Section 3715.01

(A) As used in this chapter:

(1) "Public health council" means the public health council established by section 3701.33 of the Revised Code.

(2) "Person" means an individual, partnership, corporation, or association.

(3) "Food" means:

(a) Articles used for food or drink for humans or animals;

(b) Chewing gum;

(c) Articles used for components of any such articles.

(4) "Drug" means:

(a) Articles recognized in the United States pharmacopoeia and national formulary, or any supplement to them;

(b) Articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or animals;

(c) Articles, other than food, intended to affect the structure or any function of the body of humans or other animals;

(d) Articles intended for use as a component of any of the foregoing articles, other than devices or their components, parts, or accessories.

(5) "Device," except when used in division (B)(1) of this section and in division (A)(10) of section 3715.52, division (F) of section 3715.60, division (A)(5) of section 3715.64, and division (C) of section 3715.67 of the Revised Code, means any instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, that is any of the following:

(a) Recognized in the united states pharmacopoeia and national formulary, or any supplement to them;

(B) Intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease in humans or animals;

(C) Intended to affect the structure or any function of the body of humans or animals, and that does not achieve any of its principal intended purposes through chemical action within or on the body of humans or animals and is not dependent upon being metabolized for the achievement of any of its principal intended purposes.

(6) "Cosmetic" means:

(A) Articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the

appearance;

(B) Articles intended for use as a component of any such article, except that "cosmetic" does not include soap.

(7) "Label" means a display of written, printed, or graphic matter upon the immediate container, exclusive of package liners, of any article.

Any word, statement, or other information required by this chapter to appear on the label must appear

on the outside container or wrapper, if any, of the retail package of the article, or the label must be easily legible through the outside container

or wrapper.

(8) "Labeling" means all labels and other written, printed, or graphic matter:

(a) Upon an article or any of its containers or wrappers;

(b) Accompanying such article.

(9) "Advertisement" means all representations disseminated in any manner or by any means, other than by labeling, for the purpose of inducing, or that are likely to induce, directly or indirectly, the purchase of food, drugs, devices, or cosmetics.

(10) "New drug" means:

(a) Any drug the composition of which is such that the drug is not generally recognized among experts qualified by scientific training and experience to evaluate the safety of drugs, as safe for use under the conditions prescribed, recommended, or suggested in the labeling thereof;

(b) Any drug the composition of which is such that the drug, as a result of investigation to determine its safety for use under such conditions, has become so recognized, but that has not, other than in an investigation, been used to a material extent or for a material time under such conditions.

(11) "Contaminated with filth" applies to any food, drug, device, or cosmetic that has not been protected as far as may be necessary by all reasonable means from dust, dirt, and all foreign or injurious substances.

(12) "Honey" means the nectar and saccharine exudation of plants that has been gathered, modified, and stored in a honeycomb by honeybees.

(13) "Finished dosage form" means the form of a drug that is, or is intended to be, dispensed or administered to humans or animals and requires no further manufacturing or processing other than packaging, reconstituting, or labeling.

(14)(a) "Manufacture" means the planting, cultivating, harvesting, processing, making, preparing, or otherwise engaging in any part of the production of a drug by propagating, compounding, converting, or processing, either directly or indirectly by extracting from substances of natural origin, or

independently by means of chemical synthesis, or by a combination of extraction and chemical synthesis, and includes the following:

(i) Any packaging or repackaging of the drug or labeling or relabeling of its container, the promotion and marketing of the drug, and other activities incident to production

(ii) The preparation and promotion of commercially available products from bulk compounds for resale by

pharmacies, licensed health professionals authorized to prescribe drugs, or other persons.

(B) "Manufacture" does not include the preparation, compounding, packaging, or labeling of a drug by a pharmacist as an incident to either of the following:

(i) Dispensing a drug in the usual course of professional practice;

(ii) Providing a licensed health professional authorized to prescribe drugs with a drug for the purpose of

administering to patients or for using the drug in treating patients in the professional's office.

(15) "Dangerous drug" has the same meaning as in section 4729.01 of the revised code.

(16) "Generically equivalent drug" means a drug that contains identical amounts of the identical active ingredients, but not necessarily containing the same inactive ingredients, that meets the applicable standard of identity, strength, quality, and purity,

including potency, and where applicable, content uniformity, disintegration times, or dissolution rates, as the prescribed brand name drug and the manufacturer or distributor holds, if applicable, either an approved new drug application or an approved abbreviated new drug application unless other approval by law or from the federal food and drug administration is required.

No drug shall be considered a generically equivalent drug for the purposes of this chapter if it has been

listed by the federal food and drug administration as having proven bioequivalence problems.

(17) "Licensed health professional authorized to prescribe drugs" and "prescriber" have the same meanings as in section 4729.01 .

(B) For the purposes of sections 3715.52 to 3715.72 of the revised code:

(1) If an article is alleged to be misbranded because the labeling is misleading, or if an advertisement is alleged to be false because it is misleading, then in determining whether the labeling or advertisement is misleading, there shall be taken into account, among other things, not only representations made or suggested by statement, word, design, device, sound, or in any combination thereof, but also the extent to which the labeling or advertisement fails to reveal facts material in the light of such representations or material with respect to consequence which may result from the use of the article to which the labeling or advertisement relates under the conditions of use prescribed in the labeling or advertisement thereof or under such conditions of use as are customary or usual.

(2) The provisions regarding the selling of food, drugs, devices, or cosmetics include the manufacture, production, processing, packing, exposure, offer, possession, and holding of any such article for sale; and the sale, dispensing, and giving of any such article, and the supplying or applying of any such articles in the conduct of any food, drug, or cosmetic establishmentthe provisions do not prohibit a licensed health professional authorized to prescribe drugs from administering or personally furnishing a drug or device to a patient.

(3) The representation of a drug, in its labeling or advertisement, as an antiseptic is a representation that it is a germicide, except in the case of a drug purporting to be, or represented as, an antiseptic for inhibitory use as a wet dressing, ointment, dusting powder, or other use that involves prolonged contact with the body.

(4) Whenever jurisdiction is vested in the director of agriculture or the state board of pharmacy, the jurisdiction of the board shall be limited to the sale, offering for sale, giving away, delivery, or dispensing in any manner of drugs at the wholesale and retail levels or to the consumer and shall

be exclusive in the case of such sale, offering for sale, giving away, delivery, or dispensing in any manner of drugs at the wholesale and retail levels or to the consumer in any place where prescriptions are dispensed or compounded.

(5) To assist in effectuating the provisions of those sections, the director of agriculture or state board of pharmacy may request assistance or data from any government or private agency or individual.

Section 3715.52

(A) The following acts and causing them are prohibited:

(1) The manufacture, sale, or delivery, holding or offering for sale of any food, drug, device, or cosmetic that is adulterated or misbranded;

(2) The adulteration or misbranding of any food, drug, device, or cosmetic;

(3) The receipt in commerce of any food, drug, device, or cosmetic that is adulterated or misbranded, and the delivery or proffered delivery thereof for pay or otherwise;

(4) The sale, delivery for sale, holding for sale, or offering for sale of any article in violation of section 3715.61 or 3715.65 of the Revised Code;

(5) The dissemination of any false advertisement;

(6) The refusal to permit entry or inspection, or to permit the taking of a sample, as authorized by section 3715.70 of the Revised Code;

(7) The giving of a guaranty or undertaking that is false, except by a person who relied on a guaranty or undertaking to the same effect signed by, and containing the name and address of the person residing in this state from whom the person received in good faith the food, drug, device, or cosmetic;

(8) The removal or disposal of a detained or embargoed article in violation of section 3715.55 of the Revised Code;

(9) The alteration, mutilation, destruction, obliteration, or removal of the whole or any part of the labeling of, or the doing of any other act with respect to a food, drug, device, or cosmetic, if the act is done while the article is held for sale and results in the article being misbranded;

(10) Forging, counterfeiting, simulating, or falsely representing, or without proper authority using any mark, stamp, tag, label, or other identification device authorized or required by rules adopted pursuant to sections 3715.52 to 3715.72 of the revised code;

(11) The using, on the labeling of any drug or in any advertisement relating to a drug, of any representation or suggestion that any application with respect to the drug is effective under section 3715.65 of the revised code or that the drug complies with the provisions of that

section;

(12) The using by any person to the person's own advantage, or revealing, other than to the director of agriculture or to the courts when relevant in any judicial proceeding under sections 3715.52 to 3715.72 of the Revised Code, any information acquired under authority of sections 3715.01 and 3715.52 to

3715.72 of the Revised Code, concerning any information that as a trade secret is entitled to protection;

(13) The issuance by the manufacturer, packer, or distributor of a dangerous drug of any advertisements, catalogues, or price lists, except those lists specifically designed for disseminating price change information, that do not contain in clearly legible form the name and place of business of the manufacturer who mixed the final ingredients and if different, the manufacturer who produced the drug in its finished dosage form and, if different, the packer or distributor.

(B)(1) No person at a flea market shall sell, offer for sale, or knowingly permit the sale of any of the following products:

(a) Baby food, infant formula, or similar products;

(b) Any drug, cosmetic, or device;

(c) Any product on which is printed or stamped an expiration date or a date recommended by the manufacturer as either the last day on which the product should be offered for sale or the last day on which the product should be used.

(2) Division (B)(1) of this section does not apply to a person who keeps available for public inspection an identification card identifying the person as an authorized representative of the manufacturer or distributor of any drug, cosmetic, or device, as long as the card is not false, fraudulent, or fraudulently obtained.

(3) Division (B)(1)(c) of this section does not apply to a person or governmental entity that is licensed as a food service operation under Chapter 3732. Of the Revised Code or is listed in division (A)(9) or (12) of section 3732.01 of the Revised Code.

(4) As used in division (B)(1) of this section, "flea market" means any location, other than a permanent retail store, at which space is rented or otherwise made available to others for the conduct of business as transient or limited vendors as defined in section 5739.17 of the Revised Code.

Section 3715.63

A drug or device is adulterated within the meaning of sections 3715.01 and 3715.52 to 3715.72 of the revised code, if any of the following apply:

(A) It consists, in whole or in part, of any filthy, putrid, or decomposed substance.

(B) It has been produced, processed, prepared, packed, or held under unsanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.

(C) It is a drug and its container is composed, in whole or in part, of any poisonous or deleterious substance that may render the contents injurious to health.

(D) It is a drug and it bears or contains, for purposes of coloring only, a coal-tar color other than one from a batch certified under authority of the "Federal Food, DRUG, and Cosmetic Act," 52 STAT. 1040 (1938), 21 301, as amended.

(E) It purports to be or is represented as a drug the name of which is recognized in the United States Pharmacopoeia and National Formulary, or any supplement to them, and its strength differs from or its quality or purity falls below the standard set forth in those compendiums. A determination as to strength, quality, or purity shall be made in accordance with the tests or methods of assay set forth in the compendiums, or in the absence or inadequacy of such tests or methods of assay, those prescribed under the authority of the "FEDERAL FOOD, DRUG, AND COSMETIC ACT." A drug recognized in the compendiums is not adulterated under this division because it differs from the standard of strength, quality, or purity set forth for that drug in the compendiums, if the difference in strength, quality, or purity is plainly stated on its label. whenever a drug is recognized in both the homoeopathic pharmacopoeia of the United States and in the United States Pharmacopoeia and National Formulary, including their supplements, it shall be subject to the requirements of the united states pharmacopoeia and national formulary unless it is labeled and offered for sale as a homoeopathic drug, in which case it shall be subject to the provisions of the homoeopathic pharmacopoeia of the United States and not to those of

the United States pharmacopoeia and national formulary.

(F) It is not subject to the provisions of division (E) of this section, and its strength differs from or its purity or quality falls below that which it purports or is represented to possess.

(G) It is a drug and any substance has been:

(1) Mixed or packed with the drug so as to reduce the drug's quality or strength;

(2) Substituted wholly or in part for the drug.

Section 3715.64

(A) A drug or device is misbranded within the meaning of sections 3715.01 and 3715.52 to 3715.72 of the Revised Code, if:

(1) Its labeling is false or misleading in any particular.

(2) It is in package form and does not bear a label containing both of the following:

(A) In clearly legible form, the name and place of business of the manufacturer, packer, or distributor;

(B) An accurate statement of the quantity of the contents in terms of weight, measure, or numerical count; but reasonable variations shall be permitted, and exemptions as to small packages shall apply as established by rules adopted by the director of agriculture or state board of pharmacy.

(3) It is a dangerous drug and does not bear a label containing in clearly legible form the name and place of business of the manufacturer of the finished dosage form and, if different, the packer or distributor.

(4) It is a dangerous drug in finished solid oral dosage form and it does not have clearly and prominently marked or imprinted on it an individual symbol, company name, national drug code number or other number, words, letters, or any combination thereof, identifying the drug and its manufacturer or distributor. this requirement does not apply to drugs that are compounded by a licensed pharmacist. the manufacturer or distributor of each such drug shall make available to the state board of pharmacy descriptive material identifying the mark or imprint used by the manufacturer or distributor. The board shall provide this information to all poison control centers in this state. Upon application by a manufacturer or distributor, the board may exempt a drug from the requirements of this division on the grounds that marking or imprinting the drug is not feasible because of its size, texture, or other unique characteristic.

(5) Any word, statement, or other information that is required by or under authority of sections 3715.01 and 3715.52 to 3715.72 of the revised cod to appear on the label or labeling is not prominently placed on the label or labeling in a conspicuous manner, as compared with other words, statements, designs, or devices on the label or labeling, and in terms that render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.

(6) It is a drug and it is not designated solely by a name recognized in the united states pharmacopoeia and national formulary, or any supplement to them, unless its label bears:

(a) The common or usual name of the drug, if any;

(b) In case it is fabricated from two or more ingredients, the common or usual name of each active ingredient the drug contains, including the kind and quantity or proportion of any alcohol, and also including whether active or not, the name and quantity or proportion of any bromides, ether, chloroform, acetanalid, acetophenetidin, aminopyrine, atropine, hyoscine, hyoscyamine, arsenic, digitalis, digitalis glycosides, mercury, ouabain, strophanthin, strychnine, thyroid, or any derivative or preparation of any such substances, but to the extent that compliance with these requirements is impracticable, exemptions shall apply as established by rules adopted by the director of agriculture or state board of pharmacy.

(7) Its labeling does not bear the following:

(A) Adequate directions for use of the drug or device, except that when compliance with this requirement is not necessary for a particular drug or device to protect the public health, the director shall adopt rules exempting the drug or device from the requirement;

(B) Adequate warnings against use in those pathological conditions or by children when its use may be dangerous to health, or against unsafe dosage or methods or duration of administration or application, presented in a manner and for as necessary for the protection of users

(8) It purports to be a drug the name of which is recognized in the United States pharmacopoeia and national formulary, or any supplement to them, and it is not packaged and labeled as prescribed in those compendiums, except that the method of packing may be modified with the consent of the director of agriculture. whenever a drug is recognized in both the homoeopathic pharmacopoeia of the United States and in the United States pharmacopoeia and national formulary, including their supplements, it shall be subject to the requirements of the United States pharmacopoeia and national formulary with respect to packaging and labeling unless it is labeled and offered for sale as a homoeopathic drug, in which case it shall be subject to the provisions of the homoeopathic pharmacopoeia of the United States and not to those of the United States pharmacopoeia and national formulary.

