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Florida Statutes, Title XXXIII

Florida/Statutes

← All Florida coverage

Title XXXIII, Regulation of Trade, Commerce, Investments, and Solicitations

48 chapters · 1,668 sections in this title.

All chapters in Title XXXIII1,668 Ch 501, Consumer Protection163 Ch 497, Funeral, Cemetery, and Consumer Services131 Ch 559, Regulation of Trade, Commerce, and I…119 Ch 553, Building Construction Standards111 Ch 499, Florida Drug and Cosmetic Act82 Ch 520, Retail Installment Sales80 Ch 509, Lodging and Food Service Establishme…75 Ch 550, Pari-mutuel Wagering74 Ch 560, Money Services Businesses67 Ch 494, Loan Originators and Mortgage Brokers50 Ch 548, Pugilistic Exhibitions49 Ch 517, Securities Transactions45 Ch 500, Food Products39 Ch 526, Sale of Liquid Fuels; Brake Fluid39

1,668 sections·Filtered byTitle XXXIII✕

Fla. Stat. § 499.01201 Agency for Health Care Administration review and use of statute and rule violation or compliance data
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Notwithstanding any other provision of law, the Agency for Health Care Administration may not:(1) Review or use any violation or alleged violation of s. 499.0121(6), or any rules adopted under that section, as a ground for denying or withholding any payment of a Medicaid reimburs…
Fla. Stat. § 499.0121 Storage and handling of prescription drugs; recordkeeping
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The department shall adopt rules to implement this section as necessary to protect the public health, safety, and welfare. Such rules shall include, but not be limited to, requirements for the storage and handling of prescription drugs and for the establishment and maintenance of…
Fla. Stat. § 499.01211 Drug Wholesale Distributor Advisory Council
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(1) There is created the Drug Wholesale Distributor Advisory Council within the department. The council shall meet at least once each calendar quarter. Staff for the council shall be provided by the department. The council shall consist of 12 members who shall serve without compe…
Fla. Stat. § 499.015 Registration of drugs and devices; issuance of certificates of free sale

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1(1)(a) Except for those persons exempted from the definition of manufacturer in s. 499.003, any person who manufactures, packages, repackages, labels, or relabels a drug or device in this state must register such drug or device biennially with the department; pay a fee in accord…

Fla. Stat. § 499.023 New drugs; sale, manufacture, repackaging, distribution

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A person may not sell, offer for sale, hold for sale, manufacture, repackage, distribute, or give away any new drug unless an approved application has become effective under s. 505 of the federal act or unless otherwise permitted by the Secretary of the United States Department o…

Fla. Stat. § 499.024 Drug product classification

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The department shall adopt rules to classify drug products intended for use by humans which the United States Food and Drug Administration has not classified in the federal act or the Code of Federal Regulations.(1) Drug products must be classified as proprietary, prescription, o…

Fla. Stat. § 499.025 Drug products in finished, solid, oral dosage form; identification requirements

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(1) A drug product in finished, solid, oral dosage form for which a prescription is required by federal or state law may not be manufactured or distributed within this state unless it is clearly and prominently marked or imprinted with an individual symbol, number, company name, …

Fla. Stat. § 499.026 Notification of manufacturer prescription drug price increases

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(1) As used in this section, the term:(a) “Course of therapy” means the recommended daily dose units of a prescription drug pursuant to its prescribing label for 30 days or the recommended daily dose units of a prescription drug pursuant to its prescribing label for a normal cour…

Fla. Stat. § 499.028 Drug samples or complimentary drugs; starter packs; permits to distribute

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(1) As used in this section, the term:(a) “Drug sample,” or “complimentary drug,” means a human prescription drug that is labeled “sample,” “not to be sold,” “complimentary,” or other words to that effect, that is provided as a courtesy, that is not intended to be sold, and that …

Fla. Stat. § 499.0285 International Prescription Drug Importation Program

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1(1) PROGRAM ESTABLISHED.—The department shall establish a program for the importation of safe and effective prescription drugs from foreign nations with which the United States has current mutual recognition agreements, cooperation agreements, memoranda of understanding, or othe…

