Fla. Stat. § 499.001
Florida Drug and Cosmetic Act; short title
Sections 499.001-499.94 may be cited as the “Florida Drug and Cosmetic Act.”
Florida Statutes Chapter 499 — FLORIDA DRUG AND COSMETIC ACT
Florida · statute · Fla. Stat. ch. 499 · 82 active provisions
Fla. Stat. § 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 the provisions o…
Fla. Stat. § 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,…
Fla. Stat. § 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.(2)…
Fla. Stat. § 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 pre…
Fla. Stat. § 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 any way.(b) The distribution in commerce of any drug, d…
Fla. Stat. § 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 drug and t…
Fla. Stat. § 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 paragraph, the finished dos…
Fla. Stat. § 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:…
Fla. Stat. § 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 numer…
Fla. Stat. § 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;(…
Fla. Stat. § 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 18 years of age.(b) An establishment…
Fla. Stat. § 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 payment of a Medicaid reimbursement to a pharmacy licensed under chapt…
Fla. Stat. § 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.…
Fla. Stat. § 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 chair…
Fla. Stat. § 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 with the fee schedule provided by s…
Fla. Stat. § 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 Services for shipment…
Fla. Stat. § 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…
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 dru…
Fla. Stat. § 499.026
Notification of manufacturer prescription drug price increases
(1) As used in this section, the term:(a) “Course of therapy” means the recommended daily dose units of a prescription drug pursuant to its prescribing label for 30 days or the recommended daily dose units of a prescription drug pursuant to its prescribing label for a normal course of treatment which is less than 30 da…
Fla. Stat. § 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, and that is intended to promote the sale of the d…
Fla. Stat. § 499.0285
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 ad…
Fla. Stat. § 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 pilot progra…
Fla. Stat. § 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 prescript…
Fla. Stat. § 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 specialty…
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