House Bill 4043er

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  2         An act relating to obsolete, expired, or

  3         repealed provisions of law; repealing various

  4         provisions of law that have become obsolete,

  5         have had their effect, have served their

  6         purpose, or have been impliedly repealed or

  7         superseded; repealing s. 404.22(5)(c), F.S.,

  8         relating to adoption of a fee schedule for

  9         fiscal year 1981-1982 for registration and

10         inspection of radiation machines; repealing s.

11         458.349, F.S., relating to savings clauses

12         applicable to repeal and reenactment in 1979 of

13         ch. 458, F.S., relating to medical practice;

14         repealing s. 459.024, F.S., relating to savings

15         clauses applicable to repeal and reenactment in

16         1979 of ch. 459, F.S., relating to osteopathic

17         medicine; repealing s. 461.015, F.S., relating

18         to savings clauses applicable to repeal and

19         reenactment in 1979 of ch. 461, F.S., relating

20         to podiatric medicine; repealing s. 463.019,

21         F.S., relating to savings clauses applicable to

22         repeal and reenactment in 1986 of ch. 463,

23         F.S., relating to optometry; repealing s.

24         464.0035, F.S., relating to staggering of

25         initial terms on the joint committee appointed

26         to approve acts of medical diagnosis and

27         treatment, prescription, and operation that are

28         authorized as advanced or specialized nursing

29         practice; repealing s. 464.023, F.S., relating

30         to savings clauses applicable to repeal and

31         reenactment in 1979 of ch. 464, F.S., relating


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  1         to nursing; repealing s. 468.804, F.S.,

  2         relating to the Orthotists and Prosthetists

  3         Educational Programs Task Force; repealing s.

  4         484.019, F.S., relating to savings clauses

  5         applicable to repeal and reenactment in 1986 of

  6         pt. I, ch. 484, F.S., relating to preparing and

  7         dispensing of eyeglasses and other optical

  8         devices; repealing ss. 499.018, 499.019,

  9         499.02, 499.021, and 499.022, F.S., to abolish

10         the investigational drug program and the

11         Florida Drug Technical Review Panel; repealing

12         s. 499.003(16) and (28), F.S., relating to the

13         definitions of "investigational drug" and

14         "technical panel," to conform; amending ss.

15         381.0203, 499.015, 499.024, 499.03, 499.04,

16         499.041, and 499.067, F.S.; removing or

17         revising references and related provisions, to

18         conform; repealing s. 499.025(5), F.S.,

19         relating to applicability of provisions

20         establishing identification requirements for

21         drug products in finished, solid, oral dosage

22         form; repealing s. 103, ch. 97-261, Laws of

23         Florida, and s. 2, 98-226, Laws of Florida,

24         relating to the task force on the health care

25         practitioner credentialing program; repealing

26         s. 13, ch. 99-332, Laws of Florida, relating to

27         the Task Force on Home Health Services

28         Licensure Provisions; repealing s. 28, ch.

29         99-394, Laws of Florida, relating to the

30         certified nursing assistant study group;

31         repealing ss. 125 and 175, ch. 99-397, Laws of


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  1         Florida, relating to the Task Force for the

  2         Study of Collaborative Drug Therapy Management

  3         and the Task Force on Telehealth; providing an

  4         effective date.

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

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  8         Section 1.  Paragraph (c) of subsection (5) of section

  9  404.22, Florida Statutes, is repealed.

10         Section 2.  Section 458.349, Florida Statutes, is

11  repealed.

12         Section 3.  Section 459.024, Florida Statutes, is

13  repealed.

14         Section 4.  Section 461.015, Florida Statutes, is

15  repealed.

16         Section 5.  Section 463.019, Florida Statutes, is

17  repealed.

18         Section 6.  Section 464.0035, Florida Statutes, is

19  repealed.

20         Section 7.  Section 464.023, Florida Statutes, is

21  repealed.

22         Section 8.  Section 468.804, Florida Statutes, is

23  repealed.

24         Section 9.  Section 484.019, Florida Statutes, is

25  repealed.

