The Florida Senate

499.001  Florida Drug and Cosmetic Act; short title.

499.002  Purpose of ss. 499.001-499.081.

499.003  Definitions of terms used in ss. 499.001-499.081.

499.004  Administration and enforcement by department.

499.005  Prohibited acts.

499.0053  Power to administer oaths, take depositions, and issue and serve subpoenas.

499.0054  Advertising and labeling of drugs, devices, and cosmetics.

499.0055  False or misleading advertisement.

499.0057  Advertisement exemptions.

499.006  Adulterated drug or device.

499.007  Misbranded drug or device.

499.008  Adulterated cosmetics.

499.009  Misbranded cosmetics.

499.01  Permits; applications; renewal; general requirements.

499.012  Wholesale distribution; definitions; permits; general requirements.

499.0121  Storage and handling of prescription drugs.

499.0122  Medical oxygen and veterinary legend drug retail establishments; definitions, permits, general requirements.

499.013  Manufacturers of drugs, devices, and cosmetics; definitions, permits, and general requirements.

499.014  Distribution of legend drugs by hospitals, health care entities, charitable organizations, and return or destruction companies; permits, general requirements.

499.015  Registration of drugs, devices, and cosmetics; issuance of certificates of free sale.

499.018  Applications for approval of investigational drugs.

499.019  Clinical investigations and investigational drugs.

499.02  Florida Drug Technical Review Panel; purpose; membership; meetings; records; expenses.

499.021  Authority and duties of the technical panel.

499.022  Technical review; approvals and denials.

499.023  New drugs; sale, manufacture, repackaging, distribution.

499.024  Drug product classification.

499.025  Drug products in finished, solid, oral dosage form; identification requirements.

499.028  Drug samples or complimentary drugs; starter packs; permits to distribute.

499.03  Possession of new drugs or legend drugs without prescriptions unlawful; exemptions and exceptions.

499.032  Phenylalanine; prescription required.

499.033  Ephedrine; prescription required.

499.035  Dimethyl sulfoxide (DMSO); labeling and advertising.

499.039  Sale, distribution, or transfer of harmful chemical substances; penalties; authority for enforcement.

499.04  Fee authority.

499.041  Schedule of fees for drug, device, and cosmetic applications and permits, investigational drug applications, product registrations, and free-sale certificates; trust fund.

499.05  Rules.

499.051  Inspections and investigations.

499.052  Records of interstate shipment.

499.055  Reports and dissemination of information by department.

499.057  Expenses and salaries.

499.06  Embargoing, detaining, or destroying article or processing equipment which is in violation of law or rule.

499.062  Cause for seizure and condemnation of drugs, devices, or cosmetics.

499.063  Seizure; procedure; prohibition on sale or disposal of article; penalty.

499.064  Condemnation and sale; release of seized article.

499.066  Penalties; remedies.

499.067  Denial, suspension, or revocation of permit or registration.

499.069  Punishment for violations of s. 499.005; dissemination of false advertisement.

499.07  Duty of prosecuting officer.

499.071  Issuance of warnings for minor violations.

499.081  Carriers in interstate commerce exempted from 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. 1, 52, ch. 92-69.

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 merchandising deceit involving drugs, devices, and cosmetics.

(2)  Provide uniform legislation to be administered so far as practicable in conformity with the provisions of, and regulations issued under the authority of, the Federal Food, Drug, and Cosmetic Act and that portion of the Federal Trade Commission Act which expressly prohibits the false advertisement of drugs, devices, and cosmetics.

(3)  Promote thereby uniformity of such state and federal laws, and their administration and enforcement, throughout the United States.

History.--s. 34, ch. 82-225; s. 1, ch. 83-265; s. 2, ch. 86-133; ss. 2, 52, ch. 92-69.

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 purpose of inducing, or which is likely to induce, directly or indirectly, the purchase of drugs, devices, or cosmetics.

(2)  "Certificate of free sale" means a document prepared by the department which certifies a drug, device, or cosmetic, that is registered with the department, as one that can be legally sold in the state.

(3)  "Closed pharmacy" means a pharmacy that is licensed under chapter 465 and purchases prescription drugs for use by a limited patient population and not for wholesale distribution or sale to the public. The term does not include retail pharmacies.

(4)  "Color" includes black, white, and intermediate grays.

(5)  "Color additive" means a material that:

(a)  Is a dye pigment, or other substance, made by a process of synthesis or similar artifice, or extracted, isolated, or otherwise derived, with or without intermediate or final change of identity from a vegetable, animal, mineral, or other source; or

(b)  When added or applied to a drug or cosmetic or to the human body, or any part thereof, is capable alone, or through reaction with other substances, of imparting color thereto;

except that the term does not include any material which has been or hereafter is exempt under the federal act.

(6)  "Compressed medical gas" means any liquefied or vaporized gas that is a prescription drug, whether it is alone or in combination with other gases.

(7)  "Cosmetic" means an article that is:

(a)  Intended to be rubbed, poured, sprinkled, or sprayed on; introduced into; or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance; or

(b)  Intended for use as a component of any such article;

except that the term does not include soap.

(8)  "Counterfeit drug, counterfeit device, or counterfeit cosmetic" means a drug, device, or cosmetic which, or the container, seal, or labeling of which, without authorization, bears the trademark, trade name, or other identifying mark, imprint, or device, or any likeness thereof, of a drug, device, or cosmetic manufacturer, processor, packer, or distributor other than the person that in fact manufactured, processed, packed, or distributed that drug, device, or cosmetic and which thereby falsely purports or is represented to be the product of, or to have been packed or distributed by, that other drug, device, or cosmetic manufacturer, processor, packer, or distributor.

(9)  "Department" means the Department of Health.

(10)  "Device" means any instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including its components, parts, or accessories, which is:

(a)  Recognized in the current edition of the United States Pharmacopoeia and National Formulary, or any supplement thereof,

(b)  Intended for use in the diagnosis, cure, mitigation, treatment, therapy, or prevention of disease in humans or other animals, or

(c)  Intended to affect the structure or any function of the body of humans or other animals,

and which does not achieve any of its principal intended purposes through chemical action within or on the body of humans or other animals and which is not dependent upon being metabolized for the achievement of any of its principal intended purposes.

(11)  "Drug" means an article that is:

(a)  Recognized in the current edition of the United States Pharmacopoeia and National Formulary, official Homeopathic Pharmacopoeia of the United States, or any supplement to any of those publications;

(b)  Intended for use in the diagnosis, cure, mitigation, treatment, therapy, or prevention of disease in humans or other animals;

(c)  Intended to affect the structure or any function of the body of humans or other animals; or

(d)  Intended for use as a component of any article specified in paragraph (a), paragraph (b), or paragraph (c), but does not include devices or their components, parts, or accessories.

(12)  "Establishment" means a place of business at one general physical location.

(13)  "Federal act" means the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. ss. 301 et seq.; 52 Stat. 1040 et seq.

(14)  "Health care entity" means a closed pharmacy or any person, organization, or business entity that provides diagnostic, medical, surgical, or dental treatment or care, or chronic or rehabilitative care, but does not include any wholesale distributor or retail pharmacy licensed under state law to deal in prescription drugs.

(15)  "Immediate container" does not include package liners.

(16)  "Investigational drug" means any drug recommended by the Florida Drug Technical Review Panel for a specific use under a protocol approved by the department and intended solely for investigational use in the state by experts qualified by scientific training and experience to investigate the safety and effectiveness of drugs.

(17)  "Label" means a display of written, printed, or graphic matter upon the immediate container of any drug, device, or cosmetic. A requirement made by or under authority of ss. 499.001-499.081 or rules adopted under those sections that any word, statement, or other information appear on the label is not complied with unless such word, statement, or other information also appears on the outside container or wrapper, if any, of the retail package of such drug, device, or cosmetic or is easily legible through the outside container or wrapper.

(18)  "Labeling" means all labels and other written, printed, or graphic matters:

(a)  Upon a drug, device, or cosmetic, or any of its containers or wrappers; or

(b)  Accompanying or related to such drug, device, or cosmetic.

(19)  "Legend drug," "prescription drug," or "medicinal drug" means any drug, including, but not limited to, finished dosage forms, or active ingredients subject to, defined by, or described by s. 503(b) of the Federal Food, Drug, and Cosmetic Act or s. 465.003(8), s. 499.007(12), or s. 499.0122(1)(b) or (c).

(20)  "Manufacture" means the preparation, deriving, compounding, propagation, processing, producing, or fabrication of any drug, device, or cosmetic. The term includes repackaging or otherwise changing the container, wrapper, or labeling to further the distribution of the drug, device, or cosmetic.

(21)  "Manufacturer" means a person who prepares, derives, manufactures, or produces a drug, device, or cosmetic. The term excludes pharmacies that are operating in compliance with pharmacy practice standards as defined in chapter 465 and rules adopted under that chapter.

(22)  "New drug" means:

(a)  Any drug the composition of which is such that the drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling of that drug; or

(b)  Any drug the composition of which is such that the drug, as a result of investigations to determine its safety and effectiveness for use under certain conditions, has been recognized for use under such conditions, but which drug has not, other than in those investigations, been used to a material extent or for a material time under such conditions.

(23)  "Official compendium" means the current edition of the official United States Pharmacopoeia and National Formulary, or any supplement thereto.

(24)  "Person" means any individual, child, joint venture, syndicate, fiduciary, partnership, corporation, division of a corporation, firm, trust, business trust, company, estate, public or private institution, association, organization, group, city, county, city and county, political subdivision of this state, other governmental agency within this state, and any representative, agent, or agency of any of the foregoing, or any other group or combination of the foregoing.

(25)  "Prepackaged drug product" means a drug that originally was in finished packaged form sealed by a manufacturer and that is placed in a properly labeled container by a pharmacy or practitioner authorized to dispense pursuant to chapter 465 for the purpose of dispensing in the establishment in which the prepackaging occurred.

(26)  "Prescription medical oxygen" means oxygen USP which is a drug that can only be sold on the order or prescription of a practitioner authorized by law to prescribe. The label of prescription medical oxygen must comply with current labeling requirements for oxygen under the Federal Food, Drug, and Cosmetic Act.

(27)  "Proprietary drug," or "OTC drug," means a patent or over-the-counter drug in its unbroken, original package, which drug is sold to the public by, or under the authority of, the manufacturer or primary distributor thereof, is not misbranded under the provisions of ss. 499.001-499.081, and can be purchased without a prescription.

(28)  "Technical panel" means the Florida Drug Technical Review Panel.

(29)  "Veterinary prescription drug" means a legend drug intended solely for veterinary use. The label of the drug must bear the statement, "Caution: Federal law restricts this drug to sale by or on the order of a licensed veterinarian."

History.--s. 34, ch. 82-225; s. 105, ch. 83-218; s. 1, ch. 83-265; s. 1, ch. 84-115; s. 1, ch. 87-57; s. 3, ch. 88-159; ss. 3, 52, ch. 92-69; s. 584, ch. 97-103; s. 235, ch. 99-8; s. 124, ch. 99-397.

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 of drugs, devices, and cosmetics.

History.--s. 34, ch. 82-225; s. 1, ch. 83-265; ss. 4, 52, ch. 92-69; s. 236, ch. 99-8.

499.005  Prohibited acts.--It is unlawful to perform or cause the performance of any of the following acts in this state:

(1)  The manufacture, repackaging, sale, delivery, or holding or offering for sale of any drug, device, or cosmetic that is adulterated or misbranded or has otherwise been rendered unfit for human or animal use.

(2)  The adulteration or misbranding of any drug, device, or cosmetic.

(3)  The receipt of any drug, device, or cosmetic that is adulterated or misbranded, and the delivery or proffered delivery of such drug, device, or cosmetic, for pay or otherwise.

(4)  The sale, distribution, purchase, trade, holding, or offering of any drug, device, or cosmetic in violation of ss. 499.001-499.081.

(5)  The dissemination of any false or misleading advertisement of a drug, device, or cosmetic.

(6)  The refusal or constructive refusal:

(a)  To allow the department to enter or inspect an establishment in which drugs, devices, or cosmetics are manufactured, processed, repackaged, sold, brokered, or held;

(b)  To allow inspection of any record of that establishment;

(c)  To allow the department to enter and inspect any vehicle that is being used to transport drugs, devices, or cosmetics; or

(d)  To allow the department to take samples of any drug, device, or cosmetic.

(7)  The giving of a false guaranty or false undertaking with respect to a drug, device, or cosmetic, except by a person who relied on a guaranty or undertaking to the same effect signed by, and containing the name and address of, the person residing in this state from whom she or he received in good faith the drug, device, or cosmetic.

(8)  Committing any act that causes a drug, device, or cosmetic to be a counterfeit drug, device, or cosmetic; or selling, dispensing, or holding for sale a counterfeit drug, device, or cosmetic.

(9)  The alteration, mutilation, destruction, obliteration, or removal of the whole or any part of the labeling of a drug, device, or cosmetic, or the doing of any other act with respect to a drug, device, or cosmetic, if the act is done while the drug, device, or cosmetic is held for sale and the act results in the drug, device, or cosmetic being misbranded.

(10)  Forging; counterfeiting; simulating; falsely representing any drug, device, or cosmetic; or, without the authority of the manufacturer, using any mark, stamp, tag, label, or other identification device authorized or required by rules adopted under ss. 499.001-499.081.

(11)  The use, on the labeling of any drug or in any advertisement relating to such drug, of any representation or suggestion that an application of the drug is effective when it is not or that the drug complies with ss. 499.001-499.081 when it does not.

(12)  The possession of any drug in violation of ss. 499.001-499.081.

(13)  The sale, delivery, holding, or offering for sale of any self-testing kits designed to tell persons their status concerning human immunodeficiency virus or acquired immune deficiency syndrome or related disorders or conditions. This prohibition shall not apply to home access HIV test kits approved for distribution and sale by the United States Food and Drug Administration.

(14)  The purchase or receipt of a legend drug from a person that is not authorized under this chapter to distribute legend drugs.

(15)  The sale or transfer of a legend drug to a person that is not authorized under the law of the jurisdiction in which the person receives the drug to purchase or possess legend drugs.

(16)  The purchase or receipt of a compressed medical gas from a person that is not authorized under this chapter to distribute compressed medical gases.

(17)  The sale, purchase, or trade, or the offer to sell, purchase, or trade, a drug sample as defined in s. 499.028; the distribution of a drug sample in violation of s. 499.028; or the failure to otherwise comply with s. 499.028.

(18)  Failure to maintain records as required by ss. 499.001-499.081 and rules adopted under those sections.

(19)  Providing the department with false or fraudulent records, or making false or fraudulent statements, regarding any matter within the provisions of this chapter.

(20)  The importation of a legend drug except as provided by s. 801(d) of the Federal Food, Drug, and Cosmetic Act.

(21)  The wholesale distribution of any prescription drug that was:

(a)  Purchased by a public or private hospital or other health care entity; or

(b)  Donated or supplied at a reduced price to a charitable organization.

(22)  Failure to obtain a permit or registration, or operating without a valid permit when a permit or registration is required by ss. 499.001-499.081 for that activity.

(23)  Obtaining or attempting to obtain a prescription drug or device by fraud, deceit, misrepresentation or subterfuge, or engaging in misrepresentation or fraud in the distribution of a drug or device.

(24)  The distribution of a legend device to the patient or ultimate consumer without a prescription or order from a practitioner licensed by law to use or prescribe the device.

History.--s. 34, ch. 82-225; s. 106, ch. 83-218; s. 1, ch. 83-265; s. 24, ch. 88-380; ss. 5, 52, ch. 92-69; s. 3, ch. 95-308; s. 585, ch. 97-103; s. 29, ch. 98-151; s. 37, ch. 99-397.

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 subpoenas, and compel the attendance of witnesses and the production of books, papers, documents, or other evidence. The department shall exercise this power on its own initiative. Challenges to, and enforcement of, the subpoenas and orders shall be handled as provided in s. 120.569.

History.--s. 3, ch. 86-133; s. 2, ch. 87-50; ss. 6, 52, ch. 92-69; s. 240, ch. 96-410.

