Florida Senate - 2008 COMMITTEE AMENDMENT

Bill No. SB 2756

181182

CHAMBER ACTION

Senate

Comm: RCS

4/1/2008

House

The Committee on Health Regulation (Peaden) recommended the

following amendment:

Senate Amendment (with title amendment)

Delete everything after the enacting clause

and insert:

Section 1. Section 499.002, Florida Statutes, is amended;

section 499.004, Florida Statutes, is redesignated as subsection

(2) of that section and amended; section 499.0053, Florida

Statutes, is redesignated as subsection (3) of that section and

amended; section 499.07, Florida Statutes, is redesignated as

subsection (4) of that section and amended; section 499.071,

Florida Statutes, is redesignated as subsection (5) of that

section and amended; and section 499.081, Florida Statutes, is

redesignated as subsection (6) of that section and amended, to

read:

499.002 Purpose, administration, and enforcement of and

exemption from this part ss. 499.001-499.081.--

(1) This part is Sections 499.001-499.081 are intended to:

(a)(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.

(b)(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.

(c)(3) Promote thereby uniformity of such state and federal

laws, and their administration and enforcement, throughout the

United States.

(2) 499.004 Administration and enforcement by

department.--The department of Health shall administer and

enforce this part 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.

(3) 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

this part 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.

(4) 499.07 Duty of prosecuting officer.--Each state

attorney, county attorney, or municipal attorney to whom the

department or its designated agent reports any violation of this

part ss. 499.001-499.081 shall cause appropriate proceedings to

be instituted in the proper courts without delay and to be

prosecuted in the manner required by law.

(5) 499.071 Issuance of warnings for minor

violations.--This part does Sections 499.001-499.081 do not

require the department to report, for the institution of

proceedings under this part ss. 499.001-499.081, minor violations

of this part ss. 499.001-499.081 when it believes that the public

interest will be adequately served in the circumstances by a

suitable written notice or warning.

(6) 499.081 Carriers in interstate commerce exempted from

ss. 499.001-499.081.--Carriers engaged in interstate commerce are

not subject to this part ss. 499.001-499.081 if they are engaged

in the usual course of business as carriers.

Section 2. Section 499.003, Florida Statutes, is amended;

paragraphs (a) through (f) of subsection (1) of section 499.012,

Florida Statutes, are redesignated as subsections (55), (56),

(52), and (48), paragraph (c) of subsection (48), and subsection

(53), respectively, of that section and amended; paragraphs (f)

through (j) and (l) through (n) of subsection (3) of section

499.029, Florida Statutes, are redesignated as subsections (25),

(23), (26), (27), (35), (40), (41), and (43), respectively, of

that section and amended; and subsection (1) of section 499.0661,

Florida Statutes, is redesignated as subsection (38) of that

section and amended, to read:

499.003 Definitions of terms used in this part ss. 499.001-

499.081.--As used in this part 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 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)(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;

personal information statement pursuant to s. 499.012(9) s.

499.012(4) or is required to be identified in an application for

100

a permit or to renew a permit pursuant to s. 499.012(8) s.

101

499.012(3); or

102

(d) The five largest natural shareholders that own at least

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5 percent of the permittee or applicant.

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(4)(3) "Applicant" means a person applying for a permit or

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certification under this part ss. 499.001-499.081.

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(5)(4) "Authenticate" means to affirmatively verify upon

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receipt before any distribution of a prescription legend drug

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occurs that each transaction listed on the pedigree paper

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described in s. 499.01212(2)(b) has occurred. A wholesale

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distributor is not required to open a sealed, medical convenience

111

kit to authenticate a pedigree paper for a prescription drug

112

contained within the kit.

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(6)(5) "Certificate of free sale" means a document prepared

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by the department which certifies a drug, device, or cosmetic,

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that is registered with the department, as one that can be

116

legally sold in the state.

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(7) "Chain pharmacy warehouse" means a wholesale

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distributor permitted pursuant to s. 499.01 that maintains a

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physical location for prescription drugs that functions solely as

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a central warehouse to perform intracompany transfers of such

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drugs to a member of its affiliated group.

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(8)(6) "Closed pharmacy" means a pharmacy that is licensed

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under chapter 465 and purchases prescription drugs for use by a

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limited patient population and not for wholesale distribution or

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sale to the public. The term does not include retail pharmacies.

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(9)(7) "Color" includes black, white, and intermediate

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grays.

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(10)(8) "Color additive" means, with the exception of any

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material that has been or hereafter is exempt under the federal

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act, a material that:

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(a) Is a dye pigment, or other substance, made by a process

132

of synthesis or similar artifice, or extracted, isolated, or

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otherwise derived, with or without intermediate or final change

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of identity from a vegetable, animal, mineral, or other source;

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(b) When added or applied to a drug or cosmetic or to the

137

human body, or any part thereof, is capable alone, or through

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reaction with other substances, of imparting color thereto;

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except that the term does not include any material which has been

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or hereafter is exempt under the federal act.

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(11)(9) "Compressed medical gas" means any liquefied or

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vaporized gas that is a prescription drug, whether it is alone or

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in combination with other gases.

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(12)(10) "Contraband prescription legend drug" means any

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adulterated drug, as defined in s. 499.006, any counterfeit drug,

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as defined in this section, and also means any prescription

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legend drug for which a pedigree paper does not exist, or for

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which the pedigree paper in existence has been forged,

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counterfeited, falsely created, or contains any altered, false,

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or misrepresented matter.

152

(13)(11) "Cosmetic" means an article, with the exception of

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soap, that is:

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(a) Intended to be rubbed, poured, sprinkled, or sprayed

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on; introduced into; or otherwise applied to the human body or

156

any part thereof for cleansing, beautifying, promoting

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attractiveness, or altering the appearance; or

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

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except that the term does not include soap.

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(14)(12) "Counterfeit drug," "counterfeit device," or

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"counterfeit drug, counterfeit device, or counterfeit cosmetic"

163

means a drug, device, or cosmetic which, or the container, seal,

164

or labeling of which, without authorization, bears the trademark,

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trade name, or other identifying mark, imprint, or device, or any

166

likeness thereof, of a drug, device, or cosmetic manufacturer,

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processor, packer, or distributor other than the person that in

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fact manufactured, processed, packed, or distributed that drug,

169

device, or cosmetic and which thereby falsely purports or is

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represented to be the product of, or to have been packed or

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distributed by, that other drug, device, or cosmetic

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manufacturer, processor, packer, or distributor.

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

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(16)(14) "Device" means any instrument, apparatus,

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implement, machine, contrivance, implant, in vitro reagent, or

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other similar or related article, including its components,

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parts, or accessories, which is:

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(a) Recognized in the current edition of the United States

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Pharmacopoeia and National Formulary, or any supplement thereof,

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(b) Intended for use in the diagnosis, cure, mitigation,

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treatment, therapy, or prevention of disease in humans or other

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animals, or

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body of humans or other animals,

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and that which does not achieve any of its principal intended

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purposes through chemical action within or on the body of humans

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or other animals and which is not dependent upon being

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metabolized for the achievement of any of its principal intended

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purposes.

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(17)(15) "Distribute or distribution" or "distribution"

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means to sell; offer to sell; give away; transfer, whether by

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passage of title, physical movement, or both; deliver; or offer

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to deliver. The term does not mean to administer or dispense.

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(18) "Drop shipment" means the sale of a prescription drug

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from a manufacturer to a wholesale distributor, where the

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wholesale distributor takes title to, but not possession of, the

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prescription drug and the manufacturer of the prescription drug

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ships the prescription drug directly to a chain pharmacy

200

warehouse or a person authorized by law to purchase prescription

201

drugs for the purpose of administering or dispensing the drug, as

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defined in s. 465.003.

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(16) "Diverted from the legal channels of distribution for

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prescription drugs" means an adulterated drug pursuant to s.

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499.006(10).

206

(19)(17) "Drug" means an article that is:

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(a) Recognized in the current edition of the United States

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Pharmacopoeia and National Formulary, official Homeopathic

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Pharmacopoeia of the United States, or any supplement to any of

210

those publications;

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(b) Intended for use in the diagnosis, cure, mitigation,

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treatment, therapy, or prevention of disease in humans or other

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animals;

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body of humans or other animals; or

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(d) Intended for use as a component of any article

217

specified in paragraph (a), paragraph (b), or paragraph (c), but

218

does not include devices or their components, parts, or

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accessories.

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(20)(18) "Establishment" means a place of business at one

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general physical location.

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(21)(19) "Federal act" means the Federal Food, Drug, and

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Cosmetic Act, 21 U.S.C. ss. 301 et seq.; 52 Stat. 1040 et seq.

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(22)(20) "Freight forwarder" means a person who receives

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prescription legend drugs which are owned by another person and

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designated by that person for export, and exports those

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prescription legend drugs.

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(23)(g) "Health care clinic" means a health care clinic

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licensed under part X of chapter 400.

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(24)(21) "Health care entity" means a closed pharmacy or

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any person, organization, or business entity that provides

232

diagnostic, medical, surgical, or dental treatment or care, or

233

chronic or rehabilitative care, but does not include any

234

wholesale distributor or retail pharmacy licensed under state law

235

to deal in prescription drugs.

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(25)(f) "Health care facility" means a health care facility

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licensed under chapter 395.

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(26)(h) "Hospice" means a corporation licensed under part

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IV of chapter 400.

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(27)(i) "Hospital" means a facility as defined in s.

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395.002 and licensed under chapter 395.

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(28)(22) "Immediate container" does not include package

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liners.

244

(29)(23) "Label" means a display of written, printed, or

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graphic matter upon the immediate container of any drug, device,

246

or cosmetic. A requirement made by or under authority of this

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part ss. 499.001-499.081 or rules adopted under this part those

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sections that any word, statement, or other information appear on

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the label is not complied with unless such word, statement, or

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other information also appears on the outside container or

251

wrapper, if any, of the retail package of such drug, device, or

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cosmetic or is easily legible through the outside container or

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wrapper.

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(30)(24) "Labeling" means all labels and other written,

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printed, or graphic matters:

256

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

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containers or wrappers; or

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

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cosmetic.

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(25) "Legend drug," "prescription drug," or "medicinal

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drug" means any drug, including, but not limited to, finished

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dosage forms, or active ingredients subject to, defined by, or

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described by s. 503(b) of the Federal Food, Drug, and Cosmetic

264

Act or s. 465.003(8), s. 499.007(12), or s. 499.0122(1)(b) or

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(c).

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(26) "Legend drug label" means any display of written,

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printed, or graphic matter upon the immediate container of any

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legend drug prior to its dispensing to an individual patient

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pursuant to a prescription of a practitioner authorized by law to

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prescribe.

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(31)(27) "Manufacture" means the preparation, deriving,

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compounding, propagation, processing, producing, or fabrication

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of any drug, device, or cosmetic.

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(32)(28) "Manufacturer" means a person who prepares,

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derives, manufactures, or produces a drug, device, or cosmetic.

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"Manufacturer" also means the holder or holders of a New Drug

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Application (NDA), an Abbreviated New Drug Application (ANDA), a

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Biologics License Application (BLA), or a New Animal Drug

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Application (NADA), provided that such application has become

280

effective or is otherwise approved consistent with s. 499.023; a

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private label distributor for whom the private label

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distributor's prescription drugs are originally manufactured and

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labeled for the distributor and have not been repackaged; or the

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distribution point for the manufacturer, contract manufacturer or

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private label distributor whether the establishment is a member

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of the manufacturer's affiliated group or is a contract

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distribution site.

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The term excludes pharmacies that are operating in compliance

290

with pharmacy practice standards as defined in chapter 465 and

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rules adopted under that chapter.

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(33)(29) "New drug" means:

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(a) Any drug the composition of which is such that the drug

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is not generally recognized, among experts qualified by

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scientific training and experience to evaluate the safety and

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effectiveness of drugs, as safe and effective for use under the

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conditions prescribed, recommended, or suggested in the labeling

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of that drug; or

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(b) Any drug the composition of which is such that the

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drug, as a result of investigations to determine its safety and

301

effectiveness for use under certain conditions, has been

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recognized for use under such conditions, but which drug has not,

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other than in those investigations, been used to a material

304

extent or for a material time under such conditions.

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(34) "Normal distribution chain" means a wholesale

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distribution of a prescription drug where the wholesale

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distributor or its wholly owned subsidiary purchases and receives

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the specific unit of the prescription drug directly from the

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manufacturer and distributes the prescription drug directly, or

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through up to two intracompany transfers, to a chain pharmacy

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warehouse or a person authorized by law to purchase prescription

312

drugs for the purpose of administering or dispensing the drug, as

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defined in s. 465.003. For purposes of this subsection,

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"intracompany transfer" means any transaction or transfer between

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any parent, division, or subsidiary wholly owned by a corporate

316

entity.

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(35)(j) "Nursing home" means a facility licensed under part

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II of chapter 400.

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(36)(30) "Official compendium" means the current edition of

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the official United States Pharmacopoeia and National Formulary,

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or any supplement thereto.

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(37)(31) "Pedigree paper" means:

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(a) Effective July 1, 2006, a document in written or

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electronic form approved by the department that contains of

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Health and containing information required by s. 499.01212

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regarding the sale and that records each distribution of any

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given prescription legend drug., from sale by a pharmaceutical

328

manufacturer, through acquisition and sale by any wholesaler or

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repackager, until final sale to a pharmacy or other person

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administering or dispensing the drug. The information required to

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be included on the form approved by the department pursuant to

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this paragraph must at least detail the amount of the legend

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drug; its dosage form and strength; its lot numbers; the name and

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address of each owner of the legend drug and his or her

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signature; its shipping information, including the name and

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address of each person certifying delivery or receipt of the

337

legend drug; an invoice number, a shipping document number, or

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another number uniquely identifying the transaction; and a

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certification that the recipient wholesaler has authenticated the

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pedigree papers. If the manufacturer or repackager has uniquely

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serialized the individual legend drug unit, that identifier must

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also be included on the form approved pursuant to this paragraph.

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It must also include the name, address, telephone number and, if

344

available, e-mail contact information of each wholesaler involved

345

in the chain of the legend drug's custody; or

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(b) A statement, under oath, in written or electronic form,

347

confirming that a wholesale distributor purchases and receives

348

the specific unit of the prescription drug directly from the

349

manufacturer of the prescription drug and distributes the

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prescription drug directly, or through an intracompany transfer,

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to a chain pharmacy warehouse or a person authorized by law to

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purchase prescription drugs for the purpose of administering or

353

dispensing the drug, as defined in s. 465.003. For purposes of

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this subsection, the term "chain pharmacy warehouse" means a

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wholesale distributor permitted pursuant to s. 499.01 that

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maintains a physical location for prescription drugs that

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functions solely as a central warehouse to perform intracompany

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transfers of such drugs to a member of its affiliated group as

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described in s. 499.0121(6)(f)1.

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1. The information required to be included pursuant to this

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paragraph must include:

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a. The following statement: "This wholesale distributor

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purchased the specific unit of the prescription drug directly

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from the manufacturer."

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b. The manufacturer's national drug code identifier and the

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name and address of the wholesaler and the purchaser of the

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prescription drug.

