Senate Bill sb1654c1
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Florida Senate - 2005 CS for SB 1654
By the Committee on Regulated Industries; and Senator Fasano
580-1994-05
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 veterinary prescription drug wholesaler;
8 amending s. 499.01, F.S.; requiring a limited
9 veterinary prescription drug wholesaler to
10 obtain a permit for operation from the
11 Department of Health; providing that a permit
12 for a limited veterinary prescription drug
13 wholesaler may not be issued to the address of
14 certain health care entities; amending s.
15 499.012, F.S.; establishing a permit for a
16 limited veterinary prescription drug
17 wholesaler; amending s. 499.0122, F.S.;
18 redefining the term "veterinary legend drug
19 retail establishment"; amending s. 499.041,
20 F.S.; requiring the department to assess an
21 annual fee within a certain monetary range for
22 a limited veterinary prescription drug
23 wholesaler permit; amending s. 499.065, F.S.;
24 requiring the department to inspect each
25 limited veterinary prescription drug wholesaler
26 establishment; authorizing the department to
27 determine that a limited veterinary
28 prescription drug wholesaler establishment is
29 an imminent danger to the public; providing an
30 effective date.
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Florida Senate - 2005 CS for SB 1654
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1 Be It Enacted by the Legislature of the State of Florida:
2
3 Section 1. Section 499.006, Florida Statutes, is
4 amended to read:
5 499.006 Adulterated drug or device.--A drug or device
6 is adulterated:
7 (1) If it consists in whole or in part of any filthy,
8 putrid, or decomposed substance;
9 (2) If it has been produced, prepared, packed, or held
10 under conditions whereby it could have been contaminated with
11 filth or rendered injurious to health;
12 (3) If it is a drug and the methods used in, or the
13 facilities or controls used for, its manufacture, processing,
14 packing, or holding do not conform to, or are not operated or
15 administered in conformity with, current good manufacturing
16 practices to assure that the drug meets the requirements of
17 ss. 499.001-499.081 and that the drug has the identity and
18 strength, and meets the standard of quality and purity, which
19 it purports or is represented to possess;
20 (4) If it is a drug and its container is composed, in
21 whole or in part, of any poisonous or deleterious substance
22 which could render the contents injurious to health;
23 (5) If it is a drug and it bears or contains, for the
24 purpose of coloring only, a color additive that is unsafe
25 within the meaning of the federal act; or, if it is a color
26 additive, the intended use of which in or on drugs is for the
27 purpose of coloring only, and it is unsafe within the meaning
28 of the federal act;
29 (6) If it purports to be, or is represented as, a drug
30 the name of which is recognized in the official compendium,
31 and its strength differs from, or its quality or purity falls
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Florida Senate - 2005 CS for SB 1654
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1 below, the standard set forth in such compendium. The
2 determination as to strength, quality, or purity must be made
3 in accordance with the tests or methods of assay set forth in
4 such compendium, or, when such tests or methods of assay are
5 absent or inadequate, in accordance with those tests or
6 methods of assay prescribed under authority of the federal
7 act. A drug defined in the official compendium is not
8 adulterated under this subsection merely because it differs
9 from the standard of strength, quality, or purity set forth
10 for that drug in such compendium if its difference in
11 strength, quality, or purity from such standard is plainly
12 stated on its label;
13 (7) If it is not subject to subsection (6) and its
14 strength differs from, or its purity or quality falls below
15 the standard of, that which it purports or is represented to
16 possess;
17 (8) If it is a drug:
18 (a) With which any substance has been mixed or packed
19 so as to reduce the quality or strength of the drug; or
20 (b) For which any substance has been substituted
21 wholly or in part;
22 (9) If it is a drug or device for which the expiration
23 date has passed; or
24 (10) If it is a legend drug for which the required
25 pedigree paper is nonexistent, fraudulent, or incomplete under
26 the requirements of ss. 499.001-499.081 or applicable rules,
27 or that has been purchased, held, sold, or distributed at any
28 time by a person not authorized under federal or state law to
29 do so; or.
30 (11) If it is a prescription drug subject to, defined
31 by, or described by s. 503(b) of the Federal Food, Drug, and
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Florida Senate - 2005 CS for SB 1654
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1 Cosmetic Act which has been returned by a veterinarian to a
2 limited veterinary prescription drug wholesaler.
3 Section 2. Subsection (1) and paragraph (d) of
4 subsection (2) of section 499.01, Florida Statutes, are
5 amended to read:
6 499.01 Permits; applications; renewal; general
7 requirements.--
8 (1) Prior to operating, a permit is required for each
9 person and establishment that intends to operate as:
10 (a) A prescription drug manufacturer;
11 (b) A prescription drug repackager;
12 (c) An over-the-counter drug manufacturer;
13 (d) A compressed medical gas manufacturer;
14 (e) A device manufacturer;
15 (f) A cosmetic manufacturer;
16 (g) A prescription drug wholesaler;
17 (h) A veterinary prescription drug wholesaler;
18 (i) A compressed medical gas wholesaler;
19 (j) An out-of-state prescription drug wholesaler;
20 (k) A nonresident prescription drug manufacturer;
21 (l) A freight forwarder;
22 (m) A retail pharmacy drug wholesaler;
23 (n) A veterinary legend drug retail establishment;
24 (o) A medical oxygen retail establishment;
25 (p) A complimentary drug distributor; or
26 (q) A restricted prescription drug distributor; or.
27 (r) A limited veterinary prescription drug wholesaler.
