Senate Bill sb1540c1

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    Florida Senate - 2006                           CS for SB 1540

    By the Committee on Regulated Industries; and Senator Baker





    580-1943-06

  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                           CS for SB 1540
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 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                           CS for SB 1540
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 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                           CS for SB 1540
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 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                           CS for SB 1540
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 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                           CS for SB 1540
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 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  persons:

27         a.  Licensed as veterinarians practicing on a full-time

28  basis;

29         b.  Regularly and lawfully engaged in instruction in

30  veterinary medicine;

31  

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    Florida Senate - 2006                           CS for SB 1540
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 1         c.  Regularly and lawfully engaged in law enforcement

 2  activities;

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

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

 5  for purposes of instruction in law enforcement activities,

 6  research, or testing.

 7         2.  No more than 30 percent of total annual

 8  prescription drug sales may be prescription drugs approved for

 9  human use which are subject to, defined by, or described by s.

10  503(b) of the Federal Food, Drug, and Cosmetic Act.

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

12  authorized in any state to wholesale prescription drugs

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

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

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

16  drugs on or for humans.

17         4.  A limited prescription drug veterinary wholesaler

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

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

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

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

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

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

24  payment of any administrative penalties imposed by the

25  department and any fees and costs incurred by the department

26  regarding that permit which are authorized under state law and

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

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

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

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

31  administrative or legal proceeding authorized in ss.

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    Florida Senate - 2006                           CS for SB 1540
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 1  499.001-499.081 which involves the permittee is concluded,

 2  including any appeal, whichever occurs later.

 3         5.  A limited prescription drug veterinary wholesaler

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

 5  the wholesale distribution of prescription drugs in compliance

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

 7         6.  A limited prescription drug veterinary wholesaler

 8  must comply with the requirements for wholesale distributors

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

10  veterinary wholesaler is not required to provide a pedigree

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

12  distribution of a prescription drug to a veterinarian.

13         7.  A limited prescription drug veterinary wholesaler

14  may not return to inventory for subsequent wholesale

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

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

17  Act which has been returned by a veterinarian.

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

19  permit or a limited prescription drug veterinary wholesaler

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

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

22  duly licensed to engage in the wholesale distribution of

23  prescription drugs in its state of residence to a licensed

24  limited prescription drug veterinary wholesaler in this state

25  if both wholesalers conduct wholesale distributions of

26  prescription drugs under the same business name. The

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

28  for this transaction.

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

30  499.0122, Florida Statutes, is amended to read:

31  

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    Florida Senate - 2006                           CS for SB 1540
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 1         499.0122  Medical oxygen and veterinary legend drug

 2  retail establishments; definitions, permits, general

 3  requirements.--

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

 5         (d)  "Veterinary legend drug retail establishment"

 6  means a person permitted to sell veterinary legend drugs to

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

 8  pharmacy licensed under chapter 465.

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

10  written order from a veterinarian licensed in this state who

11  has a valid client-veterinarian relationship with the

12  purchaser's animal.

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

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

15  date indicated on the order.

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

17         4.  A veterinary legend drug retail establishment may

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

19  or any controlled substance as defined in chapter 893.

20         5.  A veterinary legend drug retail establishment must

21  sell a veterinary legend drug in the original, sealed

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

23  The department may adopt by rule additional labeling

24  requirements for the sale of a veterinary legend drug.

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

26  section 499.041, Florida Statutes, to read:

27         499.041  Schedule of fees for drug, device, and

28  cosmetic applications and permits, product registrations, and

29  free-sale certificates.--

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

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

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    Florida Senate - 2006                           CS for SB 1540
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 1  ranges established in this section for the specific type of

 2  wholesaling.

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

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

 5  $500 annually.

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

 7  Florida Statutes, are amended to read:

 8         499.065  Imminent danger.--

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

10  inspect each prescription drug wholesale establishment,

11  prescription drug repackager establishment, veterinary

12  prescription drug wholesale establishment, limited

13  prescription drug veterinary wholesaler establishment, and

14  retail pharmacy drug wholesaler establishment that is required

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

16  ensure compliance with applicable laws and rules. The

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

18  facilities at any reasonable time.

19         (3)  The department may determine that a prescription

20  drug wholesale establishment, prescription drug repackager

21  establishment, veterinary prescription drug wholesale

22  establishment, limited prescription drug veterinary wholesaler

23  establishment, or retail pharmacy drug wholesaler

24  establishment that is required to be permitted under this

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

26  require its immediate closure if the establishment fails to

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

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

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

30  shall remain closed until allowed by the department or by

31  judicial order to reopen.

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    Florida Senate - 2006                           CS for SB 1540
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 1  

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

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

 4  refusal to provide the department with required documentation

 5  for purposes of inspection, constitutes an imminent danger to

 6  the public health.

 7         Section 7.  This act shall take effect July 1, 2006.

 8  

 9          STATEMENT OF SUBSTANTIAL CHANGES CONTAINED IN
                       COMMITTEE SUBSTITUTE FOR
10                         Senate Bill 1540

11                                 

12  The CS amends s. 499.012, F.S., to define additional conduct
    of what constitutes being engaged in the business of
13  wholesaling prescription and veterinary legend drugs. It also
    clarifies that the 30 percent limit for drug sales for human
14  use is on the basis of total annual revenue.

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