Fla. Stat. 499.066
Penalties; remedies


(1)

The department may institute such suits or other legal proceedings as are required to enforce any provision of this chapter. If it appears that a person has violated any provision of this chapter for which criminal prosecution is provided, the department may provide the appropriate state attorney or other prosecuting agency having jurisdiction with respect to such prosecution with the relevant information in the department’s possession.

(2)

If any person engaged in any activity covered by this chapter violates any provision of this chapter, any rule adopted under this chapter, or a cease and desist order as provided by this chapter, the department may obtain an injunction in the circuit court of the county in which the violation occurred or in which the person resides or has its principal place of business, and may apply in that court for such temporary and permanent orders as the department considers necessary to restrain the person from engaging in any such activities until the person complies with this chapter, the rules adopted under this chapter, and the orders of the department authorized by this chapter or to mandate compliance with this chapter, the rules adopted under this chapter, and any order or permit issued by the department under this chapter.

(3)

The department may impose an administrative fine, not to exceed $5,000 per violation per day, for the violation of any provision of this chapter or rules adopted under this chapter. Each day a violation continues constitutes a separate violation, and each separate violation is subject to a separate fine. All amounts collected pursuant to this section shall be deposited into the Professional Regulation Trust Fund and are appropriated for the use of the department in administering this chapter. In determining the amount of the fine to be levied for a violation, the department shall consider:The severity of the violation;Any actions taken by the person to correct the violation or to remedy complaints; andAny previous violations.

(a)

The severity of the violation;

(b)

Any actions taken by the person to correct the violation or to remedy complaints; and

(c)

Any previous violations.

(4)

The department shall deposit any rewards, fines, or collections that are due the department and which derive from joint enforcement activities with other state and federal agencies which relate to this chapter, chapter 893, or the federal act, into the Professional Regulation Trust Fund. The proceeds of those rewards, fines, and collections are appropriated for the use of the department in administering this chapter.

(5)

The department may issue an emergency order immediately suspending or revoking a permit if it determines that any condition in the establishment presents a danger to the public health, safety, and welfare.

(6)

The department may issue an emergency order to immediately remove from commerce and public access any drug, device, or cosmetic, if the department determines that the drug, device, or cosmetic presents a clear and present danger to the public health, safety, and welfare.

(7)

Resignation or termination of an affiliated party does not affect the department’s jurisdiction or discretion to proceed with action to suspend or revoke a permit or to impose other penalties or enforcement actions authorized by law.

(8)(a)

The department shall adopt rules to authorize the issuance of a remedial, nondisciplinary citation. A citation shall be issued to the person alleged to have committed a violation and contain the person’s name, address, and license number, if applicable; a brief factual statement; the sections of the law allegedly violated; and the monetary assessment and or other remedial measures imposed. The person shall have 30 days after the citation is served to contest the citation by providing supplemental and clarifying information to the department. The citation must clearly state that the person may choose, in lieu of accepting the citation, to have the department rescind the citation and conduct an investigation pursuant to s. 499.051 of only those alleged violations contained in the citation. The citation shall be rescinded by the department if the person remedies or corrects the violations or deficiencies contained in the citation within 30 days after the citation is served. If the person does not successfully contest the citation to the satisfaction of the department, or complete remedial action pursuant to this paragraph, the citation becomes a final order and does not constitute discipline.The department is entitled to recover the costs of investigation, in addition to any penalty provided according to department rule, as part of the penalty levied pursuant to a citation.A citation must be issued within 6 months after the filing of the complaint that is the basis for the citation.Service of a citation may be made by personal service or certified mail, restricted delivery, to the person at the person’s last known address of record with the department, or to the person’s Florida registered agent.The department may adopt rules to designate those violations for which a person is subject to the issuance of a citation and the monetary assessments or other remedial measures that must be taken for those violations. Violations designated as subject to issuance of a citation shall include violations for which there is no substantial threat to the public health, safety, or welfare. The department has continuous authority to amend its rules adopted pursuant to this section.