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 of any false advertisement of any drug, device, or cosmetic. An advertisement is false if it is false or misleading in any way.

(2)  The distribution in commerce of any drug, device, or cosmetic, if its labeling or advertising is in violation of ss. 499.001-499.081.

(3)  The manufacturing, repackaging, packaging, selling, delivery, holding, or offering for sale of any drug, device, or cosmetic for which the advertising or labeling is false or misleading.

(4)  The advertising of any drug, device, or cosmetic that is adulterated or misbranded.

(5)  The receiving in commerce of any drug, device, or cosmetic that is falsely advertised or labeled or the delivering or proffering for delivery of any such drug, device, or cosmetic.

(6)  The advertising or labeling of any product containing ephedrine, a salt of ephedrine, an isomer of ephedrine, or a salt of an isomer of ephedrine, for the indication of stimulation, mental alertness, weight loss, appetite control, energy, or other indications not approved by the pertinent United States Food and Drug Administration Over-the-Counter Final or Tentative Final Monograph or approved new drug application under the federal act. In determining compliance with this requirement, the department may consider the following factors:

(a)  The packaging of the product.

(b)  The name and labeling of the product.

(c)  The manner of distribution, advertising, and promotion of the product, including verbal representations at the point of sale.

(d)  The duration, scope, and significance of abuse of the particular product.

(7)  The advertising of any drug or device represented to have any effect in any of the following conditions, disorders, diseases, or processes:

(a)  Blood disorders.

(b)  Bone or joint diseases.

(c)  Kidney diseases or disorders.

(d)  Cancer.

(e)  Diabetes.

(f)  Gall bladder diseases or disorders.

(g)  Heart and vascular diseases.

(h)  High blood pressure.

(i)  Diseases or disorders of the ear or auditory apparatus, including hearing loss or deafness.

(j)  Mental disease or mental retardation.

(k)  Paralysis.

(l)  Prostate gland disorders.

(m)  Conditions of the scalp affecting hair loss.

(n)  Baldness.

(o)  Endocrine disorders.

(p)  Sexual impotence.

(q)  Tumors.

(r)  Venereal diseases.

(s)  Varicose ulcers.

(t)  Breast enlargement.

(u)  Purifying blood.

(v)  Metabolic disorders.

(w)  Immune system disorders or conditions affecting the immune system.

(x)  Extension of life expectancy.

(y)  Stress and tension.

(z)  Brain stimulation or performance.

(aa)  The body's natural defense mechanisms.

(bb)  Blood flow.

(cc)  Depression.

(dd)  Human immunodeficiency virus or acquired immune deficiency syndrome or related disorders or conditions.

History.--ss. 1, 4, ch. 86-271; s. 5, ch. 88-172; s. 25, ch. 88-380; ss. 7, 52, ch. 92-69; s. 2, ch. 95-415.

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 any combination thereof within the advertisement and the extent to which the advertisement fails to reveal material facts with respect to consequences that can result from the use of the drug, device, or cosmetic to which the advertisement relates under the conditions of use prescribed in the labeling or advertisement.

History.--s. 34, ch. 82-225; s. 1, ch. 83-265; ss. 8, 52, ch. 92-69.

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 the product for those indications that are safe and effective indications and the product is safe and effective for self-medication, as established by the United States Food and Drug Administration; if it is disseminated only to members of the medical, dental, pharmaceutical, or veterinary professions or appears only in the scientific periodicals of these professions.

(2)  Compliance with ss. 499.001-499.081 and the rules adopted under those sections creates no legal presumption that a drug or device is safe or effective.

History.--ss. 2, 4, ch. 86-271; ss. 9, 52, ch. 92-69; s. 3, ch. 95-415.

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, packed, or held under conditions whereby it could have been contaminated with filth or rendered injurious to health;

(3)  If it is a drug and the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with, current good manufacturing practices to assure that the drug meets the requirements of ss. 499.001-499.081 and that the drug has the identity and strength, and meets the standard of quality and purity, which it purports or is represented to possess;

(4)  If it is a drug and its container is composed, in whole or in part, of any poisonous or deleterious substance which could render the contents injurious to health;

(5)  If it is a drug and it bears or contains, for the purpose of coloring only, a color additive that is unsafe within the meaning of the federal act; or, if it is a color additive, the intended use of which in or on drugs is for the purpose of coloring only, and it is unsafe within the meaning of the federal act;

(6)  If it purports to be, or is represented as, a drug the name of which is recognized in the official compendium, and its strength differs from, or its quality or purity falls below, the standard set forth in such compendium. The determination as to strength, quality, or purity must be made in accordance with the tests or methods of assay set forth in such compendium, or, when such tests or methods of assay are absent or inadequate, in accordance with those tests or methods of assay prescribed under authority of the federal act. A drug defined in the official compendium is not adulterated under this subsection merely because it differs from the standard of strength, quality, or purity set forth for that drug in such compendium if its difference in strength, quality, or purity from such standard is plainly stated on its label;

(7)  If it is not subject to subsection (6) and its strength differs from, or its purity or quality falls below the standard of, that which it purports or is represented to possess; or

(8)  If it is a drug:

(a)  With which any substance has been mixed or packed so as to reduce the quality or strength of the drug; or

(b)  For which any substance has been substituted wholly or in part.

(9)  If it is a drug or device for which the expiration date has passed.

History.--s. 34, ch. 82-225; s. 1, ch. 83-265; ss. 10, 52, ch. 92-69.

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 containing:

(a)  The name and place of business of the manufacturer or distributor; in addition, for a medicinal drug, as defined in s. 499.003, the label must contain the name and place of business of the manufacturer of the finished dosage form of the drug. For the purpose of this paragraph, the finished dosage form of a medicinal drug is that form of the drug which is, or is intended to be, dispensed or administered to the patient and requires no further manufacturing or processing other than packaging, reconstitution, and labeling; and

(b)  An accurate statement of the quantity of the contents in terms of weight, measure, or numerical count; however, under this section, reasonable variations are permitted, and the department shall establish by rule exemptions for small packages.

(3)  If any word, statement, or other information required by or under ss. 499.001-499.081 to appear on the label or labeling is not prominently placed thereon with such conspicuousness as compared with other words, statements, designs, or devices in the labeling, and in such terms, as to render the word, statement, or other information likely to be read and understood under customary conditions of purchase and use.

(4)  If it is a drug and is not designated solely by a name recognized in an official compendium, unless its label bears:

(a)  The common or usual name of the drug, if any; and

(b)  In case it is fabricated from two or more ingredients, the common or usual name and quantity of each active ingredient.

(5)  Unless its labeling bears:

(a)  Adequate directions for use; and

(b)  Adequate warnings against use in those pathological conditions in which its use may be dangerous to health or against use by children if its use may be dangerous to health, or against unsafe dosage or methods or duration of administration or application, in such manner and form as are necessary for the protection of users.

(6)  If it purports to be a drug the name of which is recognized in the official compendium, unless it is packaged and labeled as prescribed therein; however, the method of packaging may be modified with the consent of the department.

(7)  If it has been found by the department to be a drug liable to deterioration, unless it is packaged in such form and manner, and its label bears a statement of such precautions, as the department by rule requires as necessary to protect the public health. Such rule may not be established for any drug recognized in an official compendium until the department has informed the appropriate body charged with the revision of such compendium of the need for such packaging or labeling requirements and that body has failed within a reasonable time to prescribe such requirements.

(8)  If it is:

(a)  A drug and its container or finished dosage form is so made, formed, or filled as to be misleading;

(b)  An imitation of another drug; or

(c)  Offered for sale under the name of another drug.

(9)  If it is dangerous to health when used in the dosage or with the frequency or duration prescribed, recommended, or suggested in the labeling of the drug.

(10)  If it is, purports to be, or is represented as a drug composed wholly or partly of insulin, unless:

(a)  It is from a batch with respect to which a certificate has been issued pursuant to s. 506 of the federal act; and

(b)  The certificate is in effect with respect to the drug.

(11)  If it is, purports to be, or is represented as a drug composed wholly or partly of any kind of antibiotic requiring certification under the federal act unless:

(a)  It is from a batch with respect to which a certificate has been issued pursuant to s. 507 of the federal act; and

(b)  The certificate is in effect with respect to the drug;

however, this subsection does not apply to any drug or class of drugs exempted by regulations adopted under s. 507(c) or (d) of the federal act.

(12)  If it is a drug intended for use by humans which is a habit-forming drug or which, because of its toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use, is not safe for use except under the supervision of a practitioner licensed by law to administer such drugs; or which is limited by an effective application under s. 505 of the federal act to use under the professional supervision of a practitioner licensed by law to prescribe such drug, unless it is dispensed only:

(a)  Upon the written prescription of a practitioner licensed by law to prescribe such drug;

(b)  Upon an oral prescription of such practitioner, which is reduced promptly to writing and filled by the pharmacist; or

(c)  By refilling any such written or oral prescription, if such refilling is authorized by the prescriber either in the original prescription or by oral order which is reduced promptly to writing and filled by the pharmacist.

This subsection does not relieve any person from any requirement prescribed by law with respect to controlled substances as defined in the applicable federal and state laws.

(13)  If it is a drug that is subject to paragraph (12)(a), and if, at any time before it is dispensed, its label fails to bear the statement:

(a)  "Caution: Federal Law Prohibits Dispensing Without Prescription";

(b)  "Rx Only";

(c)  The prescription symbol followed by the word "Only"; or

(d)  "Caution: State Law Prohibits Dispensing Without Prescription."

(14)  If it is a drug that is not subject to paragraph (12)(a), if at any time before it is dispensed its label bears the statement of caution required in subsection (13).

(15)  If it is a color additive, the intended use of which in or on drugs is for the purpose of coloring only, unless its packaging and labeling are in conformity with the packaging and labeling requirements that apply to such color additive and are prescribed under the federal act.

A drug dispensed by filling or refilling a written or oral prescription of a practitioner licensed by law to prescribe such drug is exempt from the requirements of this section, except subsections (1), (8), (10), and (11) and the packaging requirements of subsections (6) and (7), if the drug bears a label that contains the name and address of the dispenser or seller, the prescription number and the date the prescription was written or filled, the name of the prescriber and the name of the patient, and the directions for use and cautionary statements. This exemption does not apply to any drug dispensed in the course of the conduct of a business of dispensing drugs pursuant to diagnosis by mail or to any drug dispensed in violation of subsection (12). The department may, by rule, exempt drugs subject to ss. 499.062-499.064 from subsection (12) if compliance with that subsection is not necessary to protect the public health, safety, and welfare.

History.--s. 34, ch. 82-225; s. 107, ch. 83-218; s. 1, ch. 83-265; s. 2, ch. 84-115; ss. 11, 52, ch. 92-69; s. 586, ch. 97-103; s. 38, ch. 99-397.

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 the labeling or advertisement thereof or under such conditions of use as are customary or usual; however, this subsection does not apply to coal-tar hair dye:

(a)  The label of which bears the following legend conspicuously displayed thereon: "Caution: This product contains ingredients which may cause skin irritation on certain individuals, and a preliminary test according to accompanying directions should first be made. This product must not be used for dyeing the eyelashes or eyebrows; to do so may cause blindness"; and

(b)  The labeling of which bears adequate directions for such preliminary testing.

For the purposes of this subsection and subsection (4), the term "hair dye" does not include eyelash dyes or eyebrow dyes.

(2)  If it consists in whole or in part of any filthy, putrid, or decomposed substance.

(3)  If it has been produced, prepared, packed, or held under conditions whereby it could have become contaminated with filth or whereby it could have been rendered injurious to health.

(4)  If it is not a hair dye and it is, or it bears or contains, a color additive that is unsafe within the meaning of the federal act.

History.--s. 34, ch. 82-225; s. 1, ch. 83-265; ss. 12, 52, ch. 92-69.

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 name and place of business of the manufacturer, packer, or distributor;

(b)  An accurate statement of the quantity of the contents in terms of weight, measure, or numerical count; however, under this paragraph reasonable variations are permitted, and the department shall establish by rule exemptions for small packages; and

(c)  A declaration of ingredients in descending order of predominance, or as otherwise required by federal law.

(3)  If any word, statement, or other information required by or under authority of ss. 499.001-499.081 to appear on the label or labeling is not prominently placed thereon with such conspicuousness as compared with other words, statements, designs, or devices in the labeling, and in such terms, as to render the word, statement, or other information likely to be read and understood by an individual under customary conditions of purchase and use.

(4)  If its container is so made, formed, or filled as to be misleading.

(5)  Unless, if it is a color additive, its packaging and labeling are in conformity with the packaging and labeling requirements applicable to that color additive prescribed under the federal act. This subsection does not apply to packages of color additives that, with respect to their use for cosmetics, are marketed and intended for use only in or on hair dyes.

History.--s. 34, ch. 82-225; s. 1, ch. 83-265; ss. 13, 52, ch. 92-69.

499.01  Permits; applications; renewal; general requirements.--

(1)  Any person that is required under ss. 499.001-499.081 to have a permit must apply to the department on forms furnished by the department.

(a)  A permit issued pursuant to ss. 499.001-499.081 may be issued only to an individual who is at least 18 years of age or to a corporation that is registered pursuant to chapter 607 or chapter 617 and each officer of which is at least 18 years of age.

(b)  An establishment that is a place of residence may not receive a permit and may not operate under ss. 499.001-499.081.

(c)  A person that applies for or renews a permit to manufacture or distribute legend drugs may not use a name identical to the name used by any other establishment or licensed person authorized to purchase prescription drugs in this state, except that a restricted drug distributor permit issued to a health care entity will be issued in the name in which the institutional pharmacy permit is issued and a retail pharmacy drug wholesaler will be issued a permit in the name of its retail pharmacy permit.

(d)  A permit is required for each establishment that operates as a:

1.  Prescription drug manufacturer;

2.  Over-the-counter drug manufacturer;

3.  Compressed medical gas manufacturer;

4.  Device manufacturer;

5.  Cosmetic manufacturer;

6.  Prescription drug wholesaler;

7.  Compressed medical gas wholesaler;

8.  Out-of-state prescription drug wholesaler;

9.  Retail pharmacy drug wholesaler;

10.  Veterinary legend drug retail establishment;

11.  Medical oxygen retail establishment;

12.  Complimentary drug distributor; or

13.  Restricted prescription drug distributor.

(e)  A permit for a prescription drug manufacturer, prescription drug wholesaler, or retail pharmacy wholesaler may not be issued to the address of a health care entity.

(f)  Notwithstanding subsection (4), a permitted person in good standing may change the type of permit issued to that person by completing a new application for the requested permit, paying the amount of the difference in the permit fees if the fee for the new permit is more than the fee for the original permit, and meeting the applicable permitting conditions for the new permit type. The new permit expires on the expiration date of the original permit being changed. A refund may not be issued if the biennial fee for the new permit is less than the original permit for which a fee was paid.

(2)  The department shall establish, by rule, the form of the application to obtain or renew a permit. The applicant must submit to the department with the application a statement that swears or affirms that the information is true and correct.

(a)  Information that an applicant must provide includes, but need not be limited to:

1.  The name, full business address, and telephone number of the applicant;

2.  All trade or business names used by the applicant;

3.  The address, telephone numbers, and the names of contact persons for each facility used by the applicant for the storage, handling, and distribution of prescription drugs;

4.  The type of ownership or operation, such as a partnership, corporation, or sole proprietorship; and

5.  The names of the owner and the operator of the establishment, including:

a.  If an individual, the name of the individual;

b.  If a partnership, the name of each partner and the name of the partnership;

c.  If a corporation, the name and title of each corporate officer and director, the corporate names, and the name of the state of incorporation;

d.  If a sole proprietorship, the full name of the sole proprietor and the name of the business entity; and

e.  Any other relevant information that the department requires.

(b)  Upon approval of the application by the department and payment of the required fee, the department shall issue a permit to the applicant, if the applicant meets the requirements of ss. 499.001-499.081 and rules adopted under those sections.

(c)  Any change in information required under paragraph (a) must be submitted to the department before the change occurs.