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c. The name of the prescription drug as it appears on the

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label.

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d. The quantity, dosage form, and strength of the

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prescription drug.

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2. The wholesale distributor must also maintain and make

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available to the department, upon request, the point of origin of

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the prescription drugs, including intracompany transfers; the

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date of the shipment from the manufacturer to the wholesale

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distributor; the lot numbers of such drugs; and the invoice

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numbers from the manufacturer.

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The department may adopt rules and forms relating to the

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requirements of this subsection.

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(38)(1) DEFINITION.--As used in this section, the term

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"Permittee" means any person holding a permit issued pursuant to

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s. 499.012.

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(39)(32) "Person" means any individual, child, joint

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venture, syndicate, fiduciary, partnership, corporation, division

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of a corporation, firm, trust, business trust, company, estate,

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public or private institution, association, organization, group,

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city, county, city and county, political subdivision of this

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state, other governmental agency within this state, and any

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representative, agent, or agency of any of the foregoing, or any

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other group or combination of the foregoing.

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(40) "Person authorized by law" to "purchase," "posses,"

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"administer" or "receive" prescription or legend drugs means:

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(a) A person authorized by law to administer the drug, as

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defined in s. 465.003; and

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(b) An entity of which a person authorized by law to

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administer the drug, as defined in s. 465.003, is a member,

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officer, employee or agent, including but not limited to, a

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professional corporation or a professional limited liability

400

company described in chapter 621 of the Business Organizations

401

Code, provided that:

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1. The entity provides to the seller of the drug with a

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copy of the license under which the person authorized to

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administer the drug may purchase the drug;

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2. The entity designates, to the seller of the drug, a

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person employed by the entity who will be responsible for

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complying with all legal and regulatory requirements with respect

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to the purchase, storage and handling of the drug; and

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3. If the entity fails to designate the person described in

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subparagraph 2., the person whose license was provided to the

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seller under subparagraph 1. is deemed the person responsible for

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complying with all legal and regulatory requirements with respect

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to the purchase, storage and handling of the drug.

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(41)(l) "Pharmacist" means a person licensed under chapter

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465.

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(42)(m) "Pharmacy" means an entity licensed under chapter

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465.

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(43)(33) "Prepackaged drug product" means a drug that

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originally was in finished packaged form sealed by a manufacturer

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and that is placed in a properly labeled container by a pharmacy

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or practitioner authorized to dispense pursuant to chapter 465

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for the purpose of dispensing in the establishment in which the

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prepackaging occurred.

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(44)(n) "Prescribing practitioner" means a physician

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licensed under chapter 458 or chapter 459 or any other medical

426

professional with authority under state law to prescribe cancer

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medication.

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(45) "Prescription drug" means a prescription, medicinal,

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or legend drug, including, but not limited to, finished dosage

430

forms or active ingredients subject to, defined by, or described

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by s. 503(b) of the Federal Food, Drug, and Cosmetic Act or s.

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465.003(8), s. 499.007(13), or subsection (11), subsection (48),

433

or subsection (55).

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(46) "Prescription drug label" means any display of

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written, printed, or graphic matter upon the immediate container

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of any prescription drug prior to its dispensing to an individual

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patient pursuant to a prescription of a practitioner authorized

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by law to prescribe.

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(47)(34) "Prescription label" means any display of written,

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printed, or graphic matter upon the immediate container of any

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prescription legend drug dispensed pursuant to a prescription of

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a practitioner authorized by law to prescribe.

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(48)(35) "Prescription medical oxygen" means oxygen USP

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which is a drug that can only be sold on the order or

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prescription of a practitioner authorized by law to prescribe.

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The label of prescription medical oxygen must comply with current

447

labeling requirements for oxygen under the Federal Food, Drug,

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and Cosmetic Act.

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(49)(d) "Primary wholesale distributor wholesaler" means

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any wholesale distributor that:

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(a)1. Purchased 90 percent or more of the total dollar

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volume of its purchases of prescription drugs directly from

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manufacturers in the previous year; and

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(b)1.2.a. Directly purchased prescription drugs from not

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fewer than 50 different prescription drug manufacturers in the

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previous year; or

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2.b. Has, or the affiliated group, as defined in s. 1504 of

458

the Internal Revenue Code, of which the wholesale distributor is

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a member has, not fewer than 250 employees.

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(c)(e) For purposes of this subsection, "directly from

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manufacturers a manufacturer" means:

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1. Purchases made by the wholesale distributor directly

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from the manufacturer of prescription drugs; and

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2. Transfers from a member of an affiliated group, as

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defined in s. 1504 of the Internal Revenue Code, of which the

466

wholesale distributor is a member, if:

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a. The affiliated group purchases 90 percent or more of the

468

total dollar volume of its purchases of prescription drugs from

469

the manufacturer in the previous year; and

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b. The wholesale distributor discloses to the department

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the names of all members of the affiliated group of which the

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wholesale distributor is a member and the affiliated group agrees

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in writing to provide records on prescription drug purchases by

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the members of the affiliated group not later than 48 hours after

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the department requests access to such records, regardless of the

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location where the records are stored.

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(50)(36) "Proprietary drug," or "OTC drug," means a patent

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or over-the-counter drug in its unbroken, original package, which

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drug is sold to the public by, or under the authority of, the

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manufacturer or primary distributor thereof, is not misbranded

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under the provisions of this part ss. 499.001-499.081, and can be

482

purchased without a prescription.

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(51)(37) "Repackage" includes repacking or otherwise

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changing the container, wrapper, or labeling to further the

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distribution of the drug, device, or cosmetic.

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(52)(38) "Repackager" means a person who repackages. The

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term excludes pharmacies that are operating in compliance with

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pharmacy practice standards as defined in chapter 465 and rules

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adopted under that chapter.

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(53)(c) "Retail pharmacy" means a community pharmacy

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licensed under chapter 465 that purchases prescription drugs at

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fair market prices and provides prescription services to the

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public.

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(54)(f) "Secondary wholesale distributor wholesaler" means

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a wholesale distributor that is not a primary wholesale

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distributor wholesaler.

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(55)(39) "Veterinary prescription drug" means a

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prescription legend drug intended solely for veterinary use. The

499

label of the drug must bear the statement, "Caution: Federal law

500

restricts this drug to sale by or on the order of a licensed

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veterinarian."

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(40) "Veterinary prescription drug wholesaler" means any

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person engaged in wholesale distribution of veterinary

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prescription drugs in or into this state.

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(56)(a) "Wholesale distribution" means distribution of

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prescription drugs to persons other than a consumer or patient,

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but does not include:

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(a)1. Any of the following activities, which is not a

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violation of s. 499.005(21) if such activity is conducted in

510

accordance with s. 499.01(2)(g) s. 499.014:

511

1.a. The purchase or other acquisition by a hospital or

512

other health care entity that is a member of a group purchasing

513

organization of a prescription drug for its own use from the

514

group purchasing organization or from other hospitals or health

515

care entities that are members of that organization.

516

2.b. The sale, purchase, or trade of a prescription drug or

517

an offer to sell, purchase, or trade a prescription drug by a

518

charitable organization described in s. 501(c)(3) of the Internal

519

Revenue Code of 1986, as amended and revised, to a nonprofit

520

affiliate of the organization to the extent otherwise permitted

521

by law.

522

3.c. The sale, purchase, or trade of a prescription drug or

523

an offer to sell, purchase, or trade a prescription drug among

524

hospitals or other health care entities that are under common

525

control. For purposes of this subparagraph section, "common

526

control" means the power to direct or cause the direction of the

527

management and policies of a person or an organization, whether

528

by ownership of stock, by voting rights, by contract, or

529

otherwise.

530

4.d. The sale, purchase, trade, or other transfer of a

531

prescription drug from or for any federal, state, or local

532

government agency or any entity eligible to purchase prescription

533

drugs at public health services prices pursuant to Pub. L. No.

534

102-585, s. 602 to a contract provider or its subcontractor for

535

eligible patients of the agency or entity under the following

536

conditions:

537

a.(I) The agency or entity must obtain written

538

authorization for the sale, purchase, trade, or other transfer of

539

a prescription drug under this subparagraph sub-subparagraph from

540

the State Surgeon General or his or her designee.

541

b.(II) The contract provider or subcontractor must be

542

authorized by law to administer or dispense prescription drugs.

543

c.(III) In the case of a subcontractor, the agency or

544

entity must be a party to and execute the subcontract.

545

d.(IV) A contract provider or subcontractor must maintain

546

separate and apart from other prescription drug inventory any

547

prescription drugs of the agency or entity in its possession.

548

e.(V) The contract provider and subcontractor must maintain

549

and produce immediately for inspection all records of movement or

550

transfer of all the prescription drugs belonging to the agency or

551

entity, including, but not limited to, the records of receipt and

552

disposition of prescription drugs. Each contractor and

553

subcontractor dispensing or administering these drugs must

554

maintain and produce records documenting the dispensing or

555

administration. Records that are required to be maintained

556

include, but are not limited to, a perpetual inventory itemizing

557

drugs received and drugs dispensed by prescription number or

558

administered by patient identifier, which must be submitted to

559

the agency or entity quarterly.

560

f.(VI) The contract provider or subcontractor may

561

administer or dispense the prescription drugs only to the

562

eligible patients of the agency or entity or must return the

563

prescription drugs for or to the agency or entity. The contract

564

provider or subcontractor must require proof from each person

565

seeking to fill a prescription or obtain treatment that the

566

person is an eligible patient of the agency or entity and must,

567

at a minimum, maintain a copy of this proof as part of the

568

records of the contractor or subcontractor required under sub-

569

subparagraph e. sub-sub-subparagraph (V).

570

g.(VII) In addition to the departmental inspection

571

authority set forth in s. 499.051, the establishment of the

572

contract provider and subcontractor and all records pertaining to

573

prescription drugs subject to this subparagraph sub-subparagraph

574

shall be subject to inspection by the agency or entity. All

575

records relating to prescription drugs of a manufacturer under

576

this subparagraph sub-subparagraph shall be subject to audit by

577

the manufacturer of those drugs, without identifying individual

578

patient information.

579

(b)2. Any of the following activities, which is not a

580

violation of s. 499.005(21) if such activity is conducted in

581

accordance with rules established by the department:

582

1.a. The sale, purchase, or trade of a prescription drug

583

among federal, state, or local government health care entities

584

that are under common control and are authorized to purchase such

585

prescription drug.

586

2.b. The sale, purchase, or trade of a prescription drug or

587

an offer to sell, purchase, or trade a prescription drug for

588

emergency medical reasons. For purposes of this subparagraph sub-

589

subparagraph, the term "emergency medical reasons" includes

590

transfers of prescription drugs by a retail pharmacy to another

591

retail pharmacy to alleviate a temporary shortage.

592

3.c. The transfer of a prescription drug acquired by a

593

medical director on behalf of a licensed emergency medical

594

services provider to that emergency medical services provider and

595

its transport vehicles for use in accordance with the provider's

596

license under chapter 401.

597

4.d. The revocation of a sale or the return of a

598

prescription drug to the person's prescription drug wholesale

599

supplier.

600

5.e. The donation of a prescription drug by a health care

601

entity to a charitable organization that has been granted an

602

exemption under s. 501(c)(3) of the Internal Revenue Code of

603

1986, as amended, and that is authorized to possess prescription

604

drugs.

605

6.f. The transfer of a prescription drug by a person

606

authorized to purchase or receive prescription drugs to a person

607

licensed or permitted to handle reverse distributions or

608

destruction under the laws of the jurisdiction in which the

609

person handling the reverse distribution or destruction receives

610

the drug.

611

7.g. The transfer of a prescription drug by a hospital or

612

other health care entity to a person licensed under this part

613

chapter to repackage prescription drugs for the purpose of

614

repackaging the prescription drug for use by that hospital, or

615

other health care entity and other health care entities that are

616

under common control, if ownership of the prescription drugs

617

remains with the hospital or other health care entity at all

618

times. In addition to the recordkeeping requirements of s.

619

499.0121(6), the hospital or health care entity that transfers

620

prescription drugs pursuant to this subparagraph sub-subparagraph

621

must reconcile all drugs transferred and returned and resolve any

622

discrepancies in a timely manner.

623

624

manufacturers' representatives or distributors' representatives

625

conducted in accordance with s. 499.028.

626

(d)4. The sale, purchase, or trade of blood and blood

627

components intended for transfusion. As used in this paragraph

628

subparagraph, the term "blood" means whole blood collected from a

629

single donor and processed either for transfusion or further

630

manufacturing, and the term "blood components" means that part of

631

the blood separated by physical or mechanical means.

632

(e)5. The lawful dispensing of a prescription drug in

633

accordance with chapter 465.

634

(f)6. The sale, purchase, or trade of a prescription drug

635

between pharmacies as a result of a sale, transfer, merger, or

636

consolidation of all or part of the business of the pharmacies

637

from or with another pharmacy, whether accomplished as a purchase

638

and sale of stock or of business assets.

639

(57)(b) "Wholesale distributor" means any person engaged in

640

wholesale distribution of prescription drugs in or into this

641

state, including, but not limited to, manufacturers; repackagers;

642

own-label distributors; jobbers; private-label distributors;

643

brokers; warehouses, including manufacturers' and distributors'

644

warehouses, chain drug warehouses, and wholesale drug warehouses;

645

independent wholesale drug traders; exporters; retail pharmacies;

646

and the agents thereof that conduct wholesale distributions.

647

Section 3. Subsections (4), (10), (11), (12), (14), (15),

648

(18), (19), (20), (22), (24), (28), and (29) of section 499.005,

649

Florida Statutes, are amended to read:

650

499.005 Prohibited acts.--It is unlawful for a person to

651

perform or cause the performance of any of the following acts in

652

this state:

653

(4) The sale, distribution, purchase, trade, holding, or

654

offering of any drug, device, or cosmetic in violation of this

655

part ss. 499.001-499.081.

656

(10) Forging; counterfeiting; simulating; falsely

657

representing any drug, device, or cosmetic; or, without the

658

authority of the manufacturer, using any mark, stamp, tag, label,

659

or other identification device authorized or required by rules

660

adopted under this part ss. 499.001-499.081.

661

(11) The use, on the labeling of any drug or in any

662

advertisement relating to such drug, of any representation or

663

suggestion that an application of the drug is effective when it

664

is not or that the drug complies with this part ss. 499.001-

665

499.081 when it does not.

666

(12) The possession of any drug in violation of this part

667

ss. 499.001-499.081.

668

(14) The purchase or receipt of a prescription legend drug

669

from a person that is not authorized under this chapter to

670

distribute prescription legend drugs to that purchaser or

671

recipient.

672

(15) The sale or transfer of a prescription legend drug to

673

a person that is not authorized under the law of the jurisdiction

674

in which the person receives the drug to purchase or possess

675

prescription legend drugs from the person selling or transferring

676

the prescription legend drug.

677

(18) Failure to maintain records as required by this part

678

ss. 499.001-499.081 and rules adopted under this part those

679

sections.

680

(19) Providing the department with false or fraudulent

681

records, or making false or fraudulent statements, regarding any

682

matter within the provisions of this part chapter.

