reglab/statecodes huggingface dataset:
2023 Ohio Revised Code › Title 37 | Health-Safety-Morals › Chapter 3715 | Pure Food and Drug Law › Section 3715.504 | Administering Overdose Reversal Drugs.

Effective:
April 6, 2023
Latest Legislation:
House Bill 558 - 134th General Assembly
(A) In the case of an individual who is not otherwise authorized under the Revised Code to administer drugs, the individual may administer an overdose reversal drug under this section. This authority may be exercised by any individual who is in a position to assist another individual who is apparently experiencing an opioid-related overdose.
(B) An individual who administers an overdose reversal drug under the authority conferred by division (A) of this section is not liable for damages in a civil action for injury, death, or loss to person or property for an act or omission that arises from administering the drug, and not subject to administrative action or criminal prosecution for an act or omission that arises from administering the drug, if the individual, acting in good faith, does all of the following:
(1) Obtains the overdose reversal drug under section 3715.50, 3715.501, 3715.502, or 3715.503 or the Revised Code;
(2) Administers the overdose reversal drug to an individual who is apparently experiencing an opioid-related overdose;
(3) Attempts to summon emergency services as soon as practicable either before or after administering the overdose reversal drug, except that making such an attempt is not required if the individual administering the drug knows that emergency services already have been summoned or are present.
Last updated March 16, 2023 at 6:17 PM
2023 Ohio Revised Code › Title 37 | Health-Safety-Morals › Chapter 3715 | Pure Food and Drug Law › Section 3715.505 | [Former r.c. 4765.44, Amended and Renumbered by h.b. 558, 134th General Assembly, Effective 4/6/2023] Disclosure to Law Enforcement Agency Related to Administration of Overdose Reversal Drug.

Effective:
April 6, 2023
Latest Legislation:
House Bill 558 - 134th General Assembly
(A) As used in this section:
(1) "Emergency medical service personnel," "firefighter," and "volunteer firefighter" have the same meanings as in section 4765.01 of the Revised Code.
(2) "Law enforcement agency" means a government entity that employs peace officers to perform law enforcement duties.
(3) "Peace officer" has the same meaning as in section 2921.51 of the Revised Code.
(B)(1) Upon request of a law enforcement agency as described in division (B)(2) of this section, emergency medical service personnel and any firefighter or volunteer firefighter acting within the course of the firefighting profession shall disclose the name and address, if known, of an individual to whom the emergency medical service personnel, firefighter, or volunteer firefighter administered an overdose reversal drug due to an actual or suspected drug overdose, unless the emergency medical service personnel, firefighter, or volunteer firefighter reasonably believes that the law enforcement agency making the request does not have jurisdiction over the place where the overdose reversal drug was administered.
(2) A law enforcement agency may request a name and address of an individual under division (B)(1) of this section for the purposes of investigation or treatment referral and may use a name and address received under that division for either or both of those purposes.
Last updated March 16, 2023 at 6:23 PM
2023 Ohio Revised Code › Title 37 | Health-Safety-Morals › Chapter 3715 | Pure Food and Drug Law › Section 3715.521 | Prohibition Against Sale or Delivery of Expired Drug, Infant Formula or Baby Food.

Effective:
September 12, 2008
Latest Legislation:
House Bill 283 - 127th General Assembly
No person shall sell, offer for sale, or deliver at retail or to the consumer, any of the following:
(A) Any drug after the expiration date required by 21 C.F.R. 211.137 except pursuant to sections 3715.88 to 3715.92 of the Revised Code;
(B) Any infant formula after the "use by" date required by 21 C.F.R. 107.20;
(C) Any baby food after any expiration date, "use by" date, or sale date required by state or federal law or marked on the container by the manufacturer, processor, or packager.
2023 Ohio Revised Code › Title 37 | Health-Safety-Morals › Chapter 3715 | Pure Food and Drug Law › Section 3715.53 | Injunctions.

Effective:
July 22, 1998
Latest Legislation:
Senate Bill 66 - 122nd General Assembly
In addition to the remedies provided and irrespective of whether or not there exists an adequate remedy at law, the director of agriculture or the state board of pharmacy is hereby authorized to apply to the court of common pleas in the county wherein any of the provisions of section 3715.52 of the Revised Code are being violated for a temporary or permanent injunction restraining any person from committing the violation.
2023 Ohio Revised Code › Title 37 | Health-Safety-Morals › Chapter 3715 | Pure Food and Drug Law › Section 3715.54 | Exceptions to Liability.

Effective:
July 22, 1998
Latest Legislation:
Senate Bill 66 - 122nd General Assembly
(A) No person shall be subject to the penalties prescribed in section 3715.99 of the Revised Code for violating division (A)(1) or (3) of section 3715.52 of the Revised Code if the person established a guaranty or undertaking signed by, and containing the name and address of, the person residing in this state from whom the person received in good faith the article, to the effect that the article is not adulterated or misbranded within the meaning of sections 3715.01 and 3715.52 to 3715.72 of the Revised Code.
(B) No publisher, radio-broadcast licensee, or agency or medium for the dissemination of an advertisement, except the manufacturer, packer, distributor, or seller of the article to which a false advertisement relates, shall be liable under this section by reason of the dissemination of a false advertisement.
2023 Ohio Revised Code › Title 37 | Health-Safety-Morals › Chapter 3715 | Pure Food and Drug Law › Section 3715.551 | Embargo of Food.