(d)  The department shall consider, at a minimum, the following factors in reviewing the qualifications of persons to be permitted under ss. 499.001-499.081:

1.  The applicant's having been found guilty, regardless of adjudication, in a court of this state or other jurisdiction, of a violation of a law that directly relates to a drug, device, or cosmetic. A plea of nolo contendere constitutes a finding of guilt for purposes of this subparagraph.

2.  The applicant's having been disciplined by a regulatory agency in any state for any offense that would constitute a violation of ss. 499.001-499.081.

3.  Any felony conviction of the applicant under a federal, state, or local law;

4.  The applicant's past experience in manufacturing or distributing drugs, devices, or cosmetics;

5.  The furnishing by the applicant of false or fraudulent material in any application made in connection with manufacturing or distributing drugs, devices, or cosmetics;

6.  Suspension or revocation by a federal, state, or local government of any permit currently or previously held by the applicant for the manufacture or distribution of any drugs, devices, or cosmetics;

7.  Compliance with permitting requirements under any previously granted permits;

8.  Compliance with requirements to maintain or make available to the state permitting authority or to federal, state, or local law enforcement officials those records required under this section; and

9.  Any other factors or qualifications the department considers relevant to and consistent with the public health and safety.

(3)  The department shall adopt rules for the biennial renewal of permits.

(a)  The department shall renew a permit upon receipt of the renewal application and renewal fee if the applicant meets the requirements established under ss. 499.001-499.081 and the rules adopted under those sections.

(b)  A permit, unless sooner suspended or revoked, automatically expires 2 years after the last day of the anniversary month in which the permit was originally issued. A permit issued under ss. 499.001-499.081 must be renewed by making application for renewal on forms furnished by the department and paying the appropriate fees. If a renewal application and fee are not submitted and postmarked by the expiration date of the permit, the permit may be reinstated only upon payment of a delinquent fee of $100, plus the required renewal fee, within 60 days after the expiration date.

(c)  Failure to renew a permit in accordance with this section precludes any future renewal of that permit. Continuing to engage in activities that require a permit under ss. 499.001-499.081 requires a new permit application and payment of an application fee, initial permit fee, and applicable penalties.

(4)  A permit issued by the department is nontransferable. Each permit is valid only for the person or governmental unit to which it is issued and is not subject to sale, assignment, or other transfer, voluntarily or involuntarily; nor is a permit valid for any establishment other than the establishment for which it was originally issued.

(a)  A person permitted under ss. 499.001-499.081 must notify the department before making a change of address. The department shall set a change of location fee not to exceed $100.

(b)1.  An application for a new permit is required when a majority of the ownership or controlling interest of a permitted establishment is transferred or assigned or when a lessee agrees to undertake or provide services to the extent that legal liability for operation of the establishment will rest with the lessee. The application for the new permit must be made before the date of the sale, transfer, assignment, or lease.

2.  A permittee that is authorized to distribute legend drugs may transfer such drugs to the new owner or lessee under subparagraph 1. only after the new owner or lessee has been approved for a permit to distribute legend drugs.

(c)  The department shall deny, suspend, or revoke the permit of any person or establishment if the assignment, sale, transfer, or lease of an establishment permitted under ss. 499.001-499.081 will avoid an administrative penalty, civil action, or criminal prosecution.

(d)  If an establishment permitted under ss. 499.001-499.081 closes, the owner must notify the department in writing before the effective date of closure and must:

1.  Return the permit to the department;

2.  If the permittee is authorized to distribute legend drugs, indicate the disposition of such drugs, including the name, address, and inventory. Transfer of ownership of legend drugs may be made only to persons authorized to possess legend drugs under ss. 499.001-499.081.

(5)  A permit must be posted in a conspicuous place on the licensed premise.

History.--s. 34, ch. 82-225; s. 108, ch. 83-218; s. 1, ch. 83-265; ss. 14, 52, ch. 92-69; s. 30, ch. 98-151.

499.012  Wholesale distribution; definitions; permits; 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 include:

1.  Any of the following activities, which is not a violation of s. 499.005(21) if such activity is conducted in accordance with s. 499.014:

a.  The purchase or other acquisition by a hospital or other health care entity that is a member of a group purchasing organization of a prescription drug for its own use from the group purchasing organization or from other hospitals or health care entities that are members of that organization.

b.  The sale, purchase, or trade of a prescription drug or an offer to sell, purchase, or trade a prescription drug by a charitable organization described in s. 501(c)(3) of the Internal Revenue Code of 1986, as amended and revised, to a nonprofit affiliate of the organization to the extent otherwise permitted by law.

c.  The sale, purchase, or trade of a prescription drug or an offer to sell, purchase, or trade a prescription drug among hospitals or other health care entities that are under common control. For purposes of this section, "common control" means the power to direct or cause the direction of the management and policies of a person or an organization, whether by ownership of stock, by voting rights, by contract, or otherwise.

d.  The sale, purchase, trade, or other transfer of a prescription drug from or for any federal, state, or local government agency or any entity eligible to purchase prescription drugs at public health services prices pursuant to Pub. L. No. 102-585, s. 602 to a contract provider or its subcontractor for eligible patients of the agency or entity under the following conditions:

(I)  The agency or entity must obtain written authorization for the sale, purchase, trade, or other transfer of a prescription drug under this sub-subparagraph from the Secretary of Health or his or her designee.

(II)  The contract provider or subcontractor must be authorized by law to administer or dispense prescription drugs.

(III)  In the case of a subcontractor, the agency or entity must be a party to and execute the subcontract.

(IV)  A contract provider or subcontractor must maintain separate and apart from other prescription drug inventory any prescription drugs of the agency or entity in its possession.

(V)  The contract provider and subcontractor must maintain and produce immediately for inspection all records of movement or transfer of all the prescription drugs belonging to the agency or entity, including, but not limited to, the records of receipt and disposition of prescription drugs. Each contractor and subcontractor dispensing or administering these drugs must maintain and produce records documenting the dispensing or administration. Records that are required to be maintained include, but are not limited to, a perpetual inventory itemizing drugs received and drugs dispensed by prescription number or administered by patient identifier, which must be submitted to the agency or entity quarterly.

(VI)  The contract provider or subcontractor may administer or dispense the prescription drugs only to the eligible patients of the agency or entity or must return the prescription drugs for or to the agency or entity. The contract provider or subcontractor must require proof from each person seeking to fill a prescription or obtain treatment that the person is an eligible patient of the agency or entity and must, at a minimum, maintain a copy of this proof as part of the records of the contractor or subcontractor required under sub-sub-subparagraph (V).

(VII)  The prescription drugs transferred pursuant to this sub-subparagraph may not be billed to Medicaid.

(VIII)  In addition to the departmental inspection authority set forth in s. 499.051, the establishment of the contract provider and subcontractor and all records pertaining to prescription drugs subject to this sub-subparagraph shall be subject to inspection by the agency or entity. All records relating to prescription drugs of a manufacturer under this sub-subparagraph shall be subject to audit by the manufacturer of those drugs, without identifying individual patient information.

2.  Any of the following activities, which is not a violation of s. 499.005(21) if such activity is conducted in accordance with rules established by the department:

a.  The sale, purchase, or trade of a prescription drug among federal, state, or local government health care entities that are under common control and are authorized to purchase such prescription drug.

b.  The sale, purchase, or trade of a prescription drug or an offer to sell, purchase, or trade a prescription drug for emergency medical reasons. For purposes of this sub-subparagraph, the term "emergency medical reasons" includes transfers of prescription drugs by a retail pharmacy to another retail pharmacy to alleviate a temporary shortage.

c.  The transfer of a prescription drug acquired by a medical director on behalf of a licensed emergency medical services provider to that emergency medical services provider and its transport vehicles for use in accordance with the provider's license under chapter 401.

d.  The revocation of a sale or the return of a prescription drug to the person's prescription drug wholesale supplier.

e.  The donation of a prescription drug by a health care entity to a charitable organization that has been granted an exemption under s. 501(c)(3) of the Internal Revenue Code of 1986, as amended, and that is authorized to possess prescription drugs.

f.  The transfer of a prescription drug by a person authorized to purchase or receive prescription drugs to a person licensed or permitted to handle reverse distributions or destruction under the laws of the jurisdiction in which the person handling the reverse distribution or destruction receives the drug.

3.  The distribution of prescription drug samples by manufacturers' representatives or distributors' representatives conducted in accordance with s. 499.028.

4.  The sale, purchase, or trade of blood and blood components intended for transfusion. As used in this subparagraph, the term "blood" means whole blood collected from a single donor and processed either for transfusion or further manufacturing, and the term "blood components" means that part of the blood separated by physical or mechanical means.

5.  The lawful dispensing of a prescription drug in accordance with chapter 465.

(b)  "Wholesale distributor" means any person engaged in wholesale distribution of prescription drugs in or into this state, including, but not limited to, manufacturers; repackers; own-label distributors; jobbers; private-label distributors; brokers; warehouses, including manufacturers' and distributors' warehouses, chain drug warehouses, and wholesale drug warehouses; independent wholesale drug traders; exporters; retail pharmacies; and the agents thereof that conduct wholesale distributions.

(c)  "Retail pharmacy" means a community pharmacy licensed under chapter 465 that purchases prescription drugs at fair market prices and provides prescription services to the public.

(2)  The following types of wholesaler permits are established:

(a)  A prescription drug wholesaler's permit. A prescription drug wholesaler is a wholesale distributor that may engage in the wholesale distribution of prescription drugs. A prescription drug wholesaler that applies to the department after January 1, 1993, must submit a bond of $200, payable to the Florida Drug, Device, and Cosmetic Trust Fund. This bond will be refunded to the permittee when the permit is returned to the department and the permittee ceases to function as a business. A permittee that fails to notify the department before changing the address of the business, fails to notify the department before closing the business, or fails to notify the department before a change of ownership forfeits its bond. The department may adopt rules for issuing a prescription drug wholesaler-broker permit to a person who engages in the wholesale distribution of prescription drugs and does not take physical possession of any prescription drugs.

(b)  A compressed medical gas wholesaler's permit. A compressed medical gas wholesaler is a wholesale distributor that is limited to the wholesale distribution of compressed medical gases to other than the consumer or patient. The compressed medical gas must be in the original sealed container that was purchased by that wholesaler. A compressed medical gas wholesaler may not possess or engage in the wholesale distribution of any prescription drug other than compressed medical gases. The department shall adopt rules that govern the wholesale distribution of prescription medical oxygen for emergency use. With respect to the emergency use of prescription medical oxygen, those rules may not be inconsistent with rules and regulations of federal agencies unless the Legislature specifically directs otherwise.

(c)  An out-of-state prescription drug wholesaler's permit. An out-of-state prescription drug wholesaler is a wholesale distributor located outside this state which engages in the wholesale distribution of prescription drugs into this state and which must be permitted by the department and comply with all the provisions required of a wholesale distributor under ss. 499.001-499.081.

1.  The out-of-state drug wholesaler must maintain at all times a license or permit to engage in the wholesale distribution of prescription drugs in compliance with laws of the state in which it is a resident.

2.  An out-of-state prescription drug wholesaler's permit is not required for an intracompany sale or transfer of a prescription drug from an out-of-state establishment that is duly licensed as a prescription drug wholesaler, in its state of residence, to a licensed prescription drug wholesaler in this state, if both wholesalers are under common control. The recordkeeping requirements of s. 499.0121(6) must be followed for this transaction.

3.  The department may adopt rules that allow out-of-state drug wholesalers to obtain a drug wholesale permit on the basis of reciprocity to the extent that an out-of-state drug wholesaler:

a.  Possesses a valid permit granted by another state that has requirements comparable to those that a drug wholesaler in this state must meet as prerequisites to obtaining a permit under the laws of this state.

b.  Can show that the other state from which the wholesaler holds a permit would extend reciprocal treatment under its own laws to a drug wholesaler of this state.

(d)  A retail pharmacy wholesaler's permit. A retail pharmacy wholesaler is a retail pharmacy engaged in wholesale distribution of prescription drugs within this state under the following conditions:

1.  The pharmacy must obtain a retail pharmacy wholesaler's permit pursuant to ss. 499.001-499.081 and the rules adopted under those sections.

2.  The wholesale distribution activity does not exceed 30 percent of the total annual purchases of prescription drugs. If the wholesale distribution activity exceeds the 30-percent maximum, the pharmacy must obtain a prescription drug wholesaler's permit.

3.  The transfer of prescription drugs that appear in any schedule contained in chapter 893 is subject to chapter 893 and the federal Comprehensive Drug Abuse Prevention and Control Act of 1970.

4.  The transfer is between a retail pharmacy and another retail pharmacy or a health care practitioner licensed in this state and authorized by law to dispense or prescribe prescription drugs.

5.  All records of sales of prescription drugs subject to this section must be maintained separate and distinct from other records and comply with the recordkeeping requirements of ss. 499.001-499.081.

(3)  A person that engages in wholesale distribution of prescription drugs in this state must have a wholesale distributor's permit issued by the department, except as noted in this section. Each establishment must be separately permitted except as noted in this subsection.

(a)  A separate establishment permit is not required when a permitted prescription drug wholesaler consigns a prescription drug to a pharmacy that is permitted under chapter 465 and located in this state, provided that:

1.  The consignor wholesaler notifies the department in writing of the contract to consign prescription drugs to a pharmacy along with the identity and location of each consignee pharmacy;

2.  The pharmacy maintains its permit under chapter 465;

3.  The consignor wholesaler, which has no legal authority to dispense prescription drugs, complies with all wholesale distribution requirements of s. 499.0121 with respect to the consigned drugs and maintains records documenting the transfer of title or other completion of the wholesale distribution of the consigned prescription drugs;

4.  The distribution of the prescription drug is otherwise lawful under this chapter and other applicable law;

5.  Open packages containing prescription drugs within a pharmacy are the responsibility of the pharmacy, regardless of how the drugs are titled; and

6.  The pharmacy dispenses the consigned prescription drug in accordance with the limitations of its permit under chapter 465 or returns the consigned prescription drug to the consignor wholesaler. In addition, a person who holds title to prescription drugs may transfer the drugs to a person permitted or licensed to handle the reverse distribution or destruction of drugs. Any other distribution by and means of the consigned prescription drug by any person, not limited to the consignor wholesaler or consignee pharmacy, to any other person is prohibited.

(b)  A wholesale distributor's permit is not required for the one-time transfer of title of a pharmacy's lawfully acquired prescription drug inventory by a pharmacy with a valid permit issued under chapter 465 to a consignor prescription drug wholesaler, permitted under this chapter, in accordance with a written consignment agreement between the pharmacy and that wholesaler if: the permitted pharmacy and the permitted prescription drug wholesaler comply with all of the provisions of paragraph (a) and the prescription drugs continue to be within the permitted pharmacy's inventory for dispensing in accordance with the limitations of the pharmacy permit under chapter 465. A consignor drug wholesaler may not use the pharmacy as a wholesale distributor through which it distributes the legend drugs to other pharmacies. Nothing in this section is intended to prevent a wholesale drug distributor from obtaining this inventory in the event of nonpayment by the pharmacy.

(c)  The department shall require information from each wholesale distributor as part of the permit and renewal of such permit, as required under s. 499.01.

(4)  Personnel employed in wholesale distribution must have appropriate education and experience to enable them to perform their duties in compliance with state permitting requirements.

(5)  The department may adopt rules governing the recordkeeping, storage, and handling with respect to each of the distributions of prescription drugs specified in subparagraphs (1)(a)1.-4.

History.--s. 15, ch. 92-69; s. 187, ch. 97-264; s. 31, ch. 98-151; s. 172, ch. 99-397.

499.0121  Storage and handling of prescription drugs.--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 be limited to, requirements for the storage and handling of prescription drugs and for the establishment and maintenance of prescription drug distribution records.

(1)  ESTABLISHMENTS.--An establishment at which prescription drugs are stored, warehoused, handled, held, offered, marketed, or displayed must:

(a)  Be of suitable size and construction to facilitate cleaning, maintenance, and proper operations;

(b)  Have storage areas designed to provide adequate lighting, ventilation, temperature, sanitation, humidity, space, equipment, and security conditions;

(c)  Have a quarantine area for storage of prescription drugs that are outdated, damaged, deteriorated, misbranded, or adulterated, or that are in immediate or sealed, secondary containers that have been opened;

(d)  Be maintained in a clean and orderly condition; and

(e)  Be free from infestation by insects, rodents, birds, or vermin of any kind.

