499.001 Florida Drug and Cosmetic Act; short title.—Sections 499.001-499.94 may be cited as the “Florida Drug and Cosmetic Act.” History.—s. 34, ch. 82-225; s. 1, ch. 83-265; s. 1, ch. 86-133; ss. 1, 52, ch. 92-69; s. 122, ch. 2014-17; s. 1, ch. 2014-89.
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 […]
499.003 Definitions of terms used in this part.—As used in this part, the term: (1) “Active pharmaceutical ingredient” includes any substance or mixture of substances intended, represented, or labeled for use in drug manufacturing that furnishes or is intended to furnish, in a finished dosage form, any pharmacological activity or other direct effect in the diagnosis, cure, […]
499.005 Prohibited acts.—It is unlawful for a person to perform or cause the performance of any of the following acts in this state: (1) The manufacture, repackaging, sale, delivery, or holding or offering for sale of any drug, device, or cosmetic that is adulterated or misbranded or has otherwise been rendered unfit for human or animal use. […]
499.0051 Criminal acts.— (1) FAILURE TO MAINTAIN OR DELIVER TRANSACTION HISTORY, TRANSACTION INFORMATION, OR TRANSACTION STATEMENT.— (a) A person engaged in the distribution of prescription drugs who fails to deliver to another person a complete and accurate transaction history, transaction information, or transaction statement concerning a prescription drug or contraband prescription drug, as required by this chapter and […]
499.0054 Advertising and labeling of drugs, devices, and cosmetics; exemptions.— (1) It is a violation of the Florida Drug and Cosmetic Act to perform or cause the performance of any of the following acts: (a) The dissemination of any false advertisement of any drug, device, or cosmetic. An advertisement is false if it is false or misleading in […]
499.006 Adulterated drug or device.—A drug or device is adulterated, if any of the following apply: (1) It consists in whole or in part of any filthy, putrid, or decomposed substance. (2) It has been produced, prepared, packed, or held under conditions whereby it could have been contaminated with filth or rendered injurious to health. (3) It is a […]
499.007 Misbranded drug or device.—A drug or device is misbranded: (1) If its labeling is in any way false or misleading. (2) If in package form, it does not bear a label containing: (a) The name and place of business of the manufacturer, repackager, or distributor of the finished dosage form of the drug. For the purpose of this […]
499.008 Adulterated cosmetics.—A cosmetic is adulterated: (1) If it bears or contains any poisonous or deleterious substance that is injurious to users under the conditions of use prescribed in the labeling or advertisement thereof or under such conditions of use as are customary or usual; however, this subsection does not apply to coal-tar hair dye: (a) The label […]
499.009 Misbranded cosmetics.—A cosmetic is misbranded: (1) If its labeling is false or misleading in any particular. (2) If in package form, it does not bear a label containing: (a) The name and place of business of the manufacturer, packer, or distributor; (b) An accurate statement of the quantity of the contents in terms of weight, measure, or numerical count; […]
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 […]
499.012 Permit application requirements.— (1)(a) A permit issued pursuant to this part may be issued only to a natural person who is at least 18 years of age or to an applicant that is not a natural person if each person who, directly or indirectly, manages, controls, or oversees the operation of that applicant is at least […]
499.01201 Agency for Health Care Administration review and use of statute and rule violation or compliance data.—Notwithstanding any other provision of law, the Agency for Health Care Administration may not: (1) Review or use any violation or alleged violation of s. 499.0121(6), or any rules adopted under that section, as a ground for denying or withholding any […]
499.0121 Storage and handling of prescription drugs; recordkeeping.—The department shall adopt rules to implement this section as necessary to protect the public health, safety, and welfare. Such rules shall include, but not be limited to, requirements for the storage and handling of prescription drugs and for the establishment and maintenance of prescription drug distribution records. (1) ESTABLISHMENTS.—An […]
499.01211 Drug Wholesale Distributor Advisory Council.— (1) There is created the Drug Wholesale Distributor Advisory Council within the department. The council shall meet at least once each calendar quarter. Staff for the council shall be provided by the department. The council shall consist of 12 members who shall serve without compensation. The council shall elect a chairperson […]
499.015 Registration of drugs and devices; issuance of certificates of free sale.— 1(1)(a) Except for those persons exempted from the definition of manufacturer in s. 499.003, any person who manufactures, packages, repackages, labels, or relabels a drug or device in this state must register such drug or device biennially with the department; pay a fee in accordance […]
499.023 New drugs; sale, manufacture, repackaging, distribution.—A person may not sell, offer for sale, hold for sale, manufacture, repackage, distribute, or give away any new drug unless an approved application has become effective under s. 505 of the federal act or unless otherwise permitted by the Secretary of the United States Department of Health and Human […]
499.024 Drug product classification.—The department shall adopt rules to classify drug products intended for use by humans which the United States Food and Drug Administration has not classified in the federal act or the Code of Federal Regulations. (1) Drug products must be classified as proprietary, prescription, or investigational drugs. (2) If a product is distributed without required […]
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, […]
499.028 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, […]
