The 2023 Florida Statutes (including Special Session C)

Title XXXIII
REGULATION OF TRADE, COMMERCE, INVESTMENTS, AND SOLICITATIONS

Chapter 499
FLORIDA DRUG AND COSMETIC ACT

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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.

(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.

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; s. 2, ch. 2023-29.

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.

F.S. 499.005 on Google Scholar

F.S. 499.005 on Casetext

Amendments to 499.005

Arrestable Offenses / Crimes under Fla. Stat. 499.005

Level: Degree
Misdemeanor/Felony: First/Second/Third

S499.005 1 - HEALTH-SAFETY - REMOVED - M: F

S499.005 1 - HEALTH-SAFETY - REMOVED - M: S

S499.005 1 - HEALTH-SAFETY - MFG SELL MISBRAND DEVICE COSMETIC 1ST OFF - M: S

S499.005 1 - HEALTH-SAFETY - MFG SELL MISBRAND DEVICE COSMETIC SUBSQ OFF - M: F

S499.005 2 - HEALTH-SAFETY - REMOVED - M: F

S499.005 2 - HEALTH-SAFETY - REMOVED - M: S

S499.005 2 - HEALTH-SAFETY - ADULTERATE MISBRAND DEVICE COSMETIC 1ST OFF - M: S

S499.005 2 - HEALTH-SAFETY - ADULTERATE MISBRAND DEVICE COSMETIC SUBSQ OFF - M: F

S499.005 3 - FRAUD - REMOVED - M: F

S499.005 3 - FRAUD - REMOVED - M: S

S499.005 3 - FRAUD - RECEIVE MISBRANDED DEVICE COSMETIC 1ST OFF - M: S

S499.005 3 - FRAUD - RECEIVE MISBRANDED DEVICE COSMETIC SUBSQ OFF - M: F

S499.005 4 - HEALTH-SAFETY - REMOVED - M: F

S499.005 4 - HEALTH-SAFETY - REMOVED - M: S

S499.005 4 - HEALTH-SAFETY - SELL PRODUCT VIOL DRUG COSMETIC ACT 1ST OFF - M: S

S499.005 4 - HEALTH-SAFETY - SELL PRODUCT VIOL DRUG COSMETIC ACT SUBSQ OFF - M: F

S499.005 5 - FRAUD - REMOVED - M: F

S499.005 5 - FRAUD - REMOVED - M: S

S499.005 5 - FRAUD - DISSEMINATE FALSE AD DRUG DEV COSMETIC 1ST OFF - M: S

S499.005 5 - FRAUD - DISSEMINATE FALSE AD DRUG DEV COSMETIC SUB OFF - M: F

S499.005 6 - OBSTRUCT CRIMINAL INVEST - REMOVED - M: F

S499.005 6 - OBSTRUCT CRIMINAL INVEST - REMOVED - M: S

S499.005 6 - OBSTRUCT CRIMINAL INVEST - REFUSE INSPEC ESTAB VEH RECORDS 1ST OFF - M: S

S499.005 6 - OBSTRUCT CRIMINAL INVEST - REFUSE INSPEC ESTAB VEH RECORDS SUBSQ OFF - M: F

S499.005 7 - FRAUD - REMOVE PENALTY 2003-155 - M: F

S499.005 7 - FRAUD - REMOVE PENALTY 2003-155 - M: S

S499.005 7 - DRUGS-HEALTH OR SAFETY - PURCH SELL RX DRUG WHOLESALE DISTRIBU 1ST OFF - M: S

S499.005 7 - DRUGS-HEALTH OR SAFETY - PURCH SELL RX DRUG WHOLESALE DISTRIBU SUB OFF - M: F

S499.005 8 - HEALTH-SAFETY - REMOVED - F: T

S499.005 8 - COUNTERFEITING OF - RENUMBERED. SEE REC # 8437 - M: S

S499.005 8 - DRUGS-HEALTH OR SAFETY - OR SELLING COUNTERFEIT DEVICE OR COSMETIC - F: T

