Senate Bill sb2312c2

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    Florida Senate - 2003                    CS for CS for SB 2312

    By the Committees on Appropriations; Health, Aging, and
    Long-Term Care; and Senator Peaden




    309-2438-03

  1                      A bill to be entitled

  2         An act relating to the distribution of

  3         prescription drugs; providing a short title;

  4         providing legislative findings and intent with

  5         respect to a report by the Seventeenth

  6         Statewide Grand Jury; amending s. 499.003,

  7         F.S.; defining additional terms; amending s.

  8         499.005, F.S.; prohibiting the purchase or sale

  9         of prescription drugs in wholesale distribution

10         in exchange for currency; clarifying provisions

11         prohibiting the transfer of legend drugs from

12         or to any person not authorized to possess such

13         drugs; prohibiting additional acts concerning

14         the distribution of prescription drugs;

15         creating s. 499.0051, F.S.; providing that

16         failure to maintain or deliver pedigree papers,

17         failure to authenticate pedigree papers,

18         forgery of pedigree papers, purchase of legend

19         drugs from an unlicensed person, sale of legend

20         drugs to an unlicensed person, possession or

21         sale of contraband legend drugs and possession

22         with intent to sell or deliver contraband

23         legend drugs, and forgery of prescription

24         labels or legend drug labels are felony

25         offenses; providing penalties; creating s.

26         499.0052, F.S.; providing that trafficking in

27         contraband legend drugs is a felony offense;

28         providing penalties; providing enhanced

29         penalties if the defendant is a corporation or

30         not a natural person; creating s. 499.0053,

31         F.S.; providing that the sale or purchase of a

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 1         contraband legend drug resulting in great

 2         bodily harm is a first-degree felony; creating

 3         s. 499.0054, F.S.; providing that the sale or

 4         purchase of a contraband legend drug resulting

 5         in death is a first-degree felony; amending s.

 6         499.006, F.S.; providing that a legend drug

 7         that is unaccompanied by a proper pedigree

 8         paper or that has been in the possession of an

 9         unauthorized person is an adulterated drug;

10         amending s. 499.007, F.S.; revising labeling

11         requirements to conform to federal law;

12         amending s. 499.01, F.S.; requiring that

13         prescription drug repackagers, nonresident

14         prescription drug manufacturers, and freight

15         forwarders obtain a permit from the Department

16         of Health in order to do business; prohibiting

17         a county or municipality from issuing an

18         occupational license prior to an establishment

19         obtaining a permit required under ch. 499,

20         F.S., under specified circumstances; providing

21         for early expiration of certain permits;

22         amending s. 499.012, F.S.; excluding the

23         transfer of prescription drugs within a

24         hospital from the definition of wholesale

25         distribution; providing bond requirements for

26         prescription drug wholesalers; deleting

27         provisions authorizing the department to grant

28         out-of-state wholesalers reciprocity; requiring

29         freight forwarders and nonresident prescription

30         drug manufacturers to obtain a permit;

31         providing requirements for permit applications;

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 1         providing definitions; providing requirements

 2         for the permitting of prescription drug

 3         wholesalers and out-of-state prescription drug

 4         wholesalers; providing criteria for permit

 5         denials; requiring prescription drug

 6         wholesalers to designate a representative;

 7         providing criteria for designation as a

 8         representative; amending s. 499.0121, F.S.;

 9         requiring record review; requiring pedigree

10         papers for the transfer and sale of legend

11         drugs; providing exemptions; providing

12         documentation requirements for the shipment of

13         prescription drugs; providing requirements for

14         wholesale drug distributors with respect to the

15         exercise of due diligence; providing rulemaking

16         authority; creating s. 499.01211, F.S.;

17         creating the Drug Wholesaler Advisory Council

18         within the Department of Health; providing for

19         membership of the council and terms of office;

20         requiring the council to review rules and make

21         recommendations to the secretary of the

22         department; amending s. 499.013, F.S.;

23         providing requirements for repackagers of

24         drugs, devices, and cosmetics; requiring that a

25         repackager obtain a permit from the department;

26         providing labeling requirements; amending s.

27         499.014, F.S.; specifying that certain

28         restricted distributors are exempt from the

29         requirements concerning pedigree papers;

30         amending s. 499.041, F.S.; revising the

31         schedule of fees for permits; amending s.

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 1         499.051, F.S.; revising the authority of the

 2         Department of Health to inspect pharmacies and

 3         pharmacy wholesalers; authorizing the

 4         department and the Department of Law

 5         Enforcement to inspect certain financial

 6         documents and records; amending s. 499.055,

 7         F.S.; requiring the Department of Health to

 8         establish a website listing all permitholders

 9         and pending enforcement actions; creating s.

10         499.065, F.S.; authorizing the department to

11         enter and inspect all permitted facilities at

12         any reasonable time; authorizing the department

13         to seize and destroy prescription drugs

14         representing a threat to public health;

15         authorizing the department to close facilities

16         that represent an imminent danger to public

17         health; amending s. 499.066, F.S.; providing

18         for administrative actions by the department;

19         creating s. 499.0661, F.S.; providing for the

20         department to issue cease and desist orders;

21         providing for the department to order the

22         removal of certain persons from involvement

23         with certain drug wholesalers; providing

24         penalties; amending s. 499.067, F.S.;

25         specifying additional grounds for denial of a

26         permit or certification; amending s. 499.069,

27         F.S.; revising certain penalty provisions;

28         creating s. 499.0691, F.S.; providing criminal

29         penalties for violations related to drugs or

30         false advertisement; amending s. 921.0022,

31         F.S., relating to the offense severity ranking

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 1         chart of the Criminal Punishment Code;

 2         conforming provisions to changes made by the

 3         act; amending s. 895.02, F.S.; including

 4         certain violations of part I of ch. 499, F.S.,

 5         within the definition of racketeering activity;

 6         amending ss. 16.56 and 905.34, F.S.;

 7         authorizing criminal violations of part I of

 8         ch. 499, F.S., to be prosecuted by the Office

 9         of Statewide Prosecution and heard by the

10         Statewide Grand Jury; providing for

11         severability; providing an appropriation;

12         providing an effective date.

13  

14  Be It Enacted by the Legislature of the State of Florida:

15  

16         Section 1.  This act may be cited as the "Prescription

17  Drug Protection Act."

18         Section 2.  Legislative findings and intent.--Based on

19  the report of the Seventeenth Statewide Grand Jury in its

20  First Interim Report the Legislature finds that prescription

21  drugs brought into the state by wholesalers are being

22  relabeled and falsely represented as being of a higher dosage

23  by other wholesalers in order to charge higher prices for

24  those drugs and that counterfeit substances labeled as genuine

25  pharmaceuticals are being distributed, thereby causing an

26  extreme danger that persons eventually receiving the drugs by

27  prescription are receiving ineffective drugs in nontherapeutic

28  doses, or even receiving dangerous or unwholesome substances,

29  with the result that the health and well-being of the public

30  is at risk. The Statewide Grand Jury also found that the lack

31  of an effective pedigree paper requirement has resulted in the

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 1  inability of prescription drug users to have confidence in the

 2  purity and efficacy of the drugs they use. The Statewide Grand

 3  Jury further noted that present laws do not allow effective

 4  criminal prosecution of persons involved in such false

 5  representations. It is the intent of the Legislature that the

 6  statutory changes and recommendations outlined in the

 7  Statewide Grand Jury's report be implemented as provided by

 8  this act.

 9         Section 3.  Section 499.003, Florida Statutes, is

10  amended to read:

11         499.003  Definitions of terms used in ss.

12  499.001-499.081.--As used in ss. 499.001-499.081, the term:

13         (1)  "Advertisement" means any representation

14  disseminated in any manner or by any means, other than by

15  labeling, for the purpose of inducing, or which is likely to

16  induce, directly or indirectly, the purchase of drugs,

17  devices, or cosmetics.

18         (2)  "Affiliated party" means:

19         (a)  A director, officer, trustee, partner, or

20  committee member of a permittee or applicant or a subsidiary

21  or service corporation of the permittee or applicant;

22         (b)  A person who, directly or indirectly, manages,

23  controls, or oversees the operation of a permittee or

24  applicant, regardless of whether such person is a partner,

25  shareholder, manager, member, officer, director, independent

26  contractor, or employee of the permittee or applicant;

27         (c)  A person who has filed or is required to file a

28  personal information statement pursuant to s. 499.012(4) or is

29  required to be identified in an application for a permit or to

30  renew a permit pursuant to s. 499.012(3); or

31  

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

 2  least 5 percent of the permittee or applicant.

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

 4  or certification under ss. 499.001-499.081.

 5         (4)  "Authenticate" means to affirmatively verify

 6  before any distribution of a legend drug occurs that each

 7  transaction listed on the pedigree paper has occurred.

 8         (5)(2)  "Certificate of free sale" means a document

 9  prepared by the department which certifies a drug, device, or

10  cosmetic, that is registered with the department, as one that

11  can be legally sold in the state.

12         (6)(3)  "Closed pharmacy" means a pharmacy that is

13  licensed under chapter 465 and purchases prescription drugs

14  for use by a limited patient population and not for wholesale

15  distribution or sale to the public.  The term does not include

16  retail pharmacies.

17         (7)(4)  "Color" includes black, white, and intermediate

18  grays.

19         (8)(5)  "Color additive" means a material that:

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

21  process of synthesis or similar artifice, or extracted,

22  isolated, or otherwise derived, with or without intermediate

23  or final change of identity from a vegetable, animal, mineral,

24  or other source; or

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

26  the human body, or any part thereof, is capable alone, or

27  through reaction with other substances, of imparting color

28  thereto;

29  

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

31  been or hereafter is exempt under the federal act.

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 1         (9)(6)  "Compressed medical gas" means any liquefied or

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

 3  or in combination with other gases.

 4         (10)  "Contraband legend drug" means any adulterated

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

 6  defined in this section, and also means any legend drug for

 7  which a pedigree paper does not exist, or for which the

 8  pedigree paper in existence has been forged, counterfeited,

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

10  misrepresented matter.

11         (11)(7)  "Cosmetic" means an article that is:

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

13  sprayed on; introduced into; or otherwise applied to the human

14  body or any part thereof for cleansing, beautifying, promoting

15  attractiveness, or altering the appearance; or

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

17  article;

18  

19  except that the term does not include soap.

20         (12)(8)  "Counterfeit drug, counterfeit device, or

21  counterfeit cosmetic" means a drug, device, or cosmetic which,

22  or the container, seal, or labeling of which, without

23  authorization, bears the trademark, trade name, or other

24  identifying mark, imprint, or device, or any likeness thereof,

25  of a drug, device, or cosmetic manufacturer, processor,

26  packer, or distributor other than the person that in fact

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

28  device, or cosmetic and which thereby falsely purports or is

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

30  distributed by, that other drug, device, or cosmetic

31  manufacturer, processor, packer, or distributor.

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 1         (13)(9)  "Department" means the Department of Health.

 2         (14)(10)  "Device" means any instrument, apparatus,

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

 4  other similar or related article, including its components,

 5  parts, or accessories, which is:

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

 7  States Pharmacopoeia and National Formulary, or any supplement

 8  thereof,

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

10  mitigation, treatment, therapy, or prevention of disease in

11  humans or other animals, or

12         (c)  Intended to affect the structure or any function

13  of the body of humans or other animals,

14  

15  and which does not achieve any of its principal intended

16  purposes through chemical action within or on the body of

17  humans or other animals and which is not dependent upon being

18  metabolized for the achievement of any of its principal

19  intended purposes.

20         (15)(11)  "Distribute or distribution" means to sell;

21  offer to sell; give away; transfer, whether by passage of

22  title, physical movement, or both; deliver; or offer to

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

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

25  for prescription drugs" means an adulterated drug pursuant to

26  s. 499.006(10).

27         (17)(12)  "Drug" means an article that is:

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

29  States Pharmacopoeia and National Formulary, official

30  Homeopathic Pharmacopoeia of the United States, or any

31  supplement to any of those publications;

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

 2  mitigation, treatment, therapy, or prevention of disease in

 3  humans or other animals;

 4         (c)  Intended to affect the structure or any function

 5  of the body of humans or other animals; or

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

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

 8  but does not include devices or their components, parts, or

 9  accessories.

10         (18)(13)  "Establishment" means a place of business at

11  one general physical location.

12         (19)(14)  "Federal act" means the Federal Food, Drug,

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

14  seq.

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

16  legend drugs which are owned by another person and designated

17  by that person for export, and exports those legend drugs.

18         (21)(15)  "Health care entity" means a closed pharmacy

19  or any person, organization, or business entity that provides

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

21  chronic or rehabilitative care, but does not include any

22  wholesale distributor or retail pharmacy licensed under state

23  law to deal in prescription drugs.

24         (22)(16)  "Immediate container" does not include

25  package liners.

26         (23)(17)  "Label" means a display of written, printed,

27  or graphic matter upon the immediate container of any drug,

28  device, or cosmetic.  A requirement made by or under authority

29  of ss. 499.001-499.081 or rules adopted under those sections

30  that any word, statement, or other information appear on the

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

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 1  other information also appears on the outside container or

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

 3  or cosmetic or is easily legible through the outside container

 4  or wrapper.

 5         (24)(18)  "Labeling" means all labels and other

 6  written, printed, or graphic matters:

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

 8  containers or wrappers; or

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

10  cosmetic.

11         (25)(19)  "Legend drug," "prescription drug," or

12  "medicinal drug" means any drug, including, but not limited

13  to, finished dosage forms, or active ingredients subject to,

14  defined by, or described by s. 503(b) of the Federal Food,

15  Drug, and Cosmetic Act or s. 465.003(8), s. 499.007(12), or s.

16  499.0122(1)(b) or (c).

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

18  printed, or graphic matter upon the immediate container of any

19  legend drug prior to its dispensing to an individual patient

20  pursuant to a prescription of a practitioner authorized by law

21  to prescribe.

22         (27)(20)  "Manufacture" means the preparation,

23  deriving, compounding, propagation, processing, producing, or

24  fabrication of any drug, device, or cosmetic.  The term

25  includes repackaging or otherwise changing the container,

26  wrapper, or labeling to further the distribution of the drug,

27  device, or cosmetic.

28         (28)(21)  "Manufacturer" means a person who prepares,

29  derives, manufactures, or produces a drug, device, or

30  cosmetic. The term excludes pharmacies that are operating in

31  

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 1  compliance with pharmacy practice standards as defined in

 2  chapter 465 and rules adopted under that chapter.

 3         (29)(22)  "New drug" means:

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

 5  drug is not generally recognized, among experts qualified by

 6  scientific training and experience to evaluate the safety and

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

 8  the conditions prescribed, recommended, or suggested in the

 9  labeling of that drug; or

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

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

12  and effectiveness for use under certain conditions, has been

13  recognized for use under such conditions, but which drug has

14  not, other than in those investigations, been used to a

15  material extent or for a material time under such conditions.

16         (30)(23)  "Official compendium" means the current

17  edition of the official United States Pharmacopoeia and

18  National Formulary, or any supplement thereto.

19         (31)  "Pedigree paper" means:

20         (a)  A document required pursuant to s. 499.0121(6)(d)

21  or (e); or

22         (b)  Effective July 1, 2006, a document in a form

23  approved by the Department of Health and containing

24  information that records each distribution of any given legend

25  drug, from sale by a pharmaceutical manufacturer, through

26  acquisition and sale by any wholesaler or repackager, until

27  final sale to a pharmacy or other person administering or

28  dispensing the drug. The information required to be included

29  on a legend drug's pedigree paper must at least detail the

30  amount of the legend drug, its dosage form and strength, its

31  lot numbers, the name and address of each owner of the legend

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 1  drug and his or her signature, its shipping information,

 2  including the name and address of each person certifying

 3  delivery or receipt of the legend drug, and a certification

 4  that the recipient has authenticated the pedigree papers. It

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

 6  available, e-mail contact information of each wholesaler

 7  involved in the chain of the legend drug's custody. The

 8  department shall adopt rules and a form relating to the

 9  requirements of this paragraph no later than 90 days after the

10  effective date of this act.

11         (32)(24)  "Person" means any individual, child, joint

12  venture, syndicate, fiduciary, partnership, corporation,

13  division of a corporation, firm, trust, business trust,

14  company, estate, public or private institution, association,

15  organization, group, city, county, city and county, political

16  subdivision of this state, other governmental agency within

17  this state, and any representative, agent, or agency of any of

18  the foregoing, or any other group or combination of the

19  foregoing.

20         (33)(25)  "Prepackaged drug product" means a drug that

21  originally was in finished packaged form sealed by a

22  manufacturer and that is placed in a properly labeled

23  container by a pharmacy or practitioner authorized to dispense

24  pursuant to chapter 465 for the purpose of dispensing in the

25  establishment in which the prepackaging occurred.

26         (34)  "Prescription label" means any display of

27  written, printed, or graphic matter upon the immediate

28  container of any legend drug dispensed pursuant to a

29  prescription of a practitioner authorized by law to prescribe.

30         (35)(26)  "Prescription medical oxygen" means oxygen

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

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 1  prescription of a practitioner authorized by law to prescribe.

 2  The label of prescription medical oxygen must comply with

 3  current labeling requirements for oxygen under the Federal

 4  Food, Drug, and Cosmetic Act.

 5         (36)(27)  "Proprietary drug," or "OTC drug," means a

 6  patent or over-the-counter drug in its unbroken, original

 7  package, which drug is sold to the public by, or under the

 8  authority of, the manufacturer or primary distributor thereof,

 9  is not misbranded under the provisions of ss. 499.001-499.081,

10  and can be purchased without a prescription.

11         (37)  "Repackage" includes repacking or otherwise

12  changing the container, wrapper, or labeling to further the

13  distribution of the drug, device, or cosmetic.

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

15  term excludes pharmacies that are operating in compliance with

16  pharmacy practice standards as defined in chapter 465 and

17  rules adopted under that chapter.

18         (39)(28)  "Veterinary prescription drug" means a legend

19  drug intended solely for veterinary use.  The label of the

20  drug must bear the statement, "Caution:  Federal law restricts

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

22  veterinarian."

23         Section 4.  Section 499.005, Florida Statutes, is

24  amended to read:

25         499.005  Prohibited acts.--It is unlawful for a person

26  to perform or cause the performance of any of the following

27  acts in this state:

28         (1)  The manufacture, repackaging, sale, delivery, or

29  holding or offering for sale of any drug, device, or cosmetic

30  that is adulterated or misbranded or has otherwise been

31  rendered unfit for human or animal use.

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 1         (2)  The adulteration or misbranding of any drug,

 2  device, or cosmetic.

 3         (3)  The receipt of any drug, device, or cosmetic that

 4  is adulterated or misbranded, and the delivery or proffered

 5  delivery of such drug, device, or cosmetic, for pay or

 6  otherwise.

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

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

 9  ss. 499.001-499.081.

10         (5)  The dissemination of any false or misleading

11  advertisement of a drug, device, or cosmetic.

12         (6)  The refusal or constructive refusal:

13         (a)  To allow the department to enter or inspect an

14  establishment in which drugs, devices, or cosmetics are

15  manufactured, processed, repackaged, sold, brokered, or held;

16         (b)  To allow inspection of any record of that

17  establishment;

18         (c)  To allow the department to enter and inspect any

19  vehicle that is being used to transport drugs, devices, or

20  cosmetics; or

21         (d)  To allow the department to take samples of any

22  drug, device, or cosmetic.

23         (7)  The purchase or sale of prescription drugs for

24  wholesale distribution in exchange for currency, as defined in

25  s. 560.103(6). The giving of a false guaranty or false

26  undertaking with respect to a drug, device, or cosmetic,

27  except by a person who relied on a guaranty or undertaking to

28  the same effect signed by, and containing the name and address

29  of, the person residing in this state from whom she or he

30  received in good faith the drug, device, or cosmetic.

31  

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 1         (8)  Committing any act that causes a drug, device, or

 2  cosmetic to be a counterfeit drug, device, or cosmetic; or

 3  selling, dispensing, or holding for sale a counterfeit drug,

 4  device, or cosmetic.

 5         (9)  The alteration, mutilation, destruction,

 6  obliteration, or removal of the whole or any part of the

 7  labeling of a drug, device, or cosmetic, or the doing of any

 8  other act with respect to a drug, device, or cosmetic, if the

 9  act is done while the drug, device, or cosmetic is held for

10  sale and the act results in the drug, device, or cosmetic

11  being misbranded.

12         (10)  Forging; counterfeiting; simulating; falsely

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

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

15  label, or other identification device authorized or required

16  by rules adopted under ss. 499.001-499.081.

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

18  advertisement relating to such drug, of any representation or

19  suggestion that an application of the drug is effective when

20  it is not or that the drug complies with ss. 499.001-499.081

21  when it does not.

22         (12)  The possession of any drug in violation of ss.

23  499.001-499.081.

24         (13)  The sale, delivery, holding, or offering for sale

25  of any self-testing kits designed to tell persons their status

26  concerning human immunodeficiency virus or acquired immune

27  deficiency syndrome or related disorders or conditions.  This

28  prohibition shall not apply to home access HIV test kits

29  approved for distribution and sale by the United States Food

30  and Drug Administration.

31  

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 1         (14)  The purchase or receipt of a legend drug from a

 2  person that is not authorized under this chapter to distribute

 3  legend drugs to that purchaser or recipient.

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

 5  that is not authorized under the law of the jurisdiction in

 6  which the person receives the drug to purchase or possess

 7  legend drugs from the person selling or transferring the

 8  legend drug.

 9         (16)  The purchase or receipt of a compressed medical

10  gas from a person that is not authorized under this chapter to

11  distribute compressed medical gases.

12         (17)  The sale, purchase, or trade, or the offer to

13  sell, purchase, or trade, a drug sample as defined in s.

14  499.028; the distribution of a drug sample in violation of s.

15  499.028; or the failure to otherwise comply with s. 499.028.

16         (18)  Failure to maintain records as required by ss.

17  499.001-499.081 and rules adopted under those sections.

18         (19)  Providing the department with false or fraudulent

19  records, or making false or fraudulent statements, regarding

20  any matter within the provisions of this chapter.

21         (20)  The importation of a legend drug except as

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

23  Act.

24         (21)  The wholesale distribution of any prescription

25  drug that was:

26         (a)  Purchased by a public or private hospital or other

27  health care entity; or

28         (b)  Donated or supplied at a reduced price to a

29  charitable organization.

30  

31  

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

 2  operating without a valid permit when a permit or registration

 3  is required by ss. 499.001-499.081 for that activity.

 4         (23)  Obtaining or attempting to obtain a prescription

 5  drug or device by fraud, deceit, misrepresentation or

 6  subterfuge, or engaging in misrepresentation or fraud in the

 7  distribution of a drug or device.

 8         (24)  The distribution of a legend device to the

 9  patient or ultimate consumer without a prescription or order

10  from a practitioner licensed by law to use or prescribe the

11  device.

12         (25)  Charging a dispensing fee for dispensing,

13  administering, or distributing a prescription drug sample.

14         (26)  Removing a pharmacy's dispensing label from a

15  dispensed prescription drug with the intent to further

16  distribute the prescription drug.

17         (27)  Distributing a prescription drug that was

18  previously dispensed by a licensed pharmacy, unless such

19  distribution was authorized in chapter 465 or the rules

20  adopted under chapter 465.

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

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

23  wholesale distribution without first receiving a pedigree

24  paper that was attested to as accurate and complete by the

25  wholesale distributor.

