The Florida Senate

499.005  Prohibited acts.--It is unlawful 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 ss. 499.001-499.081.

(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;

(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 giving of a false guaranty or false undertaking with respect to a drug, device, or cosmetic, except by a person who relied on a guaranty or undertaking to the same effect signed by, and containing the name and address of, the person residing in this state from whom she or he received in good faith the drug, device, or cosmetic.

(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 ss. 499.001-499.081.

(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 ss. 499.001-499.081 when it does not.

(12)  The possession of any drug in violation of ss. 499.001-499.081.

(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 legend drug from a person that is not authorized under this chapter to distribute legend drugs.

(15)  The sale or transfer of a legend 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 legend drugs.

(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 ss. 499.001-499.081 and rules adopted under those sections.

(19)  Providing the department with false or fraudulent records, or making false or fraudulent statements, regarding any matter within the provisions of this chapter.

(20)  The importation of a legend 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.

(22)  Failure to obtain a permit or registration, or operating without a valid permit when a permit or registration is required by ss. 499.001-499.081 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 legend 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)  Dispensing, administering, or distributing an investigational drug authorized under ¹s. 499.018, except pursuant to a protocol approved by the department.

History.--s. 34, ch. 82-225; s. 106, ch. 83-218; s. 1, ch. 83-265; s. 24, ch. 88-380; ss. 5, 52, ch. 92-69; s. 3, ch. 95-308; s. 585, ch. 97-103; s. 29, ch. 98-151; s. 37, ch. 99-397; s. 35, ch. 2000-242.

¹Note.--Repealed by s. 10, ch. 2000-326.