Definitions of terms used in this part.

As used in this part, the term:

(1) “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 animals.

(2) “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.

(3) “Affiliate” means a business entity that has a relationship with another business entity in which, directly or indirectly:

(a) The business entity controls, or has the power to control, the other business entity; or

(b) A third party controls, or has the power to control, both business entities.

(4) “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.

(5) “Applicant” means a person applying for a permit or certification under this part.

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

(7) “Chain pharmacy warehouse” means a 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 between members of an affiliate.

(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 transaction history, transaction information, or transaction statement does not exist, or for which the transaction history, transaction information, or transaction statement 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, purchase, trade, deliver, handle, store, or receive. The term does not mean to administer or dispense.

(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), and includes active pharmaceutical ingredients, but does not include devices or their nondrug components, parts, or accessories.

(18) “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.

(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 prescription drugs which are owned by another person and designated by that person for export, and exports those prescription 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. However, a blood establishment is a health care entity that may engage in the wholesale distribution of prescription drugs under s. 499.01(2)(h)1.c.

(22) “Health care facility” means a health care facility licensed under chapter 395.

(23) “Hospice” means a corporation licensed under part IV of chapter 400.

(24) “Hospital” means a facility as defined in s. 395.002 and licensed under chapter 395.

(25) “Immediate container” does not include package liners.

(26) “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.

(27) “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.

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

(29) “Manufacturer” means:

(a) A person who holds a New Drug Application, an Abbreviated New Drug Application, a Biologics License Application, or a New Animal Drug Application approved under the federal act or a license issued under s. 351 of the Public Health Service Act, 42 U.S.C. s. 262, for such drug or biologics, or if such drug or biologics are not the subject of an approved application or license, the person who manufactured the drug or biologics;

(b) A co-licensed partner of the person described in paragraph (a) who obtains the drug or biologics directly from a person described in paragraph (a), paragraph (c), or this paragraph;

(c) An affiliate of a person described in paragraph (a), paragraph (b), or this paragraph that receives the drug or biologics directly from a person described in paragraph (a), paragraph (b), or this paragraph; or

(d) A person who manufactures a device or a cosmetic.

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.

(30) “Medical convenience kit” means packages or units that contain combination products as defined in 21 C.F.R. s. 3.2(e)(2).

(31) “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.

(32) “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.

(33) “Nursing home” means a facility licensed under part II of chapter 400.

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

(35) “Permittee” means any person holding a permit issued under this chapter.

(36) “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.

(37) “Pharmacist” means a person licensed under chapter 465.

(38) “Pharmacy” means an entity licensed under chapter 465.

(39) “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 or by a facility holding a Class III institutional pharmacy permit.

(40) “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, s. 499.007(13), subsection (31), or subsection (47), 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.

(41) “Prescription drug label” means any display of written, printed, or graphic matter upon the immediate container of any prescription drug before it is dispensed to an individual patient pursuant to a prescription of a practitioner authorized by law to prescribe.

(42) “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.

(43) “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.

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

(45) “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.

(46) “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.

(47) “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.”

(48) “Wholesale distribution” means the distribution of a prescription drug to a person other than a consumer or patient, or the receipt of a prescription drug by a person other than the 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)(h):

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 distribution of a prescription drug or an offer to distribute 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 distribution of 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 distribution 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 distribution 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 distribution 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 distribution of a prescription drug or offer to distribute a prescription drug for emergency medical reasons, which may include transfers of prescription drugs by a retail pharmacy to another retail pharmacy to alleviate a temporary shortage. For purposes of this subparagraph, a drug shortage not caused by a public health emergency does not constitute an emergency medical reason.

3. The distribution 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 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.

5. The distribution 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.

6. The distribution 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 record-keeping requirements of s. 499.0121(6), the hospital or health care entity that distributes prescription drugs pursuant to this subparagraph must reconcile all drugs distributed and returned and resolve any discrepancies in a timely manner.

