Senate Bill sb1540

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    Florida Senate - 2006                                  SB 1540

    By Senator Baker





    20-1096-06                                          See HB 685

  1                      A bill to be entitled

  2         An act relating to veterinary drug

  3         distribution; amending s. 499.006, F.S.;

  4         providing that a drug is adulterated if it is a

  5         certain prescription drug that has been

  6         returned by a veterinarian to a limited

  7         prescription drug veterinary wholesaler;

  8         amending s. 499.01, F.S.; requiring a limited

  9         prescription drug veterinary wholesaler to

10         obtain a permit for operation from the

11         Department of Health; providing that a permit

12         for a limited prescription drug veterinary

13         wholesaler may not be issued to the address of

14         certain health care entities; amending s.

15         499.012, F.S.; revising permit requirements for

16         a veterinary prescription drug wholesaler that

17         distributes prescription drugs; establishing a

18         permit for a limited prescription drug

19         veterinary wholesaler; providing requirements;

20         providing an exception; amending s. 499.0122,

21         F.S.; redefining the term "veterinary legend

22         drug retail establishment"; amending s.

23         499.041, F.S.; requiring the department to

24         assess an annual fee within a certain monetary

25         range for a limited prescription drug

26         veterinary wholesaler permit; amending s.

27         499.065, F.S.; requiring the department to

28         inspect each limited prescription drug

29         veterinary wholesaler establishment;

30         authorizing the department to determine that a

31         limited prescription drug veterinary wholesaler

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    Florida Senate - 2006                                  SB 1540
    20-1096-06                                          See HB 685




 1         establishment is an imminent danger to the

 2         public; providing an effective date.

 3  

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

 5  

 6         Section 1.  Section 499.006, Florida Statutes, is

 7  amended to read:

 8         499.006  Adulterated drug or device.--A drug or device

 9  is adulterated:

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

11  putrid, or decomposed substance;

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

13  under conditions whereby it could have been contaminated with

14  filth or rendered injurious to health;

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

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

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

18  administered in conformity with, current good manufacturing

19  practices to assure that the drug meets the requirements of

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

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

22  it purports or is represented to possess;

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

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

25  which could render the contents injurious to health;

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

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

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

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

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

31  of the federal act;

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    Florida Senate - 2006                                  SB 1540
    20-1096-06                                          See HB 685




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

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

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

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

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

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

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

 8  absent or inadequate, in accordance with those tests or

 9  methods of assay prescribed under authority of the federal

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

11  adulterated under this subsection merely because it differs

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

13  for that drug in such compendium if its difference in

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

15  stated on its label;

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

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

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

19  possess;

20         (8)  If it is a drug:

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

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

23         (b)  For which any substance has been substituted

24  wholly or in part;

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

26  date has passed; or

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

28  pedigree paper is nonexistent, fraudulent, or incomplete under

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

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

31  

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    Florida Senate - 2006                                  SB 1540
    20-1096-06                                          See HB 685




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

 2  do so ; or.

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

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

 5  Cosmetic Act which has been returned by a veterinarian to a

 6  limited prescription drug veterinary wholesaler.

 7         Section 2.  Subsection (1) and paragraph (d) of

 8  subsection (2) of section 499.01, Florida Statutes, are

 9  amended to read:

10         499.01  Permits; applications; renewal; general

11  requirements.--

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

13  person and establishment that intends to operate as:

14         (a)  A prescription drug manufacturer;

15         (b)  A prescription drug repackager;

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

17         (d)  A compressed medical gas manufacturer;

18         (e)  A device manufacturer;

19         (f)  A cosmetic manufacturer;

20         (g)  A prescription drug wholesaler;

21         (h)  A veterinary prescription drug wholesaler;

22         (i)  A compressed medical gas wholesaler;

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

24         (k)  A nonresident prescription drug manufacturer;

25         (l)  A freight forwarder;

26         (m)  A retail pharmacy drug wholesaler;

27         (n)  A veterinary legend drug retail establishment;

28         (o)  A medical oxygen retail establishment;

29         (p)  A complimentary drug distributor; or

30         (q)  A restricted prescription drug distributor; or.