(9) It has been found by the director of agriculture to be a drug liable to deterioration, unless it is packaged in the form and manner, and its label bears a statement of precautions, as required by rules adopted by the director as necessary for the protection of public health. no rule shall be established for any drug recognized the United States pharmacopoeia and national formulary, or any supplements to them, until the director has informed the appropriate bodies charged with the revision of those compendiums of the need for packaging or labeling requirements and those bodies have failed within a reasonable time to prescribe such requirements.

(10)(a) It is a drug and its container is so made, formed, or filled as to be misleading.

(b) It is an imitation of another drug.

(c) It is offered for sale under the name of another drug.

(d) The drug sold or dispensed is not the brand or drug specifically prescribed or ordered or, when dispensed by a pharmacist upon prescription, is neither the

brand or drug prescribed nor a generically equivalent drug.

(11) It is dangerous to health when used in the dosage, or with the frequency or duration prescribed, recommended, or suggested in its labeling .

(12) It is a drug intended for human use to which the following apply:

(a) Because of its toxicity or other potentiality for harmful effect, the method of its use, or the collateral measures necessary to its use, the drug is not safe for use except under the supervision of a licensed health professional authorized to prescribe drugs;

(b) The drug is limited by an effective application under section 505 of the "Federal Food, Drug, and Cosmetic Act," 52 STAT. 1040 (1938), 21 301, as amended, to use under professional supervision by a licensed health professional authorized to prescribe drugs, unless it is dispensed only:

(i) Upon a written or electronic prescription ;

(ii) Upon an oral prescription, which is reduced promptly to writing by the pharmacist;

(iii) By refilling A prescription if refilling is authorized by the prescriber either in the original prescription or by oral order, which is promptly reduced to writing by the pharmacist.

(B) Any drug dispensed pursuant to a written, electronic, or oral prescription of a licensed health professional authorized to prescribe drugs shall be exempt from the requirements of division (a) of this section, except divisions (a)(1) and (10) of this section, if the drug bears a label containing the name and address of the dispenser, the serial number and the date the prescription is dispensed, the name of the prescriber, the name of the patient, and, if stated in the prescription, the directions for use and cautionary statements unless the prescription directions prohibit labeling, the label shall include the brand name of the drug dispensed. if the drug dispensed has no brand name, the generic name and the distributor of the finished dosage form shall be included.

Section 3719.01 Definitions

As used in this chapter:

(A) "Administer" means the direct application of a drug, whether by injection, inhalation, ingestion, or any other means to a person or an animal.

(B) "Drug enforcement administration" means the drug enforcement administration of the United States department of justice or its successor agency.

(C) "Controlled substance" means a drug, compound, mixture, preparation, or substance included in schedule I, II, III, IV, or V.

(D) "Dangerous drug" has the same meaning as in section 4729.01 of the Revised Code.

(E) "Dispense" means to sell, leave with, give away, dispose of, or deliver.

(F) "Distribute" means to deal in, ship, transport, or deliver but does not include administering or dispensing a drug.

(G) "Drug" has the same meaning as in section 4729.01 of the Revised Code.

(H) "Drug abuse offense," "felony drug abuse offense," "cocaine," and "hashish" have the same meanings as in section 2925.01 of the Revised Code.

(I) "Federal drug abuse control laws" means the "Comprehensive Drug Abuse Prevention and Control Act of 1970," 84 Stat. 1242, 21 U.S.C. 801, as amended.

(J) "Hospital" means an institution for the care and treatment of the sick and injured that is certified by the department of health and approved by the state board of pharmacy as proper to be entrusted with the custody of controlled substances and the professional use of controlled substances

(K) "Hypodermic" means a hypodermic syringe or needle, or other instrument or device for the injection of medication.

(L) "Isomer," except as otherwise expressly stated, means the optical isomer.

(M) "Laboratory" means a laboratory approved by the state board of pharmacy as proper to be entrusted with the custody of controlled substances and the use of controlled substances for scientific and clinical purposes and for purposes of instruction.

(N) "Manufacturer" means a person who manufactures a controlled substance as "manufacture" is defined in section 3715.01 .

(O) "Marihuana" means all parts of a plant of the genus cannabis, whether growing or not; the seeds of a plant of that type; the resin extracted from a part of a plant of that type; and every compound, manufacture, salt, derivative, mixture, or preparation of a plant of that type or of its seeds or resin. "marihuana" does not include the mature stalks of the plant, fiber produced from the stalks, oils or cake made from the seeds of the plant, or any other compound, manufacture, salt, derivative, mixture, or preparation of the mature stalks, except the resin extracted from the mature stalks, fiber, oil or cake, or the sterilized seed of the plant that is incapable of germination.

(P) "Narcotic drugs" means coca leaves, opium, isonipecaine, amidone, isoamidone, ketobemidone, as defined in this division, and every substance not chemically distinguished from them and every drug, other than cannabis, that may be included in the meaning of "narcotic drug" under the federal drug abuse control laws. as used in this division:

(1) "Coca leaves" includes cocaine and any compound, manufacture, salt, derivative, mixture, or preparation of coca leaves, except derivatives of coca leaves, that does not contain cocaine, ecgonine, or substances from which cocaine or ecgonine may be synthesized or made.

(2) "isonipecaine" means any substance identified chemically as 1-methyl-4-phenyl-piperidine-4-carboxylic acid ethyl ester, or any salt thereof, by whatever trade name designated.

(3) "amidone" means any substance identified chemically as 4-4-diphenyl-6-dimethylamino-heptanone-3, or any salt thereof, by whatever trade name designated.

(4) "isoamidone" means any substance identified chemically as 4-4-diphenyl-5-methyl-6-dimethylaminohexanone-3, or any salt thereof, by whatever trade name designated.

(5) "ketobemidone" means any substance identified chemically as 4-(3-hydroxyphenyl)-1-methyl-4-piperidyl ethyl ketone hydrochloride, or any salt thereof, by whatever trade name designated.

(Q) "Official written order" means an order written on a form provided for that purpose by the director of the United States drug enforcement administration, under any laws of the United States making provision for the order, if the order forms are authorized and required by federal law.

(R) "Opiate" means any substance having an addiction-forming or addiction-sustaining liability similar to morphine or being capable of conversion into a drug having addiction-forming or addiction-sustaining liability. "Opiate" does not include, unless specifically designated as controlled under section 3719.41 of the Revised Code, the dextrorotatory isomer of 3-methoxy-n-methylmorphinan and its salts (dextro-methorphan). "Opiate" does include its racemic and levoratory forms.

(S) "Opium poppy" means the plant of the species papaver somniferum L., except its seeds.

(T) "Person" means any individual, corporation, government, governmental subdivision or agency, business trust, estate, trust, partnership, association, or other legal entity.

(U) "Pharmacist" means a person licensed under chapter 4729. to engage in the practice of pharmacy.

(V) "Pharmacy" has the same meaning as in section 4729.01 .

(W) "Poison" means any drug, chemical, or preparation likely to be deleterious or destructive to adult human life in quantities of four grams or less.

(X) "Poppy straw" means all parts, except the seeds, of the opium poppy, after mowing.

(Y) "Licensed health professional authorized to prescribe drugs," "prescriber," and "prescription" have the same meanings as in section 4729.01 .

(Z) "Registry number" means the number assigned to each person registered under the federal drug abuse control laws.

(AA) "Sale" includes delivery, barter, exchange, transfer, or gift, or offer thereof, and each transaction of those natures made by any person, whether as principal, proprietor, agent, servant, or employee.

(BB) "Schedule I," "Schedule II," "Schedule III," "Schedule IV," and "Schedule V" mean controlled substance schedules I, II, III, IV, and V, respectively, established pursuant to section 3719.41 of the revised code, as amended pursuant to section 3719.43 or 3719.44 of the revised code.

(CC) "Wholesaler" means a person who, on official written orders other than prescriptions, supplies controlled substances that the person has not manufactured, produced, or prepared personally and includes a "wholesale distributor of dangerous drugs" as defined in section 4729.01 of the revised code.

(DD) "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.

(EE) "Terminal distributor of dangerous drugs" has the same meaning as in section 4729.01 of the revised code.

(FF) "Category III license" means a license issued to a terminal distributor of dangerous drugs as set forth in section 4729.54 of the revised code.

(GG) "Prosecutor" has the same meaning as in section 2935.01 of the revised code.

Section 3719.011 Definition of Controlled Substance, Drug Dependence

As used in the Revised Code:

(A) "Drug of abuse" means any controlled substance as defined in section 3719.01 of the Revised Code, any harmful intoxicant as defined in section 2925.01 of the Revised Code, and any dangerous drug as defined in section 4729.01 of the Revised Code.

(B) "Drug dependent person" means any person who, by reason of the use of any drug of abuse, is physically, psychologically, or physically and psychologically dependent upon the use of such drug, to the detriment of the person's health or welfare.

(C) "Person in danger of becoming a drug dependent person" means any person who, by reason of the person's habitual or incontinent use of any drug of abuse, is in imminent danger of becoming a drug dependent person.

Section 3719.02 Manufacturer of Controlled Substance; license fee

A person may cultivate, grow, or by other process produce or manufacture, and a person on land owned, occupied, or controlled by such person may knowingly allow to be cultivated, grown, or produced, any controlled substance if the person first obtains a license as a manufacturer of controlled substances from the state board of pharmacy.

All licenses issued pursuant to this section shall be for a period of one year from the last day of June and may be renewed for a like period annually according to the standard renewal procedure of sections 4745.01 to 4745.03 of the Revised Code.

The annual license fee shall be twenty-five dollars and shall accompany each application for a license or renewal thereof. A license that has not been renewed by the first day of August in any year may be reinstated upon payment of the renewal fee and a penalty of thirty-seven dollars and fifty cents.

The state board of pharmacy, subject to the approval of the controlling board, may establish a fee in excess of the amount provided in this section, provided that the fee does not exceed the amount established by this section by more than fifty per cent.

Section 3719.021

Persons other than a licensed manufacturer, pharmacist, or owner of a pharmacy who possess for sale, sell, or dispense controlled substances at wholesale shall first obtain a license as a wholesaler of controlled substances from the state board of pharmacy.

All licenses issued pursuant to this section shall be for a period of one year from the thirtieth day of June and may be renewed for a like period annually according to the standard renewal procedure of sections 4745.01 to 4745.03 of the Revised Code.

The annual license fee shall be twenty-five dollars and shall accompany each application for such license or renewal thereof. All such renewal fees shall be paid in advance by the renewal applicant to the treasurer of state, and entered by the treasurer of state on the records of the state board of pharmacy. A license that has not been renewed by the first day of August in any year may be reinstated upon payment of the renewal fee and a penalty of thirty-seven dollars and fifty cents.

The state board of pharmacy, subject to the approval of the controlling board, may establish a fee in excess of the amount provided in this section, provided that the fee does not exceed the amount established by this section by more than fifty per cent.

Section 3719.03 Qualifications of applicant

No license shall be issued under section 3719.02 or 3719.021 of the Revised Code unless and until the applicant therefor has furnished proof satisfactory to the state board of pharmacy:

(A) That the applicant is of good moral character or, if the applicant be an association or corporation, that the managing officers are of good moral character;

(B) That the applicant is equipped as to land, buildings, and paraphernalia properly to carry on the business described in his application;

(C) That the applicant's trade connections are such that there is a reasonable probability that he will apply all controlled substances grown, cultivated, processed, produced, or possessed by him to scientific, experimental, medicinal, or instructive purposes;

(D) That the applicant is in sufficiently good financial condition to carry out his obligation;

(E) That the applicant has satisfactorily shown that the granting of such license is in the public interest.

No license shall be granted to any person who has, within five years, been convicted of a drug abuse offense as defined in section 3719.01 of the Revised Code, or to any person who is a drug dependent person.

The board may suspend or revoke, for cause, any license issued under section 3719.02 or

3719.021 of the Revised Code.

Section 3719.04 Regulations for sale by manufacturer; official written orders

(A) A licensed manufacturer or wholesaler of controlled substances may sell at wholesale controlled substances to any of the following persons and subject to the following conditions:

(1) To a licensed manufacturer or wholesaler of controlled substances, or a terminal distributor of dangerous drugs having a category III license;

(2) To a person in the employ of the United States government or of any state, territorial, district, county, municipal, or insular government, purchasing, receiving, possessing, or dispensing controlled substances by reason of his official duties;

(3) To a master of a ship or a person in charge of any aircraft upon which no physician is regularly employed, for the actual medical needs of persons on board the ship or aircraft, when not in port; provided such controlled substances shall be sold to the master of the ship or person in charge of the aircraft only in pursuance of a special official written order approved by a commissioned medical officer or acting assistant surgeon of the United States public health service;

(4) To a person in a foreign country, if the federal drug abuse control laws are complied with.

(B) An official written order for any schedule II controlled substances shall be signed in triplicate by the person giving the order or by his authorized agent. The original shall be presented to the person who sells or dispenses the schedule II controlled substances named in the order and, if that person accepts the order, each party to the transaction shall preserve his copy of the order for a period of two years in such a way as to be readily accessible for inspection by any public officer or employee engaged in the enforcement of Chapter 3719. of the Revised Code. Compliance with the federal drug abuse control laws, respecting the requirements governing the use of a special official written order constitutes compliance with this division.

Section 3719.05 Regulations for pharmacists

(A)

A pharmacist may dispense controlled substances to any person upon a prescription issued in accordance with section 3719.06 . when dispensing controlled substances, a pharmacist shall act in accordance with rules adopted by the state board of pharmacy and in accordance with the following:

(1) The prescription shall be retained on file by the owner of the pharmacy in which it is filled for a period of three years, so as to be readily accessible for inspection by any public officer or employee engaged in the enforcement of Chapter 2925., 3719., or 4729. of the Revised Code.

(2) Each oral prescription shall be recorded by the pharmacist and the record shall show the name and address of the patient for whom, or of the owner of the animal for which the controlled substance is dispensed, the full

name, address, and registry number under the federal drug abuse control laws of the prescriber, the name of the controlled substance dispensed, the amount dispensed, and the date when dispensed. the record shall be retained on file by the owner of the pharmacy in which it is filled for a period of three

years.

(3) A schedule II controlled substance shall be dispensed only upon a written prescription, except that it may be dispensed upon an oral prescription in emergency situations as provided in the federal drug abuse control laws.

(4) A prescription for a schedule II controlled substance shall not be refilled.

(5) Prescriptions for schedule III and IV controlled substances may be refilled not more than five times in a six-month period from the date the prescription is given by a prescriber.

(B) The legal owner of any stock of schedule II controlled substances in a pharmacy, upon discontinuance of dealing in those drugs, may sell the stock to a manufacturer, wholesaler, or owner of a pharmacy registered under the federal drug abuse control laws pursuant to an official written order.

Section 3719.06 Regulations for prescribers; prescriptions

(A) A licensed health professional authorized to prescribe drugs, if acting in the course of professional practice, in accordance with the laws regulating the professional's practice, and in accordance with rules adopted by the state board of pharmacy, may do the following:

(1) Prescribe schedule II

(2) Administer or personally furnish to patients schedule II, III, IV, AND V controlled substances;

(3) Cause schedule II, III, IV, AND V controlled substances to be administered under the prescriber's direction and supervision.

