499.05 – Rules.
499.05 Rules.— (1) The department shall adopt rules to implement and enforce this chapter with respect to: (a) The definition of terms used in this chapter, and used in the rules adopted under this chapter, when the use of the term is not its usual and ordinary meaning. (b) Labeling requirements for drugs, devices, and cosmetics. (c) The establishment of […]
499.024 – Drug product classification.
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 […]
499.051 – Inspections and investigations.
499.051 Inspections and investigations.— (1) The agents of the department and of the Department of Law Enforcement, after they present proper identification, may inspect, monitor, and investigate any establishment permitted pursuant to this chapter during business hours for the purpose of enforcing this chapter, chapters 465, 501, and 893, and the rules of the department that protect […]
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, […]
499.0051 – Criminal acts.
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.
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.
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.
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 […]