Florida Statutes
Fla. Stat. § 499.005 (2025)
Prohibited acts.
✓ 2025 Florida Statutes: current through the 2025 Regular Session
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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.—Section 11, ch. 2019-99, which was codified as s. 499.02851, 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.” If the contingency occurs, subsection (20), as amended by s. 4, ch. 2019-99, will 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.
Arrestable Offenses under F.S. 499.005
M = misdemeanor · F = felony · degree: F=1st S=2nd T=3rd§499.005(1)HEALTH-SAFETYREMOVED
§499.005(1)HEALTH-SAFETYREMOVED
§499.005(1)HEALTH-SAFETYMFG SELL MISBRAND DEVICE COSMETIC 1ST VIOL
§499.005(1)HEALTH-SAFETYMFG SELL MISBRAND DEVICE COSMETIC PREV CONV
§499.005(2)HEALTH-SAFETYADULTERATE MISBRAND DEVICE COSMETIC PREV CONV
§499.005(2)HEALTH-SAFETYADULTERATE MISBRAND DEVICE COSMETIC 1ST VIOL
§499.005(2)HEALTH-SAFETYREMOVED
§499.005(2)HEALTH-SAFETYREMOVED
§499.005(3)FRAUDRECEIVE MISBRANDED DEVICE COSMETIC PREV CONV
§499.005(3)FRAUDRECEIVE MISBRANDED DEVICE COSMETIC 1ST VIOL
§499.005(3)FRAUDREMOVED
§499.005(3)FRAUDREMOVED
§499.005(4)HEALTH-SAFETYSELL PRODUCT VIOL DRUG COSMETIC ACT PREV CONV
§499.005(4)HEALTH-SAFETYREMOVED
§499.005(4)HEALTH-SAFETYREMOVED
§499.005(4)HEALTH-SAFETYSELL PRODUCT VIOL DRUG COSMETIC ACT 1ST VIOL
§499.005(5)FRAUDREMOVED
§499.005(5)FRAUDDISSEMINATE FALSE AD DRUG/DEV/COSMETIC 1STVIOL
§499.005(5)FRAUDDISSEMINATE FALSE AD DRUG/COSMETIC PREV CONV
§499.005(5)FRAUDREMOVED
§499.005(6)OBSTRUCT CRIMINAL INVESTREMOVED
§499.005(6)OBSTRUCT CRIMINAL INVESTRENUMBERED. SEE REC # 9980
§499.005(6)OBSTRUCT CRIMINAL INVESTRENUMBERED. SEE REC # 9979
§499.005(6)OBSTRUCT CRIMINAL INVESTREMOVED
§499.005(6)OBSTRUCTREFUSE INSPECTION DRUG/COSMETIC EST 1ST VIOL
§499.005(6)OBSTRUCTREFUSE INSPECTION DRUG/COSMETIC EST PREV CONV
§499.005(7)DRUGS-HEALTH OR SAFETYPURCH/SELL RX DRUG WHOLESALE DISTRIB PREV CONV
§499.005(7)FRAUDREMOVE PENALTY 2003-155
§499.005(7)FRAUDREMOVE PENALTY 2003-155
§499.005(7)DRUGS-HEALTH OR SAFETYPURCH/SELL RX DRUG WHOLESALE DISTRIB 1ST VIOL
§499.005(8)DRUGS-HEALTH OR SAFETYSELL COUNTERFEIT DRUG/DEVICE/COSMETIC
§499.005(8)HEALTH-SAFETYREMOVED
§499.005(8)COUNTERFEITING OFRENUMBERED. SEE REC # 8437
§499.005(9)DRUGS-MISBRANDEDREMOVED
§499.005(9)DRUGS-MISBRANDEDREMOVE/ALTER LABEL DRUG/DEV/COSMETIC PREV CONV
§499.005(9)DRUGS-MISBRANDEDREMOVED
§499.005(9)DRUGS-MISBRANDEDREMOVE/ALTER LABEL DRUG/DEV/COSMETIC 1ST VIOL