S499.005 9 - DRUGS-MISBRANDED - REMOVED - M: F

S499.005 9 - DRUGS-MISBRANDED - REMOVED - M: S

S499.005 9 - DRUGS-MISBRANDED - REMOVE ALTER LABEL DEVICE COSMETIC 1ST OFF - M: S

S499.005 9 - DRUGS-MISBRANDED - REMOVE ALTER LABEL DEVICE COSMETIC SUBSQ OFF - M: F

S499.005 10 - FORGERY OF - MARK STAMP DEVICE COSMETIC SUBSQ OFF - F: T

S499.005 10 - FORGERY OF - MARK STAMP DEVICE COSMETIC 1ST OFF - M: S

S499.005 10 - COUNTERFEITING OF - SIMULATE MARK STAMP DEVICE COSMETIC SUBSQ OFF - F: T

S499.005 10 - COUNTERFEITING OF - SIMULATE MARK STAMP DEVICE COSMETIC 1ST OFF - M: S

S499.005 10 - HEALTH-SAFETY - REMOVED - F: T

S499.005 10 - FRAUD - MISREP MARK STAMP DEVICE COSMETIC 1ST OFF - M: S

S499.005 10 - HEALTH-SAFETY - MISREPRESENT DEVICE OR COSMETIC MISUSE LABEL - F: T

S499.005 11 - FRAUD - REMOVE PENALTY 2003-155 - M: F

S499.005 11 - FRAUD - REMOVE PENALTY 2003-155 - M: S

S499.005 11 - DRUGS-MISBRANDED - LABEL ADVERTSE DRUG EFFECTIVE WHEN NOT 1ST OFF - M: S

S499.005 11 - DRUGS-MISBRANDED - LABEL ADVERTSE DRUG EFFECTIVE WHEN NOT SUB OFF - M: F

S499.005 12 - DRUGS-HEALTH OR SAFETY - REMOVE PENALTY 2003-155 - M: F

S499.005 12 - DRUGS-HEALTH OR SAFETY - REMOVE PENALTY 2003-155 - M: S

S499.005 12 - DRUGS-HEALTH OR SAFETY - POSSESS VIOLATE DRUG AND COSMETIC ACT 1ST OFF - M: S

S499.005 12 - DRUGS-HEALTH OR SAFETY - POSSESS VIOLATE DRUG AND COSMETIC ACT SUB OFF - M: F

S499.005 13 - DRUGS-HEALTH OR SAFETY - REMOVED - M: F

S499.005 13 - DRUGS-HEALTH OR SAFETY - REMOVED - M: S

S499.005 13 - DRUGS-HEALTH OR SAFETY - SELL DELIVER HIV AIDS SELF TEST KIT 1ST OFF - M: S

S499.005 13 - DRUGS-HEALTH OR SAFETY - SELL DELIVER HIV AIDS SELF TEST KIT SUBSQ OFF - M: F

S499.005 14 - DANGEROUS DRUGS - REMOVE PENALTY 2003-155 - F: T

S499.005 14 - DRUGS-HEALTH OR SAFETY - REMOVE PENALTY 2003-155 - M: S

S499.005 14 - HEALTH-SAFETY - PURCHASE RX DRUG UNAUTHORIZED PERSON 1ST OFF - M: S

S499.005 14 - HEALTH-SAFETY - PURCHASE RX DRUG UNAUTHORIZED PERSON SUB OFF - M: F

S499.005 15 - DRUGS-HEALTH OR SAFETY - REMOVE PENALTY 2003-155 - F: T

S499.005 15 - DRUGS-HEALTH OR SAFETY - REMOVE PENALTY 2003-155 - M: S

S499.005 15 - DRUGS-HEALTH OR SAFETY - SELL RX DRUG TO UNAUTHORIZED PERSON 1ST OFF - M: S

S499.005 15 - DRUGS-HEALTH OR SAFETY - SELL RX DRUG TO UNAUTHORIZED PERSON SUBSQ OFF - M: F

S499.005 16 - DANGEROUS DRUGS - REMOVE PENALTY 2003-155 - M: F

S499.005 16 - DRUGS-HEALTH OR SAFETY - REMOVE PENALTY 2003-155 - M: S

S499.005 16 - DRUGS-HEALTH OR SAFETY - PURCHASE MEDICAL GAS FRM UNAUTH PERSON 1ST OFF - M: S

S499.005 16 - DRUGS-HEALTH OR SAFETY - PURCHASE MEDICAL GAS UNAUTH PERSON SUBSQ OFF - M: F