Fla. Stat. § 499.02851 Federal arrangement to operate a pilot program for importing prescription drugs

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Notwithstanding the Federal Food, Drug, and Cosmetic Act, the Department of Business and Professional Regulation, in collaboration with the Department of Health, shall negotiate a federal arrangement to operate a pilot program for importing prescription drugs into this state. The…

Fla. Stat. § 499.029 Cancer Drug Donation Program

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(1) This section may be cited as the “Cancer Drug Donation Program Act.”(2) There is created a Cancer Drug Donation Program within the department for the purpose of authorizing and facilitating the donation of cancer drugs and supplies to eligible patients.(3) As used in this sec…

Fla. Stat. § 499.0295 Experimental treatments for terminal conditions

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(1) This section may be cited as the “Right to Try Act.”1(2) As used in this section, the term:(a) “Eligible patient” means a person who:1. Has a terminal condition that is attested to by the patient’s physician and confirmed by a second independent evaluation by a board-certifie…

Fla. Stat. § 499.03 Possession of certain drugs without prescriptions unlawful; exemptions and exceptions

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(1) A person may not possess, or possess with intent to sell, dispense, or deliver, any habit-forming, toxic, harmful, or new drug subject to s. 499.003(32), or prescription drug as defined in s. 499.003(40), unless the possession of the drug has been obtained by a valid prescrip…

Fla. Stat. § 499.032 Phenylalanine; prescription required

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Phenylalanine restricted formula is declared to be a prescription drug and may be dispensed only upon the prescription of a practitioner authorized by law to prescribe prescription drugs.History.—s. 34, ch. 82-225; s. 1, ch. 83-265; ss. 31, 52, ch. 92-69; s. 23, ch. 2008-207.

Fla. Stat. § 499.033 Ephedrine; prescription required

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Ephedrine is declared to be a prescription drug.(1) Except as provided in subsection (2), any product that contains any quantity of ephedrine, a salt of ephedrine, an optical isomer of ephedrine, or a salt of an optical isomer of ephedrine may be dispensed only upon the prescript…

Fla. Stat. § 499.035 Dimethyl sulfoxide (DMSO); labeling and advertising

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(1) Dimethyl sulfoxide (DMSO) not approved for drug use must be clearly marked in at least 12-point boldfaced type: “May be unsafe. Not approved for human use.”(2) All advertisements for the sale of dimethyl sulfoxide (DMSO) not approved for drug use must contain, within the adve…

Fla. Stat. § 499.036 Restrictions on sale of dextromethorphan

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(1) As used in this section, the term:(a) “Finished drug product” means a drug legally marketed under the Federal Food, Drug, and Cosmetic Act that is in finished dosage form. For purposes of this paragraph, the term “drug” has the same meaning as provided in s. 499.003(17).(b) “…

Fla. Stat. § 499.039 Sale, distribution, or transfer of harmful chemical substances; penalties; authority for enforcement

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It is unlawful for a person to sell, deliver, or give to a person under the age of 18 years any compound, liquid, or chemical containing toluol, hexane, trichloroethylene, acetone, toluene, ethyl acetate, methyl ethyl ketone, trichloroethane, isopropanol, methyl isobutyl ketone, …

Fla. Stat. § 499.04 Fee authority

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The department may collect fees for all drug, device, and cosmetic applications, permits, product registrations, and free-sale certificates. The total amount of fees collected from all permits, applications, product registrations, and free-sale certificates must be adequate to fu…

Fla. Stat. § 499.041 Schedule of fees for drug, device, and cosmetic applications and permits, product registrations, and free-sale certificates

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(1) The department shall assess applicants requiring a manufacturing permit an annual fee within the ranges established in this section for the specific type of manufacturer.(a) The fee for a prescription drug manufacturer permit may not be less than $500 or more than $750 annual…

Fla. Stat. § 499.05 Rules

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(1) The department shall adopt rules to implement and enforce this chapter with respect to:(a) The definition of terms used in this chapter, and used in the rules adopted under this chapter, when the use of the term is not its usual and ordinary meaning.(b) Labeling requirements …