(2)  SECURITY.--

(a)  An establishment that is used for wholesale drug distribution must be secure from unauthorized entry.

1.  Access from outside the premises must be kept to a minimum and be well-controlled.

2.  The outside perimeter of the premises must be well-lighted.

3.  Entry into areas where prescription drugs are held must be limited to authorized personnel.

(b)  An establishment that is used for wholesale drug distribution must be equipped with:

1.  An alarm system to detect entry after hours; however, the department may exempt by rule establishments that only hold a permit as prescription drug wholesaler-brokers and establishments that only handle medical oxygen; and

2.  A security system that will provide suitable protection against theft and diversion. When appropriate, the security system must provide protection against theft or diversion that is facilitated or hidden by tampering with computers or electronic records.

(3)  STORAGE.--All prescription drugs shall be stored at appropriate temperatures and under appropriate conditions in accordance with requirements, if any, in the labeling of such drugs, or with requirements in the official compendium.

(a)  If no storage requirements are established for a prescription drug, the drug may be held at "controlled" room temperature, as defined in the official compendium, to help ensure that its identity, strength, quality, and purity are not adversely affected.

(b)  Appropriate manual, electromechanical, or electronic temperature and humidity recording equipment, devices, or logs must be used to document proper storage of prescription drugs.

(c)  The recordkeeping requirements in subsection (6) must be followed for all stored prescription drugs.

(4)  EXAMINATION OF MATERIALS.--

(a)  Upon receipt, each outside shipping container must be visually examined for identity and to prevent the acceptance of contaminated prescription drugs that are otherwise unfit for distribution. This examination must be adequate to reveal container damage that would suggest possible contamination or other damage to the contents.

(b)  Each outgoing shipment must be carefully inspected for identity of the prescription drug products and to ensure that there is no delivery of prescription drugs that have expired or been damaged in storage or held under improper conditions.

(c)  The recordkeeping requirements in subsection (6) must be followed for all incoming and outgoing prescription drugs.

(5)  RETURNED, DAMAGED, OR OUTDATED PRESCRIPTION DRUGS.--

(a)1.  Prescription drugs that are outdated, damaged, deteriorated, misbranded, or adulterated must be quarantined and physically separated from other prescription drugs until they are destroyed or returned to their supplier. A quarantine section must be separate and apart from other sections where prescription drugs are stored so that prescription drugs in this section are not confused with usable prescription drugs.

2.  Prescription drugs must be examined at least every 12 months, and drugs for which the expiration date has passed must be removed and quarantined.

(b)  Any prescription drugs of which the immediate or sealed outer containers or sealed secondary containers have been opened or used must be identified as such and must be quarantined and physically separated from other prescription drugs until they are either destroyed or returned to the supplier.

(c)  If the conditions under which a prescription drug has been returned cast doubt on the drug's safety, identity, strength, quality, or purity, the drug must be destroyed or returned to the supplier, unless examination, testing, or other investigation proves that the drug meets appropriate standards of safety, identity, strength, quality, and purity. In determining whether the conditions under which a drug has been returned cast doubt on the drug's safety, identity, strength, quality, or purity, the wholesale drug distributor must consider, among other things, the conditions under which the drug has been held, stored, or shipped before or during its return and the conditions of the drug and its container, carton, or labeling, as a result of storage or shipping.

(d)  The recordkeeping requirements in subsection (6) must be followed for all outdated, damaged, deteriorated, misbranded, or adulterated prescription drugs.

(6)  RECORDKEEPING.--The department shall adopt rules that require keeping such records of prescription drugs as are necessary for the protection of the public health.

(a)  Wholesale drug distributors must establish and maintain inventories and records of all transactions regarding the receipt and distribution or other disposition of prescription drugs. These records must provide a complete audit trail from receipt to sale or other disposition, be readily retrievable for inspection, and include, at a minimum, the following information:

1.  The source of the drugs, including the name and principal address of the seller or transferor, and the address of the location from which the drugs were shipped;

2.  The name, principal address, and state license permit or registration number of the person authorized to purchase prescription drugs;

3.  The name, strength, dosage form, and quantity of the drugs received and distributed or disposed of; and

4.  The dates of receipt and distribution or other disposition of the drugs.

(b)  Inventories and records must be made available for inspection and photocopying by authorized federal, state, or local officials for a period of 2 years following disposition of the drugs.

(c)  Records described in this section that are kept at the inspection site or that can be immediately retrieved by computer or other electronic means must be readily available for authorized inspection during the retention period. Records that are kept at a central location outside of this state and that are not electronically retrievable must be made available for inspection within 2 working days after a request by an authorized official of a federal, state, or local law enforcement agency. Records that are maintained at a central location within this state must be maintained at an establishment that is permitted pursuant to ss. 499.001-499.081 and must be readily available.

(d)1.  Each person who is engaged in the wholesale distribution of a prescription drug, and who is not an authorized distributor of record of such drug, must provide to each wholesale distributor of such drug, before the sale is made to such wholesale distributor, a written statement identifying each previous sale of the drug. The written statement identifying all sales of such drug must accompany the drug for each subsequent wholesale distribution of the drug to a wholesale distributor. The department shall adopt rules relating to the requirements of this written statement.

2.  Each wholesale distributor of prescription drugs must maintain separate and distinct from other required records all statements that are required under subparagraph 1.

3.  Each manufacturer of a prescription drug sold in this state must maintain at its corporate offices a current list of authorized distributors and must make such list available to the department upon request.

For the purposes of this subsection, the term "authorized distributors of record" means those distributors with whom a manufacturer has established an ongoing relationship to distribute the manufacturer's products.

(7)  WRITTEN POLICIES AND PROCEDURES.--Wholesale drug distributors must establish, maintain, and adhere to written policies and procedures, which must be followed for the receipt, security, storage, inventory, and distribution of prescription drugs, including policies and procedures for identifying, recording, and reporting losses or thefts, and for correcting all errors and inaccuracies in inventories. Wholesale drug distributors must include in their written policies and procedures:

(a)  A procedure whereby the oldest approved stock of a prescription drug product is distributed first. The procedure may permit deviation from this requirement, if the deviation is temporary and appropriate.

(b)  A procedure to be followed for handling recalls and withdrawals of prescription drugs. Such procedure must be adequate to deal with recalls and withdrawals due to:

1.  Any action initiated at the request of the Food and Drug Administration or any other federal, state, or local law enforcement or other government agency, including the department.

2.  Any voluntary action by the manufacturer to remove defective or potentially defective drugs from the market; or

3.  Any action undertaken to promote public health and safety by replacing existing merchandise with an improved product or new package design.

(c)  A procedure to ensure that wholesale drug distributors prepare for, protect against, and handle any crisis that affects security or operation of any facility if a strike, fire, flood, or other natural disaster, or a local, state, or national emergency, occurs.

(d)  A procedure to ensure that any outdated prescription drugs are segregated from other drugs and either returned to the manufacturer or destroyed. This procedure must provide for written documentation of the disposition of outdated prescription drugs. This documentation must be maintained for 2 years after disposition of the outdated drugs.

(8)  RESPONSIBLE PERSONS.--Wholesale drug distributors must establish and maintain lists of officers, directors, managers, and other persons in charge of wholesale drug distribution, storage, and handling, including a description of their duties and a summary of their qualifications.

(9)  COMPLIANCE WITH FEDERAL, STATE, AND LOCAL LAW.--A wholesale drug distributor must operate in compliance with applicable federal, state, and local laws and regulations.

(a)  A wholesale drug distributor must allow the department and authorized federal, state, and local officials to enter and inspect its premises and delivery vehicles, and to audit its records and written operating procedures, at reasonable times and in a reasonable manner, to the extent authorized by law.

(b)  A wholesale drug distributor that deals in controlled substances must register with the Drug Enforcement Administration and must comply with all applicable state, local, and federal laws. A wholesale drug distributor that distributes any substance controlled under chapter 893 must notify the department when registering with the Drug Enforcement Administration pursuant to that chapter and must provide the department with its DEA number.

(10)  SALVAGING AND REPROCESSING.--A wholesale drug distributor is subject to any applicable federal, state, or local laws or regulations that relate to prescription drug product salvaging or reprocessing.

History.--s. 16, ch. 92-69; s. 32, ch. 98-151.

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 be based on an order from a practitioner authorized by law to prescribe. The term does not include a pharmacy licensed under chapter 465.

1.  A medical oxygen retail establishment may not possess, purchase, sell, or trade any legend drug other than medical oxygen.

2.  A medical oxygen retail establishment may refill medical oxygen for an individual patient based on an order from a practitioner authorized by law to prescribe. A medical oxygen retail establishment that refills medical oxygen must comply with all appropriate state and federal good manufacturing practices.

(b)  "Prescription medical oxygen" means oxygen USP that is a compressed medical gas and which can only be sold on the order or prescription of a practitioner authorized by law to prescribe. The label of prescription medical oxygen must comply with current labeling requirements for oxygen under the Federal Food, Drug, and Cosmetic Act.

(c)  "Veterinary legend drug" means a legend drug intended solely for veterinary use. The label of the drug must bear the statement, "Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian."

(d)  "Veterinary legend drug retail establishment" means a person permitted to sell veterinary legend drugs to the public or to veterinarians, but does not include a pharmacy licensed under chapter 465.

1.  The sale to the public must be based on a valid written order from a veterinarian licensed in this state who has a valid client-veterinarian relationship with the purchaser's animal.

2.  Veterinary legend drugs may not be sold in excess of the amount clearly indicated on the order or beyond the date indicated on the order.

3.  An order may not be valid for more than 1 year.

4.  A veterinary legend drug retail establishment may not purchase, sell, trade, or possess human prescription drugs or any controlled substance as defined in chapter 893.

5.  A veterinary legend drug retail establishment must sell a veterinary legend drug in the original, sealed manufacturer's container with all labeling intact and legible. The department may adopt by rule additional labeling requirements for the sale of a veterinary legend drug.

(2)(a)  A person that engages in the retail sale of medical oxygen or veterinary legend drugs in this state must have a retail establishment permit issued by the department.

(b)  The department shall adopt rules relating to information required from each retail establishment pursuant to s. 499.01(2).

(c)  A retail establishment must comply with all of the wholesale distribution requirements of s. 499.0121 except those set forth in s. 499.0121(6)(d).

(d)  Legend drugs sold by a retail establishment pursuant to a practitioner's order may not be returned into the retail establishment's inventory.

History.--s. 17, ch. 92-69; s. 33, ch. 98-151.

499.013  Manufacturers of drugs, devices, and cosmetics; definitions, permits, and general requirements.--

(1)  As used in this section, the term "manufacture" has the meaning assigned to it under s. 499.003. A pharmacy is exempt from this definition if it is operating in compliance with pharmacy practice standards as defined in chapter 465 and the rules adopted under that chapter.

(2)  Any person that engages in the manufacture of drugs, devices, or cosmetics in this state must first obtain one of the following permits and may engage only in the activity allowed under that permit:

(a)  A prescription drug manufacturer's permit is required for any person that manufactures a prescription drug in this state.

1.  A person that operates an establishment permitted as a prescription drug manufacturer may engage in wholesale distribution of prescription drugs manufactured at that establishment and must comply with all the provisions of ss. 499.001-499.081 and the rules adopted under those sections that apply to a wholesale distributor.

2.  A prescription drug manufacturer permittee must comply with all appropriate state and federal good manufacturing practices.

(b)  An over-the-counter drug manufacturer's permit is required for any person that engages in the manufacture of an over-the-counter drug.

1.  An over-the-counter drug manufacturer permittee may not possess or purchase prescription drugs.

2.  A pharmacy is exempt from obtaining an over-the-counter drug manufacturer's permit if it is operating in compliance with pharmacy practice standards as defined in chapter 465 and the rules adopted under that chapter.

3.  An over-the-counter drug manufacturer permittee must comply with all appropriate state and federal good manufacturing practices.

(c)  A compressed medical gas manufacturer's permit is required for any person that engages in the manufacture of compressed medical gases or repackages compressed medical gases from one container to another.

1.  A compressed medical gas manufacturer permittee may not manufacture or possess any prescription drug other than compressed medical gases.

2.  A compressed medical gas manufacturer permittee may engage in wholesale distribution of compressed medical gases manufactured at that establishment and must comply with all the provisions of ss. 499.001-499.081 and the rules adopted under those sections that apply to a wholesale distributor.

3.  A compressed medical gas manufacturer permittee must comply with all appropriate state and federal good manufacturing practices.

(d)  A device manufacturer's permit is required for any person that engages in the manufacture or assembly of medical devices for human use in this state.

1.  A manufacturer of medical devices in this state must comply with all appropriate state and federal good manufacturing practices.

2.  The department shall adopt rules related to storage, handling, and recordkeeping requirements for manufacturers of medical devices for human use.

(e)  A cosmetic manufacturer's permit is required for any person that manufactures cosmetics in this state. A person that only labels or changes the labeling of a cosmetic but does not open the container sealed by the manufacturer of the product is exempt from obtaining a permit under this paragraph.

(3)  The department may adopt such rules as are necessary for the protection of the public health, safety, and welfare regarding good manufacturing practices that manufacturers must follow to ensure the safety of the products.

History.--s. 18, ch. 92-69; s. 34, ch. 98-151.

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 "wholesale distribution" under s. 499.012(1)(a)1.

(2)  A person who engages in the receipt or distribution of a legend drug in this state for the purpose of processing its return or its destruction must obtain a permit as a restricted prescription drug distributor if such person is not the person initiating the return, the prescription drug wholesale supplier of the person initiating the return, or the manufacturer of the drug.

(3)  Storage and handling, and recordkeeping of these distributions must comply with the requirements for wholesale distributors under s. 499.0121.

(4)  A person who applies for a permit as a restricted prescription drug distributor, or for the renewal of such a permit, must provide to the department the information required under s. 499.01.

(5)  The department may issue permits to restricted prescription drug distributors and may adopt rules regarding the distribution of prescription drugs by hospitals, health care entities, charitable organizations, or other persons not involved in wholesale distribution, which rules are necessary for the protection of the public health, safety, and welfare.

History.--s. 19, ch. 92-69; s. 35, ch. 98-151.

499.015  Registration of drugs, devices, and cosmetics; issuance of certificates of free sale.--

(1)  Except for those persons exempted from the definition in s. 499.003(21), any person who manufactures, packages, repackages, labels, or relabels a drug, device, or cosmetic in this state must register such drug, device, or cosmetic biennially with the department; pay a fee in accordance with the fee schedule provided by s. 499.041; and comply with this section. The registrant must list each separate and distinct drug, device, or cosmetic at the time of registration.

(2)  The department may require the submission of a catalog and specimens of labels at the time of application for registration of drugs, devices, and cosmetics packaged and prepared in compliance with the federal act, which submission constitutes a satisfactory compliance for registration of the products. With respect to all other drugs, devices, and cosmetics, the department may require the submission of a catalog and specimens of labels at the time of application for registration, but the registration will not become effective until the department has examined and approved the label of the drug, device, or cosmetic product. This approval or denial must include written notification to the manufacturer.

(3)  Except for those persons exempted from the definition in s. 499.003(21), a person may not sell any product that he or she has failed to register in conformity with this section. Such failure to register subjects such drug, device, or cosmetic product to seizure and condemnation as provided in ss. 499.062-499.064, and subjects such person to the penalties and remedies provided in ss. 499.001-499.081.

(4)  Unless a registration is renewed, it expires 2 years after the last day of the month in which it was issued. The department may issue a stop-sale notice or order against a person that is subject to the requirements of this section and that fails to comply with this section within 31 days after the date the registration expires. The notice or order shall prohibit such person from selling or causing to be sold any drugs, devices, or cosmetics covered by ss. 499.001-499.081 until he or she complies with the requirements of this section.

