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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 0051
Criminal acts.
F.S. 499.0051
499.0051 Criminal acts.—
(1) FAILURE TO MAINTAIN OR DELIVER TRANSACTION HISTORY, TRANSACTION INFORMATION, OR TRANSACTION STATEMENT.—
(a) A person engaged in the distribution of prescription drugs who fails to deliver to another person a complete and accurate transaction history, transaction information, or transaction statement concerning a prescription drug or contraband prescription drug, as required by this chapter and rules adopted under this chapter, before, or simultaneous with, the transfer of the prescription drug or contraband prescription drug to another person commits a felony of the third degree, punishable as provided in s. 775.082, s. 775.083, or s. 775.084.
(b) A person engaged in the distribution of prescription drugs who fails to acquire a complete and accurate transaction history, transaction information, or transaction statement concerning a prescription drug or contraband prescription drug, as required by this chapter and rules adopted under this chapter, before, or simultaneous with, the receipt of the prescription drug or contraband prescription drug from another person commits a felony of the third degree, punishable as provided in s. 775.082, s. 775.083, or s. 775.084.
(c) Any person who knowingly destroys, alters, conceals, or fails to maintain a complete and accurate transaction history, transaction information, or transaction statement concerning any prescription drug or contraband prescription drug, as required by this chapter and rules adopted under this chapter, in his or her possession commits a felony of the third degree, punishable as provided in s. 775.082, s. 775.083, or s. 775.084.
(2) KNOWING FORGERY OF TRANSACTION HISTORY, TRANSACTION INFORMATION, OR TRANSACTION STATEMENT.—A person who knowingly forges, counterfeits, or falsely creates any transaction history, transaction information, or transaction statement; who falsely represents any factual matter contained on any transaction history, transaction information, or transaction statement; or who knowingly omits to record material information required to be recorded in a transaction history, transaction information, or transaction statement, commits a felony of the second degree, punishable as provided in s. 775.082, s. 775.083, or s. 775.084.
(3) KNOWING PURCHASE OR RECEIPT OF PRESCRIPTION DRUG FROM UNAUTHORIZED PERSON.—A person who knowingly purchases or receives from a person not authorized to distribute prescription drugs under this chapter a prescription drug in a wholesale distribution transaction commits a felony of the second degree, punishable as provided in s. 775.082, s. 775.083, or s. 775.084.
(4) KNOWING SALE OR TRANSFER OF PRESCRIPTION DRUG TO UNAUTHORIZED PERSON.—A person who knowingly sells or transfers to a person not authorized to purchase or possess prescription drugs, under the law of the jurisdiction in which the person receives the drug, a prescription drug in a wholesale distribution transaction commits a felony of the second degree, punishable as provided in s. 775.082, s. 775.083, or s. 775.084.
(5) KNOWING SALE OR DELIVERY, OR POSSESSION WITH INTENT TO SELL, CONTRABAND PRESCRIPTION DRUGS.—A person who is knowingly in actual or constructive possession of any amount of contraband prescription drugs, who knowingly sells or delivers, or who possesses with intent to sell or deliver any amount of contraband prescription drugs, commits a felony of the second degree, punishable as provided in s. 775.082, s. 775.083, or s. 775.084.
(6) KNOWING TRAFFICKING IN CONTRABAND PRESCRIPTION DRUGS.—A person who knowingly sells, purchases, manufactures, delivers, or brings into this state, or who is knowingly in actual or constructive possession of any amount of contraband prescription drugs valued at $25,000 or more commits a felony of the first degree, punishable as provided in s. 775.082, s. 775.083, or s. 775.084.
(a) Upon conviction, each defendant shall be ordered to pay a mandatory fine according to the following schedule:
1. If the value of contraband prescription drugs involved is $25,000 or more, but less than $100,000, the defendant shall pay a mandatory fine of $25,000. If the defendant is a corporation or other person that is not a natural person, it shall pay a mandatory fine of $75,000.
2. If the value of contraband prescription drugs involved is $100,000 or more, but less than $250,000, the defendant shall pay a mandatory fine of $100,000. If the defendant is a corporation or other person that is not a natural person, it shall pay a mandatory fine of $300,000.
3. If the value of contraband prescription drugs involved is $250,000 or more, the defendant shall pay a mandatory fine of $200,000. If the defendant is a corporation or other person that is not a natural person, it shall pay a mandatory fine of $600,000.