26         Section 10.  Subsections (16) and (28) of section

27  499.003, Florida Statutes, and sections 499.018, 499.019,

28  499.02, 499.021, and 499.022, Florida Statutes, are repealed.

29         Section 11.  Subsection (2) of section 381.0203,

30  Florida Statutes, is amended to read:

31         381.0203  Pharmacy services.--


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  1         (2)  The department may establish and maintain a

  2  pharmacy services program, including, but not limited to:

  3         (a)  A central pharmacy to support pharmaceutical

  4  services provided by the county health departments, including

  5  pharmaceutical repackaging, dispensing, and the purchase and

  6  distribution of immunizations and other pharmaceuticals.

  7         (b)  Regulation of drugs, cosmetics, and household

  8  products pursuant to chapter 499.

  9         (c)  An investigational drug program.

10         (c)(d)  Consultation to county health departments as

11  required by s. 154.04(1)(c).

12         (d)(e)  A contraception distribution program which

13  shall be implemented, to the extent resources permit, through

14  the licensed pharmacies of county health departments.  A woman

15  who is eligible for participation in the contraceptive

16  distribution program is deemed a patient of the county health

17  department.

18         1.  To be eligible for participation in the program a

19  woman must:

20         a.  Be a client of the department or the Department of

21  Children and Family Services.

22         b.  Be of childbearing age with undesired fertility.

23         c.  Have an income between 150 and 200 percent of the

24  federal poverty level.

25         d.  Have no Medicaid benefits or applicable health

26  insurance benefits.

27         e.  Have had a medical examination by a licensed health

28  care provider within the past 6 months.

29         f.  Have a valid prescription for contraceptives that

30  are available through the contraceptive distribution program.

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  1         g.  Consent to the release of necessary medical

  2  information to the county health department.

  3         2.  Fees charged for the contraceptives under the

  4  program must cover the cost of purchasing and providing

  5  contraceptives to women participating in the program.

  6         3.  The department may adopt rules to administer this

  7  program.

  8         Section 12.  Subsections (1) and (3) of section

  9  499.015, Florida Statutes, are amended to read:

10         499.015  Registration of drugs, devices, and cosmetics;

11  issuance of certificates of free sale.--

12         (1)  Except for those persons exempted from the

13  definition in s. 499.003(20)(21), any person who manufactures,

14  packages, repackages, labels, or relabels a drug, device, or

15  cosmetic in this state must register such drug, device, or

16  cosmetic biennially with the department; pay a fee in

17  accordance with the fee schedule provided by s. 499.041; and

18  comply with this section. The registrant must list each

19  separate and distinct drug, device, or cosmetic at the time of

20  registration.

21         (3)  Except for those persons exempted from the

22  definition in s. 499.003(20)(21), a person may not sell any

23  product that he or she has failed to register in conformity

24  with this section. Such failure to register subjects such

25  drug, device, or cosmetic product to seizure and condemnation

26  as provided in ss. 499.062-499.064, and subjects such person

27  to the penalties and remedies provided in ss. 499.001-499.081.

28         Section 13.  Section 499.024, Florida Statutes, is

29  amended to read:

30         499.024  Drug product classification.--The secretary

31  shall adopt rules to classify drug products intended for use


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  1  by humans which the United States Food and Drug Administration

  2  has not classified in the federal act or the Code of Federal

  3  Regulations.

  4         (1)  The Florida Drug Technical Review Panel may review

  5  and make recommendations on products.

  6         (1)(2)  Drug products must be classified as

  7  proprietary, prescription, or investigational drugs.

  8         (2)(3)  If a product is distributed without required

  9  labeling, it is misbranded while held for sale.

10         (3)(4)  Any product that falls under the drug

11  definition, s. 499.003(11), may be classified under the

12  authority of this section.  This section does not subject

13  portable emergency oxygen inhalators to classification;

14  however, this section does not exempt any person from ss.

15  499.01 and 499.015.

16         (4)(5)  Any product classified under the authority of

17  this section reverts to the federal classification, if

18  different, upon the federal regulation or act becoming

19  effective.

20         (5)(6)  The department may by rule reclassify drugs

21  subject to ss. 499.001-499.081 when such classification action

22  is necessary to protect the public health.

