Chapter 499 Drug, Cosmetic, And Household Products
Part I - Drugs; Devices; Cosmetics; Household Products
(ss. 499.001-499.081)
- §499.001 Florida Drug and Cosmetic Act; short title.
Sections 499.001-499.081 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....
- §499.002 Purpose of ss. 499.001-499.081.
Sections 499.001-499.081 are intended to: (1) Safeguard the public health and promote the public welfare by protecting the public from injury by product use and by...
- §499.003 Definitions of terms used in ss. 499.001-499.081.
As used in ss. 499.001-499.081, the term: (1) "Advertisement" means any representation disseminated in any manner or by any means, other than by labeling, for the...
- §499.004 Administration and enforcement by department.
The Department of Health shall administer and enforce ss. 499.001-499.081 to prevent fraud, adulteration, misbranding, or false advertising in the preparation, manufacture, repackaging, or distribution...
- §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,...
- §499.0051 Criminal acts involving contraband or adulterated drugs.
(1) FAILURE TO MAINTAIN OR DELIVER PEDIGREE PAPERS.-- (a) A person, other than a manufacturer, engaged in the wholesale distribution of legend drugs who fails to deliver...
- §499.0052 Trafficking in contraband legend drugs.
A person who knowingly sells, purchases, manufactures, delivers, or brings into this state, or who is knowingly in actual or constructive possession of any amount...
- §499.0053 Power to administer oaths, take depositions, and issue and serve subpoenas.
For the purpose of any investigation or proceeding conducted by the department under ss. 499.001-499.081, the department may administer oaths, take depositions, issue and serve...
- §499.00535 Sale or purchase of contraband legend drugs resulting in great bodily harm.
A person who knowingly sells, purchases, manufactures, delivers, or brings into this state, or who is knowingly in actual or constructive possession of any amount...
- §499.0054 Advertising and labeling of drugs, devices, and cosmetics.
It is a violation of the Florida Drug and Cosmetic Act to perform or cause the performance of any of the following acts: (1) The dissemination...
- §499.00545 Sale or purchase of contraband legend drugs resulting in death.
A person who knowingly manufactures, sells, purchases, delivers, or brings into this state, or who is knowingly in actual or constructive possession of any amount...
- §499.0055 False or misleading advertisement.
In determining whether an advertisement is false or misleading, the department shall review the representations made or suggested by statement, word, design, device, sound, or...
- §499.0057 Advertisement exemptions.
(1) An advertisement that is not prohibited under s. 499.0054(1) is not prohibited under s. 499.0054(7) if it is disseminated to the public solely to advertise...
- §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...
- §499.007 Misbranded drug or device.
A drug or device is misbranded: (1) If its labeling is in any way false or misleading. (2) Unless, if in package form, it bears a label...
- §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...
- §499.009 Misbranded cosmetics.
A cosmetic is misbranded: (1) If its labeling is false or misleading in any particular. (2) Unless, if in package form, it bears a label containing: (a) The...
- §499.01 Permits; applications; renewal; general requirements.
(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;...
- §499.012 Wholesale distribution; definitions; permits; applications; general requirements.
(1) As used in this section, the term: (a) "Wholesale distribution" means distribution of prescription drugs to persons other than a consumer or patient, but does not...
- §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...
- §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 Wholesaler Advisory Council.
(1) There is created the Drug Wholesaler Advisory Council within the department. The council shall meet at least once each calendar quarter. Staff for the council...
- §499.0122 Medical oxygen and veterinary legend drug retail establishments; definitions, permits, general requirements.
(1) As used in this section, the term: (a) "Medical oxygen retail establishment" means a person licensed to sell medical oxygen to patients only. The sale must...
- §499.013 Manufacturers and repackagers of drugs, devices, and cosmetics; definitions, permits, and general requirements.
(1) As used in this section, the terms "manufacture" and "repackage" have the meaning as in s. 499.003. A pharmacy is exempt from these definitions if...
- §499.014 Distribution of legend drugs by hospitals, health care entities, charitable organizations, and return or destruction companies; permits, general requirements.
(1) A restricted prescription drug distributor permit is required for any person that engages in the distribution of a legend drug, which distribution is not considered...
- §499.015 Registration of drugs, devices, and cosmetics; issuance of certificates of free sale.
(1)(a) Except for those persons exempted from the definition in s. 499.003(28), any person who manufactures, packages, repackages, labels, or relabels a drug, device, or cosmetic...
- §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 1State Surgeon General shall adopt rules to classify drug products intended for use by humans which the United States Food and Drug Administration has...
- §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,"...
- §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 of Health...
- §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(29),...
- §499.032 Phenylalanine; prescription required.
Phenylalanine restricted formula is declared to be a prescription legend drug and may be dispensed only upon the prescription of a practitioner authorized by law...
- §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...
- §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....
- §499.05 Rules.
(1) The department shall adopt rules to implement and enforce ss. 499.001-499.081 with respect to: (a) The definition of terms used in ss. 499.001-499.081, and used in...
- §499.051 Inspections and investigations.
(1) The agents of the Department of Health and of the Department of Law Enforcement, after they present proper identification, may inspect, monitor, and investigate any...
- §499.052 Records of interstate shipment.
For the purpose of enforcing ss. 499.001-499.081, 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.
All expenses and salaries shall be paid out of the special fund hereby created in the office of the Chief Financial Officer, which fund is...
- §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 Cause for seizure and condemnation of drugs, devices, or cosmetics.
Any article of any drug, device, or cosmetic that is adulterated or misbranded under ss. 499.001-499.081 is subject to seizure and condemnation by the department...