683

(20) The importation of a prescription legend drug except

684

as provided by s. 801(d) of the Federal Food, Drug, and Cosmetic

685

Act.

686

(22) Failure to obtain a permit or registration, or

687

operating without a valid permit when a permit or registration is

688

required by this part ss. 499.001-499.081 for that activity.

689

(24) The distribution of a prescription legend device to

690

the patient or ultimate consumer without a prescription or order

691

from a practitioner licensed by law to use or prescribe the

692

device.

693

(28) Failure to acquire obtain or deliver pass on a

694

pedigree paper as required under this part.

695

(29) The receipt of a prescription drug pursuant to a

696

wholesale distribution without having previously received or

697

simultaneously either first receiving a pedigree paper that was

698

attested to as accurate and complete by the wholesale distributor

699

as required under this part or complying with the provisions of

700

s. 499.0121(6)(d)5.

701

Section 4. Section 499.0051, Florida Statutes, is amended;

702

section 499.0052, Florida Statutes, is redesignated as subsection

703

(7) of that section and amended; section 499.00535, Florida

704

Statutes, is redesignated as subsection (9) of that section and

705

amended; section 499.00545, Florida Statutes, is redesignated as

706

subsection (10) of that section and amended; section 499.069,

707

Florida Statutes, is redesignated as subsection (11) of that

708

section and amended; and section 499.0691, Florida Statutes, is

709

redesignated as subsections (12) through (15) of that section and

710

amended, to read:

711

499.0051 Criminal acts involving contraband or adulterated

712

drugs.--

713

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

714

(a) A person, other than a manufacturer, engaged in the

715

wholesale distribution of prescription legend drugs who fails to

716

deliver to another person complete and accurate pedigree papers

717

concerning a prescription legend drug or contraband prescription

718

legend drug prior to, or simultaneous with, the transfer of

719

transferring the prescription legend drug or contraband

720

prescription legend drug to another person commits a felony of

721

the third degree, punishable as provided in s. 775.082, s.

722

775.083, or s. 775.084.

723

(b) A person engaged in the wholesale distribution of

724

prescription legend drugs who fails to acquire complete and

725

accurate pedigree papers concerning a prescription legend drug or

726

contraband prescription legend drug prior to, or simultaneous

727

with, the receipt of obtaining the prescription legend drug or

728

contraband prescription legend drug from another person commits a

729

felony of the third degree, punishable as provided in s. 775.082,

730

s. 775.083, or s. 775.084.

731

732

fails to maintain complete and accurate pedigree papers

733

concerning any prescription legend drug or contraband

734

prescription legend drug in his or her possession commits a

735

felony of the third degree, punishable as provided in s. 775.082,

736

s. 775.083, or s. 775.084.

737

(2) FAILURE TO AUTHENTICATE PEDIGREE PAPERS.--Effective

738

July 1, 2006:

739

(a) A person engaged in the wholesale distribution of

740

prescription legend drugs who is in possession of pedigree papers

741

concerning prescription legend drugs or contraband prescription

742

legend drugs and who fails to authenticate the matters contained

743

in the pedigree papers and who nevertheless attempts to further

744

distribute prescription legend drugs or contraband prescription

745

legend drugs commits a felony of the third degree, punishable as

746

provided in s. 775.082, s. 775.083, or s. 775.084.

747

(b) A person in possession of pedigree papers concerning

748

prescription legend drugs or contraband prescription legend drugs

749

who falsely swears or certifies that he or she has authenticated

750

the matters contained in the pedigree papers commits a felony of

751

the third degree, punishable as provided in s. 775.082, s.

752

775.083, or s. 775.084.

753

(3) KNOWING FORGERY OF PEDIGREE PAPERS.--A person who

754

knowingly forges, counterfeits, or falsely creates any pedigree

755

paper; who falsely represents any factual matter contained on any

756

pedigree paper; or who knowingly omits to record material

757

information required to be recorded in a pedigree paper, commits

758

a felony of the second degree, punishable as provided in s.

759

775.082, s. 775.083, or s. 775.084.

760

(4) KNOWING PURCHASE OR RECEIPT OF PRESCRIPTION LEGEND DRUG

761

FROM UNAUTHORIZED PERSON.--A person who knowingly purchases or

762

receives from a person not authorized to distribute prescription

763

legend drugs under this chapter a prescription legend drug in a

764

wholesale distribution transaction commits a felony of the second

765

degree, punishable as provided in s. 775.082, s. 775.083, or s.

766

775.084.

767

(5) KNOWING SALE OR TRANSFER OF PRESCRIPTION LEGEND DRUG TO

768

UNAUTHORIZED PERSON.--A person who knowingly sells or transfers

769

to a person not authorized to purchase or possess prescription

770

legend drugs, under the law of the jurisdiction in which the

771

person receives the drug, a prescription legend drug in a

772

wholesale distribution transaction commits a felony of the second

773

degree, punishable as provided in s. 775.082, s. 775.083, or s.

774

775.084.

775

(6) KNOWING SALE OR DELIVERY, OR POSSESSION WITH INTENT TO

776

SELL, CONTRABAND PRESCRIPTION LEGEND DRUGS.--A person who is

777

knowingly in actual or constructive possession of any amount of

778

contraband prescription legend drugs, who knowingly sells or

779

delivers, or who possesses with intent to sell or deliver any

780

amount of contraband prescription legend drugs, commits a felony

781

of the second degree, punishable as provided in s. 775.082, s.

782

775.083, or s. 775.084.

783

(7)499.0052 KNOWING TRAFFICKING IN CONTRABAND PRESCRIPTION

784

LEGEND DRUGS.--A person who knowingly sells, purchases,

785

manufactures, delivers, or brings into this state, or who is

786

knowingly in actual or constructive possession of any amount of

787

contraband prescription legend drugs valued at $25,000 or more

788

commits a felony of the first degree, punishable as provided in

789

s. 775.082, s. 775.083, or s. 775.084.

790

(a) Upon conviction, each defendant shall be ordered to pay

791

a mandatory fine according to the following schedule:

792

1.(1) If the value of contraband prescription legend drugs

793

involved is $25,000 or more, but less than $100,000, the

794

defendant shall pay a mandatory fine of $25,000. If the defendant

795

is a corporation or other person that is not a natural person, it

796

shall pay a mandatory fine of $75,000.

797

2.(2) If the value of contraband prescription legend drugs

798

involved is $100,000 or more, but less than $250,000, the

799

defendant shall pay a mandatory fine of $100,000. If the

800

defendant is a corporation or other person that is not a natural

801

person, it shall pay a mandatory fine of $300,000.

802

3.(3) If the value of contraband prescription legend drugs

803

involved is $250,000 or more, the defendant shall pay a mandatory

804

fine of $200,000. If the defendant is a corporation or other

805

person that is not a natural person, it shall pay a mandatory

806

fine of $600,000.

807

(b) As used in this subsection section, the term "value"

808

means the market value of the property at the time and place of

809

the offense or, if such cannot be satisfactorily ascertained, the

810

cost of replacement of the property within a reasonable time

811

after the offense. Amounts of value of separate contraband

812

prescription legend drugs involved in distinct transactions for

813

the distribution of the contraband prescription legend drugs

814

committed pursuant to one scheme or course of conduct, whether

815

involving the same person or several persons, may be aggregated

816

in determining the punishment of the offense.

817

(8)(7) KNOWING FORGERY OF PRESCRIPTION OR PRESCRIPTION

818

LEGEND DRUG LABELS.--A person who knowingly forges, counterfeits,

819

or falsely creates any prescription label or prescription legend

820

drug label, or who falsely represents any factual matter

821

contained on any prescription label or prescription legend drug

822

label, commits a felony of the first degree, punishable as

823

provided in s. 775.082, s. 775.083, or s. 775.084.

824

(9)499.00535 KNOWING Sale or purchase of contraband

825

prescription legend drugs resulting in great bodily harm.--A

826

person who knowingly sells, purchases, manufactures, delivers, or

827

brings into this state, or who is knowingly in actual or

828

constructive possession of any amount of contraband prescription

829

legend drugs, and whose acts in violation of this subsection

830

section result in great bodily harm to a person, commits a felony

831

of the first degree, as provided in s. 775.082, s. 775.083, or s.

832

775.084.

833

(10)499.00545 Knowing Sale or purchase of contraband

834

prescription legend drugs resulting in death.--A person who

835

knowingly manufactures, sells, purchases, delivers, or brings

836

into this state, or who is knowingly in actual or constructive

837

possession of any amount of contraband prescription legend drugs,

838

and whose acts in violation of this subsection section result in

839

the death of a person, commits a felony of the first degree,

840

punishable by a term of years not exceeding life, as provided in

841

s. 775.082, s. 775.083, or s. 775.084.

842

(11)499.069 Criminal punishment for VIOLATIONS OF S.

843

499.005 RELATED TO DEVICES AND COSMETICS; DISSEMINATION OF FALSE

844

ADVERTISEMENT.--

845

(a)(1) Any person who violates any of the provisions of s.

846

499.005 with respect to a device or cosmetic commits a

847

misdemeanor of the second degree, punishable as provided in s.

848

775.082 or s. 775.083; but, if the violation is committed after a

849

conviction of such person under this subsection section has

850

become final, such person is guilty of a misdemeanor of the first

851

degree, punishable as provided in s. 775.082 or s. 775.083 or as

852

otherwise provided in this part ss. 499.001-499.081, except that

853

any person who violates s. 499.005(8) or (10) subsection (8) or

854

subsection (10) of s. 499.005 with respect to a device or

855

cosmetic commits a felony of the third degree, punishable as

856

provided in s. 775.082, s. 775.083, or s. 775.084, or as

857

otherwise provided in this part ss. 499.001-499.081.

858

(b)(2) A publisher, radio broadcast licensee, or agency or

859

medium for the dissemination of an advertisement, except the

860

manufacturer, wholesaler, or seller of the article to which a

861

false advertisement relates, is not liable under this subsection

862

section by reason of the dissemination by him or her of such

863

false advertisement, unless he or she has refused, on the request

864

of the department, to furnish to the department the name and post

865

office address of the manufacturer, wholesaler, seller, or

866

advertising agency that asked him or her to disseminate such

867

advertisement.

868

(12)499.0691 ADULTERATED AND MISBRANDED DRUGS; FALSE

869

ADVERTISEMENT; FAILURE TO MAINTAIN RECORDS RELATING TO DRUGS

870

Criminal punishment for violations related to drugs;

871

dissemination of false advertisement.--(1) Any person who

872

violates any of the following provisions commits a misdemeanor of

873

the second degree, punishable as provided in s. 775.082 or s.

874

775.083; but, if the violation is committed after a conviction of

875

such person under this subsection section has become final, such

876

person commits a misdemeanor of the first degree, punishable as

877

provided in s. 775.082 or s. 775.083, or as otherwise provided in

878

this part ss. 499.001-499.081:

879

(a) The manufacture, repackaging, sale, delivery, or

880

holding or offering for sale of any drug that is adulterated or

881

misbranded or has otherwise been rendered unfit for human or

882

animal use.

883

(b) The adulteration or misbranding of any drug intended

884

for further distribution.

885

886

misbranded, and the delivery or proffered delivery of such drug,

887

for pay or otherwise.

888

(d) The dissemination of any false or misleading

889

advertisement of a drug.

890

(e) The use, on the labeling of any drug or in any

891

advertisement relating to such drug, of any representation or

892

suggestion that an application of the drug is effective when it

893

is not or that the drug complies with this part ss. 499.001-

894

499.081 when it does not.

895

(f) The purchase or receipt of a compressed medical gas

896

from a person that is not authorized under this chapter to

897

distribute compressed medical gases.

898

(g) Charging a dispensing fee for dispensing,

899

administering, or distributing a prescription drug sample.

900

(h) The failure to maintain records related to a drug as

901

required by this part ss. 499.001-499.081 and rules adopted under

902

this part those sections, except for pedigree papers, invoices,

903

or shipping documents related to prescription legend drugs.

904

(i) The possession of any drug in violation of this part

905

ss. 499.001-499.081, except if the violation relates to a

906

deficiency in pedigree papers.

907

(13) REFUSAL TO ALLOW INSPECTION; SELLING, PURCHASING, OR

908

TRADING DRUG SAMPLES; FAILURE TO MAINTAIN RECORDS RELATING TO

909

PRESCRIPTION DRUGS.--(2) Any person who violates any of the

910

following provisions commits a felony of the third degree,

911

punishable as provided in s. 775.082, s. 775.083, or s. 775.084,

912

or as otherwise provided in this part: ss. 499.001-499.081.

913

(a) The refusal or constructive refusal to allow:

914

1. The department to enter or inspect an establishment in

915

which drugs are manufactured, processed, repackaged, sold,

916

brokered, or held;

917

2. Inspection of any record of that establishment;

918

3. The department to enter and inspect any vehicle that is

919

being used to transport drugs; or

920

4. The department to take samples of any drug.

921

(b) The sale, purchase, or trade, or the offer to sell,

922

purchase, or trade, a drug sample as defined in s. 499.028; the

923

distribution of a drug sample in violation of s. 499.028; or the

924

failure to otherwise comply with s. 499.028.

925

926

records, or making false or fraudulent statements, regarding any

927

matter within the provisions of this part chapter related to a

928

drug.

929

(d) The failure to receive, maintain, or provide invoices

930

and shipping documents, other than pedigree papers, if

931

applicable, related to the distribution of a prescription legend

932

drug.

933

(e) The importation of a prescription legend drug for

934

wholesale distribution, except as provided by s. 801(d) of the

935

Federal Food, Drug, and Cosmetic Act.

936

(f) The wholesale distribution of a any prescription drug

937

that was:

938

1. Purchased by a public or private hospital or other

939

health care entity; or

940

2. Donated or supplied at a reduced price to a charitable

941

organization.

942

(g) The failure to obtain a permit as a prescription drug

943

wholesale distributor wholesaler when a permit is required by

944

this part ss. 499.001-499.081 for that activity.

945

(h) Knowingly possessing any adulterated or misbranded

946

prescription legend drug outside of a designated quarantine area.

947

(i) The purchase or sale of a prescription drug drugs for

948

wholesale distribution in exchange for currency, as defined in s.

949

560.103(6).

950

(14) OTHER VIOLATIONS.--(3) Any person who violates any of

951

the following provisions commits a felony of the second degree,

952

punishable as provided in s. 775.082, s. 775.083, or s. 775.084,

953

or as otherwise provided in this part: ss. 499.001-499.081.

954

(a) Knowingly manufacturing, repackaging, selling,

955

delivering, or holding or offering for sale any drug that is

956

adulterated or misbranded or has otherwise been rendered unfit

957

for human or animal use.

958

(b) Knowingly adulterating a drug that is intended for

959

further distribution.

960

961

delivering or proffering delivery of such drug for pay or

962

otherwise.

963

(d) Committing any act that causes a drug to be a

964

counterfeit drug, or selling, dispensing, or knowingly holding

965

for sale a counterfeit drug.

