Florida Senate - 2005 COMMITTEE AMENDMENT
Bill No. SB 1654
Barcode 461900
CHAMBER ACTION
Senate House
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11 The Committee on Regulated Industries (Wise) recommended the
12 following amendment:
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14 Senate Amendment (with title amendment)
15 Delete everything after the enacting clause
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17 and insert:
18 Section 1. Section 499.006, Florida Statutes, is
19 amended to read:
20 499.006 Adulterated drug or device.--A drug or device
21 is adulterated:
22 (1) If it consists in whole or in part of any filthy,
23 putrid, or decomposed substance;
24 (2) If it has been produced, prepared, packed, or held
25 under conditions whereby it could have been contaminated with
26 filth or rendered injurious to health;
27 (3) If it is a drug and the methods used in, or the
28 facilities or controls used for, its manufacture, processing,
29 packing, or holding do not conform to, or are not operated or
30 administered in conformity with, current good manufacturing
31 practices to assure that the drug meets the requirements of
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1 ss. 499.001-499.081 and that the drug has the identity and
2 strength, and meets the standard of quality and purity, which
3 it purports or is represented to possess;
4 (4) If it is a drug and its container is composed, in
5 whole or in part, of any poisonous or deleterious substance
6 which could render the contents injurious to health;
7 (5) If it is a drug and it bears or contains, for the
8 purpose of coloring only, a color additive that is unsafe
9 within the meaning of the federal act; or, if it is a color
10 additive, the intended use of which in or on drugs is for the
11 purpose of coloring only, and it is unsafe within the meaning
12 of the federal act;
13 (6) If it purports to be, or is represented as, a drug
14 the name of which is recognized in the official compendium,
15 and its strength differs from, or its quality or purity falls
16 below, the standard set forth in such compendium. The
17 determination as to strength, quality, or purity must be made
18 in accordance with the tests or methods of assay set forth in
19 such compendium, or, when such tests or methods of assay are
20 absent or inadequate, in accordance with those tests or
21 methods of assay prescribed under authority of the federal
22 act. A drug defined in the official compendium is not
23 adulterated under this subsection merely because it differs
24 from the standard of strength, quality, or purity set forth
25 for that drug in such compendium if its difference in
26 strength, quality, or purity from such standard is plainly
27 stated on its label;
28 (7) If it is not subject to subsection (6) and its
29 strength differs from, or its purity or quality falls below
30 the standard of, that which it purports or is represented to
31 possess;
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Florida Senate - 2005 COMMITTEE AMENDMENT
Bill No. SB 1654
Barcode 461900
1 (8) If it is a drug:
2 (a) With which any substance has been mixed or packed
3 so as to reduce the quality or strength of the drug; or
4 (b) For which any substance has been substituted
5 wholly or in part;
6 (9) If it is a drug or device for which the expiration
7 date has passed; or
8 (10) If it is a legend drug for which the required
9 pedigree paper is nonexistent, fraudulent, or incomplete under
10 the requirements of ss. 499.001-499.081 or applicable rules,
11 or that has been purchased, held, sold, or distributed at any
12 time by a person not authorized under federal or state law to
13 do so; or.
14 (11) If it is a prescription drug subject to, defined
15 by, or described by s. 503(b) of the Federal Food, Drug, and
16 Cosmetic Act which has been returned by a veterinarian to a
17 limited veterinary prescription drug wholesaler.
18 Section 2. Subsection (1) and paragraph (d) of
19 subsection (2) of section 499.01, Florida Statutes, are
20 amended to read:
21 499.01 Permits; applications; renewal; general
22 requirements.--
23 (1) Prior to operating, a permit is required for each
24 person and establishment that intends to operate as:
25 (a) A prescription drug manufacturer;
26 (b) A prescription drug repackager;
27 (c) An over-the-counter drug manufacturer;
28 (d) A compressed medical gas manufacturer;
29 (e) A device manufacturer;
30 (f) A cosmetic manufacturer;
31 (g) A prescription drug wholesaler;
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Florida Senate - 2005 COMMITTEE AMENDMENT
Bill No. SB 1654
Barcode 461900
1 (h) A veterinary prescription drug wholesaler;
2 (i) A compressed medical gas wholesaler;
3 (j) An out-of-state prescription drug wholesaler;
4 (k) A nonresident prescription drug manufacturer;
5 (l) A freight forwarder;
6 (m) A retail pharmacy drug wholesaler;
7 (n) A veterinary legend drug retail establishment;
8 (o) A medical oxygen retail establishment;
9 (p) A complimentary drug distributor; or
10 (q) A restricted prescription drug distributor; or.
11 (r) A limited veterinary prescription drug wholesaler.