(B) No licensed health professional authorized to prescribe drugs shall prescribe, administer, or personally furnish a schedule iii anabolic steroid for the purpose of human muscle building or enhancing human athletic performance and no pharmacist shall dispense a schedule III

anabolic steroid for either purpose, unless it has been approved for that purpose under the "federal food, drug, and cosmetic act," 52 stat. 1040 (1938), 21 u.s.c.a. 301, as amended.

(C) Each written prescription shall be properly executed, dated, and signed by the prescriber on the day when issued and shall bear the full name and address of the person for whom, or the owner of the animal for which, the controlled substance is prescribed and the full name, address, and registry number under the federal drug abuse control laws of the prescriber. if the prescription is for an animal, it shall state

Section 3719.07 Records of controlled substances handled

(A) As used in this section, "description" means the dosage form, strength, and quantity, and the brand name, if any, or the generic name, of a drug or controlled substance.

(B)(1) Every licensed health professional authorized to prescribe substances received and a record of all controlled substances administered, dispensed, or used other than by prescription. every other person, except a pharmacist, manufacturer, or wholesaler, who is authorized to purchase and use controlled substances shall keep a record of all controlled substances purchased and used other than by prescription. the records shall be kept drugs shall keep a record of all controlled in accordance with division(C)(1) of this section.

(2) Manufacturers and wholesalers shall keep records of all controlled substances compounded, mixed, cultivated, grown, or by any other process produced or prepared by them, and of all controlled substances received or sold by them. the records shall be kept in accordance with division (C)(2) of this section.

(3) Every category III terminal distributor of dangerous drugs shall keep records of all controlled substances received or sold. the records shall be kept in accordance with division (C)(3) of this section.

(4) Every person who sells or purchases for resale schedule V controlled substances exempted by section 3719.15 of the Revised Code shall keep a record showing the quantities and kinds thereof received or sold. the records shall be kept in accordance with divisions (C)(1), (2), and (3) of this section.

(C)(1) The records required by divisions (b)(1) and (4) of this section shall contain the following:

(a) The description of all controlled substances received, the name and address of the person from whom received, and the date of receipt;

(b) The description of controlled substances administered, dispensed, purchased, sold, or used; the date of administering, dispensing, purchasing, selling, or using; the name and address of the person to whom, or for whose

use, or the owner and species of the animal for which the controlled substance was administered, dispensed, purchased,

sold, or used.

(2) The records required by divisions (B)(2) and (4) of this section shall contain the following:

(a) The description of all controlled substances produced or prepared, the name and address of the person from whom received, and the date of receipt; (b) The description of controlled substances sold, the name and address of each person to whom a controlled substance is sold, the amount of the controlled substance sold to each person, and the date it was sold.

(3) The records required by divisions (b)(3) and (4) of this section shall contain the following:

(a) The description of controlled substances received, the name and address of the person from whom controlled substances are received, and the date of receipt;

(b) The name and place of residence of each person to whom controlled substances, including those otherwise exempted by section 3719.15 of the revised code, are sold, the description of the controlled substances sold to each person, and the date the controlled substances are sold to each person

(D) Every record required by this section shall be kept for a period of two years.

The keeping of a record required by or under the federal drug abuse control laws, containing substantially the same information as specified in this section, constitutes compliance with this section.

Every person who purchases for resale or who sells controlled substance preparations exempted by section 3719.15 of the Revised Code shall keep the record required by or under the federal drug abuse control laws.

Section 3719.08 Labeling

(A) Whenever a manufacturer sells a controlled substance, and whenever a wholesaler sells a controlled substance in a package the wholesaler has prepared, the manufacturer or wholesaler shall securely affix to each package in which the controlled substance is contained a label showing in legible english the name and address of the vendor and the quantity, kind, and form of controlled substance contained therein. no person, except a pharmacist for the purpose of dispensing a controlled substance upon a prescription shall alter, deface, or remove any label so affixed.

(B) Except as provided in division (c) of this section, when a pharmacist dispenses any controlled substance on a prescription for use by a patient, or supplies a controlled substance to a licensed health professional authorized to prescribe drugs for use by the professional in personally furnishing patients with controlled substances, the pharmacist shall affix to the container in which the controlled substance is dispense or supplied a label showing the following:

(1) The name and address of the pharmacy dispensing or supplying the controlled substance;

(2) The name of the patient for whom the controlled substance is prescribed and, if the patient is an animal, the name of the owner and the species of the animal;

(3) The name of the prescriber;

(4) ALL directions for use stated on the prescription or provided by the prescriber on usage of the drug;

(5) The date on which the controlled substance was dispensed or supplied; (6) The name, quantity, and strength of the controlled substance and, if applicable, the name of the distributor or manufacturer.

(C) The requirements of division (b) of this section do not apply when a controlled substance is prescribed or supplied for administration to an ultimate user who is institutionalized.

(D) A licensed health professional authorized to prescribe drugs who personally furnishes a controlled substance to a patient shall comply with division (B) of section 4729.29 with respect to labeling and packaging of the controlled substance.

(E) No person shall alter, deface, or remove any label affixed pursuant to this section as long as any of the original contents remain.

(F) Every label for a schedule II, III, or IV controlled substance shall contain the following warning:

"Caution: federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed."

Section 3719.09 Authorized possession of controlled substances

Possession or control of controlled substances is authorized in the following instances and subject to the following conditions:

(A) Possession of controlled substances in the course of business by a manufacturer, wholesaler, licensed health professional authorized to prescribe drugs, pharmacist, category III terminal distributor of dangerous drugs, or other person authorized to possess controlled substances under this chapter or Chapter 4729. of the Revised Code;

(B) Possession by any person of any schedule V narcotic drug exempted under section 3719.15 of the Revised Code, where the quantity of the drug does not exceed one hundred thirty milligrams of opium, thirty-two and five-tenths milligrams of morphine or any of its salts, two hundred sixty milligrams of codeine or any of its salts, one hundred thirty milligrams of dihydrocodeine or any of its salts, or thirty-two and five-tenths milligrams of ethylmorphine or any of its salts, or, in the case of any other schedule V controlled substance or any combination of narcotic drugs, where the quantity does not exceed in pharmacologic potency any one of the drugs named above in the quantity stated;

(C) Possession by any person of any controlled substance that the person obtained pursuant to a prescription issued by a licensed health professional authorized to prescribe drugs or that was obtained for the person pursuant to a prescription issued by a prescriber, when the drug is in a container regardless of whether the container is the original container in which the drug was dispensed to that person directly or indirectly by a pharmacist or personally furnished to that person by the prescriber;

(D) Possession in the course of business of combination drugs that contain pentobarbital and at least one noncontrolled substance active ingredient, in a manufactured dosage form, the only indication of which is for euthanizing animals, or other substance that the state veterinary medical licensing board and the state board of pharmacy both approve under division (A) of section 4729.532 of the Revised Code, by an agent or employee of an animal shelter who is authorized by the licensure of the animal shelter with the state board of pharmacy to purchase and possess the drug solely for use as specified in that section. As used in this division, "in the course of business" means possession or use at an establishment described in a license issued under section 4729.54 of the Revised Code, or outside that establishment when necessary because of a risk to the health or safety of any person, provided that the substance is in a quantity no greater than reasonably could be used to alleviate the risk, is in the original manufacturer's container, and is returned to the establishment as soon as possible after the risk has passed.

Section 3719.12 Procedure upon convictions; suspension or revocations of license or registration

Unless a report has been made pursuant to section 2929.24 of the Revised Code, on the conviction of a manufacturer, wholesaler, terminal distributor of dangerous drugs, pharmacist, pharmacy intern, dentist, doctor of medicine or osteopathic medicine, podiatrist, registered nurse, licensed practical nurse, physician assistant, optometrist, or veterinarian of the violation of this chapter or chapter 2925. of the revised code, the prosecutor in the case promptly shall report the conviction to the board that licensed, certified, or registered the person to practice or to carry on business. the responsible board shall provide forms to the prosecutor. Within thirty days of the receipt of this information, the board shall initiate action in accordance with Chapter 119. of the Revised Code to determine whether to suspend or revoke the person's license, certificate, or registration.

Section 3719.121 Suspensions of licenses or registrations of addicts

(A) Except as otherwise provided in section 4723.28, 4723.35, 4730.25, or 4731.22 of the Revised Code, the license, certificate, or registration of any dentist, doctor of medicine or osteopathic medicine, podiatrist, registered nurse, licensed practical nurse, physician assistant, pharmacist, pharmacy intern, optometrist, or veterinarian who is or becomes addicted to the use of controlled substances shall be suspended by the board that authorized the person's license, certificate, or registration until the person offers satisfactory proof to the board that the person no longer is addicted to the use of controlled substances.

(B) If the board under which a person has been issued a license, certificate, or evidence of registration determines that there is clear and convincing evidence that continuation of the person's professional practice or method of prescribing or personally furnishing controlled substances presents a danger of immediate and serious harm to others, the board may suspend the person's license, certificate, or registration without a hearing. Except as otherwise provided in sections 4715.30, 4723.281, 4730.25, and 4731.22 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 ninety days after the hearing, the suspension shall be void on the ninety-first day after the hearing.

(C) On receiving notification pursuant to section 2929.24 or 3719.12 of the Revised Code, the board under which a person has been issued a license, certificate, or evidence of registration immediately shall suspend the license, certificate, or registration of that person on a plea of guilty to, a finding by a jury or court of the person's guilt of, or conviction of a felony drug abuse offense; a finding by a court of the person's eligibility for treatment in lieu of conviction; a plea of guilty to, or a finding by a jury or court of the person's guilt of, or the person's conviction of an offense in another jurisdiction that is essentially the same as a felony drug abuse offense; or a finding by a court of the person's eligibility for treatment in lieu of conviction in another jurisdiction. The board shall notify the holder of the license, certificate, or registration of the suspension, which shall remain in effect until the board holds an adjudicatory hearing under Chapter 119. of the Revised Code.

Section 3719.13

Prescriptions, orders, and records, required by Chapter 3719. of the Revised Code, and stocks of dangerous drugs and controlled substances, shall be open for inspection only to federal, state, county, and municipal officers, and employees of the state board of pharmacy whose duty it is to enforce the laws of this state or of the United States relating to controlled substances. Such prescriptions, orders, records, and stocks shall be open for inspection by employees of the state medical board for purposes of enforcing Chapter 4731. of the Revised Code. No person having knowledge of any such prescription, order, or record shall divulge such knowledge, except in connection with a prosecution or proceeding in court or before a licensing or registration board or officer, to which prosecution or proceeding the person to whom such prescriptions, orders, or records relate is a party.

Section 3719.15 Substances exempt

This chapter and chapter 2925. of the Revised Codeshall not apply, except as specifically provided otherwise in those chapters, to the following cases:

(A) Where a licensed health professional authorized to prescribe drugs administers or personally furnishes, or where a pharmacist sells at retail, any medicinal preparation that contains in thirty milliliters, or if a solid or semisolid preparation, in thirty grams, of any of the following:

(1) Not more than one hundred thirty milligrams of opium;

(2) Not more than sixteen and twenty-five one hundreths milligrams of morphine or of any of its salts;

(3) Not more than sixty-five milligrams of codeine or of any of its salts;

(4) Not more than thirty-two and five-tenths milligrams of dihydrocodeine or any of its salts;

(5) Not more than sixteen and twenty-five one hundreths milligrams of

ethylmorphine or any of its salts.

Each preparation specified in divisions (A)(1), (2), (3), (4), and (5) of this section shall in addition contain one or more non-narcotic active medicinal ingredients in sufficient proportion to confer upon the preparation valuable medicinal qualities other than those possessed by the narcotic drug alone.

(6) Pharmaceutical preparations in solid form containing not more than two and five-tenths milligrams diphenoxylate and not less than twenty-five micrograms atropine sulfate per dosage unit.

(B) Where a licensed health professional authorized to prescribe drugs administers or personally furnishes, or where a pharmacist sells at retail, liniments, ointments, and other preparations, that are susceptible of external use only and that contain narcotic drugs in a combination that prevents the drugs from being readily extracted from the liniments, ointments, or preparations, except that this chapter and chapter 2925. shall apply to all liniments, ointments, and other preparations that contain coca leaves in any quantity or combination.

The medicinal preparation, or the liniment, ointment, or other preparation susceptible of external use only, prescribed, personally furnished, administered, dispensed, or sold, shall contain, in addition to the narcotic drug in it, some drug or drugs conferring upon it medicinal qualities other than those possessed by the narcotic drug alone. the preparation shall be prescribed, personally furnished, administered, compounded, dispensed, and sold in good faith as a medicine, and not for the purpose of evading this chapter or chapter 2925. .

Section 3719.16 Sale of exempted drugs

No person shall dispense or sell, under the exemptions of section 3719.15 of the Revised Code to any one person, or for the use of any one person or animal, any preparation included within such section, when he knows, or can by reasonable diligence ascertain, that such dispensing or selling will provide the person to whom or for whose use, or the owner of the animal for the use of which, such preparation is dispensed or sold, within any forty-eight consecutive hours, with more than two grains of opium, or more than one-half of a grain of morphine or any of its salts, or more than four grains of codeine or any of its salts, or more than two grains of dihydrocodeine or any of its salts, or more than one-half grain of ethylmorphine or any of its salts, or will provide such person or the owner of such animal, within forty-eight consecutive hours, with more than one preparation exempted by the provisions of section 3719.15 of the Revised Code.

No person shall obtain or attempt to obtain, under the exemptions of section 3719.15 of the Revised

Code, more than one preparation exempted by the provisions of that section within forty-eight

consecutive hours.

Section 3719.172 Possession, sale, and disposal of hypodermics

(A) Possession of a hypodermic is authorized for the following:

(1) A manufacturer or distributor of, or dealer in, hypodermics or medication packaged in hypodermics, and any authorized agent or employee of that manufacturer, distributor, or dealer, in the regular course of business;

(2) A terminal distributor of dangerous drugs, in the regular course of business;

(3) A person authorized to administer injections, in the regular course of the person's profession or employment;

(4) A person, when the hypodermic was lawfully obtained and is kept and used for the purpose of self-administration of insulin or other drug prescribed for the treatment of disease by a licensed health professional authorized to prescribe drugs;

(5) A person whose use of a hypodermic is for legal research, clinical, educational, or medicinal purposes;

(6) A farmer, for the lawful administration of a drug to an animal;

(7) A person whose use of a hypodermic is for lawful professional, mechanical, trade, or craft PURPOSES.

(B) No manufacturer or distributor of, or dealer in, hypodermics or medication packaged in hypodermics, or their authorized agents or employees, and no terminal distributor of dangerous drugs, shall display any hypodermic for sale. No person authorized to possess a hypodermic pursuant to division (A) of this section shall negligently fail to take reasonable precautions to prevent any hypodermic in the person's possession from theft or acquisition by any unauthorized person.