966

(e) Forging, counterfeiting, simulating, or falsely

967

representing any drug, or, without the authority of the

968

manufacturer, using any mark, stamp, tag, label, or other

969

identification device authorized or required by rules adopted

970

under this part ss. 499.001-499.081.

971

(f) Knowingly obtaining or attempting to obtain a

972

prescription drug for wholesale distribution by fraud, deceit,

973

misrepresentation, or subterfuge, or engaging in

974

misrepresentation or fraud in the distribution of a drug.

975

(g) Removing a pharmacy's dispensing label from a dispensed

976

prescription drug with the intent to further distribute the

977

prescription drug.

978

(h) Knowingly distributing a prescription drug that was

979

previously dispensed by a licensed pharmacy, unless such

980

distribution was authorized in chapter 465 or the rules adopted

981

under chapter 465.

982

(15) FALSE ADVERTISEMENT.--(4) A publisher, radio

983

broadcast licensee, or agency or medium for the dissemination of

984

an advertisement, except the manufacturer, repackager, wholesale

985

distributor wholesaler, or seller of the article to which a false

986

advertisement relates, is not liable under subsection (12),

987

subsection (13), or subsection (14) this section by reason of the

988

dissemination by him or her of such false advertisement, unless

989

he or she has refused, on the request of the department, to

990

furnish to the department the name and post office address of the

991

manufacturer, repackager, wholesale distributor wholesaler,

992

seller, or advertising agency that asked him or her to

993

disseminate such advertisement.

994

Section 5. Section 499.0054, Florida Statutes, is amended;

995

section 499.0055, Florida Statutes, is redesignated as subsection

996

(2) of that section and amended; and section 499.0057, Florida

997

Statutes, is redesignated as subsection (3) of that section and

998

amended, to read:

999

499.0054 Advertising and labeling of drugs, devices, and

1000

cosmetics; exemptions.--

1001

(1) It is a violation of the Florida Drug and Cosmetic Act

1002

to perform or cause the performance of any of the following acts:

1003

(a)(1) The dissemination of any false advertisement of any

1004

drug, device, or cosmetic. An advertisement is false if it is

1005

false or misleading in any way.

1006

(b)(2) The distribution in commerce of any drug, device, or

1007

cosmetic, if its labeling or advertising is in violation of this

1008

part ss. 499.001-499.081.

1009

(c)(3) The manufacturing, repackaging, packaging, selling,

1010

delivery, holding, or offering for sale of any drug, device, or

1011

cosmetic for which the advertising or labeling is false or

1012

misleading.

1013

(d)(4) The advertising of any drug, device, or cosmetic

1014

that is adulterated or misbranded.

1015

(e)(5) The receiving in commerce of any drug, device, or

1016

cosmetic that is falsely advertised or labeled or the delivering

1017

or proffering for delivery of any such drug, device, or cosmetic.

1018

(f)(6) The advertising or labeling of any product

1019

containing ephedrine, a salt of ephedrine, an isomer of

1020

ephedrine, or a salt of an isomer of ephedrine, for the

1021

indication of stimulation, mental alertness, weight loss,

1022

appetite control, energy, or other indications not approved by

1023

the pertinent United States Food and Drug Administration Over-

1024

the-Counter Final or Tentative Final Monograph or approved new

1025

drug application under the federal act. In determining compliance

1026

with this requirement, the department may consider the following

1027

factors:

1028

1.(a) The packaging of the product.

1029

2.(b) The name and labeling of the product.

1030

3.(c) The manner of distribution, advertising, and

1031

promotion of the product, including verbal representations at the

1032

point of sale.

1033

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

1034

particular product.

1035

(g)(7) The advertising of any drug or device represented to

1036

have any effect in any of the following conditions, disorders,

1037

diseases, or processes:

1038

1.(a) Blood disorders.

1039

2.(b) Bone or joint diseases.

1040

3.(c) Kidney diseases or disorders.

1041

4.(d) Cancer.

1042

5.(e) Diabetes.

1043

6.(f) Gall bladder diseases or disorders.

1044

7.(g) Heart and vascular diseases.

1045

8.(h) High blood pressure.

1046

9.(i) Diseases or disorders of the ear or auditory

1047

apparatus, including hearing loss or deafness.

1048

10.(j) Mental disease or mental retardation.

1049

11.(k) Paralysis.

1050

12.(l) Prostate gland disorders.

1051

13.(m) Conditions of the scalp affecting hair loss.

1052

14.(n) Baldness.

1053

15.(o) Endocrine disorders.

1054

16.(p) Sexual impotence.

1055

17.(q) Tumors.

1056

18.(r) Venereal diseases.

1057

19.(s) Varicose ulcers.

1058

20.(t) Breast enlargement.

1059

21.(u) Purifying blood.

1060

22.(v) Metabolic disorders.

1061

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

1062

immune system.

1063

24.(x) Extension of life expectancy.

1064

25.(y) Stress and tension.

1065

26.(z) Brain stimulation or performance.

1066

27.(aa) The body's natural defense mechanisms.

1067

28.(bb) Blood flow.

1068

29.(cc) Depression.

1069

30.(dd) Human immunodeficiency virus or acquired immune

1070

deficiency syndrome or related disorders or conditions.

1071

(h)(8) The representation or suggestion in labeling or

1072

advertising that an article is approved under this part ss.

1073

499.001-499.081, when such is not the case.

1074

(2)499.0055 False or misleading advertisement.--In

1075

determining whether an advertisement is false or misleading, the

1076

department shall review the representations made or suggested by

1077

statement, word, design, device, sound, or any combination

1078

thereof within the advertisement and the extent to which the

1079

advertisement fails to reveal material facts with respect to

1080

consequences that can result from the use of the drug, device, or

1081

cosmetic to which the advertisement relates under the conditions

1082

of use prescribed in the labeling or advertisement.

1083

(3)499.0057 Advertisement exemptions.--

1084

(a)(1) An advertisement that is not prohibited under

1085

paragraph (1)(a) s. 499.0054(1) is not prohibited under paragraph

1086

(1)(g) s. 499.0054(7) if it is disseminated:

1087

1. To the public solely to advertise the product for those

1088

indications that are safe and effective indications and the

1089

product is safe and effective for self-medication, as established

1090

by the United States Food and Drug Administration; or

1091

2. if it is disseminated Only to members of the medical,

1092

dental, pharmaceutical, or veterinary professions or appears only

1093

in the scientific periodicals of these professions.

1094

(b)(2) Compliance with this part ss. 499.001-499.081 and

1095

the rules adopted under this part those sections creates no legal

1096

presumption that a drug or device is safe or effective.

1097

Section 6. Subsections (3), (10), and (11) of section

1098

499.006, Florida Statutes, are amended to read:

1099

499.006 Adulterated drug or device.--A drug or device is

1100

adulterated:

1101

(3) If it is a drug and the methods used in, or the

1102

facilities or controls used for, its manufacture, processing,

1103

packing, or holding do not conform to, or are not operated or

1104

administered in conformity with, current good manufacturing

1105

practices to assure that the drug meets the requirements of this

1106

part ss. 499.001-499.081 and that the drug has the identity and

1107

strength, and meets the standard of quality and purity, which it

1108

purports or is represented to possess;

1109

(10) If it is a prescription legend drug for which the

1110

required pedigree paper is nonexistent, fraudulent, or incomplete

1111

under the requirements of this part ss. 499.001-499.081 or

1112

applicable rules, or that has been purchased, held, sold, or

1113

distributed at any time by a person not authorized under federal

1114

or state law to do so; or

1115

(11) If it is a prescription drug subject to, defined by,

1116

or described by s. 503(b) of the Federal Food, Drug, and Cosmetic

1117

Act which has been returned by a veterinarian to a limited

1118

prescription drug veterinary wholesale distributor wholesaler.

1119

Section 7. Section 499.007, Florida Statutes, is amended to

1120

read:

1121

499.007 Misbranded drug or device.--A drug or device is

1122

misbranded:

1123

(1) If its labeling is in any way false or misleading.

1124

(2) Unless, If in package form, it does not bear bears a

1125

label containing:

1126

(a) The name and place of business of the manufacturer,

1127

repackager, or distributor of the finished dosage form of the

1128

drug. For the purpose of this paragraph, the finished dosage form

1129

of a prescription medicinal drug is that form of the drug which

1130

is, or is intended to be, dispensed or administered to the

1131

patient and requires no further manufacturing or processing other

1132

than packaging, reconstitution, and labeling; and

1133

(b) An accurate statement of the quantity of the contents

1134

in terms of weight, measure, or numerical count.; However, under

1135

this section, reasonable variations are permitted, and the

1136

department shall establish by rule exemptions for small packages.

1137

(3) If it is an active pharmaceutical ingredient in bulk

1138

form and does not bear a label containing:

1139

(a) The name and place of business of the manufacturer,

1140

repackager, or distributor; and

1141

(b) An accurate statement of the quantity of the contents

1142

in terms of weight, measure, or numerical count.

1143

(4)(3) If any word, statement, or other information

1144

required by or under this part ss. 499.001-499.081 to appear on

1145

the label or labeling is not prominently placed thereon with such

1146

conspicuousness as compared with other words, statements,

1147

designs, or devices in the labeling, and in such terms, as to

1148

render the word, statement, or other information likely to be

1149

read and understood under customary conditions of purchase and

1150

use.

1151

(5)(4) If it is a drug and is not designated solely by a

1152

name recognized in an official compendium and, unless its label

1153

does not bear bears:

1154

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

1155

(b) In case it is fabricated from two or more ingredients,

1156

the common or usual name and quantity of each active ingredient.

1157

(6)(5) If Unless its labeling does not bear bears:

1158

(a) Adequate directions for use; and

1159

(b) Adequate warnings against use in those pathological

1160

conditions in which its use may be dangerous to health or against

1161

use by children if its use may be dangerous to health, or against

1162

unsafe dosage or methods or duration of administration or

1163

application, in such manner and form as are necessary for the

1164

protection of users.

1165

(7)(6) If it purports to be a drug the name of which is

1166

recognized in the official compendium and, unless it is not

1167

packaged and labeled as prescribed therein.; However, the method

1168

of packaging may be modified with the consent of the department.

1169

(8)(7) If it has been found by the department to be a drug

1170

liable to deterioration and, unless it is not packaged in such

1171

form and manner, and its label bears a statement of such

1172

precautions, as the department by rule requires as necessary to

1173

protect the public health. Such rule may not be established for

1174

any drug recognized in an official compendium until the

1175

department has informed the appropriate body charged with the

1176

revision of such compendium of the need for such packaging or

1177

labeling requirements and that body has failed within a

1178

reasonable time to prescribe such requirements.

1179

(9)(8) If it is:

1180

(a) A drug and its container or finished dosage form is so

1181

made, formed, or filled as to be misleading;

1182

(b) An imitation of another drug; or

1183

1184

(10)(9) If it is dangerous to health when used in the

1185

dosage or with the frequency or duration prescribed, recommended,

1186

or suggested in the labeling of the drug.

1187

(11)(10) If it is, purports to be, or is represented as a

1188

drug composed wholly or partly of insulin and, unless:

1189

(a) it is not from a batch with respect to which a

1190

certificate has been issued pursuant to s. 506 of the federal

1191

act, which; and

1192

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

1193

(12)(11) If it is, purports to be, or is represented as a

1194

drug composed wholly or partly of any kind of antibiotic

1195

requiring certification under the federal act and unless:

1196

(a) it is not from a batch with respect to which a

1197

certificate has been issued pursuant to s. 507 of the federal

1198

act, which; and

1199

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

1200

1201

However, this subsection does not apply to any drug or class of

1202

drugs exempted by regulations adopted under s. 507(c) or (d) of

1203

the federal act.

1204

(13)(12) If it is a drug intended for use by humans which

1205

is a habit-forming drug or which, because of its toxicity or

1206

other potentiality for harmful effect, or the method of its use,

1207

or the collateral measures necessary to its use, is not safe for

1208

use except under the supervision of a practitioner licensed by

1209

law to administer such drugs,; or which is limited by an

1210

effective application under s. 505 of the federal act to use

1211

under the professional supervision of a practitioner licensed by

1212

law to prescribe such drug, if unless it is not dispensed only:

1213

(a) Upon the written prescription of a practitioner

1214

licensed by law to prescribe such drug;

1215

(b) Upon an oral prescription of such practitioner, which

1216

is reduced promptly to writing and filled by the pharmacist; or

1217

1218

such refilling is authorized by the prescriber either in the

1219

original prescription or by oral order which is reduced promptly

1220

to writing and filled by the pharmacist.

1221

1222

This subsection does not relieve any person from any requirement

1223

prescribed by law with respect to controlled substances as

1224

defined in the applicable federal and state laws.

1225

(14)(13) If it is a drug that is subject to paragraph

1226

(13)(12)(a), and if, at any time before it is dispensed, its

1227

label does not fails to bear the statement:

1228

(a) "Caution: Federal Law Prohibits Dispensing Without

1229

Prescription";

1230

(b) "Rx Only";

1231

1232

(d) "Caution: State Law Prohibits Dispensing Without

1233

Prescription."

1234

(15)(14) If it is a drug that is not subject to paragraph

1235

(13)(12)(a), if at any time before it is dispensed its label

1236

bears the statement of caution required in subsection (14) (13).

1237

(16)(15) If it is a color additive, the intended use of

1238

which in or on drugs is for the purpose of coloring only and,

1239

unless its packaging and labeling are not in conformity with the

1240

packaging and labeling requirements that apply to such color

1241

additive and are prescribed under the federal act.

1242

(17) A drug dispensed by filling or refilling a written or

1243

oral prescription of a practitioner licensed by law to prescribe

1244

such drug is exempt from the requirements of this section, except

1245

subsections (1), (9) (8), (11) (10), and (12) (11) and the

1246

packaging requirements of subsections (7) (6) and (8) (7), if the

1247

drug bears a label that contains the name and address of the

1248

dispenser or seller, the prescription number and the date the

1249

prescription was written or filled, the name of the prescriber

1250

and the name of the patient, and the directions for use and

1251

cautionary statements. This exemption does not apply to any drug

1252

dispensed in the course of the conduct of a business of

1253

dispensing drugs pursuant to diagnosis by mail or to any drug

1254

dispensed in violation of subsection (13) (12). The department

1255

may, by rule, exempt drugs subject to s. 499.062 ss. 499.062-

1256

499.064 from subsection (13) (12) if compliance with that

1257

subsection is not necessary to protect the public health, safety,

1258

and welfare.

1259

Section 8. Subsection (1) of section 499.008, Florida

1260

Statutes, is amended and subsection (5) is added to that section

1261

to read:

1262

499.008 Adulterated cosmetics.--A cosmetic is adulterated:

1263

(1) If it bears or contains any poisonous or deleterious

1264

substance that is injurious to users under the conditions of use

1265

prescribed in the labeling or advertisement thereof or under such

1266

conditions of use as are customary or usual; however, this

1267

subsection does not apply to coal-tar hair dye:

1268

(a) The label of which bears the following legend

1269

conspicuously displayed thereon: "Caution: This product contains

1270

ingredients which may cause skin irritation on certain

1271

individuals, and a preliminary test according to accompanying

1272

directions should first be made. This product must not be used

1273

for dyeing the eyelashes or eyebrows; to do so may cause

1274

blindness"; and

1275

(b) The labeling of which bears adequate directions for

1276

such preliminary testing.