23         (6)(7)  The department may adopt rules that exempt from

24  any labeling or packaging requirements of ss. 499.001-499.081

25  drugs classified under this section if those requirements are

26  not necessary to protect the public health.

27         Section 14.  Subsection (1) of section 499.03, Florida

28  Statutes, is amended to read:

29         499.03  Possession of new drugs or legend drugs without

30  prescriptions unlawful; exemptions and exceptions.--

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  1         (1)  A person may not possess, or possess with intent

  2  to sell, dispense, or deliver, any habit-forming, toxic,

  3  harmful, or new drug subject to s. 499.003(21)(22), or legend

  4  drug as defined in s. 499.003(18), unless the possession of

  5  the drug has been obtained by a valid prescription of a

  6  practitioner licensed by law to prescribe the drug.  However,

  7  this section does not apply to the delivery of such drugs to

  8  persons included in any of the classes named in this

  9  subsection, or to the agents or employees of such persons, for

10  use in the usual course of their businesses or practices or in

11  the performance of their official duties, as the case may be;

12  nor does this section apply to the possession of such drugs by

13  those persons or their agents or employees for such use:

14         (a)  A licensed pharmacist or any person under the

15  licensed pharmacist's supervision while acting within the

16  scope of the licensed pharmacist's practice;

17         (b)  A licensed practitioner authorized by law to

18  prescribe legend drugs or any person under the licensed

19  practitioner's supervision while acting within the scope of

20  the licensed practitioner's practice;

21         (c)  A qualified person who uses legend drugs for

22  lawful research, teaching, or testing, and not for resale;

23         (d)  A licensed hospital or other institution that

24  procures such drugs for lawful administration or dispensing by

25  practitioners;

26         (e)  An officer or employee of a federal, state, or

27  local government; or

28         (f)  A person that holds a valid permit issued by the

29  department pursuant to ss. 499.001-499.081 which authorizes

30  that person to possess prescription drugs.

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  1         Section 15.  Section 499.04, Florida Statutes, is

  2  amended to read:

  3         499.04  Fee authority.--The department may collect fees

  4  for all drug, device, and cosmetic applications, permits,

  5  investigational drug applications, product registrations, and

  6  free-sale certificates.  The total amount of fees collected

  7  from all permits, applications, product registrations, and

  8  free-sale certificates must be adequate to fund the expenses

  9  incurred by the department in carrying out ss.

10  499.001-499.081. The department shall, by rule, establish a

11  schedule of fees that are within the ranges provided in this

12  section and shall adjust those fees from time to time based on

13  the costs associated with administering ss. 499.001-499.081.

14  The fees are payable to the department to be deposited into

15  the Florida Drug, Device, and Cosmetic Trust Fund for the sole

16  purpose of carrying out the provisions of ss. 499.001-499.081.

17         Section 16.  Section 499.041, Florida Statutes, is

18  amended to read:

19         499.041  Schedule of fees for drug, device, and

20  cosmetic applications and permits, investigational drug

21  applications, product registrations, and free-sale

22  certificates; trust fund.--

23         (1)  The department shall assess applicants requiring a

24  manufacturing permit an annual fee within the ranges

25  established in this section for the specific type of

26  manufacturer.

27         (a)  The fee for a prescription drug manufacturer's

28  permit may not be less than $500 or more than $600 annually.

29         (b)  The fee for a device manufacturer's permit may not

30  be less than $500 or more than $600 annually.

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  1         (c)  The fee for a cosmetic manufacturer's permit may

  2  not be less than $250 or more than $400 annually.

  3         (d)  The fee for an over-the-counter drug

  4  manufacturer's permit may not be less than $300 or more than

  5  $400 annually.

  6         (e)  The fee for a compressed medical gas

  7  manufacturer's permit may not be less than $400 or more than

  8  $500 annually.

  9         (f)  A manufacturer may not be required to pay more

10  than one fee per establishment to obtain an additional

11  manufacturing permit, but each manufacturer must pay the

12  highest fee applicable to his or her operation in each

13  establishment.

14         (2)  The department shall assess an applicant that is

15  required to have a wholesaling permit an annual fee within the

16  ranges established in this section for the specific type of

17  wholesaling.

