As used in this part, 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 group” means an affiliated group as defined by s. 1504 of the Internal Revenue Code of 1986, as amended, which is composed of chain drug entities, including at least 50 retail pharmacies, warehouses, or repackagers, which are members of the same affiliated group. The affiliated group must disclose the names of all its members to the department.
(3) “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(9) or is required to be identified in an application for a permit or to renew a permit pursuant to s. 499.012(8); or
(d) The five largest natural shareholders that own at least 5 percent of the permittee or applicant.
(4) “Applicant” means a person applying for a permit or certification under this part.
(5) “Authenticate” means to affirmatively verify upon receipt of a prescription drug that each transaction listed on the pedigree paper has occurred.
(a) A wholesale distributor is not required to open a sealed, medical convenience kit to authenticate a pedigree paper for a prescription drug contained within the kit.
(b) Authentication of a prescription drug included in a sealed, medical convenience kit shall be limited to verifying the transaction and pedigree information received.
(6) “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.
(7) “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.
(8) “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.
(9) “Color” includes black, white, and intermediate grays.
(10) “Color additive” means, with the exception of any material that has been or hereafter is exempt under the federal act, 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.
(11) “Contraband prescription drug” means any adulterated drug, as defined in s. 499.006, any counterfeit drug, as defined in this section, and also means any prescription 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. (12) “Cosmetic” means an article, with the exception of soap, 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.
(13) “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.
(14) “Department” means the Department of Business and Professional Regulation.
(15) “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 that 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.
(16) “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 and does not include the billing and invoicing activities that commonly follow a wholesale distribution transaction.
(17) “Drop shipment” means the sale of a prescription drug from a manufacturer to a wholesale distributor, where the wholesale distributor takes title to, but not possession of, the prescription drug, and the manufacturer of the prescription drug ships the prescription drug directly 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. (18) “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), and includes active pharmaceutical ingredients, but does not include devices or their nondrug components, parts, or accessories. For purposes of this paragraph, an “active pharmaceutical ingredient” includes any substance or mixture of substances intended, represented, or labeled for use in drug manufacturing that furnishes or is intended to furnish, in a finished dosage form, any pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, therapy, or prevention of disease in humans or other animals, or to affect the structure or any function of the body of humans or other animals.
(19) “Establishment” means a place of business which is at one general physical location and may extend to one or more contiguous suites, units, floors, or buildings operated and controlled exclusively by entities under common operation and control. Where multiple buildings are under common exclusive ownership, operation, and control, an intervening thoroughfare does not affect the contiguous nature of the buildings. For purposes of permitting, each suite, unit, floor, or building must be identified in the most recent permit application.
(20) “Federal act” means the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. ss. 301 et seq.; 52 Stat. 1040 et seq.
(21) “Freight forwarder” means a person who receives prescription drugs which are owned by another person and designated by that person for export, and exports those prescription drugs.
(22) “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. However, a blood establishment is a health care entity that may engage in the wholesale distribution of prescription drugs under s. 499.01(2)(g)1.c.
(23) “Health care facility” means a health care facility licensed under chapter 395.
(24) “Hospice” means a corporation licensed under part IV of chapter 400.
(25) “Hospital” means a facility as defined in s. 395.002 and licensed under chapter 395.
(26) “Immediate container” does not include package liners.
(27) “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 this part or rules adopted under this part 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.
(28) “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.
(29) “Manufacture” means the preparation, deriving, compounding, propagation, processing, producing, or fabrication of any drug, device, or cosmetic.
(30) “Manufacturer” means:
(a) A person who prepares, derives, manufactures, or produces a drug, device, or cosmetic;
(b) The holder or holders of a New Drug Application (NDA), an Abbreviated New Drug Application (ANDA), a Biologics License Application (BLA), or a New Animal Drug Application (NADA), provided such application has become effective or is otherwise approved consistent with s. 499.023;
(c) A private label distributor for whom the private label distributor’s prescription drugs are originally manufactured and labeled for the distributor and have not been repackaged;
(d) A person registered under the federal act as a manufacturer of a prescription drug, who is described in paragraph (a), paragraph (b), or paragraph (c), who has entered into a written agreement with another prescription drug manufacturer that authorizes either manufacturer to distribute the prescription drug identified in the agreement as the manufacturer of that drug consistent with the federal act and its implementing regulations;
(e) A member of an affiliated group that includes, but is not limited to, persons described in paragraph (a), paragraph (b), paragraph (c), or paragraph (d), which member distributes prescription drugs, whether or not obtaining title to the drugs, only for the manufacturer of the drugs who is also a member of the affiliated group. As used in this paragraph, the term “affiliated group” means an affiliated group as defined in s. 1504 of the Internal Revenue Code of 1986, as amended. The manufacturer must disclose the names of all of its affiliated group members to the department; or
(f) A person permitted as a third party logistics provider, only while providing warehousing, distribution, or other logistics services on behalf of a person described in paragraph (a), paragraph (b), paragraph (c), paragraph (d), or paragraph (e).