S499.005 17 - DRUGS-HEALTH OR SAFETY - REMOVE PENALTY 2003-155 - F: T

S499.005 17 - DRUGS-HEALTH OR SAFETY - REMOVE PENALTY 2003-155 - M: S

S499.005 17 - DRUGS-HEALTH OR SAFETY - SELL PURCHASE TRADE DRUG SAMPLE 1ST OFF - M: S

S499.005 17 - DRUGS-HEALTH OR SAFETY - SELL PURCHASE TRADE DRUG SAMPLE SUBSEQUENT OFF - M: F

S499.005 18 - HEALTH-SAFETY - REMOVED - M: S

S499.005 18 - HEALTH-SAFETY - REMOVED - M: F

S499.005 18 - HEALTH-SAFETY - FAIL MAINTAIN REQ RECORD DRUG COSMETIC 1ST OFF - M: S

S499.005 18 - HEALTH-SAFETY - FAIL MAINTAIN REQ RECORD DRUG COSMETIC SUB OFF - M: F

S499.005 19 - FRAUD - REMOVED - M: S

S499.005 19 - FRAUD - REMOVED - M: F

S499.005 19 - FRAUD - PROVIDE DEPT FALSE FRAUD RECORD INFO 1ST OFF - M: S

S499.005 19 - FRAUD - PROVIDE DEPT FALSE FRAUD RECORD INFO SUBSQ OFF - M: F

S499.005 20 - DRUGS-HEALTH OR SAFETY - REMOVE PENALTY 2003-155 - M: S

S499.005 20 - DRUGS-HEALTH OR SAFETY - REMOVE PENALTY 2003-155 - M: F

S499.005 20 - DRUGS-HEALTH OR SAFETY - IMPORT PRESCRIPTION DRUG 1ST OFF - M: S

S499.005 20 - DRUGS-HEALTH OR SAFETY - IMPORT PRESCRIPTION DRUG SUBSQ OFF - M: F

S499.005 21 - DRUGS-HEALTH OR SAFETY - REMOVE PENALTY 2003-155 - M: S

S499.005 21 - DRUGS-HEALTH OR SAFETY - REMOVE PENALTY 2003-155 - M: F

S499.005 21 - DRUGS-HEALTH OR SAFETY - WHLSALE DIST RX DRUG HOSPIT CHARIT ORG 1ST OFF - M: S

S499.005 21 - DRUGS-HEALTH OR SAFETY - WHLSALE DIST RX DRUG HOSPT CHARIT ORG SUB OFF - M: F

S499.005 22 - DRUGS-HEALTH OR SAFETY - REMOVED - M: S

S499.005 22 - DRUGS-HEALTH OR SAFETY - REMOVED - M: F

S499.005 22 - DRUGS-HEALTH OR SAFETY - FAIL OBTAIN REQ PERMIT REGIS 1ST OFF - M: S

S499.005 22 - DRUGS-HEALTH OR SAFETY - FAIL OBTAIN REQ PERMIT REGIS SUBSQ OFF - M: F

S499.005 23 - FRAUD - REMOVED - M: S

S499.005 23 - FRAUD - REMOVED - M: F

S499.005 23 - FRAUD - FRAUD OBTAIN DISTRIB DEVICE 1ST OFF - M: S

S499.005 23 - FRAUD - FRAUD OBTAIN DISTRIB DEVICE SUBSQ OFF - M: F

S499.005 24 - HEALTH-SAFETY - REMOVED - M: S

S499.005 24 - HEALTH-SAFETY - REMOVED - M: F

S499.005 24 - HEALTH-SAFETY - DISTRIBUTE DEVICE WO PRESCRIPTION 1ST OFF - M: S

S499.005 24 - HEALTH-SAFETY - DISTRIBUTE DEVICE WO PRESCRIPTION SUBSQ OFF - M: F

S499.005 25 - DRUGS-HEALTH OR SAFETY - REMOVE PENALTY 2003-155 - M: S

S499.005 25 - DRUGS-HEALTH OR SAFETY - REMOVE PENALTY 2003-155 - M: F

S499.005 25 - DRUGS-HEALTH OR SAFETY - CHARGE FEE TO DISPENSE RX DRUG SAMPLE 1ST OFF - M: S

S499.005 25 - DRUGS-HEALTH OR SAFETY - CHARGE FEE TO DISPENSE RX DRUG SAMPLE SUB OFF - M: F

S499.005 26 - DRUGS-HEALTH OR SAFETY - REMOVE PENALTY 2003-155 - M: S

S499.005 26 - DRUGS-HEALTH OR SAFETY - PENALTY DELETED 2003-155 - M: F