(8)(a)

The department shall adopt rules to authorize the issuance of a remedial, nondisciplinary citation. A citation shall be issued to the person alleged to have committed a violation and contain the person’s name, address, and license number, if applicable; a brief factual statement; the sections of the law allegedly violated; and the monetary assessment and or other remedial measures imposed. The person shall have 30 days after the citation is served to contest the citation by providing supplemental and clarifying information to the department. The citation must clearly state that the person may choose, in lieu of accepting the citation, to have the department rescind the citation and conduct an investigation pursuant to s. 499.051 of only those alleged violations contained in the citation. The citation shall be rescinded by the department if the person remedies or corrects the violations or deficiencies contained in the citation within 30 days after the citation is served. If the person does not successfully contest the citation to the satisfaction of the department, or complete remedial action pursuant to this paragraph, the citation becomes a final order and does not constitute discipline.

(b)

The department is entitled to recover the costs of investigation, in addition to any penalty provided according to department rule, as part of the penalty levied pursuant to a citation.

(c)

A citation must be issued within 6 months after the filing of the complaint that is the basis for the citation.

(d)

Service of a citation may be made by personal service or certified mail, restricted delivery, to the person at the person’s last known address of record with the department, or to the person’s Florida registered agent.

(e)

The department may adopt rules to designate those violations for which a person is subject to the issuance of a citation and the monetary assessments or other remedial measures that must be taken for those violations. Violations designated as subject to issuance of a citation shall include violations for which there is no substantial threat to the public health, safety, or welfare. The department has continuous authority to amend its rules adopted pursuant to this section.

Source: Section 499.066 — Penalties; remedies, https://www.­flsenate.­gov/Laws/Statutes/2024/0499.­066 (accessed Aug. 7, 2025).

499.01
Permits
499.001
Florida Drug and Cosmetic Act
499.002
Purpose, administration, and enforcement of and exemption from this part
499.03
Possession of certain drugs without prescriptions unlawful
499.003
Definitions of terms used in this part
499.04
Fee authority
499.05
Rules
499.005
Prohibited acts
499.06
Embargoing, detaining, or destroying article or processing equipment which is in violation of law or rule
499.006
Adulterated drug or device
499.007
Misbranded drug or device
499.008
Adulterated cosmetics
499.009
Misbranded cosmetics
499.012
Permit application requirements
499.015
Registration of drugs and devices
499.023
New drugs
499.024
Drug product classification
499.025
Drug products in finished, solid, oral dosage form
499.026
Notification of manufacturer prescription drug price increases
499.028
Drug samples or complimentary drugs
499.029
Cancer Drug Donation Program
499.032
Phenylalanine
499.033
Ephedrine
499.035
Dimethyl sulfoxide (DMSO)
499.036
Restrictions on sale of dextromethorphan
499.039
Sale, distribution, or transfer of harmful chemical substances
499.041
Schedule of fees for drug, device, and cosmetic applications and permits, product registrations, and free-sale certificates
499.051
Inspections and investigations
499.0051
Criminal acts
499.052
Records of interstate shipment
499.0054
Advertising and labeling of drugs, devices, and cosmetics
499.055
Reports and dissemination of information by department
499.057
Expenses and salaries
499.062
Seizure and condemnation of drugs, devices, or cosmetics
499.065
Inspections
499.066
Penalties
499.067
Denial, suspension, or revocation of permit, certification, or registration
499.0121
Storage and handling of prescription drugs
499.0285
International Prescription Drug Importation Program
499.0295
Experimental treatments for terminal conditions
499.0661
Cease and desist orders
499.01201
Agency for Health Care Administration review and use of statute and rule violation or compliance data
499.01211
Drug Wholesale Distributor Advisory Council
499.02851
Federal arrangement to operate a pilot program for importing prescription drugs

Current through Fall 2025

§ 499.066. Penalties; remedies's source at flsenate​.gov