US Laws, Codes, Statutes & Cases

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.

499.0051  Criminal acts involving contraband or adulterated drugs.

499.0052  Trafficking in contraband legend drugs.

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

499.00535  Sale or purchase of contraband legend drugs resulting in great bodily harm.

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

499.00545  Sale or purchase of contraband legend drugs resulting in death.

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; applications; general requirements.

499.01201  Agency for Health Care Administration review and use of statute and rule violation or compliance data.

499.0121  Storage and handling of prescription drugs; recordkeeping.

499.01211  Drug Wholesaler Advisory Council.

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

499.013  Manufacturers and repackagers 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.

499.023  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 certain 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, product registrations, and free-sale certificates.

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.

499.065  Imminent danger.

499.066  Penalties; remedies.

499.0661  Cease and desist orders; removal of certain persons.

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

499.069  Criminal punishment for violations of s. 499.005 related to devices and cosmetics; dissemination of false advertisement.

499.0691  Criminal punishment for violations related to drugs; 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)  "Affiliated party" means:

(a)  A director, officer, trustee, partner, or committee member of a permittee or applicant or a subsidiary or service corporation of the permittee or applicant;

(b)  A person who, directly or indirectly, manages, controls, or oversees the operation of a permittee or applicant, regardless of whether such person is a partner, shareholder, manager, member, officer, director, independent contractor, or employee of the permittee or applicant;

(c)  A person who has filed or is required to file a personal information statement pursuant to s. 499.012(4) or is required to be identified in an application for a permit or to renew a permit pursuant to s. 499.012(3); or

(d)  The five largest natural shareholders that own at least 5 percent of the permittee or applicant.

(3)  "Applicant" means a person applying for a permit or certification under ss. 499.001-499.081.

(4)  "Authenticate" means to affirmatively verify before any distribution of a legend drug occurs that each transaction listed on the pedigree paper has occurred.

(5)  "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.

(6)  "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.

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

(8)  "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.

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

(10)  "Contraband legend drug" means any adulterated drug, as defined in s. 499.006, any counterfeit drug, as defined in this section, and also means any legend drug for which a pedigree paper does not exist, or for which the pedigree paper in existence has been forged, counterfeited, falsely created, or contains any altered, false, or misrepresented matter.

(11)  "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.

(12)  "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.

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

(14)  "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.

(15)  "Distribute or distribution" means to sell; offer to sell; give away; transfer, whether by passage of title, physical movement, or both; deliver; or offer to deliver. The term does not mean to administer or dispense.

(16)  "Diverted from the legal channels of distribution for prescription drugs" means an adulterated drug pursuant to s. 499.006(10).

(17)  "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.

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

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

(20)  "Freight forwarder" means a person who receives legend drugs which are owned by another person and designated by that person for export, and exports those legend drugs.

(21)  "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.

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

(23)  "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.

(24)  "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.

(25)  "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).

(26)  "Legend drug label" means any display of written, printed, or graphic matter upon the immediate container of any legend drug prior to its dispensing to an individual patient pursuant to a prescription of a practitioner authorized by law to prescribe.

(27)  "Manufacture" means the preparation, deriving, compounding, propagation, processing, producing, or fabrication of any drug, device, or cosmetic.

(28)  "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.

(29)  "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.

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

(31)  "Pedigree paper" means:

(a)  A document required pursuant to s. 499.0121(6)(d) or (e); or

(b)  Effective July 1, 2006, a document or electronic form approved by the Department of Health and containing information that records each distribution of any given legend drug, from sale by a pharmaceutical manufacturer, through acquisition and sale by any wholesaler or repackager, until final sale to a pharmacy or other person administering or dispensing the drug. The information required to be included on a legend drug's pedigree paper must at least detail the amount of the legend drug; its dosage form and strength; its lot numbers; the name and address of each owner of the legend drug and his or her signature; its shipping information, including the name and address of each person certifying delivery or receipt of the legend drug; an invoice number, a shipping document number, or another number uniquely identifying the transaction; and a certification that the recipient wholesaler has authenticated the pedigree papers. If the manufacturer or repackager has uniquely serialized the individual legend drug unit, that identifier must also be included on the pedigree. It must also include the name, address, telephone number and, if available, e-mail contact information of each wholesaler involved in the chain of the legend drug's custody. The department shall adopt rules and a form relating to the requirements of this paragraph no later than 90 days after the effective date of this act.

(32)  "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.

(33)  "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.

(34)  "Prescription label" means any display of written, printed, or graphic matter upon the immediate container of any legend drug dispensed pursuant to a prescription of a practitioner authorized by law to prescribe.

(35)  "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.

(36)  "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.

(37)  "Repackage" includes repacking or otherwise changing the container, wrapper, or labeling to further the distribution of the drug, device, or cosmetic.

(38)  "Repackager" means a person who repackages. The term excludes pharmacies that are operating in compliance with pharmacy practice standards as defined in chapter 465 and rules adopted under that chapter.

(39)  "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."

(40)  "Veterinary prescription drug wholesaler" means any person engaged in wholesale distribution of veterinary prescription drugs in or into this state.

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; s. 34, ch. 2000-242; s. 10, ch. 2000-326; s. 3, ch. 2003-155; s. 1, ch. 2004-328; s. 1, ch. 2005-248.

