Senate Bill sb1824e1

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    CS for SB 1824                           First Engrossed (ntc)



  1                      A bill to be entitled

  2         An act relating to veterinary prescription

  3         drugs; amending s. 499.003, F.S.; defining the

  4         term "veterinary prescription drug wholesaler";

  5         amending s. 499.01, F.S.; requiring a person or

  6         establishment to obtain a permit in order to

  7         operate as a veterinary prescription drug

  8         wholesaler; amending s. 499.012, F.S.;

  9         requiring a person to have a veterinary

10         prescription drug wholesaler permit to

11         distribute veterinary prescription drugs in or

12         into this state; requiring a veterinary

13         prescription drug wholesaler that also

14         distributes human prescription drugs that it

15         did not manufacture to obtain a prescription

16         drug wholesaler or out-of-state prescription

17         drug wholesaler permit in lieu of the

18         veterinary prescription drug wholesaler permit;

19         amending s. 499.0121, F.S.; requiring certain

20         prescription wholesalers to use due diligence

21         when purchasing prescription drugs from others;

22         amending s. 499.041, F.S.; requiring an annual

23         fee for a veterinary prescription drug

24         wholesaler's permit; amending s. 499.065, F.S.;

25         requiring the Department of Health to inspect

26         veterinary prescription drug wholesale

27         establishments; authorizing the department to

28         close such establishment if it creates an

29         imminent danger to the public health; providing

30         an effective date.

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    CS for SB 1824                           First Engrossed (ntc)



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

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 3         Section 1.  Subsection (40) is added to section

 4  499.003, Florida Statutes, to read:

 5         499.003  Definitions of terms used in ss.

 6  499.001-499.081.--As used in ss. 499.001-499.081, the term:

 7         (40)  "Veterinary prescription drug wholesaler" means

 8  any person engaged in wholesale distribution of veterinary

 9  prescription drugs in or into this state.

10         Section 2.  Subsection (1) of section 499.01, Florida

11  Statutes, is amended to read:

12         499.01  Permits; applications; renewal; general

13  requirements.--

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

15  person and establishment that intends to operate as:

16         (a)  A prescription drug manufacturer;

17         (b)  A prescription drug repackager;

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

19         (d)  A compressed medical gas manufacturer;

20         (e)  A device manufacturer;

21         (f)  A cosmetic manufacturer;

22         (g)  A prescription drug wholesaler;

23         (h)  A veterinary prescription drug wholesaler;

24         (i)(h)  A compressed medical gas wholesaler;

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

26         (k)(j)  A nonresident prescription drug manufacturer;

27         (l)(k)  A freight forwarder;

28         (m)(l)  A retail pharmacy drug wholesaler;

29         (n)(m)  A veterinary legend drug retail establishment;

30         (o)(n)  A medical oxygen retail establishment;

31         (p)(o)  A complimentary drug distributor; or


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    CS for SB 1824                           First Engrossed (ntc)



 1         (q)(p)  A restricted prescription drug distributor.

 2         Section 3.  Paragraph (g) is added to subsection (2) of

 3  section 499.012, Florida Statutes, to read:

 4         499.012  Wholesale distribution; definitions; permits;

 5  applications; general requirements.--

 6         (2)  The following types of wholesaler permits are

 7  established:

 8         (g)  A veterinary prescription drug wholesaler

 9  permit.--A veterinary prescription drug wholesaler permit is

10  required for any person that engages in the distribution of

11  veterinary prescription drugs in or into this state. A

12  veterinary prescription drug wholesaler that also distributes

13  prescription drugs subject to, defined by, or described by s.

14  503(b) of the Federal Food, Drug, and Cosmetic Act which it

15  did not manufacture must obtain a permit as a prescription

16  drug wholesaler or out-of-state prescription drug wholesaler

17  in lieu of the veterinary prescription drug wholesaler permit.

18  A veterinary prescription drug wholesaler must comply with the

19  requirements for wholesale distributors under s. 499.0121,

20  except those set forth in s. 499.0121(6)(d), (e), or (f).

21         Section 4.  Subsection (12) of section 499.0121,

22  Florida Statutes, is amended to read:

23         499.0121  Storage and handling of prescription drugs;

24  recordkeeping.--The department shall adopt rules to implement

25  this section as necessary to protect the public health,

26  safety, and welfare.  Such rules shall include, but not be

27  limited to, requirements for the storage and handling of

28  prescription drugs and for the establishment and maintenance

29  of prescription drug distribution records.

