Terms Used In Florida Statutes > Chapter 499 > Part I - Drugs; Devices; Cosmetics; Household Products

• Acquittal:
  1. Judgement that a criminal defendant has not been proved guilty beyond a reasonable doubt.
  2. A verdict of "not guilty."
   
• Active pharmaceutical ingredient: includes any substance or mixture of substances intended, represented, or labeled for use in drug manufacturing that furnishes or is intended to furnish, in a finished dosage form, any pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, therapy, or prevention of disease in humans or other animals, or to affect the structure or any function of the body of humans or animals. See Florida Statutes 499.003
• Advertisement: means any representation disseminated in any manner or by any means, other than by labeling, for the purpose of inducing, or which is likely to induce, directly or indirectly, the purchase of drugs, devices, or cosmetics. See Florida Statutes 499.003
• Affiliate: means a business entity that has a relationship with another business entity in which, directly or indirectly:
  (a) The business entity controls, or has the power to control, the other business entity; or
  (b) A third party controls, or has the power to control, both business entities. See Florida Statutes 499.003
• Affiliated party: means :
  (a) A director, officer, trustee, partner, or committee member of a permittee or applicant or a subsidiary or service corporation of the permittee or applicant;
  (b) A person who, directly or indirectly, manages, controls, or oversees the operation of a permittee or applicant, regardless of whether such person is a partner, shareholder, manager, member, officer, director, independent contractor, or employee of the permittee or applicant;
  (c) A person who has filed or is required to file a personal information statement pursuant to…. See Florida Statutes 499.003
• Allegation: something that someone says happened.
• Answer: The formal written statement by a defendant responding to a civil complaint and setting forth the grounds for defense.
• 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.
• Applicant: means a person applying for a permit or certification under this part. See Florida Statutes 499.003
• Appropriation: The provision of funds, through an annual appropriations act or a permanent law, for federal agencies to make payments out of the Treasury for specified purposes. The formal federal spending process consists of two sequential steps: authorization
• Assets: (1) The property comprising the estate of a deceased person, or (2) the property in a trust account.
• Beneficiary: A person who is entitled to receive the benefits or proceeds of a will, trust, insurance policy, retirement plan, annuity, or other contract. ^{Source: OCC}
• Bequest: Property gifted by will.
• blood: means whole blood collected from a single donor and processed for transfusion or further manufacturing, and the term "blood components" means that part of the blood separated by physical or mechanical means. See Florida Statutes 499.003
• Certificate of free sale: means a document prepared by the department which certifies a drug or device that is registered with the department as one that can be legally sold in the state. See Florida Statutes 499.003
• Closed pharmacy: means a pharmacy that is licensed under chapter 465 and purchases prescription drugs for use by a limited patient population and not for wholesale distribution or sale to the public. See Florida Statutes 499.003
• Color: includes black, white, and intermediate grays. See Florida Statutes 499.003
• Color additive: means , with the exception of any material that has been or hereafter is exempt under the federal act, a material that:
  (a) Is a dye pigment, or other substance, made by a process of synthesis or similar artifice, or extracted, isolated, or otherwise derived, with or without intermediate or final change of identity from a vegetable, animal, mineral, or other source; or
  (b) When added or applied to a drug or cosmetic or to the human body, or any part thereof, is capable alone, or through reaction with other substances, of imparting color thereto. See Florida Statutes 499.003
• common control: means the power to direct or cause the direction of the management and policies of a person or an organization, whether by ownership of stock, by voting rights, by contract, or otherwise. See Florida Statutes 499.003
• Complaint: A written statement by the plaintiff stating the wrongs allegedly committed by the defendant.
• Contraband prescription drug: means any adulterated drug, as defined in…. See Florida Statutes 499.003
• Contract: A legal written agreement that becomes binding when signed.
• Conviction: A judgement of guilt against a criminal defendant.
• 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 an article, with the exception of soap, that is:
  (a) 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; or
  (b) Intended for use as a component of any such article. See Florida Statutes 499.003
• Damages: Money paid by defendants to successful plaintiffs in civil cases to compensate the plaintiffs for their injuries.
• Deed: The legal instrument used to transfer title in real property from one person to another.
• Defendant: In a civil suit, the person complained against; in a criminal case, the person accused of the crime.
• Department: means the Department of Business and Professional Regulation. See Florida Statutes 499.003
• Dependent: A person dependent for support upon another.
• Device: means any instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including its components, parts, or accessories, which is:
  (a) Recognized in the current edition of the United States Pharmacopoeia and National Formulary, or any supplement thereof,
  (b) Intended for use in the diagnosis, cure, mitigation, treatment, therapy, or prevention of disease in humans or other animals, or
  (c) Intended to affect the structure or any function of the body of humans or other animals,

  and that does not achieve any of its principal intended purposes through chemical action within or on the body of humans or other animals and which is not dependent upon being metabolized for the achievement of any of its principal intended purposes. See Florida Statutes 499.003

• Devise: To gift property by will.
• Discovery: Lawyers' examination, before trial, of facts and documents in possession of the opponents to help the lawyers prepare for trial.