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 for a person 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 purchase or sale of prescription drugs for wholesale distribution in exchange for currency, as defined in s. 560.103(6).

(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 to that purchaser or recipient.

(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 from the person selling or transferring the legend drug.

(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.

(25)  Charging a dispensing fee for dispensing, administering, or distributing a prescription drug sample.

(26)  Removing a pharmacy's dispensing label from a dispensed prescription drug with the intent to further distribute the prescription drug.

(27)  Distributing a prescription drug that was previously dispensed by a licensed pharmacy, unless such distribution was authorized in chapter 465 or the rules adopted under chapter 465.

(28)  Failure to obtain or pass on a pedigree paper.

(29)  The receipt of a prescription drug pursuant to a wholesale distribution without first receiving a pedigree paper that was attested to as accurate and complete by the wholesale distributor.

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; s. 35, ch. 2000-242; s. 17, ch. 2001-63; s. 32, ch. 2001-89; s. 4, ch. 2003-155.

499.0051  Criminal acts involving contraband or adulterated drugs.--

(1)  FAILURE TO MAINTAIN OR DELIVER PEDIGREE PAPERS.--

(a)  A person, other than a manufacturer, engaged in the wholesale distribution of legend drugs who fails to deliver to another person complete and accurate pedigree papers concerning a legend drug or contraband legend drug prior to transferring the legend drug or contraband legend drug to another person commits a felony of the third degree, punishable as provided in s. 775.082, s. 775.083, or s. 775.084.

(b)  A person engaged in the wholesale distribution of legend drugs who fails to acquire complete and accurate pedigree papers concerning a legend drug or contraband legend drug prior to obtaining the legend drug or contraband legend drug from another person commits a felony of the third degree, punishable as provided in s. 775.082, s. 775.083, or s. 775.084.

(c)  Any person who knowingly destroys, alters, conceals, or fails to maintain complete and accurate pedigree papers concerning any legend drug or contraband legend drug in his or her possession commits a felony of the third degree, punishable as provided in s. 775.082, s. 775.083, or s. 775.084.

(2)  FAILURE TO AUTHENTICATE PEDIGREE PAPERS.--

(a)1.  A person engaged in the wholesale distribution of legend drugs who is in possession of documents required under s. 499.0121(6)(e) and who fails to authenticate the matters contained in the documents and who nevertheless attempts to further distribute legend drugs or contraband legend drugs commits a felony of the third degree, punishable as provided in s. 775.082, s. 775.083, or s. 775.084.

2.  A person in possession of documents required under s. 499.0121(6)(e) who falsely swears or certifies that he or she has authenticated the matters contained in the documents commits a felony of the third degree, punishable as provided in s. 775.082, s. 775.083, or s. 775.084.

3.  This paragraph expires July 1, 2006.

(b)  Effective July 1, 2006:

1.  A person engaged in the wholesale distribution of legend drugs who is in possession of pedigree papers concerning legend drugs or contraband legend drugs and who fails to authenticate the matters contained in the pedigree papers and who nevertheless attempts to further distribute legend drugs or contraband legend drugs commits a felony of the third degree, punishable as provided in s. 775.082, s. 775.083, or s. 775.084.

2.  A person in possession of pedigree papers concerning legend drugs or contraband legend drugs who falsely swears or certifies that he or she has authenticated the matters contained in the pedigree papers commits a felony of the third degree, punishable as provided in s. 775.082, s. 775.083, or s. 775.084.

(3)  FORGERY OF PEDIGREE PAPERS.--A person who knowingly forges, counterfeits, or falsely creates any pedigree paper; who falsely represents any factual matter contained on any pedigree paper; or who knowingly omits to record material information required to be recorded in a pedigree paper, commits a felony of the second degree, punishable as provided in s. 775.082, s. 775.083, or s. 775.084.

(4)  PURCHASE OR RECEIPT OF LEGEND DRUG FROM UNAUTHORIZED PERSON.--A person who knowingly purchases or receives from a person not authorized to distribute legend drugs under this chapter a legend drug in a wholesale distribution transaction commits a felony of the second degree, punishable as provided in s. 775.082, s. 775.083, or s. 775.084.

(5)  SALE OR TRANSFER OF LEGEND DRUG TO UNAUTHORIZED PERSON.--A person who knowingly sells or transfers to a person not authorized to purchase or possess legend drugs, under the law of the jurisdiction in which the person receives the drug, a legend drug in a wholesale distribution transaction commits a felony of the second degree, punishable as provided in s. 775.082, s. 775.083, or s. 775.084.

(6)  SALE OR DELIVERY, OR POSSESSION WITH INTENT TO SELL, CONTRABAND LEGEND DRUGS.--A person who is knowingly in actual or constructive possession of any amount of contraband legend drugs, who knowingly sells or delivers, or who possesses with intent to sell or deliver any amount of contraband legend drugs, commits a felony of the second degree, punishable as provided in s. 775.082, s. 775.083, or s. 775.084.

(7)  FORGERY OF PRESCRIPTION OR LEGEND DRUG LABELS.--A person who knowingly forges, counterfeits, or falsely creates any prescription label or legend drug label, or who falsely represents any factual matter contained on any prescription label or legend drug label, commits a felony of the first degree, punishable as provided in s. 775.082, s. 775.083, or s. 775.084.

History.--s. 5, ch. 2003-155.