12 (2)
13 (d) A permit for a prescription drug manufacturer,
14 prescription drug repackager, prescription drug wholesaler,
15 limited veterinary prescription drug wholesaler, or retail
16 pharmacy wholesaler may not be issued to the address of a
17 health care entity or to a pharmacy licensed under chapter
18 465, except as provided in this paragraph. The department may
19 issue a prescription drug manufacturer permit to an applicant
20 at the same address as a licensed nuclear pharmacy, which is a
21 health care entity, for the purpose of manufacturing
22 prescription drugs used in positron emission tomography or
23 other radiopharmaceuticals, as listed in a rule adopted by the
24 department pursuant to this paragraph. The purpose of this
25 exemption is to assure availability of state-of-the-art
26 pharmaceuticals that would pose a significant danger to the
27 public health if manufactured at a separate establishment
28 address from the nuclear pharmacy from which the prescription
29 drugs are dispensed. The department may also issue a retail
30 pharmacy wholesaler permit to the address of a community
31 pharmacy licensed under chapter 465 which does not meet the
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Florida Senate - 2005 COMMITTEE AMENDMENT
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1 definition of a closed pharmacy in s. 499.003.
2 Section 3. Paragraph (h) 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 (h) Limited veterinary prescription drug wholesaler
9 permit.--Unless engaging in the activities of and permitted as
10 a prescription drug manufacturer, nonresident prescription
11 drug manufacturer, prescription drug wholesaler, or
12 out-of-state prescription drug wholesaler, a limited
13 veterinary prescription drug wholesaler permit is required for
14 any person that engages in the distribution in or into this
15 state of veterinary prescription drugs and prescription drugs
16 subject to, defined by, or described by s. 503(b) of the
17 Federal Food, Drug, and Cosmetic Act to veterinarians under
18 the following conditions:
19 1. The person is engaged in the business of
20 wholesaling prescription and veterinary legend drugs to
21 veterinarians on a full-time basis.
22 2. No more than 30 percent of prescription drug sales
23 may be prescription drugs approved for human use which are
24 subject to, defined by, or described by s. 503(b) of the
25 Federal Food, Drug, and Cosmetic Act.
26 3. The person is not permitted, licensed, or otherwise
27 authorized in any state to wholesale prescription drugs
28 subject to, defined by, or described by s. 503(b) of the
29 Federal Food, Drug, and Cosmetic Act to any person who is
30 authorized to sell, distribute, purchase, trade, or use these
31 drugs on or for humans.
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Florida Senate - 2005 COMMITTEE AMENDMENT
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1 4. A limited veterinary prescription drug wholesaler
2 that applies to the department for a new permit or the renewal
3 of a permit must submit a bond of $20,000, or other equivalent
4 means of security acceptable to the department, such as an
5 irrevocable letter of credit or a deposit in a trust account
6 or financial institution, payable to the Florida Drug, Device,
7 and Cosmetic Trust Fund. The purpose of the bond is to secure
8 payment of any administrative penalties imposed by the
9 department and any fees and costs incurred by the department
10 regarding that permit which are authorized under state law and
11 which the permittee fails to pay 30 days after the fine or
12 costs become final. The department may make a claim against
13 such bond or security until 1 year after the permittee's
14 license ceases to be valid or until 60 days after any
15 administrative or legal proceeding authorized in ss.
16 499.001-499.081 which involves the permittee is concluded,
17 including any appeal, whichever occurs later.
18 5. A limited veterinary prescription drug wholesaler
19 must maintain at all times a license or permit to engage in
20 the wholesale distribution of prescription drugs in compliance
21 with laws of the state in which it is a resident.
22 6. A limited veterinary prescription drug wholesaler
23 must comply with the requirements for wholesale distributors
24 under s. 499.0121, except that a limited veterinary
25 prescription drug wholesaler is not required to provide a
26 pedigree paper as required by s. 499.0121(6)(f) upon the
27 wholesale distribution of a prescription drug to a
28 veterinarian.
29 7. A limited veterinary prescription drug wholesaler
30 may not return to inventory for subsequent wholesale
31 distribution any prescription drug subject to, defined by, or
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Florida Senate - 2005 COMMITTEE AMENDMENT
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1 described by s. 503(b) of the Federal Food, Drug, and Cosmetic
2 Act which has been returned by a veterinarian.
3 8. An out-of-state prescription drug wholesaler's
4 permit is not required for an intracompany sale or transfer of
5 a prescription drug from an out-of-state establishment that is
6 duly licensed as a limited veterinary prescription drug
7 wholesaler in its state of residence to a licensed
8 prescription drug wholesaler in this state if both wholesalers
9 conduct wholesale distributions of prescription drugs under
10 the same business name. The recordkeeping requirements of s.
11 499.0121(6) must be followed for this transaction.