• Dismissal: The dropping of a case by the judge without further consideration or hearing. ^Source:
• distribution: means to sell, purchase, trade, deliver, handle, store, or receive. See Florida Statutes 499.003
• Donor: The person who makes a gift.
• Drug: means an article that is:
  (a) Recognized in the current edition of the United States Pharmacopoeia and National Formulary, official Homeopathic Pharmacopoeia of the United States, or any supplement to any of those publications;
  (b) Intended for use in the diagnosis, cure, mitigation, treatment, therapy, or prevention of disease in humans or other animals;
  (c) Intended to affect the structure or any function of the body of humans or other animals; or
  (d) Intended for use as a component of any article specified in paragraph (a), paragraph (b), or paragraph (c), and includes active pharmaceutical ingredients, but does not include devices or their nondrug components, parts, or accessories. See Florida Statutes 499.003
• Embezzlement: In most states, embezzlement is defined as theft/larceny of assets (money or property) by a person in a position of trust or responsibility over those assets. Embezzlement typically occurs in the employment and corporate settings. ^{Source: OCC}
• Entitlement: A Federal program or provision of law that requires payments to any person or unit of government that meets the eligibility criteria established by law. Entitlements constitute a binding obligation on the part of the Federal Government, and eligible recipients have legal recourse if the obligation is not fulfilled. Social Security and veterans' compensation and pensions are examples of entitlement programs.
• Establishment: means a place of business which is at one general physical location and may extend to one or more contiguous suites, units, floors, or buildings operated and controlled exclusively by entities under common operation and control. See Florida Statutes 499.003
• Evidence: Information presented in testimony or in documents that is used to persuade the fact finder (judge or jury) to decide the case for one side or the other.
• Executor: A male person named in a will to carry out the decedent
• Federal act: means the Federal Food, Drug, and Cosmetic Act, 21 U. See Florida Statutes 499.003
• Fiduciary: A trustee, executor, or administrator.
• Fiscal year: The fiscal year is the accounting period for the government. For the federal government, this begins on October 1 and ends on September 30. The fiscal year is designated by the calendar year in which it ends; for example, fiscal year 2006 begins on October 1, 2005 and ends on September 30, 2006.
• Forgery: The fraudulent signing or alteration of another's name to an instrument such as a deed, mortgage, or check. The intent of the forgery is to deceive or defraud. ^{Source: OCC}
• Fraud: Intentional deception resulting in injury to another.
• Freight forwarder: means a person who receives prescription drugs which are owned by another person and designated by that person for export, and exports those prescription drugs. See Florida Statutes 499.003
• Gift: A voluntary transfer or conveyance of property without consideration, or for less than full and adequate consideration based on fair market value.
• Grand jury: agreement providing that a lender will delay exercising its rights (in the case of a mortgage,
• Guardian: A person legally empowered and charged with the duty of taking care of and managing the property of another person who because of age, intellect, or health, is incapable of managing his (her) own affairs.
• Health care entity: means a closed pharmacy or any person, organization, or business entity that provides diagnostic, medical, surgical, or dental treatment or care, or chronic or rehabilitative care, but does not include any wholesale distributor or retail pharmacy licensed under state law to deal in prescription drugs. See Florida Statutes 499.003
• Health care facility: means a health care facility licensed under chapter 395. See Florida Statutes 499.003
• Hospice: means a corporation licensed under part IV of chapter 400. See Florida Statutes 499.003
• Hospital: means a facility as defined in…. See Florida Statutes 499.003
• Injunction: An order of the court prohibiting (or compelling) the performance of a specific act to prevent irreparable damage or injury.
• 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 of any drug, device, or cosmetic. See Florida Statutes 499.003
• Labeling: means all labels and other written, printed, or graphic matters:
  (a) Upon a drug, device, or cosmetic, or any of its containers or wrappers; or
  (b) Accompanying or related to such drug, device, or cosmetic. See Florida Statutes 499.003
• Lease: A contract transferring the use of property or occupancy of land, space, structures, or equipment in consideration of a payment (e.g., rent). ^{Source: OCC}
• Manufacture: means the preparation, deriving, compounding, propagation, processing, producing, or fabrication of any drug, device, or cosmetic. See Florida Statutes 499.003
• Manufacturer: means :
  (a) A person who holds a New Drug Application, an Abbreviated New Drug Application, a Biologics License Application, or a New Animal Drug Application approved under the federal act or a license issued under…. See Florida Statutes 499.003
• Medical convenience kit: means packages or units that contain combination products as defined in Florida Statutes 499.003
• Medical gas: means any liquefied or vaporized gas that is a prescription drug, whether alone or in combination with other gases, and as defined in the federal act. See Florida Statutes 499.003
• minor: includes any person who has not attained the age of 18 years. See Florida Statutes 1.01
• 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 and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling of that drug; or
  (b) Any drug the composition of which is such that the drug, as a result of investigations to determine its safety and effectiveness for use under certain conditions, has been recognized for use under such conditions, but which drug has not, other than in those investigations, been used to a material extent or for a material time under such conditions. See Florida Statutes 499.003
• Nolo contendere: No contest-has the same effect as a plea of guilty, as far as the criminal sentence is concerned, but may not be considered as an admission of guilt for any other purpose.
