-party logistics provider ” means a person that provides or coordinates warehousing or other logistics services

pertaining to dangerous drugs including distribution, on behalf of a manufacturer,

wholesale distributor, or terminal distributor of dangerous drugs, but does not take

ownership of the drugs or have responsibility to direct the sale or disposition of

the drugs. (Z) “ Repackager of dangerous drugs ” or “ repackager ” means a person that repacks and relabels dangerous drugs for sale or distribution. (AA) “ Outsourcing facility ” means a facility that is engaged in the compounding and sale of sterile drugs and

is registered as an outsourcing facility with the United States food and drug administration. (BB) “ Laboratory ” means a laboratory licensed under this chapter as a terminal distributor of dangerous

drugs and entrusted to have custody of any of the following drugs and to use the drugs

for scientific and clinical purposes and for purposes of instruction:  dangerous drugs

that are not controlled substances, as defined in section 3719.01 of the Revised Code ;  dangerous drugs that are controlled substances, as defined in that section;  and

controlled substances in schedule I, as defined in that section. (CC) “ Overdose reversal drug ” means both of the following: (1) Naloxone; (2) Any other drug that the state board of pharmacy, through rules adopted in accordance

with Chapter 119. of the Revised Code, designates as a drug that is approved by the

federal food and drug administration for the reversal of a known or suspected opioid-related

overdose.