(C) No person other than one of the following shall sell or furnish a hypodermic to another person:

(1) A manufacturer or distributor of, or dealer in, hypodermics or medication packaged in hypodermics, or their authorized agents or employees;

(2) A terminal distributor of dangerous drugs;

(3) A person under the direct supervision of a pharmacist;

(4) A licensed health professional authorized to prescribe drugs, acting in the regular course of business and as permitted by law;

(5) An individual who holds a current license, certificate, or registration issued under Title 47 of the Revised Code and has been certified to conduct diabetes education by a national certifying body specified in rules adopted by the state board of pharmacy under section 4729.68 of the Revised Code, but only if diabetes education is within the individual's scope of practice under statutes and rules regulating the individual's profession.

(D) No person shall sell or furnish a hypodermic to another whom the person knows or has reasonable cause to believe is not authorized by division (A) of this section to possess a hypodermic.

Section 3719.27

Persons required, by Chapter 3719. of the Revised Code, to keep files or records shall, upon the

written request of an officer or employee designated by the state board of pharmacy, make such files or records available to such officer or employee, at all reasonable hours, for inspection and copying, and accord to such officer or employee full opportunity to check the correctness of such files or records, including opportunity to make inventory of all stocks of controlled substances on hand. No person shall fail to make such files or records available or to accord such opportunity to check their correctness.

Section 3719.28

(A) The state board of pharmacy, pursuant to Chapter 119. of the Revised Code, shall adopt rules

for administration and enforcement of Chapter 3719. of the Revised Code and prescribing the

manner of keeping and the form and content of records to be kept by persons authorized to

manufacture, distribute, dispense, conduct research in, prescribe, administer, or otherwise deal with

controlled substances. Such rules shall be designed to:

(1) Facilitate surveillance of traffic in drugs, to prevent the improper acquisition or use of controlled substances or their diversion into illicit channels;

(2) Aid the state board of pharmacy and state, local, and federal law enforcement officers in enforcing the laws of this state and the federal government dealing with drug abuse and control of drug traffic.

(B) Rules adopted pursuant to this section shall not provide any less stringent requirements with respect to records than the requirements of the federal drug abuse control laws and regulations adopted thereunder. To the extent that records kept under the federal drug abuse control laws and regulations adopted thereunder fulfill requirements for similar records under rules adopted pursuant to this section, compliance with the federal law and regulations shall constitute compliance with the law and rules of this state with respect to such records.

Section 3719.30

No person shall leave or deposit dangerous drugs, poisons, or substances containing dangerous drugs or poisons in a common, street, alley, lane, or thoroughfare, or a yard or enclosure occupied by another.

Whoever violates this section shall be liable to the person injured for all damages sustained as a result of leaving or depositing the dangerous drugs, poisons, or other substances.

Section 3719.33

No person shall sell or deliver to another a substance named in section 3719.32 of the Revised Code without having first learned by due inquiry that such person is aware of the poisonous character of such substance and that it is desired for a lawful purpose; or without plainly labeling "poison," and the names of two or more antidotes therefor, upon the box, bottle, or package containing it; or deliver such substance without recording in a book kept for the purpose, the name thereof, the quantity delivered, the purpose for which it is alleged to be used, the date of its delivery, the name and address of the purchaser, and the name of the dispenser; or fail to preserve said book for five years and submit it at all times for inspection to proper officers of the law.

Section 3719.43

When pursuant to the federal drug abuse control laws the attorney general of the United States adds a compound, mixture, preparation, or substance to a schedule of the laws, transfers any of the same between one schedule of the laws to another, or removes a compound, mixture, preparation, or substance from the schedules of the laws then such addition, transfer, or removal is automatically effected in the corresponding schedule or schedules in section 3719.41 of the Revised Code, subject to amendment pursuant to section 3719.44 of the Revised Code.

Section 3719.44 Board may amend schedules

(A) Pursuant to this section, and by rule adopted in accordance with Chapter 119. of the Revised Code, the state board of pharmacy may do any of the following with respect to schedules I, II, III, IV, and V established in section 3719.41 of the Revised Code:

(1) Add a previously unscheduled compound, mixture, preparation, or substance to any schedule;

(2) Transfer a compound, mixture, preparation, or substance from one schedule to another, provided the transfer does not have the effect under Chapter 3719. of the Revised Code of providing less stringent control of the compound, mixture, preparation, or substance than is provided under the federal drug abuse control laws;

(3) Remove a compound, mixture, preparation, or substance from the schedules where the board had previously added the compound, mixture, preparation, or substance to the schedules, provided that the removal shall not have the effect under Chapter 3719. of the Revised Code of providing less stringent control of the compound, mixture, preparation, or substance than is provided under the federal drug abuse control laws.

(B) In making a determination to add, remove, or transfer pursuant to division (A) of this section, the board shall consider the following:

(1) The actual or relative potential for abuse;

(2) The scientific evidence of the pharmacological effect of the substance, if known;

(3) The state of current scientific knowledge regarding the substance;

(4) The history and current pattern of abuse;

(5) The scope, duration, and significance of abuse;

(6) The risk to the public health;

(7) The potential of the substance to produce psychic or physiological dependence liability;

(8) Whether the substance is an immediate precursor.

(C) The board may add or transfer a compound, mixture, preparation, or substance to schedule I when it appears that there is a high potential for abuse, that it has no accepted medical use in treatment in this state, or lacks accepted safety for use in treatment under medical supervision.

(D) The board may add or transfer a compound, mixture, preparation, or substance to schedule II when it appears that there is a high potential for abuse, that it has a currently accepted medical use in treatment in this state, or currently accepted medical use in treatment with severe restrictions, and that its abuse may lead to severe physical or severe psychological dependence.

(E) The board may add or transfer a compound, mixture, preparation, or substance to schedule III when it appears that there is a potential for abuse less than the substances included in schedules I and II, that it has a currently accepted medical use in treatment in this state, and that its abuse may lead to moderate or low physical or high psychological dependence.

(F) The board may add or transfer a compound, mixture, preparation, or substance to schedule IV when it appears that it has a low potential for abuse relative to substances included in schedule III, and that it has a currently accepted medical use in treatment in this state, and that its abuse may lead to limited physical or psychological dependence relative to the substances included in schedule III.

(G) The board may add or transfer a compound, mixture, preparation, or substance to schedule V when it appears that it has lower potential for abuse than substances included in schedule IV, and that it has currently accepted medical use in treatment in this state, and that its abuse may lead to limited physical or psychological dependence relative to substances included in schedule IV.

(H) Even though a compound, mixture, preparation, or substance does not otherwise meet the criteria in this section for adding or transferring it to a schedule, the board may nevertheless add or transfer it to a schedule as an immediate precursor when all of the following apply:

(1) It is the principal compound used, or produced primarily for use, in the manufacture of a controlled substance;

(2) It is an immediate chemical intermediary used or likely to be used in the manufacture of such a controlled substance;

(3) Its control is necessary to prevent, curtail, or limit the manufacture of the scheduled compound, mixture, preparation, or substance of which it is the immediate precursor.

(I) Authority to control under this section does not extend to distilled spirits, wine, or malt beverages, as those terms are defined or used in Chapter 4301. of the Revised Code.

(J) Authority to control under this section does not extend to any nonnarcotic substance if such substance may, under the Federal Food, Drug, and Cosmetic Act and the laws of this state, be lawfully sold over the counter without a prescription. Should a pattern of abuse develop for any nonnarcotic drug sold over the counter, the board may, by rule adopted in accordance with Chapter 119. of the Revised Code, after a public hearing and a documented study to determine that the substance actually meets the criteria listed in division (B) of this section, place such abused substance on a controlled substance schedule.

(K)(1) A drug product containing ephedrine that is known as one of the following and is in the form specified shall not be considered a schedule V controlled substance:

(a) Amesec capsules;

(b) Bronitin tablets;

(c) Bronkotabs;

(d) Bronkolixir;

(e) Bronkaid tablets;

(f) Efedron nasal jelly;

(g) Guiaphed elixir;

(h) Haysma;

(i) Pazo hemorrhoid ointment and suppositories;

(j) Primatene "M" formula tablets;

(k) Primatene "P" formula tablets;

(l) Tedrigen tablets;

(m) Tedral tablets, suspension and elixir;

(n) T.E.P.;

(o) Vatronol nose drops.

(2)(a) A product containing ephedrine shall not be considered a controlled substance if the product is a food product or dietary supplement that meets all of the following criteria:

(i) It contains, per dosage unit or serving, not more than the lesser of twenty-five milligrams of ephedrine alkaloids or theaximum amount of ephedrine alkaloids provided in applicable regulations adopted by the United States food and drug administration, and no other controlled substance.

(ii) It contains no hydrochloride or sulfate salts of ephedrine alkaloids.

(iii) It is packaged with a prominent label securely affixed to each package that states all of the following: the amount in milligrams of ephedrine in a serving or dosage unit; the amount of the food product or dietary supplement that constitutes a serving or dosage unit; that the maximum recommended dosage of ephedrine for a healthy adult human is the lesser of one hundred milligrams in a twenty-four-hour period for not more than twelve weeks or the maximum recommended dosage or period of use provided in applicable regulations adopted by the United States food and drug administration; and that improper use of the product may be hazardous to a person's health.

(b)(i) Subject to division (K)(2)(b)(ii) of this section, no person shall dispense, sell, or otherwise give a product described in division (K)(2)(a) of this section to any individual under eighteen years of age.

(ii) Division (K)(2)(b)(i) of this section does not apply to a physician or pharmacist who dispenses, sells, or otherwise gives a product described in division (K)(2)(a) of this section to an individual under eighteen years of age, to a parent or guardian of an individual under eighteen years of age who dispenses, sells, or otherwise gives a product of that nature to the individual under eighteen years of age, or to a person who, as authorized by the individual's parent or legal guardian, dispenses, sells, or otherwise gives a product of that nature to an individual under eighteen years of age.

(c) No person in the course of selling, offering for sale, or otherwise distributing a product described in division (K)(2)(a) of this section shall advertise or represent in any manner that the product causes euphoria, ecstasy, a "buzz" or "high," or an altered mental state; heightens sexual performance; or, because it contains ephedrine alkaloids, increased muscle mass.

(3) A drug product that contains the isomer pseudoephedrine, or any of its salts, optical isomers, or salts of optical isomers, shall not be considered a controlled substance if the drug product is labeled in a manner consistent with federal law or with the product's over-the-counter tentative final monograph or final monograph issued by the United States food and drug administration.

(4) At the request of any person, the board may except any product containing ephedrine not described in division (K)(1) or (2) of this section or any class of products containing ephedrine from being included as a schedule V controlled substance if it determines that the product or class of products does not contain any other controlled substance. The board shall make the determination in accordance with this section and by rule adopted in accordance with Chapter 119. of the Revised Code.

(L) As used in this section:

(1) "Food" has the same meaning as in section 3715.01 of the Revised Code; (2) "Dietary supplement" has the meaning given in the "Federal Food, Drug, and Cosmetic Act," 108 Stat. 4327 (1994), 21U.S.C.A. 321 (ff), as amended.

(3) "Ephedrine alkaloids" means ephedrine, pseudoephedrine, norephedrine, norpseudoephedrine, methylephedrine, and methylpseudoephedrine.

Section 3719.61

Nothing in the laws dealing with drugs of abuse shall be construed to prohibit treatment of narcotic drug dependent persons by the continuing maintenance of their dependence through the administration of methadone in accordance with the rules adopted by the department of alcohol and drug addiction services under section 3793.11 of the Revised Code, when all of the following apply:

(A) The likelihood that any person undergoing maintenance treatment will be cured of dependence on narcotic drugs is remote, the treatment is prescribed for the purpose of alleviating or controlling the patient's drug dependence, and the patient's prognosis while undergoing treatment is at least a partial improvement in the

patient's asocial or antisocial behavior patterns;

(B) In the case of an inpatient in a hospital or clinic, the amount of the maintenance drug dispensed at any one time does not exceed the quantity necessary for a single dose, and the dose is administered to the patient immediately;

(C) In the case of an outpatient, the amount of the maintenance drug dispensed at any one time shall be determined by the patient's treatment provider taking into account the patient's progress in the treatment program and the patient's needs for gainful employment, education, and responsible homemaking, except that in no event shall the dosage be greater than the amount permitted by federal law and rules adopted by the department pursuant to section 3793.11 of the Revised Code;

(D) The drug is not dispensed in any case to replace or supplement any part of a supply of the drug previously dispensed, or when there is reasonable cause to believe it will be used or disposed of unlawfully;

(E) The drug is dispensed through a program licensed and operated in accordance with section 3793.11 of the Revised Code.

Section 3719.81

(A) A person may furnish another a sample of any drug of abuse, or of any drug or pharmaceutical preparation that would be hazardous to health or safety if used without the supervision of a licensed health professional authorized to prescribe drugs, if all of the following apply:

(1) The sample is furnished by a manufacturer, manufacturer's representative, or wholesale dealer in pharmaceuticals to a licensed health professional authorized to prescribe drugs, or is furnished by such a professional to a patient for use as medication;

(2) The drug is in the original container in which it was placed by the manufacturer, and the container is plainly marked as a sample;

(3) Prior to its being furnished, the drug sample has been stored under the proper conditions to prevent its deterioration or contamination;

(4) If the drug is of a type which deteriorates with time, the sample container is plainly marked with the date beyond which the drug sample is unsafe to use, and THE date has not expired on the sample furnished. Compliance with the labeling requirements of the "Federal Food, Drug, and Cosmetic Act," 52 stat. 1040 (1938), 21 301, as amended, shall be deemed compliance with this section.

(5) The drug is distributed, stored, or discarded in such a way that the drug sample may not be acquired or used by any unauthorized person, or by any person, including a child, for whom it may present a health or safety hazard.

(B) Division (A) of this section does not do any of the following:

(1) Apply to or restrict the furnishing of any sample of a nonnarcotic substance if the substance may, under the "Federal Food, Drug, and Cosmetic Act"and under the laws of this state, otherwise be lawfully sold over the counter without a prescription;

(2) Authorize an advanced practice nurse to furnish a sample of any drug;

(3) Authorize an optometrist to furnish a sample of a drug that is not a drug the optometrist is authorized to prescribe.

(C) The state board of pharmacy shall, in accordance with chapter 119. of the revised code, adopt rules as necessary to give effect to this section.

Section 3719.82

On receipt of a notice pursuant to section 2301.373 of the Revised Code, the state board of pharmacy shall comply with that section with respect to a license issued pursuant to this chapter.

Section 3719.99 Penalties

(A) Whoever violates section 3719.16 or 3719.161 of the Revised Code is guilty of a felony of the fifth degree. If the offender previously has been convicted of a violation of section 3719.16 or 3719.161 of the Revised Code or a drug abuse offense, a violation of section 3719.16 or 3719.161 of the Revised Code is a felony of the fourth degree. If the violation involves the sale, offer to sell, or possession of a schedule I or II controlled substance, with the exception of marihuana, and if the offender, as a result of the violation, is a major drug offender, division (D) of this section applies.