§499.005(10)HEALTH-SAFETYMISREPRESENT DEVICE OR COSMETIC MISUSE LABEL
§499.005(10)FRAUDMISREP MARK STAMP DEVICE COSMETIC 1ST OFF
§499.005(10)COUNTERFEITING OFSIMULATE MARK STAMP DEVICE COSMETIC SUBSQ OFF
§499.005(10)FORGERY OFMARK STAMP DEVICE COSMETIC 1ST OFF
§499.005(10)FORGERY OFMARK STAMP DEVICE COSMETIC SUBSQ OFF
§499.005(10)COUNTERFEITING OFSIMULATE MARK STAMP DEVICE COSMETIC 1ST OFF
§499.005(10)HEALTH-SAFETYREMOVED
§499.005(11)FRAUDREMOVE PENALTY 2003-155
§499.005(11)FRAUDREMOVE PENALTY 2003-155
§499.005(11)DRUGS-MISBRANDEDFALSELY LABEL/ADVERTISE DRUG EFFECTS 1ST VIOL
§499.005(11)DRUGS-MISBRANDEDFALSELY LABEL/ADVERTISE DRUG EFFECTS PREV CONV
§499.005(12)DRUGS-HEALTH OR SAFETYREMOVE PENALTY 2003-155
§499.005(12)DRUGS-HEALTH OR SAFETYREMOVE PENALTY 2003-155
§499.005(12)DRUGS-HEALTH OR SAFETYPOSSESS VIOLATE DRUG AND COSMETIC ACT 1ST VIOL
§499.005(12)DRUGS-HEALTH OR SAFETYPOSSESS VIOL DRUG AND COSMETIC ACT PREV CONV
§499.005(13)DRUGS-HEALTH OR SAFETYSELL/DELIV NONAPPROVED HIV/AIDS TEST 1ST VIOL
§499.005(13)DRUGS-HEALTH OR SAFETYREMOVED
§499.005(13)DRUGS-HEALTH OR SAFETYSELL/DELIV NONAPPROVED HIV/AIDS TEST PREV CONV
§499.005(13)DRUGS-HEALTH OR SAFETYREMOVED
§499.005(14)CONTROLLED SUBSTANCEREMOVED 2003-155
§499.005(14)DRUGS-HEALTH OR SAFETYREMOVE PENALTY 2003-155
§499.005(14)HEALTH-SAFETYPURCHASE RX DRUG UNAUTHORIZED PERSON 1ST VIOL
§499.005(14)HEALTH-SAFETYPURCHASE RX DRUG UNAUTHORIZED PERSON PREV CONV
§499.005(15)DRUGS-HEALTH OR SAFETYSELL RX DRUG TO UNAUTHORIZED PERSON 1ST VIOL
§499.005(15)DRUGS-HEALTH OR SAFETYREMOVE PENALTY 2003-155
§499.005(15)DRUGS-HEALTH OR SAFETYSELL RX DRUG TO UNAUTHORIZED PERSON PREV CONV
§499.005(15)DRUGS-HEALTH OR SAFETYREMOVE PENALTY 2003-155
§499.005(16)CONTROLLED SUBSTANCEREMOVED 2003-155
§499.005(16)DRUGS-HEALTH OR SAFETYPURCHASE MED GAS FROM UNAUTH PERSON 1ST VIOL
§499.005(16)DRUGS-HEALTH OR SAFETYPURCHASE MED GAS FROM UNAUTH PERSON PREV CONV
§499.005(16)DRUGS-HEALTH OR SAFETYREMOVE PENALTY 2003-155
§499.005(17)DRUGS-HEALTH OR SAFETYREMOVE PENALTY 2003-155
§499.005(17)DRUGS-HEALTH OR SAFETYREMOVE PENALTY 2003-155
§499.005(17)DRUGS-HEALTH OR SAFETYSELL/PURCHASE/TRADE DRUG SAMPLE 1ST VIOL
§499.005(17)DRUGS-HEALTH OR SAFETYSELL/PURCHASE/TRADE DRUG SAMPLE PREV CONV
§499.005(18)HEALTH-SAFETYFAIL MAINTAIN REQ DRUG/COSMETIC RECS PREV CONV
§499.005(18)HEALTH-SAFETYREMOVED
§499.005(18)HEALTH-SAFETYFAIL MAINTAIN REQ DRUG/COSMETIC RECS 1ST VIOL
§499.005(18)HEALTH-SAFETYREMOVED