(5)  A product regulated under this section which is not included in the biennial registration may not be sold until it is registered and complies with this section.

(6)  The department may issue a certificate of free sale for any product that is required to be registered under ss. 499.001-499.081.

(7)  A product registration is valid only for the company named on the registration and located at the address on the registration. A person whose product is registered by the department under this section must notify the department before any change in the name or address of the establishment to which the product is registered. If a person whose product is registered ceases conducting business, the person must notify the department before closing the business.

(8)  Notwithstanding any requirements set forth in ss. 499.001-499.081, a manufacturer of medical devices that is registered with the federal Food and Drug Administration is exempt from this section and s. 499.041(6) if:

(a)  The manufacturer's medical devices are approved for marketing by, or listed with the federal Food and Drug Administration in accordance with federal law for commercial distribution; or

(b)  The manufacturer subcontracts with a manufacturer of medical devices to manufacture components of such devices.

(9)  However, the manufacturer must submit evidence of such registration, listing, or approval with its initial application for a permit to do business in this state, as required in s. 499.013 and any changes to such information previously submitted at the time of renewal of the permit. Evidence of approval, listing, and registration by the federal Food and Drug Administration must include:

(a)  For Class II devices, a copy of the pre-market notification letter (510K);

(b)  For Class III devices, a Federal Drug Administration pre-market approval number;

(c)  For a manufacturer who subcontracts with a manufacturer of medical devices to manufacture components of such devices, a Federal Drug Administration registration number; or

(d)  For a manufacturer of medical devices whose devices are exempt from pre-market approval by the Federal Drug Administration, a Federal Drug Administration registration number.

History.--s. 34, ch. 82-225; s. 110, ch. 83-218; s. 1, ch. 83-265; s. 3, ch. 84-115; ss. 20, 52, ch. 92-69; s. 587, ch. 97-103; s. 36, ch. 98-151; s. 1, ch. 99-165.

499.018  Applications for approval of investigational drugs.--

(1)  A person that applies for use of an investigational drug that does not have a Notice of Claimed Investigational Exemption for a New Drug on file with the federal Food and Drug Administration or that is otherwise unlawful in interstate commerce must, in accordance with ss. 499.001-499.081, submit in writing to the department for review by the technical panel the following, if applicable:

(a)  The best available descriptive name of the drug, including to the extent known the chemical name and structure of any substance composing the drug, and a description of how the drug is to be used and administered.

(b)  A full report, by the applicant, to justify the proposed use of the drug.

(c)  A complete list of the components of the drug.

(d)  A complete statement of the quantitative composition of the drug, including reasonable variations that can be expected during its use.

(e)  A description of the source and preparation of any substances used as components, including the name and address of each supplier or processor, other than the applicant, for each substance.

(f)  A statement of the methods, facilities, and controls used for manufacturing, processing, and packing the investigational drug in accordance with good manufacturing practices as provided in rules adopted by the department.

(g)  The specific nature of the investigation to be conducted, together with information to show the scope and detail of the planned clinical observations and the clinical laboratory tests to be made and reported.

(h)  The proposed protocols for each investigator.

(i)  Written assurance that an institutional review committee is responsible for initial and continuing review and approval of the proposed clinical study, if the phases of the clinical study are conducted by a person affiliated with a state institution that agrees to assume responsibility for the study.

(j)  A statement that the applicant will:

1.  Notify the department within 10 days after the initiation of the clinical study or studies, and within 10 days after the termination of the clinical study or studies, giving the reasons for such termination; and

2.  Submit reports at least annually on all studies.

(k)  A statement that the applicant will notify each subcontractor if the investigation is discontinued.

(l)  Complete justification of all charges to be made related to the clinical study or studies.

(m)  A statement that the applicant assures that clinical studies in humans will not be initiated sooner than 45 days after the date the department receives the application, the provisions of chapter 120 notwithstanding, and that such clinical studies will not be conducted if so requested by the department before the expiration of the 45 days.

(n)  Documentation that the drug has been submitted to the Food and Drug Administration of the United States Department of Health and Human Services and that the Food and Drug Administration did not allow the application to become effective 180 days after submission of the application, the provisions of chapter 120 notwithstanding. Documentation must include all material submitted to and received from the Food and Drug Administration.

(o)  A report of the scientific training and experience considered appropriate by the applicant to qualify himself or herself or the subcontractor as a suitable expert to investigate the safety and use of the drug. The report must include the names and addresses of all subcontractors.

(p)  A list of the names and a summary of the training and experience of each investigator and of the individual in charge of the use of the drug, and a statement from the applicant that he or she has obtained from each subcontractor a completed and signed form and a statement that the subcontractor is qualified by scientific training and experience as an appropriate expert.

(q)  An outline of all phases of the planned investigations that will include clinical pharmacology. Data available must show the method of determining human toxicity, metabolism, absorption, elimination, and other pharmacological action; the preferred route of administration; and the potential safe dosage range.

(r)  A statement covering all information available to the applicant derived from preclinical investigations and any clinical studies or experience with the drug, including adequate information about the investigations, studies made on laboratory animals, and the basis on which the applicant has concluded that it is reasonably safe to initiate or continue clinical investigations with the drug.

All information contained in the application for approval of an investigational drug is confidential and exempt from the provisions of s. 119.07(1).

(2)  In addition to the requirements of subsection (1), if the drug has been marketed commercially or investigated outside the United States, complete information regarding any distribution or investigation must be submitted, along with a complete bibliography of any publications about the drug, which information must include all informational material, including the label and labeling, which was supplied to each subcontractor to whom the applicant subcontracted the use of the drug. The information must include an accurate description of the prior investigations and experience and their results pertinent to the safety and possible usefulness of the drug under the conditions of the investigation and must include a description of all hazards, contraindications, side effects, and precautions suggested by prior investigations and experience with the drug under investigation and related drugs.

(3)  A manufacturer who is licensed under ss. 499.01 and 499.013 and who was licensed before July 1, 1984, under former s. 402.36 may continue to be licensed under ss. 499.001-499.081 and may have the product for which it was licensed under former s. 402.36 registered under this subsection if the manufacturer continues to meet the requirements imposed on it before July 1, 1984, through its agreement with the department and meets good manufacturing practices as established by rule. Protocols approved under former s. 402.36 may be continued, but other uses or protocols for use must be approved under paragraph (1)(h) and rules adopted under that paragraph.

(4)  The department may deny an application, or suspend or revoke an approved application, for an investigational drug for any violation of ss. 499.001-499.081 or the rules adopted under those sections or for a violation of the protocol approved by the department.

History.--s. 34, ch. 82-225; s. 112, ch. 83-218; s. 1, ch. 83-265; s. 4, ch. 84-115; ss. 5, 14, ch. 88-159; s. 4, ch. 89-296; ss. 21, 52, ch. 92-69; s. 331, ch. 96-406; s. 1155, ch. 97-103.

499.019  Clinical investigations and investigational drugs.--

(1)  Clinical investigation reports of investigational drug products must be submitted to the department in writing periodically as required by the department.

(2)  An adverse reaction report must be submitted to the department within 15 days after an adverse reaction.

History.--s. 34, ch. 82-225; s. 1, ch. 83-265; ss. 22, 52, ch. 92-69.

499.02  Florida Drug Technical Review Panel; purpose; membership; meetings; records; expenses.--

(1)  The Florida Drug Technical Review Panel, hereinafter referred to as the "technical panel," is established within the department and shall consist of five members appointed by the Secretary of Health. The technical panel shall provide assistance to the department and make recommendations on applications for investigational drugs not involved in interstate commerce.

(2)  Members of the technical panel shall be qualified by scientific training and experience and shall be residents of this state. The technical panel shall consist of:

(a)  At least one practitioner licensed under chapter 465.

(b)  At least one practitioner licensed under chapter 458 or chapter 459.

(c)  At least two pharmacologists.

(d)  At least one practitioner with clinical testing experience who is licensed under chapter 458.

(3)  A vacancy in membership occurring before the expiration of a term shall be filled by a member appointed by the Secretary of Health for the remainder of that term.

(4)  As the terms of members naturally expire, the Secretary of Health shall appoint successors for terms of 4 years each. Members of the technical panel may be reappointed.

(5)(a)  The technical panel shall select a chair from its membership. The technical panel shall meet at the request of the department or shall respond in writing to a request by the department for technical assistance or for review of an application. In performing its responsibilities the panel shall use accepted rules of procedure.

(b)  A designee of the department shall serve as recording secretary of the technical panel. The recording secretary shall keep a complete record documenting the activities of the technical panel. The record shall show the names of members present at each meeting or include the response of each panel member if responding in writing and shall document the discussions of the panel members, their recommendations, and actions taken. The recording secretary shall keep the records on file and shall make the records available to any interested person.

(6)  Members of the technical panel shall serve without compensation but shall be entitled to receive reimbursement for per diem and travel expenses as provided in s. 112.061.

History.--ss. 34, 40, ch. 82-225; s. 113, ch. 83-218; s. 2, ch. 83-265; ss. 6, 13, 14, ch. 88-159; s. 5, ch. 91-429; s. 23, ch. 92-69; s. 588, ch. 97-103; s. 237, ch. 99-8.

499.021  Authority and duties of the technical panel.--The technical panel shall have the authority to make recommendations to the department on applications submitted pursuant to s. 499.018. The duties of the technical panel include, but are not limited to, reviewing and making recommendations relating to:

(1)  The need for or use of consulting contracts for scientific evaluation or analysis of an investigational drug for which an application has been submitted.

(2)  The need for or use of consulting contracts for evaluations on the continuance, revision, or termination of investigational drug product permits and for monitoring an investigational drug for which an application has been submitted.

(3)  The need for and use of consulting contracts for preparation of executive summaries of an application for approval of an investigational drug.

(4)  The use and approval of laboratory facilities to analyze investigational drugs.

(5)  The establishment of label and labeling requirements for investigational drugs.

(6)  The information required for applications and registrations of investigational drugs.

(7)  The approval or denial of investigational drug applications.

(8)  Matters referred to it by the department.

History.--s. 34, ch. 82-225; s. 2, ch. 83-265; s. 87, ch. 85-81; ss. 7, 13, 14, ch. 88-159; s. 5, ch. 91-429; s. 24, ch. 92-69.

499.022  Technical review; approvals and denials.--

(1)  The technical panel shall review each investigational drug application and, based on the information provided by the applicant under s. 499.018, shall recommend approval or denial to the Secretary of Health.

(2)  An application for the manufacture, use, distribution, or repackaging of an investigational drug becomes effective 120 days after the filing for application with the department for review by the technical panel, if the panel has not made its recommendation for approval or denial to the secretary. After due notice to the applicant and the opportunity for administrative hearing in accordance with the provisions of chapter 120, the department may issue an order refusing to permit the application to become effective.

History.--s. 34, ch. 82-225; s. 1, ch. 83-265; s. 6, ch. 87-50; ss. 8, 13, 14, ch. 88-159; s. 5, ch. 91-429; s. 25, ch. 92-69; s. 238, ch. 99-8.

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 Services for shipment in interstate commerce.

History.--s. 34, ch. 82-225; s. 1, ch. 83-265; ss. 26, 52, ch. 92-69.

499.024  Drug product classification.--The secretary 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)  The Florida Drug Technical Review Panel may review and make recommendations on products.

(2)  Drug products must be classified as proprietary, prescription, or investigational drugs.

(3)  If a product is distributed without required labeling, it is misbranded while held for sale.

(4)  Any product that falls under the drug definition, s. 499.003(11), may be classified under the authority of this section. This section does not subject portable emergency oxygen inhalators to classification; however, this section does not exempt any person from ss. 499.01 and 499.015.

(5)  Any product classified under the authority of this section reverts to the federal classification, if different, upon the federal regulation or act becoming effective.

(6)  The department may by rule reclassify drugs subject to ss. 499.001-499.081 when such classification action is necessary to protect the public health.

(7)  The department may adopt rules that exempt from any labeling or packaging requirements of ss. 499.001-499.081 drugs classified under this section if those requirements are not necessary to protect the public health.

History.--s. 9, ch. 88-159; s. 1, ch. 89-296; ss. 27, 52, ch. 92-69; s. 589, ch. 97-103.

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, words, letters, marking, or national drug code, or any combination thereof, that identifies the drug product and the manufacturer or distributor of the drug product which has the ability to respond to requests for information regarding the drug product.

(2)  A manufacturer or distributor must make available to the department on request descriptive material that identifies each current imprint used by the manufacturer.

(3)  The department, upon application by a manufacturer, may exempt a particular drug product from the requirements of subsection (1) on the ground that imprinting is not feasible because of the size, texture, or other unique characteristic of the drug product.

(4)  This section does not apply to drug products compounded by a pharmacist licensed under chapter 465 in a pharmacy operating under a permit issued by the Board of Pharmacy.

(5)  This section applies to any prescription drug manufactured after January 1, 1982.

(6)  The department shall adopt rules for implementing this section.

History.--s. 34, ch. 82-225; s. 1, ch. 83-265; s. 22, ch. 86-256; ss. 28, 52, ch. 92-69.

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, and that is intended to promote the sale of the drug.

(b)  "Starter packs," also known as "stock samples," "trade packages," "initial dose packs," or "starter stocks," means human prescription drugs that are generally distributed without charge by manufacturers or distributors to pharmacies to be placed in stock and sold at retail. Although starter packs are generally given without charge to the pharmacy, they are not intended to be a free sample to the consumer nor are they labeled as such. Starter packs are subject to regulation as prescription drugs under the Florida Drug and Cosmetic Act in the same manner as stock shipments of prescription drugs. Starter packs are not drug samples.

(2)  A person may not sell, purchase, or trade or offer to sell, purchase, or trade any drug sample. An officer or executive of a drug manufacturer or distributor is not subject to criminal liability solely because of a sale, purchase, trade, or offer to sell, purchase, or trade of a drug sample in violation of this subsection by other employees of the manufacturer or distributor.

(3)  Except as provided in this section, a representative of a drug manufacturer or distributor may not distribute any drug sample.

(a)  The manufacturer or distributor of a human prescription drug may, in accordance with this paragraph, distribute drug samples by mail or common carrier to practitioners licensed to prescribe such drugs or, at the request of a licensed practitioner, to pharmacies of hospitals or to pharmacies of other health care entities. Such a distribution of drug samples may only be made:

1.  In response to a written request for drug samples made on a form that meets the requirements of paragraph (b); and

2.  Under a system that requires the recipient of the drug sample to execute a written receipt for the drug sample upon its delivery and to return the receipt to the manufacturer or distributor.

(b)  A written request for a drug sample that is required by this section must contain:

1.  The name, address, professional designation, and signature of the practitioner who makes the request;

2.  The name, strength, and dosage form of the drug sample requested and the quantity requested;

3.  The name of the manufacturer of the drug sample requested; and

4.  The date of the request.

(c)  Each drug manufacturer or distributor that makes distributions by mail or common carrier under this paragraph must maintain, for a period of 3 years, the request forms submitted for such distributions and the receipts submitted for such distributions and must maintain a record of distributions of drug samples which identifies the drugs distributed and the recipients of the distributions. Forms, receipts, and records required to be maintained under this paragraph must be made available by the drug manufacturer or distributor to the department for its review and inspection.

(d)  The manufacturer or distributor of a drug subject to paragraph (1)(a) may, by means other than mail or common carrier, distribute drug samples only if the manufacturer or distributor makes the distributions in accordance with paragraph (e) and carries out the activities described in subsections (4) through (9).

(e)  Drug samples may only be distributed:

1.  To a practitioner authorized by law to prescribe such drugs if the practitioner makes a written request for the drug samples; or

2.  At the written request of such a practitioner, to pharmacies of hospitals or to pharmacies of other health care entities. The written request for drug samples must be made on a form that contains the practitioner's name, address, and professional designation, the name, strength, and dosage form of the drug sample requested, the quantity of drug samples requested, the name of the manufacturer or distributor of the drug sample, the date of the request, and the signature of the practitioner that makes the request.

(4)  A drug manufacturer or distributor must store drug samples under the conditions described on their labels that will maintain the stability, integrity, and effectiveness of the drug samples and will assure that the drug samples remain free of contamination, deterioration, and adulteration.