Effective:
November 3, 1999
Latest Legislation:
House Bill 223 - 123rd General Assembly
(A) As used in this section, "board of health," "retail food establishment," and "food service operation" have the same meanings as in section 3717.01 of the Revised Code.
(B) The embargoing of a food may be performed by a board of health approved under section 3717.11 of the Revised Code to serve as the licensor of retail food establishments or food service operations, the director of health acting under section 3717.11 of the Revised Code as the licensor of food service operations, or a representative authorized to act on behalf of the board of health or director of health.
The director of agriculture shall adopt rules in accordance with Chapter 119. of the Revised Code specifying the conditions under which a food may be embargoed under this section and the procedures that must be followed when that action is taken.
2023 Ohio Revised Code › Title 37 | Health-Safety-Morals › Chapter 3715 | Pure Food and Drug Law › Section 3715.56 | Attorney General, Prosecuting Attorney or City Director of Law to Institute Proceedings and Prosecutions.

Effective:
July 22, 1998
Latest Legislation:
Senate Bill 66 - 122nd General Assembly
The attorney general, prosecuting attorney, or city director of law to whom the director of agriculture or the state board of pharmacy reports any violation of sections 3715.01 and 3715.52 to 3715.72 of the Revised Code, shall cause appropriate proceedings to be instituted in the proper court without delay and to be prosecuted in the manner required by law. The director of agriculture, before reporting any violation of sections 3715.01 and 3715.52 to 3715.72 of the Revised Code to any such attorney for the institution of a criminal proceeding, shall give the person against whom the proceeding is contemplated appropriate notice and an opportunity to present testimony before the director, either orally or in writing, in person, or by attorney, with regard to the contemplated proceeding.
2023 Ohio Revised Code › Title 37 | Health-Safety-Morals › Chapter 3715 | Pure Food and Drug Law › Section 3715.57 | Written Notice or Warning for Minor Violations Sufficient.

Effective:
July 22, 1998
Latest Legislation:
Senate Bill 66 - 122nd General Assembly
Nothing in sections 3715.01 and 3715.52 to 3715.72 of the Revised Code, shall be construed as requiring the director of agriculture or the state board of pharmacy to report minor violations for the institution of proceedings under sections 3715.01 and 3715.52 to 3715.72 of the Revised Code, whenever the director or board believes that the public interest will be adequately served in the circumstances by a suitable written notice or warning.
2023 Ohio Revised Code › Title 37 | Health-Safety-Morals › Chapter 3715 | Pure Food and Drug Law › Section 3715.59 | When Food Is Adulterated.

Effective:
November 21, 2001
Latest Legislation:
Senate Bill 136 - 124th General Assembly
Food is adulterated within the meaning of sections 3715.01, 3715.02, 3715.022, and 3715.52 to 3715.72 of the Revised Code, if any of the following apply:
(A) It bears or contains any poisonous or deleterious substance that may render it injurious to health; but in case the substance is not an added substance, the food shall not be considered adulterated if the quantity of the substance in the food does not ordinarily render it injurious to health.
(B) It bears or contains any added poisonous or added deleterious substance that is unsafe within the meaning of section 3715.62 of the Revised Code.
(C) It consists in whole or in part of a diseased, contaminated, filthy, putrid, or decomposed substance, or if it is otherwise unfit for food.
(D) It has been produced, processed, prepared, packed, or held under unsanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered diseased, unwholesome, or injurious to health.
(E) It is the product of a diseased animal or an animal that has died otherwise than by slaughter, or an animal that has been fed upon the uncooked offal from a slaughterhouse.
(F) Its container is composed, in whole or in part, of any poisonous or deleterious substance that may render the contents injurious to health.
(G) Any valuable constituent has been, in whole or in part, omitted or abstracted from the food.
(H) Any substance has been substituted wholly or in part for the food.
(I) Damage or inferiority has been concealed in any manner.
(J) Any substance has been added to or mixed or packed with the food so as to increase its bulk or weight, reduce its quality or strength, or make it appear better or of greater value than it is.
(K) It is confectionery and it bears or contains any alcohol or nonnutritive article or substance other than harmless coloring, harmless flavoring, harmless resinous glaze not in excess of four-tenths of one per cent, harmless natural wax not in excess of four-tenths of one per cent, harmless natural gum, or pectin, except that this division shall not apply to any confectionery by reason of its containing less than one-half of one per cent by volume of alcohol derived solely from the use of flavoring extracts, or to any chewing gum by reason of its containing harmless nonnutritive masticatory substances.
(L) It bears or contains 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 U.S.C.A. 301, as amended.
(M) It has been processed or produced in violation of section 3715.025 of the Revised Code.
2023 Ohio Revised Code › Title 37 | Health-Safety-Morals › Chapter 3715 | Pure Food and Drug Law › Section 3715.61 | Director of Agriculture - Powers Regarding Permits.