1277

1278

For the purposes of this subsection and subsection (4), the term

1279

"hair dye" does not include eyelash dyes or eyebrow dyes.

1280

(5) For the purposes of subsections (1) and (4), the term

1281

"hair dye" does not include eyelash dyes or eyebrow dyes.

1282

Section 9. Subsections (2), (3), and (5) of section

1283

499.009, Florida Statutes, are amended to read:

1284

499.009 Misbranded cosmetics.--A cosmetic is misbranded:

1285

(2) Unless, If in package form, it does not bear bears a

1286

label containing:

1287

(a) The name and place of business of the manufacturer,

1288

packer, or distributor;

1289

(b) An accurate statement of the quantity of the contents

1290

in terms of weight, measure, or numerical count; however, under

1291

this paragraph reasonable variations are permitted, and the

1292

department shall establish by rule exemptions for small packages;

1293

and

1294

1295

predominance, or as otherwise required by federal law.

1296

(3) If any word, statement, or other information required

1297

by or under authority of this part ss. 499.001-499.081 to appear

1298

on the label or labeling is not prominently placed thereon with

1299

such conspicuousness as compared with other words, statements,

1300

designs, or devices in the labeling, and in such terms, as to

1301

render the word, statement, or other information likely to be

1302

read and understood by an individual under customary conditions

1303

of purchase and use.

1304

(5) Unless, If it is a color additive, its packaging and

1305

labeling are not in conformity with the packaging and labeling

1306

requirements applicable to that color additive prescribed under

1307

the federal act. This subsection does not apply to packages of

1308

color additives that, with respect to their use for cosmetics,

1309

are marketed and intended for use only in or on hair dyes.

1310

Section 10. Section 499.01, Florida Statutes, is amended;

1311

the introductory paragraph and paragraphs (a) through (h) of

1312

subsection (2) of section 499.012, Florida Statutes, are

1313

redesignated as the introductory paragraph and paragraphs (d),

1314

(n), (e), (f), (c), (i), (k), and (l), respectively, of

1315

subsection (2) of that section and amended; paragraphs (b)

1316

through (e) of subsection (2) of section 499.013, Florida

1317

Statutes, are redesignated as paragraphs (p), (o), (q), and (r),

1318

respectively, of subsection (2) of that section and amended; and

1319

section 499.014, Florida Statutes, is redesignated as paragraph

1320

(g) of subsection (2) of that section and amended, to read:

1321

499.01 Permits; applications; renewal; general

1322

requirements.--

1323

(1) Prior to operating, a permit is required for each

1324

person and establishment that intends to operate as:

1325

(a) A prescription drug manufacturer;

1326

(b) A prescription drug repackager;

1327

1328

(d) A prescription drug wholesale distributor;

1329

(e) An out-of-state prescription drug wholesale

1330

distributor;

1331

(f) A retail pharmacy drug wholesale distributor;

1332

(g) A restricted prescription drug distributor;

1333

(h) A complimentary drug distributor;

1334

(i) A freight forwarder;

1335

(j) A veterinary prescription drug retail establishment;

1336

(k) A veterinary prescription drug wholesale distributor;

1337

(l) A limited prescription drug veterinary wholesale

1338

distributor;

1339

(m) A medical oxygen retail establishment;

1340

(n) A compressed medical gas wholesale distributor;

1341

(o) A compressed medical gas manufacturer;

1342

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

1343

(d) A compressed medical gas manufacturer;

1344

(q)(e) A device manufacturer; or

1345

(r)(f) A cosmetic manufacturer.;

1346

(g) A prescription drug wholesaler;

1347

(h) A veterinary prescription drug wholesaler;

1348

(i) A compressed medical gas wholesaler;

1349

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

1350

(k) A nonresident prescription drug manufacturer;

1351

(l) A freight forwarder;

1352

(m) A retail pharmacy drug wholesaler;

1353

(n) A veterinary legend drug retail establishment;

1354

(o) A medical oxygen retail establishment;

1355

(p) A complimentary drug distributor;

1356

(q) A restricted prescription drug distributor; or

1357

(r) A limited prescription drug veterinary wholesaler.

1358

(2) The following types of wholesaler permits are

1359

established:

1360

(a) Prescription drug manufacturer permit.--A prescription

1361

drug manufacturer permit is required for any person that

1362

manufactures a prescription drug in this state.

1363

1. A person that operates an establishment permitted as a

1364

prescription drug manufacturer may engage in wholesale

1365

distribution of prescription drugs manufactured at that

1366

establishment and must comply with all the provisions of this

1367

part and the rules adopted under this part that apply to a

1368

wholesale distributor.

1369

2. A prescription drug manufacturer must comply with all

1370

appropriate state and federal good manufacturing practices.

1371

(b) Prescription drug repackager permit.--A prescription

1372

drug repackager permit is required for any person that repackages

1373

a prescription drug in this state.

1374

1. A person that operates an establishment permitted as a

1375

prescription drug repackager may engage in wholesale distribution

1376

of prescription drugs repackaged at that establishment and must

1377

comply with all the provisions of this part and the rules adopted

1378

under this part that apply to a wholesale distributor.

1379

2. A prescription drug repackager must comply with all

1380

appropriate state and federal good manufacturing practices.

1381

(c)(e) Nonresident prescription drug manufacturer

1382

permit.--A nonresident prescription drug manufacturer permit is

1383

required for any person that is a manufacturer of prescription

1384

drugs, or the distribution point for a manufacturer of

1385

prescription drugs, and located outside of this state, or that is

1386

an entity to whom an approved new drug application has been

1387

issued by the United States Food and Drug Administration, or the

1388

contracted manufacturer of the approved new drug application

1389

holder, and located outside the United States, which engages in

1390

the wholesale distribution in this state of the prescription

1391

drugs it manufactures or is responsible for manufacturing. Each

1392

such manufacturer or entity must be permitted by the department

1393

and comply with all the provisions required of a wholesale

1394

distributor under this part ss. 499.001-499.081, except s.

1395

499.01212 s. 499.0121(6)(d).

1396

1. A person that distributes prescription drugs that it did

1397

not manufacture must also obtain an out-of-state prescription

1398

drug wholesale distributor wholesaler permit pursuant to this

1399

section to engage in the wholesale distribution of the

1400

prescription drugs manufactured by another person and comply with

1401

the requirements of an out-of-state prescription drug wholesale

1402

distributor wholesaler.

1403

2. Any such person must comply with the licensing or

1404

permitting requirements of the jurisdiction in which the

1405

establishment is located and the federal act, and any product

1406

wholesaled into this state must comply with this part ss.

1407

499.001-499.081. If a person intends to import prescription drugs

1408

from a foreign country into this state, the nonresident

1409

prescription drug manufacturer must provide to the department a

1410

list identifying each prescription drug it intends to import and

1411

document approval by the United States Food and Drug

1412

Administration for such importation.

1413

(d)(a) A Prescription drug wholesale distributor

1414

wholesaler's permit.--A prescription drug wholesale distributor

1415

wholesaler is a wholesale distributor that may engage in the

1416

wholesale distribution of prescription drugs. A prescription drug

1417

wholesale distributor wholesaler that applies to the department

1418

for a new permit or the renewal of a permit must submit a bond of

1419

$100,000, or other equivalent means of security acceptable to the

1420

department, such as an irrevocable letter of credit or a deposit

1421

in a trust account or financial institution, payable to the

1422

Florida Drug, Device, and Cosmetic Trust Fund. The purpose of the

1423

bond is to secure payment of any administrative penalties imposed

1424

by the department and any fees and costs incurred by the

1425

department regarding that permit which are authorized under state

1426

law and which the permittee fails to pay 30 days after the fine

1427

or costs become final. The department may make a claim against

1428

such bond or security until 1 year after the permittee's license

1429

ceases to be valid or until 60 days after any administrative or

1430

legal proceeding authorized in this part ss. 499.001-499.081

1431

which involves the permittee is concluded, including any appeal,

1432

whichever occurs later. The department may adopt rules for

1433

issuing a prescription drug wholesale distributor-broker

1434

wholesaler-broker permit to a person who engages in the wholesale

1435

distribution of prescription drugs and does not take physical

1436

possession of any prescription drugs.

1437

(e)(c) An Out-of-state prescription drug wholesale

1438

distributor wholesaler's permit.--An out-of-state prescription

1439

drug wholesale distributor wholesaler is a wholesale distributor

1440

located outside this state which engages in the wholesale

1441

distribution of prescription drugs into this state and which must

1442

be permitted by the department and comply with all the provisions

1443

required of a wholesale distributor under this part ss. 499.001-

1444

499.081. An out-of-state prescription drug wholesale distributor

1445

wholesaler that applies to the department for a new permit or the

1446

renewal of a permit must submit a bond of $100,000, or other

1447

equivalent means of security acceptable to the department, such

1448

as an irrevocable letter of credit or a deposit in a trust

1449

account or financial institution, payable to the Florida Drug,

1450

Device, and Cosmetic Trust Fund. The purpose of the bond is to

1451

secure payment of any administrative penalties imposed by the

1452

department and any fees and costs incurred by the department

1453

regarding that permit which are authorized under state law and

1454

which the permittee fails to pay 30 days after the fine or costs

1455

become final. The department may make a claim against such bond

1456

or security until 1 year after the permittee's license ceases to

1457

be valid or until 60 days after any administrative or legal

1458

proceeding authorized in this part ss. 499.001-499.081 which

1459

involves the permittee is concluded, including any appeal,

1460

whichever occurs later.

1461

1. The out-of-state prescription drug wholesale distributor

1462

wholesaler must maintain at all times a license or permit to

1463

engage in the wholesale distribution of prescription drugs in

1464

compliance with laws of the state in which it is a resident.

1465

2. An out-of-state prescription drug wholesale distributor

1466

wholesaler's permit is not required for an intracompany sale or

1467

transfer of a prescription drug from an out-of-state

1468

establishment that is duly licensed as a prescription drug

1469

wholesale distributor wholesaler, in its state of residence, to a

1470

licensed prescription drug wholesale distributor wholesaler in

1471

this state, if both wholesale distributors wholesalers conduct

1472

wholesale distributions of prescription drugs under the same

1473

business name. The recordkeeping requirements of ss. s.

1474

499.0121(6) and 499.01212 must be followed for this transaction.

1475

(f)(d) A Retail pharmacy drug wholesale distributor

1476

wholesaler's permit.--A retail pharmacy drug wholesale

1477

distributor wholesaler is a retail pharmacy engaged in wholesale

1478

distribution of prescription drugs within this state under the

1479

following conditions:

1480

1. The pharmacy must obtain a retail pharmacy drug

1481

wholesale distributor wholesaler's permit pursuant to this part

1482

ss. 499.001-499.081 and the rules adopted under this part those

1483

sections.

1484

2. The wholesale distribution activity does not exceed 30

1485

percent of the total annual purchases of prescription drugs. If

1486

the wholesale distribution activity exceeds the 30-percent

1487

maximum, the pharmacy must obtain a prescription drug wholesale

1488

distributor wholesaler's permit.

1489

3. The transfer of prescription drugs that appear in any

1490

schedule contained in chapter 893 is subject to chapter 893 and

1491

the federal Comprehensive Drug Abuse Prevention and Control Act

1492

of 1970.

1493

4. The transfer is between a retail pharmacy and another

1494

retail pharmacy, or a Modified Class II institutional pharmacy,

1495

or a health care practitioner licensed in this state and

1496

authorized by law to dispense or prescribe prescription drugs.

1497

5. All records of sales of prescription drugs subject to

1498

this section must be maintained separate and distinct from other

1499

records and comply with the recordkeeping requirements of this

1500

part ss. 499.001-499.081.

1501

(g)499.014 Restricted prescription drug distributor permit

1502

Distribution of legend drugs by hospitals, health care entities,

1503

charitable organizations, and return or destruction companies;

1504

permits, general requirements.--

1505

(1) A restricted prescription drug distributor permit is

1506

required for any person that engages in the distribution of a

1507

prescription legend drug, which distribution is not considered

1508

"wholesale distribution" under s. 499.003(56)(a) s.

1509

499.012(1)(a)1.

1510

1.(2) A person who engages in the receipt or distribution

1511

of a prescription legend drug in this state for the purpose of

1512

processing its return or its destruction must obtain a permit as

1513

a restricted prescription drug distributor if such person is not

1514

the person initiating the return, the prescription drug wholesale

1515

supplier of the person initiating the return, or the manufacturer

1516

of the drug.

1517

2.(3) Storage, handling, and recordkeeping of these

1518

distributions must comply with the requirements for wholesale

1519

distributors under s. 499.0121, but not except those set forth in

1520

s. 499.01212 s. 499.0121(6)(d).

1521

3.(4) A person who applies for a permit as a restricted

1522

prescription drug distributor, or for the renewal of such a

1523

permit, must provide to the department the information required

1524

under s. 499.012 s. 499.01.

1525

4.(5) The department may issue permits to restricted

1526

prescription drug distributors and may adopt rules regarding the

1527

distribution of prescription drugs by hospitals, health care

1528

entities, charitable organizations, or other persons not involved

1529

in wholesale distribution, which rules are necessary for the

1530

protection of the public health, safety, and welfare.

1531

(h) Complimentary drug distributor permit.--A complimentary

1532

drug distributor permit is required for any person that engages

1533

in the distribution of a complimentary drug, subject to the

1534

requirements of s. 499.028.

1535

(i)(f) Freight forwarder permit.--A freight forwarder

1536

permit is required for any person that engages in the

1537

distribution of a prescription legend drug as a freight forwarder

1538

unless the person is a common carrier. The storage, handling, and

1539

recordkeeping of such distributions must comply with the

1540

requirements for wholesale distributors under s. 499.0121, but

1541

not except those set forth in s. 499.01212 s. 499.0121(6)(d). A

1542

freight forwarder must provide the source of the prescription

1543

legend drugs with a validated airway bill, bill of lading, or

1544

other appropriate documentation to evidence the exportation of

1545

the product.

1546

(j) Veterinary prescription drug retail establishment

1547

permit.--A veterinary prescription drug retail establishment

1548

permit is required for any person that sells veterinary

1549

prescription drugs to the public but does not include a pharmacy

1550

licensed under chapter 465.

1551

1. The sale to the public must be based on a valid written

1552

order from a veterinarian licensed in this state who has a valid

1553

client-veterinarian relationship with the purchaser's animal.

1554

2. Veterinary prescription drugs may not be sold in excess

1555

of the amount clearly indicated on the order or beyond the date

1556

indicated on the order.

1557

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

1558

4. A veterinary prescription drug retail establishment may

1559

not purchase, sell, trade, or possess human prescription drugs or

1560

any controlled substance as defined in chapter 893.

1561

5. A veterinary prescription drug retail establishment must

1562

sell a veterinary prescription drug in the original, sealed

1563

manufacturer's container with all labeling intact and legible.

1564

The department may adopt by rule additional labeling requirements

1565

for the sale of a veterinary prescription drug.