30         (12)  DUE DILIGENCE OF SUPPLIERS.--Prior to purchasing

31  any prescription drugs from another wholesale drug


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    CS for SB 1824                           First Engrossed (ntc)



 1  distributor, a prescription drug wholesaler, an out-of-state

 2  prescription drug wholesaler, or a prescription drug

 3  repackager a wholesale drug distributor must:

 4         (a)  Enter an agreement with the selling wholesale drug

 5  distributor by which the selling wholesale drug distributor

 6  will indemnify the purchasing wholesale drug distributor for

 7  any loss caused to the purchasing wholesale drug distributor

 8  related to the purchase of drugs from the selling wholesale

 9  drug distributor which are determined to be counterfeit or to

10  have been distributed in violation of any federal or state law

11  governing the distribution of drugs.

12         (b)  Determine that the selling wholesale drug

13  distributor has insurance coverage of not less than the

14  greater of 1 percent of the amount of total dollar volume of

15  the prescription drug sales reported to the department under

16  pursuant to s. 499.012(3)(g) or $500,000; however the coverage

17  need not exceed $2 million.

18         (c)  Obtain information from the selling wholesale drug

19  distributor, including the length of time the selling

20  wholesale drug distributor has been licensed in this state, a

21  copy of the selling wholesale drug distributor's licenses or

22  permits, and background information concerning the ownership

23  of the selling wholesale drug distributor, including the

24  experience of the wholesale distributor in the wholesale

25  distribution of prescription drugs.

26         (d)  Verify that the selling wholesale drug

27  distributor's Florida permit is valid.

28         (e)  Inspect the selling wholesale drug distributor's

29  licensed establishment to document that it has a policies and

30  procedures manual relating to the distribution of drugs, the

31  appropriate temperature controlled environment for drugs


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    CS for SB 1824                           First Engrossed (ntc)



 1  requiring temperature control, an alarm system, appropriate

 2  access restrictions, and procedures to ensure that records

 3  related to the wholesale distribution of prescription drugs

 4  are maintained as required by law:

 5         1.  Before purchasing any drug from the wholesale drug

 6  distributor, and at least once each subsequent year; or

 7         2.  Before purchasing any drug from the wholesale drug

 8  distributor, and each subsequent year obtain a complete copy

 9  of the most recent inspection report for the establishment

10  which was prepared by the department or the regulatory

11  authority responsible for wholesale drug distributors in the

12  state in which the establishment is located.

13         Section 5.  Paragraph (g) is added to subsection (2) of

14  section 499.041, Florida Statutes, to read:

15         499.041  Schedule of fees for drug, device, and

16  cosmetic applications and permits, product registrations, and

17  free-sale certificates.--

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

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

20  ranges established in this section for the specific type of

21  wholesaling.

22         (g)  The fee for a veterinary prescription drug

23  wholesaler's permit may not be less than $300 or more than

24  $500 annually.

25         Section 6.  Section 499.065, Florida Statutes, is

26  amended to read:

27         499.065  Imminent danger.--

28         (1)  Notwithstanding s. 499.051, the department shall

29  inspect each prescription drug wholesale establishment,

30  prescription drug repackager establishment, veterinary

31  prescription drug wholesale establishment, and retail pharmacy


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    CS for SB 1824                           First Engrossed (ntc)



 1  drug wholesaler establishment that is required to be permitted

 2  under this chapter as often as necessary to ensure compliance

 3  with applicable laws and rules. The department shall have the

 4  right of entry and access to these facilities at any

 5  reasonable time.

 6         (2)  To protect the public from prescription drugs that

 7  are adulterated or otherwise unfit for human or animal

 8  consumption, the department may examine, sample, seize, and

 9  stop the sale or use of prescription drugs to determine the

10  condition of those drugs. The department may immediately seize

11  and remove any prescription drugs if the Secretary of Health

12  or his or her designee determines that the such prescription

13  drugs represent a threat to the public health. The owner of

14  any property seized under this section may, within 10 days

15  after the seizure, apply to a court of competent jurisdiction

16  for whatever relief is appropriate. At any time after 10 days,

17  the department may destroy the drugs as contraband.

18         (3)  The department may determine that a prescription

19  drug wholesale establishment, prescription drug repackager

20  establishment, veterinary prescription drug wholesale

21  establishment, or retail pharmacy drug wholesaler

22  establishment that is required to be permitted under this

23  chapter is an imminent danger to the public health and shall

24  require its immediate closure if the such establishment fails

25  to comply with applicable laws and rules and, because of the

26  such failure, presents an imminent threat to the public's

27  health, safety, or welfare. Any establishment so deemed and

28  closed shall remain closed until allowed by the department or

29  by judicial order to reopen.

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    CS for SB 1824                           First Engrossed (ntc)



 1  For purposes of this section, a refusal to allow entry to the

 2  department for inspection at reasonable times, or a failure or

 3  refusal to provide the department with required documentation

 4  for purposes of inspection, constitutes an imminent danger to

 5  the public health.

 6         Section 7.  This act shall take effect July 1, 2004.

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