(5)  A drug manufacturer or distributor must conduct, at least annually, a complete and accurate inventory of all drug samples in the possession of representatives of the manufacturer or distributor. A drug manufacturer or distributor must maintain lists of the names and addresses of each of its representatives who distribute drug samples and of the sites where drug samples are stored. A drug manufacturer or distributor must maintain for at least 3 years records of all drug samples distributed, destroyed, or returned to the manufacturer or distributor, of all inventories maintained under this subsection, of all thefts or significant losses of drug samples, and of all requests made under ¹subparagraph 1. for drug samples. The drug manufacturer or distributor must make available to the department upon request any record or list maintained under this subsection. The department shall provide to the Department of Business and Professional Regulation the names of those practitioners who have received an excessive or inappropriate quantity of such drugs.

(6)  A drug manufacturer or distributor must notify the department of any significant loss of drug samples and any known theft of drug samples.

(7)  A drug manufacturer or distributor must report to the department any conviction of itself or of its assigns, agents, employees, or representatives for a violation of s. 503(c)(1) of the federal act or of ss. 499.001-499.081 because of the sale, purchase, or trade of a drug sample or the offer to sell, purchase, or trade a drug sample.

(8)  Drug manufacturers or distributors must provide to the department the name and telephone number of the individual responsible for responding to a request for information regarding drug samples.

(9)  All out-of-date drug samples must be returned to the manufacturer or distributor of that drug sample.

(10)  A manufacturer or distributor may not directly or through its agents, employees, or independent contractors, hold, distribute, or otherwise dispose of any complimentary drugs or drug samples in this state without first obtaining a complimentary drug distributor permit pursuant to this section.

(11)(a)  Application for a permit by a manufacturer or distributor to hold, distribute, or otherwise dispose of drugs pursuant to this section must be made on a form prescribed by the department and must be accompanied by an application fee in an amount not exceeding $250 per year, as is determined by the department.

(b)  A permit issued under this section expires 2 years after the date of issuance, unless sooner suspended or revoked.

(c)  A permit is renewable biennially upon the filing of an application for renewal and the payment of a renewal fee of not more than $250 per year, as determined by the department, if the applicant meets the requirements established by this section and the rules adopted under this section.

(12)  The department may suspend or revoke a permit issued under this section, after giving notice and an opportunity to be heard pursuant to chapter 120, when:

(a)  Such permit was obtained by misrepresentation or fraud or through a mistake of the department.

(b)  The holder of the permit has distributed or disposed of any legend drug, directly or through its agents, employees, or independent contractors, to any person not authorized to possess such drug.

(c)  The holder of the permit, or its agents, employees, or independent contractors, has distributed or possessed any legend drug except in the usual course of its business.

(d)  The holder of the permit, or its agents, employees, or independent contractors, has distributed any legend drug that is misbranded or adulterated under ss. 499.001-499.081.

(e)  The holder of the permit, or its agents, employees, or independent contractors, has distributed any legend drug without written request, when a written request is required by this section.

(f)  The holder of the permit has in its employ, or uses as agent or independent contractor for the purpose of distributing or disposing of drugs, any person who has:

1.  Violated the requirements of this section or any rule adopted under this section.

2.  Been convicted in any of the courts of this state, the United States, or any other state of a felony or any other crime involving moral turpitude or involving those drugs named or described in chapter 893.

(13)  The department may, pursuant to chapter 120, impose an administrative fine, not to exceed $5,000 per violation per day, for the violation of this section or rules adopted under this section. Each day such violation continues constitutes a separate violation, and each such separate violation is subject to a separate fine. All amounts collected under this section shall be deposited into the Drug, Device, and Cosmetic Trust Fund. In determining the amount of fine to be levied for a violation, the following factors must be considered:

(a)  The severity of the violation.

(b)  Any actions taken by the permittee to correct the violation or to remedy complaints.

(c)  Any previous violations.

(14)  Chapter 893 applies to all drug samples that are controlled substances.

(15)  A person may not possess a prescription drug sample unless:

(a)  The drug sample was prescribed to her or him as evidenced by the label required in s. 465.0276(5).

(b)  She or he is the employee of a complimentary drug distributor that holds a permit issued under ss. 499.001-499.081.

(c)  She or he is a person to whom prescription drug samples may be distributed pursuant to this section.

(d)  He or she is an officer or employee of a federal, state, or local government acting within the scope of his or her employment.

History.--s. 34, ch. 82-225; s. 114, ch. 83-218; s. 1, ch. 83-265; s. 8, ch. 84-115; s. 23, ch. 86-256; ss. 29, 52, ch. 92-69; s. 198, ch. 94-218; s. 23, ch. 97-98; s. 590, ch. 97-103; s. 39, ch. 99-397.

¹Note.--Subsection (5) does not contain subparagraphs.

499.03  Possession of new drugs or legend 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(22), or legend drug as defined in s. 499.003, unless the possession of the drug has been obtained by a valid prescription of a practitioner licensed by law to prescribe the drug. However, this section does not apply to the delivery of such drugs to persons included in any of the classes named in this subsection, or to the agents or employees of such persons, for use in the usual course of their businesses or practices or in the performance of their official duties, as the case may be; nor does this section apply to the possession of such drugs by those persons or their agents or employees for such use:

(a)  A licensed pharmacist or any person under the licensed pharmacist's supervision while acting within the scope of the licensed pharmacist's practice;

(b)  A licensed practitioner authorized by law to prescribe legend drugs or any person under the licensed practitioner's supervision while acting within the scope of the licensed practitioner's practice;

(c)  A qualified person who uses legend drugs for lawful research, teaching, or testing, and not for resale;

(d)  A licensed hospital or other institution that procures such drugs for lawful administration or dispensing by practitioners;

(e)  An officer or employee of a federal, state, or local government; or

(f)  A person that holds a valid permit issued by the department pursuant to ss. 499.001-499.081 which authorizes that person to possess prescription drugs.

(2)  The possession of a drug under subsection (1) by any person not exempted under this section, which drug is not properly labeled to indicate that possession is by a valid prescription of a practitioner licensed by law to prescribe such drug, is prima facie evidence that such possession is unlawful.

(3)  Violation of subsection (1) is a misdemeanor of the second degree, punishable as provided in s. 775.082 or s. 775.083, except that possession with the intent to sell, dispense, or deliver is a third degree felony, punishable as provided in s. 775.082, s. 775.083, or s. 775.084.

(4)  The department may adopt rules regarding persons engaged in lawful teaching, research, or testing who possess prescription drugs and may issue letters of exemption to facilitate the lawful possession of prescription drugs under this section.

History.--s. 34, ch. 82-225; s. 1, ch. 83-265; s. 5, ch. 84-115; s. 75, ch. 87-243; ss. 30, 52, ch. 92-69; s. 37, ch. 98-151.

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 to prescribe medicinal drugs.

History.--s. 34, ch. 82-225; s. 1, ch. 83-265; ss. 31, 52, ch. 92-69.

499.033  Ephedrine; prescription required.--Ephedrine is declared to be a prescription drug.

(1)  Except as provided in this subsection, any product that contains any quantity of ephedrine, a salt of ephedrine, an optical isomer of ephedrine, or a salt of an optical isomer of ephedrine may be dispensed only upon the prescription of a duly licensed practitioner authorized by the laws of the state to prescribe medicinal drugs.

(2)  A product containing ephedrine described in paragraphs (a)-(e) is exempt from subsection (1) if it may lawfully be sold over the counter without a prescription under the federal act; is labeled and marketed in a manner consistent with the pertinent United States Food and Drug Administration Over-the-Counter Tentative Final or Final Monograph; and is manufactured and distributed for legitimate medicinal use in a manner that reduces or eliminates the likelihood of abuse, when considered in the context with: the package sizes and the manner of packaging of the drug product; the name and labeling of the product; the manner of distribution, advertising, and promotion of the product; the duration, scope, health significance, and societal cost of abuse of the particular product; the need to provide medically important ephedrine-containing therapies to the public for United States Food and Drug Administration approved indications on an unrestricted, over-the-counter basis; and other facts as may be relevant to and consistent with public health and safety.

(a)  Solid oral dosage forms that combine active ingredients in the following ranges for each dosage unit:

1.  Theophylline (100-130mg), ephedrine (12.5-24mg).

2.  Theophylline (60-100mg), ephedrine (12.5-24mg), guaifenesin (200-400mg).

3.  Ephedrine (12.5-25mg), guaifenesin (200-400mg).

4.  Phenobarbital (not greater than 8mg) in combination with the ingredients of subparagraph 1. or subparagraph 2.

(b)  Liquid oral dosage forms that combine active ingredients in the following ranges for each (5ml) dose:

1.  Theophylline (not greater than 45mg), ephedrine (not greater than 36mg), guaifenesin (not greater than 100mg), phenobarbital (not greater than 12mg).

2.  Phenylephrine (not greater than 5mg), ephedrine (not greater than 5mg), chlorpheniramine (not greater than 2mg), dextromethorphan (not greater than 10mg), ammonium chloride (not greater than 40mg), ipecac fluid extract (not greater than 0.005ml).

(c)  Anorectal preparations containing less than 5 percent ephedrine.

(d)  Nasal decongestant compounds, mixtures, or preparations containing 0.5 percent or less ephedrine.

(e)  Any drug product containing ephedrine that is marketed pursuant to an approved new drug application or legal equivalent under the federal act.

(3)  The department may implement this section by rule.

History.--s. 7, ch. 94-309; s. 1, ch. 95-415.

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 use."

(2)  All advertisements for the sale of dimethyl sulfoxide (DMSO) not approved for drug use must contain, within the advertisement and in bold lettering, the following statement: "Warning. May be unsafe. Not approved for human use."

History.--s. 34, ch. 82-225; s. 26, ch. 82-402; s. 1, ch. 83-265; ss. 32, 52, ch. 92-69; ss. 1, 5, 8, ch. 94-309.

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 containing toluol, hexane, trichloroethylene, acetone, toluene, ethyl acetate, methyl ethyl ketone, trichloroethane, isopropanol, methyl isobutyl ketone, ethylene glycol monomethyl ether acetate, cyclohexanone, nitrous oxide, diethyl ether, alkyl nitrites (butyl nitrite), or any similar substance for the purpose of inducing by breathing, inhaling, or ingesting a condition of intoxication or which is intended to distort or disturb the auditory, visual, or other physical or mental processes.

(1)  On the first violation of this section, the department may issue a warning according to s. 499.071, if the violation has not caused temporary or permanent physical or mental injury to the user.

(2)  If any violation of this section has caused temporary or permanent physical or mental injury to the user, the department may, pursuant to chapter 120, impose fines according to s. 499.066 and may report any violation to the appropriate state attorney for prosecution.

(3)  The Department of Health shall adopt rules to implement this section.

History.--s. 12, ch. 86-133; s. 1, ch. 89-296; ss. 33, 52, ch. 92-69; s. 239, ch. 99-8.

499.04  Fee authority.--The department may collect fees for all drug, device, and cosmetic applications, permits, investigational drug applications, 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 ss. 499.001-499.081. The department shall, by rule, establish a schedule of fees that are within the ranges provided in this section and shall adjust those fees from time to time based on the costs associated with administering ss. 499.001-499.081. The fees are payable to the department to be deposited into the Florida Drug, Device, and Cosmetic Trust Fund for the sole purpose of carrying out the provisions of ss. 499.001-499.081.

History.--s. 34, ch. 82-225; s. 115, ch. 83-218; s. 1, ch. 83-265; ss. 34, 52, ch. 92-69.

499.041  Schedule of fees for drug, device, and cosmetic applications and permits, investigational drug applications, product registrations, and free-sale certificates; trust fund.--

(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's permit may not be less than $500 or more than $600 annually.

(b)  The fee for a device manufacturer's permit may not be less than $500 or more than $600 annually.

(c)  The fee for a cosmetic manufacturer's permit may not be less than $250 or more than $400 annually.

(d)  The fee for an over-the-counter drug manufacturer's permit may not be less than $300 or more than $400 annually.

(e)  The fee for a compressed medical gas manufacturer's permit may not be less than $400 or more than $500 annually.

(f)  A manufacturer may not be required to pay more than one fee per establishment to obtain an additional manufacturing permit, but each manufacturer must pay the highest fee applicable to his or her operation in each establishment.

(2)  The department shall assess an applicant that is required to have a wholesaling permit an annual fee within the ranges established in this section for the specific type of wholesaling.

(a)  The fee for a prescription drug wholesaler's permit may not be less than $300 or more than $400 annually;

(b)  The fee for a compressed medical gas wholesaler's permit may not be less than $200 or more than $300 annually;

(c)  The fee for an out-of-state prescription drug wholesaler's permit may not be less than $200 or more than $300 annually;

(d)  The fee for a retail pharmacy wholesaler's permit may not be less than $35 or more than $50 annually.

(3)  The department shall assess an applicant that is required to have a retail establishment permit an annual fee within the ranges established in this section for the specific type of retail establishment.

(a)  The fee for a veterinary legend drug retail establishment permit may not be less than $200 or more than $300 annually;

(b)  The fee for a medical oxygen retail establishment permit may not be less than $200 or more than $300 annually.

(4)  The department shall assess an applicant that is required to have a restricted prescription drug distributor's permit an annual fee of not less than $200 or more than $300.

(5)  In addition to the fee charged for a permit required by ss. 499.001-499.081, beginning January 1, 1993, the department shall assess applicants an initial application fee of $150 for each new permit issued by the department which requires an onsite inspection.

(6)  A person that is required to register drugs, devices, or cosmetic products under s. 499.015 shall pay an annual product registration fee of not less than $5 or more than $15 for each separate and distinct product in package form. The registration fee is in addition to the fee charged for a free-sale certificate.

(7)  The department shall assess an applicant that requests a free-sale certificate a fee of $25. A fee of $2 will be charged for each signature copy of a free-sale certificate that is obtained at the same time the free-sale certificate is issued.

(8)  The department shall assess an applicant that makes application for approval of an investigational drug pursuant to s. 499.018 a filing fee of not less than $1,000 or more than $1,100.

(9)  The department shall assess each individual applicant the fees for consulting contracts provided for in s. 499.021. The consulting contracts must be completed by contractors approved by the department. In awarding a consulting contract, preference must be given to the universities in the state and government laboratory resources, which must be contracted with when appropriate.

(10)  Consulting contract fees must be set by the actual cost submitted by the contractor for each product application. All fees paid to the department, as provided in this section, must be placed in the Florida Drug, Device, and Cosmetic Trust Fund and used by the department for the administration of ss. 499.001-499.081.

(11)  The department shall assess other fees as provided in ss. 499.001-499.081.

History.--s. 34, ch. 82-225; s. 116, ch. 83-218; s. 1, ch. 83-265; ss. 10, 14, ch. 88-159; s. 4, ch. 89-296; ss. 35, 52, ch. 92-69; s. 591, ch. 97-103.

499.05  Rules.--

(1)  The department shall adopt rules to implement and enforce ss. 499.001-499.081.

(2)  With respect to products in interstate commerce, those rules must not be inconsistent with rules and regulations of federal agencies unless specifically otherwise directed by the Legislature.

(3)  The department shall adopt rules regulating recordkeeping for and the storage, handling, and distribution of medical devices and over-the-counter drugs to protect the public from adulterated products.

History.--s. 34, ch. 82-225; s. 1, ch. 83-265; s. 6, ch. 84-115; s. 88, ch. 85-81; s. 4, ch. 86-133; s. 36, ch. 92-69; ss. 2, 5, 8, ch. 94-309; s. 38, ch. 98-151.

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 establishment permitted pursuant to ss. 499.001-499.081 during business hours for the purpose of enforcing ss. 499.001-499.081, chapters 465, 501, and 893, and the rules of the department that protect the public health, safety, and welfare.

