Florida Statutes
Title XXXIII - Regulation of Trade, Commerce, Investments, and Solicitations
Chapter 499 - Florida Drug and Cosmetic Act

499.01201 - Agency for Health Care Administration review and use of statute and rule violation or compliance data. - (1) Review or use any violation or alleged violation of...

499.0121 - Storage and handling of prescription drugs; recordkeeping. - (1) ESTABLISHMENTS.—An establishment at which prescription drugs are stored, warehoused,...

499.01211 - Drug Wholesale Distributor Advisory Council. - (1) There is created the Drug Wholesale Distributor Advisory Council...

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...

499.023 - New drugs; sale, manufacture, repackaging, distribution. - History.—s. 34, ch. 82-225; s. 1, ch. 83-265; ss. 26,...

499.024 - Drug product classification. - (1) Drug products must be classified as proprietary, prescription, or...

499.025 - Drug products in finished, solid, oral dosage form; identification requirements. - (1) A drug product in finished, solid, oral dosage form...

499.028 - Drug samples or complimentary drugs; starter packs; permits to distribute. - (1) As used in this section, the term: (a) “Drug...

499.0285 - International Prescription Drug Importation Program. - (1) PROGRAM ESTABLISHED.—The department shall establish a program for the...

499.02851 - Federal arrangement to operate a pilot program for importing prescription drugs. - History.—s. 11, ch. 2019-99.

499.029 - Cancer Drug Donation Program. - (1) This section may be cited as the “Cancer Drug...

499.0295 - Experimental treatments for terminal conditions. - (1) This section may be cited as the “Right to...

499.03 - Possession of certain drugs without prescriptions unlawful; exemptions and exceptions. - (1) A person may not possess, or possess with intent...

499.032 - Phenylalanine; prescription required. - History.—s. 34, ch. 82-225; s. 1, ch. 83-265; ss. 31,...

499.033 - Ephedrine; prescription required. - (1) Except as provided in subsection (2), any product that...

499.035 - Dimethyl sulfoxide (DMSO); labeling and advertising. - (1) Dimethyl sulfoxide (DMSO) not approved for drug use must...

499.036 - Restrictions on sale of dextromethorphan. - (1) As used in this section, the term: (a) “Finished...

499.039 - Sale, distribution, or transfer of harmful chemical substances; penalties; authority for enforcement. - (1) On the first violation of this section, the department...

499.04 - Fee authority. - History.—s. 34, ch. 82-225; s. 115, ch. 83-218; s. 1,...

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...

499.05 - Rules. - (1) The department shall adopt rules to implement and enforce...

499.051 - Inspections and investigations. - (1) The agents of the department and of the Department...

499.052 - Records of interstate shipment. - History.—s. 34, ch. 82-225; s. 1, ch. 83-265; ss. 38,...

499.055 - Reports and dissemination of information by department. - (1) The department may cause to be published from time...

499.057 - Expenses and salaries. - History.—s. 34, ch. 82-225; s. 1, ch. 83-265; ss. 40,...

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,...

499.062 - Seizure and condemnation of drugs, devices, or cosmetics. - (1) Any article of any drug, device, or cosmetic that...

499.065 - Inspections; imminent danger. - 1(1) Notwithstanding s. 499.051, the department shall inspect each prescription...

499.066 - Penalties; remedies. - (1) The department may institute such suits or other legal...

499.0661 - Cease and desist orders; removal of certain persons. - (1) CEASE AND DESIST ORDERS.— (a) In addition to any...

499.067 - Denial, suspension, or revocation of permit, certification, or registration. - (1)(a) The department may deny, suspend, or revoke a permit...

Part II - Ether (Ss. 499.601-499.79)

499.601 - Legislative intent; construction. - (1) The Legislature finds that the unregulated possession of bulk...

499.61 - Definitions. - (1) “Dealer” means any person, firm, corporation, or other entity...

499.62 - License or permit required of manufacturer, distributor, dealer, or purchaser of ether. - (1) It shall be unlawful for any person to engage...

499.63 - Forms for applications for licenses and permits. - (1) The forms for applications for ether licenses and permits...

499.64 - Issuance of licenses and permits; prohibitions. - (1) Each license and permit issued by the department shall...

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...

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...

499.67 - Maintenance of records by purchasers; inspections. - (1) It is unlawful for any person to purchase, receive,...

499.68 - Reports of thefts, illegal use, or illegal possession. - (1) Any sheriff, police department, or law enforcement officer of...

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...

499.701 - Adoption of rules by the department. - (1) The department shall adopt and enforce rules necessary to...

499.71 - Procedure for cease and desist orders. - (1) Whenever the department has reason to believe that any...

499.72 - Administrative fines. - (1) If any person violates any provision of this part...

499.73 - Suspension or revocation of license or permit. - (1) The violation of any provision of this part, any...

499.74 - Conduct of hearings; review of orders of the department. - (1) All hearings shall be conducted in accordance with the...

499.75 - Penalties. - (1) Any person who knowingly manufactures, distributes, or deals in...

499.76 - Injunctive relief. - History.—ss. 10, 11, ch. 86-133; s. 4, ch. 91-429; s....

499.77 - Exceptions. - History.—ss. 10, 11, ch. 86-133; s. 4, ch. 91-429.

499.78 - County and municipal ordinances. - History.—ss. 10, 11, ch. 86-133; s. 4, ch. 91-429.

499.79 - Deposit of fees. - History.—ss. 10, 11, ch. 86-133; s. 4, ch. 91-429; s....

Part III - Medical Gas (Ss. 499.81-499.94)

499.81 - Administration and enforcement. - (1) This part is cumulative and shall be construed and...

499.82 - Definitions. - (1) “Adulterated” means a medical gas that: (a) Consists, in...

499.83 - Permits. - (1) A person or entity that intends to distribute medical...

499.831 - Permit application. - (1) The department shall adopt rules to establish the form...

499.832 - Expiration and renewal of a permit. - (1) A permit issued under this part automatically expires 2...

499.833 - Permitholder changes. - (1) A permit issued under this part is valid only...

499.834 - Minimum qualifications. - (1) A finding by the department that the applicant has...

499.84 - Minimum requirements for the storage and handling of medical gases. - (1) A facility where a medical gas is received, stored,...

499.85 - Security. - (1) A permitholder that has a facility used for the...

499.86 - Examination of materials. - (1) A wholesale distributor must visually examine a medical gas...

499.87 - Returned, damaged, and outdated medical gas. - (1) A medical gas that has left the control of...

499.88 - Due diligence. - (1) A wholesale distributor shall obtain, before the initial acquisition...

499.89 - Recordkeeping. - (1) A permitholder under this part shall establish and maintain...

499.90 - Policies and procedures. - (1) A procedure for handling recalls and withdrawals of medical...

499.91 - Prohibited acts. - (1) The manufacture, sale, or delivery, or the holding or...

499.92 - Criminal acts. - (1) A person commits a felony of the third degree,...

499.93 - Inspections. - (1) The department may require a facility that engages in...

499.94 - Fees. - History.—s. 31, ch. 2014-89.

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Florida Statutes Title XXXIII - Regulation of Trade, Commerce, Investments, and Solicitations Chapter 499 - Florida Drug and Cosmetic Act

Florida Statutes
Title XXXIII - Regulation of Trade, Commerce, Investments, and Solicitations
Chapter 499 - Florida Drug and Cosmetic Act