Fla. Stat. 499.024
Drug product classification

(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.

Source: Section 499.024 — Drug product classification, https://www.­flsenate.­gov/Laws/Statutes/2024/0499.­024 (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

§ 499.024. Drug product classification's source at flsenate​.gov