Effective:
September 10, 2012
Latest Legislation:
House Bill 487 - 129th General Assembly
(A) Whenever the director of agriculture finds after investigation that the distribution in this state of any class of food may, by reason of contamination with microorganisms during manufacture, processing, or packing thereof in any locality, be injurious to health, and that such injurious nature cannot be adequately determined after such articles have entered commerce, and in such case only, the director shall adopt rules providing for the issuance, to manufacturers, processor, or packers of such class of food in such locality, of permits to which shall be attached such conditions governing the manufacture, processing, or packing of such class food, for such temporary period of time, as may be necessary to protect the public health; and after the effective date of such regulations, and during such temporary period, no person shall introduce or deliver for introduction into commerce any such food manufactured, processed, or packed by any such manufacturer, processor, or packer unless such manufacturer, processor, or packer holds a permit issued by the director as provided by such rules.
(B) The director is authorized to suspend immediately upon notice any permit issued under authority of this section if it is found that any of the conditions of the permit have been violated. The holder of a permit so suspended shall be privileged at any time to apply for the reinstatement of such permit, and the director shall, immediately after prompt hearing and on inspection of the establishment, reinstate such permit if it is found that adequate measures have been taken to comply with and maintain the conditions of the permit, as originally issued, or as amended.
(C) The director shall have access to any factory or establishment, the operator of which holds a permit from the director for the purpose of ascertaining whether or not the conditions of the permit are being complied with, and denial of access for such inspection shall be ground for suspension of the permit until such access is freely given by the operator.
2023 Ohio Revised Code › Title 37 | Health-Safety-Morals › Chapter 3715 | Pure Food and Drug Law › Section 3715.62 | Unsafe Food.

Effective:
September 10, 2012
Latest Legislation:
House Bill 487 - 129th General Assembly
Any poisonous or deleterious substance added to any food, except where such substance is required in the production thereof or cannot be avoided by good manufacturing practice, shall be unsafe for purposes of the application of division (B) of section 3715.59 of the Revised Code, but when such substance is so required or cannot be so avoided, the director of agriculture shall adopt rules limiting the quantity therein or thereon to such extent as the director finds necessary for the protection of public health, and any quantity exceeding the limits so fixed shall also be deemed to be unsafe for purposes of the application of division (B) of section 3715.59 of the Revised Code. While such a regulation is in effect limiting the quantity of any such substance in the case of any food, such food shall not, by reason of bearing or containing any added amount of such substance, be considered to be adulterated within the meaning of division (A) of section 3715.59 of the Revised Code. In determining the quantity of such added substance to be tolerated in or on different articles of food, the director shall take into account the extent to which the use of such substance is required or cannot be avoided in the production of each such article and the other ways in which the consumer may be affected by the same or other poisonous or deleterious substances.
2023 Ohio Revised Code › Title 37 | Health-Safety-Morals › Chapter 3715 | Pure Food and Drug Law › Section 3715.63 | When Drug or Device Is Adulterated.

Effective:
September 12, 2008
Latest Legislation:
House Bill 283 - 127th General Assembly
(A) 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:
(1) It consists, in whole or in part, of any filthy, putrid, or decomposed substance.
(2) 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.
(3) 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.
(4) 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 U.S.C.A. 301, as amended.
(5) 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.
(6) It is not subject to the provisions of division (A)(5) of this section, and its strength differs from or its purity or quality falls below that which it purports or is represented to possess.
(7) It is a drug and any substance has been:
(a) Mixed or packed with the drug so as to reduce the drug's quality or strength;
(b) Substituted wholly or in part for the drug.
(B) An expired drug is not adulterated within the meaning of sections 3715.01 and 3715.52 to 3715.72 of the Revised Code if the drug is donated pursuant to sections 3715.88 to 3715.92 of the Revised Code.
2023 Ohio Revised Code › Title 37 | Health-Safety-Morals › Chapter 3715 | Pure Food and Drug Law › Section 3715.65 | Application for New Drug Required.

Effective:
April 15, 2005
Latest Legislation:
Senate Bill 202 - 125th General Assembly
(A) No person shall sell, deliver, offer for sale, hold for sale, or give away any new drug unless an application with respect to the drug has become effective under section 505 of the "Federal Food, Drug, and Cosmetic Act," 52 Stat. 1040 (1938), 21 U.S.C.A. 301, as amended.
(B) This section does not apply to the following:
(1) A drug intended solely for investigational use by experts qualified by scientific training and experience to investigate the safety of drugs, provided that the drug is plainly labeled "For investigational use only";
(2) A drug sold in this state at any time prior to the enactment of sections 3715.01 and 3715.52 to 3715.72 of the Revised Code, or introduced into interstate commerce at any time prior to the enactment of the "Federal Food, Drug, and Cosmetic Act";
(3) Any drug that is licensed under the "Public Health Service Act," 58 Stat. 682 (1944), 42 U.S.C.A. 301, as amended, or under the "Virus-Serum-Toxin Act," 37 Stat. 832 (1913), 21 U.S.C.A. 151, as amended.
2023 Ohio Revised Code › Title 37 | Health-Safety-Morals › Chapter 3715 | Pure Food and Drug Law › Section 3715.66 | Adulterated Cosmetics.

