(1) Drug products must be classified as proprietary, prescription, or investigational drugs.
(2) If a product is distributed without required labeling, it is misbranded while held for sale.
(3) Any product that falls under the definition of drug in s. 499.003 may be classified under the authority of this section. This section does not subject portable emergency oxygen inhalators to classification; however, this section does not exempt any person from ss. 499.01 and 499.015.
(4) Any product classified under the authority of this section reverts to the federal classification, if different, upon the federal regulation or act becoming effective.
(5) The department may by rule reclassify drugs subject to this part when such classification action is necessary to protect the public health.
(6) The department may adopt rules that exempt from any labeling or packaging requirements of this part drugs classified under this section if those requirements are not necessary to protect the public health.
History.—s. 9, ch. 88-159; s. 1, ch. 89-296; ss. 27, 52, ch. 92-69; s. 589, ch. 97-103; s. 42, ch. 2000-242; s. 13, ch. 2000-326; s. 61, ch. 2006-1; s. 106, ch. 2008-6; s. 19, ch. 2008-207; s. 5, ch. 2012-143; s. 37, 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.