Fla. Stat. § 499.051 Inspections and investigations

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(1) The agents of the department and of the Department of Law Enforcement, after they present proper identification, may inspect, monitor, and investigate any establishment permitted pursuant to this chapter during business hours for the purpose of enforcing this chapter, chapter…

Fla. Stat. § 499.052 Records of interstate shipment

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For the purpose of enforcing this part, carriers engaged in interstate commerce and persons receiving drugs, devices, or cosmetics in interstate commerce must, upon the request, in the manner set out below, by an officer or employee duly designated by the department, permit the o…

Fla. Stat. § 499.055 Reports and dissemination of information by department

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(1) The department may cause to be published from time to time reports summarizing all judgments, decrees, and court orders that have been rendered under ss. 499.001-499.79, including the nature of any charges and the dispositions of the charges.(2) The department may also cause …

Fla. Stat. § 499.057 Expenses and salaries

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Except as otherwise provided in the General Appropriations Act, all expenses and salaries shall be paid out of the Professional Regulation Trust Fund.History.—s. 34, ch. 82-225; s. 1, ch. 83-265; ss. 40, 52, ch. 92-69; s. 564, ch. 2003-261; s. 14, ch. 2012-143.

Fla. Stat. § 499.06 Embargoing, detaining, or destroying article or processing equipment which is in violation of law or rule

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(1) When a duly authorized agent of the department finds, or has probable cause to believe, that any drug, device, or cosmetic is in violation of any provision of this part or any rule adopted under this part so as to be dangerous, unwholesome, or fraudulent within the meaning of…

Fla. Stat. § 499.062 Seizure and condemnation of drugs, devices, or cosmetics

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(1) Any article of any drug, device, or cosmetic that is adulterated or misbranded under this part is subject to seizure and condemnation by the department or by its duly authorized agents designated for that purpose in regard to drugs, devices, or cosmetics.(2) Whenever a duly a…

Fla. Stat. § 499.065 Inspections; imminent danger

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1(1) Notwithstanding s. 499.051, the department shall inspect each prescription drug wholesale distributor establishment, prescription drug repackager establishment, veterinary prescription drug wholesale distributor establishment, limited prescription drug veterinary wholesale d…

Fla. Stat. § 499.066 Penalties; remedies

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In addition to other penalties and other enforcement provisions:(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 crimin…

Fla. Stat. § 499.0661 Cease and desist orders; removal of certain persons

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(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 o…

Fla. Stat. § 499.067 Denial, suspension, or revocation of permit, certification, or registration

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(1)(a) The department may deny, suspend, or revoke a permit if it finds that there has been a substantial failure to comply with this chapter or chapter 465, chapter 501, or chapter 893, the rules adopted under those chapters, any final order of the department, or applicable fede…

Fla. Stat. § 499.601 Legislative intent; construction

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(1) The Legislature finds that the unregulated possession of bulk quantities of ether poses a substantial risk to the health, safety, and welfare of the citizens of this state, and it is the intent of the Legislature that this part be liberally construed to provide all protection…

Fla. Stat. § 499.61 Definitions

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As used in this part:(1) “Dealer” means any person, firm, corporation, or other entity selling, brokering, or transferring ether to anyone other than a licensed ether manufacturer, distributor, or dealer.(2) “Department” means the Department of Business and Professional Regulatio…

Fla. Stat. § 499.62 License or permit required of manufacturer, distributor, dealer, or purchaser of ether

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(1) It shall be unlawful for any person to engage in the business of manufacturing, distributing, or dealing in ether in this state, except when done in conformity with the provisions of this part. No person shall be required to obtain more than one license under this part to han…

Fla. Stat. § 499.63 Forms for applications for licenses and permits

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(1) The forms for applications for ether licenses and permits shall be prescribed by the department.(2) Each application for a license or permit required by the provisions of this part shall be filed in writing with the department. Each application shall require, as a minimum, th…