499.0052  Trafficking in contraband legend drugs.--A person who knowingly sells, purchases, manufactures, delivers, or brings into this state, or who is knowingly in actual or constructive possession of any amount of contraband legend drugs valued at $25,000 or more commits a felony of the first degree, punishable as provided in s. 775.082, s. 775.083, or s. 775.084. Upon conviction, each defendant shall be ordered to pay a mandatory fine according to the following schedule:

(1)  If the value of contraband legend drugs involved is $25,000 or more, but less than $100,000, the defendant shall pay a mandatory fine of $25,000. If the defendant is a corporation or other person that is not a natural person, it shall pay a mandatory fine of $75,000.

(2)  If the value of contraband legend drugs involved is $100,000 or more, but less than $250,000, the defendant shall pay a mandatory fine of $100,000. If the defendant is a corporation or other person that is not a natural person, it shall pay a mandatory fine of $300,000.

(3)  If the value of contraband legend drugs involved is $250,000 or more, the defendant shall pay a mandatory fine of $200,000. If the defendant is a corporation or other person that is not a natural person, it shall pay a mandatory fine of $600,000.

As used in this section, the term "value" means the market value of the property at the time and place of the offense or, if such cannot be satisfactorily ascertained, the cost of replacement of the property within a reasonable time after the offense. Amounts of value of separate contraband legend drugs involved in distinct transactions for the distribution of the contraband legend drugs committed pursuant to one scheme or course of conduct, whether involving the same person or several persons, may be aggregated in determining the punishment of the offense.

History.--s. 6, ch. 2003-155.

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.

499.00535  Sale or purchase of contraband legend drugs resulting in great bodily harm.--A person who knowingly sells, purchases, manufactures, delivers, or brings into this state, or who is knowingly in actual or constructive possession of any amount of contraband legend drugs, and whose acts in violation of this section result in great bodily harm to a person, commits a felony of the first degree, as provided in s. 775.082, s. 775.083, or s. 775.084.

History.--s. 7, ch. 2003-155.

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.

(8)  The representation or suggestion in labeling or advertising that an article is approved under ss. 499.001-499.081, when such is not the case.

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; s. 36, ch. 2000-242.

499.00545  Sale or purchase of contraband legend drugs resulting in death.--A person who knowingly manufactures, sells, purchases, delivers, or brings into this state, or who is knowingly in actual or constructive possession of any amount of contraband legend drugs, and whose acts in violation of this section result in the death of a person, commits a felony of the first degree, punishable by a term of years not exceeding life, as provided in s. 775.082, s. 775.083, or s. 775.084.

History.--s. 8, ch. 2003-155.

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;

(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; or

(10)  If it is a legend drug for which the required pedigree paper is nonexistent, fraudulent, or incomplete under the requirements of ss. 499.001-499.081 or applicable rules, or that has been purchased, held, sold, or distributed at any time by a person not authorized under federal or state law to do so.

History.--s. 34, ch. 82-225; s. 1, ch. 83-265; ss. 10, 52, ch. 92-69; s. 9, ch. 2003-155.

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, repackager, or distributor 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; s. 10, ch. 2003-155; s. 84, ch. 2004-5.

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)  Prior to operating, a permit is required for each person and establishment that intends to operate as:

(a)  A prescription drug manufacturer;

(b)  A prescription drug repackager;

(c)  An over-the-counter drug manufacturer;

(d)  A compressed medical gas manufacturer;

(e)  A device manufacturer;

(f)  A cosmetic manufacturer;

(g)  A prescription drug wholesaler;

(h)  A veterinary prescription drug wholesaler;

(i)  A compressed medical gas wholesaler;

(j)  An out-of-state prescription drug wholesaler;

(k)  A nonresident prescription drug manufacturer;

(l)  A freight forwarder;

(m)  A retail pharmacy drug wholesaler;

(n)  A veterinary legend drug retail establishment;

(o)  A medical oxygen retail establishment;

(p)  A complimentary drug distributor; or

(q)  A restricted prescription drug distributor.

(2)(a)  A permit issued pursuant to ss. 499.001-499.081 may be issued only to a natural person who is at least 18 years of age or to an applicant that is not a natural person if each person who, directly or indirectly, manages, controls, or oversees the operation of that applicant 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 for a prescription drug manufacturer, prescription drug repackager, prescription drug wholesaler, or retail pharmacy wholesaler may not be issued to the address of a health care entity or to a pharmacy licensed under chapter 465, except as provided in this paragraph. The department may issue a prescription drug manufacturer permit to an applicant at the same address as a licensed nuclear pharmacy, which is a health care entity, for the purpose of manufacturing prescription drugs used in positron emission tomography or other radiopharmaceuticals, as listed in a rule adopted by the department pursuant to this paragraph. The purpose of this exemption is to assure availability of state-of-the-art pharmaceuticals that would pose a significant danger to the public health if manufactured at a separate establishment address from the nuclear pharmacy from which the prescription drugs are dispensed. The department may also issue a retail pharmacy wholesaler permit to the address of a community pharmacy licensed under chapter 465 which does not meet the definition of a closed pharmacy in s. 499.003.

(e)  A county or municipality may not issue an occupational license for any licensing period beginning on or after October 1, 2003, for any establishment that requires a permit pursuant to ss. 499.001-499.081, unless the establishment exhibits a current permit issued by the department for the establishment. Upon presentation of the requisite permit issued by the department, an occupational license may be issued by the municipality or county in which application is made. The department shall furnish to local agencies responsible for issuing occupational licenses a current list of all establishments licensed pursuant to ss. 499.001-499.081.