(B) Whoever violates division (C) or (D) of section 3719.172 of the Revised Code is guilty of a felony of the fifth degree. If the offender previously has been convicted of a violation of division (C) or (D) of section 3719.172 of the Revised Code or a drug abuse offense, a violation of division (C) or (D) of section 3719.172 of the Revised Code is a felony of the fourth degree. If the violation involves the sale, offer to sell, or possession of a schedule I or II controlled substance, with the exception of marihuana, and if the offender, as a result of the violation, is a major drug offender, division (D) of this section applies.

(C) Whoever violates section 3719.07 or 3719.08 of the Revised Code is guilty of a misdemeanor of the first degree. If the offender previously has been convicted of a violation of section 3719.07 or 3719.08 of the Revised Code or a drug abuse offense, a violation of section 3719.07 or 3719.08 of the Revised Code is a felony of the fifth degree. If the violation involves the sale, offer to sell, or possession of a schedule I or II controlled substance, with the exception of marihuana, and if the offender, as a result of the violation, is a major drug offender, division (D) of this section applies.

(D)(1) If an offender is convicted of or pleads guilty to a felony violation of section 3719.07, 3719.08, 3719.16, or 3719.161 or of division (C) or (D) of section 3719.172 of the Revised Code, if the violation involves the sale, offer to sell, or possession of a schedule I or II controlled substance, with the exception of marihuana, and if the offender, as a result of the violation, is a major drug offender, the court that sentences the offender, in lieu of the prison term authorized or required by division (A), (B), or (C) 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 (D)(3)(a) of section 2929.14 of the Revised Code, the mandatory prison term specified in that division and may impose an additional prison term under division (D)(3)(b) of that section.

(2) Notwithstanding any contrary provision of section 3719.21 of the Revised Code, the clerk of the court shall pay any fine imposed for a felony violation of section 3719.07, 3719.08, 3719.16, or 3719.161 or of division (C) or (D) of section 3719.172 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.

(E) Whoever violates section 3719.05, 3719.06, 3719.13, or 3719.31 or division (B) of section 3719.172 of the Revised Code is guilty of a misdemeanor of the third degree. If the offender previously has been convicted of a violation of section 3719.05, 3719.06, 3719.13, or 3719.31 or division (B) of section 3719.172 of the Revised Code or a drug abuse offense, a violation of section 3719.05, 3719.06, 3719.13, or 3719.31 or division (B) of section 3719.172 of the Revised Code is a misdemeanor of the first degree.

(F) Whoever violates section 3719.30 of the Revised Code is guilty of a misdemeanor of the fourth degree. If the offender previously has been convicted of a violation of section 3719.30 of the Revised Code or a drug abuse offense, a violation of section 3719.30 of the Revised Code is a misdemeanor of the third degree.

(G) Whoever violates section 3719.32 or 3719.33 of the Revised Code is guilty of a minor misdemeanor.

(H) Whoever violates division (K)(2)(b) of section 3719.44 of the Revised Code is guilty of a felony of the fifth degree.

(I) Whoever violates division (K)(2)(c) of section 3719.44 of the Revised Code is guilty of a misdemeanor of the second degree.

(J) As used in this section, "major drug offender" has the same meaning as in section 2929.01 of the Revised Code.

Sec. 4729.01. Definitions

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) compounding or dispensing drugs and dispensing drug therapy related devices;

(3) 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;

(4) performing drug regimen reviews with individuals by discussing all of the drugs that the individual is taking and explaining the interactions of the drugs;

(5) 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;

(6) advising an individual and the health care professionals treating an individual with regard to the individual's drug therapy;

(7) acting pursuant to a consult agreement with a physician authorized under chapter 4731. of the revised code to practice medicine and surgery or osteopathic medicine and surgery, if an agreement has been established with the physician.

(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 prescription drug orders based on routine, regularly observed dispensing patterns.

(D) "Consult agreement" means an agreement to manage an individual's drug therapy that has been entered into by a pharmacist and a physician authorized under chapter 4731. of the revised code to practice medicine and surgery or osteopathic medicine and surgery.

(E) "Drug" means:

(1) Any article recognized in the United States pharmacopoeia and national formulary, or any supplement to them, intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or animals;

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

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

(4) Any article intended for use as a component of any article specified in division (C)(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), 21 301, as amended, the drug is required to bear a label containing the legend "Caution: Federal law prohibits dispensing without prescription" or "Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian" or any similar restrictive statement, or the drug may be dispensed only upon a prescription;

(b) Under Chapter 3715. or 3719. of the Revised Code, THE DRUG may be dispensed only upon a prescription

(2) Any drug that contains a schedule V controlled substance and that is exempt from Chapter 3719. of the Revised Code or to which that chapter does not apply;

(3) Any drug intended for administration by injection into the human body other than through a natural orifice of the human body.

(G) "Federal drug abuse control laws" has the same meaning as in section 3719.01 of the Revised Code.

(H) "Prescription" means A written, electronic, or oral order for drugs or combinations or mixtures of drugs to be used by a particular individual or for treating a particular animal, issued by a licensed health professional authorized to prescribe drugs.

(I) "Licensed health professional authorized to prescribe drugs" or "prescriber" means n 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) An advanced practice nurse approved under section 4723.56 of the Revised Code to prescribe drugs and therapeutic devices;

(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 podiatry;

(5) A veterinarian licensed under chapter 4741. of the revised code.

(J) "Sale" and "sell" include delivery, transfer, barter, exchange, or gift, or offer therefor, and each such transaction made by any person, whether as principal proprietor, agent, or employee.

(K) "Wholesale sale" and "sale at wholesale" mean any sale in which the purpose of the purchaser is to resell the article purchased or received by the purchaser.

(L) "Retail sale" and "sale at retail" mean any sale other than a wholesale sale or sale at wholesale.

(M) "Retail seller" means any person that sells any dangerous drug to consumers without assuming control over and responsibility for its administration. Mere advice or instructions regarding administration do not constitute control or establish responsibility.

(N) "Price information" means the price charged for a prescription for a particular drug product and, in an easily understandable manner, all of the following:

(1) The proprietary name of the drug product;

(2) The established (generic) name of the drug product;

(3) The strength of the drug product if the product contains a single active ingredient or if the drug product contains more than one active ingredient and a relevant strength can be associated with the product without indicating each active ingredient. The established name and quantity of each active ingredient are required if such a relevant strength cannot be so associated with a drug product containing more than one ingredient.

(4) The dosage form;

(5) The price charged for a specific quantity of the drug product. The stated price shall include all charges to the consumer, including, but not limited to, the cost of the drug product, professional fees, handling fees, if any, and a statement identifying professional services routinely furnished by the pharmacy. Any mailing fees and delivery fees may be stated separately without repetition. The information shall not be false or misleading.

(O) "Wholesale distributor of dangerous drugs" means a person engaged in the sale of dangerous drugs at wholesale and includes any agent or employee of such a person authorized by the person to engage in the sale of dangerous drugs at wholesale.

(P) "Manufacturer of dangerous drugs" means a person, other than a pharmacist, who manufactures dangerous drugs and who is engaged in the sale of those dangerous drugs within this state.

(Q) "Terminal distributor of dangerous drugs" means a person who is engaged in the sale of dangerous drugs at retail, or any person, other than a wholesale distributor or a pharmacist, who has possession, custody, or control of dangerous drugs for any purpose other than for that person's own use and consumption, and includes pharmacies, hospitals, nursing homes, and laboratories and all other persons who procure dangerous drugs for sale or other distribution by or under the supervision of a pharmacist or licensed health professional authorized to prescribe drugs.

(R) "Promote to the public" means disseminating a representation to the public in any manner or by any means, other than by labeling, for the purpose of inducing, or that is likely to induce, directly or indirectly, the purchase of a dangerous drug at retail.

(S) "Person" includes any individual, partnership, association, limited liability company, or corporation, the state, any political subdivision of the state, and any district, department, or agency of the state or its political subdivisions.

(T) "Finished dosage form" has the same meaning as in section 3715.01 of the Revised Code.

(U) "Generically equivalent drug" has the same meaning as in section 3715.01 of the Revised Code.

(V) "Animal shelter" means a facility operated by a humane society or any society organized under Chapter 1717. of the Revised Code or a dog pound operated pursuant to Chapter 955. of the Revised Code.

(W) "Food" has the same meaning as in section 3715.01 of the Revised Code.

Sec. 4729.02. State board of pharmacy

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.

Section 4729.03 Organization

The state board of pharmacy shall organize by electing a president and a vice-president who are members of the board. The president shall preside over the meetings of the board, but shall not vote upon matters determined by the board, except in the event of a tie vote, in which case the president shall vote. The board shall also employ an executive director who is a licensed pharmacist in good standing in the practice of pharmacy in this state. The person employed shall not be a member of the board. Each of the officers elected shall serve for a term of one year. The members of the board shall receive an amount fixed pursuant to division (J) of section 124.15 of the Revised Code for each day employed in the discharge of their official duties and their necessary expenses while engaged therein.

(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.

4729.05 Quorum; meetings

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.

Section 4729.06 Records; court evidence

The state board of pharmacy shall keep a record of its proceedings and a register of all persons to whom identification cards and licenses have been granted as pharmacists or pharmacy interns, together with each renewal and suspension or revocation of an identification card and license. The books and registers of the board shall be prima-facie evidence of the matters therein recorded. The president and executive director of the board may administer oaths.

A statement signed by the executive director to which is affixed the official seal of the board to the effect that it appears from the records of the board that the board has not issued an identification card and license to practice pharmacy, or any of its branches, to the person specified in the statement, or that an identification card and license, if issued, has been revoked or suspended, shall be received as prima-facie evidence of the record of the board in any court or before any officer of this state.

Section 4729.07 Application for registration; examination

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, and appear before the board to 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 make use of 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 to perform its duties under this section. The board may require applicants for licensure by examination to purchase the examination and any related materials from the organization providing it.

Section 4729.08 Qualifications

Every applicant for examination and licensure as a pharmacist shall:

(A) Be at least eighteen years of age;

(B) Be of good moral character and habits;

(C) Have obtained a degree in pharmacy from a program that has been recognized and approved by the state board of pharmacy, except that graduates of schools or colleges of pharmacy that are located outside the United States and have not demonstrated that the standards of their programs are at least equivalent to programs recognized and approved by the board shall be required to pass an equivalency examination recognized and approved by the board and to establish written and oral proficiency in English.

(D) Have satisfactorily completed at least the minimum requirements for pharmacy internship as outlined by the board.

If the board is satisfied that the applicant meets the foregoing requirements and if the applicant passes the examination required under section 4729.07 of the Revised Code, the board shall issue to the applicant a license and an identification card authorizing the individual to practice pharmacy.

Section 4729.09 Reciprocal registration

The state board of pharmacy may license an individual as a pharmacist without examination and issue an identification card to the pharmacist if the individual:

(A) Holds a license in good standing to practice pharmacy under the laws of another state, has successfully completed an examination for licensure in the other state, and in the opinion of the board, the examination was at least as thorough as that required by the board at the time the individual took the examination;

(B) Is of good moral character and habit;

(C) Has filed with the licensing body of the other state at least the credentials or the equivalent that were required by this state at the time the individual was licensed a pharmacist.

The board shall not issue any identification card or license to an individual licensed in another state if the state in which the individual is licensed does not reciprocate by granting licenses to practice pharmacy to persons holding valid licenses received through examination by the state board of pharmacy.

Section 4729.11 Pharmacy internship program; registration; director; duties

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, and shall be issued an identification card and license as a pharmacy intern if in the opinion of the board the applicant is actively pursuing an educational program in preparation for licensure as a pharmacist and meets the other requirements as determined by the board. An identification card and license shall be valid until the next annual renewal date and shall be renewed only if the intern is meeting the requirements and rules of the board.

The state board of pharmacy may appoint a director of pharmacy internship who is a licensed pharmacist and who is not directly or indirectly connected with a school or college of pharmacy or department of pharmacy of a university.

The director of pharmacy internship shall be responsible to the board for the operation and direction of the pharmacy internship program established by the board under this section, and for such other duties as the board may assign.

4729.12 Identification card; display of certificate of registration; renewal; renewal after lapse

An identification card issued by the state board of pharmacy under section 4729.08 entitles the individual to whom it is issued to practice as a pharmacist or as a pharmacy intern in this state until the next annual renewal date.

Identification cards shall be renewed annually on the fifteenth day of September, according to the standard renewal procedure of Chapter 4745. of the Revised Code.

Each pharmacist and pharmacy intern shall carry the identification card or renewal identification card while engaged in the practice of pharmacy. the license shall be conspicuously exposed at the principal place where the pharmacist or pharmacy intern practices pharmacy.

A pharmacist or pharmacy intern who desires to continue in the practice of pharmacy shall file with the board an application in such form and containing such data as the board may require for renewal of an identification card. if the board finds that the applicant's card has not been revoked or placed under suspension and that the applicant has paid the renewal fee, has continued pharmacy education in accordance with the rules of the board, and is entitled to continue in the practice of pharmacy, the board shall issue a renewal identification card to the applicant.

When an identification card has lapsed for more than sixty days but application is made within three years after the expiration of the card, the applicant shall be issued a renewal identification card without further examination if the applicant meets the requirements of this section and pays the fee designated under division (E) of section 4729.15 of the Revised Code.

4729.13 Renewal of identification card after three year lapse

A pharmacist who fails to make application to the state board of pharmacy for a renewal identification card within a period of three years from the expiration of the identification card must pass an examination for registration; except that a pharmacist whose registration has expired, but who has continually practiced pharmacy in another state under a license issued by the authority of that state, may obtain a renewal identification card upon payment to the executive director of the board the fee designated under division (F) of section 4729.15 of the Revised Code.

4729.14 Replacement certificate or identification card.

A replacement license or identification card may be issued a person registered with the state board of pharmacy as a pharmacist or as a pharmacy intern whose license or identification card has been lost or destroyed, upon condition that the applicant by affidavit sets forth the facts concerning the loss or destruction of the previously issued license or identification card.

Section 4729.15 Fees

The state board of pharmacy shall charge the following fees:

(A) For applying for a license to practice as a pharmacist, an amount adequate to cover all rentals, compensation for proctors, and other expenses of the board related to examination except the expenses of procuring and grading the examination, which fee shall not be returned if the applicant fails to pass the examination;

(B) For the examination of an applicant for licensure as a pharmacist, an amount adequate to cover any expenses to the board of procuring and grading the examination or any part thereof, which fee shall not be returned if the applicant fails to pass the examination;

(C) For issuing a license and an identification card to an individual who passes the examination described in section 4729.07 of the Revised Code, an amount that is adequate to cover the expense;

(D) For a pharmacist applying for renewal of an identification card within sixty days after the expiration date, ninety-seven dollars and fifty cents, which fee shall not be returned if the applicant fails to qualify for renewal;

(E) For a pharmacist applying for renewal of an identification card that has lapsed for more than sixty days, but for less than three years, one hundred thirty-five dollars, which fee shall not be returned if the applicant fails to qualify for renewal;

(F) For a pharmacist applying for renewal of an identification card that has lapsed for more than three years, three hundred thirty-seven dollars and fifty cents, which fee shall not be returned if the applicant fails to qualify for renewal;

(G) For a pharmacist applying for a license and identification card, on presentation of a pharmacist license granted by another state, three hundred thirty-seven dollars and fifty cents, which fee shall not be returned if the applicant fails to qualify for licensure.

