The Florida Senate

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)1.  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 the form approved by the department pursuant to this subparagraph 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 form approved pursuant to this subparagraph. 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; or

2.  A statement, under oath, in written or electronic form, confirming that a wholesale distributor purchases and receives the specific unit of the prescription drug directly from the manufacturer of the prescription drug and distributes the prescription drug directly, or through an intracompany transfer, to a chain pharmacy warehouse or a person authorized by law to purchase prescription drugs for the purpose of administering or dispensing the drug, as defined in s. 465.003 For purposes of this paragraph, the term "chain pharmacy warehouse" means a wholesale distributor permitted pursuant to s. 499.01 that maintains a physical location for prescription drugs that functions solely as a central warehouse to perform intracompany transfers of such drugs to a member of its affiliated group as described in s. 499.0121(6)(h)1.

a.  The information required to be included pursuant to this subparagraph must include:

(I)  The following statement: "This wholesale distributor purchased the specific unit of the prescription drug directly from the manufacturer."

(II)  The manufacturer's national drug code identifier and the name and address of the wholesaler and the purchaser of the prescription drug.

(III)  The name of the prescription drug as it appears on the label.

(IV)  The quantity, dosage form, and strength of the prescription drug.

b.  The wholesale distributor must also maintain and make available to the department, upon request, the point of origin of the prescription drugs, including intracompany transfers; the date of the shipment from the manufacturer to the wholesale distributor; the lot numbers of such drugs; and the invoice numbers from the manufacturer.

The department may adopt rules and forms relating to the requirements of this subsection.

(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; s. 3, ch. 2006-310.