26         Section 5.  Section 499.0051, Florida Statutes, is

27  created to read:

28         499.0051  Criminal acts involving contraband or

29  adulterated drugs.--

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

31  

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

 2  the wholesale distribution of legend drugs who fails to

 3  deliver to another person complete and accurate pedigree

 4  papers concerning a legend drug or contraband legend drug

 5  prior to transferring the legend drug or contraband legend

 6  drug to another person commits a felony of the third degree,

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

 8  775.084.

 9         (b)  A person engaged in the wholesale distribution of

10  legend drugs who fails to acquire complete and accurate

11  pedigree papers concerning a legend drug or contraband legend

12  drug prior to obtaining the legend drug or contraband legend

13  drug from another person commits a felony of the third degree,

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

15  775.084.

16         (c)  Any person who knowingly destroys, alters,

17  conceals, or fails to maintain complete and accurate pedigree

18  papers concerning any legend drug or contraband legend drug in

19  his or her possession commits a felony of the third degree,

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

21  775.084.

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

23         (a)1.  A person engaged in the wholesale distribution

24  of legend drugs who is in possession of documents required

25  under s. 499.0121(6)(e) and who fails to authenticate the

26  matters contained in the documents and who nevertheless

27  attempts to further distribute legend drugs or contraband

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

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

30         2.  A person in possession of documents required under

31  s. 499.0121(6)(e) who falsely swears or certifies that he or

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 1  she has authenticated the matters contained in the documents

 2  commits a felony of the third degree, punishable as provided

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

 4         3.  This paragraph expires July 1, 2006.

 5         (b)  Effective July 1, 2006:

 6         1.  A person engaged in the wholesale distribution of

 7  legend drugs who is in possession of pedigree papers

 8  concerning legend drugs or contraband legend drugs and who

 9  fails to authenticate the matters contained in the pedigree

10  papers and who nevertheless attempts to further distribute

11  legend drugs or contraband legend drug commits a felony of the

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

13  775.083, or s. 775.084.

14         2.  A person in possession of pedigree papers

15  concerning legend drugs or contraband legend drugs who falsely

16  swears or certifies that he or she has authenticated the

17  matters contained in the pedigree papers commits a felony of

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

19  775.083, or s. 775.084.

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

21  knowingly forges, counterfeits, or falsely creates any

22  pedigree paper; who falsely represents any factual matter

23  contained on any pedigree paper; or who knowingly omits to

24  record material information required to be recorded in a

25  pedigree paper, commits a felony of the second degree,

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

27  775.084.

28         (4)  PURCHASE OR RECEIPT OF LEGEND DRUG FROM

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

30  receives from a person not authorized to distribute legend

31  drugs under this chapter a legend drug in a wholesale

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 1  distribution transaction commits a felony of the second

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

 3  s. 775.084.

 4         (5)  SALE OR TRANSFER OF LEGEND DRUG TO UNAUTHORIZED

 5  PERSON.--A person who knowingly sells or transfers to a person

 6  not authorized to purchase or possess legend drugs, under the

 7  law of the jurisdiction in which the person receives the drug,

 8  a legend drug in a wholesale distribution transaction commits

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

10  775.082, s. 775.083, or s. 775.084.

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

12  SELL, CONTRABAND LEGEND DRUGS.--A person who is knowingly in

13  actual or constructive possession of any amount of contraband

14  legend drugs, who knowingly sells or delivers, or who

15  possesses with intent to sell or deliver any amount of

16  contraband legend drugs, commits a felony of the second

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

18  s. 775.084.

19         (7)  FORGERY OF PRESCRIPTION OR LEGEND DRUG LABELS.--A

20  person who knowingly forges, counterfeits, or falsely creates

21  any prescription label or legend drug label, or who falsely

22  represents any factual matter contained on any prescription

23  label or legend drug label, commits a felony of the first

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

25  s. 775.084.

26         Section 6.  Section 499.0052, Florida Statutes, is

27  created to read:

28         499.0052  Trafficking in contraband legend drugs.--A

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

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

31  constructive possession of any amount of contraband legend

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 1  drugs valued at $25,000 or more commits a felony of the first

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

 3  s. 775.084. Upon conviction, each defendant shall be ordered

 4  to pay a mandatory fine according to the following schedule:

 5         (1)  If the value of contraband legend drugs involved

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

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

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

 9  shall pay a mandatory fine of $75,000.

10         (2)  If the value of contraband legend drugs involved

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

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

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

14  shall pay a mandatory fine of $300,000.

15         (3)  If the value of contraband legend drugs involved

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

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

18  that is not a natural person, it shall pay a mandatory fine of

19  $600,000.

20  

21  As used in this section, the term "value" means the market

22  value of the property at the time and place of the offense or,

23  if such cannot be satisfactorily ascertained, the cost of

24  replacement of the property within a reasonable time after the

25  offense. Amounts of value of separate contraband legend drugs

26  involved in distinct transactions for the distribution of the

27  contraband legend drugs committed pursuant to one scheme or

28  course of conduct, whether involving the same person or

29  several persons, may be aggregated in determining the

30  punishment of the offense.

31  

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 1         Section 7.  Section 499.0053, Florida Statutes, is

 2  created, to read:

 3         499.0053  Sale or purchase of contraband legend drugs

 4  resulting in great bodily harm.--A person who knowingly sells,

 5  purchases, manufactures, delivers, or brings into this state,

 6  or who is knowingly in actual or constructive possession of

 7  any amount of contraband legend drugs, and whose acts in

 8  violation of this section result in great bodily harm to a

 9  person, commits a felony of the first degree, as provided in

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

11         Section 8.  Section 499.0054, Florida Statutes, is

12  created to read:

13         499.0054  Sale or purchase of contraband legend drugs

14  resulting in death.--A person who knowingly manufactures,

15  sells, purchases, delivers, or brings into this state, or who

16  is knowingly in actual or constructive possession of any

17  amount of contraband legend drugs, and whose acts in violation

18  of this section result in the death of a person, commits a

19  felony of the first degree, punishable by a term of years not

20  exceeding life, as provided in s. 775.082, s. 775.083, or s.

21  775.084.

22         Section 9.  Section 499.006, Florida Statutes, is

23  amended to read:

24         499.006  Adulterated drug or device.--A drug or device

25  is adulterated:

26         (1)  If it consists in whole or in part of any filthy,

27  putrid, or decomposed substance;

28         (2)  If it has been produced, prepared, packed, or held

29  under conditions whereby it could have been contaminated with

30  filth or rendered injurious to health;

31  

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

 2  facilities or controls used for, its manufacture, processing,

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

 4  administered in conformity with, current good manufacturing

 5  practices to assure that the drug meets the requirements of

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

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

 8  it purports or is represented to possess;

 9         (4)  If it is a drug and its container is composed, in

10  whole or in part, of any poisonous or deleterious substance

11  which could render the contents injurious to health;

12         (5)  If it is a drug and it bears or contains, for the

13  purpose of coloring only, a color additive that is unsafe

14  within the meaning of the federal act; or, if it is a color

15  additive, the intended use of which in or on drugs is for the

16  purpose of coloring only, and it is unsafe within the meaning

17  of the federal act;

18         (6)  If it purports to be, or is represented as, a drug

19  the name of which is recognized in the official compendium,

20  and its strength differs from, or its quality or purity falls

21  below, the standard set forth in such compendium.  The

22  determination as to strength, quality, or purity must be made

23  in accordance with the tests or methods of assay set forth in

24  such compendium, or, when such tests or methods of assay are

25  absent or inadequate, in accordance with those tests or

26  methods of assay prescribed under authority of the federal

27  act.  A drug defined in the official compendium is not

28  adulterated under this subsection merely because it differs

29  from the standard of strength, quality, or purity set forth

30  for that drug in such compendium if its difference in

31  

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 1  strength, quality, or purity from such standard is plainly

 2  stated on its label;

 3         (7)  If it is not subject to subsection (6) and its

 4  strength differs from, or its purity or quality falls below

 5  the standard of, that which it purports or is represented to

 6  possess; or

 7         (8)  If it is a drug:

 8         (a)  With which any substance has been mixed or packed

 9  so as to reduce the quality or strength of the drug; or

10         (b)  For which any substance has been substituted

11  wholly or in part;.

12         (9)  If it is a drug or device for which the expiration

13  date has passed; or.

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

15  pedigree paper is nonexistent, fraudulent, or incomplete under

16  the requirements of ss. 499.001-499.081 or applicable rules,

17  or that has been purchased, held, sold, or distributed at any

18  time by a person not authorized under federal or state law to

19  do so.

20         Section 10.  Subsection (2) of section 499.007, Florida

21  Statutes, is amended to read:

22         499.007  Misbranded drug or device.--A drug or device

23  is misbranded:

24         (2)  Unless, if in package form, it bears a label

25  containing:

26         (a)  The name and place of business of the

27  manufacturer, repackager, or distributor; in addition, for a

28  medicinal drug, as defined in s. 499.003, the label must

29  contain the name and place of business of the manufacturer of

30  the finished dosage form of the drug.  For the purpose of this

31  paragraph, the finished dosage form of a medicinal drug is

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 1  that form of the drug which is, or is intended to be,

 2  dispensed or administered to the patient and requires no

 3  further manufacturing or processing other than packaging,

 4  reconstitution, and labeling; and

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

 6  contents in terms of weight, measure, or numerical count;

 7  however, under this section, reasonable variations are

 8  permitted, and the department shall establish by rule

 9  exemptions for small packages.

10         Section 11.  Subsections (1) and (3) of section 499.01,

11  Florida Statutes, are amended to read:

12         499.01  Permits; applications; renewal; general

13  requirements.--

14         (1)  Any person that is required under ss.

15  499.001-499.081 to have a permit must apply to the department

16  on forms furnished by the department.

17         (a)  A permit issued pursuant to ss. 499.001-499.081

18  may be issued only to a natural person an individual who is at

19  least 18 years of age or to an applicant that is not a natural

20  person if each person who, directly or indirectly, manages,

21  controls, or oversees the operation of that applicant a

22  corporation that is registered pursuant to chapter 607 or

23  chapter 617 and each officer of which is at least 18 years of

24  age.

25         (b)  An establishment that is a place of residence may

26  not receive a permit and may not operate under ss.

27  499.001-499.081.

28         (c)  A person that applies for or renews a permit to

29  manufacture or distribute legend drugs may not use a name

30  identical to the name used by any other establishment or

31  licensed person authorized to purchase prescription drugs in

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 1  this state, except that a restricted drug distributor permit

 2  issued to a health care entity will be issued in the name in

 3  which the institutional pharmacy permit is issued and a retail

 4  pharmacy drug wholesaler will be issued a permit in the name

 5  of its retail pharmacy permit.

 6         (d)  A permit is required for each establishment that

 7  operates as a:

 8         1.  Prescription drug manufacturer;

 9         2.  Over-the-counter drug manufacturer;

10         3.  Compressed medical gas manufacturer;

11         4.  Device manufacturer;

12         5.  Cosmetic manufacturer;

13         6.  Prescription drug wholesaler;

14         7.  Compressed medical gas wholesaler;

15         8.  Out-of-state prescription drug wholesaler;

16         9.  Retail pharmacy drug wholesaler;

17         10.  Veterinary legend drug retail establishment;

18         11.  Medical oxygen retail establishment;

19         12.  Complimentary drug distributor; or

20         13.  Restricted prescription drug distributor.

21         (e)  A permit for a prescription drug manufacturer,

22  prescription drug wholesaler, or retail pharmacy wholesaler

23  may not be issued to the address of a health care entity or to

24  a pharmacy licensed under chapter 465, except as provided in

25  this paragraph. The department may issue a prescription drug

26  manufacturer permit to an applicant at the same address as a

27  licensed nuclear pharmacy, which is a health care entity, for

28  the purpose of manufacturing prescription drugs used in

29  positron emission tomography or other radiopharmaceuticals, as

30  listed in a rule adopted by the department pursuant to this

31  paragraph. The purpose of this exemption is to assure

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 1  availability of state-of-the-art pharmaceuticals that would

 2  pose a significant danger to the public health if manufactured

 3  at a separate establishment address from the nuclear pharmacy

 4  from which the prescription drugs are dispensed. The

 5  department may also issue a retail pharmacy wholesaler permit

 6  to the address of a community pharmacy licensed under chapter

 7  465 which does not meet the definition of a closed pharmacy in

 8  s. 499.003.

 9         (f)  A county or municipality may not issue an

10  occupational license for any licensing period beginning on or

11  after October 1, 2003, for any establishment that requires a

12  permit pursuant to ss. 499.001-499.081, unless the

13  establishment exhibits a current permit issued by the

14  department for the establishment. Upon presentation of the

15  requisite permit issued by the department, an occupational

16  license may be issued by the municipality or county in which

17  application is made. The department shall furnish to local

18  agencies responsible for issuing occupational licenses a

19  current list of all establishments licensed pursuant to ss.

20  499.001-499.081.

21         (g)(f)  Notwithstanding subsection (4), a permitted

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

23  to that person by completing a new application for the

24  requested permit, paying the amount of the difference in the

25  permit fees if the fee for the new permit is more than the fee

26  for the original permit, and meeting the applicable permitting

27  conditions for the new permit type. The new permit expires on

28  the expiration date of the original permit being changed;

29  however, a new permit for a prescription drug wholesaler and

30  an out-of-state prescription drug wholesaler shall expire on

31  the expiration date of the original permit or 1 year after the

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 1  date of issuance of the new permit, whichever is earlier. A

 2  refund may not be issued if the biennial fee for the new

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

 4  which a fee was paid.

 5         (3)  The department shall adopt rules for the biennial

 6  renewal of permits.

 7         (a)  The department shall renew a permit upon receipt

 8  of the renewal application and renewal fee if the applicant

 9  meets the requirements established under ss. 499.001-499.081

10  and the rules adopted under those sections.

11         (b)  A permit, unless sooner suspended or revoked,

12  automatically expires 2 years after the last day of the

13  anniversary month in which the permit was originally issued;

14  except that a prescription drug wholesaler permit or an

15  out-of-state prescription drug wholesaler permit issued from

16  July 1, 2003, through December 31, 2003, shall expire 1 year

17  after the last day of the anniversary month in which the

18  permit was issued. Any valid prescription drug wholesaler or

19  out-of-state prescription drug wholesaler permit issued by the

20  department on or before June 30, 2003, with an expiration date

21  between January 1, 2005, and June 30, 2005, shall

22  automatically expire 1 year prior to the expiration date

23  stated on the permit. A permittee that submits a renewal

24  application for a permit with a stated expiration date between

25  January 1, 2005, and June 30, 2005, shall receive a credit of

26  one-half of the permit fee paid when the application for the

27  expiring permit was submitted. Any valid prescription drug

28  wholesaler or out-of-state prescription drug wholesaler permit

29  issued by the department on or before June 30, 2003, with an

30  expiration date between July 1, 2004, and December 31, 2004,

31  shall automatically expire 6 months prior to the expiration

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 1  date stated on the permit. A permittee that submits a renewal

 2  application for a permit with a stated expiration date between

 3  July 1, 2004, and December 31, 2004, shall receive a credit of

 4  one-fourth of the permit fee paid when the application for the

 5  expiring permit was submitted. A permittee whose permit

 6  expiration date was accelerated in this paragraph may request

 7  a pro rata refund equivalent to the credit available for

 8  submission of a renewal application if the permittee does not

 9  submit a renewal application. A permit issued under ss.

10  499.001-499.081 may must be renewed by making application for

11  renewal on forms furnished by the department and paying the

12  appropriate fees.  If a renewal application and fee are not

13  submitted and postmarked after by the expiration date of the

14  permit, the permit may be renewed reinstated only upon payment

15  of a late renewal delinquent fee of $100, plus the required

16  renewal fee, not later than within 60 days after the

17  expiration date.

18         (c)  Failure to renew a permit in accordance with this

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

20  permit issued pursuant to this section has expired and cannot

21  be renewed, before an establishment may engage in activities

22  that require a permit under ss. 499.001-499.081, the

23  establishment must submit an application for a new permit, pay

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

25  all applicable penalties, and be issued a new permit by the

26  department. Continuing to engage in activities that require a

27  permit under ss. 499.001-499.081 requires a new permit

28  application and payment of an application fee, initial permit

29  fee, and applicable penalties.

30         Section 12.  Effective January 1, 2004, section 499.01,

31  Florida Statutes, as amended by this act, is amended to read:

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 1         499.01  Permits; applications; renewal; general

 2  requirements.--

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

 4  person and establishment that intends to operate as:

 5         (a)  A prescription drug manufacturer;

 6         (b)  A prescription drug repackager;

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

 8         (d)  A compressed medical gas manufacturer;

 9         (e)  A device manufacturer;

10         (f)  A cosmetic manufacturer;

11         (g)  A prescription drug wholesaler;

12         (h)  A compressed medical gas wholesaler;

13         (i)  An out-of-state prescription drug wholesaler;

14         (j)  A nonresident prescription drug manufacturer;

15         (k)  A freight forwarder;

16         (l)  A retail pharmacy drug wholesaler;

17         (m)  A veterinary legend drug retail establishment;

18         (n)  A medical oxygen retail establishment;

19         (o)  A complimentary drug distributor; or

20         (p)  A restricted prescription drug distributor.

21         (1)  Any person that is required under ss.

22  499.001-499.081 to have a permit must apply to the department

23  on forms furnished by the department.

24         (2)(a)  A permit issued pursuant to ss. 499.001-499.081

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

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

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

28  or oversees the operation of that applicant is at least 18

29  years of age.

30  

31  

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 1         (b)  An establishment that is a place of residence may

 2  not receive a permit and may not operate under ss.

 3  499.001-499.081.

 4         (c)  A person that applies for or renews a permit to

 5  manufacture or distribute legend drugs may not use a name

 6  identical to the name used by any other establishment or

 7  licensed person authorized to purchase prescription drugs in

 8  this state, except that a restricted drug distributor permit

 9  issued to a health care entity will be issued in the name in

10  which the institutional pharmacy permit is issued and a retail

11  pharmacy drug wholesaler will be issued a permit in the name

12  of its retail pharmacy permit.

13         (d)  A permit is required for each establishment that

14  operates as a:

15         1.  Prescription drug manufacturer;

16         2.  Over-the-counter drug manufacturer;

17         3.  Compressed medical gas manufacturer;

18         4.  Device manufacturer;

19         5.  Cosmetic manufacturer;

20         6.  Prescription drug wholesaler;

21         7.  Compressed medical gas wholesaler;

22         8.  Out-of-state prescription drug wholesaler;

23         9.  Retail pharmacy drug wholesaler;

24         10.  Veterinary legend drug retail establishment;

25         11.  Medical oxygen retail establishment;

26         12.  Complimentary drug distributor; or

27         13.  Restricted prescription drug distributor.

28         (d)(e)  A permit for a prescription drug manufacturer,

29  prescription drug repackager, prescription drug wholesaler, or

30  retail pharmacy wholesaler may not be issued to the address of

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

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 1  465, except as provided in this paragraph. The department may

 2  issue a prescription drug manufacturer permit to an applicant

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

 4  health care entity, for the purpose of manufacturing

 5  prescription drugs used in positron emission tomography or

 6  other radiopharmaceuticals, as listed in a rule adopted by the

 7  department pursuant to this paragraph. The purpose of this

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

 9  pharmaceuticals that would pose a significant danger to the

10  public health if manufactured at a separate establishment

11  address from the nuclear pharmacy from which the prescription

12  drugs are dispensed. The department may also issue a retail

13  pharmacy wholesaler permit to the address of a community

14  pharmacy licensed under chapter 465 which does not meet the

15  definition of a closed pharmacy in s. 499.003.

16         (e)(f)  A county or municipality may not issue an

17  occupational license for any licensing period beginning on or

18  after October 1, 2003, for any establishment that requires a

19  permit pursuant to ss. 499.001-499.081, unless the

20  establishment exhibits a current permit issued by the

21  department for the establishment. Upon presentation of the

22  requisite permit issued by the department, an occupational

23  license may be issued by the municipality or county in which

24  application is made. The department shall furnish to local

25  agencies responsible for issuing occupational licenses a

26  current list of all establishments licensed pursuant to ss.

27  499.001-499.081.

28         (3)(g)  Notwithstanding subsection (7)(4), a permitted

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

30  to that person by completing a new application for the

31  requested permit, paying the amount of the difference in the

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 1  permit fees if the fee for the new permit is more than the fee

 2  for the original permit, and meeting the applicable permitting

 3  conditions for the new permit type. The new permit expires on

 4  the expiration date of the original permit being changed;

 5  however, a new permit for a prescription drug wholesaler, an

 6  out-of-state prescription drug wholesaler, or a retail

 7  pharmacy drug wholesaler shall expire on the expiration date

 8  of the original permit or 1 year after the date of issuance of

 9  the new permit, whichever is earlier. A refund may not be

10  issued if the fee for the new permit is less than the fee that

11  was paid original permit.

12         (4)(2)  A written application for a permit or to renew

13  a permit must be filed with the department on forms furnished

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

15  the form and content of the application to obtain or renew a

16  permit.  The applicant must submit to the department with the

17  application a statement that swears or affirms that the

18  information is true and correct.

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

20  wholesaler or an out-of-state prescription drug wholesaler, an

21  application for a permit must include Information that an

22  applicant must provide includes, but need not be limited to:

23         1.  The name, full business address, and telephone

24  number of the applicant;

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

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

27  contact persons for each facility used by the applicant for

28  the storage, handling, and distribution of prescription drugs;

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

30  partnership, corporation, or sole proprietorship; and

31  

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

 2  establishment, including:

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

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

 5  name of the partnership;

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

 7  corporate officer and director, the corporate names, and the

 8  name of the state of incorporation;

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

10  proprietor and the name of the business entity; and

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

12  member, the name of each manager, the name of the limited

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

14  limited liability company was organized; and

15         f.e.  Any other relevant information that the

16  department requires.

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

18  and payment of the required fee, the department shall issue a

19  permit to the applicant, if the applicant meets the

20  requirements of ss. 499.001-499.081 and rules adopted under

21  those sections.

22         (c)  Any change in information required under paragraph

23  (a) must be submitted to the department before the change

24  occurs.

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

26  following factors in reviewing the qualifications of persons

27  to be permitted under ss. 499.001-499.081:

28         1.  The applicant's having been found guilty,

29  regardless of adjudication, in a court of this state or other

30  jurisdiction, of a violation of a law that directly relates to

31  a drug, device, or cosmetic.  A plea of nolo contendere

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 1  constitutes a finding of guilt for purposes of this

 2  subparagraph.

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

 4  regulatory agency in any state for any offense that would

 5  constitute a violation of ss. 499.001-499.081.

 6         3.  Any felony conviction of the applicant under a

 7  federal, state, or local law;

 8         4.  The applicant's past experience in manufacturing or

 9  distributing drugs, devices, or cosmetics;

10         5.  The furnishing by the applicant of false or

11  fraudulent material in any application made in connection with

12  manufacturing or distributing drugs, devices, or cosmetics;

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

14  local government of any permit currently or previously held by

15  the applicant for the manufacture or distribution of any

16  drugs, devices, or cosmetics;

17         7.  Compliance with permitting requirements under any

18  previously granted permits;

19         8.  Compliance with requirements to maintain or make

20  available to the state permitting authority or to federal,

21  state, or local law enforcement officials those records

22  required under this section; and

23         9.  Any other factors or qualifications the department

24  considers relevant to and consistent with the public health

25  and safety.

26         (6)  Except for permits for prescription drug

27  wholesalers or out-of-state prescription drug wholesalers:

28         (a)(3)  The department shall adopt rules for the

29  biennial renewal of permits.