31         (r)  A limited prescription drug veterinary wholesaler.

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    Florida Senate - 2006                                  SB 1540
    20-1096-06                                          See HB 685




 1         (2)

 2         (d)  A permit for a prescription drug manufacturer,

 3  prescription drug repackager, prescription drug wholesaler,

 4  limited prescription drug veterinary wholesaler, or retail

 5  pharmacy wholesaler may not be issued to the address of a

 6  health care entity or to a pharmacy licensed under chapter

 7  465, except as provided in this paragraph. The department may

 8  issue a prescription drug manufacturer permit to an applicant

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

10  health care entity, for the purpose of manufacturing

11  prescription drugs used in positron emission tomography or

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

13  department pursuant to this paragraph. The purpose of this

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

15  pharmaceuticals that would pose a significant danger to the

16  public health if manufactured at a separate establishment

17  address from the nuclear pharmacy from which the prescription

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

19  pharmacy wholesaler permit to the address of a community

20  pharmacy licensed under chapter 465 which does not meet the

21  definition of a closed pharmacy in s. 499.003.

22         Section 3.  Paragraph (g) of subsection (2) of section

23  499.012, Florida Statutes, is amended, and paragraph (h) is

24  added to that subsection, to read:

25         499.012  Wholesale distribution; definitions; permits;

26  applications; general requirements.--

27         (2)  The following types of wholesaler permits are

28  established:

29         (g)  A veterinary prescription drug wholesaler

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

31  required for any person that engages in the distribution of

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    Florida Senate - 2006                                  SB 1540
    20-1096-06                                          See HB 685




 1  veterinary prescription drugs in or into this state. A

 2  veterinary prescription drug wholesaler that also distributes

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

 4  503(b) of the Federal Food, Drug, and Cosmetic Act which it

 5  did not manufacture must obtain a permit as a prescription

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

 7  wholesaler, or a limited prescription drug veterinary

 8  wholesaler in lieu of the veterinary prescription drug

 9  wholesaler permit. A veterinary prescription drug wholesaler

10  must comply with the requirements for wholesale distributors

11  under s. 499.0121, except those set forth in s.

12  499.0121(6)(d), (e), or (f).

13         (h)  Limited prescription drug veterinary wholesaler

14  permit.--Unless engaging in the activities of and permitted as

15  a prescription drug manufacturer, nonresident prescription

16  drug manufacturer, prescription drug wholesaler, or

17  out-of-state prescription drug wholesaler, a limited

18  prescription drug veterinary wholesaler permit is required for

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

20  state of veterinary prescription drugs and prescription drugs

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

22  Federal Food, Drug, and Cosmetic Act under the following

23  conditions:

24         1.  The person is engaged in the business of

25  wholesaling prescription and veterinary legend drugs to

26  veterinarians on a full-time basis.

27         2.  No more than 30 percent of prescription drug sales

28  may be prescription drugs approved for human use which are

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

30  Federal Food, Drug, and Cosmetic Act.

31  

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    Florida Senate - 2006                                  SB 1540
    20-1096-06                                          See HB 685




 1         3.  The person is not permitted, licensed, or otherwise

 2  authorized in any state to wholesale prescription drugs

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

 4  Federal Food, Drug, and Cosmetic Act to any person who is

 5  authorized to sell, distribute, purchase, trade, or use these

 6  drugs on or for humans.

 7         4.  A limited prescription drug veterinary wholesaler

 8  that applies to the department for a new permit or the renewal

 9  of a permit must submit a bond of $20,000, or other equivalent

10  means of security acceptable to the department, such as an

11  irrevocable letter of credit or a deposit in a trust account

12  or financial institution, payable to the Florida Drug, Device,

13  and Cosmetic Trust Fund. The purpose of the bond is to secure

14  payment of any administrative penalties imposed by the

15  department and any fees and costs incurred by the department

16  regarding that permit which are authorized under state law and

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

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

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

20  license ceases to be valid or until 60 days after any

21  administrative or legal proceeding authorized in ss.

22  499.001-499.081 which involves the permittee is concluded,

23  including any appeal, whichever occurs later.