(c) Intracompany distribution of any drug between members of an affiliate or within a manufacturer.

(d) The distribution of a prescription drug by the manufacturer of the prescription drug.

(e) The distribution of prescription drug samples by manufacturers’ representatives or distributors’ representatives conducted in accordance with s. 499.028.

(f) The distribution of a prescription drug by a third-party logistics provider permitted or licensed pursuant to and operating in compliance with the laws of this state and federal law if such third-party logistics provider does not take ownership of the prescription drug.

(g) The distribution of a prescription drug, or an offer to distribute a prescription drug by a repackager registered as a drug establishment with the United States Food and Drug Administration that has taken ownership or possession of the prescription drug and repacks it in accordance with this part.

(h) The purchase or other acquisition by a dispenser, hospital, or other health care entity of a prescription drug for use by such dispenser, hospital, or other health care entity.

(i) The distribution of a prescription drug by a hospital or other health care entity, or by a wholesale distributor or manufacturer operating at the direction of the hospital or other health care entity, to a repackager 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 drug remains with the hospital or other health care entity at all times.

(j) The distribution 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.

(k) The lawful dispensing of a prescription drug in accordance with chapter 465.

(l) The distribution 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.

(m) The distribution of minimal quantities of prescription drugs by a licensed retail pharmacy to a licensed practitioner for office use in compliance with chapter 465 and rules adopted thereunder. The department shall adopt rules specifying the quantities of prescription drugs which are considered to be minimal quantities. However, until such rules are adopted, minimal quantities distributed may not exceed 3 percent of the retail pharmacy’s total annual purchases of prescription drugs.

(n) The distribution of an intravenous prescription drug that, by its formulation, is intended for the replenishment of fluids and electrolytes, such as sodium, chloride, and potassium or calories, such as dextrose and amino acids.

(o) The distribution of an intravenous prescription drug used to maintain the equilibrium of water and minerals in the body, such as dialysis solutions.

(p) The distribution of a prescription drug that is intended for irrigation or sterile water, whether intended for such purposes or for injection.

(q) The distribution of an exempt medical convenience kit pursuant to 21 U.S.C. s. 353(e)(4)(M).

(r) A common carrier that transports a prescription drug, if the common carrier does not take ownership of the prescription drug.

(s) Saleable drug returns when conducted by a dispenser.

(t) Facilitating the distribution of a prescription drug by providing solely administrative services, including processing of orders and payments.

(u) The distribution by a charitable organization described in s. 501(c)(3) of the Internal Revenue Code of prescription drugs donated to or supplied at a reduced price to the charitable organization to:

1. A licensed health care practitioner, as defined in s. 456.001, who is authorized under the appropriate practice act to prescribe and administer prescription drugs;

2. A health care clinic establishment permitted pursuant to this chapter; or

3. The Department of Health or the licensed medical director of a government agency health care entity, authorized to possess prescription drugs, for storage and use in the treatment of persons in need of emergency medical services, including controlling communicable diseases or providing protection from unsafe conditions that pose an imminent threat to public health,

if the distributor and the receiving entity receive no direct or indirect financial benefit other than tax benefits related to charitable contributions. Distributions under this section that involve controlled substances must comply with all state and federal regulations pertaining to the handling of controlled substances.

(v) The distribution of medical gas pursuant to part III of this chapter.

(w) A hospital covered by s. 340B of the Public Health Service Act, 42 U.S.C. s. 256b, that arranges for a prescription drug wholesale distributor to distribute prescription drugs covered under that act directly to a contract pharmacy. Such hospital is exempt from obtaining a restricted prescription drug distributor permit under s. 499.01(2)(h).

(x) The dispensing or distribution of a medicinal drug by a Class III institutional pharmacy pursuant to s. 465.019.

(49) “Wholesale distributor” means a person, other than a manufacturer, a manufacturer’s co-licensed partner, a third-party logistics provider, or a repackager, who is engaged in wholesale distribution.