30         (b)(a)  The department shall renew a permit upon

31  receipt of the renewal application and renewal fee if the

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 1  applicant meets the requirements established under ss.

 2  499.001-499.081 and the rules adopted under those sections.

 3         (c)(b)  A permit, unless sooner suspended or revoked,

 4  automatically expires 2 years after the last day of the

 5  anniversary month in which the permit was originally issued;

 6  except that a prescription drug wholesaler permit and an

 7  out-of-state prescription drug wholesaler permit, issued from

 8  July 1, 2003, through December 31, 2003, shall expire 1 year

 9  after the last day of the anniversary month in which the

10  permit was issued. Any valid prescription drug wholesaler or

11  out-of-state prescription drug wholesaler permit issued by the

12  department on or before June 30, 2003, with an expiration date

13  between January 1, 2005, and June 30, 2005, shall

14  automatically expire 1 year prior to the expiration date

15  stated on the permit. A permittee that submits a renewal

16  application for a permit with a stated expiration date between

17  January 1, 2005, and June 30, 2005, shall receive a credit of

18  one-half of the permit fee paid when the application for the

19  expiring permit was submitted. Any valid prescription drug

20  wholesaler or out-of-state prescription drug wholesaler permit

21  issued by the department on or before June 30, 2003, with an

22  expiration date between July 1, 2004, and December 31, 2004,

23  shall automatically expire 6 months prior to the expiration

24  date stated on the permit. A permittee that submits a renewal

25  application for a permit with a stated expiration date between

26  July 1, 2004, and December 31, 2004, shall receive a credit of

27  one-fourth of the permit fee paid when the application for the

28  expiring permit was submitted. A permittee whose permit

29  expiration date was accelerated in this paragraph may request

30  a pro rata refund equivalent to the credit available for

31  submission of a renewal application if the permittee does not

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 1  submit a renewal application. A permit issued under ss.

 2  499.001-499.081 may be renewed by making application for

 3  renewal on forms furnished by the department and paying the

 4  appropriate fees.  If a renewal application and fee are

 5  submitted and postmarked after the expiration date of the

 6  permit, the permit may be renewed only upon payment of a late

 7  renewal delinquent fee of $100, plus the required renewal fee,

 8  not later than 60 days after the expiration date.

 9         (d)(c)  Failure to renew a permit in accordance with

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

11  permit issued pursuant to this section has expired and cannot

12  be renewed, before an establishment may engage in activities

13  that require a permit under ss. 499.001-499.081, the

14  establishment must submit an application for a new permit, pay

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

16  all applicable penalties, and be issued a new permit by the

17  department.

18         (7)(4)  A permit issued by the department is

19  nontransferable.  Each permit is valid only for the person or

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

21  sale, assignment, or other transfer, voluntarily or

22  involuntarily; nor is a permit valid for any establishment

23  other than the establishment for which it was originally

24  issued.

25         (a)  A person permitted under ss. 499.001-499.081 must

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

27  department shall set a change of location fee not to exceed

28  $100.

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

30  a majority of the ownership or controlling interest of a

31  permitted establishment is transferred or assigned or when a

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 1  lessee agrees to undertake or provide services to the extent

 2  that legal liability for operation of the establishment will

 3  rest with the lessee.  The application for the new permit must

 4  be made before the date of the sale, transfer, assignment, or

 5  lease.

 6         2.  A permittee that is authorized to distribute legend

 7  drugs may transfer such drugs to the new owner or lessee under

 8  subparagraph 1. only after the new owner or lessee has been

 9  approved for a permit to distribute legend drugs.

10         (c)  The department shall deny, suspend, or revoke the

11  permit of any person or establishment if the assignment, sale,

12  transfer, or lease of an establishment permitted under ss.

13  499.001-499.081 will avoid an administrative penalty, civil

14  action, or criminal prosecution.

15         (c)(d)  If an establishment permitted under ss.

16  499.001-499.081 closes, the owner must notify the department

17  in writing before the effective date of closure and must:

18         1.  Return the permit to the department;

19         2.  If the permittee is authorized to distribute legend

20  drugs, indicate the disposition of such drugs, including the

21  name, address, and inventory, and provide the name and address

22  of a person to contact regarding access to records that are

23  required to be maintained under ss. 499.001-499.081.  Transfer

24  of ownership of legend drugs may be made only to persons

25  authorized to possess legend drugs under ss. 499.001-499.081.

26  

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

28  to comply with the requirements of this subsection.

29         (8)(5)  A permit must be posted in a conspicuous place

30  on the licensed premise.

31  

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 1         Section 13.  Section 499.012, Florida Statutes, is

 2  amended to read:

 3         499.012  Wholesale distribution; definitions; permits;

 4  applications; general requirements.--

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

 6         (a)  "Wholesale distribution" means distribution of

 7  prescription drugs to persons other than a consumer or

 8  patient, but does not include:

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

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

11  accordance with s. 499.014:

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

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

14  purchasing organization of a prescription drug for its own use

15  from the group purchasing organization or from other hospitals

16  or health care entities that are members of that organization.

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

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

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

20  Internal Revenue Code of 1986, as amended and revised, to a

21  nonprofit affiliate of the organization to the extent

22  otherwise permitted by law.

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

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

25  among hospitals or other health care entities that are under

26  common control. For purposes of this section, "common control"

27  means the power to direct or cause the direction of the

28  management and policies of a person or an organization,

29  whether by ownership of stock, by voting rights, by contract,

30  or otherwise.

31  

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

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

 3  government agency or any entity eligible to purchase

 4  prescription drugs at public health services prices pursuant

 5  to Pub. L. No. 102-585, s. 602 to a contract provider or its

 6  subcontractor for eligible patients of the agency or entity

 7  under the following conditions:

 8         (I)  The agency or entity must obtain written

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

10  of a prescription drug under this sub-subparagraph from the

11  Secretary of Health or his or her designee.

12         (II)  The contract provider or subcontractor must be

13  authorized by law to administer or dispense prescription

14  drugs.

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

16  entity must be a party to and execute the subcontract.

17         (IV)  A contract provider or subcontractor must

18  maintain separate and apart from other prescription drug

19  inventory any prescription drugs of the agency or entity in

20  its possession.

21         (V)  The contract provider and subcontractor must

22  maintain and produce immediately for inspection all records of

23  movement or transfer of all the prescription drugs belonging

24  to the agency or entity, including, but not limited to, the

25  records of receipt and disposition of prescription drugs. Each

26  contractor and subcontractor dispensing or administering these

27  drugs must maintain and produce records documenting the

28  dispensing or administration. Records that are required to be

29  maintained include, but are not limited to, a perpetual

30  inventory itemizing drugs received and drugs dispensed by

31  

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 1  prescription number or administered by patient identifier,

 2  which must be submitted to the agency or entity quarterly.

 3         (VI)  The contract provider or subcontractor may

 4  administer or dispense the prescription drugs only to the

 5  eligible patients of the agency or entity or must return the

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

 7  contract provider or subcontractor must require proof from

 8  each person seeking to fill a prescription or obtain treatment

 9  that the person is an eligible patient of the agency or entity

10  and must, at a minimum, maintain a copy of this proof as part

11  of the records of the contractor or subcontractor required

12  under sub-sub-subparagraph (V).

13         (VII)  In addition to the departmental inspection

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

15  contract provider and subcontractor and all records pertaining

16  to prescription drugs subject to this sub-subparagraph shall

17  be subject to inspection by the agency or entity. All records

18  relating to prescription drugs of a manufacturer under this

19  sub-subparagraph shall be subject to audit by the manufacturer

20  of those drugs, without identifying individual patient

21  information.

22         2.  Any of the following activities, which is not a

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

24  accordance with rules established by the department:

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

26  among federal, state, or local government health care entities

27  that are under common control and are authorized to purchase

28  such prescription drug.

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

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

31  for emergency medical reasons. For purposes of this

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 1  sub-subparagraph, the term "emergency medical reasons"

 2  includes transfers of prescription drugs by a retail pharmacy

 3  to another retail pharmacy to alleviate a temporary shortage.

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

 5  medical director on behalf of a licensed emergency medical

 6  services provider to that emergency medical services provider

 7  and its transport vehicles for use in accordance with the

 8  provider's license under chapter 401.

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

10  prescription drug to the person's prescription drug wholesale

11  supplier.

12         e.  The donation of a prescription drug by a health

13  care entity to a charitable organization that has been granted

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

15  of 1986, as amended, and that is authorized to possess

16  prescription drugs.

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

18  authorized to purchase or receive prescription drugs to a

19  person licensed or permitted to handle reverse distributions

20  or destruction under the laws of the jurisdiction in which the

21  person handling the reverse distribution or destruction

22  receives the drug.

23         g.  The transfer of a prescription drug by a hospital

24  or other health care entity to a person licensed under this

25  chapter to repackage prescription drugs for the purpose of

26  repackaging the prescription drug for use by that hospital, or

27  other health care entity and other health care entities that

28  are under common control, if ownership of the prescription

29  drugs remains with the hospital or other health care entity at

30  all times. In addition to the recordkeeping requirements of s.

31  499.0121(6), the hospital or health care entity that transfers

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 1  prescription drugs pursuant to this sub-subparagraph must

 2  reconcile all drugs transferred and returned and resolve any

 3  discrepancies in a timely manner.

 4         3.  The distribution of prescription drug samples by

 5  manufacturers' representatives or distributors'

 6  representatives conducted in accordance with s. 499.028.

 7         4.  The sale, purchase, or trade of blood and blood

 8  components intended for transfusion. As used in this

 9  subparagraph, the term "blood" means whole blood collected

10  from a single donor and processed either for transfusion or

11  further manufacturing, and the term "blood components" means

12  that part of the blood separated by physical or mechanical

13  means.

14         5.  The lawful dispensing of a prescription drug in

15  accordance with chapter 465.

16         (b)  "Wholesale distributor" means any person engaged

17  in wholesale distribution of prescription drugs in or into

18  this state, including, but not limited to, manufacturers;

19  repackagers repackers; own-label distributors; jobbers;

20  private-label distributors; brokers; warehouses, including

21  manufacturers' and distributors' warehouses, chain drug

22  warehouses, and wholesale drug warehouses; independent

23  wholesale drug traders; exporters; retail pharmacies; and the

24  agents thereof that conduct wholesale distributions.

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

26  licensed under chapter 465 that purchases prescription drugs

27  at fair market prices and provides prescription services to

28  the public.

29         (2)  The following types of wholesaler permits are

30  established:

31  

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 1         (a)  A prescription drug wholesaler's permit. A

 2  prescription drug wholesaler is a wholesale distributor that

 3  may engage in the wholesale distribution of prescription

 4  drugs. A prescription drug wholesaler that applies to the

 5  department for a new permit or the renewal of a permit after

 6  July 1, 2003 January 1, 1993, must submit a bond of $100,000,

 7  or other equivalent means of security acceptable to the

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

 9  deposit in a trust account or financial institution $200,

10  payable to the Florida Drug, Device, and Cosmetic Trust Fund.

11  The purpose of the bond is to secure payment of any

12  administrative penalties imposed by the department and any

13  fees and costs incurred by the department regarding that

14  permit which are authorized under state law and which the

15  permittee fails to pay 30 days after the fine or costs become

16  final. The department may make a claim against such bond or

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

18  be valid or until 60 days after any administrative or legal

19  proceeding authorized in ss. 499.001-499.081 which involves

20  the permittee is concluded, including any appeal, whichever

21  occurs later. This bond will be refunded to the permittee when

22  the permit is returned to the department and the permittee

23  ceases to function as a business. A permittee that fails to

24  notify the department before changing the address of the

25  business, fails to notify the department before closing the

26  business, or fails to notify the department before a change of

27  ownership forfeits its bond. The department may adopt rules

28  for issuing a prescription drug wholesaler-broker permit to a

29  person who engages in the wholesale distribution of

30  prescription drugs and does not take physical possession of

31  any prescription drugs.

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 1         (b)  A compressed medical gas wholesaler's permit. A

 2  compressed medical gas wholesaler is a wholesale distributor

 3  that is limited to the wholesale distribution of compressed

 4  medical gases to other than the consumer or patient. The

 5  compressed medical gas must be in the original sealed

 6  container that was purchased by that wholesaler. A compressed

 7  medical gas wholesaler may not possess or engage in the

 8  wholesale distribution of any prescription drug other than

 9  compressed medical gases. The department shall adopt rules

10  that govern the wholesale distribution of prescription medical

11  oxygen for emergency use. With respect to the emergency use of

12  prescription medical oxygen, those rules may not be

13  inconsistent with rules and regulations of federal agencies

14  unless the Legislature specifically directs otherwise.

15         (c)  An out-of-state prescription drug wholesaler's

16  permit. An out-of-state prescription drug wholesaler is a

17  wholesale distributor located outside this state which engages

18  in the wholesale distribution of prescription drugs into this

19  state and which must be permitted by the department and comply

20  with all the provisions required of a wholesale distributor

21  under ss. 499.001-499.081. An out-of-state prescription drug

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

23  the renewal of a permit after July 1, 2003, must submit a bond

24  of $100,000, or other equivalent means of security acceptable

25  to the department, such as an irrevocable letter of credit or

26  a deposit in a trust account or financial institution, payable

27  to the Florida Drug, Device, and Cosmetic Trust Fund. The

28  purpose of the bond is to secure payment of any administrative

29  penalties imposed by the department and any fees and costs

30  incurred by the department regarding that permit which are

31  authorized under state law and which the permittee fails to

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 1  pay 30 days after the fine or costs become final. The

 2  department may make a claim against such bond or security

 3  until 1 year after the permittee's license ceases to be valid

 4  or until 60 days after any administrative or legal proceeding

 5  authorized in ss. 499.001-499.081 which involves the permittee

 6  is concluded, including any appeal, whichever occurs later.

 7         1.  The out-of-state drug wholesaler must maintain at

 8  all times a license or permit to engage in the wholesale

 9  distribution of prescription drugs in compliance with laws of

10  the state in which it is a resident.

11         2.  An out-of-state prescription drug wholesaler's

12  permit is not required for an intracompany sale or transfer of

13  a prescription drug from an out-of-state establishment that is

14  duly licensed as a prescription drug wholesaler, in its state

15  of residence, to a licensed prescription drug wholesaler in

16  this state, if both wholesalers conduct wholesale

17  distributions of prescription drugs under the same business

18  name are under common control. The recordkeeping requirements

19  of s. 499.0121(6) must be followed for this transaction.

20         3.  The department may adopt rules that allow

21  out-of-state drug wholesalers to obtain a drug wholesale

22  permit on the basis of reciprocity to the extent that an

23  out-of-state drug wholesaler:

24         a.  Possesses a valid permit granted by another state

25  that has requirements comparable to those that a drug

26  wholesaler in this state must meet as prerequisites to

27  obtaining a permit under the laws of this state.

28         b.  Can show that the other state from which the

29  wholesaler holds a permit would extend reciprocal treatment

30  under its own laws to a drug wholesaler of this state.

31  

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 1         (d)  A retail pharmacy wholesaler's permit. A retail

 2  pharmacy wholesaler is a retail pharmacy engaged in wholesale

 3  distribution of prescription drugs within this state under the

 4  following conditions:

 5         1.  The pharmacy must obtain a retail pharmacy

 6  wholesaler's permit pursuant to ss. 499.001-499.081 and the

 7  rules adopted under those sections.

 8         2.  The wholesale distribution activity does not exceed

 9  30 percent of the total annual purchases of prescription

10  drugs. If the wholesale distribution activity exceeds the

11  30-percent maximum, the pharmacy must obtain a prescription

12  drug wholesaler's permit.

13         3.  The transfer of prescription drugs that appear in

14  any schedule contained in chapter 893 is subject to chapter

15  893 and the federal Comprehensive Drug Abuse Prevention and

16  Control Act of 1970.

17         4.  The transfer is between a retail pharmacy and

18  another retail pharmacy, or a Modified Class II institutional

19  pharmacy, or a health care practitioner licensed in this state

20  and authorized by law to dispense or prescribe prescription

21  drugs.

22         5.  All records of sales of prescription drugs subject

23  to this section must be maintained separate and distinct from

24  other records and comply with the recordkeeping requirements

25  of ss. 499.001-499.081.

26         (3)  A person that engages in wholesale distribution of

27  prescription drugs in this state must have a wholesale

28  distributor's permit issued by the department, except as noted

29  in this section. Each establishment must be separately

30  permitted except as noted in this subsection.

31  

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 1         (a)  A separate establishment permit is not required

 2  when a permitted prescription drug wholesaler consigns a

 3  prescription drug to a pharmacy that is permitted under

 4  chapter 465 and located in this state, provided that:

 5         1.  The consignor wholesaler notifies the department in

 6  writing of the contract to consign prescription drugs to a

 7  pharmacy along with the identity and location of each

 8  consignee pharmacy;

 9         2.  The pharmacy maintains its permit under chapter

10  465;

11         3.  The consignor wholesaler, which has no legal

12  authority to dispense prescription drugs, complies with all

13  wholesale distribution requirements of s. 499.0121 with

14  respect to the consigned drugs and maintains records

15  documenting the transfer of title or other completion of the

16  wholesale distribution of the consigned prescription drugs;

17         4.  The distribution of the prescription drug is

18  otherwise lawful under this chapter and other applicable law;

19         5.  Open packages containing prescription drugs within

20  a pharmacy are the responsibility of the pharmacy, regardless

21  of how the drugs are titled; and

22         6.  The pharmacy dispenses the consigned prescription

23  drug in accordance with the limitations of its permit under

24  chapter 465 or returns the consigned prescription drug to the

25  consignor wholesaler. In addition, a person who holds title to

26  prescription drugs may transfer the drugs to a person

27  permitted or licensed to handle the reverse distribution or

28  destruction of drugs. Any other distribution by and means of

29  the consigned prescription drug by any person, not limited to

30  the consignor wholesaler or consignee pharmacy, to any other

31  person is prohibited.

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 1         (b)  A wholesale distributor's permit is not required

 2  for the one-time transfer of title of a pharmacy's lawfully

 3  acquired prescription drug inventory by a pharmacy with a

 4  valid permit issued under chapter 465 to a consignor

 5  prescription drug wholesaler, permitted under this chapter, in

 6  accordance with a written consignment agreement between the

 7  pharmacy and that wholesaler if:  the permitted pharmacy and

 8  the permitted prescription drug wholesaler comply with all of

 9  the provisions of paragraph (a) and the prescription drugs

10  continue to be within the permitted pharmacy's inventory for

11  dispensing in accordance with the limitations of the pharmacy

12  permit under chapter 465. A consignor drug wholesaler may not

13  use the pharmacy as a wholesale distributor through which it

14  distributes the legend drugs to other pharmacies. Nothing in

15  this section is intended to prevent a wholesale drug

16  distributor from obtaining this inventory in the event of

17  nonpayment by the pharmacy.

18         (c)  The department shall require information from each

19  wholesale distributor as part of the permit and renewal of

20  such permit, as required under s. 499.01.

21         (4)  Personnel employed in wholesale distribution must

22  have appropriate education and experience to enable them to

23  perform their duties in compliance with state permitting

24  requirements.

25         (5)  The department may adopt rules governing the

26  recordkeeping, storage, and handling with respect to each of

27  the distributions of prescription drugs specified in

28  subparagraphs (1)(a)1.-4.

29         Section 14.  Effective January 1, 2004, section

30  499.012, Florida Statutes, as amended by this act, is amended

31  to read:

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 1         499.012  Wholesale distribution; definitions; permits;

 2  applications; general requirements.--

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

 4         (a)  "Wholesale distribution" means distribution of

 5  prescription drugs to persons other than a consumer or

 6  patient, but does not include:

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

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

 9  accordance with s. 499.014:

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

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

12  purchasing organization of a prescription drug for its own use

13  from the group purchasing organization or from other hospitals

14  or health care entities that are members of that organization.

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

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

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

18  Internal Revenue Code of 1986, as amended and revised, to a

19  nonprofit affiliate of the organization to the extent

20  otherwise permitted by law.

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

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

23  among hospitals or other health care entities that are under

24  common control. For purposes of this section, "common control"

25  means the power to direct or cause the direction of the

26  management and policies of a person or an organization,

27  whether by ownership of stock, by voting rights, by contract,

28  or otherwise.

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

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

31  government agency or any entity eligible to purchase

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 1  prescription drugs at public health services prices pursuant

 2  to Pub. L. No. 102-585, s. 602 to a contract provider or its

 3  subcontractor for eligible patients of the agency or entity

 4  under the following conditions:

 5         (I)  The agency or entity must obtain written

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

 7  of a prescription drug under this sub-subparagraph from the

 8  Secretary of Health or his or her designee.

 9         (II)  The contract provider or subcontractor must be

10  authorized by law to administer or dispense prescription

11  drugs.

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

13  entity must be a party to and execute the subcontract.

14         (IV)  A contract provider or subcontractor must

15  maintain separate and apart from other prescription drug

16  inventory any prescription drugs of the agency or entity in

17  its possession.

18         (V)  The contract provider and subcontractor must

19  maintain and produce immediately for inspection all records of

20  movement or transfer of all the prescription drugs belonging

21  to the agency or entity, including, but not limited to, the

22  records of receipt and disposition of prescription drugs. Each

23  contractor and subcontractor dispensing or administering these

24  drugs must maintain and produce records documenting the

25  dispensing or administration. Records that are required to be

26  maintained include, but are not limited to, a perpetual

27  inventory itemizing drugs received and drugs dispensed by

28  prescription number or administered by patient identifier,

29  which must be submitted to the agency or entity quarterly.

30         (VI)  The contract provider or subcontractor may

31  administer or dispense the prescription drugs only to the

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 1  eligible patients of the agency or entity or must return the

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

 3  contract provider or subcontractor must require proof from

 4  each person seeking to fill a prescription or obtain treatment

 5  that the person is an eligible patient of the agency or entity

 6  and must, at a minimum, maintain a copy of this proof as part

 7  of the records of the contractor or subcontractor required

 8  under sub-sub-subparagraph (V).

 9         (VII)  In addition to the departmental inspection

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

11  contract provider and subcontractor and all records pertaining

12  to prescription drugs subject to this sub-subparagraph shall

13  be subject to inspection by the agency or entity. All records

14  relating to prescription drugs of a manufacturer under this

15  sub-subparagraph shall be subject to audit by the manufacturer

16  of those drugs, without identifying individual patient

17  information.

18         2.  Any of the following activities, which is not a

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

20  accordance with rules established by the department:

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

22  among federal, state, or local government health care entities

23  that are under common control and are authorized to purchase

24  such prescription drug.

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

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

27  for emergency medical reasons. For purposes of this

28  sub-subparagraph, the term "emergency medical reasons"

29  includes transfers of prescription drugs by a retail pharmacy

30  to another retail pharmacy to alleviate a temporary shortage.

31  

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

 2  medical director on behalf of a licensed emergency medical

 3  services provider to that emergency medical services provider

 4  and its transport vehicles for use in accordance with the

 5  provider's license under chapter 401.

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

 7  prescription drug to the person's prescription drug wholesale

 8  supplier.

 9         e.  The donation of a prescription drug by a health

10  care entity to a charitable organization that has been granted

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

12  of 1986, as amended, and that is authorized to possess

13  prescription drugs.

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

15  authorized to purchase or receive prescription drugs to a

16  person licensed or permitted to handle reverse distributions

17  or destruction under the laws of the jurisdiction in which the

18  person handling the reverse distribution or destruction

19  receives the drug.