(3)  Notwithstanding subsection (7), 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; however, a new permit for a prescription drug wholesaler, an out-of-state prescription drug wholesaler, or a retail pharmacy drug wholesaler shall expire on the expiration date of the original permit or 1 year after the date of issuance of the new permit, whichever is earlier. A refund may not be issued if the fee for the new permit is less than the fee that was paid for the original permit.

(4)  A written application for a permit or to renew a permit must be filed with the department on forms furnished by the department. The department shall establish, by rule, the form and content 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.

(5)(a)  Except for a permit for a prescription drug wholesaler or an out-of-state prescription drug wholesaler, an application for a permit must include:

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;

e.  If a limited liability company, the name of each member, the name of each manager, the name of the limited liability company, and the name of the state in which the limited liability company was organized; and

f.  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.

(6)  Except for permits for prescription drug wholesalers or out-of-state prescription drug wholesalers:

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

(b)  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.

(c)  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 may 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 submitted and postmarked after the expiration date of the permit, the permit may be renewed only upon payment of a late renewal delinquent fee of $100, plus the required renewal fee, not later than 60 days after the expiration date.

(d)  Failure to renew a permit in accordance with this section precludes any future renewal of that permit. If a permit issued pursuant to this section has expired and cannot be renewed, before an establishment may engage in activities that require a permit under ss. 499.001-499.081, the establishment must submit an application for a new permit, pay the applicable application fee, the initial permit fee, and all applicable penalties, and be issued a new permit by the department.

(7)  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)  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, and provide the name and address of a person to contact regarding access to records that are required to be maintained under ss. 499.001-499.081. Transfer of ownership of legend drugs may be made only to persons authorized to possess legend drugs under ss. 499.001-499.081.

The department may revoke the permit of any person that fails to comply with the requirements of this subsection.

(8)  A permit must be posted in a conspicuous place on the licensed premises.

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; s. 37, ch. 2000-242; ss. 11, 12, ch. 2003-155; s. 85, ch. 2004-5; s. 2, ch. 2004-328.

499.012  Wholesale distribution; definitions; permits; applications; general requirements.--

(1)  As used in this section, the term:

(a)  "Wholesale distribution" means distribution of prescription drugs to persons other than a consumer or patient, but does not 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)  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.

g.  The transfer of a prescription drug by a hospital or other health care entity to a person licensed under this chapter to repackage prescription drugs for the purpose of repackaging the prescription drug for use by that hospital, or other health care entity and other health care entities that are under common control, if ownership of the prescription drugs remains with the hospital or other health care entity at all times. In addition to the recordkeeping requirements of s. 499.0121(6), the hospital or health care entity that transfers prescription drugs pursuant to this sub-subparagraph must reconcile all drugs transferred and returned and resolve any discrepancies in a timely manner.

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.

6.  The sale, purchase, or trade of a prescription drug between pharmacies as a result of a sale, transfer, merger, or consolidation of all or part of the business of the pharmacies from or with another pharmacy, whether accomplished as a purchase and sale of stock or of business assets.

(b)  "Wholesale distributor" means any person engaged in wholesale distribution of prescription drugs in or into this state, including, but not limited to, manufacturers; repackagers; 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.

(d)  "Primary wholesaler" means any wholesale distributor that:

1.  Purchased 90 percent or more of the total dollar volume of its purchases of prescription drugs directly from manufacturers in the previous year; and

2.a.  Directly purchased prescription drugs from not fewer than 50 different prescription drug manufacturers in the previous year; or

b.  Has, or the affiliated group, as defined in s. 1504 of the Internal Revenue Code, of which the wholesale distributor is a member has, not fewer than 250 employees.

(e)  "Directly from a manufacturer" means:

1.  Purchases made by the wholesale distributor directly from the manufacturer of prescription drugs; and

2.  Transfers from a member of an affiliated group, as defined in s. 1504 of the Internal Revenue Code, of which the wholesale distributor is a member, if:

a.  The affiliated group purchases 90 percent or more of the total dollar volume of its purchases of prescription drugs from the manufacturer in the previous year; and

b.  The wholesale distributor discloses to the department the names of all members of the affiliated group of which the wholesale distributor is a member and the affiliated group agrees in writing to provide records on prescription drug purchases by the members of the affiliated group not later than 48 hours after the department requests access to such records, regardless of the location where the records are stored.

(f)  "Secondary wholesaler" means a wholesale distributor that is not a primary wholesaler.