S499.005 26 - DRUGS-HEALTH OR SAFETY - REMOVE PHARM DISP LABEL DISTRB RX DRUG 1ST OFF - M: S

S499.005 26 - DRUGS-HEALTH OR SAFETY - REMOVE PHARM DISP LABEL DISTRB RX DRUG SUB OFF - M: F

S499.005 27 - DRUGS-HEALTH OR SAFETY - DIST RX DRUG PREV DISP BY LISCEN PHARM 1ST OFF - M: S

S499.005 27 - DRUGS-HEALTH OR SAFETY - DIST RX DRUG PREV DISP BY LISCEN PHARM SUB OFF - M: F

S499.005 28 - HEALTH-SAFETY - FAIL ACCQUIRE TRANSACTION HISTORY INFO 1ST OFF - M: S

S499.005 28 - HEALTH-SAFETY - FAIL ACCQU TRANSACTION HISTORY INFO SUBSQ OFF - M: F

Annotations, Discussions, Cases:

Cases from cite.case.law:

SAFFORD UNIFIED SCHOOL DISTRICT v. REDDING, 557 U.S. 364 (9th Cir. 2009)

. . . . §499.005(14) (2007); N. H. Rev. Stat. Ann. §318:42(1) (West Supp. 2008). . . .

BIO- MED PLUS, INC. v. STATE DEPARTMENT OF HEALTH,, 915 So. 2d 669 (Fla. Dist. Ct. App. 2005)

. . . misrepresentation and subterfuge in the acquisition of prescription drugs for resale in violation of s. 499.005 . . . distributed prescription drugs that were adulterated, as defined in s. 499.006, F.S., in violation of s. 499.005 . . . drugs as required by ss. 499.001-499.081 and the rules adopted under those sections in violation of s. 499.005 . . .

AMENDMENTS TO FLORIDA RULES OF CRIMINAL PROCEDURE RE SENTENCING GUIDELINES, 628 So. 2d 1084 (Fla. 1993)

. . . Category 7: Drugs: Section 499.005 and chapter 893. . . .

AMENDMENTS TO FLORIDA RULES OF CRIMINAL PROCEDURE- SENTENCING GUIDELINES RULES, 613 So. 2d 1307 (Fla. 1993)

. . . amended section 499.069, Florida Statutes, to provide that violations of new subsections of section 499.005 . . . Category 7: Drugs: Section 499.005 and Cchapter 893. . . . Rule 3.988(g) Category 7: Drugs Section 499.005 — Regulation of Drugs and Cosmetics Chapter 893 — Drugs . . .

ARTHRITIS MEDICAL CENTER, INC. v. DEPARTMENT OF HEALTH AND REHABILITATIVE SERVICES,, 543 So. 2d 1304 (Fla. Dist. Ct. App. 1989)

. . . , HRS filed an “Administrative Complaint” seeking a total fine of $10,000 for violations of section 499.005 . . .

DEPARTMENT OF HEALTH AND REHABILITATIVE SERVICES v ARTHRITIS MEDICAL CENTER, INC., 32 Fla. Supp. 2d 197 (Fla. Div. Admin. Hearings 1988)

. . . The administrative complaint alleges that respondent violated Subsection 499.005(5), Florida Statutes . . . establishment in which drugs, devices, or costmetics are . . . held,” respondent has violated both Subsection 499.005 . . . This being so, it is concluded that respondent has violated Subsection 499.005(6) and Rule 10D-45.0545 . . . fact and conclusions of law, it is RECOMMENDED that respondent be found guilty of violating Subsection 499.005 . . .