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2021 Florida Statutes (Including 2021B Session)

Title XXXIII REGULATION OF TRADE, COMMERCE, INVESTMENTS, AND SOLICITATIONS
Chapter 499 FLORIDA DRUG AND COSMETIC ACT Entire Chapter
SECTION 005
Prohibited acts.
F.S. 499.005
499.005 Prohibited acts.—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;
(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.
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; s. 17, ch. 2001-63; s. 32, ch. 2001-89; s. 4, ch. 2003-155; s. 4, ch. 2006-310; s. 21, ch. 2007-6; s. 48, ch. 2008-177; s. 3, ch. 2008-207; s. 3, ch. 2012-37; s. 3, ch. 2016-212; s. 4, ch. 2019-99.
1Note.—

A. Section 11, ch. 2019-99, provides in part that “[i]mplementation of sections 2 through 10 of this act is contingent upon authorization granted under federal law, rule, or approval.” Section 11, ch. 2019-99, was codified as s. 499.02851. Section 12, ch. 2019-99, provides that “[t]his act shall take effect July 1, 2019.”

B. Subject to the contingency as to implementation in s. 11, ch. 2019-99, s. 4, ch. 2019-99, amends subsection (20), to read:

(20) The importation of a prescription drug except as provided by s. 801(d) of the Federal Food, Drug, and Cosmetic Act or s. 499.0285.