1566

6. A veterinary prescription drug retail establishment must

1567

comply with all of the wholesale distribution requirements of s.

1568

499.0121.

1569

7. Prescription drugs sold by a veterinary prescription

1570

drug retail establishment pursuant to a practitioner's order may

1571

not be returned into the retail establishment's inventory.

1572

(k)(g) A veterinary prescription drug wholesale distributor

1573

wholesaler permit.--A veterinary prescription drug wholesale

1574

distributor wholesaler permit is required for any person that

1575

engages in the distribution of veterinary prescription drugs in

1576

or into this state. A veterinary prescription drug wholesale

1577

distributor wholesaler that also distributes prescription drugs

1578

subject to, defined by, or described by s. 503(b) of the Federal

1579

Food, Drug, and Cosmetic Act which it did not manufacture must

1580

obtain a permit as a prescription drug wholesale distributor

1581

wholesaler, an out-of-state prescription drug wholesale

1582

distributor wholesaler, or a limited prescription drug veterinary

1583

wholesale distributor wholesaler in lieu of the veterinary

1584

prescription drug wholesale distributor wholesaler permit. A

1585

veterinary prescription drug wholesale distributor wholesaler

1586

must comply with the requirements for wholesale distributors

1587

under s. 499.0121, but not except those set forth in s. 499.01212

1588

s. 499.0121(6)(d).

1589

(l)(h) Limited prescription drug veterinary wholesale

1590

distributor wholesaler permit.--Unless engaging in the activities

1591

of and permitted as a prescription drug manufacturer, nonresident

1592

prescription drug manufacturer, prescription drug wholesale

1593

distributor wholesaler, or out-of-state prescription drug

1594

wholesale distributor wholesaler, a limited prescription drug

1595

veterinary wholesale distributor wholesaler permit is required

1596

for any person that engages in the distribution in or into this

1597

state of veterinary prescription drugs and prescription drugs

1598

subject to, defined by, or described by s. 503(b) of the Federal

1599

Food, Drug, and Cosmetic Act under the following conditions:

1600

1. The person is engaged in the business of wholesaling

1601

prescription and veterinary prescription legend drugs to persons:

1602

a. Licensed as veterinarians practicing on a full-time

1603

basis;

1604

b. Regularly and lawfully engaged in instruction in

1605

veterinary medicine;

1606

c. Regularly and lawfully engaged in law enforcement

1607

activities;

1608

d. For use in research not involving clinical use; or

1609

e. For use in chemical analysis or physical testing or for

1610

purposes of instruction in law enforcement activities, research,

1611

or testing.

1612

2. No more than 30 percent of total annual prescription

1613

drug sales may be prescription drugs approved for human use which

1614

are subject to, defined by, or described by s. 503(b) of the

1615

Federal Food, Drug, and Cosmetic Act.

1616

3. The person does not distribute is not permitted,

1617

licensed, or otherwise authorized in any jurisdiction state to

1618

wholesale prescription drugs subject to, defined by, or described

1619

by s. 503(b) of the Federal Food, Drug, and Cosmetic Act to any

1620

person who is authorized to sell, distribute, purchase, trade, or

1621

use these drugs on or for humans.

1622

4. A limited prescription drug veterinary wholesale

1623

distributor wholesaler that applies to the department for a new

1624

permit or the renewal of a permit must submit a bond of $20,000,

1625

or other equivalent means of security acceptable to the

1626

department, such as an irrevocable letter of credit or a deposit

1627

in a trust account or financial institution, payable to the

1628

Florida Drug, Device, and Cosmetic Trust Fund. The purpose of the

1629

bond is to secure payment of any administrative penalties imposed

1630

by the department and any fees and costs incurred by the

1631

department regarding that permit which are authorized under state

1632

law and which the permittee fails to pay 30 days after the fine

1633

or costs become final. The department may make a claim against

1634

such bond or security until 1 year after the permittee's license

1635

ceases to be valid or until 60 days after any administrative or

1636

legal proceeding authorized in this part ss. 499.001-499.081

1637

which involves the permittee is concluded, including any appeal,

1638

whichever occurs later.

1639

5. A limited prescription drug veterinary wholesale

1640

distributor wholesaler must maintain at all times a license or

1641

permit to engage in the wholesale distribution of prescription

1642

drugs in compliance with laws of the state in which it is a

1643

resident.

1644

6. A limited prescription drug veterinary wholesale

1645

distributor wholesaler must comply with the requirements for

1646

wholesale distributors under ss. s. 499.0121 and 499.01212,

1647

except that a limited prescription drug veterinary wholesale

1648

distributor wholesaler is not required to provide a pedigree

1649

paper as required by s. 499.01212 s. 499.0121(6)(d) upon the

1650

wholesale distribution of a prescription drug to a veterinarian.

1651

7. A limited prescription drug veterinary wholesale

1652

distributor wholesaler may not return to inventory for subsequent

1653

wholesale distribution any prescription drug subject to, defined

1654

by, or described by s. 503(b) of the Federal Food, Drug, and

1655

Cosmetic Act which has been returned by a veterinarian.

1656

8. An out-of-state prescription drug wholesaler's permit or

1657

A limited prescription drug veterinary wholesale distributor

1658

wholesaler permit is not required for an intracompany sale or

1659

transfer of a prescription drug from an out-of-state

1660

establishment that is duly licensed to engage in the wholesale

1661

distribution of prescription drugs in its state of residence to a

1662

licensed limited prescription drug veterinary wholesale

1663

distributor wholesaler in this state if both wholesale

1664

distributors wholesalers conduct wholesale distributions of

1665

prescription drugs under the same business name. The

1666

recordkeeping requirements of ss. s. 499.0121(6) and 499.01212

1667

must be followed for this transaction.

1668

(m) Medical oxygen retail establishment permit.--A medical

1669

oxygen retail establishment permit is required for any person

1670

that sells medical oxygen to patients only. The sale must be

1671

based on an order from a practitioner authorized by law to

1672

prescribe. The term does not include a pharmacy licensed under

1673

chapter 465.

1674

1. A medical oxygen retail establishment may not possess,

1675

purchase, sell, or trade any prescription drug other than medical

1676

oxygen.

1677

2. A medical oxygen retail establishment may refill medical

1678

oxygen for an individual patient based on an order from a

1679

practitioner authorized by law to prescribe. A medical oxygen

1680

retail establishment that refills medical oxygen must comply with

1681

all appropriate state and federal good manufacturing practices.

1682

3. A medical oxygen retail establishment must comply with

1683

all of the wholesale distribution requirements of s. 499.0121.

1684

4. Prescription medical oxygen sold by a medical oxygen

1685

retail establishment pursuant to a practitioner's order may not

1686

be returned into the retail establishment's inventory.

1687

(n)(b) A compressed medical gas wholesale distributor

1688

wholesaler's permit.--A compressed medical gas wholesale

1689

distributor wholesaler is a wholesale distributor that is limited

1690

to the wholesale distribution of compressed medical gases to

1691

other than the consumer or patient. The compressed medical gas

1692

must be in the original sealed container that was purchased by

1693

that wholesale distributor wholesaler. A compressed medical gas

1694

wholesale distributor wholesaler may not possess or engage in the

1695

wholesale distribution of any prescription drug other than

1696

compressed medical gases. The department shall adopt rules that

1697

govern the wholesale distribution of prescription medical oxygen

1698

for emergency use. With respect to the emergency use of

1699

prescription medical oxygen, those rules may not be inconsistent

1700

with rules and regulations of federal agencies unless the

1701

Legislature specifically directs otherwise.

1702

(o)(c) Compressed medical gas manufacturer permit.--A

1703

compressed medical gas manufacturer manufacturer's permit is

1704

required for any person that engages in the manufacture of

1705

compressed medical gases or repackages compressed medical gases

1706

from one container to another.

1707

1. A compressed medical gas manufacturer permittee may not

1708

manufacture or possess any prescription drug other than

1709

compressed medical gases.

1710

2. A compressed medical gas manufacturer permittee may

1711

engage in wholesale distribution of compressed medical gases

1712

manufactured at that establishment and must comply with all the

1713

provisions of this part ss. 499.001-499.081 and the rules adopted

1714

under this part those sections that apply to a wholesale

1715

distributor.

1716

3. A compressed medical gas manufacturer permittee must

1717

comply with all appropriate state and federal good manufacturing

1718

practices.

1719

(p)(b) Over-the-counter drug manufacturer permit.--An over-

1720

the-counter drug manufacturer manufacturer's permit is required

1721

for any person that engages in the manufacture or repackaging of

1722

an over-the-counter drug.

1723

1. An over-the-counter drug manufacturer permittee may not

1724

possess or purchase prescription drugs.

1725

2. A pharmacy is exempt from obtaining an over-the-counter

1726

drug manufacturer manufacturer's permit if it is operating in

1727

compliance with pharmacy practice standards as defined in chapter

1728

465 and the rules adopted under that chapter.

1729

3. An over-the-counter drug manufacturer permittee must

1730

comply with all appropriate state and federal good manufacturing

1731

practices.

1732

(q)(d) Device manufacturer permit.--A device manufacturer

1733

manufacturer's permit is required for any person that engages in

1734

the manufacture, repackaging, or assembly of medical devices for

1735

human use in this state, except that a permit is not required if

1736

the person is engaged only in manufacturing, repackaging, or

1737

assembling a medical device pursuant to a practitioner's order

1738

for a specific patient.

1739

1. A manufacturer or repackager of medical devices in this

1740

state must comply with all appropriate state and federal good

1741

manufacturing practices and quality system rules.

1742

2. The department shall adopt rules related to storage,

1743

handling, and recordkeeping requirements for manufacturers of

1744

medical devices for human use.

1745

(r)(e) Cosmetic manufacturer permit.--A cosmetic

1746

manufacturer manufacturer's permit is required for any person

1747

that manufactures or repackages cosmetics in this state. A person

1748

that only labels or changes the labeling of a cosmetic but does

1749

not open the container sealed by the manufacturer of the product

1750

is exempt from obtaining a permit under this paragraph.

1751

Section 11. Section 499.012, Florida Statutes, is amended

1752

and subsections (2) through (8) of section 499.01, Florida

1753

States, are redesignated as subsections (1) through (7) of that

1754

section and amended, to read:

1755

499.012 Permit application Wholesale distribution;

1756

definitions; permits; applications; general requirements.--

1757

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

1758

(2)(a) A permit issued pursuant to this part ss. 499.001-

1759

499.081 may be issued only to a natural person who is at least 18

1760

years of age or to an applicant that is not a natural person if

1761

each person who, directly or indirectly, manages, controls, or

1762

oversees the operation of that applicant is at least 18 years of

1763

age.

1764

(b) An establishment that is a place of residence may not

1765

receive a permit and may not operate under this part ss. 499.001-

1766

499.081.

1767

1768

manufacture or distribute prescription legend drugs may not use a

1769

name identical to the name used by any other establishment or

1770

licensed person authorized to purchase prescription drugs in this

1771

state, except that a restricted drug distributor permit issued to

1772

a health care entity will be issued in the name in which the

1773

institutional pharmacy permit is issued and a retail pharmacy

1774

drug wholesale distributor wholesaler will be issued a permit in

1775

the name of its retail pharmacy permit.

1776

(d) A permit for a prescription drug manufacturer,

1777

prescription drug repackager, prescription drug wholesale

1778

distributor wholesaler, limited prescription drug veterinary

1779

wholesale distributor wholesaler, or retail pharmacy drug

1780

wholesale distributor wholesaler may not be issued to the address

1781

of a health care entity or to a pharmacy licensed under chapter

1782

465, except as provided in this paragraph. The department may

1783

issue a prescription drug manufacturer permit to an applicant at

1784

the same address as a licensed nuclear pharmacy, which is a

1785

health care entity, for the purpose of manufacturing prescription

1786

drugs used in positron emission tomography or other

1787

radiopharmaceuticals, as listed in a rule adopted by the

1788

department pursuant to this paragraph. The purpose of this

1789

exemption is to assure availability of state-of-the-art

1790

pharmaceuticals that would pose a significant danger to the

1791

public health if manufactured at a separate establishment address

1792

from the nuclear pharmacy from which the prescription drugs are

1793

dispensed. The department may also issue a retail pharmacy drug

1794

wholesale distributor wholesaler permit to the address of a

1795

community pharmacy licensed under chapter 465 which does not meet

1796

the definition of a closed pharmacy in s. 499.003.

1797

(e) A county or municipality may not issue an occupational

1798

license for any licensing period beginning on or after October 1,

1799

2003, for any establishment that requires a permit pursuant to

1800

this part ss. 499.001-499.081, unless the establishment exhibits

1801

a current permit issued by the department for the establishment.

1802

Upon presentation of the requisite permit issued by the

1803

department, an occupational license may be issued by the

1804

municipality or county in which application is made. The

1805

department shall furnish to local agencies responsible for

1806

issuing occupational licenses a current list of all

1807

establishments licensed pursuant to this part ss. 499.001-

1808

499.081.

1809

(2)(3) Notwithstanding subsection (6) (7), a permitted

1810

person in good standing may change the type of permit issued to

1811

that person by completing a new application for the requested

1812

permit, paying the amount of the difference in the permit fees if

1813

the fee for the new permit is more than the fee for the original

1814

permit, and meeting the applicable permitting conditions for the

1815

new permit type. The new permit expires on the expiration date of

1816

the original permit being changed; however, a new permit for a

1817

prescription drug wholesale distributor wholesaler, an out-of-

1818

state prescription drug wholesale distributor wholesaler, or a

1819

retail pharmacy drug wholesale distributor wholesaler shall

1820

expire on the expiration date of the original permit or 1 year

1821

after the date of issuance of the new permit, whichever is

1822

earlier. A refund may not be issued if the fee for the new permit

1823

is less than the fee that was paid for the original permit.

1824

(3)(4) A written application for a permit or to renew a

1825

permit must be filed with the department on forms furnished by

1826

the department. The department shall establish, by rule, the form

1827

and content of the application to obtain or renew a permit. The

1828

applicant must submit to the department with the application a

1829

statement that swears or affirms that the information is true and

1830

correct.

1831

(4)(5)(a) Except for a permit for a prescription drug

1832

wholesale distributor wholesaler or an out-of-state prescription

1833

drug wholesale distributor wholesaler, an application for a

1834

permit must include:

1835

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

1836

the applicant;

1837

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

1838

3. The address, telephone numbers, and the names of contact

1839

persons for each facility used by the applicant for the storage,

1840

handling, and distribution of prescription drugs;

1841

4. The type of ownership or operation, such as a

1842

partnership, corporation, or sole proprietorship; and

1843

5. The names of the owner and the operator of the

1844

establishment, including:

1845

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

1846

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

1847

of the partnership;

1848

c. If a corporation, the name and title of each corporate

1849

officer and director, the corporate names, and the name of the

1850

state of incorporation;

1851

d. If a sole proprietorship, the full name of the sole

1852

proprietor and the name of the business entity;

1853

e. If a limited liability company, the name of each member,

1854

the name of each manager, the name of the limited liability

1855

company, and the name of the state in which the limited liability

1856

company was organized; and

1857

f. Any other relevant information that the department

1858

requires.