Effective:
July 22, 1998
Latest Legislation:
Senate Bill 66 - 122nd General Assembly
(A) A cosmetic is adulterated within the meaning of sections 3715.01 and 3715.52 to 3715.72 of the Revised Code, if:
(1) It bears or contains any poisonous or deleterious substance that may render it injurious to users under the conditions of use prescribed in the labeling or advertisement of the cosmetic, or under conditions of use that are customary or usual, except that this provision does not apply to coal-tar hair dye if both of the following conditions are met:
(a) The label bears the following legend conspicuously displayed thereon: "Caution-This product contains ingredients which may cause skin irritation on certain individuals and a preliminary test according to accompanying directions should first be made. This product must not be used for dyeing the eyelashes or eyebrows; to do so may cause blindness."
(b) The labeling bears adequate directions for preliminary testing.
(2) It contains, in whole or in part, any filthy, putrid, or decomposed substance.
(3) It has been produced, processed, prepared, packed, or held under unsanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.
(4) Its container is composed, in whole or in part, of any poisonous or deleterious substance that may render the contents injurious to health.
(5) It is not a hair dye and it bears or contains 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 U.S.C.A. 301, as amended.
(B) For purposes of divisions (A)(1) and (5) of this section, "hair dye" does not include eyelash dye or eyebrow dye.
2023 Ohio Revised Code › Title 37 | Health-Safety-Morals › Chapter 3715 | Pure Food and Drug Law › Section 3715.67 | Misbranded Cosmetics.

Effective:
January 9, 1961
Latest Legislation:
House Bill 1 - 104th General Assembly
A cosmetic is misbranded within the meaning of sections 3715.01 and 3715.52 to 3715.72, inclusive, of the Revised Code, if:
(A) Its labeling is false or misleading in any particular.
(B) It is in package form unless it bears a label containing:
(1) The name and place of business of the manufacturer, packer, or distributor;
(2) An accurate statement of the quantity of the contents in terms of weight, measure, or numerical count; provided, that reasonable variations shall be permitted, and exemptions as to small packages shall be established by regulations prescribed by the director of agriculture.
(C) Any word, statement, or other information required by or under authority of sections 3715.01 and 3715.52 to 3715.72, inclusive, of the Revised Code, to appear on the label or labeling is not prominently placed thereon with such conspicuousness, as compared with other words, statements, designs, or devices, in the labeling, and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
(D) Its container is so made, formed, or filled as to be misleading.
2023 Ohio Revised Code › Title 37 | Health-Safety-Morals › Chapter 3715 | Pure Food and Drug Law › Section 3715.68 | False or Misleading Advertisement.

Effective:
September 10, 2012
Latest Legislation:
House Bill 487 - 129th General Assembly
(A) An advertisement of food, drug, device, or cosmetic is false if it is false or misleading in any particular.
(B) For the purpose of sections 3715.01 and 3715.52 to 3715.72 of the Revised Code, the advertisement of a drug or device representing it to have any effect in albuminuria, appendicitis, arteriosclerosis, blood poison, bone disease, Bright's disease, cancer, carbuncles, cholecystitis, diabetes, diphtheria, dropsy, erysipelas, gallstones, heart and vascular diseases, high blood pressure, mastoiditis, measles, meningitis, mumps, nephritis, otitis media, paralysis, pneumonia, poliomyelitis (infantile paralysis), prostate gland disorders, pyelitis, scarlet fever, sexual impotence, sinus infection, tuberculosis, tumors, typhoid, uremia, venereal disease, is also false, except that no advertisement not in violation of division (A) of this section is false under this division if it is disseminated only to members of the medical, dental, pharmaceutical, or veterinary profession, or appears only in the scientific periodicals of these professions; provided, that whenever the director of agriculture determines that an advance in medical science has made any type of self-medication safe as to any of the diseases named above, the director shall adopt rules authorizing the advertisement of drugs having curative or therapeutic effect for such disease, subject to such conditions and restrictions as the director may deem necessary in the interests of public health; provided, that this division shall not be construed as indicating that self-medication for diseases other than those named in this section is safe or efficacious.
2023 Ohio Revised Code › Title 37 | Health-Safety-Morals › Chapter 3715 | Pure Food and Drug Law › Section 3715.69 | Adoption of Rules for Enforcement.

Effective:
July 22, 1998
Latest Legislation:
Senate Bill 66 - 122nd General Assembly
The authority to adopt rules for the enforcement of section 3715.02, divisions (E), (G), (H), and (I) of section 3715.60, division (A)(2) of section 3715.64, and section 3715.67 of the Revised Code is vested in the director of agriculture. The authority to adopt rules for the enforcement of sections 3715.01 and 3715.52 to 3715.72 of the Revised Code, excluding divisions (E), (G), (H), and (I) of section 3715.60, division (A)(2) of section 3715.64, and section 3715.67 of the Revised Code, is vested in the director of agriculture or the state board of pharmacy. The rules adopted in so far as practicable shall conform with the regulations promulgated under the "Federal Food, Drug, and Cosmetic Act," 52 Stat. 1040 (1938), 21 U.S.C.A. 301, as amended.
2023 Ohio Revised Code › Title 37 | Health-Safety-Morals › Chapter 3715 | Pure Food and Drug Law › Section 3715.70 | Right of Entry - Examination of Samples.