28 (2)
29 (d) A permit for a prescription drug manufacturer,
30 prescription drug repackager, prescription drug wholesaler,
31 limited veterinary prescription drug wholesaler, or retail
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Florida Senate - 2005 CS for SB 1654
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1 pharmacy wholesaler may not be issued to the address of a
2 health care entity or to a pharmacy licensed under chapter
3 465, except as provided in this paragraph. The department may
4 issue a prescription drug manufacturer permit to an applicant
5 at the same address as a licensed nuclear pharmacy, which is a
6 health care entity, for the purpose of manufacturing
7 prescription drugs used in positron emission tomography or
8 other radiopharmaceuticals, as listed in a rule adopted by the
9 department pursuant to this paragraph. The purpose of this
10 exemption is to assure availability of state-of-the-art
11 pharmaceuticals that would pose a significant danger to the
12 public health if manufactured at a separate establishment
13 address from the nuclear pharmacy from which the prescription
14 drugs are dispensed. The department may also issue a retail
15 pharmacy wholesaler permit to the address of a community
16 pharmacy licensed under chapter 465 which does not meet the
17 definition of a closed pharmacy in s. 499.003.
18 Section 3. Paragraph (h) is added to subsection (2) of
19 section 499.012, Florida Statutes, to read:
20 499.012 Wholesale distribution; definitions; permits;
21 applications; general requirements.--
22 (2) The following types of wholesaler permits are
23 established:
24 (h) Limited veterinary prescription drug wholesaler
25 permit.--Unless engaging in the activities of and permitted as
26 a prescription drug manufacturer, nonresident prescription
27 drug manufacturer, prescription drug wholesaler, or
28 out-of-state prescription drug wholesaler, a limited
29 veterinary prescription drug wholesaler permit is required for
30 any person that engages in the distribution in or into this
31 state of veterinary prescription drugs and prescription drugs
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1 subject to, defined by, or described by s. 503(b) of the
2 Federal Food, Drug, and Cosmetic Act to veterinarians under
3 the following conditions:
4 1. The person is engaged in the business of
5 wholesaling prescription and veterinary legend drugs to
6 veterinarians on a full-time basis.
7 2. No more than 30 percent of prescription drug sales
8 may be prescription drugs approved for human use which are
9 subject to, defined by, or described by s. 503(b) of the
10 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 veterinary prescription drug 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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1 499.001-499.081 which involves the permittee is concluded,
2 including any appeal, whichever occurs later.
3 5. A limited veterinary prescription drug 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 veterinary prescription drug wholesaler
8 must comply with the requirements for wholesale distributors
9 under s. 499.0121, except that a limited veterinary
10 prescription drug wholesaler is not required to provide a
11 pedigree paper as required by s. 499.0121(6)(f) upon the
12 wholesale distribution of a prescription drug to a
13 veterinarian.
14 7. A limited veterinary prescription drug wholesaler
15 may not return to inventory for subsequent wholesale
16 distribution any prescription drug subject to, defined by, or
17 described by s. 503(b) of the Federal Food, Drug, and Cosmetic
18 Act which has been returned by a veterinarian.
19 8. An out-of-state prescription drug wholesaler's
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 as a limited veterinary prescription drug
23 wholesaler in its state of residence to a licensed
24 prescription drug wholesaler in this state if both wholesalers
25 conduct wholesale distributions of prescription drugs under
26 the same business name. The recordkeeping requirements of s.
27 499.0121(6) must be followed for this transaction.
28 Section 4. Paragraph (d) of subsection (1) of section
29 499.0122, Florida Statutes, is amended to read:
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Florida Senate - 2005 CS for SB 1654
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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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1 ranges established in this section for the specific type of
2 wholesaling.
3 (h) The fee for a limited veterinary prescription drug
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 veterinary
13 prescription drug wholesaler establishment, and retail
14 pharmacy drug wholesaler establishment that is required to be
15 permitted under this chapter as often as necessary to ensure
16 compliance with applicable laws and rules. The department
17 shall have the right of entry and access to these facilities
18 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 veterinary prescription drug 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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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, 2005.
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9 STATEMENT OF SUBSTANTIAL CHANGES CONTAINED IN
COMMITTEE SUBSTITUTE FOR
10 Senate Bill 1654
11
12 The committee substitute (CS) amends s. 499.006, F.S., to
define prescription drugs returned by a veterinarian to a
13 limited veterinary prescription drug wholesaler as an
adulterated drug.
14
The CS amends s. 4990.01, F.S., to create the limited
15 veterinary prescription drug wholesaler permit. The CS
deletes the permit classification for a distributor
16 distributing both veterinary legend drugs and certain human
drugs permitted by the department.
17
The CS does not amend s. 499.0121(6)(f), F.S., to limit the
18 pedigree paper requirement to prescription drugs intended for
sale to a human recipient, and to exempt approved human drugs
19 sold directly to veterinarians from the pedigree paper
requirement.
20
The CS amends s. 499.012, F.S., to establish the limited
21 veterinary prescription drug wholesaler permit, and provide
several permit requirements and conditions under the permit,
22 including a bond requirement, and permissible transactions.
23 The CS amends s. 499.0122(1)(d), F.S., to amend the definition
of the term "veterinary legend drug retail establishment."
24
The CS amends s. 499.041, F.S., to establish the minimum and
25 maximum fee for a limited veterinary prescription drug
wholesaler's permit.
26
The CS amends s. 499.065, F.S., to require department
27 inspection of each limited veterinary prescription drug
wholesaler. It also permits the department to order the
28 immediate closure of a limited veterinary prescription drug
wholesaler to protect the public health, safety, or welfare.
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