Terms Used In Ohio Code > Chapter 3715 - Pure Food and Drug Law

• 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. See Ohio Code 3715.01
• agriculture: includes farming; ranching; aquaculture; algaculture meaning the farming of algae; apiculture and related apicultural activities, production of honey, beeswax, honeycomb, and other related products; horticulture; viticulture, winemaking, and related activities; animal husbandry, including, but not limited to, the care and raising of livestock, equine, and fur-bearing animals; poultry husbandry and the production of poultry and poultry products; dairy production; the production of field crops, tobacco, fruits, vegetables, nursery stock, ornamental shrubs, ornamental trees, flowers, sod, or mushrooms; timber; pasturage; any combination of the foregoing; the processing, drying, storage, and marketing of agricultural products when those activities are conducted in conjunction with, but are secondary to, such husbandry or production; and any additions or modifications to the foregoing made by the director of agriculture by rule adopted in accordance with Chapter 119 of the Revised Code. See Ohio Code 1.61
• Amendment: A proposal to alter the text of a pending bill or other measure by striking out some of it, by inserting new language, or both. Before an amendment becomes part of the measure, thelegislature must agree to it.
• Another: when used to designate the owner of property which is the subject of an offense, includes not only natural persons but also every other owner of property. See Ohio Code 1.02
• Appeal: A request made after a trial, asking another court (usually the court of appeals) to decide whether the trial was conducted properly. To make such a request is "to appeal" or "to take an appeal." One who appeals is called the appellant.
• Biological product: means , except as provided in section 3715. See Ohio Code 3715.01
• Bond: includes an undertaking. See Ohio Code 1.02
• Certified nurse practitioner: means an advanced practice registered nurse who holds a current, valid license issued under Chapter 4723 of the Revised Code and is designated as a certified nurse practitioner in accordance with section 4723. See Ohio Code 1.64
• Certified nurse-midwife: means an advanced practice registered nurse who holds a current, valid license issued under Chapter 4723 of the Revised Code and is designated as a certified nurse-midwife in accordance with section 4723. See Ohio Code 1.64
• Clinical nurse specialist: means an advanced practice registered nurse who holds a current, valid license issued under Chapter 4723 of the Revised Code and is designated as a clinical nurse specialist in accordance with section 4723. See Ohio Code 1.64
• Common law: The legal system that originated in England and is now in use in the United States. It is based on judicial decisions rather than legislative action.
• Complaint: A written statement by the plaintiff stating the wrongs allegedly committed by the defendant.
• Contract: A legal written agreement that becomes binding when signed.
• Corporation: A legal entity owned by the holders of shares of stock that have been issued, and that can own, receive, and transfer property, and carry on business in its own name.
• 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. See Ohio Code 3715.01

• Cottage food production operation: means a person who, in the person's home, produces food items that are not potentially hazardous foods, including bakery products, jams, jellies, candy, fruit butter, and similar products specified in rules adopted pursuant to section 3715. See Ohio Code 3715.01
• Damages: Money paid by defendants to successful plaintiffs in civil cases to compensate the plaintiffs for their injuries.
• Dependent: A person dependent for support upon another.
• Discovery: Lawyers' examination, before trial, of facts and documents in possession of the opponents to help the lawyers prepare for trial.
• 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. See Ohio Code 3715.01

• 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. See Ohio Code 3715.01
• 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. See Ohio Code 3715.01

• Fraud: Intentional deception resulting in injury to another.
• 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 identical compendial or other 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. See Ohio Code 3715.01
• Gift: A voluntary transfer or conveyance of property without consideration, or for less than full and adequate consideration based on fair market value.
• Home: means the primary residence occupied by the residence's owner, on the condition that the residence contains only one stove or oven used for cooking, which may be a double oven, designed for common residence usage and not for commercial usage, and that the stove or oven be operated in an ordinary kitchen within the residence. See Ohio Code 3715.01
• Honey: means the nectar and saccharine exudation of plants that has been gathered, modified, and stored in a honeycomb by honeybees. See Ohio Code 3715.01
• in writing: includes any representation of words, letters, symbols, or figures; this provision does not affect any law relating to signatures. See Ohio Code 1.59
• Injunction: An order of the court prohibiting (or compelling) the performance of a specific act to prevent irreparable damage or injury.
• Interchangeable biological product: means , except as provided in section 3715. See Ohio Code 3715.01
• Internet: means the international computer network of both federal and nonfederal interoperable packet switched data networks, including the graphical subnetwork known as the world wide web. See Ohio Code 1.59
• Joint committee: Committees including membership from both houses of teh legislature. Joint committees are usually established with narrow jurisdictions and normally lack authority to report legislation.
• Jurisdiction: (1) The legal authority of a court to hear and decide a case. Concurrent jurisdiction exists when two courts have simultaneous responsibility for the same case. (2) The geographic area over which the court has authority to decide cases.
• Label: means a display of written, printed, or graphic matter upon the immediate container, exclusive of package liners, of any article. See Ohio Code 3715.01
• 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. See Ohio Code 3715.01

• 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. See Ohio Code 3715.01

• 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. See Ohio Code 3715.01

• Partnership: A voluntary contract between two or more persons to pool some or all of their assets into a business, with the agreement that there will be a proportional sharing of profits and losses.
• Person: means an individual, partnership, corporation, or association. See Ohio Code 3715.01
• Physician assistant: means an individual who is licensed under Chapter 4730 of the Revised Code to provide services as a physician assistant to patients under the supervision, control, and direction of one or more physicians. See Ohio Code 1.64
• Potentially hazardous food: means a food that is natural or synthetic, to which any of the following apply:

  (a) It has a pH level greater than 4. See Ohio Code 3715.01

• Property: means real and personal property. See Ohio Code 1.59
• Prosecute: To charge someone with a crime. A prosecutor tries a criminal case on behalf of the government.
• Rule: includes regulation. See Ohio Code 1.59
• state: means the state of Ohio. See Ohio Code 1.59
• Statute: A law passed by a legislature.
• Subpoena: A command to a witness to appear and give testimony.
• Testimony: Evidence presented orally by witnesses during trials or before grand juries.
• Tort: A civil wrong or breach of a duty to another person, as outlined by law. A very common tort is negligent operation of a motor vehicle that results in property damage and personal injury in an automobile accident.
• Undertaking: includes a bond. See Ohio Code 1.02
• United States: includes all the states. See Ohio Code 1.59
• Whoever: includes all persons, natural and artificial; partners; principals, agents, and employees; and all officials, public or private. See Ohio Code 1.02