Effective:
July 22, 1998
Latest Legislation:
Senate Bill 66 - 122nd General Assembly
(A) The director of agriculture or the state board of pharmacy shall have free access at all reasonable hours to any factory, warehouse, or establishment in which foods, drugs, devices, or cosmetics are manufactured, processed, packed, or held for introduction into commerce, or to enter any vehicle being used to transport or hold foods, drugs, devices, or cosmetics in commerce, for the following purposes:
(1) To inspect the factory, warehouse, establishment, or vehicle to determine if any of the provisions of sections 3715.01 or 3715.52 to 3715.72 of the Revised Code, are being violated;
(2) To secure samples of specimens of any food, drug, device, or cosmetic.
(B) The director or the board shall make or cause to be made examinations of samples secured under the provisions of this section to determine whether or not any provisions of sections 3715.01 and 3715.52 to 3715.72 of the Revised Code are being violated.
2023 Ohio Revised Code › Title 37 | Health-Safety-Morals › Chapter 3715 | Pure Food and Drug Law › Section 3715.71 | Publication of Reports - Dissemination of Information.

Effective:
July 22, 1998
Latest Legislation:
Senate Bill 66 - 122nd General Assembly
The director of agriculture or the state board of pharmacy may cause to be published from time to time reports summarizing all judgments, decrees, and court orders that have been rendered under sections 3715.01 and 3715.52 to 3715.72 of the Revised Code, including the nature of the charge and the disposition thereof.
The director or board may also cause to be disseminated any information regarding food, drugs, devices, and cosmetics that the director or board deems necessary in the interest of public health and the protection of the consumer against fraud.
Nothing in this section shall be construed to prohibit the director or board from collecting, reporting, and illustrating the results of investigations conducted by the director or board.
2023 Ohio Revised Code › Title 37 | Health-Safety-Morals › Chapter 3715 | Pure Food and Drug Law › Section 3715.72 | Administrative Procedure - Exceptions.

Effective:
March 26, 1971
Latest Legislation:
House Bill 1 - 109th General Assembly
(A) Sections 3715.01 and 3715.52 to 3715.71, inclusive, of the Revised Code shall be governed by and be administered in accordance with sections 119.01 to 119.13, inclusive, of the Revised Code.
(B) Sections 3715.01 and 3715.52 to 3715.71, inclusive, and section 3715.99, of the Revised Code, do not apply when such sections are in conflict with sections 923.41 to 923.55, inclusive, and section 923.99 of the Revised Code.
(C) Sections 3715.52 to 3715.71, inclusive, of the Revised Code do not permit the manufacture, sale, or offering for sale, of any food, drug, cosmetic, or device otherwise prohibited by any provision of the Revised Code or by any regulations promulgated pursuant to any provision of the Revised Code; nor do sections 3715.52 to 3715.71, inclusive, of the Revised Code or any regulations thereunder, prohibit the sale or offering for sale, of any food, drug, cosmetic, or device through any outlet where such items are now permitted by any provisions of the Revised Code to be sold or offered for sale.
2023 Ohio Revised Code › Title 37 | Health-Safety-Morals › Chapter 3715 | Pure Food and Drug Law › Section 3715.73 | Fines or Forfeited Bonds to Be Paid Into State Treasury.

Effective:
July 22, 1998
Latest Legislation:
Senate Bill 66 - 122nd General Assembly
(A) All fines or forfeited bonds assessed and collected under prosecution by the director of agriculture or prosecution commenced by the director in enforcement of this chapter shall, within thirty days, be paid to the director and by the director paid into the state treasury.
(B) All fines or forfeited bonds assessed and collected under prosecution by the state board of pharmacy or prosecution commenced by the board in enforcement of this chapter shall, within thirty days, be paid to the executive director of the board and by the executive director paid into the state treasury.
2023 Ohio Revised Code › Title 37 | Health-Safety-Morals › Chapter 3715 | Pure Food and Drug Law › Section 3715.80 | Dietary Supplement Defined.

Effective:
March 22, 2001
Latest Legislation:
House Bill 381 - 123rd General Assembly
As used in sections 3715.80 to 3715.86 of the Revised Code, "dietary supplement" has the meaning given in the federal "Food, Drug, and Cosmetic Act," 108 Stat. 4327 (1994), 21 U.S.C.A. 321(ff), as amended.
2023 Ohio Revised Code › Title 37 | Health-Safety-Morals › Chapter 3715 | Pure Food and Drug Law › Section 3715.81 | Dietary Supplement to Be Treated as a Food.

Effective:
March 22, 2001
Latest Legislation:
House Bill 381 - 123rd General Assembly
For purposes of this chapter, a dietary supplement shall be treated as a food. The director of agriculture shall administer and enforce sections 3715.80 to 3715.86 of the Revised Code and any rules adopted under those sections in accordance with Chapter 3717. of the Revised Code.
2023 Ohio Revised Code › Title 37 | Health-Safety-Morals › Chapter 3715 | Pure Food and Drug Law › Section 3715.82 | Adoption of Rules.