- §499.063 Seizure; procedure; prohibition on sale or disposal of article; penalty.
Whenever a duly authorized officer or employee of the department finds cause, or has probable cause to believe that cause exists, for the seizure of...
- §499.064 Condemnation and sale; release of seized article.
(1) When any article detained or seized under s. 499.063 has been found by the department to be subject to seizure and condemnation under s. 499.063,...
- §499.065 Imminent danger.
(1) Notwithstanding s. 499.051, the department shall inspect each prescription drug wholesale establishment, prescription drug repackager establishment, veterinary prescription drug wholesale establishment, limited prescription drug veterinary...
- §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...
- §499.0661 Cease and desist orders; removal of certain persons.
(1) DEFINITION.--As used in this section, the term "permittee" means any person holding a permit issued pursuant to s. 499.012. (2) CEASE AND DESIST ORDERS.-- (a) In addition...
- §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 ss. 499.001-499.081 or...
- §499.069 Criminal punishment for violations of s. 499.005 related to devices and cosmetics; dissemination of false advertisement.
(1) Any person who violates any of the provisions of s. 499.005 with respect to a device or cosmetic commits a misdemeanor of the second degree,...
- §499.0691 Criminal punishment for violations related to drugs; dissemination of false advertisement.
(1) Any person who violates any of the following provisions commits a misdemeanor of the second degree, punishable as provided in s. 775.082 or s. 775.083;...
- §499.07 Duty of prosecuting officer.
Each state attorney, county attorney, or municipal attorney to whom the department or its designated agent reports any violation of ss. 499.001-499.081 shall cause appropriate...
- §499.071 Issuance of warnings for minor violations.
Sections 499.001-499.081 do not require the department to report, for the institution of proceedings under ss. 499.001-499.081, minor violations of ss. 499.001-499.081 when it believes...
- §499.081 Carriers in interstate commerce exempted from ss. 499.001-499.081.
Carriers engaged in interstate commerce are not subject to ss. 499.001-499.081 if they are engaged in the usual course of business as carriers. History.--s. 34,...
Part II - Ether (ss. 499.601-499.79)
- §499.601 Legislative intent; construction.
(1) The Legislature finds that the unregulated possession of bulk quantities of ether poses a substantial risk to the health, safety, and welfare of the citizens...
- §499.61 Definitions.
As used in this part: (1) "Dealer" means any person, firm, corporation, or other entity selling, brokering, or transferring ether to anyone other than a licensed...
- §499.62 License or permit required of manufacturer, distributor, dealer, or purchaser of ether.
(1) It shall be unlawful for any person to engage in the business of manufacturing, distributing, or dealing in ether in this state, except when done...
- §499.63 Forms for applications for licenses and permits.
(1) The forms for applications for ether licenses and permits shall be prescribed by the department. (2) Each application for a license or permit required by the...
- §499.64 Issuance of licenses and permits; prohibitions.
(1) Each license and permit issued by the department shall set forth, as a minimum, the full name, date of birth, and physical description of the...
- §499.65 Possession of ether without license or permit prohibited; confiscation and disposal; exceptions.
(1) It is unlawful for any person to possess 2.5 gallons, or equivalent by weight, or more of ether unless she or he is the holder...
- §499.66 Maintenance of records and sales of ether by manufacturers, distributors, and dealers; inspections.
(1) It is unlawful for any manufacturer, distributor, or dealer to sell, distribute, or otherwise transfer ether to any person except a person presenting a current...
- §499.67 Maintenance of records by purchasers; inspections.
(1) It is unlawful for any person to purchase, receive, store, or use ether without maintaining an accurate and current written inventory of all ether purchased,...
- §499.68 Reports of thefts, illegal use, or illegal possession.
(1) Any sheriff, police department, or law enforcement officer of this state shall give immediate notice to the department of any theft, illegal use, or illegal...
- §499.69 Possession in or near residential housing prohibited; legal entitlement to possession of premises not a defense.
(1) Notwithstanding the possession of a current valid license or permit as provided in this part, it is unlawful for any person to possess 2.5 gallons,...
- §499.701 Adoption of rules by the department.
(1) The department shall adopt and enforce rules necessary to the administration of its authority under this part. The rules must be such as are reasonably...
- §499.71 Procedure for cease and desist orders.
(1) Whenever the department has reason to believe that any person is or has been violating any provision of this part or any rules adopted pursuant...
- §499.72 Administrative fines.
(1) If any person violates any provision of this part or any rule adopted pursuant thereto, or violates a cease and desist order issued by the...
- §499.73 Suspension or revocation of license or permit.
(1) The violation of any provision of this part, any rule adopted pursuant thereto, or any cease and desist order issued by the department by a...
- §499.74 Conduct of hearings; review of orders of the department.
(1) All hearings shall be conducted in accordance with the provisions of chapter 120. (2) All review of orders of the department shall be in accordance with...
- §499.75 Penalties.
(1) Any person who knowingly manufactures, distributes, or deals in ether without possessing a valid current license as required by s. 499.62(2) is guilty of a...
- §499.76 Injunctive relief.
In addition to the penalties and other enforcement provisions of this part, in the event any person engaged in any of the activities covered by...
- §499.77 Exceptions.
Nothing contained in this part shall apply to the regular military and naval forces of the United States, or to the duly organized military forces...
- §499.78 County and municipal ordinances.
Nothing contained in this part shall affect any existing ordinance, rule, or regulation pertaining to ether in any county or municipality in this state, which...
- §499.79 Deposit of fees.
All fees collected for licenses and permits required by this part shall be deposited in the Florida Drug, Device, and Cosmetic Trust Fund created by...