§499.005(19)FRAUDREMOVED
§499.005(19)FRAUDREMOVED
§499.005(19)FRAUDPROV DEPT FALSE RECORDS/STATEMENTS PREV CONV
§499.005(19)FRAUDPROV DEPT FALSE RECORDS/STATEMENTS 1ST VIOL
§499.005(20)DRUGS-HEALTH OR SAFETYIMPORT PRESCRIPTION DRUGS 1ST VIOL
§499.005(20)DRUGS-HEALTH OR SAFETYIMPORT PRESCRIPTION DRUGS PREV CONV
§499.005(20)DRUGS-HEALTH OR SAFETYREMOVE PENALTY 2003-155
§499.005(20)DRUGS-HEALTH OR SAFETYREMOVE PENALTY 2003-155
§499.005(21)DRUGS-HEALTH OR SAFETYUNAUTH WHOLESALE DISTR OF RX DRUG 1ST VIOL
§499.005(21)DRUGS-HEALTH OR SAFETYREMOVE PENALTY 2003-155
§499.005(21)DRUGS-HEALTH OR SAFETYREMOVE PENALTY 2003-155
§499.005(21)DRUGS-HEALTH OR SAFETYUNAUTH WHOLESALE DISTR OF RX DRUG PREV CONV
§499.005(22)DRUGS-HEALTH OR SAFETYFAIL TO OBTAIN PERMIT/REGISTRATION PREV CONV
§499.005(22)DRUGS-HEALTH OR SAFETYFAIL TO OBTAIN PERMIT/REGISTRATION 1ST VIOL
§499.005(22)DRUGS-HEALTH OR SAFETYREMOVED
§499.005(22)DRUGS-HEALTH OR SAFETYREMOVED
§499.005(23)FRAUDFRAUDLY OBTAIN/DISTR RX DRUG/DEVICE PREV CONV
§499.005(23)FRAUDFRAUDLY OBTAIN/DISTR RX DRUG/DEVICE 1ST VIOL
§499.005(23)FRAUDREMOVED
§499.005(23)FRAUDREMOVED
§499.005(24)HEALTH-SAFETYREMOVED
§499.005(24)HEALTH-SAFETYDISTRIBUTE RX DEVICE W/O RX 1ST VIOL
§499.005(24)HEALTH-SAFETYREMOVED
§499.005(24)HEALTH-SAFETYDISTRIBUTE RX DEVICE W/O RX PREV CONV
§499.005(25)DRUGS-HEALTH OR SAFETYCHARGE FEE TO DISPENSE RX DRUG SAMPLE PREVCONV
§499.005(25)DRUGS-HEALTH OR SAFETYCHARGE FEE TO DISPENSE RX DRUG SAMPLE 1ST VIOL
§499.005(25)DRUGS-HEALTH OR SAFETYREMOVE PENALTY 2003-155
§499.005(25)DRUGS-HEALTH OR SAFETYREMOVE PENALTY 2003-155
§499.005(26)DRUGS-HEALTH OR SAFETYREMOVE RX DISP LABEL TO DISTR RX DRUG PREVCONV
§499.005(26)DRUGS-HEALTH OR SAFETYREMOVE RX DISP LABEL TO DISTR RX DRUG 1ST VIOL
§499.005(26)DRUGS-HEALTH OR SAFETYREMOVE PENALTY 2003-155
§499.005(26)DRUGS-HEALTH OR SAFETYPENALTY DELETED 2003-155
§499.005(27)DRUGS-HEALTH OR SAFETYRE-DISTR PREV DISPENSED RX DRUG 1ST VIOL
§499.005(27)DRUGS-HEALTH OR SAFETYRE-DISTR PREV DISPENSED RX DRUG PREV CONV
§499.005(28)HEALTH-SAFETYFAIL ACQUIRE TRANSACTION HISTORY/INFO 1ST VIOL
§499.005(28)HEALTH-SAFETYFAIL ACQUIRE TRANSACTION HISTORY/INFO PREVCONV
§499.005(29)HEALTH-SAFETYFAIL SUBMIT DRUG PRICE INCREASE INFO PREV CONV
§499.005(29)HEALTH-SAFETYFAIL SUBMIT DRUG PRICE INCREASE INFO 1ST VIOL
Notes of Decisions
Cited in 7
cases (2 in the last 5 years), 1988–2025 · leading case: Safford Unified Sch. Dist. 1 v. Redding, 557 U.S. 364 (2009).
