(1) CEASE AND DESIST ORDERS.—
(a) In addition to any authority otherwise provided in this chapter, the department may issue and serve a complaint stating charges upon a permittee or upon an affiliated party, whenever the department has reasonable cause to believe that the person or individual named therein is engaging in or has engaged in conduct that is:
1. An act that demonstrates a lack of fitness or trustworthiness to engage in the business authorized under the permit issued pursuant to this chapter, is hazardous to the public health, or constitutes business operations that are a detriment to the public health;
2. A violation of a provision of this chapter;
3. A violation of a rule of the department;
4. A violation of an order of the department; or
5. A breach of a written agreement with the department.
(b) The complaint must contain a statement of facts and notice of opportunity for a hearing pursuant to ss. 120.569 and 120.57.
(c) If a hearing is not requested within the time allowed by ss. 120.569 and 120.57, or if a hearing is held and the department finds that any of the charges are proven, the department may enter an order directing the permittee or the affiliated party named in the complaint to cease and desist from engaging in the conduct complained of and take corrective action to remedy the effects of past improper conduct and assure future compliance.
(d) A contested or default cease and desist order is effective when reduced to writing and served upon the permittee or affiliated party named therein. An uncontested cease and desist order is effective as agreed.
(e) Whenever the department finds that conduct described in paragraph (a) is likely to cause an immediate threat to the public health, it may issue an emergency cease and desist order requiring the permittee or any affiliated party to immediately cease and desist from engaging in the conduct complained of and to take corrective and remedial action. The emergency order is effective immediately upon service of a copy of the order upon the permittee or affiliated party named therein and remains effective for 90 days. If the department begins nonemergency cease and desist proceedings under this subsection, the emergency order remains effective until the conclusion of the proceedings under ss. 120.569 and 120.57.
(2) REMOVAL OF AFFILIATED PARTIES BY THE DEPARTMENT.—
(a) The department may issue and serve a complaint stating charges upon an affiliated party and upon the permittee involved whenever the department has reason to believe that an affiliated party is engaging in or has engaged in conduct that constitutes:
1. An act that demonstrates a lack of fitness or trustworthiness to engage in the business authorized under the permit issued pursuant to this chapter, is hazardous to the public health, or constitutes business operations that are a detriment to the public health;
2. A willful violation of this chapter; however, if the violation constitutes a misdemeanor, a complaint may not be served as provided in this section until the affiliated party is notified in writing of the matter of the violation and has been afforded a reasonable period of time, as set forth in the notice, to correct the violation and has failed to do so;
3. A violation of a law involving fraud or moral turpitude which constitutes a felony;
4. A willful violation of a rule of the department;
5. A willful violation of an order of the department; or
6. A material misrepresentation of fact, made knowingly and willfully or made with reckless disregard for the truth of the matter.
(b) The complaint must contain a statement of facts and notice of opportunity for a hearing pursuant to ss. 120.569 and 120.57.
(c) If a hearing is not requested within the time allotted by ss. 120.569 and 120.57, or if a hearing is held and the department finds that any of the charges in the complaint are proven true, the department may enter an order removing the affiliated party or restricting or prohibiting participation by the person in the affairs of that permittee or of any other permittee.
(d) A contested or default order of removal, restriction, or prohibition is effective when reduced to writing and served on the permittee and the affiliated party. An uncontested order of removal, restriction, or prohibition is effective as agreed.
(e)1. The chief executive officer, designated representative, or the person holding the equivalent office, of a permittee shall promptly notify the department if she or he has actual knowledge that any affiliated party is charged with a felony in a state or federal court.
2. Whenever any affiliated party is charged with a felony in a state or federal court or with the equivalent of a felony in the courts of any foreign country with which the United States maintains diplomatic relations, and the charge alleges violation of any law involving prescription drugs, pharmaceuticals, fraud, theft, or moral turpitude, the department may enter an emergency order suspending the affiliated party or restricting or prohibiting participation by the affiliated party in the affairs of the particular permittee or of any other permittee upon service of the order upon the permittee and the affiliated party charged. The order must contain notice of opportunity for a hearing pursuant to ss. 120.569 and 120.57, where the affiliated party may request a postsuspension hearing to show that continued service to or participation in the affairs of the permittee does not pose a threat to the public health or the interests of the permittee and does not threaten to impair public confidence in the permittee. In accordance with applicable departmental rules, the department shall notify the affiliated party whether the order suspending or prohibiting the person from participation in the affairs of a permittee will be rescinded or otherwise modified. The emergency order remains in effect, unless otherwise modified by the department, until the criminal charge is disposed of. The acquittal of the person charged, or the final, unappealed dismissal of all charges against the person, dissolves the emergency order but does not prohibit the department from instituting proceedings under paragraph (a). If the person charged is convicted or pleads guilty or nolo contendere, whether or not an adjudication of guilt is entered by the court, the emergency order shall become final.
(f) Any affiliated party removed pursuant to this section is not eligible for reemployment by the permittee or to be an affiliated party of any permittee except upon the written consent of the department. Any affiliated party who is removed, restricted, or prohibited from participating in the affairs of a permittee pursuant to this section may petition the department for modification or termination of the removal, restriction, or prohibition.
History.—s. 25, ch. 2003-155; ss. 2, 36, ch. 2008-207; s. 10, ch. 2014-89.
Structure Florida Statutes
Title XXXIII - Regulation of Trade, Commerce, Investments, and Solicitations
Chapter 499 - Florida Drug and Cosmetic Act
Part I - Drugs; Devices; Cosmetics; Household Products (Ss. 499.001-499.067)
499.001 - Florida Drug and Cosmetic Act; short title.
499.002 - Purpose, administration, and enforcement of and exemption from this part.
499.003 - Definitions of terms used in this part.
499.0054 - Advertising and labeling of drugs, devices, and cosmetics; exemptions.
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.
499.0121 - Storage and handling of prescription drugs; recordkeeping.
499.01211 - Drug Wholesale Distributor Advisory Council.
499.015 - Registration of drugs and devices; issuance of certificates of free sale.
499.023 - New drugs; sale, manufacture, repackaging, distribution.
499.024 - Drug product classification.
499.025 - Drug products in finished, solid, oral dosage form; identification requirements.
499.028 - Drug samples or complimentary drugs; starter packs; permits to distribute.
499.0285 - International Prescription Drug Importation Program.
499.02851 - Federal arrangement to operate a pilot program for importing prescription drugs.
499.029 - Cancer Drug Donation Program.
499.0295 - Experimental treatments for terminal conditions.
499.03 - Possession of certain drugs without prescriptions unlawful; exemptions and exceptions.
499.032 - Phenylalanine; prescription required.
499.033 - Ephedrine; prescription required.
499.035 - Dimethyl sulfoxide (DMSO); labeling and advertising.
499.036 - Restrictions on sale of dextromethorphan.
499.051 - Inspections and investigations.
499.052 - Records of interstate shipment.
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; imminent danger.
499.066 - Penalties; remedies.
499.0661 - Cease and desist orders; removal of certain persons.
499.067 - Denial, suspension, or revocation of permit, certification, or registration.