(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 for a new permit or the renewal of a permit must submit a bond of $100,000, or other equivalent means of security acceptable to the department, such as an irrevocable letter of credit or a deposit in a trust account or financial institution, payable to the Florida Drug, Device, and Cosmetic Trust Fund. The purpose of the bond is to secure payment of any administrative penalties imposed by the department and any fees and costs incurred by the department regarding that permit which are authorized under state law and which the permittee fails to pay 30 days after the fine or costs become final. The department may make a claim against such bond or security until 1 year after the permittee's license ceases to be valid or until 60 days after any administrative or legal proceeding authorized in ss. 499.001-499.081 which involves the permittee is concluded, including any appeal, whichever occurs later. 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. An out-of-state prescription drug wholesaler that applies to the department for a new permit or the renewal of a permit must submit a bond of $100,000, or other equivalent means of security acceptable to the department, such as an irrevocable letter of credit or a deposit in a trust account or financial institution, payable to the Florida Drug, Device, and Cosmetic Trust Fund. The purpose of the bond is to secure payment of any administrative penalties imposed by the department and any fees and costs incurred by the department regarding that permit which are authorized under state law and which the permittee fails to pay 30 days after the fine or costs become final. The department may make a claim against such bond or security until 1 year after the permittee's license ceases to be valid or until 60 days after any administrative or legal proceeding authorized in ss. 499.001-499.081 which involves the permittee is concluded, including any appeal, whichever occurs later.

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 conduct wholesale distributions of prescription drugs under the same business name. The recordkeeping requirements of s. 499.0121(6) must be followed for this transaction.

(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 Modified Class II institutional 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.

(e)  Nonresident prescription drug manufacturer permit.--A nonresident prescription drug manufacturer permit is required for any person that is a manufacturer of prescription drugs, or the distribution point for a manufacturer of prescription drugs, and located outside of this state, or that is an entity to whom an approved new drug application has been issued by the United States Food and Drug Administration, or the contracted manufacturer of the approved new drug application holder, and located outside the United States, which engages in the wholesale distribution in this state of the prescription drugs it manufactures or is responsible for manufacturing. Each such manufacturer or entity must be permitted by the department and comply with all the provisions required of a wholesale distributor under ss. 499.001-499.081, except s. 499.0121(6)(d), (e), or (f).

1.  A person that distributes prescription drugs that it did not manufacture must also obtain an out-of-state prescription drug wholesaler permit pursuant to this section to engage in the wholesale distribution of the prescription drugs manufactured by another person and comply with the requirements of an out-of-state prescription drug wholesaler.

2.  Any such person must comply with the licensing or permitting requirements of the jurisdiction in which the establishment is located and the federal act, and any product wholesaled into this state must comply with ss. 499.001-499.081. If a person intends to import prescription drugs from a foreign country into this state, the nonresident prescription drug manufacturer must provide to the department a list identifying each prescription drug it intends to import and document approval by the United States Food and Drug Administration for such importation.

(f)  Freight forwarder permit.--A freight forwarder permit is required for any person that engages in the distribution of a legend drug as a freight forwarder unless the person is a common carrier. The storage, handling, and recordkeeping of such distributions must comply with the requirements for wholesale distributors under s. 499.0121, except those set forth in s. 499.0121(6)(d), (e), or (f). A freight forwarder must provide the source of the legend drugs with a validated airway bill, bill of lading, or other appropriate documentation to evidence the exportation of the product.

(g)  A veterinary prescription drug wholesaler permit.--A veterinary prescription drug wholesaler permit is required for any person that engages in the distribution of veterinary prescription drugs in or into this state. A veterinary prescription drug wholesaler that also distributes prescription drugs subject to, defined by, or described by s. 503(b) of the Federal Food, Drug, and Cosmetic Act which it did not manufacture must obtain a permit as a prescription drug wholesaler or out-of-state prescription drug wholesaler in lieu of the veterinary prescription drug wholesaler permit. A veterinary prescription drug wholesaler must comply with the requirements for wholesale distributors under s. 499.0121, except those set forth in s. 499.0121(6)(d), (e), or (f).

(3)  An application for a permit or to renew a permit for a prescription drug wholesaler or an out-of-state prescription drug wholesaler submitted to the department must include:

(a)  The name, full business address, and telephone number of the applicant.

(b)  All trade or business names used by the applicant.

(c)  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.

(d)  The type of ownership or operation, such as a partnership, corporation, or sole proprietorship.

(e)  The names of the owner and the operator of the establishment, including:

1.  If an individual, the name of the individual.

2.  If a partnership, the name of each partner and the name of the partnership.

3.  If a corporation:

a.  The name, address, and title of each corporate officer and director.

b.  The name and address of the corporation, resident agent of the corporation, the resident agent's address, and the corporation's state of incorporation.

c.  The name and address of each shareholder of the corporation that owns 5 percent or more of the outstanding stock of the corporation.

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

5.  If a limited liability company:

a.  The name and address of each member.

b.  The name and address of each manager.

c.  The name and address of the limited liability company, the resident agent of the limited liability company, and the name of the state in which the limited liability company was organized.

(f)  If applicable, the name and address of each member of the affiliated group of which the applicant is a member.

(g)1.  For an application for a new permit, the estimated annual dollar volume of prescription drug sales of the applicant, the estimated annual percentage of the applicant's total company sales that are prescription drugs, the applicant's estimated annual total dollar volume of purchases of prescription drugs, and the applicant's estimated annual total dollar volume of prescription drug purchases directly from manufacturers.

2.  For an application to renew a permit, the total dollar volume of prescription drug sales in the previous year, the total dollar volume of prescription drug sales made in the previous 6 months, the percentage of total company sales that were prescription drugs in the previous year, the total dollar volume of purchases of prescription drugs in the previous year, and the total dollar volume of prescription drug purchases directly from manufacturers in the previous year.

Such portions of the information required pursuant to this paragraph which are a trade secret, as defined in s. 812.081, shall be maintained by the department as trade secret information is required to be maintained under s. 499.051.