Safford Unified Sch. Dist. 1 v. Redding, 557 U.S. 364 (2009). “2008); Fla. Stat. §499.005 (14) (2007); N. H. Rev.”
Amendments to Florida Rules of Crim. Procedure re Sentencing Guidelines, 628 So. 2d 1084 (Fla. 1993). “Category 7: Drugs: Section 499.005 and chapter 893. Category 8: Weapons: Chapter 790 and section 944.”
Amendments to Florida Rules of Crim. Procedure, 613 So. 2d 1307 (Fla. 1993). “069, Florida Statutes, to provide that violations of new *1308 subsections of section 499.005, Florida Statutes, relating to the regulation of drugs and cosmetics are third-degree felonies.”
Novo Nordisk Inc. v. Brooksville Pharm. Inc. (M.D. Fla. 2025). “The Instant Litigation Novo Nordisk’s central claim is that Brooksville is manufacturing and selling adulterated and misbranded drugs in violation of the Florida Drug and Cosmetic Act (“Florida DCA”), Fla. Stat. § 499.005 (1); id. §§ 499.006(2), (7); id.”
Dep't of Health & Rehabilitative Servs. v. Arthritis Med. Ctr., Inc., 32 Fla. Supp. 2d 197 (Fla. Div. Admin. Hr'g 1988). “The administrative complaint alleges that respondent violated Subsection 499.005(5), Florida Statutes (1987), by failing to grant HRS inspectors access to its premises.”
Clinger v. Edgewell Pers. Care Brands, LLC (D. Conn. 2023). “Count Eleven alleges a violation of FDUTPA insofar as the defendants have violated both the federal FDCA and the Florida Drug and Cosmetic Act, Fla. Stat. § 499.005 . To the extent that this count explicitly relies on the federal FDCA as the basis for a state law duty, I…”
Arthritis Med. Ctr., Inc. v. Dep't of Health & Rehabilitative Servs., 543 So. 2d 1304 (Fla. 4th DCA 1989). “After appellant allegedly refused to allow two inspections of its business premises, HRS filed an “Administrative Complaint” seeking a total fine of ,000 for violations of section 499.005(6), Florida *1305 Statutes (1987) and rule 10D-45.”
499.005(1): 1 case
Novo Nordisk Inc. v. Brooksville Pharm. Inc. (M.D. Fla. 2025). “The Instant Litigation Novo Nordisk’s central claim is that Brooksville is manufacturing and selling adulterated and misbranded drugs in violation of the Florida Drug and Cosmetic Act (“Florida DCA”), Fla. Stat. § 499.005 (1); id. §§ 499.006(2), (7); id.”
499.005(5): 1 case
Dep't of Health & Rehabilitative Servs. v. Arthritis Med. Ctr., Inc., 32 Fla. Supp. 2d 197 (Fla. Div. Admin. Hr'g 1988). “The administrative complaint alleges that respondent violated Subsection 499.005(5), Florida Statutes (1987), by failing to grant HRS inspectors access to its premises.”
499.005(6): 2 cases
Dep't of Health & Rehabilitative Servs. v. Arthritis Med. Ctr., Inc., 32 Fla. Supp. 2d 197 (Fla. Div. Admin. Hr'g 1988). “The administrative complaint alleges that respondent violated Subsection 499.005(5), Florida Statutes (1987), by failing to grant HRS inspectors access to its premises.”
Arthritis Med. Ctr., Inc. v. Dep't of Health & Rehabilitative Servs., 543 So. 2d 1304 (Fla. 4th DCA 1989). “After appellant allegedly refused to allow two inspections of its business premises, HRS filed an “Administrative Complaint” seeking a total fine of ,000 for violations of section 499.005(6), Florida *1305 Statutes (1987) and rule 10D-45.”
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