Florida Statutes
Part I - Drugs; Devices; Cosmetics; Household Products (Ss. 499.001-499.067)
499.002 - Purpose, administration, and enforcement of and exemption from this part.


(1) This part is intended to:
(a) Safeguard the public health and promote the public welfare by protecting the public from injury by product use and by merchandising deceit involving drugs, devices, and cosmetics.
(b) Provide uniform legislation to be administered so far as practicable in conformity with the provisions of, and regulations issued under the authority of, the Federal Food, Drug, and Cosmetic Act and that portion of the Federal Trade Commission Act which expressly prohibits the false advertisement of drugs, devices, and cosmetics.
(c) Promote thereby uniformity of such state and federal laws, and their administration and enforcement, throughout the United States.

(2) The department shall administer and enforce this part to prevent fraud, adulteration, misbranding, or false advertising in the preparation, manufacture, repackaging, or distribution of drugs, devices, and cosmetics.
(3) For the purpose of any investigation or proceeding conducted by the department under this part, the department may administer oaths, take depositions, issue and serve subpoenas, and compel the attendance of witnesses and the production of books, papers, documents, or other evidence. The department shall exercise this power on its own initiative. Challenges to, and enforcement of, the subpoenas and orders shall be handled as provided in s. 120.569.
(4) Each state attorney, county attorney, or municipal attorney to whom the department or its designated agent reports any violation of this part shall cause appropriate proceedings to be instituted in the proper courts without delay and to be prosecuted in the manner required by law.
(5) This part does not require the department to report, for the institution of proceedings under this part, minor violations of this part when it believes that the public interest will be adequately served in the circumstances by a suitable written notice or warning.
(6) Common carriers engaged in interstate commerce are not subject to this part if they are engaged in the usual course of business as common carriers.
(7) Notwithstanding any other law or local ordinance or regulation to the contrary, the regulation of over-the-counter proprietary drugs and cosmetics is expressly preempted to the state.
History.—s. 34, ch. 82-225; s. 1, ch. 83-265; ss. 2, 3, ch. 86-133; s. 2, ch. 87-50; ss. 2, 4, 6, 48, 49, 50, 52, ch. 92-69; s. 240, ch. 96-410; s. 236, ch. 99-8; s. 1, ch. 2008-207; s. 1, ch. 2020-118.
Note.—Subsection (2) former s. 499.004; subsection (3) former s. 499.0053; subsection (4) former s. 499.07; subsection (5) former s. 499.071; subsection (6) former s. 499.081.

Structure Florida Statutes

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.

499.005 - Prohibited acts.

499.0051 - Criminal acts.

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.

499.01 - Permits.

499.012 - Permit application requirements.

499.01201 - Agency for Health Care Administration review and use of statute and rule violation or compliance data.

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.

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

499.04 - Fee authority.

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

499.05 - Rules.

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.

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

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.