(2)  In addition to the authority set forth in subsection (1), the department and any duly designated officer or employee of the department may enter and inspect any other establishment for the purpose of determining compliance with ss. 499.001-499.081 and rules adopted under those sections regarding any drug, device, or cosmetic product. The authority to enter and inspect does not extend to the practice of the profession of pharmacy, as defined in chapter 465 and the rules adopted under that chapter, in a pharmacy permitted under chapter 465. The Department of Business and Professional Regulation shall conduct routine inspections of retail pharmacy wholesalers at the time of the regular pharmacy permit inspection and shall send the inspection report regarding drug wholesale activity to the Department of Health.

(3)  Any application for a permit or product registration or for renewal of such permit or registration made pursuant to ss. 499.001-499.081 and rules adopted under those sections constitutes permission for any entry or inspection of the premises in order to verify compliance with those sections and rules; to discover, investigate, and determine the existence of compliance; or to elicit, receive, respond to, and resolve complaints and violations.

(4)  The authority to inspect under this section includes the authority to secure:

(a)  Samples or specimens of any drug, device, or cosmetic; or

(b)  Such other evidence as is needed for any action to enforce ss. 499.001-499.081 and the rules adopted under those sections.

(5)  The complaint and all information obtained pursuant to the investigation by the department are confidential and exempt from the provisions of s. 119.07(1) and s. 24(a), Art. I of the State Constitution until the investigation and the enforcement action are completed. However, trade secret information contained therein as defined by s. 812.081(1)(c) shall remain confidential and exempt from the provisions of s. 119.07(1) and s. 24(a), Art. I of the State Constitution, as long as the information is retained by the department. This subsection does not prohibit the department from using such information for regulatory or enforcement proceedings under this chapter or from providing such information to any law enforcement agency or any other regulatory agency. However, the receiving agency shall keep such records confidential and exempt as provided in this subsection. In addition, this subsection is not intended to prevent compliance with the provisions of s. 499.0121(6)(d), and the pedigree papers required in that subsection shall not be deemed a trade secret.

History.--s. 34, ch. 82-225; s. 26, ch. 82-402; s. 1, ch. 83-265; s. 5, ch. 86-133; s. 11, ch. 88-159; ss. 37, 52, ch. 92-69; s. 199, ch. 94-218; ss. 3, 5, 8, ch. 94-309; s. 7, ch. 95-366; s. 332, ch. 96-406; s. 240, ch. 99-8.

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 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 to copy all records showing the movement in interstate commerce of any drug, device, or cosmetic, and the quantity, shipper, and consignee thereof.

History.--s. 34, ch. 82-225; s. 1, ch. 83-265; ss. 38, 52, ch. 92-69.

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. 499.001-499.79, including the nature of any charges and the dispositions of the charges.

(2)  The department may also cause to be disseminated such information regarding drugs, devices, and cosmetics as considered necessary in the interest of public health and the protection of consumers against fraud.

(3)  This section does not prohibit the department from collecting, reporting, and illustrating the results of its investigations.

History.--s. 34, ch. 82-225; s. 1, ch. 83-265; s. 6, ch. 86-133; ss. 39, 52, ch. 92-69.

499.057  Expenses and salaries.--All expenses and salaries shall be paid out of the special fund hereby created in the office of the Treasurer, which fund is to be known as the "Florida Drug, Device, and Cosmetic Trust Fund."

History.--s. 34, ch. 82-225; s. 1, ch. 83-265; ss. 40, 52, ch. 92-69.

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 any provision of ss. 499.001-499.081 or any rule adopted under such sections so as to be dangerous, unwholesome, or fraudulent within the meaning of ss. 499.001-499.081, she or he may issue and enforce a stop-sale, stop-use, removal, or hold order, which order gives notice that such article or processing equipment is, or is suspected of being, in violation and has been detained or embargoed, and which order warns all persons not to remove, use, or dispose of such article or processing equipment by sale or otherwise until permission for removal, use, or disposal is given by such agent or the court. It is unlawful for any person to remove, use, or dispose of such detained or embargoed article or processing equipment by sale or otherwise without such permission; and such act is a felony of the second degree, punishable as provided in s. 775.082, s. 775.083, or s. 775.084.

(2)  When an article or processing equipment detained or embargoed under subsection (1) has been found by such agent to be in violation of law or rule, she or he shall, within 90 days after the issuance of such notice, petition the circuit court, in the jurisdiction of which the article or processing equipment is detained or embargoed, for an order for condemnation of such article or processing equipment. When such agent has found that an article or processing equipment so detained or embargoed is not in violation, she or he shall rescind the stop-sale, stop-use, removal, or hold order.

(3)  If the court finds that the detained or embargoed article or processing equipment is in violation, such article or processing equipment shall, after entry of the court order, be destroyed or made sanitary at the expense of the claimant thereof, under the supervision of such agent; and all court costs, fees, and storage and other proper expenses shall be taxed against the claimant of such article or processing equipment or her or his agent. However, when the violation can be corrected by proper labeling of the article or sanitizing of the processing equipment, and after such costs, fees, and expenses have been paid and a good and sufficient bond, conditioned that such article be so labeled or processed or such processing equipment be so sanitized, has been executed, the court may by order direct that such article or processing equipment be delivered to the claimant thereof for such labeling, processing, or sanitizing, under the supervision of an agent of the department. The expense of such supervision shall be paid by the claimant. Such bond shall be returned to the claimant of the article or processing equipment upon representation to the court by the department that the article or processing equipment is no longer in violation of ss. 499.001-499.081 and that the expenses of such supervision have been paid.

(4)  When the department or any of its authorized agents finds in any room, building, vehicle of transportation, or other structure any perishable articles that are unsound or contain any filthy, decomposed, or putrid substances, or which may be poisonous or deleterious to health or otherwise unsafe, the same being hereby declared to be a nuisance, the department, or its authorized agent, shall forthwith condemn or destroy such articles or in any other manner render such articles unsalable.

History.--s. 34, ch. 82-225; s. 1, ch. 83-265; ss. 41, 52, ch. 92-69; s. 592, ch. 97-103.

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 or by its duly authorized agents designated for that purpose in regard to drugs, devices, or cosmetics.

History.--s. 34, ch. 82-225; s. 1, ch. 83-265; ss. 42, 52, ch. 92-69.

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 any drug, device, or cosmetic, as set out in ss. 499.001-499.081, he or she shall affix to the article a tag, stamp, or other appropriate marking, giving notice that the article is, or is suspected of being, subject to seizure under ss. 499.001-499.081 and that the article has been detained and seized by the department. Such officer or employee shall also warn all persons not to remove or dispose of the article, by sale or otherwise, until permission is given by the department or the court. Any person who violates this section is guilty of a felony of the second degree, punishable as provided in s. 775.082, s. 775.083, or s. 775.084.

History.--s. 34, ch. 82-225; s. 1, ch. 83-265; ss. 43, 52, ch. 92-69; s. 593, ch. 97-103.

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, the department shall petition the court for an order of condemnation or sale, as the court directs. The proceeds of the sale of drugs, devices, and cosmetics, less the legal costs and charges, shall be deposited into the Florida Drug, Device, and Cosmetic Trust Fund.

(2)  If the department finds that any article seized under s. 499.063 was not subject to seizure under that section, the department or the designated officer or employee shall remove the tag or marking.

History.--s. 34, ch. 82-225; s. 1, ch. 83-265; ss. 44, 52, ch. 92-69.

499.066  Penalties; remedies.--In addition to other penalties and other enforcement provisions:

(1)  When the department believes that any person has violated ss. 499.001-499.081 or any rules adopted pursuant to those sections, it may issue and deliver an order to cease and desist from such violation.

(2)  If any person engaged in any activity covered by ss. 499.001-499.081 violates any provision of those sections, any rule adopted under those sections, or a cease and desist order as provided by those sections, the department may obtain an injunction in the circuit court of the county in which the violation occurred or in which the person resides or has its principal place of business, and may apply in that court for such temporary and permanent orders as the department considers necessary to restrain the person from engaging in any such activities until the person complies with ss. 499.001-499.081, the rules adopted under those sections, and the orders of the department authorized by those sections or to mandate compliance with ss. 499.001-499.081, the rules adopted under those sections, and any order or permit issued by the department under those sections.

(3)  The department may impose an administrative fine, not to exceed $5,000 per violation per day, for the violation of any provision of ss. 499.001-499.081 or rules adopted under those sections. Each day a violation continues constitutes a separate violation, and each separate violation is subject to a separate fine. All amounts collected pursuant to this section shall be deposited into the Florida Drug, Device, and Cosmetic Trust Fund and are appropriated for the use of the department in administering ss. 499.001-499.081. In determining the amount of the fine to be levied for a violation, the department shall consider:

(a)  The severity of the violation;

(b)  Any actions taken by the person to correct the violation or to remedy complaints; and

(c)  Any previous violations.

(4)  The department shall deposit any rewards, fines, or collections that are due the department and which derive from joint enforcement activities with other state and federal agencies which relate to ss. 499.001-499.081, chapter 893, or the federal act, into the Florida Drug, Device, and Cosmetic Trust Fund. The proceeds of those rewards, fines, and collections are appropriated for the use of the department in administering ss. 499.001-499.081.

(5)  The department may issue an emergency order immediately suspending or revoking a permit if it determines that any condition in the establishment presents a danger to the public health, safety, and welfare.

(6)  The department may issue an emergency order to immediately remove from commerce and public access any drug, device, or cosmetic, if the department determines that the drug, device, or cosmetic presents a clear and present danger to the public health, safety, and welfare.

History.--s. 34, ch. 82-225; s. 26, ch. 82-402; s. 117, ch. 83-218; s. 1, ch. 83-265; s. 7, ch. 86-133; s. 3, ch. 86-271; ss. 45, 52, ch. 92-69; ss. 4, 5, 8, ch. 94-309.

499.067  Denial, suspension, or revocation of permit 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 chapter 465, chapter 501, or chapter 893, the rules adopted under any of those sections or chapters, any final order of the department, the procedures and protocols established for any investigational drug product by the department, or applicable federal laws or regulations or other state laws or rules governing drugs, devices, or cosmetics.

(b)  The department may deny an application for a permit if it is shown that the applicant is not of good moral character or that it would be a danger or not in the best interest of the public health, safety, and welfare if the applicant were issued a permit.

(2)  The department may deny, suspend, or revoke any registration required by the provisions of ss. 499.001-499.081 for the violation of any provision of ss. 499.001-499.081 or of any rules adopted under those sections.

(3)  The department may revoke or suspend a permit:

(a)  If the permit was obtained by misrepresentation or fraud or through a mistake of the department;

(b)  If the permit was procured, or attempted to be procured, for any other person by making or causing to be made any false representation; or

(c)  If the permittee has violated any provision of ss. 499.001-499.081 or rules adopted under those sections.

(4)  If any permit issued under ss. 499.001-499.081 is revoked or suspended, the owner, manager, operator, or proprietor of the establishment shall cease to operate as the permit authorized, from the effective date of the suspension or revocation until the person is again registered with the department and possesses the required permit. If a permit is revoked or suspended, the owner, manager, or proprietor shall remove all signs and symbols that identify the operation as premises permitted as a drug wholesaling establishment; drug, device, or cosmetic manufacturing establishment; or retail establishment. The department shall determine the length of time for which the permit is to be suspended. If a permit is revoked, the person that owns or operates the establishment may not apply for any permit under ss. 499.001-499.081 for a period of 1 year after the date of the revocation. A revocation of a permit may be permanent if the department considers that to be in the best interest of the public health.

(5)  The department may deny, suspend, or revoke a permit issued under ss. 499.001-499.081 which authorizes the permittee to purchase prescription drugs, if any owner, officer, employee, or other person who participates in administering or operating the establishment has been found guilty of any violation of ss. 499.001-499.081 or chapter 465, chapter 501, or chapter 893, any rules adopted under any of those sections or chapters, or any federal or state drug law, regardless of whether the person has been pardoned, had her or his civil rights restored, or had adjudication withheld.

History.--s. 34, ch. 82-225; s. 1, ch. 83-265; s. 8, ch. 86-133; ss. 12, 14, ch. 88-159; s. 4, ch. 89-296; ss. 46, 52, ch. 92-69; s. 44, ch. 95-144; s. 594, ch. 97-103.

499.069  Punishment for violations of s. 499.005; dissemination of false advertisement.--

(1)  Any person who violates any of the provisions of s. 499.005 is guilty of a misdemeanor of the second degree, punishable as provided in s. 775.082 or s. 775.083; but, if the violation is committed after a conviction of such person under this section has become final, such person is guilty of a misdemeanor of the first degree, punishable as provided in s. 775.082 or s. 775.083 or as otherwise provided in ss. 499.001-499.081, except that any person who violates subsection (8), subsection (10), subsection (14), subsection (15), or subsection (17) of s. 499.005 is guilty of a felony of the third degree, punishable as provided in s. 775.082, s. 775.083, or s. 775.084, or as otherwise provided in ss. 499.001-499.081.

(2)  A person is not subject to the penalties of subsection (1) for having violated any of the provisions of s. 499.005 if he or she establishes a guaranty or undertaking, which guaranty or undertaking is signed by and contains the name and address of the person residing in the state, or the manufacturer, from whom he or she received the article in good faith, to the effect that such article is not adulterated or misbranded within the meaning of ss. 499.001-499.081, citing such sections.

(3)  A publisher, radio broadcast licensee, or agency or medium for the dissemination of an advertisement, except the manufacturer, wholesaler, or seller of the article to which a false advertisement relates, is not liable under this section by reason of the dissemination by him or her of such false advertisement, unless he or she has refused, on the request of the department, to furnish to the department the name and post office address of the manufacturer, wholesaler, seller, or advertising agency that asked him or her to disseminate such advertisement.

History.--s. 34, ch. 82-225; s. 118, ch. 83-218; s. 1, ch. 83-265; ss. 47, 52, ch. 92-69; s. 595, ch. 97-103; s. 40, ch. 99-397.

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 proceedings to be instituted in the proper courts without delay and to be prosecuted in the manner required by law.

History.--s. 34, ch. 82-225; s. 1, ch. 83-265; ss. 48, 52, ch. 92-69.

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 that the public interest will be adequately served in the circumstances by a suitable written notice or warning.

History.--s. 34, ch. 82-225; s. 1, ch. 83-265; ss. 49, 52, ch. 92-69.

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, ch. 82-225; s. 1, ch. 83-265; ss. 50, 52, ch. 92-69.

499.601  Legislative intent; construction.

499.61  Definitions.

499.62  License or permit required of manufacturer, distributor, dealer, or purchaser of ether.

499.63  Forms for applications for licenses and permits.

499.64  Issuance of licenses and permits; prohibitions.

499.65  Possession of ether without license or permit prohibited; confiscation and disposal; exceptions.

499.66  Maintenance of records and sales of ether by manufacturers, distributors, and dealers; inspections.

499.67  Maintenance of records by purchasers; inspections.

499.68  Reports of thefts, illegal use, or illegal possession.

499.69  Possession in or near residential housing prohibited; legal entitlement to possession of premises not a defense.

499.701  Adoption of rules by the department.

499.71  Procedure for cease and desist orders.

499.72  Administrative fines.

499.73  Suspension or revocation of license or permit.

499.74  Conduct of hearings; review of orders of the department.

499.75  Penalties.

499.76  Injunctive relief.

499.77  Exceptions.

499.78  County and municipal ordinances.

499.79  Deposit of fees.

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 of this state, and it is the intent of the Legislature that this part be liberally construed to provide all protection necessary for the citizens of this state.

(2)  The provisions of this part are cumulative and shall not be construed as repealing or affecting any powers, duties, or authority of the Department of Health under any other law of this state; except that, with respect to the regulation of ether as herein provided, in instances in which the provisions of this part may conflict with any other such law, the provisions of this part shall control.

History.--ss. 10, 11, ch. 86-133; s. 4, ch. 91-429; s. 241, ch. 99-8.

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 ether manufacturer, distributor, or dealer.

(2)  "Department" means the Department of Health.

(3)  "Distributor" means any person, firm, corporation, or other entity distributing, selling, marketing, transferring, or otherwise supplying ether to retailers, dealers, or any other entity in the primary channel of trade, but does not include retailers.

(4)  "Ether" means diethyl ether in any form.