(H) For a license and identification card to practice as a pharmacy intern, twenty-two dollars and fifty cents, which fee shall not be returned if the applicant fails to qualify for licensure;

(I) For the renewal of a pharmacy intern identification card, twenty-two dollars and fifty cents, which fee shall not be returned if the applicant fails to qualify for renewal;

(J) For issuing a replacement license to a pharmacist, twenty-two dollars and fifty cents;

(K) For issuing a replacement license to a pharmacy intern, seven dollars and fifty cents;

(L) For issuing a replacement identification card to a pharmacist, thirty-seven dollars and fifty cents, or pharmacy intern, seven

dollars and fifty cents;

(M) For certifying licensure and grades for reciprocal licensure, ten dollars;

(N) For making copies of any application, affidavit, or other document filed in the state board of pharmacy office, an amount fixed by the board that is adequate to cover the expense, except that for copies required by federal or state agencies or law enforcement officers for official purposes, no charge need be made;

(O) For certifying and affixing the seal of the board, an amount fixed by the board that is adequate to cover the expense, except that for certifying and affixing the seal of the board to a document required by federal or state agencies or law enforcement officers for official purposes, no charge need be made;

(P) For each copy of a book or pamphlet that includes laws administered by the state board of pharmacy, rules adopted by the board, and chapters of the Revised Code with which the board is required to comply, an amount fixed by the board that is adequate to cover the expense of publishing and furnishing the book or pamphlet.

4729.16 Revoke, suspend, place on probation, or refuse to grant or renew identification card hearing, notice; penalty; return of card

(A) The state board of pharmacy, after notice and hearing in accordance with Chapter 119. of the Revised Code, may revoke, suspend, place on probation, or refuse to grant or renew an identification card , or may impose a monetary penalty or forfeiture not to exceed in severity any fine designated under the Revised Code for a similar offense, or in the case of a violation of a section of the Revised Code that does not bear a penalty, a monetary penalty or forfeiture of not more than five hundred dollars, if the board finds a pharmacist or pharmacy intern:

(1) Guilty of a felony or gross immorality;

(2) Guilty of dishonesty or unprofessional conduct in the practice of pharmacy;

(3) Addicted to or abusing liquor or drugs or impaired physically or mentally to such a degree as to render the pharmacist or pharmacy intern unfit to practice pharmacy;

(4) Has been convicted of a misdemeanor related to, or committed in, the practice of pharmacy;

(5) Guilty of willfully violating, conspiring to violate, attempting to violate, or aiding and abetting the violation of any of the

provisions of this chapter, sections 3715.52 to 3715.72 , or Chapter 2925. OR 3719. of the Revised

Code;

(6) Guilty of permitting anyone other than a pharmacist or pharmacy intern to practice pharmacy;

(7) Guilty of knowingly lending the pharmacist's or pharmacy intern's name to an illegal practitioner of pharmacy or having professional connection with an illegal practitioner of pharmacy;

(8) Guilty of dividing or agreeing to divide remuneration made in the practice of pharmacy with any other individual, including, but not limited to, any licensed health professional authorized to prescribe drugs or any owner, manager, or employee of a health care facility, residential care facility, or nursing home;

(9) Has violated the terms of a consult agreement entered into pursuant to section 4729.39 .

(B) Any individual whose identification card is revoked, suspended, or refused, shall return the identification card and license to the offices of the state board of pharmacy within ten days after receipt of notice of such action.

(C) As used in this section:

"Unprofessional conduct in the practice of pharmacy" includes any of the following:

(1) Advertising or displaying signs that promote dangerous drugs to the public in a manner that is false or misleading;

(2) Except as provided in section 4729.281 , THE sale of any drug for which a prescription is required, without having received a prescription for the rug;

(3) Willfully and knowingly filling prescriptions or selling drugs for false or forged prescriptions;

(4) Willfully and knowingly failing to maintain complete and accurate records of all controlled substances 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) Obtaining or attempting to obtain a license issued under this chapter or chapter 3715.of the revised code from the state board of pharmacy by fraud, misrepresentation, or deception.

4729.17 Hearing before board

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.

4729.18 Treatment provider for pharmacists with substance abuse problems

The state board of pharmacy shall adopt rules in accordance with Chapter 119. of the Revised Code establishing standards for approving and designating physicians and facilities as treatment providers for pharmacists with substance abuse problems and shall approve and designate treatment providers in accordance with the rules. The rules shall include standards for both inpatient and outpatient treatment. The rules shall provide that to be approved, a treatment provider must be capable of making an initial examination to determine the type of treatment required for a pharmacist with substance abuse problems. Subject to the rules, the board shall review and approve treatment providers on a regular basis and may, at its discretion, withdraw or deny approval.

An approved treatment provider shall:

(A) Report to the board the name of any pharmacist suffering or showing evidence of suffering impairment by reason of being addicted to or abusing liquor or drugs as described in division (A)(3) of section 4729.16 of the Revised Code who fails to comply within one week with a referral for examination;

(B) Report to the board the name of any impaired pharmacist who fails to enter treatment within forty-eight hours following the provider’s determination that the pharmacist needs treatment;

(C) Require every pharmacist who enters treatment to agree to a treatment contract establishing the terms of treatment and aftercare, including any required supervision or restrictions of practice during treatment or aftercare;

(D) Require a pharmacist to suspend practice on entering any required inpatient treatment;

(E) Report to the board any failure by an impaired pharmacist to comply with the terms of the treatment contract during inpatient or outpatient treatment or aftercare;

(F) Report to the board the resumption of practice of any impaired pharmacist before the treatment provider has made a clear determination that the pharmacist is capable of practicing according to acceptable and prevailing standards;

(G) Require a pharmacist who resumes practice after completion of treatment to comply with an aftercare contract that meets the requirements of rules adopted by the board for approval of treatment providers;

(H) Report to the board any pharmacist who suffers a relapse at any time during or following aftercare.

Any pharmacist who enters into treatment by an approved treatment provider shall be deemed to have waived any confidentiality requirements that would otherwise prevent the treatment provider from making reports required under this section.

In the absence of fraud or bad faith. no professional association of pharmacists licensed under this chapter that sponsors a committee or program to provide peer assistance to pharmacists with substance abuse problems, no representative or agent of such a committee or program, and no member of the state board of pharmacy shall be liable to any person for damages in a civil action by reason of actions taken to refer a pharmacist to a treatment provider designated by the board or actions or omissions of the provider in treating a pharmacist. In the absence of fraud or bad faith, no person who reports to the board a pharmacist with a suspected substance abuse problem shall be liable to any person for damages in a civil action as a result of the report.

Section 4729.25 Board to enforce and investigate violations

(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 in accordance with its rules adopted under section 4729.26 of the revised code. with regard to violations of sections 4729.51 to 4729.62 , the board's actions also shall be taken in accordance with section 4729.63 .

(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.

Section 4729.26 Board to adopt rules

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 pertaining to the practice of pharmacy. The rules shall be published and made available by the board to each pharmacist licensed under this chapter.

Section 4729.27 Pharmacist must be in charge of pharmacy

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.

Section 4729.28 Only pharmacist or intern to engage in practice of pharmacy

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.

Section 4729.281 Pharmacist dispensing drug without a prescription; Conditions

(A) A pharmacist may dispense or sell a dangerous drug, other than a schedule II controlled substance as defined in section 3719.01 of the revised code, without a written or oral prescription from a licensed health professional authorized to prescribe drugs if all of the following conditions are met:

(1) The pharmacy at which the pharmacist works has a record of a prescription for the drug in the name of the patient who is requesting it, but the prescription does not provide for a refill or the time permitted by rules adopted by the state board of pharmacy for providing refills has elapsed.

(2) The pharmacist is unable to obtain authorization to refill the prescription from the health care professional who issued the prescription or another health professional responsible for the patient's care.

(3) In the exercise of the pharmacist's professional judgment:

(a) The drug is essential to sustain the life of the patient or continue therapy for a chronic condition of the patient.

(b) Failure to dispense or sell the drug to the patient could result in harm to the health of the patient.

(4) The amount of the drug that is dispensed or sold under this section does not exceed a seventy-two hour supply as provided in the prescription.

(B) A pharmacist who dispenses or sells a drug under this section shall do all of the following:

(1) For one year after the date of dispensing or sale, maintain a record in accordance with this chapter of the drug dispensed or sold, including the name and address of the patient and the individual receiving the drug, if the individual receiving the drug is not the patient, the amount dispensed or sold, and the original prescription number;

(2) Notify the health professional who issued the prescription described in division (a)(1) of this section or another health professional responsible for the patient's care not later than seventy-two hours after the drug is sold or dispensed; (3) If applicable, obtain authorization for additional dispensing from one of the health professionals described in division (b)(2) of this section.

(C) A pharmacist who dispenses or sells a drug under this section may do so once for each prescription described in division (a)(1) of this section.

Section 4729.29 Prescriber dispensing and labeling

(A) Divisions (A) and (B) of section 4729.01 and SECTION 4729.28 of the Revised Code do not do either of the following:

(1) Apply to a licensed health professional authorized to prescribe drugs or 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.

(2) Apply to the sale of oxygen, peritoneal dialysis solutions, or the sale of drugs that are not dangerous drugs by a retail dealer, in original packages when labeled as required by the "Federal Food, Drug, and Cosmetic Act," 52 Stat. 1040 (1938), 21 U.S.C.A. 301, as amended.

(B) When a prescriber personally furnishes drugs to a patient pursuant to division (a)(1) of this section, 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.

(C) Nothing in this chapter prohibits a person who is certified to administer topical ocular pharmaceutical agents under Chapter 4725. of the Revised Code from purchasing, possessing, or administering topical ocular pharmaceutical agents in accordance with Chapter 4725. of the Revised Code.

Section 4729.30 Conditions for selling Paris Green

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.

4729.31 Exceptions

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.

4729.32 Requirements for sale of denatured or wood alcohol in five gallon lots or more

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.

4729.33 Requirements for sale of denatured or wood alcohol in less than five gallon lots

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.

4729.34 Advertising

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.

472935 Unlawful distribution of drugs of abuse; prosecution

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.

4729.36 Advertising prohibitions

(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.

Section 4729.37 Filling prescriptions; records

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.

Section 4729.38 Substitution of generically equivalent drugs; conditions

(A) Unless instructed otherwise by the person receiving the drug pursuant to the prescription, a pharmacist filling a prescription for a drug prescribed by its brand name may select a generically equivalent drug, as defined in section 3715.01 of the Revised Code, subject to the following conditions:

(1) The pharmacist shall not select a generically equivalent drug if the prescriber handwrites "dispense as written," or "D.A.W.," on the written prescription, or, when ordering a prescription electronically or orally, the prescriber specifies that the prescribed drug is medically necessary. These designations shall not be preprinted or stamped on the prescription. Division (A)(1) of this section does not preclude a reminder of the procedure required to prohibit the selection of a generically equivalent drug from being preprinted on the prescription.

(2) The pharmacist shall not select a generically equivalent drug unless its price to the patient is less than or equal to the price of the prescribed drug.

(3) The pharmacist, or the pharmacist's agent, assistant, or employee shall inform the patient or the patient's agent if a generically equivalent drug isavailable at a lower or equal cost, and of the person's right to refuse the drug selected. Division (A)(3) of this section does not apply to any:

(a) Prescription that is billed to any agency, division, or department of this state which will reimburse the pharmacy;

(b) Prescriptions for patients of a hospital, nursing home, or similar patient care facility.

(B) Unless the prescriber instructs otherwise, the label for every drug dispensed shall include the drug's brand name, if any, or

its generic name and the name of the distributor, using abbreviations if necessary. WHEN dispensing at retail a generically equivalent drug for the brand

name drug prescribed, the pharmacist shall indicate on the drug's label or container that a genericsubstitution was made. the labeling requirements established by this division are inaddition to all other labeling requirements of Chapter 3715. of the Revised Code.

(C) A pharmacist who selects a generically equivalent drug pursuant to this section assumes no greater liability for selecting thedispensed drug than would be incurred in filling a prescription for a drug prescribed by its brand name.

(D) The failure of a prescriber to restrict a prescription by specifying "dispense as written," or "D.A.W.," pursuant to division(A)(1) of this section shall not constitute evidence of the prescriber's negligence unless the prescriber had reasonable cause to believe that the health condition of the patient for whom the drug was intended warranted the prescription of a specific brand name drug and no other. No prescriber shall be liable for civil damages or in any criminal prosecution arising from the interchange of a generically equivalent drug for a prescribed brand name drug by a pharmacist, unless the prescribed brand name drug would have reasonably caused the same loss, damage, injury, or death.

Section 4729.381 Pharmacist not liable for dispensing in certain situations

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.

Section 4729.39 Consult agreements authorized; conditions

(A) A pharmacist may enter into a consult agreement with a physician authorized under chapter 4731. of the revised code to practice medicine and surgery or osteopathic medicine and surgery. under a consult agreement, a pharmacist is authorized to manage an individual's drug therapy, but only to the extent specified in the agreement by the individual's physician and to the extent specified in this section and the rules adopted under this section.

A separate consult agreement must be entered into for each individual whose drug therapy is to be managed by a pharmacist. a consult agreement applies only to the particular diagnosis for which a physician prescribed an individual's drug therapy. If a different diagnosis is made for the individual, the pharmacist and physician must enter into a new or additional consult agreement.

Management of an individual's drug therapy by a pharmacist under a consult agreement may include monitoring and modifying a prescription that has been issued for the individual. Except as provided in section 4729.38 of the revised code for the selection of generically equivalent drugs, management of an individual's drug therapy by a pharmacist under a consult agreement shall not include dispensing a drug that has not been prescribed by the physician.

Each consult agreement shall be in writing, except that a consult agreement may be entered into verbally if it is immediately reduced to writing. a consult agreement may not be implemented until it has been signed by the pharmacist, the physician, and the individual whose drug therapy will be managed or another person who has the authority to provide consent to treatment on behalf of the individual. The physician shall specify in the agreement the extent to which the pharmacist is authorized to manage the drug therapy of the individual specified in the agreement. The physician shall include in the individual's medical record the fact that a consult agreement has been entered into with a pharmacist.

Prior to commencing any action to manage an individual's drug therapy under a consult agreement, the pharmacist shall make reasonable attempts to contact and confer with the physician who entered into the consult agreement with the pharmacist. A pharmacist may commence an action to manage an individual's drug therapy prior to conferring with the physician, but shall immediately cease the action that was commenced if the pharmacist has not conferred with the physician within forty-eight hours.

A pharmacist acting under a consult agreement shall maintain a record of each action taken to manage an individual's drug therapy. the pharmacist shall send to the individual's physician a written report of all actions taken to manage the individual's drug therapy at intervals the physician shall specify when entering into the agreement. The physician shall include the pharmacist's report in the medical records the physician maintains for the individual.

A consult agreement may be terminated by either the pharmacist or physician who entered into the agreement. by withdrawing consent, the individual whose drug therapy is being managed or the individual who consented to the treatment on behalf of the individual may terminate a consult agreement. the pharmacist or physician who receives the individual's withdrawal of consent shall provide written notice to the opposite party. a pharmacist or physician who terminates a consult agreement shall provide written notice to the opposite party and to the individual who consented to treatment under the agreement. the termination of a consult agreement shall be recorded by the pharmacist and physician in the records they maintain on the individual being treated.