The term does not include a pharmacy that is operating in compliance with pharmacy practice standards as defined in chapter 465 and rules adopted under that chapter.
(31) “Medical convenience kit” means packages or units that contain combination products as defined in 21 C.F.R. s. 3.2(e)(2).
(32) “Medical gas” means any liquefied or vaporized gas that is a prescription drug, whether alone or in combination with other gases, and as defined in the federal act.
(33) “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.
(34) “Normal distribution chain” means a wholesale distribution of a prescription drug in which the wholesale distributor or its wholly owned subsidiary purchases and receives the specific unit of the prescription drug directly from the manufacturer and distributes the prescription drug directly, or through up to two intracompany transfers, 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 subsection, the term “intracompany” means any transaction or transfer between any parent, division, or subsidiary wholly owned by a corporate entity.
(35) “Nursing home” means a facility licensed under part II of chapter 400.
(36) “Official compendium” means the current edition of the official United States Pharmacopoeia and National Formulary, or any supplement thereto.
(37) “Pedigree paper” means a document in written or electronic form approved by the department which contains information required by s. 499.01212 regarding the sale and distribution of any given prescription drug. (38) “Permittee” means any person holding a permit issued pursuant to s. 499.012.
(39) “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.
(40) “Pharmacist” means a person licensed under chapter 465.
(41) “Pharmacy” means an entity licensed under chapter 465.
(42) “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.
(43) “Prescription drug” means a prescription, medicinal, or legend drug, including, but not limited to, finished dosage forms or active pharmaceutical ingredients subject to, defined by, or described by s. 503(b) of the federal act or s. 465.003(8), s. 499.007(13), subsection (32), or subsection (52), except that an active pharmaceutical ingredient is a prescription drug only if substantially all finished dosage forms in which it may be lawfully dispensed or administered in this state are also prescription drugs.
(44) “Prescription drug label” means any display of written, printed, or graphic matter upon the immediate container of any prescription drug prior to its dispensing to an individual patient pursuant to a prescription of a practitioner authorized by law to prescribe.
(45) “Prescription label” means any display of written, printed, or graphic matter upon the immediate container of any prescription drug dispensed pursuant to a prescription of a practitioner authorized by law to prescribe.
(46) “Primary wholesale distributor” means any wholesale distributor that:
(a) Purchased 90 percent or more of the total dollar volume of its purchases of prescription drugs directly from manufacturers in the previous year; and
(b)1. Directly purchased prescription drugs from not fewer than 50 different prescription drug manufacturers in the previous year; or
2. 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.
(c) For purposes of this subsection, “directly from manufacturers” 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.
(47) “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 this part, and can be purchased without a prescription.
(48) “Repackage” includes repacking or otherwise changing the container, wrapper, or labeling to further the distribution of the drug, device, or cosmetic.
(49) “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.
(50) “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.
(51) “Secondary wholesale distributor” means a wholesale distributor that is not a primary wholesale distributor.
(52) “Veterinary prescription drug” means a prescription 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.”
(53) “Wholesale distribution” means distribution of prescription drugs to persons other than a consumer or patient, but does not include: (a) Any of the following activities, which is not a violation of s. 499.005(21) if such activity is conducted in accordance with s. 499.01(2)(g):
1. 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.
2. 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.
3. 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 subparagraph, “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.
4. 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:
a. The agency or entity must obtain written authorization for the sale, purchase, trade, or other transfer of a prescription drug under this subparagraph from the Secretary of Business and Professional Regulation or his or her designee.
b. The contract provider or subcontractor must be authorized by law to administer or dispense prescription drugs.
c. In the case of a subcontractor, the agency or entity must be a party to and execute the subcontract.
d. 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.
e. 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-subparagraph d.
f. 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 subparagraph shall be subject to inspection by the agency or entity. All records relating to prescription drugs of a manufacturer under this subparagraph shall be subject to audit by the manufacturer of those drugs, without identifying individual patient information. (b) 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:
1. 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.
2. 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 subparagraph, the term “emergency medical reasons” includes transfers of prescription drugs by a retail pharmacy to another retail pharmacy to alleviate a temporary shortage.
3. 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.
4. The revocation of a sale or the return of a prescription drug to the person’s prescription drug wholesale supplier.
5. 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.
6. 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.
7. The transfer of a prescription drug by a hospital or other health care entity to a person licensed under this part 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 subparagraph must reconcile all drugs transferred and returned and resolve any discrepancies in a timely manner. (c) The distribution of prescription drug samples by manufacturers’ representatives or distributors’ representatives conducted in accordance with s. 499.028.
(d) The sale, purchase, or trade of blood and blood components intended for transfusion. As used in this paragraph, the term “blood” means whole blood collected from a single donor and processed for transfusion or further manufacturing, and the term “blood components” means that part of the blood separated by physical or mechanical means.
(e) The lawful dispensing of a prescription drug in accordance with chapter 465.
(f) 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.
(54) “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.