Florida Statutes Part I - Drugs; Devices; Cosmetics; Household Products (Ss. 499.001-499.067)

• 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,...
• 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...
• 499.003 - Definitions Of Terms Used In This Part.
  As used in this part, the term:(1) “Advertisement” means any representation disseminated in any manner or by any means, other than by labeling, for the purpose...
• 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,...
• 499.0051 - Criminal Acts.
  (1) FAILURE TO MAINTAIN OR DELIVER PEDIGREE PAPERS.—(a) A person, other than a manufacturer, engaged in the wholesale distribution of prescription drugs who fails to deliver to...
• 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...
• 499.006 - Adulterated Drug Or Device.
  A drug or device is adulterated:(1) If it consists in whole or in part of any filthy, putrid, or decomposed substance;(2) If it has been produced, prepared,...
• 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...
• 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...
• 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...
• 499.01 - Permits.
  (1) Prior to 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...
• 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...
• 499.01201 - Agency For Health Care Administration Review And Use Of Statute And Rule Violation Or Compliance Data.
  Notwithstanding any other provisions of law to the contrary, the Agency for Health Care Administration may not:(1) Review or use any violation or alleged violation of...
• 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...
• 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...
• 499.01212 - Pedigree Paper.
  (1) APPLICATION.—Each person who is engaged in the wholesale distribution of a prescription drug must, prior to or simultaneous with each wholesale distribution, provide a pedigree...
• 499.015 - Registration Of Drugs, Devices, And Cosmetics; Issuance Of Certificates Of Free Sale.
  (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, device,...
• 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...
• 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...
• 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...
• 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,”...
• 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...
• 499.0295 - Experimental Treatments For Terminal Conditions.
  (1) This section may be cited as the “Right to Try Act.”(2) As used in this section, the term:(a) “Eligible patient” means a person who:1. Has a terminal condition...
• 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(33),...
• 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...
• 499.033 - Ephedrine; Prescription Required.
  Ephedrine is declared to be a prescription drug.(1) Except as provided in subsection (2), any product that contains any quantity of ephedrine, a salt of ephedrine,...
• 499.035 - Dimethyl Sulfoxide (Dmso); Labeling And Advertising.
  (1) Dimethyl sulfoxide (DMSO) not approved for drug use must be clearly marked in at least 12-point boldfaced type: “May be unsafe. Not approved for human...
• 499.039 - Sale, Distribution, Or Transfer Of Harmful Chemical Substances; Penalties; Authority For Enforcement.
  It is unlawful for a person to sell, deliver, or give to a person under the age of 18 years any compound, liquid, or chemical...
• 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...
• 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...
• 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...
• 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...
• 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...
• 499.055 - Reports And Dissemination Of Information By Department.
  (1) The department may cause to be published from time to time reports summarizing all judgments, decrees, and court orders that have been rendered under ss....
• 499.057 - Expenses And Salaries.
  Except as otherwise provided in the General Appropriations Act, all expenses and salaries shall be paid out of the Professional Regulation Trust Fund.History.—s. 34, ch....
• 499.06 - Embargoing, Detaining, Or Destroying Article Or Processing Equipment Which Is In Violation Of Law Or Rule.
  (1) When a duly authorized agent of the department finds, or has probable cause to believe, that any drug, device, or cosmetic is in violation of...
• 499.062 - Seizure And Condemnation Of Drugs, Devices, Or Cosmetics.
  (1) Any article of any drug, device, or cosmetic that is adulterated or misbranded under this part is subject to seizure and condemnation by the department...
• 499.065 - Inspections; Imminent Danger.
  (1) Notwithstanding s. 499.051, the department shall inspect each prescription drug wholesale distributor establishment, prescription drug repackager establishment, veterinary prescription drug wholesale distributor establishment, limited prescription...
• 499.066 - Penalties; Remedies.
  In addition to other penalties and other enforcement provisions:(1) The department may institute such suits or other legal proceedings as are required to enforce any provision...
• 499.0661 - Cease And Desist Orders; Removal Of Certain Persons.
  (1) CEASE AND DESIST ORDERS.—(a) In addition to any authority otherwise provided in this chapter, the department may issue and serve a complaint stating charges upon a...
• 499.067 - Denial, Suspension, Or Revocation Of Permit, Certification, Or Registration.
  (1)(a) The department may deny, suspend, or revoke a permit if it finds that there has been a substantial failure to comply with this chapter or...

Last modified: September 23, 2016