(b) As used in this subsection, the term “value” means the market value of the property at the time and place of the offense or, if such cannot be satisfactorily ascertained, the cost of replacement of the property within a reasonable time after the offense. Amounts of value of separate contraband prescription drugs involved in distinct transactions for the distribution of the contraband prescription drugs committed pursuant to one scheme or course of conduct, whether involving the same person or several persons, may be aggregated in determining the punishment of the offense.
(7) KNOWING FORGERY OF PRESCRIPTION OR PRESCRIPTION DRUG LABELS.—A person who knowingly forges, counterfeits, or falsely creates any prescription label or prescription drug label, or who falsely represents any factual matter contained on any prescription label or prescription drug label, commits a felony of the first degree, punishable as provided in s. 775.082, s. 775.083, or s. 775.084.
(8) KNOWING SALE OR PURCHASE OF CONTRABAND PRESCRIPTION DRUGS RESULTING IN GREAT BODILY HARM.—A person who knowingly sells, purchases, manufactures, delivers, or brings into this state, or who is knowingly in actual or constructive possession of any amount of contraband prescription drugs, and whose acts in violation of this subsection result in great bodily harm to a person, commits a felony of the first degree, as provided in s. 775.082, s. 775.083, or s. 775.084.
(9) KNOWING SALE OR PURCHASE OF CONTRABAND PRESCRIPTION DRUGS RESULTING IN DEATH.—A person who knowingly manufactures, sells, purchases, delivers, or brings into this state, or who is knowingly in actual or constructive possession of any amount of contraband prescription drugs, and whose acts in violation of this subsection result in the death of a person, commits a felony of the first degree, punishable by a term of years not exceeding life, as provided in s. 775.082, s. 775.083, or s. 775.084.
(10) VIOLATIONS OF S. 499.005 RELATED TO DEVICES AND COSMETICS; DISSEMINATION OF FALSE ADVERTISEMENT.—
(a) Any person who violates any of the provisions of s. 499.005 with respect to a device or cosmetic commits a misdemeanor of the second degree, punishable as provided in s. 775.082 or s. 775.083; but, if the violation is committed after a conviction of such person under this subsection has become final, such person is guilty of a misdemeanor of the first degree, punishable as provided in s. 775.082 or s. 775.083 or as otherwise provided in this part, except that any person who violates s. 499.005(8) or (10) with respect to a device or cosmetic commits a felony of the third degree, punishable as provided in s. 775.082, s. 775.083, or s. 775.084, or as otherwise provided in this part.
(b) A publisher, radio broadcast licensee, or agency or medium for the dissemination of an advertisement, except the manufacturer, wholesaler, or seller of the article to which a false advertisement relates, is not liable under this subsection by reason of the dissemination by him or her of such false advertisement, unless he or she has refused, on the request of the department, to furnish to the department the name and post office address of the manufacturer, wholesaler, seller, or advertising agency that asked him or her to disseminate such advertisement.
(11) ADULTERATED AND MISBRANDED DRUGS; FALSE ADVERTISEMENT; FAILURE TO MAINTAIN RECORDS RELATING TO DRUGS.—Any person who violates any of the following provisions commits a misdemeanor of the second degree, punishable as provided in s. 775.082 or s. 775.083; but, if the violation is committed after a conviction of such person under this subsection has become final, such person commits a misdemeanor of the first degree, punishable as provided in s. 775.082 or s. 775.083, or as otherwise provided in this part:
(a) The manufacture, repackaging, sale, delivery, or holding or offering for sale of any drug that is adulterated or misbranded or has otherwise been rendered unfit for human or animal use.
(b) The adulteration or misbranding of any drug intended for further distribution.
(c) The receipt of any drug that is adulterated or misbranded, and the delivery or proffered delivery of such drug, for pay or otherwise.
(d) The dissemination of any false or misleading advertisement of a drug.
(e) 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.
(f) The purchase or receipt of a compressed medical gas from a person that is not authorized under this chapter to distribute compressed medical gases.
(g) Charging a dispensing fee for dispensing, administering, or distributing a prescription drug sample.
(h) The failure to maintain records related to a drug as required by this part and rules adopted under this part, except for transaction histories, transaction information, or transaction statements, invoices, or shipping documents related to prescription drugs.
(i) The possession of any drug in violation of this part, except if the violation relates to a deficiency in transaction histories, transaction information, or transaction statements.