Fla. Stat. § 499.64 Issuance of licenses and permits; prohibitions

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(1) Each license and permit issued by the department shall set forth, as a minimum, the full name, date of birth, and physical description of the licensee or permittee and shall have permanently affixed an accurate and current photograph of the licensee or permittee. A license or…

Fla. Stat. § 499.65 Possession of ether without license or permit prohibited; confiscation and disposal; exceptions

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(1) It is unlawful for any person to possess 2.5 gallons, or equivalent by weight, or more of ether unless she or he is the holder of a current valid license or permit as provided by this part.(2) Whenever the department has reason to believe that any person is or has been violat…

Fla. Stat. § 499.66 Maintenance of records and sales of ether by manufacturers, distributors, and dealers; inspections

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(1) It is unlawful for any manufacturer, distributor, or dealer to sell, distribute, or otherwise transfer ether to any person except a person presenting a current valid license or permit as provided by this part.(2) Each sale or transfer of ether shall be evidenced by an invoice…

Fla. Stat. § 499.67 Maintenance of records by purchasers; inspections

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(1) It is unlawful for any person to purchase, receive, store, or use ether without maintaining an accurate and current written inventory of all ether purchased, received, stored, and used.(2) Such records shall include, but not be limited to, invoices, receipts, sales tickets, a…

Fla. Stat. § 499.68 Reports of thefts, illegal use, or illegal possession

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(1) Any sheriff, police department, or law enforcement officer of this state shall give immediate notice to the department of any theft, illegal use, or illegal possession of ether involving any person and shall forward a copy of his or her final written report to the department.…

Fla. Stat. § 499.69 Possession in or near residential housing prohibited; legal entitlement to possession of premises not a defense

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(1) Notwithstanding the possession of a current valid license or permit as provided in this part, it is unlawful for any person to possess 2.5 gallons, or equivalent by weight, or more of ether in, or within 500 feet of, any residential housing structure.(2) A defendant’s legal e…

Fla. Stat. § 499.701 Adoption of rules by the department

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(1) The department shall adopt and enforce rules necessary to the administration of its authority under this part. The rules must be such as are reasonably necessary for the protection of the health, welfare, and safety of the public and persons manufacturing, distributing, deali…

Fla. Stat. § 499.71 Procedure for cease and desist orders

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(1) Whenever the department has reason to believe that any person is or has been violating any provision of this part or any rules adopted pursuant thereto, it shall proceed to determine the matter.(2) If the department determines that any provision of this part or any rules adop…

Fla. Stat. § 499.72 Administrative fines

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(1) If any person violates any provision of this part or any rule adopted pursuant thereto, or violates a cease and desist order issued by the department, the department may impose an administrative fine, not to exceed $5,000 for each violation per day, or may suspend or revoke t…

Fla. Stat. § 499.73 Suspension or revocation of license or permit

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(1) The violation of any provision of this part, any rule adopted pursuant thereto, or any cease and desist order issued by the department by a licensee or permittee as provided in this part shall be cause for revocation or suspension of all licenses or permits held by such licen…

Fla. Stat. § 499.74 Conduct of hearings; review of orders of the department

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(1) All hearings shall be conducted in accordance with the provisions of chapter 120.(2) All review of orders of the department shall be in accordance with the provisions of chapter 120.History.—ss. 10, 11, ch. 86-133; s. 4, ch. 91-429.

Fla. Stat. § 499.75 Penalties

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(1) Any person who knowingly manufactures, distributes, or deals in ether without possessing a valid current license as required by s. 499.62(2) is guilty of a felony of the second degree, punishable as provided in s. 775.082, s. 775.083, or s. 775.084.(2) Any person who knowingl…

Fla. Stat. § 499.76 Injunctive relief

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In addition to the penalties and other enforcement provisions of this part, in the event any person engaged in any of the activities covered by this part violates any provision of this part, any rule adopted pursuant thereto, or any cease and desist order as provided by this part…

Fla. Stat. § 499.77 Exceptions

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Nothing contained in this part shall apply to the regular military and naval forces of the United States, or to the duly organized military forces of any state or territory thereof, provided that they are acting within their respective official capacities and in the performance o…