The authority of a pharmacist to manage an individual's drug therapy under a consult agreement does not permit the pharmacist to manage drug therapy prescribed by any other physician or to manage an individual's drug therapy in a hospital or health care facility at which the pharmacist is not authorized to practice.

(B) The state board of pharmacy, in consultation with the state medical board, shall adopt rules to be followed by pharmacists, and the state medical board, in consultation with the state board of pharmacy, shall adopt rules to be followed by physicians, that establish standards and procedures for entering into a consult agreement and managing an individual's drug therapy under a consult agreement. The boards shall specify in the rules any categories of drugs or types of diseases for which a consult agreement may not be established. either board may adopt any other rules it considers necessary for the implementation and administration of this section. all rules adopted under this division shall be adopted in accordance with chapter 119. of the revised code.

4729.51 Persons who may sell, deliver, distribute and possess dangerous drugs

(A) No person other than a registered wholesale distributor of dangerous drugs shall possess for sale, sell, distribute, or deliver, at wholesale, dangerous drugs, except as follows:

(1) A pharmacist who is a licensed terminal distributor of dangerous drugs or who is employed by a licensed terminal distributor of dangerous drugs may make occasional sales of dangerous drugs at wholesale;

(2) A licensed terminal distributor of dangerous drugs having more than one establishment or place may transfer or deliver dangerous drugs from one establishment or place for which a license has been issued to the terminal distributor to another establishment or place for which a license has been issued to the terminal distributor if the license issued for each establishment or place is in effect at the time of the transfer or delivery.

(B)(1) No registered wholesale distributor of dangerous drugs shall possess for sale, or sell, at wholesale, dangerous drugs to any person other than the following:

(a) A licensed health professional authorized to prescribe drugs;

(b) A registered wholesale distributor of dangerous drugs;

(c) A manufacturer of dangerous drugs;

(d) A licensed terminal distributor of dangerous drugs, subject to division (B)(2) of this section;

(e) Carriers or warehousers for the purpose of carriage or storage;

(f) Terminal or wholesale distributors of dangerous drugs who are not engaged in the sale of dangerous drugs within this state;

(g) An individual who holds a current license, certificate, or registration issued under Title 47 of the Revised Code and has been certified to conduct diabetes education by a national certifying body specified in rules adopted by the state board of pharmacy under section 4729.68 of the Revised Code, but only with respect to insulin that will be used for the purpose of diabetes education and only if diabetes education is within the individual's scope of practice under statutes and rules regulating the individual's profession.

(2) No registered wholesale distributor of dangerous drugs shall possess dangerous drugs for sale at wholesale, or sell such drugs at wholesale, to a licensed terminal distributor of dangerous drugs, except to:

(a) A terminal distributor who has a category I license, only dangerous drugs described in category I, as defined in division (A)(1) of section 4729.54 of the Revised Code;

(b) A terminal distributor who has a category II license, only dangerous drugs described in category I and category II, as defined in divisions (A)(1) and (2) of section 4729.54 of the Revised Code;

(c) A terminal distributor who has a category III license, dangerous drugs described in category I, category II, and category III, as defined in divisions (A)(1), (2), and (3) of section 4729.54 of the Revised Code;

(d) A terminal distributor who has a limited category I, II, or III license, only the dangerous drugs specified in the certificate furnished by the terminal distributor in accordance with section 4729.60 of the Revised Code.

(C)

(1) Except as provided in division (C)(4) of this section, no person shall sell, at retail, dangerous drugs.

(2) Except as provided in division (C)(4) of this section, no person shall possess for sale, at retail, dangerous drugs.

(3) Except as provided in division (C)(4) of this section, no person shall possess dangerous drugs.

(4) Divisions (C)(1), (2), and (3) of this section do not apply to a registered wholesale distributor of dangerous drugs, a licensed terminal distributor of dangerous drugs, or a person who possesses, or possesses for sale or sells, at retail, a dangerous drug in accordance with Chapters 3719., 4715., 4725., 4729., 4731., and 4741. or section 4723.56 of the Revised Code.

Divisions (C)(1), (2), and (3) of this section do not apply to an individual who holds a current license, certificate, or registration issued under Title 47 of the Revised Code and has been certified to conduct diabetes education by a national certifying body specified in rules adopted by the state board of pharmacy under section 4729.68 of the Revised Code, but only to the extent that the individual possesses insulin or personally supplies insulin solely for the purpose of diabetes education and only if diabetes education is within the individual's scope of practice under statutes and rules regulating the individual's profession.

(D) No licensed terminal distributor of dangerous drugs shall purchase for the purpose of resale dangerous drugs from any person other than a registered wholesale distributor of dangerous drugs, except as follows:

(1) A licensed terminal distributor of dangerous drugs may make occasional purchases of dangerous drugs for resale from a pharmacist who is a licensed terminal distributor of dangerous drugs or who is employed by a licensed terminal distributor ofdangerous drugs;

(2) A licensed terminal distributor of dangerous drugs having more than one establishment or place may transfer or receive dangerous drugs from one establishment or place for which a license has been issued to the terminal distributor to another establishment or place for which a license has been issued to the terminal distributor if the license issued for each establishment or place is in effect at the time of the transfer or receipt.

(E) No licensed terminal distributor of dangerous drugs shall engage in the sale or other distribution of dangerous drugs at retail or maintain possession, custody, or control of dangerous drugs for any purpose other than the distributor's personal use or consumption, at any establishment or place other than that or those described in the license issued by the board of pharmacy to such terminal distributor.

(F) Nothing in this section shall be construed to interfere with the performance of official duties by any law enforcement official authorized by municipal, county, state, or federal law to collect samples of any drug, regardless of its nature or in whose possession it may be.

Section 4729.52 Registration as wholesaler distributor; fees

(A) A person desiring to be registered as a wholesale distributor of dangerous drugs shall file with the executive director of the state board of pharmacy a verified application containing such information as the board requires of the applicant relative to the qualifications to be registered as a wholesale distributor of dangerous drugs set forth in section 4729.53 of the Revised Code and the rules adopted under that section. The board shall register as a wholesale distributor of dangerous drugs each applicant who has paid the required registration fee, if the board determines that the applicant meets the qualifications to be registered as a wholesale distributor of dangerous drugs set forth in section 4729.53 of the revised code and the rules adopted under that section.

(B) The board may register and issue to a person who does not reside in this state a registration certificate as a wholesale distributor of dangerous drugs if the person possesses a current and valid wholesale distributor of dangerous drugs registration certificate or license issued by another state that has qualifications for licensure or registration comparable to the registration requirements in this state and pays the required registration fee.

(C) All registration certificates issued pursuant to this section are effective for a period of twelve months from the first day of July of each year. A registration certificate shall be renewed annually by the board for a like period, pursuant to this section and the standard renewal procedure of Chapter 4745. of the Revised Code. A person desiring to renew a registration certificate shall submit an application for renewal and pay the required renewal fee before the first day of July each year.

(D) Each registration certificate and its application shall describe not more than one establishment or place where the registrant or applicant may engage in the sale of dangerous drugs at wholesale. No registration certificate shall authorize or permit the wholesale distributor of dangerous drugs named therein to engage in the sale of drugs at wholesale or to maintain possession, custody, or control of dangerous drugs for any purpose other than for the registrant's own use and consumption at any establishment or place other than that described in the certificate.

(E)(1) The registration fee is one hundred fifty dollars and shall accompany each application for registration. The registration renewal fee is one hundred fifty dollars and shall accompany each renewal application.

A registration certificate that has not been renewed in any year by the first day of August may be reinstated upon payment of the renewal fee and a penalty of fifty-five dollars.

(2) Renewal fees and penalties assessed under division (E)(1) of this section shall not be returned if the applicant fails to qualify for renewal.

(F) The registration of any person as a wholesale distributor of dangerous drugs subjects the person and the person's agents and employees to the jurisdiction of the board and to the laws of this state for the purpose of the enforcement of this chapter and the rules of the board. However, the filing of an application for registration as a wholesale distributor of dangerous drugs by, or on behalf of, any person or the registration of any person as a wholesale distributor of dangerous drugs shall not, of itself, constitute evidence that the person is doing business within this state.

(A) The board of pharmacy shall not register any person as a wholesale distributor of dangerous drugs unless the applicant for registration furnishes satisfactory proof to the board of pharmacy that he meets all of the following:

(1) That if the applicant has been convicted of a violation of any federal, state, or local law relating to drug samples, wholesale or retail drug distribution, or distribution of controlled substances or of a felony, or if a federal, state, or local governmental entity has suspended or revoked any current or prior license or registration of the applicant for the manufacture or sale of any dangerous drugs, including controlled substances, the applicant, to the satisfaction of the board, assures that he has in place adequate safeguards to prevent the recurrence of any such violations;

(2) The applicant’s past experience in the manufacture or distribution of dangerous drugs, including controlled substances, is acceptable to the board.

(3) The applicant is equipped as to land, buildings, equipment, and personnel to properly carry on the business of a wholesale distributor of dangerous drugs, including providing adequate security for and proper storage conditions and handling for dangerous drugs, and is complying with the requirements under this chapter and the rules adopted pursuant thereto for maintaining and making available records to properly identified board officials and federal, state, and local law enforcement agencies.

(4) Personnel employed by the applicant have the appropriate education or experience, as determined by the board, to assume responsibility for positions related to compliance with this chapter and the rules adopted pursuant thereto.

(5) The applicant has designated the name and address of a person to whom communications from the board may be directed and upon whom the notices and citations provided for in section 4729.56 of the Revised Code may be served.

(6) Adequate safeguards are assured to prevent the sale of dangerous drugs to any person other than those named in division (B) of section 4729.51 of the Revised Code.

(7) Any other requirement or qualification the board, by rule adopted in accordance with Chapter 119. of the Revised Code, considers relevant to and consistent with the public safety and health.

(B) The board may refuse to register or renew the registration certificate of any person if the board determines that the granting of the registration certificate or its renewal is not in the public interest.

(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.

(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 licensed 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 120^th general assembly.

4729.54 Categories of licenses of terminal distributors of dangerous drugs; applications; authority fees; requirements upon licensees

(A) As used in this section:

(1) "Category I" means single-dose injections of intravenous fluids, including saline, Ringer's lactate, five per cent dextrose and distilled water, and other intravenous fluids or parenteral solutions included in this category by rule of the board of pharmacy, that have a volume of one hundred milliliters or more and that contain no added substances, or single-dose injections of epinephrine to be administered pursuant to sections 4765.38 and 4765.39 of the Revised Code.

(2) "Category II" means any dangerous drug that is not included in category I or III.

(3) "Category III" means any controlled substance that is contained in schedule I, II, III, IV, or V.

(4) "Emergency medical service organization" has the same meaning as in section 4765.01 of the Revised Code.

(5) "Person" includes an emergency medical service organization.

(6) "Schedule I, schedule II, schedule III, schedule IV, and schedule V" mean controlled substance schedules I, II, III, IV, and V, respectively, as established pursuant to section 3719.41 of the Revised Code and as amended.

(B) A person who desires to be licensed as a terminal distributor of dangerous drugs shall file with the executive director of the board of pharmacy a verified application that contains the following:

(1) Information that the board requires relative to the qualifications of a terminal distributor of dangerous drugs set forth in section 4729.55 of the Revised Code;

(2) A statement that the person wishes to be licensed as a category I, category II, category III, limited category I, limited category II, or limited category III terminal distributor of dangerous drugs;

(3) If the person wishes to be licensed as a limited category I, limited category II, or limited category III terminal distributor of

dangerous drugs, a notarized list of the dangerous drugs that the person wishes to possess, have custody or control of, and distribute, which list shall also specify the purpose for which those drugs will be used and their source;

(4) If the person is an emergency medical service organization, the information that is specified in division (C)(1) of this section;

(5) Except for an emergency medical service organization, the identity of the one establishment or place at which the person intends to engage in the sale or other distribution of dangerous drugs at retail, and maintain possession, custody, or control of dangerous drugs for purposes other than the person's own use or consumption.

(C)(1) An emergency medical service organization that wishes to be licensed as a terminal distributor of dangerous drugs shall list in its application for licensure the following additional information:

(a) The units under its control that the organization determines will possess dangerous drugs for the purpose of administering emergency medical services in accordance with Chapter 4765. of the Revised Code;

(b) With respect to each such unit, whether the dangerous drugs that the organization determines the unit will possess are in category I, II, or III.

(2) An emergency medical service organization that is licensed as a terminal distributor of dangerous drugs shall file a new application for such licensure if there is any change in the number, or location of, any of its units or any change in the category of the dangerous drugs that any unit will possess.

(3) A unit listed in an application for licensure pursuant to division (C)(1) of this section may obtain the dangerous drugs it is authorized to possess from its emergency medical service organization or, on a replacement basis, from a hospital pharmacy. If units will obtain dangerous drugs from a hospital pharmacy, the organization shall file, and maintain in current form, the following items with the pharmacist who is responsible for the hospital's terminal distributor of dangerous drugs license:

(a) A copy of its standing orders or protocol;

(b) A list of the personnel employed or used by the organization to provide emergency medical services in accordance with Chapter 4765. of the Revised Code, who are authorized to possess the drugs, which list also shall indicate the personnel who are authorized to administer the drugs.

(D) Each emergency medical service organization that applies for a terminal distributor of dangerous drugs license shall submit with its application the following:

(1) A notarized copy of its standing orders or protocol, which orders or protocol shall be signed by a physician and specify the dangerous drugs that its units may carry, expressed in standard dose units;

(2) A list of the personnel employed or used by the organization to provide emergency medical services in accordance with Chapter 4765. of the Revised Code.

An emergency medical service organization that is licensed as a terminal distributor shall notify the board immediately of any changes in its standing orders or protocol.

(E) There shall be six categories of terminal distributor of dangerous drugs licenses, which categories shall be as follows:

(1) Category I license. A person who obtains this license may possess, have custody or control of, and distribute only the dangerous drugs described in category I.

(2) Limited category I license. A person who obtains this license may possess, have custody or control of, and distribute only the dangerous drugs described in category I that were listed in the application for licensure.

(3) Category II license. A person who obtains this license may possess, have custody or control of, and distribute only the dangerous drugs described in category I and category II.

(4) Limited category II license. A person who obtains this license may possess, have custody or control of, and distribute only the dangerous drugs described in category I or category II that were listed in the application for licensure.

(5) Category III license. A person who obtains this license may possess, have custody or control of, and distribute the dangerous drugs described in category I, category II, and category III.

(6) Limited category III license. A person who obtains this license may possess, have custody or control of, and distribute only the dangerous drugs described in category I, category II, or category III that were listed in the application for licensure.

(F) Except for an application made on behalf of an animal shelter, if an applicant for licensure as a limited category I, II, or III terminal distributor of dangerous drugs intends to administer dangerous drugs to a person or animal, the applicant shall submit, with the application, a notarized copy of its protocol or standing orders, which protocol or orders shall be signed by a licensed health professional authorized to prescribe drugs, specify the dangerous drugs to be administered, and list personnel who are authorized to administer the dangerous drugs in accordance with federal law or the law of this state. An application made on behalf of an animal shelter shall include a notarized list of the dangerous drugs to be administered to animals and the personnel who are authorized to administer the drugs to animals in accordance with section 4729.532 of the Revised Code. After obtaining a terminal distributor license, a licensee shall notify the board immediately of any changes in its protocol or standing orders, or in such personnel.