(5)  "Manufacturer" means any person, firm, corporation, or other entity preparing, deriving, producing, synthesizing, or otherwise making ether in any form or repacking, relabeling, or manipulating ether.

(6)  "Purchaser" means any person, firm, corporation, or other entity who purchases ether in quantities of 2.5 gallons, or equivalent by weight, or more for any purpose whatsoever, but does not include a dealer, distributor, or manufacturer.

History.--ss. 10, 11, ch. 86-133; s. 4, ch. 91-429; s. 242, ch. 99-8.

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 in conformity with the provisions of this part. No person shall be required to obtain more than one license under this part to handle ether, but each person shall pay the highest fee applicable to her or his operation in each location.

(2)  Any person who manufactures, distributes, or deals in ether in this state must possess a current valid license issued by the department, except that a manufacturer, distributor, or dealer who also purchases ether in this state shall not be required to obtain an additional permit as a purchaser of ether.

(3)  Any person who manufactures, distributes, or deals in ether at or from more than one location must possess a current valid license for each location.

(4)  Any person who purchases ether in this state must possess a current valid permit issued by the department, except that no permit shall be required of any person who purchases ether in quantities of less than 2.5 gallons, or equivalent by weight.

(5)  Annual fees for licenses and permits shall be specified by rule of the department, but shall not exceed the following amounts:

(a)  Manufacturer's license ....... $700

(b)  Distributor's license ....... $700

(c)  Dealer's license ....... $350

(d)  Purchaser's permit ....... $150

(6)  Licenses and permits issued by the department shall be valid beginning on October 1 of the year for which they are issued and shall expire on the following September 30.

(7)  A licensed or permitted facility shall renew its license or permit prior to its expiration date. If a renewal application and fee are not filed by the expiration date of any year, the permit may be reinstated only upon payment of a delinquent fee of $50, plus the required renewal fee, within 30 days after the date of expiration. If any person who is subject to the requirements of this part fails to comply with the renewal, the department shall have the authority to seize all ether products and dispose of them as of November 1 of the year the license or permit expires. Any funds collected from the disposal shall be placed in the Florida Drug, Device, and Cosmetic Trust Fund.

History.--ss. 10, 11, ch. 86-133; s. 4, ch. 91-429; s. 596, ch. 97-103.

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 provisions of this part shall be filed in writing with the department. Each application shall require, as a minimum, the full name, date of birth, place of birth, social security number, physical description of the applicant, residence address and telephone number, and business address and telephone number of the applicant. Each application must be accompanied by an accurate and current photograph of the applicant and a complete set of fingerprints of the applicant taken by an authorized law enforcement officer; however, a set of fingerprints shall not be required if the applicant has possessed a valid Florida license or permit under this part during the prior license or permit year and such Florida license or permit has not lapsed or been suspended or revoked. If fingerprints are required, the set of fingerprints shall be submitted by the department to the Department of Law Enforcement for state processing and to the Federal Bureau of Investigation for federal processing. If the application does not require a set of fingerprints, the department shall submit the name and other identifying data to the Department of Law Enforcement for processing. Each application shall be in such form as to provide that the data and other information set forth therein shall be sworn to by the applicant or, if the applicant is a corporation, by all officers of the corporation. The officers applying on behalf of a corporation shall provide all the data and other information required by this subsection and subsection (3), and shall meet all other requirements, which are required of a natural person.

(3)  The department may require an applicant to furnish such other information or data not required by this section if the information or data is deemed necessary by the department.

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

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 licensee or permittee and shall have permanently affixed an accurate and current photograph of the licensee or permittee. A license or permit issued to a corporation shall set forth the full name, date of birth, and physical description of the chief executive officer and/or resident agent residing in this state and shall have permanently affixed an accurate and current photograph of the chief executive officer and/or resident agent residing in this state. Each license and permit shall also contain a license or permit number.

(2)  The department may, in its discretion, include other data or information in the license or permit when deemed appropriate.

(3)  No license or permit shall be issued, renewed, or allowed to remain in effect for any natural person, or for any corporation which has any corporate officer:

(a)  Under 18 years of age.

(b)  Who has been convicted of a felony under the prescription drug or controlled substance laws of this state or any other state or federal jurisdiction, regardless of whether he or she has been pardoned or had his or her civil rights restored.

(c)  Who has been convicted of any felony other than a felony under the prescription drug or controlled substance laws of this state or any other state or federal jurisdiction and has not been pardoned or had his or her civil rights restored.

(d)  Who has been adjudicated mentally incompetent and has not had his or her civil rights restored.

(4)  It is unlawful for any person to knowingly withhold information or present to the department any false, fictitious, or misrepresented application, identification, document, information, or data intended or likely to deceive the department for the purpose of obtaining a license or permit.

History.--ss. 10, 11, ch. 86-133; s. 4, ch. 91-429; s. 597, ch. 97-103.

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 of a current valid license or permit as provided by this part.

(2)  Whenever the department has reason to believe that any person is or has been violating the provisions of this part or any rules adopted pursuant thereto, the department may, without further process of law, confiscate and dispose of the ether in question. The department is authorized to seize and dispose of any abandoned ether.

(3)  The department is authorized to enter into contracts with private business entities for the purpose of confiscation and disposal of ether as authorized in subsection (2).

(4)  The provisions of subsection (1) shall not apply to:

(a)  Any common carrier transporting ether into this state or within the boundaries of this state by air, highway, railroad, or water;

(b)  Any contract or private carrier transporting ether on highways into this state or within the boundaries of this state by motor vehicle when such contract or private carrier is engaged in such transport pursuant to certificate or permit, by whatever name, issued to them by any federal or state officer, agency, bureau, commission, or department;

(c)  Pharmacists, for use in the usual course of their professional practice or in the performance of their official duties;

(d)  Medical practitioners, for use in the usual course of their professional practice or in the performance of their official duties;

(e)  Persons who procure ether for disposition by or under the supervision of pharmacists or medical practitioners employed by them or for the purpose of lawful research, teaching, or testing, and not for resale;

(f)  Hospitals and other institutions which procure ether for lawful administration by practitioners;

(g)  Officers or employees of federal, state, or local governments carrying out their official duties; and

(h)  Law enforcement agencies of this state or any of its political subdivisions, and the employees thereof, so long as said agencies and employees are acting within the scope of their respective official capacities and in the performance of their duties.

(5)  The department may adopt rules regarding persons engaged in lawful teaching, research, or testing who possess ether and may issue letters of exemption to facilitate the lawful possession of ether under this section.

History.--ss. 10, 11, ch. 86-133; s. 4, ch. 91-429; s. 598, ch. 97-103; s. 39, ch. 98-151.

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 valid license or permit as provided by this part.

(2)  Each sale or transfer of ether shall be evidenced by an invoice, receipt, sales ticket, or sales slip which shall bear the name, address, and license or permit number of the manufacturer, distributor, or dealer and the purchaser or transferee, the date of sale or transfer, and the quantity sold or transferred. All original invoices, receipts, sales tickets, and sales slips shall be retained by the manufacturer, distributor, or dealer, and a copy thereof provided to the purchaser or transferee.

(3)  Each manufacturer, distributor, and dealer shall keep an accurate and current written account of all inventories, sales, and transfers of ether. Such records shall be maintained by the manufacturer, distributor, or dealer for a period of 5 years.

(4)  Records and inventories as required by subsections (2) and (3) shall be made immediately accessible to, and subject to examination and copying by, the department and any law enforcement officer of this state without any requirement of probable cause or search warrant.

(5)  It is unlawful for any person to knowingly withhold information or to make any false or fictitious entry or misrepresentation upon any invoice, receipt, sales ticket, or sales slip for the sale, distribution, or transfer of ether or upon any account of inventories of ether.

History.--ss. 10, 11, ch. 86-133; s. 4, ch. 91-429; s. 40, ch. 98-151.

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, received, stored, and used.

(2)  Such records shall include, but not be limited to, invoices, receipts, sales tickets, and sales slips; locations, quantities, and dates of use; the names of any persons using the ether; and the names and license or permit numbers of all persons making such records. Such records shall be maintained by permittees for a period of 5 years.

(3)  Such records shall be made accessible to, and subject to examination and copying by, the department and any law enforcement officer of this state without any requirement of probable cause or search warrant.

(4)  It is unlawful for any person to knowingly withhold information or make any false or fictitious entry or misrepresentation upon any such records for the purchase, receipt, storage, or use of ether.

(5)  It is unlawful for any person to refuse entry or inspection by the department of factories, warehouses, or establishments in which ether is manufactured, processed, repackaged, or held; to refuse entry by the department into any vehicle being used to transport ether; or to refuse the taking of samples by the department.

History.--ss. 10, 11, ch. 86-133; s. 4, ch. 91-429; s. 41, ch. 98-151.

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 possession of ether involving any person and shall forward a copy of his or her final written report to the department.

(2)  Any licensee or permittee who incurs a loss, an unexplained shortage, or a theft of ether, or who has knowledge of a loss, an unexplained shortage, or a theft of ether, shall, within 12 hours after the discovery thereof, report such loss, theft, or unexplained shortage to the county sheriff or police chief of the jurisdiction in which the loss, theft, or unexplained shortage occurred. Such loss, theft, or unexplained shortage must also be reported to the department by the close of the next business day following the discovery thereof.

(3)  Any law enforcement agency which investigates the causes and circumstances of any loss, theft, or unexplained shortage of ether shall forward a copy of its final written report to the department. The department shall retain all such reports in the respective files of the affected licensees and permittees.

History.--ss. 10, 11, ch. 86-133; s. 4, ch. 91-429; s. 599, ch. 97-103.

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, or equivalent by weight, or more of ether in, or within 500 feet of, any residential housing structure.

(2)  A defendant's legal entitlement to possession of the property where the violation occurred shall not be a defense to a prosecution for a violation of subsection (1).

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

499.701  Adoption of rules by the department.--The department shall adopt and enforce rules necessary to the administration of its authority under this part. Said rules shall be such as are reasonably necessary for the protection of the health, welfare, and safety of the public and persons manufacturing, distributing, dealing, and possessing ether and shall be in substantial conformity with generally accepted standards of safety concerning such subject matter. The department may adopt rules regarding recordkeeping for methyl ethyl ketone (MEK) or butyl acetate as needed. These products and records are open to inspection in the same manner as are ether products and records.

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

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 thereto, it shall proceed to determine the matter.

(2)  If the department determines that any provision of this part or any rules adopted pursuant thereto have been violated, it shall issue to the person charged with such violation an order requiring such person to cease and desist from such violation or imposing an administrative fine, or both.

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

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 department, the department may impose an administrative fine, not to exceed $5,000 for each violation per day, or may suspend or revoke the license or permit issued to such person, or both. Each day such violation continues constitutes a separate violation, and each such separate violation is subject to a separate fine. The department shall allow the licensee or permittee a reasonable period, not to exceed 30 days, within which to pay to the department the amount of the fine so imposed. If the licensee or permittee fails to pay the fine in its entirety to the department at its office in Tallahassee within the period so allowed, the licenses or permits of such person shall stand revoked upon expiration of such period.

(2)  All such fines, monetary penalties, and costs received by the department in connection with this part shall be deposited in the Florida Drug, Device, and Cosmetic Trust Fund.

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

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 licensee or permittee as provided in this part shall be cause for revocation or suspension of all licenses or permits held by such licensee or permittee after the department has determined the licensee or permittee to be guilty of such violation.

(2)  If the department finds the licensee or permittee to be guilty of such violation, it shall enter its order suspending or revoking the license or permit of the person charged. An order of suspension shall state the period of time of such suspension, which period shall not be in excess of 1 year from the date of such order. An order of revocation may be entered for a period not exceeding 5 years; such order shall effect the revocation of all licenses or permits then held by the person charged, and during such period no license or permit shall be issued to said person. If, during the period between the beginning of proceedings and the entry of an order of suspension or revocation by the department, a new license or permit has been issued to the person charged, any order of suspension or revocation shall operate effectively with respect to the new license or permit held by such person.

(3)  Any person or office of a corporation whose permit or license has been suspended or revoked shall not be issued a new permit or license under any other name or company name until the expiration of the suspension or revocation in which she or he has been involved.

(4)  The provisions of this section are cumulative and shall not affect the administrative fine and injunction provisions of ss. 499.72 and 499.76.

History.--ss. 10, 11, ch. 86-133; s. 4, ch. 91-429; s. 600, ch. 97-103.

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 the provisions of chapter 120.

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

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 felony of the second degree, punishable as provided in s. 775.082, s. 775.083, or s. 775.084.

(2)  Any person who knowingly purchases 2.5 gallons, or equivalent by weight, or more of ether without possessing a valid current permit as required by s. 499.62(4) is guilty of a felony of the third degree, punishable as provided in s. 775.082, s. 775.083, or s. 775.084.

(3)  Any person who knowingly withholds information or presents to the department any false, fictitious, or misrepresented application, identification, document, information, statement, or data intended or likely to deceive the department for the purpose of obtaining a license or permit as prohibited by s. 499.64(4) is guilty of a misdemeanor of the first degree, punishable as provided in s. 775.082 or s. 775.083.

(4)  Any person who knowingly possesses 2.5 gallons, or equivalent by weight, or more of ether and is not the holder of a valid current license or permit as prohibited by s. 499.65(1) is guilty of a felony of the third degree, punishable as provided in s. 775.082, s. 775.083, or s. 775.084.

(5)  Any person who knowingly sells or otherwise transfers 2.5 gallons, or equivalent by weight, or more of ether to any person who is not the holder of a valid current license or permit as prohibited by s. 499.66(1) is guilty of a felony of the third degree, punishable as provided in s. 775.082, s. 775.083, or s. 775.084.

(6)  Any person who knowingly withholds information or makes any false or fictitious entry or misrepresentation upon any invoice, receipt, sales ticket, sales slip, or account of inventories as prohibited by s. 499.66(5) is guilty of a misdemeanor of the first degree, punishable as provided in s. 775.082 or s. 775.083.

(7)  Any licensee who knowingly fails to maintain written accounts of inventories or records of sales or transfers as required by s. 499.66(3) is guilty of a misdemeanor of the first degree, punishable as provided in s. 775.082 or s. 775.083.

(8)  Any permittee who knowingly fails to maintain written inventories and records as required by s. 499.67 is guilty of a misdemeanor of the first degree, punishable as provided in s. 775.082 or s. 775.083.

(9)  Any licensee or permittee who fails to report the loss, unexplained shortage, or theft of ether as required by s. 499.68(2) is guilty of a misdemeanor of the first degree, punishable as provided in s. 775.082 or s. 775.083.

(10)  Any person who knowingly possesses 2.5 gallons, or equivalent by weight, or more of ether in, or within 500 feet of, any residential housing structure as prohibited by s. 499.69(1) is guilty of a felony of the second degree, punishable as provided in s. 775.082, s. 775.083, or s. 775.084.

History.--ss. 10, 11, ch. 86-133; s. 121, ch. 91-224; s. 4, ch. 91-429.

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 this part violates any provision of this part, any rule adopted pursuant thereto, or any cease and desist order as provided by this part, the department is authorized to resort to proceedings for injunction in the circuit court of the county in which the violation occurred or in which the person resides or has his or her principal place of business and may therein apply for such temporary and permanent orders as the department may deem necessary to restrain such person from engaging in any such activities until such person complies with the provisions of this part, the rules adopted pursuant thereto, and the orders of the department as authorized by this part.

History.--ss. 10, 11, ch. 86-133; s. 4, ch. 91-429; s. 601, ch. 97-103.

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 of any state or territory thereof, provided that they are acting within their respective official capacities and in the performance of their duties.

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

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 ordinance, rule, or regulation is more restrictive than the provisions of this part and the rules adopted pursuant thereto; nor shall the provisions of this part limit the power of any county or municipality to make ordinances, rules, or regulations pertaining to ether which may be more restrictive than the provisions of this part and the rules adopted pursuant thereto.

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

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 s. 499.057, and all moneys collected under the provisions of this part and deposited in such trust fund are hereby appropriated for the use of the department in the administration of this part.

History.--ss. 10, 11, ch. 86-133; s. 4, ch. 91-429; s. 45, ch. 95-144.