(h)  The tax year of the applicant.

(i)  A copy of the deed for the property on which applicant's establishment is located, if the establishment is owned by the applicant, or a copy of the applicant's lease for the property on which applicant's establishment is located that has an original term of not less than 1 calendar year, if the establishment is not owned by the applicant.

(j)  A list of all licenses and permits issued to the applicant by any other state which authorize the applicant to purchase or possess prescription drugs.

(k)  The name of the manager of the establishment that is applying for the permit or to renew the permit, the next four highest ranking employees responsible for prescription drug wholesale operations for the establishment, and the name of all affiliated parties for the establishment, together with the personal information statement and fingerprints required pursuant to subsection (4) for each of such persons.

(l)  The name of each of the applicant's designated representatives as required by subsection (11), together with the personal information statement and fingerprints required pursuant to subsection (4) for each such person.

(m)  For an applicant that is a secondary wholesaler, each of the following:

1.  A personal background information statement containing the background information and fingerprints required pursuant to subsection (4) for each person named in the applicant's response to paragraphs (k) and (l) and for each affiliated party of the applicant.

2.  If any of the five largest shareholders of the corporation seeking the permit is a corporation, the name, address, and title of each corporate officer and director of each such corporation; the name and address of such corporation; the name of such corporation's resident agent, such corporation's resident agent's address, and such corporation's state of its incorporation; and the name and address of each shareholder of such corporation that owns 5 percent or more of the stock of such corporation.

3.  The name and address of all financial institutions in which the applicant has an account which is used to pay for the operation of the establishment or to pay for drugs purchased for the establishment, together with the names of all persons that are authorized signatories on such accounts. The portions of the information required pursuant to this subparagraph which are a trade secret, as defined in s. 812.081, shall be maintained by the department as trade secret information is required to be maintained under s. 499.051.

4.  The sources of all funds and the amounts of such funds used to purchase or finance purchases of prescription drugs or to finance the premises on which the establishment is to be located.

5.  If any of the funds identified in subparagraph 4. were borrowed, copies of all promissory notes or loans used to obtain such funds.

(n)  Any other relevant information that the department requires, including, but not limited to, any information related to whether the applicant satisfies the definition of a primary wholesaler or a secondary wholesaler.

(4)(a)  Each person required by subsection (3) to provide a personal information statement and fingerprints shall provide the following information to the department on forms prescribed by the department:

1.  The person's places of residence for the past 7 years.

2.  The person's date and place of birth.

3.  The person's occupations, positions of employment, and offices held during the past 7 years.

4.  The principal business and address of any business, corporation, or other organization in which each such office of the person was held or in which each such occupation or position of employment was carried on.

5.  Whether the person has been, during the past 7 years, the subject of any proceeding for the revocation of any license and, if so, the nature of the proceeding and the disposition of the proceeding.

6.  Whether, during the past 7 years, the person has been enjoined, either temporarily or permanently, by a court of competent jurisdiction from violating any federal or state law regulating the possession, control, or distribution of prescription drugs, together with details concerning any such event.

7.  A description of any involvement by the person with any business, including any investments, other than the ownership of stock in a publicly traded company or mutual fund, during the past 7 years, which manufactured, administered, prescribed, distributed, or stored pharmaceutical products and any lawsuits in which such businesses were named as a party.

8.  A description of any felony criminal offense of which the person, as an adult, was found guilty, regardless of whether adjudication of guilt was withheld or whether the person pled guilty or nolo contendere. A criminal offense committed in another jurisdiction which would have been a felony in this state must be reported. If the person indicates that a criminal conviction is under appeal and submits a copy of the notice of appeal of that criminal offense, the applicant must, within 15 days after the disposition of the appeal, submit to the department a copy of the final written order of disposition.

9.  A photograph of the person taken in the previous 30 days.

10.  A set of fingerprints for the person on a form and under procedures specified by the department, together with payment of an amount equal to the costs incurred by the department for the criminal record check of the person.

11.  The name, address, occupation, and date and place of birth for each member of the person's immediate family who is 18 years of age or older. As used in this subparagraph, the term "member of the person's immediate family" includes the person's spouse, children, parents, siblings, the spouses of the person's children, and the spouses of the person's siblings.

12.  Any other relevant information that the department requires.

(b)  The information required pursuant to paragraph (a) shall be provided under oath.

(c)  The department shall submit the fingerprints provided by a person for initial licensure to the Department of Law Enforcement for a statewide criminal record check and for forwarding to the Federal Bureau of Investigation for a national criminal record check of the person. The department shall submit the fingerprints provided by a person as a part of a renewal application to the Department of Law Enforcement for a statewide criminal record check, and for forwarding to the Federal Bureau of Investigation for a national criminal record check, for the initial renewal of a permit after January 1, 2004; for any subsequent renewal of a permit, the department shall submit the required information for a statewide and national criminal record check of the person. Any person who as a part of an initial permit application or initial permit renewal after January 1, 2004, submits to the department a set of fingerprints required for the criminal record check required in this paragraph shall not be required to provide a subsequent set of fingerprints for a criminal record check to the department, if the person has undergone a criminal record check as a condition of the issuance of an initial permit or the initial renewal of a permit of an applicant after January 1, 2004.