20         g.  The transfer of a prescription drug by a hospital

21  or other health care entity to a person licensed under this

22  chapter to repackage prescription drugs for the purpose of

23  repackaging the prescription drug for use by that hospital, or

24  other health care entity and other health care entities that

25  are under common control, if ownership of the prescription

26  drugs remains with the hospital or other health care entity at

27  all times. In addition to the recordkeeping requirements of s.

28  499.0121(7), the hospital or health care entity that transfers

29  prescription drugs pursuant to this sub-subparagraph must

30  reconcile all drugs transferred and returned and resolve any

31  discrepancies in a timely manner.

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 1         3.  The distribution of prescription drug samples by

 2  manufacturers' representatives or distributors'

 3  representatives conducted in accordance with s. 499.028.

 4         4.  The sale, purchase, or trade of blood and blood

 5  components intended for transfusion. As used in this

 6  subparagraph, the term "blood" means whole blood collected

 7  from a single donor and processed either for transfusion or

 8  further manufacturing, and the term "blood components" means

 9  that part of the blood separated by physical or mechanical

10  means.

11         5.  The lawful dispensing of a prescription drug in

12  accordance with chapter 465.

13         (b)  "Wholesale distributor" means any person engaged

14  in wholesale distribution of prescription drugs in or into

15  this state, including, but not limited to, manufacturers;

16  repackagers; own-label distributors; jobbers; private-label

17  distributors; brokers; warehouses, including manufacturers'

18  and distributors' warehouses, chain drug warehouses, and

19  wholesale drug warehouses; independent wholesale drug traders;

20  exporters; retail pharmacies; and the agents thereof that

21  conduct wholesale distributions.

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

23  licensed under chapter 465 that purchases prescription drugs

24  at fair market prices and provides prescription services to

25  the public.

26         (d)  "Primary wholesaler" means any wholesale

27  distributor that:

28         1.  Purchased 90 percent or more of the total dollar

29  volume of its purchases of prescription drugs directly from

30  manufacturers in the previous year; and

31  

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 1         2.a.  Directly purchased prescription drugs from not

 2  fewer than 50 different prescription drug manufacturers in the

 3  previous year; or

 4         b.  Has, or the affiliated group of which the wholesale

 5  distributor is a member has, not fewer than 250 employees.

 6         (e)  "Directly from a manufacturer" means:

 7         1.  Purchases made by the wholesale distributor

 8  directly from the manufacturer of prescription drugs; and

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

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

11  wholesale distributor is a member, if:

12         a.  The affiliated group purchases 90 percent or more

13  of the total dollar volume of its purchases of prescription

14  drugs from manufacturers in the previous year; or

15         b.  The wholesale distributor discloses to the

16  department the names of all members of the affiliated group of

17  which the wholesale distributor is a member and the affiliated

18  group agrees in writing to provide records on prescription

19  drug purchases by the members of the affiliated group not

20  later than 48 hours after the department requests access to

21  such records, regardless of the location where the records are

22  stored.

23         (f)  "Secondary wholesaler" means a wholesale

24  distributor that is not a primary wholesaler.

25         (2)  The following types of wholesaler permits are

26  established:

27         (a)  A prescription drug wholesaler's permit. A

28  prescription drug wholesaler is a wholesale distributor that

29  may engage in the wholesale distribution of prescription

30  drugs. A prescription drug wholesaler that applies to the

31  department for a new permit or the renewal of a permit after

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 1  July 1, 2003, must submit a bond of $100,000, or other

 2  equivalent means of security acceptable to the department,

 3  such as an irrevocable letter of credit or a deposit in a

 4  trust account or financial institution, payable to the Florida

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

 6  is to secure payment of any administrative penalties imposed

 7  by the department and any fees and costs incurred by the

 8  department regarding that permit which are authorized under

 9  state law and which the permittee fails to pay 30 days after

10  the fine or costs become final. The department may make a

11  claim against such bond or security until 1 year after the

12  permittee's license ceases to be valid or until 60 days after

13  any administrative or legal proceeding authorized in ss.

14  499.001-499.081 which involves the permittee is concluded,

15  including any appeal, whichever occurs later. The department

16  may adopt rules for issuing a prescription drug

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

18  wholesale distribution of prescription drugs and does not take

19  physical possession of any prescription drugs.

20         (b)  A compressed medical gas wholesaler's permit. A

21  compressed medical gas wholesaler is a wholesale distributor

22  that is limited to the wholesale distribution of compressed

23  medical gases to other than the consumer or patient. The

24  compressed medical gas must be in the original sealed

25  container that was purchased by that wholesaler. A compressed

26  medical gas wholesaler may not possess or engage in the

27  wholesale distribution of any prescription drug other than

28  compressed medical gases. The department shall adopt rules

29  that govern the wholesale distribution of prescription medical

30  oxygen for emergency use. With respect to the emergency use of

31  prescription medical oxygen, those rules may not be

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 1  inconsistent with rules and regulations of federal agencies

 2  unless the Legislature specifically directs otherwise.

 3         (c)  An out-of-state prescription drug wholesaler's

 4  permit. An out-of-state prescription drug wholesaler is a

 5  wholesale distributor located outside this state which engages

 6  in the wholesale distribution of prescription drugs into this

 7  state and which must be permitted by the department and comply

 8  with all the provisions required of a wholesale distributor

 9  under ss. 499.001-499.081. An out-of-state prescription drug

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

11  the renewal of a permit after July 1, 2003, must submit a bond

12  of $100,000, or other equivalent means of security acceptable

13  to the department, such as an irrevocable letter of credit or

14  a deposit in a trust account or financial institution, payable

15  to the Florida Drug, Device, and Cosmetic Trust Fund. The

16  purpose of the bond is to secure payment of any administrative

17  penalties imposed by the department and any fees and costs

18  incurred by the department regarding that permit which are

19  authorized under state law and which the permittee fails to

20  pay 30 days after the fine or costs become final. The

21  department may make a claim against such bond or security

22  until 1 year after the permittee's license ceases to be valid

23  or until 60 days after any administrative or legal proceeding

24  authorized in ss. 499.001-499.081 which involves the permittee

25  is concluded, including any appeal, whichever occurs later.

26         1.  The out-of-state drug wholesaler must maintain at

27  all times a license or permit to engage in the wholesale

28  distribution of prescription drugs in compliance with laws of

29  the state in which it is a resident.

30         2.  An out-of-state prescription drug wholesaler's

31  permit is not required for an intracompany sale or transfer of

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 1  a prescription drug from an out-of-state establishment that is

 2  duly licensed as a prescription drug wholesaler, in its state

 3  of residence, to a licensed prescription drug wholesaler in

 4  this state, if both wholesalers conduct wholesale

 5  distributions of prescription drugs under the same business

 6  name. The recordkeeping requirements of s. 499.0121(6) must be

 7  followed for this transaction.

 8         (d)  A retail pharmacy wholesaler's permit. A retail

 9  pharmacy wholesaler is a retail pharmacy engaged in wholesale

10  distribution of prescription drugs within this state under the

11  following conditions:

12         1.  The pharmacy must obtain a retail pharmacy

13  wholesaler's permit pursuant to ss. 499.001-499.081 and the

14  rules adopted under those sections.

15         2.  The wholesale distribution activity does not exceed

16  30 percent of the total annual purchases of prescription

17  drugs. If the wholesale distribution activity exceeds the

18  30-percent maximum, the pharmacy must obtain a prescription

19  drug wholesaler's permit.

20         3.  The transfer of prescription drugs that appear in

21  any schedule contained in chapter 893 is subject to chapter

22  893 and the federal Comprehensive Drug Abuse Prevention and

23  Control Act of 1970.

24         4.  The transfer is between a retail pharmacy and

25  another retail pharmacy, or a Modified Class II institutional

26  pharmacy, or a health care practitioner licensed in this state

27  and authorized by law to dispense or prescribe prescription

28  drugs.

29         5.  All records of sales of prescription drugs subject

30  to this section must be maintained separate and distinct from

31  

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 1  other records and comply with the recordkeeping requirements

 2  of ss. 499.001-499.081.

 3         (e)  A nonresident prescription drug manufacturer

 4  permit is required for any person that is a manufacturer of

 5  prescription drugs, or the distribution point for a

 6  manufacturer of prescription drugs, and located outside of

 7  this state, or that is an an entity to whom an approved new

 8  drug application has been issued by the United States Food and

 9  Drug Administration, or the contracted manufacturer of the

10  approved new drug application holder, and located outside the

11  United States, which engages in the wholesale distribution in

12  this state of the prescription drugs it manufactures or is

13  responsible for manufacturing. Each such manufacturer or

14  entity must be permitted by the department and comply with all

15  the provisions required of a wholesale distributor under ss.

16  499.001-499.081, except s. 499.0121(6)(d), (e), or (f).

17         1.  A person that distributes prescription drugs that

18  it did not manufacture must also obtain an out-of-state

19  prescription drug wholesaler permit pursuant this section to

20  engage in the wholesale distribution of the prescription drugs

21  manufactured by another person and comply with the

22  requirements of an out-of-state prescription drug wholesaler.

23         2.  Any such person must comply with the licensing or

24  permitting requirements of the jurisdiction in which the

25  establishment is located and the federal act, and any product

26  wholesaled into this state must comply with ss.

27  499.001-499.081. If a person intends to import prescription

28  drugs from a foreign country into this state, the nonresident

29  prescription drug manufacturer must provide to the department

30  a list identifying each prescription drug it intends to import

31  

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 1  and document approval by the United States Food and Drug

 2  Administration for such importation.

 3         (f)  A freight forwarder permit is required for any

 4  person that engages in the distribution of a legend drug as a

 5  freight forwarder unless the person is a common carrier. The

 6  storage, handling, and recordkeeping of such distributions

 7  must comply with the requirements for wholesale distributors

 8  under s. 499.0121, except those set forth in s.

 9  499.0121(6)(d), (e), or (f).  A freight forwarder must provide

10  the source of the legend drugs with a validated airway bill,

11  bill of lading, or other appropriate documentation to evidence

12  the exportation of the product.

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

14  for a prescription drug wholesaler or an out-of-state

15  prescription drug wholesaler submitted to the department must

16  include:

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

18  number of the applicant.

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

20         (c)  The address, telephone numbers, and the names of

21  contact persons for each facility used by the applicant for

22  the storage, handling, and distribution of prescription drugs.

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

24  partnership, corporation, or sole proprietorship.

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

26  establishment, including:

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

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

29  name of the partnership.

30         3.  If a corporation:

31  

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

 2  officer and director.

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

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

 5  the corporation's state of incorporation.

 6         c.  The name and address of each shareholder of the

 7  corporation that owns 5 percent or more of the outstanding

 8  stock of the corporation.

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

10  proprietor and the name of the business entity.

11         5.  If a limited liability company:

12         a.  The name and address of each member.

13         b.  The name and address of each manager.

14         c.  The name and address of the limited liability

15  company, the resident agent of the limited liability company,

16  and the name of the state in which the limited liability

17  company was organized.

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

19  of the affiliated group of which the applicant is a member.

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

21  estimated annual dollar volume of prescription drug sales of

22  the applicant, the estimated annual percentage of the

23  applicant's total company sales that are prescription drugs,

24  the applicant's estimated annual total dollar volume of

25  purchases of prescription drugs, and the applicant's estimated

26  annual total dollar volume of prescription drug purchases

27  directly from manufacturers.

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

29  dollar volume of prescription drug sales in the previous year,

30  the total dollar volume of prescription drug sales made in the

31  previous 6 months, the percentage of total company sales that

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 1  were prescription drugs in the previous year, the total dollar

 2  volume of purchases of prescription drugs in the previous

 3  year, and the total dollar volume of prescription drug

 4  purchases directly from manufacturers in the previous year.

 5  

 6  Such portions of the information required pursuant to this

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

 8  shall be maintained by the department as trade secret

 9  information is required to be maintained under s. 499.051.

10         (h)  The tax year of the applicant.

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

12  applicant's establishment is located, if the establishment is

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

14  the property on which applicant's establishment is located

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

16  the establishment is not owned by the applicant.

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

18  applicant by any other state which authorize the applicant to

19  purchase or possess prescription drugs.

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

21  is applying for the permit or to renew the permit, the next

22  four highest ranking employees responsible for prescription

23  drug wholesale operations for the establishment, and the name

24  of all affiliated parties for the establishment, together with

25  the personal information statement and fingerprints required

26  pursuant to subsection (4) for each of such persons.

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

28  representatives as required by subsection (11), together with

29  the personal information statement and fingerprints, required

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

31  

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 1         (m)  For an applicant that is a secondary wholesaler,

 2  each of the following:

 3         1.  A personal background information statement

 4  containing the background information and fingerprints

 5  required pursuant to subsection (4) for each person named in

 6  the applicant's response to paragraphs (k) and (l) and for

 7  each affiliated party of the applicant.

 8         2.  If any of the five largest shareholders of the

 9  corporation seeking the permit is a corporation, the name,

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

11  each such corporation; the name and address of such

12  corporation; the name of such corporation's resident agent,

13  such corporation's resident agent's address, and such

14  corporation's state of its incorporation; and the name and

15  address of each shareholder of such corporation that owns 5

16  percent or more of the stock of such corporation.

17         3.  The name and address of all financial institutions

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

19  the operation of the establishment or to pay for drugs

20  purchased for the establishment, together with the names of

21  all persons that are authorized signatories on such accounts.

22  The portions of the information required pursuant to this

23  subparagraph which are a trade secret, as defined in s.

24  812.081, shall be maintained by the department as trade secret

25  information is required to be maintained under s. 499.051.

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

27  funds used to purchase or finance purchases of prescription

28  drugs or to finance the premises on which the establishment is

29  to be located.

30  

31  

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

 2  were borrowed, copies of all promissory notes or loans used to

 3  obtain such funds.

 4         (n)  Any other relevant information that the department

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

 6  related to whether the applicant satisfies the definition of a

 7  primary wholesaler or a secondary wholesaler.

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

 9  provide a personal information statement and fingerprints

10  shall provide the following information to the department on

11  forms prescribed by the department:

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

13  years.

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

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

16  and offices held during the past 7 years.

17         4.  The principal business and address of any business,

18  corporation, or other organization in which each such office

19  of the person was held or in which each such occupation or

20  position of employment was carried on.

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

22  years, the subject of any proceeding for the revocation of any

23  license and, if so, the nature of the proceeding and the

24  disposition of the proceeding.

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

26  been enjoined, either temporarily or permanently, by a court

27  of competent jurisdiction from violating any federal or state

28  law regulating the possession, control, or distribution of

29  prescription drugs, together with details concerning any such

30  event.

31  

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

 2  any business, including any investments, other than the

 3  ownership of stock in a publicly traded company or mutual

 4  fund, during the past 7 years, which manufactured,

 5  administered, prescribed, distributed, or stored

 6  pharmaceutical products and any lawsuits in which such

 7  businesses were named as a party.

 8         8.  A description of any felony criminal offense of

 9  which the person, as an adult, was found guilty, regardless of

10  whether adjudication of guilt was withheld or whether the

11  person pled guilty or nolo contendere. A criminal offense

12  committed in another jurisdiction which would have been a

13  felony in this state must be reported. If the person indicates

14  that a criminal conviction is under appeal and submits a copy

15  of the notice of appeal of that criminal offense, the

16  applicant must, within 15 days after the disposition of the

17  appeal, submit to the department a copy of the final written

18  order of disposition.

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

20  days.

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

22  under procedures specified by the department, together with

23  payment of an amount equal to the costs incurred by the

24  department for the criminal record check of the person.

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

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

27  is 18 years of age or older. As used in this subparagraph, the

28  term "member of the person's immediate family" includes the

29  person's spouse, children, parents, siblings, the spouses of

30  the person's children, and the spouses of the person's

31  siblings.

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 1         12.  Any other relevant information that the department

 2  requires.

 3         (b)  The information required pursuant to paragraph (a)

 4  shall be provided under oath.

 5         (c)  The department shall submit the fingerprints

 6  provided by a person for initial licensure to the Department

 7  of Law Enforcement for a statewide criminal record check and

 8  for forwarding to the Federal Bureau of Investigation for a

 9  national criminal record check of the person. The department

10  shall submit the fingerprints provided by a person as a part

11  of a renewal application to the Department of Law Enforcement

12  for a statewide criminal record check, and for forwarding to

13  the Federal Bureau of Investigation for a national criminal

14  record check, for the initial renewal of a permit after

15  January 1, 2004; for any subsequent renewal of a permit, the

16  department shall submit the required information for a

17  statewide and national criminal record check of the person.

18  Any person who as a part of an initial permit application or

19  initial permit renewal after January 1, 2004, submits to the

20  department a set of fingerprints required for the criminal

21  record check required in this paragraph shall not be required

22  to provide a subsequent set of fingerprints for a criminal

23  record check to the department, if the person has undergone a

24  criminal record check as a condition of the  the issuance of

25  an initial permit or the initial renewal of a permit of an

26  applicant after January 1, 2004.

27         (5)  The department may deny an application for a

28  permit or refuse to renew a permit for a prescription drug

29  wholesaler or an out-of-state prescription drug wholesaler if:

30         (a)  The applicant has not met the requirements for the

31  permit.

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 1         (b)  The management, officers, or directors of the

 2  applicant or any affiliated party are found by the department

 3  to be incompetent or untrustworthy.

 4         (c)  The applicant is so lacking in experience in

 5  managing a wholesale distributor as to make the issuance of

 6  the proposed permit hazardous to the public health.

 7         (d)  The applicant is so lacking in experience in

 8  managing a wholesale distributor as to jeopardize the

 9  reasonable promise of successful operation of the wholesale

10  distributor.

11         (e)  The applicant is lacking in experience in the

12  distribution of prescription drugs.

13         (f)  The applicant's past experience in manufacturing

14  or distributing prescription drugs indicates that the

15  applicant poses a public health risk.

16         (g)  The applicant is affiliated directly or indirectly

17  through ownership, control, or other business relations, with

18  any person or persons whose business operations are or have

19  been detrimental to the public health.

20         (h)  The applicant, or any affiliated party, has been

21  found guilty of or has pleaded guilty or nolo contendere to

22  any felony or crime punishable by imprisonment for 1 year or

23  more under the laws of the United States, any state, or any

24  other country, regardless of whether adjudication of guilt was

25  withheld.

26         (i)  The applicant or any affiliated party has been

27  charged with a felony in a state or federal court and the

28  disposition of that charge is pending during the application

29  review or renewal review period.

30         (j)  The applicant has furnished false or fraudulent

31  information or material in any application made in this state

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 1  or any other state in connection with obtaining a permit or

 2  license to manufacture or distribute drugs, devices, or

 3  cosmetics.

 4         (k)  That a federal, state, or local government permit

 5  currently or previously held by the applicant, or any

 6  affiliated party, for the manufacture or distribution of any

 7  drugs, devices, or cosmetics has been disciplined, suspended,

 8  or revoked and has not been reinstated.

 9         (l)  The applicant does not possess the financial or

10  physical resources to operate in compliance with the permit

11  being sought, this chapter, and the rules adopted under this

12  chapter.

13         (m)  The applicant or any affiliated party receives,

14  directly or indirectly, financial support and assistance from

15  a person who was an affiliated party of a permittee whose

16  permit was subject to discipline or was suspended or revoked,

17  other than through the ownership of stock in a publicly traded

18  company or a mutual fund.

19         (n)  The applicant or any affiliated party receives,

20  directly or indirectly, financial support and assistance from

21  a person who has been found guilty of any violation of ss.

22  499.001-499.081 or chapter 465, chapter 501, or chapter 893,

23  any rules adopted under any of those sections or chapters, any

24  federal or state drug law, or any felony where the underlying

25  facts related to drugs, regardless of whether the person has

26  been pardoned, had her or his civil rights restored, or had

27  adjudication withheld, other than through the ownership of

28  stock in a publicly traded company or a mutual fund.

29         (o)  The applicant for renewal of a permit under

30  paragraph (2)(a) or paragraph (2)(c) has not actively engaged

31  in the wholesale distribution of prescription drugs, as

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 1  demonstrated by the regular and systematic distribution of

 2  prescription drugs throughout the year as evidenced by not

 3  fewer than 12 wholesale distributions in the previous year and

 4  not fewer than three wholesale distributions in the previous 6

 5  months.

 6         (p)  Information obtained in response to paragraph

 7  (2)(a) or paragraph (2)(c) demonstrates it would not be in the

 8  best interest of the public health, safety, and welfare to

 9  issue a permit.

10         (q)  The applicant does not possess the financial

11  standing and business experience for the successful operation

12  of the applicant.

13         (r)  The applicant or any affiliated party has failed

14  to comply with the requirements for manufacturing or

15  distributing prescription drugs under ss. 499.001-499.081,

16  similar federal laws, similar laws in other states, or the

17  rules adopted under such laws.

18         (6)  Upon approval of the application by the department

19  and payment of the required fee, the department shall issue or

20  renew a prescription drug wholesaler or an out-of-state

21  prescription drug wholesaler permit to the applicant.

22         (7)  For permits for prescription drug wholesalers or

23  out-of-state prescription drug wholesalers:

24         (a)  The department shall adopt rules for the annual

25  renewal of permits. At least 90 days before the expiration of

26  a permit, the department shall forward a permit renewal

27  notification and renewal application to the prescription drug

28  wholesaler or out-of-state prescription drug wholesaler at the

29  mailing address of the permitted establishment on file with

30  the department. The permit renewal notification must state

31  conspicuously the date on which the permit for the

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 1  establishment will expire and that the establishment may not

 2  operate unless the permit for the establishment is renewed

 3  timely.

 4         (b)  A permit, unless sooner suspended or revoked,

 5  automatically expires 1 year after the last day of the

 6  anniversary month in which the permit was originally issued. A

 7  permit may be renewed by making application for renewal on

 8  forms furnished by the department and paying the appropriate

 9  fees. If a renewal application and fee are submitted and

10  postmarked after 45 days prior to the expiration date of the

11  permit, the permit may be renewed only upon payment of a late

12  renewal fee of $100, plus the required renewal fee. A

13  permittee that has submitted a renewal application in

14  accordance with this paragraph may continue to operate under

15  its permit, unless the permit is suspended or revoked, until

16  final disposition of the renewal application.

17         (c)  Failure to renew a permit in accordance with this

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

19  permit issued pursuant to this section has expired and cannot

20  be renewed, before an establishment may engage in activities

21  that require a permit under ss. 499.001-499.081, the

22  establishment must submit an application for a new permit; pay

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

24  applicable penalties; and be issued a new permit by the

25  department.

26         (8)(3)  A person that engages in wholesale distribution

27  of prescription drugs in this state must have a wholesale

28  distributor's permit issued by the department, except as noted

29  in this section. Each establishment must be separately

30  permitted except as noted in this subsection.

31  

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 1         (a)  A separate establishment permit is not required

 2  when a permitted prescription drug wholesaler consigns a

 3  prescription drug to a pharmacy that is permitted under

 4  chapter 465 and located in this state, provided that:

 5         1.  The consignor wholesaler notifies the department in

 6  writing of the contract to consign prescription drugs to a

 7  pharmacy along with the identity and location of each

 8  consignee pharmacy;

 9         2.  The pharmacy maintains its permit under chapter

10  465;

11         3.  The consignor wholesaler, which has no legal

12  authority to dispense prescription drugs, complies with all

13  wholesale distribution requirements of s. 499.0121 with

14  respect to the consigned drugs and maintains records

15  documenting the transfer of title or other completion of the

16  wholesale distribution of the consigned prescription drugs;

17         4.  The distribution of the prescription drug is

18  otherwise lawful under this chapter and other applicable law;

19         5.  Open packages containing prescription drugs within

20  a pharmacy are the responsibility of the pharmacy, regardless

21  of how the drugs are titled; and

22         6.  The pharmacy dispenses the consigned prescription

23  drug in accordance with the limitations of its permit under

24  chapter 465 or returns the consigned prescription drug to the

25  consignor wholesaler. In addition, a person who holds title to

26  prescription drugs may transfer the drugs to a person

27  permitted or licensed to handle the reverse distribution or

28  destruction of drugs. Any other distribution by and means of

29  the consigned prescription drug by any person, not limited to

30  the consignor wholesaler or consignee pharmacy, to any other

31  person is prohibited.