(G) (1) Except as provided in division (g)(2) of this seciton, each applicant for licensure as a terminal distributor of dangerous drugs shall submit, with the application, a license fee determined as follows:

(a) For a category I or limited category I license, forty-five dollars;

(b) For a category II or limited category II license, one hundred twelve dollars and fifty cents;

(c) For a category III or limited category III license, one hundred fifty dollars.

(2) For a professional association, corporation, partnership, or limited liability company organized for the purpose of practicing veterinary medicine, the fee shall be five dollars.

Fees assessed under divisions (G)(1) and (2) of this section shall not be returned if the applicant fails to qualify for registration.

(H)

(1) The board shall issue a terminal distributor of dangerous drugs license to each person who submits an application for such licensure in accordance with this section, pays the required license fee, is determined by the board to meet the requirements set forth in section 4729.55 of the Revised Code, and satisfies any other applicable requirements of this section.

(2) The license of a person other than an emergency medical service organization shall describe the one establishment or place at which the licensee may engage in the sale or other distribution of dangerous drugs at retail and maintain possession, custody, or control of dangerous drugs for purposes other than the licensee's own use or consumption. The one establishment or place shall be that which is described in the application for licensure.

No such license shall authorize or permit the terminal distributor of dangerous drugs named in it to engage in the sale or other distribution of dangerous drugs at retail or to maintain possession, custody, or control of dangerous drugs for any purpose other than the distributor's own use or consumption, at any establishment or place other than that described in the license, except that an agent or employee of an animal shelter may possess and use dangerous drugs in the course of business as provided in division (D) of section 4729.532 of the Revised Code.

(3) The license of an emergency medical service organization shall cover and describe all the units of the organization listed in its application for licensure.

(4) The license of every terminal distributor of dangerous drugs shall indicate, on its face, the category of licensure. If the license is a limited category I, II, or III license, it shall specify, and shall authorize the licensee to possess, have custody or control of, and distribute only, the dangerous drugs that were listed in the application for licensure.

(I) All licenses issued pursuant to this section shall be effective for a period of twelve months from the first day of January of each year. A license shall be renewed by the board for a like period, annually, according to the provisions of this section, and the standard renewal procedure of Chapter 4745. of the Revised Code. A person who desires to renew a license shall submit an application for renewal and pay the required fee on or before the thirty-first day of December each year. The fee required for the renewal of a license shall be the same as the fee paid for the license being renewed, and shall accompany the application for renewal.

A license that has not been renewed during December in any year and by the first day of February of the following year may be reinstated only upon payment of the required renewal fee and a penalty fee of fifty-five dollars.

(J)(1) No emergency medical service organization that is licensed as a terminal distributor of dangerous drugs shall fail to comply with division (C)(2) or (3) of this section.

(2) No emergency medical service organization that is licensed as a terminal distributor of dangerous drugs shall fail to comply with division (D) of this section.

(3) No licensed terminal distributor of dangerous drugs shall possess, have custody or control of, or distribute dangerous drugs that the terminal distributor is not entitled to possess, have custody or control of, or distribute by virtue of its category of licensure.

(4) No licensee that is required by division (F) of this section to notify the board of changes in its protocol or standing orders, or in personnel, shall fail to comply with that division.

Section 4729.55 Qualifications of terminal distributor

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 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) 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.

(E) 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.

(F) 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.

(G) 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.

(H) 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.

(A) In accordance with Chapter 119. of the Revised Code, the board of pharmacy may suspend, revoke, or refuse to renew any registration certificate issued to a wholesale distributor of dangerous drugs pursuant to section 4729.52 of the Revised Code or may impose a monetary penalty or forfeiture not to exceed in severity any fine designated under the Revised Code for a similar offense or one thousand dollars if the acts committed are not classified as an offense by the Revised Code for any of the following causes:

(1) Making any false material statements in an application for registration as a wholesale distributor of dangerous drugs;

(3) A conviction of a felony;

(4) Ceasing to satisfy the qualifications for registration under section 4729.53 of the Revised Code or the rules of the board.

(B) Upon the suspension or revocation of the registration certificate of any wholesale distributor of dangerous drugs, the distributor shall immediately surrender his registration certificate to the board.

(C) If the board suspends, revokes, or refuses to renew any registration certificate issued to a wholesale distributor of dangerous drugs and determines that there is clear and convincing evidence of a danger of immediate and serious harm to any person, the board may place under seal all dangerous drugs owned by or in the possession, custody, or control of the affected wholesale distributor of dangerous drugs. Except as provided in this division, the board shall not dispose of the dangerous drugs sealed under this division until the wholesale distributor of dangerous drugs exhausts all of his appeal rights under Chapter 119. of the Revised Code. The court involved in such an appeal may order the board, during the pendency of the appeal, to sell sealed dangerous drugs that are perishable. The board shall deposit the proceeds of the sale with the court.

4729.57 Revocation of license of terminal distributor, monetary penalty; sealing dangerous drugs of suspended licensee

(A) The state board of pharmacy may suspend, revoke, or refuse to renew any license issued to a terminal distributor of dangerous drugs pursuant to section 4729.54 of the Revised Code, or may impose a monetary penalty or forfeiture not to exceed in severity any fine designated under the Revised Code for a similar offense or one thousand dollars if the acts committed have not been classified as an offense by the Revised Code, for any of the following causes:

(1) Making any false material statements in an application for a license as a terminal distributor of dangerous drugs;

(2) Violating any rule of the board;

(3) Violating any provision of this chapter;

(4) Violating any provision of the "Federal Food, Drug, and Cosmetic Act," 52 Stat. 1040 (1938), 21 U.S.C.A. 301, or Chapter 3715. of the Revised Code;

(5) Violating any provision of the federal drug abuse control laws or chapter 2925. or 3719. of the Revised Code;

(6) Falsely or fraudulently promoting to the public a dangerous drug, except that nothing in this division prohibits a terminal distributor of dangerous drugs from furnishing information concerning a dangerous drug to a health care provider or another licensed terminal distributor;

(7) Ceasing to satisfy the qualifications of a terminal distributor of dangerous drugs set forth in section 4729.55 of the Revised Code;

(8) Except as provided in division (B) of this section:

(a)Waiving the payment of all or any part of a deductible or copayment that an individual, pursuant to a health insurance or health care policy, contract, or plan that covers the services provided by a terminal distributor of dangerous drugs, would otherwise be required to pay for the services if the waiver is used as an enticement to a patient or group of patients to receive pharmacy services from that terminal distributor;

(b) Advertising that the terminal distributor will waive the payment of all or any part of a deductible or copayment that an individual, pursuant to a health insurance or health care policy, contract, or plan that covers the pharmaceutical services, would otherwise be required to pay for the services.

(B) Sanctions shall not be imposed under division (A)(8) of this section against any terminal distributor of dangerous drugs that waives deductibles and copayments as follows:

(1) In compliance with a health benefit plan that expressly allows such a practice, waiver of the deductibles or copayments shall be made only with the full knowledge and consent of the plan purchaser, payer, and third-party administrator. Documentation of the consent shall be made available to the board on request.

(2) For professional services rendered to any other person licensed pursuant to this chapter to the extent allowed by this chapter and the rules of the board.

(C)(1) Upon the suspension or revocation of a license issued to a terminal distributor of dangerous drugs or the refusal by the board to renew such a license, the distributor shall immediately surrender the license to the board.

(2) The board may place under seal all dangerous drugs that are owned by or in the possession, custody, or control of a terminal distributor at the time the license is suspended or revoked or at the time the board refuses to renew the license. Except as otherwise provided in this division, dangerous drugs so sealed shall not be disposed of until appeal rights under Chapter 119. of the Revised Code have expired or an appeal filed pursuant to that chapter has been determined.

The court involved in an appeal filed pursuant to Chapter 119. of the Revised Code may order the board, during the pendency of the appeal, to sell sealed dangerous drugs that are perishable. The proceeds of such a sale shall be deposited with that court.

4729.58 Issuance or renewal of license or registration certificate

The board of pharmacy, within thirty days after receipt of an application filed in the form and manner set forth in section 4729.52 or 4729.54 of the Revised Code for the issuance of a new license or registration certificate or the renewal of a license or registration certificate previously issued, shall notify the applicant therefor whether or not such license or registration certificate will be issued or renewed. If the board determines that such license or registration certificate will not be issued or renewed, such notice to the applicant shall set forth the reason or reasons that such license or registration certificate will not be issued or renewed.

4729.59 Registration of distributors; roster; evidence of distributor being licensed

The executive director of the state board of pharmacy shall maintain a register of the names, addresses, and the date of registration of those persons to whom a registration certificate has been issued pursuant to section 4729.52 of the Revised Code and those persons to whom a license has been issued pursuant to section 4729.54 of the Revised Code. the register shall be the property of the board and shall be open for public examination and inspection at all reasonable times, as the board may direct.

The board shall publish or make available to registered wholesale distributors and licensed terminal distributors of dangerous drugs, annually, and at such other times and in such manner as the board shall prescribe, a roster setting forth the names and addresses of those persons who have been registered by the board pursuant to section 4729.52 of the Revised Code and those persons who have been licensed pursuant to section 4729.54 of the Revised Code, those persons whose licenses or registration certificates have been suspended, revoked, or surrendered, and those persons whose licenses or registration certificates have not been renewed.

A written statement signed and verified by the executive director of the board in which it is stated that after diligent search of the register no record or entry of the issuance of a license or registration certificate to a person is found is admissible in evidence and constitutes presumptive evidence of the fact that the person is not a licensed terminal distributor or is not a registered wholesale distributor of dangerous drugs.

Section 4729.60 Certificate required by wholesale distributor

(A) Before a registered wholesale distributor of dangerous drugs may sell dangerous drugs at wholesale to any person other than a licensed health professional authorized to prescribe drugs, a registered wholesale distributor of dangerous drugs, a manufacturer of dangerous drugs, a carrier or a warehouser but only for the purpose of carriage or storage, or a terminal distributor of dangerous drugs who is not engaged in the sale of dangerous drugs within this state, such wholesale distributor shall obtain from the purchaser and the purchaser shall furnish to the wholesale distributor a certificate indicating that the purchaser is a licensed terminal distributor of dangerous drugs. The certificate shall be in the form that the state board of pharmacy shall prescribe, and shall set forth the name of the licensee, the number of the license, a description of the place or establishment or each place or establishment for which the license was issued, the category of licensure, and, if the license is a limited category I, II, or III license, the dangerous drugs that the licensee is authorized to possess, have custody or control of, and distribute.

If no certificate is obtained or furnished before A sale is made, it shall be presumed that the sale of dangerous drugs by the wholesale distributor is in violation of division (B) of section 4729.51 of the Revised Code and the purchase of dangerous drugs by the purchaser is in violation of division (C) of section 4729.51 of the Revised Code. If a registered wholesale distributor of dangerous drugs obtains or is furnished a certificate from a terminal distributor of dangerous drugs and relies on the certificate in selling dangerous drugs at wholesale to the terminal distributor of dangerous drugs, the wholesale distributor of dangerous drugs shall be deemed not to have violated division (B) of section 4729.51 of the Revised Code in making the sale.

(B) Before a licensed terminal distributor of dangerous drugs may purchase dangerous drugs at wholesale, the terminal distributor shall obtain from the seller and the seller shall furnish to the terminal distributor the number of the seller's registration certificate to engage in the sale of dangerous drugs at wholesale.

If no registration number is obtained or furnished before A purchase is made, it shall be presumed that the purchase of dangerous drugs by the terminal distributor is in violation of division (D) of section 4729.51 of the Revised Code and the sale of dangerous drugs by the seller is in violation of division (A) of section 4729.51 of the Revised Code. If a licensed terminal distributor of dangerous drugs obtains or is furnished a registration number from a wholesale distributor of dangerous drugs and relies on the registration number in purchasing dangerous drugs at wholesale from the wholesale distributor of dangerous drugs, the terminal distributor shall be deemed not to have violated division (D) of section 4729.51 of the Revised Code in making the purchase.

4729.61 False registration certificate

(A) No person shall make or cause to be made, or furnish or cause to be furnished to a wholesale distributor of dangerous drugs, a false certificate required to be furnished to a wholesale distributor of dangerous drugs by section 4729.60 of the Revised Code for the purchase of dangerous drugs at wholesale.

(B) No person shall make or cause to be made a false registration certificate of a wholesale distributor of dangerous drugs or a false or fraudulent license of a terminal distributor of dangerous drugs.

4729.62 Surrender of license or certificate

If a wholesale distributor of dangerous drugs who has been registered ceases to engage in the sale of dangerous drugs at wholesale, or if a terminal distributor of dangerous drugs to whom a license has been issued ceases to engage in the sale of dangerous drugs at retail, such terminal or wholesale distributor of dangerous drugs shall notify the board of pharmacy of such fact and shall surrender such license or registration certificate to the board; provided, that on dissolution of a partnership by death, the surviving partner may operate under a license or registration certificate issued to the partnership until expiration, revocation, or suspension of such license or registration certificate, and the heirs or legal representatives of deceased persons, and receivers and trustees in bankruptcy appointed by any competent authority, may operate under the license or registration certificate issued to the persons succeeded in possession by such heir, representative, receiver, or trustee in bankruptcy until expiration, revocation, or suspension of such license or registration certificate.

4729.63 Enforcement by board of pharmacy

If the state board of pharmacy has information that sections 4729.51 to 4729.62 of the Revised Code have been violated, it shall investigate the matter and upon probable cause appearing file a complaint in an appropriate court for prosecution of the offender. the attorney general, prosecuting attorney, or city director of law to whom the board reports any violation of sections 4729.51 to 4729.62 of the Revised Code shall cause appropriate proceedings to be instituted in the proper court without delay and to be prosecuted in the manner provided by law.

4729.64 Injunctive proceedings

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.

(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 signed 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 mandatory fines or forfeited bail to which the board may be entitled under Chapter 2925. or division (B)(5) 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. of the Revised Code, section 2923.32, 2923.35, or 2933.43 of the Revised Code, any other section of the Revised Code, or federal law shall be deposited into the fund. Subject to division (B)(l)(b) of this section, division (D)(2)(c) of section 2923.35, and divisions (D)(l)(c) and (3) of section 2933.43 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)(l)(a) 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 him paid into the state treasury to the credit of the occupational licensing and regulatory fund. The board, subject to the approval of the controlling board and except for fees required to be established by the board at amounts "adequate" to cover designated expenses, may establish fees in excess of the amounts provided by this chapter, provided that such fees do not exceed the amounts permitted by this chapter by more than fifty per cent.

4729.66 Rules and regulations of board of pharmacy

In addition to the rules it adopts for the practice of pharmacy under section 4729.26 , 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 pertaining to the purchase for resale, possession for sale, sale, and other distribution of dangerous drugs

Section 4729.67 Board to comply with Section 2301.373