12 Section 4. Paragraph (d) of subsection (1) of section
13 499.0122, Florida Statutes, is amended to read:
14 499.0122 Medical oxygen and veterinary legend drug
15 retail establishments; definitions, permits, general
16 requirements.--
17 (1) As used in this section, the term:
18 (d) "Veterinary legend drug retail establishment"
19 means a person permitted to sell veterinary legend drugs to
20 the public or to veterinarians, but does not include a
21 pharmacy licensed under chapter 465.
22 1. The sale to the public must be based on a valid
23 written order from a veterinarian licensed in this state who
24 has a valid client-veterinarian relationship with the
25 purchaser's animal.
26 2. Veterinary legend drugs may not be sold in excess
27 of the amount clearly indicated on the order or beyond the
28 date indicated on the order.
29 3. An order may not be valid for more than 1 year.
30 4. A veterinary legend drug retail establishment may
31 not purchase, sell, trade, or possess human prescription drugs
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Florida Senate - 2005 COMMITTEE AMENDMENT
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1 or any controlled substance as defined in chapter 893.
2 5. A veterinary legend drug retail establishment must
3 sell a veterinary legend drug in the original, sealed
4 manufacturer's container with all labeling intact and legible.
5 The department may adopt by rule additional labeling
6 requirements for the sale of a veterinary legend drug.
7 Section 5. Paragraph (h) is added to subsection (2) of
8 section 499.041, Florida Statutes, to read:
9 499.041 Schedule of fees for drug, device, and
10 cosmetic applications and permits, product registrations, and
11 free-sale certificates.--
12 (2) The department shall assess an applicant that is
13 required to have a wholesaling permit an annual fee within the
14 ranges established in this section for the specific type of
15 wholesaling.
16 (h) The fee for a limited veterinary prescription drug
17 wholesaler's permit may not be less than $300 or more than
18 $500 annually.
19 Section 6. Subsections (1) and (3) of section 499.065,
20 Florida Statutes, are amended to read:
21 499.065 Imminent danger.--
22 (1) Notwithstanding s. 499.051, the department shall
23 inspect each prescription drug wholesale establishment,
24 prescription drug repackager establishment, veterinary
25 prescription drug wholesale establishment, limited veterinary
26 prescription drug wholesaler establishment, and retail
27 pharmacy drug wholesaler establishment that is required to be
28 permitted under this chapter as often as necessary to ensure
29 compliance with applicable laws and rules. The department
30 shall have the right of entry and access to these facilities
31 at any reasonable time.
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Florida Senate - 2005 COMMITTEE AMENDMENT
Bill No. SB 1654
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1 (3) The department may determine that a prescription
2 drug wholesale establishment, prescription drug repackager
3 establishment, veterinary prescription drug wholesale
4 establishment, limited veterinary prescription drug wholesaler
5 establishment, or retail pharmacy drug wholesaler
6 establishment that is required to be permitted under this
7 chapter is an imminent danger to the public health and shall
8 require its immediate closure if the establishment fails to
9 comply with applicable laws and rules and, because of the
10 failure, presents an imminent threat to the public's health,
11 safety, or welfare. Any establishment so deemed and closed
12 shall remain closed until allowed by the department or by
13 judicial order to reopen.
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15 For purposes of this section, a refusal to allow entry to the
16 department for inspection at reasonable times, or a failure or
17 refusal to provide the department with required documentation
18 for purposes of inspection, constitutes an imminent danger to
19 the public health.
20 Section 7. This act shall take effect July 1, 2005.
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24 And the title is amended as follows:
25 Delete everything before the enacting clause
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27 and insert:
28 A bill to be entitled
29 An act relating to veterinary drug
30 distribution; amending s. 499.006, F.S.;
31 providing that a drug is adulterated if it is a
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Florida Senate - 2005 COMMITTEE AMENDMENT
Bill No. SB 1654
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1 certain prescription drug that has been
2 returned by a veterinarian to a limited
3 veterinary prescription drug wholesaler;
4 amending s. 499.01, F.S.; requiring a limited
5 veterinary prescription drug wholesaler to
6 obtain a permit for operation from the
7 Department of Health; providing that a permit
8 for a limited veterinary prescription drug
9 wholesaler may not be issued to the address of
10 certain health care entities; amending s.
11 499.012, F.S.; establishing a permit for a
12 limited veterinary prescription drug
13 wholesaler; amending s. 499.0122, F.S.;
14 redefining the term "veterinary legend drug
15 retail establishment"; amending s. 499.041,
16 F.S.; requiring the department to assess an
17 annual fee within a certain monetary range for
18 a limited veterinary prescription drug
19 wholesaler permit; amending s. 499.065, F.S.;
20 requiring the department to inspect each
21 limited veterinary prescription drug wholesaler
22 establishment; authorizing the department to
23 determine that a limited veterinary
24 prescription drug wholesaler establishment is
25 an imminent danger to the public; providing an
26 effective date.
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