18         (a)  The fee for a prescription drug wholesaler's

19  permit may not be less than $300 or more than $400 annually;

20         (b)  The fee for a compressed medical gas wholesaler's

21  permit may not be less than $200 or more than $300 annually;

22         (c)  The fee for an out-of-state prescription drug

23  wholesaler's permit may not be less than $200 or more than

24  $300 annually;

25         (d)  The fee for a retail pharmacy wholesaler's permit

26  may not be less than $35 or more than $50 annually.

27         (3)  The department shall assess an applicant that is

28  required to have a retail establishment permit an annual fee

29  within the ranges established in this section for the specific

30  type of retail establishment.

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  1         (a)  The fee for a veterinary legend drug retail

  2  establishment permit may not be less than $200 or more than

  3  $300 annually;

  4         (b)  The fee for a medical oxygen retail establishment

  5  permit may not be less than $200 or more than $300 annually.

  6         (4)  The department shall assess an applicant that is

  7  required to have a restricted prescription drug distributor's

  8  permit an annual fee of not less than $200 or more than $300.

  9         (5)  In addition to the fee charged for a permit

10  required by ss. 499.001-499.081, beginning January 1, 1993,

11  the department shall assess applicants an initial application

12  fee of $150 for each new permit issued by the department which

13  requires an onsite inspection.

14         (6)  A person that is required to register drugs,

15  devices, or cosmetic products under s. 499.015 shall pay an

16  annual product registration fee of not less than $5 or more

17  than $15 for each separate and distinct product in package

18  form.  The registration fee is in addition to the fee charged

19  for a free-sale certificate.

20         (7)  The department shall assess an applicant that

21  requests a free-sale certificate a fee of $25.  A fee of $2

22  will be charged for each signature copy of a free-sale

23  certificate that is obtained at the same time the free-sale

24  certificate is issued.

25         (8)  The department shall assess an applicant that

26  makes application for approval of an investigational drug

27  pursuant to s. 499.018 a filing fee of not less than $1,000 or

28  more than $1,100.

29         (9)  The department shall assess each individual

30  applicant the fees for consulting contracts provided for in s.

31  499.021.  The consulting contracts must be completed by


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  1  contractors approved by the department.  In awarding a

  2  consulting contract, preference must be given to the

  3  universities in the state and government laboratory resources,

  4  which must be contracted with when appropriate.

  5         (10)  Consulting contract fees must be set by the

  6  actual cost submitted by the contractor for each product

  7  application. All fees paid to the department, as provided in

  8  this section, must be placed in the Florida Drug, Device, and

  9  Cosmetic Trust Fund and used by the department for the

10  administration of ss. 499.001-499.081.

11         (8)(11)  The department shall assess other fees as

12  provided in ss. 499.001-499.081.

13         Section 17.  Paragraph (a) of subsection (1) of section

14  499.067, Florida Statutes, is amended to read:

15         499.067  Denial, suspension, or revocation of permit or

16  registration.--

17         (1)(a)  The department may deny, suspend, or revoke a

18  permit if it finds that there has been a substantial failure

19  to comply with ss. 499.001-499.081 or chapter 465, chapter

20  501, or chapter 893, the rules adopted under any of those

21  sections or chapters, any final order of the department, the

22  procedures and protocols established for any investigational

23  drug product by the department, or applicable federal laws or

24  regulations or other state laws or rules governing drugs,

25  devices, or cosmetics.

26         Section 18.  Subsection (5) of section 499.025, Florida

27  Statutes, is repealed.

28         Section 19.  Section 103 of chapter 97-261, Laws of

29  Florida, and section 2 of chapter 98-226, Laws of Florida, are

30  repealed.

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  1         Section 20.  Section 13 of chapter 99-332, Laws of

  2  Florida, is repealed.

  3         Section 21.  Section 28 of chapter 99-394, Laws of

  4  Florida, is repealed.

  5         Section 22.  Sections 125 and 175 of chapter 99-397,

  6  Laws of Florida, are repealed.

  7         Section 23.  This act shall take effect upon becoming a

  8  law.

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