(5)  The department may deny an application for a permit or refuse to renew a permit for a prescription drug wholesaler or an out-of-state prescription drug wholesaler if:

(a)  The applicant has not met the requirements for the permit.

(b)  The management, officers, or directors of the applicant or any affiliated party are found by the department to be incompetent or untrustworthy.

(c)  The applicant is so lacking in experience in managing a wholesale distributor as to make the issuance of the proposed permit hazardous to the public health.

(d)  The applicant is so lacking in experience in managing a wholesale distributor as to jeopardize the reasonable promise of successful operation of the wholesale distributor.

(e)  The applicant is lacking in experience in the distribution of prescription drugs.

(f)  The applicant's past experience in manufacturing or distributing prescription drugs indicates that the applicant poses a public health risk.

(g)  The applicant is affiliated directly or indirectly through ownership, control, or other business relations, with any person or persons whose business operations are or have been detrimental to the public health.

(h)  The applicant, or any affiliated party, has been found guilty of or has pleaded guilty or nolo contendere to any felony or crime punishable by imprisonment for 1 year or more under the laws of the United States, any state, or any other country, regardless of whether adjudication of guilt was withheld.

(i)  The applicant or any affiliated party has been charged with a felony in a state or federal court and the disposition of that charge is pending during the application review or renewal review period.

(j)  The applicant has furnished false or fraudulent information or material in any application made in this state or any other state in connection with obtaining a permit or license to manufacture or distribute drugs, devices, or cosmetics.

(k)  That a federal, state, or local government permit currently or previously held by the applicant, or any affiliated party, for the manufacture or distribution of any drugs, devices, or cosmetics has been disciplined, suspended, or revoked and has not been reinstated.

(l)  The applicant does not possess the financial or physical resources to operate in compliance with the permit being sought, this chapter, and the rules adopted under this chapter.

(m)  The applicant or any affiliated party receives, directly or indirectly, financial support and assistance from a person who was an affiliated party of a permittee whose permit was subject to discipline or was suspended or revoked, other than through the ownership of stock in a publicly traded company or a mutual fund.

(n)  The applicant or any affiliated party receives, directly or indirectly, financial support and assistance from a person who 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, any federal or state drug law, or any felony where the underlying facts related to drugs, regardless of whether the person has been pardoned, had her or his civil rights restored, or had adjudication withheld, other than through the ownership of stock in a publicly traded company or a mutual fund.

(o)  The applicant for renewal of a permit under paragraph (2)(a) or paragraph (2)(c) has not actively engaged in the wholesale distribution of prescription drugs, as demonstrated by the regular and systematic distribution of prescription drugs throughout the year as evidenced by not fewer than 12 wholesale distributions in the previous year and not fewer than three wholesale distributions in the previous 6 months.

(p)  Information obtained in response to paragraph (2)(a) or paragraph (2)(c) demonstrates it would not be in the best interest of the public health, safety, and welfare to issue a permit.

(q)  The applicant does not possess the financial standing and business experience for the successful operation of the applicant.

(r)  The applicant or any affiliated party has failed to comply with the requirements for manufacturing or distributing prescription drugs under ss. 499.001-499.081, similar federal laws, similar laws in other states, or the rules adopted under such laws.

(6)  Upon approval of the application by the department and payment of the required fee, the department shall issue or renew a prescription drug wholesaler or an out-of-state prescription drug wholesaler permit to the applicant.

(7)  For permits for prescription drug wholesalers or out-of-state prescription drug wholesalers:

(a)  The department shall adopt rules for the annual renewal of permits. At least 90 days before the expiration of a permit, the department shall forward a permit renewal notification and renewal application to the prescription drug wholesaler or out-of-state prescription drug wholesaler at the mailing address of the permitted establishment on file with the department. The permit renewal notification must state conspicuously the date on which the permit for the establishment will expire and that the establishment may not operate unless the permit for the establishment is renewed timely.

(b)  A permit, unless sooner suspended or revoked, automatically expires 1 year after the last day of the anniversary month in which the permit was originally issued. A permit may 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 submitted and postmarked after 45 days prior to the expiration date of the permit, the permit may be renewed only upon payment of a late renewal fee of $100, plus the required renewal fee. A permittee that has submitted a renewal application in accordance with this paragraph may continue to operate under its permit, unless the permit is suspended or revoked, until final disposition of the renewal application.

(c)  Failure to renew a permit in accordance with this section precludes any future renewal of that permit. If a permit issued pursuant to this section has expired and cannot be renewed, before an establishment may engage in activities that require a permit under ss. 499.001-499.081, the establishment must submit an application for a new permit; pay the applicable application fee, initial permit fee, and all applicable penalties; and be issued a new permit by the department.

(8)  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 or this section.

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

(10)  The name of a permittee or establishment on a prescription drug wholesaler permit or an out-of-state prescription drug wholesaler permit may not include any indicia of attainment of any educational degree, any indicia that the permittee or establishment possesses a professional license, or any name or abbreviation that the department determines is likely to cause confusion or mistake or that the department determines is deceptive, including that of any other entity authorized to purchase prescription drugs.

(11)(a)  Each establishment that is issued an initial or renewal permit as a prescription drug wholesaler or an out-of-state prescription drug wholesaler must designate in writing to the department at least one natural person to serve as the designated representative of the wholesaler. Such person must have an active certification as a designated representative from the department.