Effective:
March 22, 2001
Latest Legislation:
House Bill 381 - 123rd General Assembly
The director of agriculture may adopt rules, in accordance with Chapter 119. of the Revised Code, to administer and enforce sections 3715.80 to 3715.86 of the Revised Code. If rules are adopted, the rules shall be no more restrictive than the regulations promulgated under the federal "Food, Drug, and Cosmetic Act," 52 Stat. 1040 (1938), 21 U.S.C.A. 301, et seq., as amended.
2023 Ohio Revised Code › Title 37 | Health-Safety-Morals › Chapter 3715 | Pure Food and Drug Law › Section 3715.83 | Dietary Supplement Considered to Be Adulterated.

Effective:
March 22, 2001
Latest Legislation:
House Bill 381 - 123rd General Assembly
In addition to the conditions specified in section 3715.59 of the Revised Code, a dietary supplement is adulterated if it presents a significant or unreasonable risk of illness or injury under the conditions of use recommended or suggested in its labeling or, if there are no recommended or suggested conditions of use, under the ordinary conditions of use.
If the director of agriculture finds or has cause to believe that a dietary supplement is adulterated under this section, the director shall proceed under the provisions of this chapter applicable to adulterated food. In any action taken under this section, the burden of proof shall be on the director.
2023 Ohio Revised Code › Title 37 | Health-Safety-Morals › Chapter 3715 | Pure Food and Drug Law › Section 3715.84 | Requirements for Labeling - Misbranding.

Effective:
March 22, 2001
Latest Legislation:
House Bill 381 - 123rd General Assembly
(A) A dietary supplement is not misbranded under section 3715.60 of the Revised Code solely because the label or labeling contains a statement that characterizes the relationship of a nutrient or dietary ingredient to a disease or health-related condition if all of the following conditions are met:
(1) The statement does one of the following:
(a) Claims a benefit related to a classical nutrient deficiency disease and discloses the prevalence of the disease in the United States;
(b) Describes the role of a nutrient or dietary ingredient intended to affect the structure or function of the human body;
(c) Characterizes a documented mechanism by which a nutrient or dietary ingredient acts to maintain the structure or function of the human body;
(d) Describes general well-being from consumption of a nutrient or dietary ingredient.
(2) The manufacturer of the dietary supplement has substantiation that the statement is not false or misleading.
(3) The label contains, prominently displayed and in boldface type, one of the following statements:
(a) In the case of a product manufactured or sold in Ohio and in other states, "This statement has not been evaluated by the United States food and drug administration. This product is not intended to diagnose, treat, cure, or prevent any disease."
(b) In the case of a product manufactured and sold only within the state of Ohio, "This statement has not been evaluated by the Ohio department of agriculture. This product is not intended to diagnose, treat, cure, or prevent any disease."
(4) The manufacturer of the dietary supplement complies with the requirements of the federal "Food, Drug, and Cosmetic Act," 108 Stat. 4327 (1994), 21 U.S.C.A. 343(r)(6), as amended.
(B) The statement described in division (A)(1) of this section shall not claim that the supplement is to be used to diagnose, mitigate, treat, cure, or prevent a specific disease or class of diseases.
(C) If the director of agriculture finds or has cause to believe that a dietary supplement is misbranded under this section, the director shall proceed under the provisions of this chapter applicable to misbranded food. In any action taken under this section, the burden of proof to establish misbranding is on the director.
(D) A dietary supplement is not a drug within the meaning of section 3715.01 or 4729.01 of the Revised Code solely because the label or labeling contains a statement authorized by this section or because a warning appears on the supplement's label.
2023 Ohio Revised Code › Title 37 | Health-Safety-Morals › Chapter 3715 | Pure Food and Drug Law › Section 3715.85 | Publication Used in Connection With Sale to Consumers of Dietary Supplement.

Effective:
March 22, 2001
Latest Legislation:
House Bill 381 - 123rd General Assembly
(A) As used in this section, "publication" includes a book chapter, article, or official abstract of a peer-reviewed scientific article prepared by the article's author or the editors of the publication in which the article is published.
(B) A publication used in connection with a sale to consumers of a dietary supplement is not considered part of the label of the dietary supplement if the publication meets all of the following criteria:
(1) The publication is reprinted in its entirety.
(2) The publication is not false or misleading.
(3) The publication does not promote a particular manufacturer or brand of dietary supplement.
(4) The publication is displayed or presented, alone or with other publications on the same subject matter, so as to present a balanced view of the available scientific information on a dietary supplement.
(5) If the publication is displayed in a location where dietary supplements are offered for sale, the publication is physically separate from the dietary supplements.
(6) The publication does not have any other information affixed to it.
(C) Division (B) of this section does not apply to or restrict the actions of a person who offers dietary supplements for sale at retail or wholesale in the sale of books or publications as part of the person's business.
(D) If the director of agriculture finds or has cause to believe that a publication under division (B) of this section is a label and that label is false or misleading under division (B) of this section, the director shall proceed under the provisions of this chapter applicable to misbranded food. In any action taken under this section, the burden of proof to establish misbranding shall be on the director.
2023 Ohio Revised Code › Title 37 | Health-Safety-Morals › Chapter 3715 | Pure Food and Drug Law › Section 3715.86 | Dietary Supplement Not Considered Food Additive.

