It is unlawful for a person to perform or cause the performance of any of the following acts in this state:

(1) The manufacture, repackaging, sale, delivery, or holding or offering for sale of any drug, device, or cosmetic that is adulterated or misbranded or has otherwise been rendered unfit for human or animal use.
(2) The adulteration or misbranding of any drug, device, or cosmetic.
(3) The receipt of any drug, device, or cosmetic that is adulterated or misbranded, and the delivery or proffered delivery of such drug, device, or cosmetic, for pay or otherwise.
(4) The sale, distribution, purchase, trade, holding, or offering of any drug, device, or cosmetic in violation of this part.
(5) The dissemination of any false or misleading advertisement of a drug, device, or cosmetic.
(6) The refusal or constructive refusal:

(a) To allow the department to enter or inspect an establishment in which drugs, devices, or cosmetics are manufactured, processed, repackaged, sold, brokered, or held;

Terms Used In Florida Statutes 499.005

  • 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
  • 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
  • Department: means the Department of Business and Professional Regulation. See Florida Statutes 499.003
  • 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

  • distribution: means to sell, purchase, trade, deliver, handle, store, or receive. See Florida Statutes 499.003
  • 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
  • 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
  • Fraud: Intentional deception resulting in injury to another.
  • 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
  • Hospital: means a facility as defined in…. See Florida Statutes 499.003
  • 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
  • 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 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
  • 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
  • Pharmacy: means an entity licensed under chapter 465. See Florida Statutes 499.003
  • 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
  • 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
(b) To allow inspection of any record of that establishment;
(c) To allow the department to enter and inspect any vehicle that is being used to transport drugs, devices, or cosmetics; or
(d) To allow the department to take samples of any drug, device, or cosmetic.
(7) The purchase or sale of prescription drugs for wholesale distribution in exchange for currency, as defined in s. 560.103.
(8) Committing any act that causes a drug, device, or cosmetic to be a counterfeit drug, device, or cosmetic; or selling, dispensing, or holding for sale a counterfeit drug, device, or cosmetic.
(9) The alteration, mutilation, destruction, obliteration, or removal of the whole or any part of the labeling of a drug, device, or cosmetic, or the doing of any other act with respect to a drug, device, or cosmetic, if the act is done while the drug, device, or cosmetic is held for sale and the act results in the drug, device, or cosmetic being misbranded.
(10) Forging; counterfeiting; simulating; falsely representing any drug, device, or cosmetic; or, without the authority of the manufacturer, using any mark, stamp, tag, label, or other identification device authorized or required by rules adopted under this part.
(11) The use, on the labeling of any drug or in any advertisement relating to such drug, of any representation or suggestion that an application of the drug is effective when it is not or that the drug complies with this part when it does not.
(12) The possession of any drug in violation of this part.
(13) The sale, delivery, holding, or offering for sale of any self-testing kits designed to tell persons their status concerning human immunodeficiency virus or acquired immune deficiency syndrome or related disorders or conditions. This prohibition shall not apply to home access HIV test kits approved for distribution and sale by the United States Food and Drug Administration.
(14) The purchase or receipt of a prescription drug from a person that is not authorized under this chapter to distribute prescription drugs to that purchaser or recipient.
(15) The sale or transfer of a prescription drug to a person that is not authorized under the law of the jurisdiction in which the person receives the drug to purchase or possess prescription drugs from the person selling or transferring the prescription drug.
(16) The purchase or receipt of a compressed medical gas from a person that is not authorized under this chapter to distribute compressed medical gases.
(17) The sale, purchase, or trade, or the offer to sell, purchase, or trade, a drug sample as defined in s. 499.028; the distribution of a drug sample in violation of s. 499.028; or the failure to otherwise comply with s. 499.028.
(18) Failure to maintain records as required by this part and rules adopted under this part.
(19) Providing the department with false or fraudulent records, or making false or fraudulent statements, regarding any matter within the provisions of this part.
1(20) The importation of a prescription drug except as provided by s. 801(d) of the Federal Food, Drug, and Cosmetic Act.
(21) The wholesale distribution of any prescription drug that was:

(a) Purchased by a public or private hospital or other health care entity; or
(b) Donated or supplied at a reduced price to a charitable organization,

unless the wholesale distribution of the prescription drug is authorized in s. 499.01(2)(h)1.c.

(22) Failure to obtain a permit or registration, or operating without a valid permit when a permit or registration is required by this part for that activity.
(23) Obtaining or attempting to obtain a prescription drug or device by fraud, deceit, misrepresentation or subterfuge, or engaging in misrepresentation or fraud in the distribution of a drug or device.
(24) The distribution of a prescription device to the patient or ultimate consumer without a prescription or order from a practitioner licensed by law to use or prescribe the device.
(25) Charging a dispensing fee for dispensing, administering, or distributing a prescription drug sample.
(26) Removing a pharmacy‘s dispensing label from a dispensed prescription drug with the intent to further distribute the prescription drug.
(27) Distributing a prescription drug that was previously dispensed by a licensed pharmacy, unless such distribution was authorized in chapter 465 or the rules adopted under chapter 465.
(28) Failure to acquire or deliver a transaction history, transaction information, or transaction statement as required under this part and rules adopted under this part.
(29) Failure to accurately complete and timely submit reportable drug price increase forms, reports, and documents as required by s. 499.026 and rules adopted thereunder.
  Previous section
Next section  
 Part I Contents