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 1         (b)  A wholesale distributor's permit is not required

 2  for the one-time transfer of title of a pharmacy's lawfully

 3  acquired prescription drug inventory by a pharmacy with a

 4  valid permit issued under chapter 465 to a consignor

 5  prescription drug wholesaler, permitted under this chapter, in

 6  accordance with a written consignment agreement between the

 7  pharmacy and that wholesaler if:  the permitted pharmacy and

 8  the permitted prescription drug wholesaler comply with all of

 9  the provisions of paragraph (a) and the prescription drugs

10  continue to be within the permitted pharmacy's inventory for

11  dispensing in accordance with the limitations of the pharmacy

12  permit under chapter 465. A consignor drug wholesaler may not

13  use the pharmacy as a wholesale distributor through which it

14  distributes the legend drugs to other pharmacies. Nothing in

15  this section is intended to prevent a wholesale drug

16  distributor from obtaining this inventory in the event of

17  nonpayment by the pharmacy.

18         (c)  The department shall require information from each

19  wholesale distributor as part of the permit and renewal of

20  such permit, as required under s. 499.01 or s. 499.012.

21         (9)(4)  Personnel employed in wholesale distribution

22  must have appropriate education and experience to enable them

23  to perform their duties in compliance with state permitting

24  requirements.

25         (10)  The name of a permittee or establishment on a

26  prescription drug wholesaler permit or an out-of-state

27  prescription drug wholesaler permit may not include any

28  indicia of attainment of any educational degree, any indicia

29  that the permittee or establishment possesses a professional

30  license, or any name or abbreviation that the department

31  determines is likely to cause confusion or mistake or that the

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 1  department determines is deceptive, including that of any

 2  other entity authorized to purchase prescription drugs.

 3         (11)(a)  Each establishment that is issued an initial

 4  or renewal permit as a prescription drug wholesaler or an

 5  out-of-state prescription drug wholesaler must designate in

 6  writing to the department at least one natural person to serve

 7  as the designated representative of the wholesaler. Such

 8  person must have an active certification as a designated

 9  representative from the department.

10         (b)  To be certified as a designated representative, a

11  natural person must:

12         1.  Submit an application on a form furnished by the

13  department and pay the appropriate fees;

14         2.  Be at least 18 years of age;

15         3.  Have not less than 2 years of verifiable full-time

16  work experience in a pharmacy licensed in this state or

17  another state, where the person's responsibilities included,

18  but were not limited to, recordkeeping for prescription drugs,

19  or have not less than 2 years of verifiable full-time

20  managerial experience with a prescription drug wholesaler

21  licensed in this state or in another state;

22         4.  Receive a passing score of at least 75 percent on

23  an examination given by the department regarding federal laws

24  governing distribution of prescription drugs and ss.

25  499.001-499.081 and the rules adopted by the department

26  governing the wholesale distribution of prescription drugs.

27  This requirement shall be effective 1 year after the results

28  of the initial examination are mailed to the persons that took

29  the examination. The department shall offer such examinations

30  at least four times each calendar year; and

31  

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 1         5.  Provide the department with a personal information

 2  statement and fingerprints pursuant to subsection (4).

 3         (c)  The department may deny an application for

 4  certification as a designated representative or may suspend or

 5  revoke a certification of a designated representative pursuant

 6  to s. 499.067.

 7         (d)  A designated representative:

 8         1.  Must be actively involved in and aware of the

 9  actual daily operation of the wholesale distributor.

10         2.  Must be employed full time in a managerial position

11  by the wholesale distributor.

12         3.  Must be physically present at the establishment

13  during normal business hours, except for time periods when

14  absent due to illness, family illness or death, scheduled

15  vacation, or other authorized absence.

16         4.  May serve as a designated representative for only

17  one wholesale distributor at any one time.

18         (e)  A wholesale distributor must notify the department

19  when a designated representative leaves the employ of the

20  wholesale distributor. Such notice must be provided to the

21  department within 10 business days after the last day of

22  designated representative's employment with the wholesale

23  distributor.

24         (f)  A wholesale distributor may not operate under a

25  prescription drug wholesaler permit or an out-of-state

26  prescription drug wholesaler permit for more than 10 business

27  days after the designated representative leaves the employ of

28  the wholesale distributor, unless the wholesale distributor

29  employs another designated representative and notifies the

30  department within 10 business days of the identity of the new

31  designated representative.

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 1         (12)(5)  The department may adopt rules governing the

 2  recordkeeping, storage, and handling with respect to each of

 3  the distributions of prescription drugs specified in

 4  subparagraphs (1)(a)1.-4.

 5         Section 15.  Subsections (4), (6), (7), and (8) of

 6  section 499.0121, Florida Statutes, are amended, and

 7  subsection (11) is added to that section, to read:

 8         499.0121  Storage and handling of prescription drugs;

 9  recordkeeping.--The department shall adopt rules to implement

10  this section as necessary to protect the public health,

11  safety, and welfare.  Such rules shall include, but not be

12  limited to, requirements for the storage and handling of

13  prescription drugs and for the establishment and maintenance

14  of prescription drug distribution records.

15         (4)  EXAMINATION OF MATERIALS AND RECORDS.--

16         (a)  Upon receipt, each outside shipping container must

17  be visually examined for identity and to prevent the

18  acceptance of contaminated prescription drugs that are

19  otherwise unfit for distribution. This examination must be

20  adequate to reveal container damage that would suggest

21  possible contamination or other damage to the contents.

22         (b)  Each outgoing shipment must be carefully inspected

23  for identity of the prescription drug products and to ensure

24  that there is no delivery of prescription drugs that have

25  expired or been damaged in storage or held under improper

26  conditions.

27         (c)  The recordkeeping requirements in subsection (6)

28  must be followed for all incoming and outgoing prescription

29  drugs.

30         (d)  Upon receipt, a wholesaler must review records

31  required under this section for the acquisition of

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 1  prescription drugs for accuracy and completeness, considering

 2  the total facts and circumstances surrounding the transactions

 3  and the wholesale distributors involved. This includes

 4  authenticating each transaction listed on a pedigree paper, as

 5  defined in s. 499.001(31).

 6         (6)  RECORDKEEPING.--The department shall adopt rules

 7  that require keeping such records of prescription drugs as are

 8  necessary for the protection of the public health.

 9         (a)  Wholesale drug distributors must establish and

10  maintain inventories and records of all transactions regarding

11  the receipt and distribution or other disposition of

12  prescription drugs.  These records must provide a complete

13  audit trail from receipt to sale or other disposition, be

14  readily retrievable for inspection, and include, at a minimum,

15  the following information:

16         1.  The source of the drugs, including the name and

17  principal address of the seller or transferor, and the address

18  of the location from which the drugs were shipped;

19         2.  The name, principal address, and state license

20  permit or registration number of the person authorized to

21  purchase prescription drugs;

22         3.  The name, strength, dosage form, and quantity of

23  the drugs received and distributed or disposed of; and

24         4.  The dates of receipt and distribution or other

25  disposition of the drugs; and.

26         5.  Any financial documentation supporting the

27  transaction.

28         (b)  Inventories and records must be made available for

29  inspection and photocopying by authorized federal, state, or

30  local officials for a period of 2 years following disposition

31  

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 1  of the drugs or 3 years after the creation of the records,

 2  whichever period is longer.

 3         (c)  Records described in this section that are kept at

 4  the inspection site or that can be immediately retrieved by

 5  computer or other electronic means must be readily available

 6  for authorized inspection during the retention period.

 7  Records that are kept at a central location outside of this

 8  state and that are not electronically retrievable must be made

 9  available for inspection within 2 working days after a request

10  by an authorized official of a federal, state, or local law

11  enforcement agency.  Records that are maintained at a central

12  location within this state must be maintained at an

13  establishment that is permitted pursuant to ss.

14  499.001-499.081 and must be readily available.

15         (d)1.  Each person who is engaged in the wholesale

16  distribution of a prescription drug, and who is not an

17  authorized distributor of record for the drug manufacturer's

18  products of such drug, must provide to each wholesale

19  distributor of such drug, before the sale is made to such

20  wholesale distributor, a written statement under oath

21  identifying each previous sale of the drug back to the last

22  authorized distributor of record, the lot number of the drug,

23  and the sales invoice number of the invoice evidencing the

24  sale of the drug.  The written statement identifying all sales

25  of such drug must accompany the drug for each subsequent

26  wholesale distribution of the drug to the next a wholesale

27  distributor. The department shall adopt rules relating to the

28  requirements of this written statement. This paragraph does

29  not apply to a manufacturer unless the manufacturer is

30  performing the manufacturing operation of repackaging

31  prescription drugs.

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 1         2.  Each wholesale distributor of prescription drugs

 2  must maintain separate and distinct from other required

 3  records all statements that are required under subparagraph 1.

 4  and paragraph (e).

 5         3.  Each manufacturer of a prescription drug sold in

 6  this state must maintain at its corporate offices a current

 7  list of authorized distributors and must make such list

 8  available to the department upon request.

 9         4.  Each manufacturer shall file a written list of all

10  of the manufacturer's authorized distributors of record with

11  the department. A manufacturer shall notify the department not

12  later than 10 days after any change to the list. The

13  department shall publish a list of all authorized distributors

14  of record on its website.

15         5.  For the purposes of this subsection, the term

16  "authorized distributors of record" means a wholesale

17  distributor those distributors with whom a manufacturer has

18  established an ongoing relationship to distribute the

19  manufacturer's products. Effective March 1, 2004, an ongoing

20  relationship is deemed to exist when a wholesale distributor,

21  including any affiliated group, as defined in s. 1504 of the

22  Internal Revenue Code, of which the wholesale distributor is a

23  member:

24         a.  Is listed on the manufacturer's current list of

25  authorized distributors of record.

26         b.  Annually purchases not less than 90 percent of all

27  of its purchases of a manufacturer's prescription drug

28  products, based on dollar volume, directly from that

29  manufacturer and has total annual prescription drug sales of

30  $100 million or more.

31  

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 1         c.  Has reported to the department pursuant to s.

 2  499.012(2)(g)2. that the wholesale distributor has total

 3  annual prescription drug sales of $100 million or more, and

 4  has a verifiable account number issued by the manufacturer

 5  authorizing the wholesale distributor to purchase the

 6  manufacturer's drug products directly from that manufacturer

 7  and that wholesale distributor makes not fewer than 12

 8  purchases of that manufacturer's drug products directly from

 9  the manufacturer using said verifiable account number in 12

10  months. The provisions of this sub-subparagraph apply with

11  respect to a manufacturer that fails to file a copy of the

12  manufacturer's list of authorized distributors of record with

13  the department by July 1, 2003; that files a list of

14  authorized distributors of record which contains fewer than

15  five wholesale distributors permitted in this state, excluding

16  the wholesale distributors described in sub-subparagraph b.;

17  or that, as a result of changes to the list of authorized

18  distributors of record filed with the department, has fewer

19  than five wholesale distributors permitted in this state as

20  authorized distributors of record, excluding the wholesale

21  distributors described in sub-subparagraph b.

22  

23  A wholesale distributor that satisfies the requirements of

24  sub-subparagraph b. or sub-subparagraph c. shall submit to the

25  department documentation substantiating its qualification

26  pursuant to sub-subparagraph b. or sub-subparagraph c. The

27  department shall add those wholesale distributors that the

28  department has determined have met the requirements of

29  sub-subparagraph b. or sub-subparagraph c. to the list of

30  authorized distributors of record on the department's website.

31         6.  This paragraph expires July 1, 2006.

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 1         (e)1.  Notwithstanding paragraph (d), each person who

 2  is engaged in the wholesale distribution of a specified drug

 3  must provide to each wholesale distributor of such specified

 4  drug:

 5         a.  Upon any sale, a written statement that:

 6         (I)  If the establishment is not a member of an

 7  affiliated group: "This establishment purchased the specific

 8  unit of the specified drug directly from the manufacturer"; or

 9         (II)  If the establishment is a member of an affiliated

10  group: "This establishment or a member of my affiliated group

11  purchased the specific unit of the specified drug directly

12  from the manufacturer"; or

13         b.  Before the wholesale distribution, a written

14  statement, under oath, that identifies each previous sale of

15  the specific unit of the specified drug back to the

16  manufacturer of the specified drug, the lot number of the

17  specific unit of the specified prescription drug, and the

18  sales invoice number of the invoice evidencing each previous

19  sale of the specific unit of the specified drug. The written

20  statement identifying all sales of such specific unit of the

21  specified drug must accompany the specific unit of the

22  specified drug for each subsequent wholesale distribution of

23  the specific unit of the specified drug to a wholesale

24  distributor.

25  

26  The department shall adopt rules to administer the

27  requirements of these written statements.

28         2.  As used in this paragraph, the term "specified

29  drug" means a specific prescription drug on the list of drugs

30  adopted by the department by rule.

31  

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 1         3.a.  A drug may be placed on the list of specified

 2  drugs if the department has seized or issued a stop sale

 3  notice on the prescription drug because of the adulteration,

 4  counterfeiting, or diversion of the prescription drug from the

 5  legal channels of distribution for prescription drugs, or the

 6  United States Food and Drug Administration, a manufacturer, a

 7  wholesale distributor, a law enforcement agency, or a

 8  government agency responsible for regulating the sale or

 9  distribution of prescription drugs in another state has

10  notified the department in writing or through a website

11  operated by one of said entities that the prescription drug

12  has been adulterated, counterfeit or diverted from the legal

13  channels of distribution for prescription drugs; and the

14  prescription drug satisfies one of the following criteria:

15         (I)  The prescription drug is included among the top

16  150 prescription drugs for which the state has incurred the

17  highest amount of Medicaid claims in the most recently ended

18  state fiscal year;

19         (II)  The prescription drug is available for normal

20  prescription use in dosages or strengths that have a wholesale

21  cost $200 or more;

22         (III)  The prescription drug is used extensively for

23  patients with human immunodeficiency virus, acquired immune

24  deficiency syndrome, cancer, or other serious, life

25  threatening conditions, where drug nonresponsiveness would not

26  be considered to be medically unusual;

27         (IV)  The prescription drug is an injectable drug;

28         (V)  The prescription drug is subject to a special,

29  limited distribution process and is not generally sold to

30  wholesale distributors by the manufacturer of the prescription

31  drug;

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 1         (VI)  The department has found not less than five

 2  instances where statements required pursuant to paragraph (d)

 3  for the prescription drug were not passed on other than

 4  because of unintentional oversight, or have been passed on by

 5  or to a wholesale distributor and such statements were

 6  fraudulent; or

 7         (VII)  A shipment of a prescription drug has been

 8  reported to a law enforcement agency as having been stolen or

 9  as missing.

10         b.  A prescription drug may be placed on the list of

11  specified drugs if the prescription drug satisfies any three

12  of the seven criteria set forth in sub-sub-subparagraphs

13  (I)-(VII). However, a prescription drug may not be included on

14  the list of specified drugs if the prescription drug is

15  unlikely to be counterfeited or diverted from the legal

16  channels of distribution for prescription drugs.

17         c.  Before the department begins the rulemaking process

18  to place a drug on the list of specified drugs, except when

19  the department files a rule under the procedure specified in

20  s. 499.0121(6)(e)3.e., the Drug Wholesaler Advisory Council

21  created in s. 499.01211 shall consider whether a prescription

22  drug should be included on or added to the list of specified

23  drugs using the criteria enumerated in sub-subparagraph 3.a.

24  or sub-subparagraph 3.b. and provide a written recommendation

25  adopted by majority vote to the secretary of the department

26  concerning each such drug. This paragraph does not apply to

27  any list of prescription drugs on which the department has

28  begun rulemaking prior to this paragraph becoming law.

29         d.  When a prescription drug is added to the list of

30  specified drugs, the requirements of this paragraph shall be

31  effective as to the prescription drug beginning 60 days after

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 1  the effective date of the rule adding the prescription drug to

 2  the list, except when the department files a rule under the

 3  procedure specified in s. 499.0121(6)(e)3.e.

 4         e.(I)  Notwithstanding chapter 120, if the Attorney

 5  General or Statewide Prosecutor certifies to the secretary of

 6  the department that a prescription drug should be added to the

 7  list of specified drugs by emergency rule, the department may

 8  proceed to add such drug to the list of specified drugs and

 9  the emergency rule shall be effective for a period of one year

10  from the date on which the emergency rule is filed, if the

11  department begins the rulemaking process to adopt a permanent

12  rule to place the drug on the list of specified drugs not

13  later than 90 days after the date on which the emergency rule

14  was filed. An emergency rule adding a drug to the list of

15  specified drugs may not be renewed.

16         (II)  A prescription drug may be placed on the list of

17  specified drugs through the procedure provided in

18  sub-subparagraph (e)3.e. when:

19         (A)  The prescription drug satisfies any two of the

20  criteria specified in sub-subparagraph (e)3.a. or

21  sub-subparagraph (e)3.b.; or

22         (B)  The prescription drug satisfies any one of the

23  criteria specified in sub-subparagraph (e)3.a. or

24  sub-subparagraph (e)3.b. if the prescription drug has not yet

25  become available for wholesale distribution or has been

26  available for wholesale distribution for not more than 60

27  days.

28         (III)  Notwithstanding chapter 120, any emergency rule

29  that places a prescription drug on the list of specified drugs

30  may be challenged as being an invalid exercise of the

31  delegated legislative authority only if the department lacks

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 1  any substantial competent evidence that the prescription drug

 2  satisfied the criteria required pursuant to

 3  sub-sub-subparagraph (I) or sub-sub-subparagraph (II). Not

 4  later than seven days after any request by any person, the

 5  department shall provide such person with the substantial

 6  competent evidence that justifies the department's adoption of

 7  an emergency rule placing a prescription drug on the list of

 8  specified drugs.

 9         (IV)  The department shall notify all prescription drug

10  wholesalers and out-of-state-prescription drug wholesalers by

11  electronic means, facsimile, or United States mail and on the

12  bureau's website when any emergency rule is adopted which

13  places a prescription drug on the list of specified drugs. Not

14  later than seven days after the department adopts an emergency

15  rule placing a prescription drug on the list of specified

16  drugs, wholesalers shall provide the department with the lot

17  numbers and quantities of such prescription drug which the

18  wholesaler owns or has in transit on the date that the

19  department adopted the emergency rule placing the prescription

20  drug on the list of specified drugs.

21         (V)  The requirements of subparagraph (e)1. do not

22  apply to those lot numbers and quantities of a prescription

23  drug which are included on a report filed pursuant to

24  sub-sub-subparagraph (e)3.e.(IV), and paragraph (6)(d) shall

25  apply to those lot numbers and quantities of the prescription

26  drug. In addition to the requirements of paragraph (6)(d), any

27  wholesale distributor selling a prescription drug included on

28  a report filed pursuant to sub-sub-subparagraph (e)3.e.(IV)

29  shall provide any wholesaler purchasing the prescription drugs

30  with a statement under oath that the prescription drugs are

31  among those included on a report filed pursuant to

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 1  sub-sub-subparagraph (e)3.e.(IV) and with a copy of the report

 2  filed by the wholesale distributor with the department for

 3  those prescription drugs.

 4         f.  Not less than annually, the council and department

 5  shall evaluate whether each prescription drug included on the

 6  list of specified drugs should remain on the list. In

 7  determining whether a prescription drug should remain on the

 8  list of specified drugs, the council and department must

 9  consider:

10         (I)  The availability of generic forms of the drug.

11         (II)  Changes in the price of the drug since the

12  prescription drug was placed on the list.

13         (III)  The current status of the drug that caused the

14  department to place the prescription drug on the list of

15  specified drugs.

16  

17  The council shall provide a written recommendation adopted by

18  majority vote to the secretary of the department concerning

19  each drug that the council recommends be removed from the list

20  of specified drugs.

21         4.  This paragraph does not apply to a manufacturer;

22  however, a repackager must comply with this paragraph.

23         5.  This paragraph expires July 1, 2006.

24         (f)1.  Effective July 1, 2006, each person who is

25  engaged in the wholesale distribution of a prescription drug

26  and who is not the manufacturer of that drug must, before each

27  wholesale distribution of such drug, provide to the person who

28  receives the drug a pedigree paper as defined in s.

29  499.003(31).

30         2.  A repackager must comply with this paragraph.

31  

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 1         3.  The pedigree paper requirements in this paragraph

 2  do not apply to compressed medical gases or veterinary legend

 3  drugs.

 4         4.  Each wholesale distributor of prescription drugs

 5  must maintain separate and distinct from other required

 6  records all statements that are required under subparagraph 1.

 7         5.  In order to verify compliance with paragraph (d)1.,

 8  each manufacturer of a prescription drug sold in this state

 9  must make available upon request distribution documentation

10  related to its sales of prescription drugs, regardless of

11  whether the prescription drug was sold directly by the

12  manufacturer to a person in Florida.

13         (g)  Each wholesale distributor, except for a

14  manufacturer, shall annually provide the department with a

15  written list of all wholesale distributors and manufacturers

16  from whom the wholesale distributor purchases prescription

17  drugs. A wholesale distributor, except a manufacturer, shall

18  notify the department not later than 10 days after any change

19  to either list. Such portions of the information required

20  pursuant to this paragraph which are a trade secret, as

21  defined in s. 812.081, shall be maintained by the department

22  as trade secret information is required to be maintained under

23  s. 499.051.

24         (7)  WRITTEN POLICIES AND PROCEDURES.--Wholesale drug

25  distributors must establish, maintain, and adhere to written

26  policies and procedures, which must be followed for the

27  receipt, security, storage, inventory, and distribution of

28  prescription drugs, including policies and procedures for

29  identifying, recording, and reporting losses or thefts, and

30  for correcting all errors and inaccuracies in inventories.

31  

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 1  Wholesale drug distributors must include in their written

 2  policies and procedures:

 3         (a)  A procedure whereby the oldest approved stock of a

 4  prescription drug product is distributed first.  The procedure

 5  may permit deviation from this requirement, if the deviation

 6  is temporary and appropriate.

 7         (b)  A procedure to be followed for handling recalls

 8  and withdrawals of prescription drugs.  Such procedure must be

 9  adequate to deal with recalls and withdrawals due to:

10         1.  Any action initiated at the request of the Food and

11  Drug Administration or any other federal, state, or local law

12  enforcement or other government agency, including the

13  department.

14         2.  Any voluntary action by the manufacturer or

15  repackager to remove defective or potentially defective drugs

16  from the market; or

17         3.  Any action undertaken to promote public health and

18  safety by replacing existing merchandise with an improved

19  product or new package design.

20         (c)  A procedure to ensure that wholesale drug

21  distributors prepare for, protect against, and handle any

22  crisis that affects security or operation of any facility if a

23  strike, fire, flood, or other natural disaster, or a local,

24  state, or national emergency, occurs.

25         (d)  A procedure to ensure that any outdated

26  prescription drugs are segregated from other drugs and either

27  returned to the manufacturer or repackager or destroyed.  This

28  procedure must provide for written documentation of the

29  disposition of outdated prescription drugs. This documentation

30  must be maintained for 2 years after disposition of the

31  outdated drugs.