(12) REFUSAL TO ALLOW INSPECTION; SELLING, PURCHASING, OR TRADING DRUG SAMPLES; FAILURE TO MAINTAIN RECORDS RELATING TO PRESCRIPTION DRUGS.—Any person who violates any of the following provisions commits a felony of the third degree, punishable as provided in s. 775.082, s. 775.083, or s. 775.084, or as otherwise provided in this part:
(a) The refusal or constructive refusal to allow:
1. The department to enter or inspect an establishment in which drugs are manufactured, processed, repackaged, sold, brokered, or held;
2. Inspection of any record of that establishment;
3. The department to enter and inspect any vehicle that is being used to transport drugs; or
4. The department to take samples of any drug.
(b) 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.
(c) Providing the department with false or fraudulent records, or making false or fraudulent statements, regarding any matter within the provisions of this part related to a drug.
(d) The failure to receive, maintain, or provide invoices and shipping documents if applicable, related to the distribution of a prescription drug.
1(e) The importation of a prescription drug for wholesale distribution, except as provided by s. 801(d) of the Federal Food, Drug, and Cosmetic Act.
(f) The wholesale distribution of a prescription drug that was:
1. Purchased by a public or private hospital or other health care entity; or
2. Donated or supplied at a reduced price to a charitable organization.
(g) The failure to obtain a permit as a prescription drug wholesale distributor when a permit is required by this part for that activity.
(h) Knowingly possessing any adulterated or misbranded prescription drug outside of a designated quarantine area.
(i) The purchase or sale of a prescription drug for wholesale distribution in exchange for currency, as defined in s. 560.103.
(13) OTHER VIOLATIONS.—Any person who violates any of the following provisions commits a felony of the second degree, punishable as provided in s. 775.082, s. 775.083, or s. 775.084, or as otherwise provided in this part:
(a) Knowingly manufacturing, repackaging, selling, delivering, or holding or offering for sale any drug that is adulterated or misbranded or has otherwise been rendered unfit for human or animal use.
(b) Knowingly adulterating a drug that is intended for further distribution.
(c) Knowingly receiving a drug that is adulterated and delivering or proffering delivery of such drug for pay or otherwise.
(d) Committing any act that causes a drug to be a counterfeit drug, or selling, dispensing, or knowingly holding for sale a counterfeit drug.
(e) Forging, counterfeiting, simulating, or falsely representing any drug, 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.
(f) Knowingly obtaining or attempting to obtain a prescription drug for wholesale distribution by fraud, deceit, misrepresentation, or subterfuge, or engaging in misrepresentation or fraud in the distribution of a drug.
(g) Removing a pharmacy’s dispensing label from a dispensed prescription drug with the intent to further distribute the prescription drug.
(h) Knowingly 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.
(14) FALSE ADVERTISEMENT.—A publisher, radio broadcast licensee, or agency or medium for the dissemination of an advertisement, except the manufacturer, repackager, wholesale distributor, or seller of the article to which a false advertisement relates, is not liable under subsection (11), subsection (12), or subsection (13) by reason of the dissemination by him or her of such false advertisement, unless he or she has refused, on the request of the department, to furnish to the department the name and post office address of the manufacturer, repackager, wholesale distributor, seller, or advertising agency that asked him or her to disseminate such advertisement.
(15) FALSE REPORT.—Any person who submits a report required by s. 499.0121(14) knowing that such report contains a false statement commits a felony of the third degree, punishable as provided in s. 775.082, s. 775.083, or s. 775.084.
(16) CONTROLLED SUBSTANCE DISTRIBUTION.—Any person who engages in the wholesale distribution of prescription drugs and who knowingly distributes controlled substances in violation of s. 499.0121(14) commits a felony of the third degree, punishable as provided in s. 775.082, s. 775.083, or s. 775.084. In addition to any other fine that may be imposed, a person convicted of such a violation may be sentenced to pay a fine that does not exceed three times the gross monetary value gained from such violation, plus court costs and the reasonable costs of investigation and prosecution.
History.—s. 34, ch. 82-225; s. 118, ch. 83-218; s. 1, ch. 83-265; ss. 47, 52, ch. 92-69; s. 595, ch. 97-103; s. 40, ch. 99-397; ss. 5, 6, 7, 8, 27, 28, ch. 2003-155; s. 16, ch. 2007-6; s. 49, ch. 2008-177; s. 4, ch. 2008-207; s. 16, ch. 2011-141; s. 4, ch. 2016-212; s. 5, 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. 5, ch. 2019-99, amends paragraph (12)(e), to read:

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

Note.—Subsection (7) former s. 499.0052; subsection (9) former s. 499.00535; subsection (10) former s. 499.00545; subsection (11) former s. 499.069; subsections (12)-(15) former s. 499.0691.