24         5.  A limited prescription drug veterinary wholesaler

25  must maintain at all times a license or permit to engage in

26  the wholesale distribution of prescription drugs in compliance

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

28         6.  A limited prescription drug veterinary wholesaler

29  must comply with the requirements for wholesale distributors

30  under s. 499.0121, except that a limited prescription drug

31  veterinary wholesaler is not required to provide a pedigree

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    Florida Senate - 2006                                  SB 1540
    20-1096-06                                          See HB 685




 1  paper as required by s. 499.0121(6)(f) upon the wholesale

 2  distribution of a prescription drug to a veterinarian.

 3         7.  A limited prescription drug veterinary wholesaler

 4  may not return to inventory for subsequent wholesale

 5  distribution any prescription drug subject to, defined by, or

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

 7  Act which has been returned by a veterinarian.

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

 9  permit or a limited prescription drug veterinary wholesaler

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

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

12  duly licensed to engage in the wholesale distribution of

13  prescription drugs in its state of residence to a licensed

14  limited prescription drug veterinary wholesaler in this state

15  if both wholesalers conduct wholesale distributions of

16  prescription drugs under the same business name. The

17  recordkeeping requirements of s. 499.0121(6) must be followed

18  for this transaction.

19         Section 4.  Paragraph (d) of subsection (1) of section

20  499.0122, Florida Statutes, is amended to read:

21         499.0122  Medical oxygen and veterinary legend drug

22  retail establishments; definitions, permits, general

23  requirements.--

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

25         (d)  "Veterinary legend drug retail establishment"

26  means a person permitted to sell veterinary legend drugs to

27  the public or to veterinarians, but does not include a

28  pharmacy licensed under chapter 465.

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

30  written order from a veterinarian licensed in this state who

31  

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    Florida Senate - 2006                                  SB 1540
    20-1096-06                                          See HB 685




 1  has a valid client-veterinarian relationship with the

 2  purchaser's animal.

 3         2.  Veterinary legend drugs may not be sold in excess

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

 5  date indicated on the order.

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

 7         4.  A veterinary legend drug retail establishment may

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

 9  or any controlled substance as defined in chapter 893.

10         5.  A veterinary legend drug retail establishment must

11  sell a veterinary legend drug in the original, sealed

12  manufacturer's container with all labeling intact and legible.

13  The department may adopt by rule additional labeling

14  requirements for the sale of a veterinary legend drug.

15         Section 5.  Paragraph (h) is added to subsection (2) of

16  section 499.041, Florida Statutes, to read:

17         499.041  Schedule of fees for drug, device, and

18  cosmetic applications and permits, product registrations, and

19  free-sale certificates.--

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

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

22  ranges established in this section for the specific type of

23  wholesaling.

24         (h)  The fee for a limited prescription drug veterinary

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

26  $500 annually.

27         Section 6.  Subsections (1) and (3) of section 499.065,

28  Florida Statutes, are amended to read:

29         499.065  Imminent danger.--

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

31  inspect each prescription drug wholesale establishment,

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    Florida Senate - 2006                                  SB 1540
    20-1096-06                                          See HB 685




 1  prescription drug repackager establishment, veterinary

 2  prescription drug wholesale establishment, limited

 3  prescription drug veterinary wholesaler establishment, and

 4  retail pharmacy drug wholesaler establishment that is required

 5  to be permitted under this chapter as often as necessary to

 6  ensure compliance with applicable laws and rules. The

 7  department shall have the right of entry and access to these

 8  facilities at any reasonable time.

 9         (3)  The department may determine that a prescription

10  drug wholesale establishment, prescription drug repackager

11  establishment, veterinary prescription drug wholesale

12  establishment, limited prescription drug veterinary wholesaler

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 shall

16  require its immediate closure if the establishment fails to

17  comply with applicable laws and rules and, because of the

18  failure, presents an imminent threat to the public's health,

19  safety, or welfare. Any establishment so deemed and closed

20  shall remain closed until allowed by the department or by

21  judicial order to 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 7.  This act shall take effect July 1, 2006.

29  

30  

31  

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