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 1         (8)  RESPONSIBLE PERSONS.--Wholesale drug distributors

 2  must establish and maintain lists of officers, directors,

 3  managers, designated representatives, and other persons in

 4  charge of wholesale drug distribution, storage, and handling,

 5  including a description of their duties and a summary of their

 6  qualifications.

 7         (11)  SHIPPING AND TRANSPORTATION.--The person

 8  responsible for shipment and transportation of a prescription

 9  drug in a wholesale distribution may use a common carrier; its

10  own vehicle or employee acting within the scope of employment

11  if authorized under s. 499.03 for the possession of

12  prescription drugs in this state; or, in the case of a

13  prescription drug intended for domestic distribution, an

14  independent contractor who must be the agent of the authorized

15  seller or recipient responsible for shipping and

16  transportation as set forth in a written contract between the

17  parties. A person selling a prescription drug for export must

18  obtain documentation, such as a validated airway bill, bill of

19  lading, or other appropriate documentation that the

20  prescription drug was exported. A person responsible for

21  shipping or transporting prescription drugs is not required to

22  maintain documentation from a common carrier that the

23  designated recipient received the prescription drugs; however,

24  the person must obtain such documentation from the common

25  carrier and make it available to the department upon request

26  of the department.

27         Section 16.  Effective January 1, 2004, subsection (12)

28  is added to section 499.0121, Florida Statutes, to read:

29         499.0121  Storage and handling of prescription drugs;

30  recordkeeping.--The department shall adopt rules to implement

31  this section as necessary to protect the public health,

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 1  safety, and welfare.  Such rules shall include, but not be

 2  limited to, requirements for the storage and handling of

 3  prescription drugs and for the establishment and maintenance

 4  of prescription drug distribution records.

 5         (12)  DUE DILIGENCE OF SUPPLIERS.--Prior to purchasing

 6  any prescription drugs from another wholesale drug

 7  distributor, a wholesale drug distributor must:

 8         (a)  Enter an agreement with the selling wholesale drug

 9  distributor by which the selling wholesale drug distributor

10  will indemnify the purchasing wholesale drug distributor for

11  any loss caused to the purchasing wholesale drug distributor

12  related to the purchase of drugs from the selling wholesale

13  drug distributor which are determined to be counterfeit or to

14  have been distributed in violation of any federal or state law

15  governing the distribution of drugs.

16         (b)  Determine that the selling wholesale drug

17  distributor has insurance coverage of not less than the

18  greater of 1 percent of the amount of total dollar volume of

19  the prescription drug sales reported to the department

20  pursuant to s. 499.012(3)(g) or $500,000; however the coverage

21  need not exceed $2 million.

22         (c)  Obtain information from the selling wholesale drug

23  distributor, including the length of time the selling

24  wholesale drug distributor has been licensed in this state, a

25  copy of the selling wholesale drug distributor's licenses or

26  permits, and background information concerning the ownership

27  of the selling wholesale drug distributor, including the

28  experience of the wholesale distributor in the wholesale

29  distribution of prescription drugs.

30         (d)  Verify that the selling wholesale drug

31  distributor's Florida permit is valid.

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 1         (e)  Inspect the selling wholesale drug distributor's

 2  licensed establishment to document that it has a policies and

 3  procedures manual relating to the distribution of drugs, the

 4  appropriate temperature controlled environment for drugs

 5  requiring temperature control, an alarm system, appropriate

 6  access restrictions, and procedures to ensure that records

 7  related to the wholesale distribution of prescription drugs

 8  are maintained as required by law:

 9         1.  Before purchasing any drug from the wholesale drug

10  distributor, and at least once each subsequent year; or

11         2.  Before purchasing any drug from the wholesale drug

12  distributor, and each subsequent year obtain a complete copy

13  of the most recent inspection report for the establishment

14  which was prepared by the department or the regulatory

15  authority responsible for wholesale drug distributors in the

16  state in which the establishment is located.

17         Section 17.  Section 499.01211, Florida Statutes, is

18  created to read:

19         499.01211  Drug Wholesaler Advisory Council.--

20         (1)  There is created the Drug Wholesaler Advisory

21  Council within the department. The council shall meet at least

22  once each calendar quarter. Staff for the council shall be

23  provided by the department. The council shall consist of 11

24  members who shall serve without compensation. The council

25  shall elect a chairperson and a vice chairperson annually.

26         (2)  The secretary of the department, or his or her

27  designee, and the Secretary of Health Care Administration, or

28  her or his designee, shall be members of the council. The

29  Secretary of Health shall appoint nine additional members to

30  the council who shall be appointed to a term of 4 years each,

31  as follows:

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 1         (a)  Three different persons each of whom is employed

 2  by a different prescription drug wholesaler licensed under

 3  this chapter which operates nationally and is a primary

 4  wholesaler, as defined in s. 499.012 (1)(d).

 5         (b)  One person employed by a prescription drug

 6  wholesaler licensed under this chapter which is a secondary

 7  wholesaler, as defined in s. 499.012(1)(f).

 8         (c)  One person employed by a retail pharmacy chain

 9  located in this state.

10         (d)  One person who is a member of the Board of

11  Pharmacy and is a pharmacist licensed under chapter 465.

12         (e)  One person who is a physician licensed pursuant to

13  chapter 458 or 459.

14         (f)  One person who is an employee of a hospital

15  licensed pursuant to chapter 395 and is a pharmacist licensed

16  pursuant to chapter 465.

17         (g)  One person who is an employee of a pharmaceutical

18  manufacturer.

19         (3)  The council shall review ss. 499.001-499.081 and

20  the rules adopted to administer ss. 499.001-499.081 annually,

21  provide input to the department regarding all proposed rules

22  to administer ss. 499.001-499.081, make written recommendation

23  to the secretary of the department regarding the listing of

24  all specified drugs pursuant to s. 499.0121(6)(e), make

25  recommendations to the department to improve the protection of

26  the prescription drugs and public health, make recommendations

27  to improve coordination with other states' regulatory agencies

28  and the federal government concerning the wholesale

29  distribution of drugs, and make recommendations to minimize

30  the impact of regulation of the wholesale distribution

31  industry while ensuring protection of the public health.

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 1         Section 18.  Effective January 1, 2004, section

 2  499.013, Florida Statutes, is amended to read:

 3         499.013  Manufacturers and repackagers of drugs,

 4  devices, and cosmetics; definitions, permits, and general

 5  requirements.--

 6         (1)  As used in this section, the terms term

 7  "manufacture" and "repackage" have has the meaning as in

 8  assigned to it under s. 499.003. A pharmacy is exempt from

 9  these definitions this definition if it is operating in

10  compliance with pharmacy practice standards as defined in

11  chapter 465 and the rules adopted under that chapter.

12         (2)  Any person that engages in the manufacture or

13  repackaging of drugs, devices, or cosmetics in this state must

14  first obtain one of the following permits and may engage only

15  in the activity allowed under that permit:

16         (a)  A prescription drug manufacturer's permit is

17  required for any person that manufactures a prescription drug

18  in this state. A prescription drug repackager's permit is

19  required for any person that repackages a prescription drug in

20  this state.

21         1.  A person that operates an establishment permitted

22  as a prescription drug manufacturer or prescription drug

23  repackager may engage in wholesale distribution of

24  prescription drugs manufactured or repackaged at that

25  establishment and must comply with all the provisions of ss.

26  499.001-499.081 and the rules adopted under those sections

27  that apply to a wholesale distributor.

28         2.  A prescription drug manufacturer permittee or

29  prescription drug repackager must comply with all appropriate

30  state and federal good manufacturing practices.

31  

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 1         (b)  An over-the-counter drug manufacturer's permit is

 2  required for any person that engages in the manufacture or

 3  repackaging of an over-the-counter drug.

 4         1.  An over-the-counter drug manufacturer permittee may

 5  not possess or purchase prescription drugs.

 6         2.  A pharmacy is exempt from obtaining an

 7  over-the-counter drug manufacturer's permit if it is operating

 8  in compliance with pharmacy practice standards as defined in

 9  chapter 465 and the rules adopted under that chapter.

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

11  must comply with all appropriate state and federal good

12  manufacturing practices.

13         (c)  A compressed medical gas manufacturer's permit is

14  required for any person that engages in the manufacture of

15  compressed medical gases or repackages compressed medical

16  gases from one container to another.

17         1.  A compressed medical gas manufacturer permittee may

18  not manufacture or possess any prescription drug other than

19  compressed medical gases.

20         2.  A compressed medical gas manufacturer permittee may

21  engage in wholesale distribution of compressed medical gases

22  manufactured at that establishment and must comply with all

23  the provisions of ss. 499.001-499.081 and the rules adopted

24  under those sections that apply to a wholesale distributor.

25         3.  A compressed medical gas manufacturer permittee

26  must comply with all appropriate state and federal good

27  manufacturing practices.

28         (d)  A device manufacturer's permit is required for any

29  person that engages in the manufacture, repackaging, or

30  assembly of medical devices for human use in this state,

31  except that a permit is not required if the person is engaged

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 1  only in manufacturing, repackaging, or assembling a medical

 2  device pursuant to a practitioner's order for a specific

 3  patient.

 4         1.  A manufacturer or repackager of medical devices in

 5  this state must comply with all appropriate state and federal

 6  good manufacturing practices and quality system rules.

 7         2.  The department shall adopt rules related to

 8  storage, handling, and recordkeeping requirements for

 9  manufacturers of medical devices for human use.

10         (e)  A cosmetic manufacturer's permit is required for

11  any person that manufactures or repackages cosmetics in this

12  state.  A person that only labels or changes the labeling of a

13  cosmetic but does not open the container sealed by the

14  manufacturer of the product is exempt from obtaining a permit

15  under this paragraph.

16         (3)  The department may adopt such rules as are

17  necessary for the protection of the public health, safety, and

18  welfare regarding good manufacturing practices that

19  manufacturers and repackagers must follow to ensure the safety

20  of the products.

21         (4)  Each manufacturer or repackager of medical

22  devices, over-the-counter drugs, or cosmetics must maintain

23  records that include the name and principal address of the

24  seller or transferor of the product, the address of the

25  location from which the product was shipped, the date of the

26  transaction, the name and quantity of the product involved,

27  and the name and principal address of the person who purchased

28  the product.

29         Section 19.  Subsection (3) of section 499.014, Florida

30  Statutes, is amended to read:

31  

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 1         499.014  Distribution of legend drugs by hospitals,

 2  health care entities, charitable organizations, and return or

 3  destruction companies; permits, general requirements.--

 4         (3)  Storage, and handling, and recordkeeping of these

 5  distributions must comply with the requirements for wholesale

 6  distributors under s. 499.0121, except those set forth in s.

 7  499.0121(6)(d), (e), or (f).

 8         Section 20.  Section 499.041, Florida Statutes, is

 9  amended to read:

10         499.041  Schedule of fees for drug, device, and

11  cosmetic applications and permits, product registrations, and

12  free-sale certificates.--

13         (1)  The department shall assess applicants requiring a

14  manufacturing permit an annual fee within the ranges

15  established in this section for the specific type of

16  manufacturer.

17         (a)  The fee for a prescription drug manufacturer's

18  permit may not be less than $500 or more than $750 $600

19  annually.

20         (b)  The fee for a device manufacturer's permit may not

21  be less than $500 or more than $600 annually.

22         (c)  The fee for a cosmetic manufacturer's permit may

23  not be less than $250 or more than $400 annually.

24         (d)  The fee for an over-the-counter drug

25  manufacturer's permit may not be less than $300 or more than

26  $400 annually.

27         (e)  The fee for a compressed medical gas

28  manufacturer's permit may not be less than $400 or more than

29  $500 annually.

30         (f)  The fee for a prescription drug repackager's

31  permit may not be less than $500 or more than $750 annually.

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 1         (g)(f)  A manufacturer may not be required to pay more

 2  than one fee per establishment to obtain an additional

 3  manufacturing permit, but each manufacturer must pay the

 4  highest fee applicable to his or her operation in each

 5  establishment.

 6         (2)  The department shall assess an applicant that is

 7  required to have a wholesaling permit an annual fee within the

 8  ranges established in this section for the specific type of

 9  wholesaling.

10         (a)  The fee for a prescription drug wholesaler's

11  permit may not be less than $300 or more than $800 $400

12  annually.;

13         (b)  The fee for a compressed medical gas wholesaler's

14  permit may not be less than $200 or more than $300 annually.;

15         (c)  The fee for an out-of-state prescription drug

16  wholesaler's permit may not be less than $300 $200 or more

17  than $800 $300 annually.;

18         (d)  The fee for a nonresident prescription drug

19  manufacturer's permit may not be less than $300 or more than

20  $500 annually.

21         (e)(d)  The fee for a retail pharmacy wholesaler's

22  permit may not be less than $35 or more than $50 annually.

23         (f)  The fee for a freight forwarder's permit may not

24  be less than $200 or more than $300 annually.

25         (3)  The department shall assess an applicant that is

26  required to have a retail establishment permit an annual fee

27  within the ranges established in this section for the specific

28  type of retail establishment.

29         (a)  The fee for a veterinary legend drug retail

30  establishment permit may not be less than $200 or more than

31  $300 annually.;

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 1         (b)  The fee for a medical oxygen retail establishment

 2  permit may not be less than $200 or more than $300 annually.

 3         (4)  The department shall assess an applicant that is

 4  required to have a restricted prescription drug distributor's

 5  permit an annual fee of not less than $200 or more than $300.

 6         (5)  In addition to the fee charged for a permit

 7  required by ss. 499.001-499.081, beginning January 1, 1993,

 8  the department shall assess applicants an initial application

 9  fee of $150 for each new permit issued by the department which

10  requires an onsite inspection.

11         (6)  A person that is required to register drugs,

12  devices, or cosmetic products under s. 499.015 shall pay an

13  annual product registration fee of not less than $5 or more

14  than $15 for each separate and distinct product in package

15  form.  The registration fee is in addition to the fee charged

16  for a free-sale certificate.

17         (7)  The department shall assess an applicant that

18  requests a free-sale certificate a fee of $25.  A fee of $2

19  will be charged for each signature copy of a free-sale

20  certificate that is obtained at the same time the free-sale

21  certificate is issued.

22         (8)  The department shall assess an out-of-state

23  prescription drug wholesaler applicant or permittee an on-site

24  inspection fee of not less than $1,000 or more than $3,000

25  annually, to be based on the actual cost of the inspection if

26  an on-site inspection is performed by agents of the

27  department.

28         (9)  The department shall assess each person applying

29  for certification as a designated representative a fee of

30  $150, plus the cost of processing the criminal history record

31  check.

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 1         (10)(8)  The department shall assess other fees as

 2  provided in ss. 499.001-499.081.

 3         Section 21.  Subsection (2) and present subsection (5)

 4  of section 499.051, Florida Statutes, are amended, present

 5  subsections (4) and (5) of that section are redesignated as

 6  subsections (6) and (7), respectively, and new subsections (4)

 7  and (5) are added to that section, to read:

 8         499.051  Inspections and investigations.--

 9         (2)  In addition to the authority set forth in

10  subsection (1), the department and any duly designated officer

11  or employee of the department may enter and inspect any other

12  establishment for the purpose of determining compliance with

13  ss. 499.001-499.081 and rules adopted under those sections

14  regarding any drug, device, or cosmetic product. The authority

15  to enter and inspect does not extend to the practice of the

16  profession of pharmacy, as defined in chapter 465 and the

17  rules adopted under that chapter, in a pharmacy permitted

18  under chapter 465. The Department of Business and Professional

19  Regulation shall conduct routine inspections of retail

20  pharmacy wholesalers at the time of the regular pharmacy

21  permit inspection and shall send the inspection report

22  regarding drug wholesale activity to the Department of Health.

23         (4)  Any application for a permit made pursuant to ss.

24  499.01 and 499.012 and rules adopted under those sections

25  constitutes permission for agents of the Department of Health

26  and the Department of Law Enforcement, after presenting proper

27  identification, to inspect, review, and copy any financial

28  document or record related to the manufacture, repackaging, or

29  distribution of a drug as is necessary to verify compliance

30  with ss. 499.001-499.081 and the rules adopted by the

31  department to administer those sections, in order to discover,

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 1  investigate, and determine the existence of compliance, or to

 2  elicit, receive, respond to, and resolve complaints and

 3  violations.

 4         (5)  The authority to inspect under this section

 5  includes the authority to access, review, and copy any and all

 6  financial documents related to the activity of manufacturing,

 7  repackaging, or distributing prescription drugs.

 8         (7)(5)  The complaint and all information obtained

 9  pursuant to the investigation by the department are

10  confidential and exempt from the provisions of s. 119.07(1)

11  and s. 24(a), Art. I of the State Constitution until the

12  investigation and the enforcement action are completed.

13  However, trade secret information contained therein as defined

14  by s. 812.081(1)(c) shall remain confidential and exempt from

15  the provisions of s. 119.07(1) and s. 24(a), Art. I of the

16  State Constitution, as long as the information is retained by

17  the department.  This subsection does not prohibit the

18  department from using such information for regulatory or

19  enforcement proceedings under this chapter or from providing

20  such information to any law enforcement agency or any other

21  regulatory agency.  However, the receiving agency shall keep

22  such records confidential and exempt as provided in this

23  subsection.  In addition, this subsection is not intended to

24  prevent compliance with the provisions of s. 499.0121(6)(d),

25  and the pedigree papers required in that subsection shall not

26  be deemed a trade secret.

27         Section 22.  Subsection (4) is added to section

28  499.055, Florida Statutes, to read:

29         499.055  Reports and dissemination of information by

30  department.--

31  

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 1         (4)  The department shall publish on the department's

 2  website and update at least monthly:

 3         (a)  A list of the prescription drug wholesalers,

 4  out-of-state prescription drug wholesalers, and retail

 5  pharmacy drug wholesalers against whom the department has

 6  initiated enforcement action pursuant to ss. 499.001-499.081

 7  to suspend or revoke a permit, seek an injunction, or

 8  otherwise file an administrative complaint and the permit

 9  number of each such wholesaler.

10         (b)  A list of the prescription drug wholesalers,

11  out-of-state prescription drug wholesalers, and retail

12  pharmacy drug wholesalers to which the department has issued a

13  permit, including the date on which each permit will expire.

14         (c)  A list of the prescription drug wholesalers,

15  out-of-state prescription drug wholesalers, and retail

16  pharmacy drug wholesalers' permits that have been returned to

17  the department, were suspended, were revoked, have expired, or

18  were not renewed in the previous year.

19         Section 23.  Section 499.065, Florida Statutes, is

20  created to read:

21         499.065  Imminent danger.--

22         (1)  Notwithstanding s. 499.051, the department shall

23  inspect each prescription drug wholesale establishment,

24  prescription drug repackager establishment, and retail

25  pharmacy drug wholesaler establishment that is required to be

26  permitted under this chapter as often as necessary to ensure

27  compliance with applicable laws and rules. The department

28  shall have the right of entry and access to these facilities

29  at any reasonable time.

30         (2)  To protect the public from prescription drugs that

31  are adulterated or otherwise unfit for human consumption, the

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 1  department may examine, sample, seize, and stop the sale or

 2  use of prescription drugs to determine the condition of those

 3  drugs. The department may immediately seize and remove any

 4  prescription drugs if the Secretary of Health or his or her

 5  designee determines that such prescription drugs represent a

 6  threat to the public health. The owner of any property seized

 7  under this section may, within 10 days after the seizure,

 8  apply to a court of competent jurisdiction for whatever relief

 9  is appropriate. At any time after 10 days, the department may

10  destroy the drugs as contraband.

11         (3)  The department may determine that a prescription

12  drug wholesale establishment, prescription drug repackager

13  establishment, or retail pharmacy drug wholesaler

14  establishment that is required to be permitted under this

15  chapter is an imminent danger to the public health and require

16  its immediate closure if such establishment fails to comply

17  with applicable laws and rules and, because of such failure,

18  presents an imminent threat to the public's health, safety, or

19  welfare. Any establishment so deemed and closed shall remain

20  closed until allowed by the department or by judicial order to

21  reopen.

22  

23  For purposes of this section, a refusal to allow entry to the

24  department for inspection at reasonable times, or a failure or

25  refusal to provide the department with required documentation

26  for purposes of inspection, constitutes an imminent danger to

27  the public health.

28         Section 24.  Subsection (1) of section 499.066, Florida

29  Statutes, is amended, and subsection (7) is added to that

30  section, to read:

31  

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 1         499.066  Penalties; remedies.--In addition to other

 2  penalties and other enforcement provisions:

 3         (1)  The department may institute such suits or other

 4  legal proceedings as are required to enforce any provision of

 5  ss. 499.001-499.081. If it appears that a person has violated

 6  any provision of ss. 499.001-499.081 for which criminal

 7  prosecution is provided, the department may provide the

 8  appropriate state attorney or other prosecuting agency having

 9  jurisdiction with respect to such prosecution with the

10  relevant information in the department's possession. When the

11  department believes that any person has violated ss.

12  499.001-499.081 or any rules adopted pursuant to those

13  sections, it may issue and deliver an order to cease and

14  desist from such violation.

15         (7)  Resignation or termination of an affiliated party

16  does not affect the department's jurisdiction or discretion to

17  proceed with action to suspend or revoke a permit or to impose

18  other penalties or enforcement actions authorized by law.

19         Section 25.  Section 499.0661, Florida Statutes, is

20  created to read:

21         499.0661  Cease and desist orders; removal of certain

22  persons.--

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

24  "permittee" means any person holding a permit issued pursuant

25  to s. 499.012.

26         (2)  CEASE AND DESIST ORDERS.--

27         (a)  In addition to any authority otherwise provided in

28  this chapter, the department may issue and serve a complaint

29  stating charges upon any permittee or upon any affiliated

30  party, whenever the department has reasonable cause to believe

31  

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 1  that the person or individual named therein is engaging in or

 2  has engaged in conduct that is:

 3         1.  An act that demonstrates a lack of fitness or

 4  trustworthiness to engage in the business authorized under the

 5  permit issued pursuant to ss. 499.001-499.081, is hazardous to

 6  the public health, or constitutes business operations that are

 7  a detriment to the public health;

 8         2.  A violation of any provision of ss.

 9  499.001-499.081;

10         3.  A violation of any rule of the department;

11         4.  A violation of any order of the department; or

12         5.  A breach of any written agreement with the

13  department.

14         (b)  The complaint must contain a statement of facts

15  and notice of opportunity for a hearing pursuant to ss.

16  120.569 and 120.57.

17         (c)  If a hearing is not requested within the time

18  allowed by ss. 120.569 and 120.57, or if a hearing is held and

19  the department finds that any of the charges are proven, the

20  department may enter an order directing the permittee or the

21  affiliated party named in the complaint to cease and desist

22  from engaging in the conduct complained of and take corrective

23  action to remedy the effects of past improper conduct and

24  assure future compliance.

25         (d)  A contested or default cease and desist order is

26  effective when reduced to writing and served upon the

27  permittee or affiliated party named therein. An uncontested

28  cease and desist order is effective as agreed.

29         (e)  Whenever the department finds that conduct

30  described in paragraph (a) is likely to cause an immediate

31  threat to the public health, it may issue an emergency cease

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 1  and desist order requiring the permittee or any affiliated

 2  party to immediately cease and desist from engaging in the

 3  conduct complained of and to take corrective and remedial

 4  action. The emergency order is effective immediately upon

 5  service of a copy of the order upon the permittee or

 6  affiliated party named therein and remains effective for 90

 7  days. If the department begins nonemergency cease and desist

 8  proceedings under this subsection, the emergency order remains

 9  effective until the conclusion of the proceedings under ss.

