499.04 – Fee authority.
499.04 Fee authority.—The department may collect fees for all drug, device, and cosmetic applications, permits, product registrations, and free-sale certificates. The total amount of fees collected from all permits, applications, product registrations, and free-sale certificates must be adequate to fund the expenses incurred by the department in carrying out this part. The department shall, by rule, […]
499.015 – Registration of drugs and devices; issuance of certificates of free sale.
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 […]
499.041 – Schedule of fees for drug, device, and cosmetic applications and permits, product registrations, and free-sale certificates.
499.041 Schedule of fees for drug, device, and cosmetic applications and permits, product registrations, and free-sale certificates.— (1) The department shall assess applicants requiring a manufacturing permit an annual fee within the ranges established in this section for the specific type of manufacturer. (a) The fee for a prescription drug manufacturer permit may not be less than $500 […]
499.023 – New drugs; sale, manufacture, repackaging, distribution.
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 […]
499.05 – 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, […]