(b)  To be certified as a designated representative, a natural person must:

1.  Submit an application on a form furnished by the department and pay the appropriate fees;

2.  Be at least 18 years of age;

3.  Have not less than 2 years of verifiable full-time work experience in a pharmacy licensed in this state or another state, where the person's responsibilities included, but were not limited to, recordkeeping for prescription drugs, or have not less than 2 years of verifiable full-time managerial experience with a prescription drug wholesaler licensed in this state or in another state;

4.  Receive a passing score of at least 75 percent on an examination given by the department regarding federal laws governing distribution of prescription drugs and ss. 499.001-499.081 and the rules adopted by the department governing the wholesale distribution of prescription drugs. This requirement shall be effective 1 year after the results of the initial examination are mailed to the persons that took the examination. The department shall offer such examinations at least four times each calendar year; and

5.  Provide the department with a personal information statement and fingerprints pursuant to subsection (4).

(c)  The department may deny an application for certification as a designated representative or may suspend or revoke a certification of a designated representative pursuant to s. 499.067.

(d)  A designated representative:

1.  Must be actively involved in and aware of the actual daily operation of the wholesale distributor.

2.  Must be employed full time in a managerial position by the wholesale distributor.

3.  Must be physically present at the establishment during normal business hours, except for time periods when absent due to illness, family illness or death, scheduled vacation, or other authorized absence.

4.  May serve as a designated representative for only one wholesale distributor at any one time.

(e)  A wholesale distributor must notify the department when a designated representative leaves the employ of the wholesale distributor. Such notice must be provided to the department within 10 business days after the last day of designated representative's employment with the wholesale distributor.

(f)  A wholesale distributor may not operate under a prescription drug wholesaler permit or an out-of-state prescription drug wholesaler permit for more than 10 business days after the designated representative leaves the employ of the wholesale distributor, unless the wholesale distributor employs another designated representative and notifies the department within 10 business days of the identity of the new designated representative.

(12)  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; s. 20, ch. 2001-53; s. 138, ch. 2001-277; s. 38, ch. 2002-400; ss. 13, 14, ch. 2003-155; s. 3, ch. 2004-328; s. 2, ch. 2005-248.

499.01201  Agency for Health Care Administration review and use of statute and rule violation or compliance data.--Notwithstanding any other provisions of law to the contrary, the Agency for Health Care Administration may not:

(1)  Review or use any violation or alleged violation of s. 499.0121(6), or any rules adopted under that section, as a ground for denying or withholding any payment of a Medicaid reimbursement to a pharmacy licensed under chapter 465; or

(2)  Review or use compliance with s. 499.0121(6), or any rules adopted under that section, as the subject of any audit of Medicaid-related records held by a pharmacy licensed under chapter 465.

History.--s. 4, ch. 2005-248.

499.0121  Storage and handling of prescription drugs; recordkeeping.--The department shall adopt rules to implement this section as necessary to protect the public health, safety, and welfare. Such rules shall include, but not 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.

(c)  Any vehicle that contains prescription drugs must be secure from unauthorized access to the prescription drugs in the vehicle.

(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 AND RECORDS.--

(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.

(d)  Upon receipt, a wholesaler must review records required under this section for the acquisition of prescription drugs for accuracy and completeness, considering the total facts and circumstances surrounding the transactions and the wholesale distributors involved. This includes authenticating each transaction listed on a pedigree paper, as defined in s. 499.001(31).

(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;

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

5.  Any financial documentation supporting the transaction.

(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 or 3 years after the creation of the records, whichever period is longer.

(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 for the drug manufacturer's products, must provide to each wholesale distributor of such drug, before the sale is made to such wholesale distributor, a written statement under oath identifying each previous sale of the drug back to the last authorized distributor of record, the lot number of the drug, and the sales invoice number of the invoice evidencing the sale of the drug. The written statement must accompany the drug to the next wholesale distributor. The department shall adopt rules relating to the requirements of this written statement. This paragraph does not apply to a manufacturer unless the manufacturer is performing the manufacturing operation of repackaging prescription drugs.

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

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.

4.  Each manufacturer shall file a written list of all of the manufacturer's authorized distributors of record with the department. A manufacturer shall notify the department not later than 10 days after any change to the list. The department shall publish a list of all authorized distributors of record on its website.

5.  For the purposes of this subsection, the term "authorized distributors of record" means a wholesale distributor with whom a manufacturer has established an ongoing relationship to distribute the manufacturer's products. Effective March 1, 2004, an ongoing relationship is deemed to exist when a wholesale distributor, including any affiliated group, as defined in s. 1504 of the Internal Revenue Code, of which the wholesale distributor is a member:

a.  Is listed on the manufacturer's current list of authorized distributors of record.

b.  Annually purchases not less than 90 percent of all of its purchases of a manufacturer's prescription drug products, based on dollar volume, directly from that manufacturer and has total annual prescription drug sales of $100 million or more.

c.  Has reported to the department pursuant to s. 499.012(3)(g)2. that the wholesale distributor has total annual prescription drug sales of $100 million or more, and has a verifiable account number issued by the manufacturer authorizing the wholesale distributor to purchase the manufacturer's drug products directly from that manufacturer and that wholesale distributor makes not fewer than 12 purchases of that manufacturer's drug products directly from the manufacturer using said verifiable account number in 12 months. The provisions of this sub-subparagraph apply with respect to a man