1859

(b) Upon approval of the application by the department and

1860

payment of the required fee, the department shall issue a permit

1861

to the applicant, if the applicant meets the requirements of this

1862

part ss. 499.001-499.081 and rules adopted under this part those

1863

sections.

1864

1865

must be submitted to the department before the change occurs.

1866

(d) The department shall consider, at a minimum, the

1867

following factors in reviewing the qualifications of persons to

1868

be permitted under this part ss. 499.001-499.081:

1869

1. The applicant's having been found guilty, regardless of

1870

adjudication, in a court of this state or other jurisdiction, of

1871

a violation of a law that directly relates to a drug, device, or

1872

cosmetic. A plea of nolo contendere constitutes a finding of

1873

guilt for purposes of this subparagraph.

1874

2. The applicant's having been disciplined by a regulatory

1875

agency in any state for any offense that would constitute a

1876

violation of this part ss. 499.001-499.081.

1877

3. Any felony conviction of the applicant under a federal,

1878

state, or local law;

1879

4. The applicant's past experience in manufacturing or

1880

distributing drugs, devices, or cosmetics;

1881

5. The furnishing by the applicant of false or fraudulent

1882

material in any application made in connection with manufacturing

1883

or distributing drugs, devices, or cosmetics;

1884

6. Suspension or revocation by a federal, state, or local

1885

government of any permit currently or previously held by the

1886

applicant for the manufacture or distribution of any drugs,

1887

devices, or cosmetics;

1888

7. Compliance with permitting requirements under any

1889

previously granted permits;

1890

8. Compliance with requirements to maintain or make

1891

available to the state permitting authority or to federal, state,

1892

or local law enforcement officials those records required under

1893

this section; and

1894

9. Any other factors or qualifications the department

1895

considers relevant to and consistent with the public health and

1896

safety.

1897

(5)(6) Except for a permit permits for a prescription drug

1898

wholesale distributor wholesalers or an out-of-state prescription

1899

drug wholesale distributor wholesalers:

1900

(a) The department shall adopt rules for the biennial

1901

renewal of permits.

1902

(b) The department shall renew a permit upon receipt of the

1903

renewal application and renewal fee if the applicant meets the

1904

requirements established under this part ss. 499.001-499.081 and

1905

the rules adopted under this part those sections.

1906

1907

automatically expires 2 years after the last day of the

1908

anniversary month in which the permit was originally issued. A

1909

permit issued under this part ss. 499.001-499.081 may be renewed

1910

by making application for renewal on forms furnished by the

1911

department and paying the appropriate fees. If a renewal

1912

application and fee are submitted and postmarked after the

1913

expiration date of the permit, the permit may be renewed only

1914

upon payment of a late renewal delinquent fee of $100, plus the

1915

required renewal fee, not later than 60 days after the expiration

1916

date.

1917

(d) Failure to renew a permit in accordance with this

1918

section precludes any future renewal of that permit. If a permit

1919

issued pursuant to this part section has expired and cannot be

1920

renewed, before an establishment may engage in activities that

1921

require a permit under this part ss. 499.001-499.081, the

1922

establishment must submit an application for a new permit, pay

1923

the applicable application fee, the initial permit fee, and all

1924

applicable penalties, and be issued a new permit by the

1925

department.

1926

(6)(7) A permit issued by the department is

1927

nontransferable. Each permit is valid only for the person or

1928

governmental unit to which it is issued and is not subject to

1929

sale, assignment, or other transfer, voluntarily or

1930

involuntarily; nor is a permit valid for any establishment other

1931

than the establishment for which it was originally issued.

1932

(a) A person permitted under this part ss. 499.001-499.081

1933

must notify the department before making a change of address. The

1934

department shall set a change of location fee not to exceed $100.

1935

(b)1. An application for a new permit is required when a

1936

majority of the ownership or controlling interest of a permitted

1937

establishment is transferred or assigned or when a lessee agrees

1938

to undertake or provide services to the extent that legal

1939

liability for operation of the establishment will rest with the

1940

lessee. The application for the new permit must be made before

1941

the date of the sale, transfer, assignment, or lease.

1942

2. A permittee that is authorized to distribute

1943

prescription legend drugs may transfer such drugs to the new

1944

owner or lessee under subparagraph 1. only after the new owner or

1945

lessee has been approved for a permit to distribute prescription

1946

legend drugs.

1947

1948

499.001-499.081 closes, the owner must notify the department in

1949

writing before the effective date of closure and must:

1950

1. Return the permit to the department;

1951

2. If the permittee is authorized to distribute

1952

prescription legend drugs, indicate the disposition of such

1953

drugs, including the name, address, and inventory, and provide

1954

the name and address of a person to contact regarding access to

1955

records that are required to be maintained under this part ss.

1956

499.001-499.081. Transfer of ownership of prescription legend

1957

drugs may be made only to persons authorized to possess

1958

prescription legend drugs under this part ss. 499.001-499.081.

1959

1960

The department may revoke the permit of any person that fails to

1961

comply with the requirements of this subsection.

1962

(7)(8) A permit must be posted in a conspicuous place on

1963

the licensed premises.

1964

(8)(3) An application for a permit or to renew a permit for

1965

a prescription drug wholesale distributor wholesaler or an out-

1966

of-state prescription drug wholesale distributor wholesaler

1967

submitted to the department must include:

1968

(a) The name, full business address, and telephone number

1969

of the applicant.

1970

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

1971

1972

contact persons for each facility used by the applicant for the

1973

storage, handling, and distribution of prescription drugs.

1974

(d) The type of ownership or operation, such as a

1975

partnership, corporation, or sole proprietorship.

1976

(e) The names of the owner and the operator of the

1977

establishment, including:

1978

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

1979

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

1980

of the partnership.

1981

3. If a corporation:

1982

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

1983

and director.

1984

b. The name and address of the corporation, resident agent

1985

of the corporation, the resident agent's address, and the

1986

corporation's state of incorporation.

1987

c. The name and address of each shareholder of the

1988

corporation that owns 5 percent or more of the outstanding stock

1989

of the corporation.

1990

4. If a sole proprietorship, the full name of the sole

1991

proprietor and the name of the business entity.

1992

5. If a limited liability company:

1993

a. The name and address of each member.

1994

b. The name and address of each manager.

1995

c. The name and address of the limited liability company,

1996

the resident agent of the limited liability company, and the name

1997

of the state in which the limited liability company was

1998

organized.

1999

(f) If applicable, the name and address of each member of

2000

the affiliated group of which the applicant is a member.

2001

(g)1. For an application for a new permit, the estimated

2002

annual dollar volume of prescription drug sales of the applicant,

2003

the estimated annual percentage of the applicant's total company

2004

sales that are prescription drugs, the applicant's estimated

2005

annual total dollar volume of purchases of prescription drugs,

2006

and the applicant's estimated annual total dollar volume of

2007

prescription drug purchases directly from manufacturers.

2008

2. For an application to renew a permit, the total dollar

2009

volume of prescription drug sales in the previous year, the total

2010

dollar volume of prescription drug sales made in the previous 6

2011

months, the percentage of total company sales that were

2012

prescription drugs in the previous year, the total dollar volume

2013

of purchases of prescription drugs in the previous year, and the

2014

total dollar volume of prescription drug purchases directly from

2015

manufacturers in the previous year.

2016

2017

Such portions of the information required pursuant to this

2018

paragraph which are a trade secret, as defined in s. 812.081,

2019

shall be maintained by the department as trade secret information

2020

is required to be maintained under s. 499.051.

2021

(h) The tax year of the applicant.

2022

(i) A copy of the deed for the property on which

2023

applicant's establishment is located, if the establishment is

2024

owned by the applicant, or a copy of the applicant's lease for

2025

the property on which applicant's establishment is located that

2026

has an original term of not less than 1 calendar year, if the

2027

establishment is not owned by the applicant.

2028

(j) A list of all licenses and permits issued to the

2029

applicant by any other state which authorize the applicant to

2030

purchase or possess prescription drugs.

2031

(k) The name of the manager of the establishment that is

2032

applying for the permit or to renew the permit, the next four

2033

highest ranking employees responsible for prescription drug

2034

wholesale operations for the establishment, and the name of all

2035

affiliated parties for the establishment, together with the

2036

personal information statement and fingerprints required pursuant

2037

to subsection (9) (4) for each of such persons.

2038

(l) The name of each of the applicant's designated

2039

representatives as required by subsection (16) (11), together

2040

with the personal information statement and fingerprints required

2041

pursuant to subsection (9) (4) for each such person.

2042

(m) For an applicant that is a secondary wholesale

2043

distributor wholesaler, each of the following:

2044

1. A personal background information statement containing

2045

the background information and fingerprints required pursuant to

2046

subsection (9) (4) for each person named in the applicant's

2047

response to paragraphs (k) and (l) and for each affiliated party

2048

of the applicant.

2049

2. If any of the five largest shareholders of the

2050

corporation seeking the permit is a corporation, the name,

2051

address, and title of each corporate officer and director of each

2052

such corporation; the name and address of such corporation; the

2053

name of such corporation's resident agent, such corporation's

2054

resident agent's address, and such corporation's state of its

2055

incorporation; and the name and address of each shareholder of

2056

such corporation that owns 5 percent or more of the stock of such

2057

corporation.

2058

3. The name and address of all financial institutions in

2059

which the applicant has an account which is used to pay for the

2060

operation of the establishment or to pay for drugs purchased for

2061

the establishment, together with the names of all persons that

2062

are authorized signatories on such accounts. The portions of the

2063

information required pursuant to this subparagraph which are a

2064

trade secret, as defined in s. 812.081, shall be maintained by

2065

the department as trade secret information is required to be

2066

maintained under s. 499.051.

2067

4. The sources of all funds and the amounts of such funds

2068

used to purchase or finance purchases of prescription drugs or to

2069

finance the premises on which the establishment is to be located.

2070

5. If any of the funds identified in subparagraph 4. were

2071

borrowed, copies of all promissory notes or loans used to obtain

2072

such funds.

2073

(n) Any other relevant information that the department

2074

requires, including, but not limited to, any information related

2075

to whether the applicant satisfies the definition of a primary

2076

wholesale distributor wholesaler or a secondary wholesale

2077

distributor wholesaler.

2078

(9)(4)(a) Each person required by subsection (8) (3) to

2079

provide a personal information statement and fingerprints shall

2080

provide the following information to the department on forms

2081

prescribed by the department:

2082

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

2083

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

2084

3. The person's occupations, positions of employment, and

2085

offices held during the past 7 years.

2086

4. The principal business and address of any business,

2087

corporation, or other organization in which each such office of

2088

the person was held or in which each such occupation or position

2089

of employment was carried on.

2090

5. Whether the person has been, during the past 7 years,

2091

the subject of any proceeding for the revocation of any license

2092

and, if so, the nature of the proceeding and the disposition of

2093

the proceeding.

2094

6. Whether, during the past 7 years, the person has been

2095

enjoined, either temporarily or permanently, by a court of

2096

competent jurisdiction from violating any federal or state law

2097

regulating the possession, control, or distribution of

2098

prescription drugs, together with details concerning any such

2099

event.

2100

7. A description of any involvement by the person with any

2101

business, including any investments, other than the ownership of

2102

stock in a publicly traded company or mutual fund, during the

2103

past 7 years, which manufactured, administered, prescribed,

2104

distributed, or stored pharmaceutical products and any lawsuits

2105

in which such businesses were named as a party.

2106

8. A description of any felony criminal offense of which

2107

the person, as an adult, was found guilty, regardless of whether

2108

adjudication of guilt was withheld or whether the person pled

2109

guilty or nolo contendere. A criminal offense committed in

2110

another jurisdiction which would have been a felony in this state

2111

must be reported. If the person indicates that a criminal

2112

conviction is under appeal and submits a copy of the notice of

2113

appeal of that criminal offense, the applicant must, within 15

2114

days after the disposition of the appeal, submit to the

2115

department a copy of the final written order of disposition.

2116

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

2117

days.

2118

10. A set of fingerprints for the person on a form and

2119

under procedures specified by the department, together with

2120

payment of an amount equal to the costs incurred by the

2121

department for the criminal record check of the person.

2122

11. The name, address, occupation, and date and place of

2123

birth for each member of the person's immediate family who is 18

2124

years of age or older. As used in this subparagraph, the term

2125

"member of the person's immediate family" includes the person's

2126

spouse, children, parents, siblings, the spouses of the person's

2127

children, and the spouses of the person's siblings.

2128

12. Any other relevant information that the department

2129

requires.

2130

(b) The information required pursuant to paragraph (a)

2131

shall be provided under oath.

2132

2133

by a person for initial licensure to the Department of Law

2134

Enforcement for a statewide criminal record check and for

2135

forwarding to the Federal Bureau of Investigation for a national

2136

criminal record check of the person. The department shall submit

2137

the fingerprints provided by a person as a part of a renewal

2138

application to the Department of Law Enforcement for a statewide

2139

criminal record check, and for forwarding to the Federal Bureau

2140

of Investigation for a national criminal record check, for the

2141

initial renewal of a permit after January 1, 2004; for any

2142

subsequent renewal of a permit, the department shall submit the

2143

required information for a statewide and national criminal record

2144

check of the person. Any person who as a part of an initial

2145

permit application or initial permit renewal after January 1,

2146

2004, submits to the department a set of fingerprints required

2147

for the criminal record check required in this paragraph shall

2148

not be required to provide a subsequent set of fingerprints for a

2149

criminal record check to the department, if the person has

2150

undergone a criminal record check as a condition of the issuance

2151

of an initial permit or the initial renewal of a permit of an

2152

applicant after January 1, 2004.

2153

(10)(5) The department may deny an application for a permit

2154

or refuse to renew a permit for a prescription drug wholesale

2155

distributor wholesaler or an out-of-state prescription drug

2156

wholesale distributor wholesaler if:

2157

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

2158

permit.

2159

(b) The management, officers, or directors of the applicant

2160

or any affiliated party are found by the department to be

2161

incompetent or untrustworthy.

2162

2163

wholesale distributor as to make the issuance of the proposed

2164

permit hazardous to the public health.

2165

(d) The applicant is so lacking in experience in managing a

2166

wholesale distributor as to jeopardize the reasonable promise of

2167

successful operation of the wholesale distributor.

2168

(e) The applicant is lacking in experience in the

2169

distribution of prescription drugs.

2170

(f) The applicant's past experience in manufacturing or

2171

distributing prescription drugs indicates that the applicant

2172

poses a public health risk.

2173

(g) The applicant is affiliated directly or indirectly

2174

through ownership, control, or other business relations, with any

2175

person or persons whose business operations are or have been

2176

detrimental to the public health.

2177

(h) The applicant, or any affiliated party, has been found

2178

guilty of or has pleaded guilty or nolo contendere to any felony

2179

or crime punishable by imprisonment for 1 year or more under the

2180

laws of the United States, any state, or any other country,

2181

regardless of whether adjudication of guilt was withheld.

