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

(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, words, letters, marking, or national drug code, or any combination thereof, that identifies the drug product and the manufacturer or distributor of the drug product which has the ability to respond to requests for information regarding the drug product.

(2)

A manufacturer or distributor must make available to the department on request descriptive material that identifies each current imprint used by the manufacturer.

(3)

The department, upon application by a manufacturer, may exempt a particular drug product from the requirements of subsection (1) on the ground that imprinting is not feasible because of the size, texture, or other unique characteristic of the drug product.

(4)

This section does not apply to drug products compounded by a pharmacist licensed under chapter 465 in a pharmacy operating under a permit issued by the Board of Pharmacy.

(5)

The department shall adopt rules for implementing this section.

Source: Section 499.025 — Drug products in finished, solid, oral dosage form; identification requirements, https://www.­flsenate.­gov/Laws/Statutes/2024/0499.­025 (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

§ 499.025. Drug products in finished, solid, oral dosage form; identification requirements's source at flsenate​.gov