Effective:
March 22, 2001
Latest Legislation:
House Bill 381 - 123rd General Assembly
A dietary supplement is not considered a "food additive" within the meaning given in the federal "Food, Drug, and Cosmetic Act," 21 U.S.C.A. 321(s), as amended.
2023 Ohio Revised Code › Title 37 | Health-Safety-Morals › Chapter 3715 | Pure Food and Drug Law › Section 3715.871 | Drugs Must Be Donated at Pharmacy, Hospital, or Nonprofit Clinic Participating in Program.

Effective:
April 6, 2023
Latest Legislation:
House Bill 558 - 134th General Assembly
(A) Any pharmacy, drug manufacturer, health care facility, or other person or government entity may donate or give prescription drugs to the drug repository program. Any person or government entity may facilitate the donation or gift of drugs to the program. Drugs may be donated or given only at a pharmacy, hospital, or nonprofit clinic participating in the program.
(B) Any pharmacy, hospital, or nonprofit clinic may elect to participate in the program if it meets eligibility criteria for participation, as established in rules adopted under section 3715.873 of the Revised Code. Participation in the program by pharmacies, hospitals, and nonprofit clinics is voluntary. Nothing in this or any other section of the Revised Code requires a pharmacy, hospital, or nonprofit clinic to participate in the program.
(C) A pharmacy, hospital, or nonprofit clinic participating in the program shall distribute the drugs it accepts under the program to individuals who are residents of this state and meet the eligibility standards established in rules adopted under section 3715.873 of the Revised Code by using either of the following methods of distribution:
(1) Distributing the drugs to eligible individuals at the pharmacy, hospital, or nonprofit clinic;
(2) Distributing the drugs to other government entities and nonprofit private entities, which then shall distribute the drugs to eligible individuals.
Regardless of which method of distribution is used, a drug may be distributed to an eligible individual only by being dispensed by a pharmacist pursuant to a prescription issued by a licensed health professional authorized to prescribe drugs or by being personally furnished by such a prescriber.
(D) A pharmacy, hospital, or nonprofit clinic participating in the program shall comply with all applicable federal laws and laws of this state dealing with storage and distribution of dangerous drugs and shall, in accordance with rules adopted under section 3715.873 of the Revised Code, inspect all drugs prior to distributing them to determine that they are not or appear not to be adulterated.
(E) A pharmacy, hospital, or nonprofit clinic participating in the program may charge individuals receiving donated or given drugs a nominal handling fee established in accordance with rules adopted under section 3715.873 of the Revised Code. Except for occasional sales at wholesale by charitable pharmacies, hospitals, and nonprofit clinics, as authorized in rules adopted under section 3715.873 of the Revised Code, drugs that are donated or given to the program may not be resold.
Last updated March 15, 2023 at 12:47 PM
2023 Ohio Revised Code › Title 37 | Health-Safety-Morals › Chapter 3715 | Pure Food and Drug Law › Section 3715.873 | Adoption of Rules.

Effective:
April 6, 2023
Latest Legislation:
House Bill 558 - 134th General Assembly
The state board of pharmacy shall adopt rules governing the drug repository program that establish all of the following:
(A) Eligibility criteria for pharmacies, hospitals, and nonprofit clinics to participate in the program, including, in the case of nonprofit clinics, a definition of "underinsured person";
(B) Standards and procedures for accepting, safely storing, and distributing drugs donated or given;
(C) Standards and procedures for inspecting the drugs described in division (C)(1) of section 3715.87 of the Revised Code to determine that the original unit dose packaging is sealed and tamper-evident and that the drugs are unadulterated, safe, and suitable for distribution;
(D) With respect to drugs described in division (D) of section 3715.87 of the Revised Code, standards and procedures to determine based on a basic visual inspection that the drugs appear to be unadulterated, safe, and suitable for distribution;
(E) Eligibility standards based on economic need for individuals to receive drugs under the program;
(F) A means, such as an identification card, by which an individual who is eligible to receive drugs under the program may demonstrate eligibility to a pharmacy, hospital, or nonprofit clinic participating in the program;
(G) A form that an individual receiving a drug under the program must sign before receiving the drug to confirm that the individual understands the immunity provisions of the program;
(H) A form that each individual who is donating or giving drugs to the program, or who represents the person or government entity that is donating or giving drugs to the program, must sign stating that the individual or the person or government entity being represented is the owner of the drugs and intends to voluntarily donate or give them to the program;
(I) A formula to determine the amount of a nominal handling fee that pharmacies, hospitals, and nonprofit clinics participating in the program may charge to drug recipients to cover restocking and distribution costs;
(J) A list of drugs or drug types, if applicable, that are ineligible to be donated or given under the program, including those described in division (C)(2)(b) of section 3715.87 of the Revised Code, and a statement as to why the listed drugs or drug types are ineligible to be donated or given;
(K) The standards by which a charitable pharmacy, hospital, or nonprofit clinic participating in the program may make occasional sales at wholesale, pursuant to section 4729.51 of the Revised Code, of drugs that have been donated or given to the program;
(L) Any other standards and procedures the board considers appropriate.
The rules shall be adopted in accordance with Chapter 119. of the Revised Code.
Last updated March 15, 2023 at 12:48 PM
2023 Ohio Revised Code › Title 37 | Health-Safety-Morals › Chapter 3715 | Pure Food and Drug Law › Section 3715.88 | Dangerous Drug Donation Definitions.