2182

(i) The applicant or any affiliated party has been charged

2183

with a felony in a state or federal court and the disposition of

2184

that charge is pending during the application review or renewal

2185

review period.

2186

(j) The applicant has furnished false or fraudulent

2187

information or material in any application made in this state or

2188

any other state in connection with obtaining a permit or license

2189

to manufacture or distribute drugs, devices, or cosmetics.

2190

(k) That a federal, state, or local government permit

2191

currently or previously held by the applicant, or any affiliated

2192

party, for the manufacture or distribution of any drugs, devices,

2193

or cosmetics has been disciplined, suspended, or revoked and has

2194

not been reinstated.

2195

(l) The applicant does not possess the financial or

2196

physical resources to operate in compliance with the permit being

2197

sought, this chapter, and the rules adopted under this chapter.

2198

(m) The applicant or any affiliated party receives,

2199

directly or indirectly, financial support and assistance from a

2200

person who was an affiliated party of a permittee whose permit

2201

was subject to discipline or was suspended or revoked, other than

2202

through the ownership of stock in a publicly traded company or a

2203

mutual fund.

2204

(n) The applicant or any affiliated party receives,

2205

directly or indirectly, financial support and assistance from a

2206

person who has been found guilty of any violation of this part

2207

ss. 499.001-499.081 or chapter 465, chapter 501, or chapter 893,

2208

any rules adopted under any of this part those sections or those

2209

chapters, any federal or state drug law, or any felony where the

2210

underlying facts related to drugs, regardless of whether the

2211

person has been pardoned, had her or his civil rights restored,

2212

or had adjudication withheld, other than through the ownership of

2213

stock in a publicly traded company or a mutual fund.

2214

(o) The applicant for renewal of a permit under s.

2215

499.01(2)(d) paragraph (2)(a) or s. 499.01(2)(e) paragraph (2)(c)

2216

has not actively engaged in the wholesale distribution of

2217

prescription drugs, as demonstrated by the regular and systematic

2218

distribution of prescription drugs throughout the year as

2219

evidenced by not fewer than 12 wholesale distributions in the

2220

previous year and not fewer than three wholesale distributions in

2221

the previous 6 months.

2222

(p) Information obtained in response to s. 499.01(2)(d)

2223

paragraph (2)(a) or s. 499.01(2)(e) paragraph (2)(c) demonstrates

2224

it would not be in the best interest of the public health,

2225

safety, and welfare to issue a permit.

2226

(q) The applicant does not possess the financial standing

2227

and business experience for the successful operation of the

2228

applicant.

2229

(r) The applicant or any affiliated party has failed to

2230

comply with the requirements for manufacturing or distributing

2231

prescription drugs under this part ss. 499.001-499.081, similar

2232

federal laws, similar laws in other states, or the rules adopted

2233

under such laws.

2234

(11)(6) Upon approval of the application by the department

2235

and payment of the required fee, the department shall issue or

2236

renew a prescription drug wholesale distributor wholesaler or an

2237

out-of-state prescription drug wholesale distributor wholesaler

2238

permit to the applicant.

2239

(12)(7) For a permit permits for a prescription drug

2240

wholesale distributor wholesalers or an out-of-state prescription

2241

drug wholesale distributor wholesalers:

2242

(a) The department shall adopt rules for the annual renewal

2243

of permits. At least 90 days before the expiration of a permit,

2244

the department shall forward a permit renewal notification and

2245

renewal application to the prescription drug wholesale

2246

distributor wholesaler or out-of-state prescription drug

2247

wholesale distributor wholesaler at the mailing address of the

2248

permitted establishment on file with the department. The permit

2249

renewal notification must state conspicuously the date on which

2250

the permit for the establishment will expire and that the

2251

establishment may not operate unless the permit for the

2252

establishment is renewed timely.

2253

(b) A permit, unless sooner suspended or revoked,

2254

automatically expires 1 year after the last day of the

2255

anniversary month in which the permit was originally issued. A

2256

permit may be renewed by making application for renewal on forms

2257

furnished by the department and paying the appropriate fees. If a

2258

renewal application and fee are submitted and postmarked after 45

2259

days prior to the expiration date of the permit, the permit may

2260

be renewed only upon payment of a late renewal fee of $100, plus

2261

the required renewal fee. A permittee that has submitted a

2262

renewal application in accordance with this paragraph may

2263

continue to operate under its permit, unless the permit is

2264

suspended or revoked, until final disposition of the renewal

2265

application.

2266

2267

section precludes any future renewal of that permit. If a permit

2268

issued pursuant to this section has expired and cannot be

2269

renewed, before an establishment may engage in activities that

2270

require a permit under this part ss. 499.001-499.081, the

2271

establishment must submit an application for a new permit; pay

2272

the applicable application fee, initial permit fee, and all

2273

applicable penalties; and be issued a new permit by the

2274

department.

2275

(13)(8) A person that engages in wholesale distribution of

2276

prescription drugs in this state must have a wholesale

2277

distributor's permit issued by the department, except as noted in

2278

this section. Each establishment must be separately permitted

2279

except as noted in this subsection.

2280

(a) A separate establishment permit is not required when a

2281

permitted prescription drug wholesale distributor wholesaler

2282

consigns a prescription drug to a pharmacy that is permitted

2283

under chapter 465 and located in this state, provided that:

2284

1. The consignor wholesale distributor wholesaler notifies

2285

the department in writing of the contract to consign prescription

2286

drugs to a pharmacy along with the identity and location of each

2287

consignee pharmacy;

2288

2. The pharmacy maintains its permit under chapter 465;

2289

3. The consignor wholesale distributor wholesaler, which

2290

has no legal authority to dispense prescription drugs, complies

2291

with all wholesale distribution requirements of ss. s. 499.0121

2292

and 499.01212 with respect to the consigned drugs and maintains

2293

records documenting the transfer of title or other completion of

2294

the wholesale distribution of the consigned prescription drugs;

2295

4. The distribution of the prescription drug is otherwise

2296

lawful under this chapter and other applicable law;

2297

5. Open packages containing prescription drugs within a

2298

pharmacy are the responsibility of the pharmacy, regardless of

2299

how the drugs are titled; and

2300

6. The pharmacy dispenses the consigned prescription drug

2301

in accordance with the limitations of its permit under chapter

2302

465 or returns the consigned prescription drug to the consignor

2303

wholesale distributor wholesaler. In addition, a person who holds

2304

title to prescription drugs may transfer the drugs to a person

2305

permitted or licensed to handle the reverse distribution or

2306

destruction of drugs. Any other distribution by and means of the

2307

consigned prescription drug by any person, not limited to the

2308

consignor wholesale distributor wholesaler or consignee pharmacy,

2309

to any other person is prohibited.

2310

(b) A wholesale distributor's permit is not required for

2311

the one-time transfer of title of a pharmacy's lawfully acquired

2312

prescription drug inventory by a pharmacy with a valid permit

2313

issued under chapter 465 to a consignor prescription drug

2314

wholesale distributor wholesaler, permitted under this chapter,

2315

in accordance with a written consignment agreement between the

2316

pharmacy and that wholesale distributor wholesaler if: the

2317

permitted pharmacy and the permitted prescription drug wholesale

2318

distributor wholesaler comply with all of the provisions of

2319

paragraph (a) and the prescription drugs continue to be within

2320

the permitted pharmacy's inventory for dispensing in accordance

2321

with the limitations of the pharmacy permit under chapter 465. A

2322

consignor drug wholesale distributor wholesaler may not use the

2323

pharmacy as a wholesale distributor through which it distributes

2324

the prescription legend drugs to other pharmacies. Nothing in

2325

this section is intended to prevent a wholesale drug distributor

2326

from obtaining this inventory in the event of nonpayment by the

2327

pharmacy.

2328

2329

wholesale distributor as part of the permit and renewal of such

2330

permit, as required under s. 499.01 or this section.

2331

(14)(9) Personnel employed in wholesale distribution must

2332

have appropriate education and experience to enable them to

2333

perform their duties in compliance with state permitting

2334

requirements.

2335

(15)(10) The name of a permittee or establishment on a

2336

prescription drug wholesale distributor wholesaler permit or an

2337

out-of-state prescription drug wholesale distributor wholesaler

2338

permit may not include any indicia of attainment of any

2339

educational degree, any indicia that the permittee or

2340

establishment possesses a professional license, or any name or

2341

abbreviation that the department determines is likely to cause

2342

confusion or mistake or that the department determines is

2343

deceptive, including that of any other entity authorized to

2344

purchase prescription drugs.

2345

(16)(11)(a) Each establishment that is issued an initial or

2346

renewal permit as a prescription drug wholesale distributor

2347

wholesaler or an out-of-state prescription drug wholesale

2348

distributor wholesaler must designate in writing to the

2349

department at least one natural person to serve as the designated

2350

representative of the wholesale distributor wholesaler. Such

2351

person must have an active certification as a designated

2352

representative from the department.

2353

(b) To be certified as a designated representative, a

2354

natural person must:

2355

1. Submit an application on a form furnished by the

2356

department and pay the appropriate fees;

2357

2. Be at least 18 years of age;

2358

3. Have not less than 2 years of verifiable full-time work

2359

experience in a pharmacy licensed in this state or another state,

2360

where the person's responsibilities included, but were not

2361

limited to, recordkeeping for prescription drugs, or have not

2362

less than 2 years of verifiable full-time managerial experience

2363

with a prescription drug wholesale distributor wholesaler

2364

licensed in this state or in another state;

2365

4. Receive a passing score of at least 75 percent on an

2366

examination given by the department regarding federal laws

2367

governing distribution of prescription drugs and this part ss.

2368

499.001-499.081 and the rules adopted by the department governing

2369

the wholesale distribution of prescription drugs. This

2370

requirement shall be effective 1 year after the results of the

2371

initial examination are mailed to the persons that took the

2372

examination. The department shall offer such examinations at

2373

least four times each calendar year; and

2374

5. Provide the department with a personal information

2375

statement and fingerprints pursuant to subsection (9)(4).

2376

2377

certification as a designated representative or may suspend or

2378

revoke a certification of a designated representative pursuant to

2379

s. 499.067.

2380

(d) A designated representative:

2381

1. Must be actively involved in and aware of the actual

2382

daily operation of the wholesale distributor.

2383

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

2384

the wholesale distributor.

2385

3. Must be physically present at the establishment during

2386

normal business hours, except for time periods when absent due to

2387

illness, family illness or death, scheduled vacation, or other

2388

authorized absence.

2389

4. May serve as a designated representative for only one

2390

wholesale distributor at any one time.

2391

(e) A wholesale distributor must notify the department when

2392

a designated representative leaves the employ of the wholesale

2393

distributor. Such notice must be provided to the department

2394

within 10 business days after the last day of designated

2395

representative's employment with the wholesale distributor.

2396

(f) A wholesale distributor may not operate under a

2397

prescription drug wholesale distributor wholesaler permit or an

2398

out-of-state prescription drug wholesale distributor wholesaler

2399

permit for more than 10 business days after the designated

2400

representative leaves the employ of the wholesale distributor,

2401

unless the wholesale distributor employs another designated

2402

representative and notifies the department within 10 business

2403

days of the identity of the new designated representative.

2404

Section 12. Section 499.01201, Florida Statutes, is amended

2405

to read:

2406

499.01201 Agency for Health Care Administration review and

2407

use of statute and rule violation or compliance

2408

data.--Notwithstanding any other provisions of law to the

2409

contrary, the Agency for Health Care Administration may not:

2410

(1) Review or use any violation or alleged violation of s.

2411

499.0121(6) or s. 499.01212, or any rules adopted under those

2412

sections that section, as a ground for denying or withholding any

2413

payment of a Medicaid reimbursement to a pharmacy licensed under

2414

chapter 465; or

2415

(2) Review or use compliance with s. 499.0121(6) or s.

2416

499.01212, or any rules adopted under those sections that

2417

section, as the subject of any audit of Medicaid-related records

2418

held by a pharmacy licensed under chapter 465.

2419

Section 13. Section 499.0121, Florida Statutes, is amended,

2420

and subsection (4) of section 499.013, Florida Statutes, is

2421

redesignated as paragraph (d) of subsection (6) of that section

2422

and amended, to read:

2423

499.0121 Storage and handling of prescription drugs;

2424

recordkeeping.--The department shall adopt rules to implement

2425

this section as necessary to protect the public health, safety,

2426

and welfare. Such rules shall include, but not be limited to,

2427

requirements for the storage and handling of prescription drugs

2428

and for the establishment and maintenance of prescription drug

2429

distribution records.

2430

(1) ESTABLISHMENTS.--An establishment at which prescription

2431

drugs are stored, warehoused, handled, held, offered, marketed,

2432

or displayed must:

2433

(a) Be of suitable size and construction to facilitate

2434

cleaning, maintenance, and proper operations;

2435

(b) Have storage areas designed to provide adequate

2436

lighting, ventilation, temperature, sanitation, humidity, space,

2437

equipment, and security conditions;

2438

2439

drugs that are outdated, damaged, deteriorated, misbranded, or

2440

adulterated, or that are in immediate or sealed, secondary

2441

containers that have been opened;

2442

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

2443

(e) Be free from infestation by insects, rodents, birds, or

2444

vermin of any kind.

2445

(2) SECURITY.--

2446

(a) An establishment that is used for wholesale drug

2447

distribution must be secure from unauthorized entry.

2448

1. Access from outside the premises must be kept to a

2449

minimum and be well-controlled.

2450

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

2451

lighted.

2452

3. Entry into areas where prescription drugs are held must

2453

be limited to authorized personnel.

2454

(b) An establishment that is used for wholesale drug

2455

distribution must be equipped with:

2456

1. An alarm system to detect entry after hours; however,

2457

the department may exempt by rule establishments that only hold a

2458

permit as prescription drug wholesale distributor-brokers

2459

wholesaler-brokers and establishments that only handle medical

2460

oxygen; and

2461

2. A security system that will provide suitable protection

2462

against theft and diversion. When appropriate, the security

2463

system must provide protection against theft or diversion that is

2464

facilitated or hidden by tampering with computers or electronic

2465

records.

2466

2467

secure from unauthorized access to the prescription drugs in the

2468

vehicle.

2469

(3) STORAGE.--All prescription drugs shall be stored at

2470

appropriate temperatures and under appropriate conditions in

2471

accordance with requirements, if any, in the labeling of such

2472

drugs, or with requirements in the official compendium.

2473

(a) If no storage requirements are established for a

2474

prescription drug, the drug may be held at "controlled" room

2475

temperature, as defined in the official compendium, to help

2476

ensure that its identity, strength, quality, and purity are not

2477

adversely affected.

2478

(b) Appropriate manual, electromechanical, or electronic

2479

temperature and humidity recording equipment, devices, or logs

2480

must be used to document proper storage of prescription drugs.

2481

2482

be followed for all stored prescription drugs.

2483

(4) EXAMINATION OF MATERIALS AND RECORDS.--

2484

(a) Upon receipt, each outside shipping container must be

2485

visually examined for identity and to prevent the acceptance of

2486

contaminated prescription drugs that are otherwise unfit for

2487

distribution. This examination must be adequate to reveal

2488

container damage that would suggest possible contamination or

2489