499.025 – Drug products in finished, solid, oral dosage form; identification requirements.
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, […]
499.052 – Records of interstate shipment.
499.052 Records of interstate shipment.—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 officer or employee to have access to and […]
499.028 – Drug samples or complimentary drugs; starter packs; permits to distribute.
499.028 Drug samples or complimentary drugs; starter packs; permits to distribute.— (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, […]
499.0285 – International Prescription Drug Importation Program.
1499.0285 International Prescription Drug Importation Program.— (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 other federal mechanisms recognizing their adherence to current good manufacturing practices for pharmaceutical products. (2) DEFINITIONS.—As […]
499.02851 – Federal arrangement to operate a pilot program for importing prescription drugs.
499.02851 Federal arrangement to operate a pilot program for importing prescription drugs.—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 proposal to operate such a […]
499.029 – Cancer Drug Donation Program.
499.029 Cancer Drug Donation Program.— (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 section: (a) “Cancer drug” means a prescription drug […]
499.0295 – Experimental treatments for terminal conditions.
499.0295 Experimental treatments for terminal conditions.— (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-certified physician in an appropriate […]
499.03 – Possession of certain drugs without prescriptions unlawful; exemptions and exceptions.
499.03 Possession of certain drugs without prescriptions unlawful; exemptions and exceptions.— (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 […]
499.032 – Phenylalanine; prescription required.
499.032 Phenylalanine; prescription required.—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.
499.01 – Permits.
499.01 Permits.— 1(1) Before operating, a permit is required for each person and establishment that intends to operate as: (a) A prescription drug manufacturer; (b) A prescription drug repackager; (c) A nonresident prescription drug manufacturer; (d) A nonresident prescription drug repackager; (e) A prescription drug wholesale distributor; (f) An out-of-state prescription drug wholesale distributor; (g) A retail pharmacy drug wholesale distributor; (h) A restricted prescription […]