Effective:
September 12, 2008
Latest Legislation:
House Bill 283 - 127th General Assembly
As used in this section and in sections 3715.89 to 3715.92 of the Revised Code:
(A) "Expired" has the same meaning as in section 3715.55 of the Revised Code.
(B) "National drug code number" means the number registered for a drug pursuant to the listing system established by the United States food and drug administration under the "Drug Listing Act of 1972," 86 Stat. 559, 21 U.S.C. 360, as amended.
(C) "Pharmacy school" means a school, college, university, or other educational institution that operates a pharmacy program recognized and approved by the state board of pharmacy.
(D) "Controlled substance" has the same meaning as in section 3719.01 of the Revised Code.
(E) "Manufacturer of dangerous drugs," "terminal distributor of dangerous drugs," and "wholesale distributor of dangerous drugs" have the same meanings as in section 4729.01 of the Revised Code.
2023 Ohio Revised Code › Title 37 | Health-Safety-Morals › Chapter 3715 | Pure Food and Drug Law › Section 3715.89 | Dangerous Drug Donation Requirements.

Effective:
September 12, 2008
Latest Legislation:
House Bill 283 - 127th General Assembly
(A) Subject to divisions (B) and (C) of this section, any manufacturer of dangerous drugs, terminal distributor of dangerous drugs, or wholesale distributor of dangerous drugs may donate a dangerous drug, including a dangerous drug that has expired, to a pharmacy school.
(B) A dangerous drug donation to a pharmacy school shall meet all of the following requirements:
(1) The dangerous drug is not a controlled substance.
(2) Each container in which a dangerous drug is donated contains a single national drug code number of that drug and no other drugs.
(3) If the dangerous drug is of a type that deteriorates with time, the container in which the drug is contained is plainly marked with the drug's expiration date.
(C) A dangerous drug donation to a pharmacy school shall be accompanied by a form signed by a representative of the manufacturer, terminal distributor, or wholesale distributor donating the drug. On delivery, a representative of the pharmacy school accepting the drug donation shall also sign the form. The form shall do both of the following:
(1) Confirm the acceptance of the dangerous drug donation by the pharmacy school;
(2) Confirm that both the manufacturer, terminal distributor, or wholesale distributor donating the dangerous drug and the pharmacy school accepting the donation understand the immunity provisions of section 3719.92 of the Revised Code.
2023 Ohio Revised Code › Title 37 | Health-Safety-Morals › Chapter 3715 | Pure Food and Drug Law › Section 3715.90 | Pharmacy School Acceptance of Dangerous Drug Donations.

Effective:
September 12, 2008
Latest Legislation:
House Bill 283 - 127th General Assembly
(A) A pharmacy school may accept a donation of a dangerous drug if the donation is made in accordance with section 3715.89 of the Revised Code.
(B) All of the following apply to a dangerous drug donated to a pharmacy school:
(1) The dangerous drug shall be used solely for instructional purposes.
(2) The dangerous drug shall not be sold or transferred for consideration of any kind.
(3) In accordance with 21 C.F.R. 201.125, the dangerous drug shall not be used for a clinical use. "Clinical use" includes the drug being furnished to a human or animal with the intent or understanding that the human or animal will ingest or otherwise absorb the drug into the human's or animal's body.
2023 Ohio Revised Code › Title 37 | Health-Safety-Morals › Chapter 3715 | Pure Food and Drug Law › Section 3715.91 | Dangerous Drug Donation Implementing Rules.

Effective:
September 12, 2008
Latest Legislation:
House Bill 283 - 127th General Assembly
The state board of pharmacy shall, in accordance with Chapter 119. of the Revised Code, adopt rules as necessary to give effect to sections 3715.89 and 3715.90 of the Revised Code.
2023 Ohio Revised Code › Title 37 | Health-Safety-Morals › Chapter 3715 | Pure Food and Drug Law › Section 3715.92 | Immunity of Pharmacy School Accepting Dangerous Drugs.

Effective:
September 12, 2008
Latest Legislation:
House Bill 283 - 127th General Assembly
The state board of pharmacy, any manufacturer of dangerous drugs, terminal distributor of dangerous drugs, or wholesale distributor of dangerous drugs that in good faith donates a dangerous drug under section 3715.89 of the Revised Code, and any pharmacy school that accepts a dangerous drug donation under section 3715.90 of the Revised Code, shall not, in the absence of bad faith, be subject to any of the following for matters related to the donation or acceptance of the drug: criminal prosecution; liability in tort or other civil action for injury, death, or loss to person or property; or professional liability.