10  120.569 and 120.57.

11         (3)  REMOVAL OF AFFILIATED PARTIES BY THE DEPARTMENT.--

12         (a)  The department may issue and serve a complaint

13  stating charges upon any affiliated party and upon the

14  permittee involved whenever the department has reason to

15  believe that an affiliated party is engaging in or has engaged

16  in conduct that constitutes:

17         1.  An act that demonstrates a lack of fitness or

18  trustworthiness to engage in the business authorized under the

19  permit issued pursuant to ss. 499.001-499.081, is hazardous to

20  the public health, or constitutes business operations that are

21  a detriment to the public health;

22         2.  A willful violation of ss. 499.001-499.081;

23  however, if the violation constitutes a misdemeanor, a

24  complaint may not be served as provided in this section until

25  the affiliated party is notified in writing of the matter of

26  the violation and has been afforded a reasonable period of

27  time, as set forth in the notice, to correct the violation and

28  has failed to do so;

29         3.  A violation of any other law involving fraud or

30  moral turpitude which constitutes a felony;

31         4.  A willful violation of any rule of the department;

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 1         5.  A willful violation of any order of the department;

 2  or

 3         6.  A material misrepresentation of fact, made

 4  knowingly and willfully or made with reckless disregard for

 5  the truth of the matter.

 6         (b)  The complaint must contain a statement of facts

 7  and notice of opportunity for a hearing pursuant to ss.

 8  120.569 and 120.57.

 9         (c)  If a hearing is not requested within the time

10  allotted by ss. 120.569 and 120.57, or if a hearing is held

11  and the department finds that any of the charges in the

12  complaint are proven true, the department may enter an order

13  removing the affiliated party or restricting or prohibiting

14  participation by the person in the affairs of that permittee

15  or of any other permittee.

16         (d)  A contested or default order of removal,

17  restriction, or prohibition is effective when reduced to

18  writing and served on the permittee and the affiliated party.

19  An uncontested order of removal, restriction, or prohibition

20  is effective as agreed.

21         (e)1.  The chief executive officer, designated

22  representative, or the person holding the equivalent office,

23  of a permittee shall promptly notify the department if she or

24  he has actual knowledge that any affiliated party is charged

25  with a felony in a state or federal court.

26         2.  Whenever any affiliated party is charged with a

27  felony in a state or federal court or with the equivalent of a

28  felony in the courts of any foreign country with which the

29  United States maintains diplomatic relations, and the charge

30  alleges violation of any law involving prescription drugs,

31  pharmaceuticals, fraud, theft, or moral turpitude, the

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 1  department may enter an emergency order suspending the

 2  affiliated party or restricting or prohibiting participation

 3  by the affiliated party in the affairs of the particular

 4  permittee or of any other permittee upon service of the order

 5  upon the permittee and the affiliated party charged. The order

 6  must contain notice of opportunity for a hearing pursuant to

 7  ss. 120.569 and 120.57, where the affiliated party may request

 8  a postsuspension hearing to show that continued service to or

 9  participation in the affairs of the permittee does not pose a

10  threat to the public health or the interests of the permittee

11  and does not threaten to impair public confidence in the

12  permittee. In accordance with applicable departmental rules,

13  the department shall notify the affiliated party whether the

14  order suspending or prohibiting the person from participation

15  in the affairs of a permittee will be rescinded or otherwise

16  modified. The emergency order remains in effect, unless

17  otherwise modified by the department, until the criminal

18  charge is disposed of. The acquittal of the person charged, or

19  the final, unappealed dismissal of all charges against the

20  person, dissolves the emergency order, but does not prohibit

21  the department from instituting proceedings under paragraph

22  (a). If the person charged is convicted or pleads guilty or

23  nolo contendere, whether or not an adjudication of guilt is

24  entered by the court, the emergency order shall become final.

25         (f)  Any affiliated party removed pursuant to this

26  section is not eligible for reemployment by the permittee or

27  to be an affiliated party of any permittee except upon the

28  written consent of the department. Any affiliated party who is

29  removed, restricted, or prohibited from participating in the

30  affairs of a permittee pursuant to this section may petition

31  

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 1  the department for modification or termination of the removal,

 2  restriction, or prohibition.

 3         Section 26.  Effective January 1, 2004, subsection (1)

 4  of section 499.067, Florida Statutes, is amended, and

 5  subsections (6) and (7) are added to that section, to read:

 6         499.067  Denial, suspension, or revocation of permit,

 7  certification, or registration.--

 8         (1)(a)  The department may deny, suspend, or revoke a

 9  permit if it finds that there has been a substantial failure

10  to comply with ss. 499.001-499.081 or chapter 465, chapter

11  501, or chapter 893, the rules adopted under any of those

12  sections or chapters, any final order of the department, or

13  applicable federal laws or regulations or other state laws or

14  rules governing drugs, devices, or cosmetics.

15         (b)  The department may deny an application for a

16  permit or certification, or suspend or revoke a permit or

17  certification, if the department finds it is shown that:

18         1.  The applicant is not of good moral character or

19  that it would be a danger or not in the best interest of the

20  public health, safety, and welfare if the applicant were

21  issued a permit or certification.

22         2.  The applicant has not met the requirements for the

23  permit or certification.

24         3.  The applicant is not eligible for a permit or

25  certification for any of the reasons enumerated in s. 499.01

26  or s. 499.012(5).

27         4.  The applicant, permittee, or person certified under

28  s. 499.012(11) demonstrates any of the conditions enumerated

29  in s. 499.01 or s. 499.012(5).

30  

31  

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 1         5.  The applicant, permittee, or person certified under

 2  s. 499.012(11) has committed any violation of ss.

 3  499.005-499.0054.

 4         (6)  The department shall deny, suspend, or revoke the

 5  permit of any person or establishment if the assignment, sale,

 6  transfer, or lease of an establishment permitted under ss.

 7  499.001-499.081 will avoid an administrative penalty, civil

 8  action, or criminal prosecution.

 9         (7)  Notwithstanding s. 120.60(5), if a permittee fails

10  to comply with s. 499.01(7), the department may revoke the

11  permit of the permittee and shall provide notice of the

12  intended agency action by posting a notice at the department's

13  headquarters and by mailing a copy of the notice of intended

14  agency action by certified mail to the most recent mailing

15  address on record with the department and, if the permittee is

16  not a natural person, to the permittee's registered agent on

17  file with the Department of State.

18         Section 27.  Section 499.069, Florida Statutes, is

19  amended to read:

20         499.069  Criminal punishment for violations of s.

21  499.005 related to devices and cosmetics; dissemination of

22  false advertisement.--

23         (1)  Any person who violates any of the provisions of

24  s. 499.005 with respect to a device or cosmetic commits is

25  guilty of a misdemeanor of the second degree, punishable as

26  provided in s. 775.082 or s. 775.083; but, if the violation is

27  committed after a conviction of such person under this section

28  has become final, such person is guilty of a misdemeanor of

29  the first degree, punishable as provided in s. 775.082 or s.

30  775.083 or as otherwise provided in ss. 499.001-499.081,

31  except that any person who violates subsection (8), or

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 1  subsection (10), subsection (14), subsection (15), or

 2  subsection (17) of s. 499.005 with respect to a device or

 3  cosmetic commits is guilty of a felony of the third degree,

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

 5  775.084, or as otherwise provided in ss. 499.001-499.081.

 6         (2)  A person is not subject to the penalties of

 7  subsection (1) for having violated any of the provisions of s.

 8  499.005 if he or she establishes a guaranty or undertaking,

 9  which guaranty or undertaking is signed by and contains the

10  name and address of the person residing in the state, or the

11  manufacturer, from whom he or she received the article in good

12  faith, to the effect that such article is not adulterated or

13  misbranded within the meaning of ss. 499.001-499.081, citing

14  such sections.

15         (2)(3)  A publisher, radio broadcast licensee, or

16  agency or medium for the dissemination of an advertisement,

17  except the manufacturer, wholesaler, or seller of the article

18  to which a false advertisement relates, is not liable under

19  this section by reason of the dissemination by him or her of

20  such false advertisement, unless he or she has refused, on the

21  request of the department, to furnish to the department the

22  name and post office address of the manufacturer, wholesaler,

23  seller, or advertising agency that asked him or her to

24  disseminate such advertisement.

25         Section 28.  Section 499.0691, Florida Statutes, is

26  created to read:

27         499.0691  Criminal punishment for violations related to

28  drugs; dissemination of false advertisement.--

29         (1)  Any person who violates any of the following

30  provisions commits a misdemeanor of the second degree,

31  punishable as provided in s. 775.082 or s. 775.083; but, if

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 1  the violation is committed after a conviction of such person

 2  under this section has become final, such person commits a

 3  misdemeanor of the first degree, punishable as provided in s.

 4  775.082 or s. 775.083, or as otherwise provided in ss.

 5  499.001-499.081:

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

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

 8  or misbranded or has otherwise been rendered unfit for human

 9  or animal use.

10         (b)  The adulteration or misbranding of any drug

11  intended for further distribution.

12         (c)  The receipt of any drug that is adulterated or

13  misbranded, and the delivery or proffered delivery of such

14  drug, for pay or otherwise.

15         (d)  The dissemination of any false or misleading

16  advertisement of a drug.

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

18  advertisement relating to such drug, of any representation or

19  suggestion that an application of the drug is effective when

20  it is not or that the drug complies with ss. 499.001-499.081

21  when it does not.

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

23  gas from a person that is not authorized under this chapter to

24  distribute compressed medical gases.

25         (g)  Charging a dispensing fee for dispensing,

26  administering, or distributing a prescription drug sample.

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

28  as required by ss. 499.001-499.081 and rules adopted under

29  those sections, except for pedigree papers, invoices, or

30  shipping documents related to legend drugs.

31  

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 1         (i)  The possession of any drug in violation of ss.

 2  499.001-499.081, except if the violation relates to a

 3  deficiency in pedigree papers.

 4         (2)  Any person who violates any of the following

 5  provisions commits a felony of the third degree, punishable as

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

 7  otherwise provided in ss. 499.001-499.081.

 8         (a)  The refusal or constructive refusal to allow:

 9         1.  The department to enter or inspect an establishment

10  in which drugs are manufactured, processed, repackaged, sold,

11  brokered, or held;

12         2.  Inspection of any record of that establishment;

13         3.  The department to enter and inspect any vehicle

14  that is being used to transport drugs; or

15         4.  The department to take samples of any drug.

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

17  sell, purchase, or trade, a drug sample as defined in s.

18  499.028; the distribution of a drug sample in violation of s.

19  499.028; or the failure to otherwise comply with s. 499.028.

20         (c)  Providing the department with false or fraudulent

21  records, or making false or fraudulent statements, regarding

22  any matter within the provisions of this chapter related to a

23  drug.

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

25  invoices and shipping documents, other than pedigree papers,

26  if applicable, related to the distribution of a legend drug.

27         (e)  The importation of a legend drug for wholesale

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

29  Food, Drug, and Cosmetic Act.

30         (f)  The wholesale distribution of any prescription

31  drug that was:

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 1         1.  Purchased by a public or private hospital or other

 2  health care entity; or

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

 4  charitable organization.

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

 6  drug wholesaler when a permit is required by ss.

 7  499.001-499.081 for that activity.

 8         (h)  Knowingly possessing any adulterated or misbranded

 9  legend drug outside of a designated quarantine area.

10         (i)  The purchase or sale of prescription drugs for

11  wholesale distribution in exchange for currency, as defined in

12  s. 560.103(6).

13         (3)  Any person who violates any of the following

14  provisions commits a felony of the second degree, punishable

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

16  otherwise provided in ss. 499.001-499.081.

17         (a)  Knowingly manufacturing, repackaging, selling,

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

19  adulterated or misbranded or has otherwise been rendered unfit

20  for human or animal use.

21         (b)  Knowingly adulterating a drug that is intended for

22  further distribution.

23         (c)  Knowingly receiving a drug that is adulterated and

24  delivering or proffering delivery of such drug for pay or

25  otherwise.

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

27  counterfeit drug, or selling, dispensing, or knowingly holding

28  for sale a counterfeit drug.

29         (e)  Forging, counterfeiting, simulating, or falsely

30  representing any drug, or, without the authority of the

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

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 1  identification device authorized or required by rules adopted

 2  under ss. 499.001-499.081.

 3         (f)  Knowingly obtaining or attempting to obtain a

 4  prescription drug for wholesale distribution by fraud, deceit,

 5  misrepresentation, or subterfuge, or engaging in

 6  misrepresentation or fraud in the distribution of a drug.

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

 8  dispensed prescription drug with the intent to further

 9  distribute the prescription drug.

10         (h)  Knowingly distributing a prescription drug that

11  was previously dispensed by a licensed pharmacy, unless such

12  distribution was authorized in chapter 465 or the rules

13  adopted under chapter 465.

14         (4)  A publisher, radio broadcast licensee, or agency

15  or medium for the dissemination of an advertisement, except

16  the manufacturer, repackager, wholesaler, or seller of the

17  article to which a false advertisement relates, is not liable

18  under this section by reason of the dissemination by him or

19  her of such false advertisement, unless he or she has refused,

20  on the request of the department, to furnish to the department

21  the name and post office address of the manufacturer,

22  repackager, wholesaler, seller, or advertising agency that

23  asked him or her to disseminate such advertisement.

24         Section 29.  Paragraphs (d), (f), (h), (i), and (j) of

25  subsection (3) of section 921.0022, Florida Statutes, are

26  amended to read:

27         921.0022  Criminal Punishment Code; offense severity

28  ranking chart.--

29         (3)  OFFENSE SEVERITY RANKING CHART

30  

31  

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 1  Florida           Felony

 2  Statute           Degree             Description

 3  

 4                     

 5                              (d)  LEVEL 4

 6  316.1935(3)        2nd      Driving at high speed or with

 7                              wanton disregard for safety while

 8                              fleeing or attempting to elude

 9                              law enforcement officer who is in

10                              a marked patrol vehicle with

11                              siren and lights activated.

12  499.0051(1)        3rd      Failure to maintain or deliver

13                              pedigree papers.

14  499.0051(2)        3rd      Failure to authenticate pedigree

15                              papers.

16  499.0051(6)        2nd      Sale or delivery, or possession

17                              with intent to sell, contraband

18                              legend drugs.

19  784.07(2)(b)       3rd      Battery of law enforcement

20                              officer, firefighter, intake

21                              officer, etc.

22  784.074(1)(c)      3rd      Battery of sexually violent

23                              predators facility staff.

24  784.075            3rd      Battery on detention or

25                              commitment facility staff.

26  784.078            3rd      Battery of facility employee by

27                              throwing, tossing, or expelling

28                              certain fluids or materials.

29  784.08(2)(c)       3rd      Battery on a person 65 years of

30                              age or older.

31  

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 1  784.081(3)         3rd      Battery on specified official or

 2                              employee.

 3  784.082(3)         3rd      Battery by detained person on

 4                              visitor or other detainee.

 5  784.083(3)         3rd      Battery on code inspector.

 6  784.085            3rd      Battery of child by throwing,

 7                              tossing, projecting, or expelling

 8                              certain fluids or materials.

 9  787.03(1)          3rd      Interference with custody;

10                              wrongly takes child from

11                              appointed guardian.

12  787.04(2)          3rd      Take, entice, or remove child

13                              beyond state limits with criminal

14                              intent pending custody

15                              proceedings.

16  787.04(3)          3rd      Carrying child beyond state lines

17                              with criminal intent to avoid

18                              producing child at custody

19                              hearing or delivering to

20                              designated person.

21  790.115(1)         3rd      Exhibiting firearm or weapon

22                              within 1,000 feet of a school.

23  790.115(2)(b)      3rd      Possessing electric weapon or

24                              device, destructive device, or

25                              other weapon on school property.

26  790.115(2)(c)      3rd      Possessing firearm on school

27                              property.

28  800.04(7)(d)       3rd      Lewd or lascivious exhibition;

29                              offender less than 18 years.

30  

31  

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 1  810.02(4)(a)       3rd      Burglary, or attempted burglary,

 2                              of an unoccupied structure;

 3                              unarmed; no assault or battery.

 4  810.02(4)(b)       3rd      Burglary, or attempted burglary,

 5                              of an unoccupied conveyance;

 6                              unarmed; no assault or battery.

 7  810.06             3rd      Burglary; possession of tools.

 8  810.08(2)(c)       3rd      Trespass on property, armed with

 9                              firearm or dangerous weapon.

10  812.014(2)(c)3.    3rd      Grand theft, 3rd degree $10,000

11                              or more but less than $20,000.

12  812.014

13   (2)(c)4.-10.      3rd      Grand theft, 3rd degree, a will,

14                              firearm, motor vehicle,

15                              livestock, etc.

16  812.0195(2)        3rd      Dealing in stolen property by use

17                              of the Internet; property stolen

18                              $300 or more.

19  817.563(1)         3rd      Sell or deliver substance other

20                              than controlled substance agreed

21                              upon, excluding s. 893.03(5)

22                              drugs.

23  817.568(2)(a)      3rd      Fraudulent use of personal

24                              identification information.

25  817.625(2)(a)      3rd      Fraudulent use of scanning device

26                              or reencoder.

27  828.125(1)         2nd      Kill, maim, or cause great bodily

28                              harm or permanent breeding

29                              disability to any registered

30                              horse or cattle.

31  837.02(1)          3rd      Perjury in official proceedings.

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 1  837.021(1)         3rd      Make contradictory statements in

 2                              official proceedings.

 3  839.13(2)(a)       3rd      Falsifying records of an

 4                              individual in the care and

 5                              custody of a state agency.

 6  839.13(2)(c)       3rd      Falsifying records of the

 7                              Department of Children and Family

 8                              Services.

 9  843.021            3rd      Possession of a concealed

10                              handcuff key by a person in

11                              custody.

12  843.025            3rd      Deprive law enforcement,

13                              correctional, or correctional

14                              probation officer of means of

15                              protection or communication.

16  843.15(1)(a)       3rd      Failure to appear while on bail

17                              for felony (bond estreature or

18                              bond jumping).

19  874.05(1)          3rd      Encouraging or recruiting another

20                              to join a criminal street gang.

21  893.13(2)(a)1.     2nd      Purchase of cocaine (or other s.

22                              893.03(1)(a), (b), or (d),

23                              (2)(a), (2)(b), or (2)(c)4.

24                              drugs).

25  914.14(2)          3rd      Witnesses accepting bribes.

26  914.22(1)          3rd      Force, threaten, etc., witness,

27                              victim, or informant.

28  914.23(2)          3rd      Retaliation against a witness,

29                              victim, or informant, no bodily

30                              injury.

31  918.12             3rd      Tampering with jurors.

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 1  934.215            3rd      Use of two-way communications

 2                              device to facilitate commission

 3                              of a crime.

 4                              (f)  LEVEL 6

 5  316.027(1)(b)      2nd      Accident involving death, failure

 6                              to stop; leaving scene.

 7  316.193(2)(b)      3rd      Felony DUI, 4th or subsequent

 8                              conviction.

 9  499.0051(3)        2nd      Forgery of pedigree papers.

10  499.0051(4)        2nd      Purchase or receipt of legend

11                              drug from unauthorized person.

12  499.0051(5)        2nd      Sale of legend drug to

13                              unauthorized person.

14  775.0875(1)        3rd      Taking firearm from law

15                              enforcement officer.

16  775.21(10)         3rd      Sexual predators; failure to

17                              register; failure to renew

18                              driver's license or

19                              identification card.

20  784.021(1)(a)      3rd      Aggravated assault; deadly weapon

21                              without intent to kill.

22  784.021(1)(b)      3rd      Aggravated assault; intent to

23                              commit felony.

24  784.041            3rd      Felony battery.

25  784.048(3)         3rd      Aggravated stalking; credible

26                              threat.

27  784.048(5)         3rd      Aggravated stalking of person

28                              under 16.

29  784.07(2)(c)       2nd      Aggravated assault on law

30                              enforcement officer.

31  

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 1  784.074(1)(b)      2nd      Aggravated assault on sexually

 2                              violent predators facility staff.

 3  784.08(2)(b)       2nd      Aggravated assault on a person 65

 4                              years of age or older.

 5  784.081(2)         2nd      Aggravated assault on specified

 6                              official or employee.

 7  784.082(2)         2nd      Aggravated assault by detained

 8                              person on visitor or other

 9                              detainee.

10  784.083(2)         2nd      Aggravated assault on code

11                              inspector.

12  787.02(2)          3rd      False imprisonment; restraining

13                              with purpose other than those in

14                              s. 787.01.

15  790.115(2)(d)      2nd      Discharging firearm or weapon on

16                              school property.

17  790.161(2)         2nd      Make, possess, or throw

18                              destructive device with intent to

19                              do bodily harm or damage

20                              property.

21  790.164(1)         2nd      False report of deadly explosive,

22                              weapon of mass destruction, or

23                              act of arson or violence to state

24                              property.

25  790.19             2nd      Shooting or throwing deadly

26                              missiles into dwellings, vessels,

27                              or vehicles.

28  794.011(8)(a)      3rd      Solicitation of minor to

29                              participate in sexual activity by

30                              custodial adult.

31  

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 1  794.05(1)          2nd      Unlawful sexual activity with

 2                              specified minor.

 3  800.04(5)(d)       3rd      Lewd or lascivious molestation;

 4                              victim 12 years of age or older

 5                              but less than 16 years; offender

 6                              less than 18 years.

 7  800.04(6)(b)       2nd      Lewd or lascivious conduct;

 8                              offender 18 years of age or

 9                              older.

10  806.031(2)         2nd      Arson resulting in great bodily

11                              harm to firefighter or any other

12                              person.

13  810.02(3)(c)       2nd      Burglary of occupied structure;

14                              unarmed; no assault or battery.

15  812.014(2)(b)1.    2nd      Property stolen $20,000 or more,

16                              but less than $100,000, grand

17                              theft in 2nd degree.

18  812.014(2)(b)2.    2nd      Property stolen; cargo valued at

19                              less than $50,000, grand theft in

20                              2nd degree.

21  812.015(9)         2nd      Retail theft; property stolen

22                              $300 or more; second or

23                              subsequent conviction.

24  812.13(2)(c)       2nd      Robbery, no firearm or other

25                              weapon (strong-arm robbery).

26  817.034(4)(a)1.    1st      Communications fraud, value

27                              greater than $50,000.

28  817.4821(5)        2nd      Possess cloning paraphernalia

29                              with intent to create cloned

30                              cellular telephones.

31  

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 1  825.102(1)         3rd      Abuse of an elderly person or

 2                              disabled adult.

 3  825.102(3)(c)      3rd      Neglect of an elderly person or

 4                              disabled adult.

 5  825.1025(3)        3rd      Lewd or lascivious molestation of

 6                              an elderly person or disabled

 7                              adult.

 8  825.103(2)(c)      3rd      Exploiting an elderly person or

 9                              disabled adult and property is

10                              valued at less than $20,000.

11  827.03(1)          3rd      Abuse of a child.

12  827.03(3)(c)       3rd      Neglect of a child.

13  827.071(2)&(3)     2nd      Use or induce a child in a sexual

14                              performance, or promote or direct

15                              such performance.

16  836.05             2nd      Threats; extortion.

17  836.10             2nd      Written threats to kill or do

18                              bodily injury.

19  843.12             3rd      Aids or assists person to escape.