• Oath: A promise to tell the truth.
• oath: includes affirmations. See Florida Statutes 1.01
• Official compendium: means the current edition of the official United States Pharmacopoeia and National Formulary, or any supplement thereto. See Florida Statutes 499.003
• 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.
• Permittee: means any person holding a permit issued under this chapter. See Florida Statutes 499.003
• Person: means any individual, child, joint venture, syndicate, fiduciary, partnership, corporation, division of a corporation, firm, trust, business trust, company, estate, public or private institution, association, organization, group, city, county, city and county, political subdivision of this state, other governmental agency within this state, and any representative, agent, or agency of any of the foregoing, or any other group or combination of the foregoing. See Florida Statutes 499.003
• person: includes individuals, children, firms, associations, joint adventures, partnerships, estates, trusts, business trusts, syndicates, fiduciaries, corporations, and all other groups or combinations. See Florida Statutes 1.01
• Pharmacist: means a person licensed under chapter 465. See Florida Statutes 499.003
• Pharmacy: means an entity licensed under chapter 465. See Florida Statutes 499.003
• Plea: In a criminal case, the defendant's statement pleading "guilty" or "not guilty" in answer to the charges, a declaration made in open court.
• political subdivision: include counties, cities, towns, villages, special tax school districts, special road and bridge districts, bridge districts, and all other districts in this state. See Florida Statutes 1.01
• Power of attorney: A written instrument which authorizes one person to act as another's agent or attorney. The power of attorney may be for a definite, specific act, or it may be general in nature. The terms of the written power of attorney may specify when it will expire. If not, the power of attorney usually expires when the person granting it dies. ^{Source: OCC}
• Precedent: A court decision in an earlier case with facts and law similar to a dispute currently before a court. Precedent will ordinarily govern the decision of a later similar case, unless a party can show that it was wrongly decided or that it differed in some significant way.
• Prescription drug: means a prescription, medicinal, or legend drug, including, but not limited to, finished dosage forms or active pharmaceutical ingredients subject to, defined by, or described by…. See Florida Statutes 499.003
• Prescription drug label: means any display of written, printed, or graphic matter upon the immediate container of any prescription drug before it is dispensed to an individual patient pursuant to a prescription of a practitioner authorized by law to prescribe. See Florida Statutes 499.003
• Prescription label: means any display of written, printed, or graphic matter upon the immediate container of any prescription drug dispensed pursuant to a prescription of a practitioner authorized by law to prescribe. See Florida Statutes 499.003
• Probable cause: A reasonable ground for belief that the offender violated a specific law.
• Probate: Proving a will
• Probation: A sentencing alternative to imprisonment in which the court releases convicted defendants under supervision as long as certain conditions are observed.
• Real property: Land, and all immovable fixtures erected on, growing on, or affixed to the land.
• Recourse: An arrangement in which a bank retains, in form or in substance, any credit risk directly or indirectly associated with an asset it has sold (in accordance with generally accepted accounting principles) that exceeds a pro rata share of the bank's claim on the asset. If a bank has no claim on an asset it has sold, then the retention of any credit risk is recourse. ^{Source: FDIC}
• Repackage: includes repacking or otherwise changing the container, wrapper, or labeling to further the distribution of the drug, device, or cosmetic. See Florida Statutes 499.003
• Repackager: means a person who repackages. See Florida Statutes 499.003
• Reporter: Makes a record of court proceedings and prepares a transcript, and also publishes the court's opinions or decisions (in the courts of appeals).
• Retail pharmacy: means a community pharmacy licensed under chapter 465 that purchases prescription drugs at fair market prices and provides prescription services to the public. See Florida Statutes 499.003
• Settlement: Parties to a lawsuit resolve their difference without having a trial. Settlements often involve the payment of compensation by one party in satisfaction of the other party's claims.
• Subpoena: A command to a witness to appear and give testimony.
• Summons: Another word for subpoena used by the criminal justice system.
• Testify: Answer questions in court.
• Testimony: Evidence presented orally by witnesses during trials or before grand juries.
• Trial: A hearing that takes place when the defendant pleads "not guilty" and witnesses are required to come to court to give evidence.
• Trust account: A general term that covers all types of accounts in a trust department, such as estates, guardianships, and agencies. ^{Source: OCC}
• Trustee: A person or institution holding and administering property in trust.
• Veterinary prescription drug: means a prescription drug intended solely for veterinary use. See Florida Statutes 499.003
• Wholesale distribution: means the distribution of a prescription drug to a person other than a consumer or patient, or the receipt of a prescription drug by a person other than the consumer or patient, but does not include:
  (a) Any of the following activities, which is not a violation of…. See Florida Statutes 499.003
• Wholesale distributor: means a person, other than a manufacturer, a manufacturer's co-licensed partner, a third-party logistics provider, or a repackager, who is engaged in wholesale distribution. See Florida Statutes 499.003
• writing: includes handwriting, printing, typewriting, and all other methods and means of forming letters and characters upon paper, stone, wood, or other materials. See Florida Statutes 1.01