20  847.0135(3)        3rd      Solicitation of a child, via a

21                              computer service, to commit an

22                              unlawful sex act.

23  914.23             2nd      Retaliation against a witness,

24                              victim, or informant, with bodily

25                              injury.

26  943.0435(9)        3rd      Sex offenders; failure to comply

27                              with reporting requirements.

28  

29  

30  

31  

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 1  944.35(3)(a)2.     3rd      Committing malicious battery upon

 2                              or inflicting cruel or inhuman

 3                              treatment on an inmate or

 4                              offender on community

 5                              supervision, resulting in great

 6                              bodily harm.

 7  944.40             2nd      Escapes.

 8  944.46             3rd      Harboring, concealing, aiding

 9                              escaped prisoners.

10  944.47(1)(a)5.     2nd      Introduction of contraband

11                              (firearm, weapon, or explosive)

12                              into correctional facility.

13  951.22(1)          3rd      Intoxicating drug, firearm, or

14                              weapon introduced into county

15                              facility.

16                              (h)  LEVEL 8

17  316.193

18   (3)(c)3.a.        2nd      DUI manslaughter.

19  327.35(3)(c)3.     2nd      Vessel BUI manslaughter.

20  499.0051(7)        1st      Forgery of prescription or legend

21                              drug labels.

22  499.0052           1st      Trafficking in contraband legend

23                              drugs.

24  560.123(8)(b)2.    2nd      Failure to report currency or

25                              payment instruments totaling or

26                              exceeding $20,000, but less than

27                              $100,000 by money transmitter.

28  

29  

30  

31  

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 1  560.125(5)(b)      2nd      Money transmitter business by

 2                              unauthorized person, currency or

 3                              payment instruments totaling or

 4                              exceeding $20,000, but less than

 5                              $100,000.

 6  655.50(10)(b)2.    2nd      Failure to report financial

 7                              transactions totaling or

 8                              exceeding $20,000, but less than

 9                              $100,000 by financial

10                              institutions.

11  777.03(2)(a)       1st      Accessory after the fact, capital

12                              felony.

13  782.04(4)          2nd      Killing of human without design

14                              when engaged in act or attempt of

15                              any felony other than arson,

16                              sexual battery, robbery,

17                              burglary, kidnapping, aircraft

18                              piracy, or unlawfully discharging

19                              bomb.

20  782.051(2)         1st      Attempted felony murder while

21                              perpetrating or attempting to

22                              perpetrate a felony not

23                              enumerated in s. 782.04(3).

24  782.071(1)(b)      1st      Committing vehicular homicide and

25                              failing to render aid or give

26                              information.

27  782.072(2)         1st      Committing vessel homicide and

28                              failing to render aid or give

29                              information.

30  

31  

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 1  790.161(3)         1st      Discharging a destructive device

 2                              which results in bodily harm or

 3                              property damage.

 4  794.011(5)         2nd      Sexual battery, victim 12 years

 5                              or over, offender does not use

 6                              physical force likely to cause

 7                              serious injury.

 8  800.04(4)          2nd      Lewd or lascivious battery.

 9  806.01(1)          1st      Maliciously damage dwelling or

10                              structure by fire or explosive,

11                              believing person in structure.

12  810.02(2)(a)       1st,PBL  Burglary with assault or battery.

13  810.02(2)(b)       1st,PBL  Burglary; armed with explosives

14                              or dangerous weapon.

15  810.02(2)(c)       1st      Burglary of a dwelling or

16                              structure causing structural

17                              damage or $1,000 or more property

18                              damage.

19  812.13(2)(b)       1st      Robbery with a weapon.

20  812.135(2)         1st      Home-invasion robbery.

21  825.102(2)         2nd      Aggravated abuse of an elderly

22                              person or disabled adult.

23  825.1025(2)        2nd      Lewd or lascivious battery upon

24                              an elderly person or disabled

25                              adult.

26  825.103(2)(a)      1st      Exploiting an elderly person or

27                              disabled adult and property is

28                              valued at $100,000 or more.

29  837.02(2)          2nd      Perjury in official proceedings

30                              relating to prosecution of a

31                              capital felony.

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 1  837.021(2)         2nd      Making contradictory statements

 2                              in official proceedings relating

 3                              to prosecution of a capital

 4                              felony.

 5  860.121(2)(c)      1st      Shooting at or throwing any

 6                              object in path of railroad

 7                              vehicle resulting in great bodily

 8                              harm.

 9  860.16             1st      Aircraft piracy.

10  893.13(1)(b)       1st      Sell or deliver in excess of 10

11                              grams of any substance specified

12                              in s. 893.03(1)(a) or (b).

13  893.13(2)(b)       1st      Purchase in excess of 10 grams of

14                              any substance specified in s.

15                              893.03(1)(a) or (b).

16  893.13(6)(c)       1st      Possess in excess of 10 grams of

17                              any substance specified in s.

18                              893.03(1)(a) or (b).

19  893.135(1)(a)2.    1st      Trafficking in cannabis, more

20                              than 2,000 lbs., less than 10,000

21                              lbs.

22  893.135

23   (1)(b)1.b.        1st      Trafficking in cocaine, more than

24                              200 grams, less than 400 grams.

25  893.135

26   (1)(c)1.b.        1st      Trafficking in illegal drugs,

27                              more than 14 grams, less than 28

28                              grams.

29  

30  

31  

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 1  893.135

 2   (1)(d)1.b.        1st      Trafficking in phencyclidine,

 3                              more than 200 grams, less than

 4                              400 grams.

 5  893.135

 6   (1)(e)1.b.        1st      Trafficking in methaqualone, more

 7                              than 5 kilograms, less than 25

 8                              kilograms.

 9  893.135

10   (1)(f)1.b.        1st      Trafficking in amphetamine, more

11                              than 28 grams, less than 200

12                              grams.

13  893.135

14   (1)(g)1.b.        1st      Trafficking in flunitrazepam, 14

15                              grams or more, less than 28

16                              grams.

17  893.135

18   (1)(h)1.b.        1st      Trafficking in

19                              gamma-hydroxybutyric acid (GHB),

20                              5 kilograms or more, less than 10

21                              kilograms.

22  893.135

23   (1)(j)1.b.        1st      Trafficking in 1,4-Butanediol, 5

24                              kilograms or more, less than 10

25                              kilograms.

26  893.135

27   (1)(k)2.b.        1st      Trafficking in Phenethylamines,

28                              200 grams or more, less than 400

29                              grams.

30  

31  

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 1  895.03(1)          1st      Use or invest proceeds derived

 2                              from pattern of racketeering

 3                              activity.

 4  895.03(2)          1st      Acquire or maintain through

 5                              racketeering activity any

 6                              interest in or control of any

 7                              enterprise or real property.

 8  895.03(3)          1st      Conduct or participate in any

 9                              enterprise through pattern of

10                              racketeering activity.

11  896.101(5)(b)      2nd      Money laundering, financial

12                              transactions totaling or

13                              exceeding $20,000, but less than

14                              $100,000.

15  896.104(4)(a)2.    2nd      Structuring transactions to evade

16                              reporting or registration

17                              requirements, financial

18                              transactions totaling or

19                              exceeding $20,000 but less than

20                              $100,000.

21                              (i)  LEVEL 9

22  316.193

23   (3)(c)3.b.        1st      DUI manslaughter; failing to

24                              render aid or give information.

25  327.35(3)(c)3.b.   1st      BUI manslaughter; failing to

26                              render aid or give information.

27  499.0053           1st      Sale or purchase of contraband

28                              legend drugs resulting in great

29                              bodily harm.

30  

31  

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 1  560.123(8)(b)3.    1st      Failure to report currency or

 2                              payment instruments totaling or

 3                              exceeding $100,000 by money

 4                              transmitter.

 5  560.125(5)(c)      1st      Money transmitter business by

 6                              unauthorized person, currency, or

 7                              payment instruments totaling or

 8                              exceeding $100,000.

 9  655.50(10)(b)3.    1st      Failure to report financial

10                              transactions totaling or

11                              exceeding $100,000 by financial

12                              institution.

13  775.0844           1st      Aggravated white collar crime.

14  782.04(1)          1st      Attempt, conspire, or solicit to

15                              commit premeditated murder.

16  782.04(3)          1st,PBL   Accomplice to murder in

17                              connection with arson, sexual

18                              battery, robbery, burglary, and

19                              other specified felonies.

20  782.051(1)         1st      Attempted felony murder while

21                              perpetrating or attempting to

22                              perpetrate a felony enumerated in

23                              s. 782.04(3).

24  782.07(2)          1st      Aggravated manslaughter of an

25                              elderly person or disabled adult.

26  787.01(1)(a)1.     1st,PBL  Kidnapping; hold for ransom or

27                              reward or as a shield or hostage.

28  787.01(1)(a)2.     1st,PBL  Kidnapping with intent to commit

29                              or facilitate commission of any

30                              felony.

31  

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 1  787.01(1)(a)4.     1st,PBL  Kidnapping with intent to

 2                              interfere with performance of any

 3                              governmental or political

 4                              function.

 5  787.02(3)(a)       1st      False imprisonment; child under

 6                              age 13; perpetrator also commits

 7                              aggravated child abuse, sexual

 8                              battery, or lewd or lascivious

 9                              battery, molestation, conduct, or

10                              exhibition.

11  790.161            1st      Attempted capital destructive

12                              device offense.

13  790.166(2)         1st,PBL  Possessing, selling, using, or

14                              attempting to use a weapon of

15                              mass destruction.

16  794.011(2)         1st      Attempted sexual battery; victim

17                              less than 12 years of age.

18  794.011(2)         Life     Sexual battery; offender younger

19                              than 18 years and commits sexual

20                              battery on a person less than 12

21                              years.

22  794.011(4)         1st      Sexual battery; victim 12 years

23                              or older, certain circumstances.

24  794.011(8)(b)      1st      Sexual battery; engage in sexual

25                              conduct with minor 12 to 18 years

26                              by person in familial or

27                              custodial authority.

28  800.04(5)(b)       1st      Lewd or lascivious molestation;

29                              victim less than 12 years;

30                              offender 18 years or older.

31  

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 1  812.13(2)(a)       1st,PBL  Robbery with firearm or other

 2                              deadly weapon.

 3  812.133(2)(a)      1st,PBL  Carjacking; firearm or other

 4                              deadly weapon.

 5  827.03(2)          1st      Aggravated child abuse.

 6  847.0145(1)        1st      Selling, or otherwise

 7                              transferring custody or control,

 8                              of a minor.

 9  847.0145(2)        1st      Purchasing, or otherwise

10                              obtaining custody or control, of

11                              a minor.

12  859.01             1st      Poisoning or introducing

13                              bacteria, radioactive materials,

14                              viruses, or chemical compounds

15                              into food, drink, medicine, or

16                              water with intent to kill or

17                              injure another person.

18  893.135            1st      Attempted capital trafficking

19                              offense.

20  893.135(1)(a)3.    1st      Trafficking in cannabis, more

21                              than 10,000 lbs.

22  893.135

23   (1)(b)1.c.        1st      Trafficking in cocaine, more than

24                              400 grams, less than 150

25                              kilograms.

26  893.135

27   (1)(c)1.c.        1st      Trafficking in illegal drugs,

28                              more than 28 grams, less than 30

29                              kilograms.

30  

31  

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 1  893.135

 2   (1)(d)1.c.        1st      Trafficking in phencyclidine,

 3                              more than 400 grams.

 4  893.135

 5   (1)(e)1.c.        1st      Trafficking in methaqualone, more

 6                              than 25 kilograms.

 7  893.135

 8   (1)(f)1.c.        1st      Trafficking in amphetamine, more

 9                              than 200 grams.

10  893.135

11   (1)(h)1.c.        1st      Trafficking in

12                              gamma-hydroxybutyric acid (GHB),

13                              10 kilograms or more.

14  893.135

15   (1)(j)1.c.        1st      Trafficking in 1,4-Butanediol, 10

16                              kilograms or more.

17  893.135

18   (1)(k)2.c.        1st      Trafficking in Phenethylamines,

19                              400 grams or more.

20  896.101(5)(c)      1st      Money laundering, financial

21                              instruments totaling or exceeding

22                              $100,000.

23  896.104(4)(a)3.    1st      Structuring transactions to evade

24                              reporting or registration

25                              requirements, financial

26                              transactions totaling or

27                              exceeding $100,000.

28                              (j)  LEVEL 10

29  499.0054           1st      Sale or purchase of contraband

30                              legend drugs resulting in death.

31  

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 1  782.04(2)          1st,PBL  Unlawful killing of human; act is

 2                              homicide, unpremeditated.

 3  787.01(1)(a)3.     1st,PBL  Kidnapping; inflict bodily harm

 4                              upon or terrorize victim.

 5  787.01(3)(a)       Life     Kidnapping; child under age 13,

 6                              perpetrator also commits

 7                              aggravated child abuse, sexual

 8                              battery, or lewd or lascivious

 9                              battery, molestation, conduct, or

10                              exhibition.

11  782.07(3)          1st      Aggravated manslaughter of a

12                              child.

13  794.011(3)         Life     Sexual battery; victim 12 years

14                              or older, offender uses or

15                              threatens to use deadly weapon or

16                              physical force to cause serious

17                              injury.

18  876.32             1st      Treason against the state.

19         Section 30.  Paragraph (a) of subsection (1) of section

20  16.56, Florida Statutes, is amended to read:

21         16.56  Office of Statewide Prosecution.--

22         (1)  There is created in the Department of Legal

23  Affairs an Office of Statewide Prosecution.  The office shall

24  be a separate "budget entity" as that term is defined in

25  chapter 216.  The office may:

26         (a)  Investigate and prosecute the offenses of:

27         1.  Bribery, burglary, criminal usury, extortion,

28  gambling, kidnapping, larceny, murder, prostitution, perjury,

29  robbery, carjacking, and home-invasion robbery;

30         2.  Any crime involving narcotic or other dangerous

31  drugs;

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 1         3.  Any violation of the provisions of the Florida RICO

 2  (Racketeer Influenced and Corrupt Organization) Act, including

 3  any offense listed in the definition of racketeering activity

 4  in s. 895.02(1)(a), providing such listed offense is

 5  investigated in connection with a violation of s. 895.03 and

 6  is charged in a separate count of an information or indictment

 7  containing a count charging a violation of s. 895.03, the

 8  prosecution of which listed offense may continue independently

 9  if the prosecution of the violation of s. 895.03 is terminated

10  for any reason;

11         4.  Any violation of the provisions of the Florida

12  Anti-Fencing Act;

13         5.  Any violation of the provisions of the Florida

14  Antitrust Act of 1980, as amended;

15         6.  Any crime involving, or resulting in, fraud or

16  deceit upon any person;

17         7.  Any violation of s. 847.0135, relating to computer

18  pornography and child exploitation prevention, or any offense

19  related to a violation of s. 847.0135; or

20         8.  Any violation of the provisions of chapter 815; or

21         9.  Any criminal violation of part I of chapter 499.

22  

23  or any attempt, solicitation, or conspiracy to commit any of

24  the crimes specifically enumerated above.  The office shall

25  have such power only when any such offense is occurring, or

26  has occurred, in two or more judicial circuits as part of a

27  related transaction, or when any such offense is connected

28  with an organized criminal conspiracy affecting two or more

29  judicial circuits.

30         Section 31.  Paragraph (a) of subsection (1) of section

31  895.02, Florida Statutes, is amended to read:

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 1         895.02  Definitions.--As used in ss. 895.01-895.08, the

 2  term:

 3         (1)  "Racketeering activity" means to commit, to

 4  attempt to commit, to conspire to commit, or to solicit,

 5  coerce, or intimidate another person to commit:

 6         (a)  Any crime which is chargeable by indictment or

 7  information under the following provisions of the Florida

 8  Statutes:

 9         1.  Section 210.18, relating to evasion of payment of

10  cigarette taxes.

11         2.  Section 403.727(3)(b), relating to environmental

12  control.

13         3.  Section 414.39, relating to public assistance

14  fraud.

15         4.  Section 409.920, relating to Medicaid provider

16  fraud.

17         5.  Section 440.105 or s. 440.106, relating to workers'

18  compensation.

19         6.  Sections 499.0051, 499.0052, 499.0053, 499.0054,

20  and 499.0691, relating to crimes involving contraband and

21  adulterated drugs.

22         7.6.  Part IV of chapter 501, relating to

23  telemarketing.

24         8.7.  Chapter 517, relating to sale of securities and

25  investor protection.

26         9.8.  Section 550.235, s. 550.3551, or s. 550.3605,

27  relating to dogracing and horseracing.

28         10.9.  Chapter 550, relating to jai alai frontons.

29         11.10.  Chapter 552, relating to the manufacture,

30  distribution, and use of explosives.

31  

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 1         12.11.  Chapter 560, relating to money transmitters, if

 2  the violation is punishable as a felony.

 3         13.12.  Chapter 562, relating to beverage law

 4  enforcement.

 5         14.13.  Section 624.401, relating to transacting

 6  insurance without a certificate of authority, s.

 7  624.437(4)(c)1., relating to operating an unauthorized

 8  multiple-employer welfare arrangement, or s. 626.902(1)(b),

 9  relating to representing or aiding an unauthorized insurer.

10         15.14.  Section 655.50, relating to reports of currency

11  transactions, when such violation is punishable as a felony.

12         16.15.  Chapter 687, relating to interest and usurious

13  practices.

14         17.16.  Section 721.08, s. 721.09, or s. 721.13,

15  relating to real estate timeshare plans.

16         18.17.  Chapter 782, relating to homicide.

17         19.18.  Chapter 784, relating to assault and battery.

18         20.19.  Chapter 787, relating to kidnapping.

19         21.20.  Chapter 790, relating to weapons and firearms.

20         22.21.  Section 796.03, s. 796.04, s.  796.05, or s.

21  796.07, relating to prostitution.

22         23.22.  Chapter 806, relating to arson.

23         24.23.  Section 810.02(2)(c), relating to specified

24  burglary of a dwelling or structure.

25         25.24.  Chapter 812, relating to theft, robbery, and

26  related crimes.

27         26.25.  Chapter 815, relating to computer-related

28  crimes.

29         27.26.  Chapter 817, relating to fraudulent practices,

30  false pretenses, fraud generally, and credit card crimes.

31  

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 1         28.27.  Chapter 825, relating to abuse, neglect, or

 2  exploitation of an elderly person or disabled adult.

 3         29.28.  Section 827.071, relating to commercial sexual

 4  exploitation of children.

 5         30.29.  Chapter 831, relating to forgery and

 6  counterfeiting.

 7         31.30.  Chapter 832, relating to issuance of worthless

 8  checks and drafts.

 9         32.31.  Section 836.05, relating to extortion.

10         33.32.  Chapter 837, relating to perjury.

11         34.33.  Chapter 838, relating to bribery and misuse of

12  public office.

13         35.34.  Chapter 843, relating to obstruction of

14  justice.

15         36.35.  Section 847.011, s. 847.012, s. 847.013, s.

16  847.06, or s. 847.07, relating to obscene literature and

17  profanity.

18         37.36.  Section 849.09, s. 849.14, s. 849.15, s.

19  849.23, or s. 849.25, relating to gambling.

20         38.37.  Chapter 874, relating to criminal street gangs.

21         39.38.  Chapter 893, relating to drug abuse prevention

22  and control.

23         40.39.  Chapter 896, relating to offenses related to

24  financial transactions.

25         41.40.  Sections 914.22 and 914.23, relating to

26  tampering with a witness, victim, or informant, and

27  retaliation against a witness, victim, or informant.

28         42.41.  Sections 918.12 and 918.13, relating to

29  tampering with jurors and evidence.

30         Section 32.  Section 905.34, Florida Statutes, is

31  amended to read:

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 1         905.34  Powers and duties; law applicable.--The

 2  jurisdiction of a statewide grand jury impaneled under this

 3  chapter shall extend throughout the state. The subject matter

 4  jurisdiction of the statewide grand jury shall be limited to

 5  the offenses of:

 6         (1)  Bribery, burglary, carjacking, home-invasion

 7  robbery, criminal usury, extortion, gambling, kidnapping,

 8  larceny, murder, prostitution, perjury, and robbery;

 9         (2)  Crimes involving narcotic or other dangerous

10  drugs;

11         (3)  Any violation of the provisions of the Florida

12  RICO (Racketeer Influenced and Corrupt Organization) Act,

13  including any offense listed in the definition of racketeering

14  activity in s. 895.02(1)(a), providing such listed offense is

15  investigated in connection with a violation of s. 895.03 and

16  is charged in a separate count of an information or indictment

17  containing a count charging a violation of s. 895.03, the

18  prosecution of which listed offense may continue independently

19  if the prosecution of the violation of s. 895.03 is terminated

20  for any reason;

21         (4)  Any violation of the provisions of the Florida

22  Anti-Fencing Act;

23         (5)  Any violation of the provisions of the Florida

24  Antitrust Act of 1980, as amended;

25         (6)  Any violation of the provisions of chapter 815;

26         (7)  Any crime involving, or resulting in, fraud or

27  deceit upon any person;

28         (8)  Any violation of s. 847.0135, s. 847.0137, or s.

29  847.0138 relating to computer pornography and child

30  exploitation prevention, or any offense related to a violation

31  of s. 847.0135, s. 847.0137, or s. 847.0138; or

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 1         (9)  Any criminal violation of part I of chapter 499.

 2  

 3  or any attempt, solicitation, or conspiracy to commit any

 4  violation of the crimes specifically enumerated above, when

 5  any such offense is occurring, or has occurred, in two or more

 6  judicial circuits as part of a related transaction or when any

 7  such offense is connected with an organized criminal

 8  conspiracy affecting two or more judicial circuits.  The

 9  statewide grand jury may return indictments and presentments

10  irrespective of the county or judicial circuit where the

11  offense is committed or triable.  If an indictment is

12  returned, it shall be certified and transferred for trial to

13  the county where the offense was committed.  The powers and

14  duties of, and law applicable to, county grand juries shall

15  apply to a statewide grand jury except when such powers,

16  duties, and law are inconsistent with the provisions of ss.

17  905.31-905.40.

18         Section 33.  If any provision of this act or its

19  application to any person or circumstance is held invalid, the

20  invalidity does not affect other provisions or applications of

21  the act which can be given effect without the invalid

22  provision or application, and to this end the provisions of

23  this act are severable.

24         Section 34.  The sum of $453,851 is appropriated from

25  the Florida Drugs, Devices, and Cosmetic Trust Fund to the

26  Department of Health and three additional full-time equivalent

27  positions are authorized to implement this act.

28         Section 35.  Except as otherwise expressly provided in

29  this act, this act shall take effect July 1, 2003.

30  

31  

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 1          STATEMENT OF SUBSTANTIAL CHANGES CONTAINED IN
                       COMMITTEE SUBSTITUTE FOR
 2                     CS for Senate Bill 2312

 3                                 

 4  The Committee Substitute revises the appropriation to the
    Department of Health to $453,851 from the Florida Drugs,
 5  Devices and Cosmetic Trust Fund.

 6  Revises the definition of "pedigree paper" to mean a document
    in a form approved by the Department of Health effective July
 7  1, 2006 (previously March 1, 2005).

 8  Revises the dates for failure to authenticate pedigree papers
    for possession of documents required under s. 499.0121(6)(e)
 9  until July 1, 2006 (previously March 1, 2005).

10  Clarifies the definition of "authorized distributors of
    record" to enable certain wholesalers to be deemed authorized
11  distributors of record.

12  

13  

14  

15  

16  

17  

18  

19  

20  

21  

22  

23  

24  

25  

26  

27  

28  

29  

30  

31  

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