Senate Bill sb2122
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Florida Senate - 2007 SB 2122
By Senator Baker
20-1330A-07
1 A bill to be entitled
2 An act relating to the distribution of
3 veterinary drugs; amending s. 499.012, F.S.;
4 revising the list of persons who are required
5 to have a limited prescription drug veterinary
6 wholesaler permit in order to engage in the
7 distribution of veterinary prescription drugs;
8 deleting a provision that requires that certain
9 persons obtain a limited prescription drug
10 veterinary wholesaler permit; providing an
11 effective date.
12
13 Be It Enacted by the Legislature of the State of Florida:
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15 Section 1. Paragraph (h) of subsection (2) of section
16 499.012, Florida Statutes, is amended to read:
17 499.012 Wholesale distribution; definitions; permits;
18 applications; general requirements.--
19 (2) The following types of wholesaler permits are
20 established:
21 (h) Limited prescription drug veterinary wholesaler
22 permit.--Unless engaging in the activities of and permitted as
23 a prescription drug manufacturer, nonresident prescription
24 drug manufacturer, prescription drug wholesaler, or
25 out-of-state prescription drug wholesaler, a limited
26 prescription drug veterinary wholesaler permit is required for
27 any person that engages in the distribution in or into this
28 state of veterinary prescription drugs and prescription drugs
29 subject to, defined by, or described by s. 503(b) of the
30 Federal Food, Drug, and Cosmetic Act under the following
31 conditions:
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Florida Senate - 2007 SB 2122
20-1330A-07
1 1. The person is engaged in the business of
2 wholesaling prescription and veterinary legend drugs to
3 persons:
4 a. Licensed as veterinarians practicing on a full-time
5 basis;
6 b. Regularly and lawfully engaged in instruction in
7 veterinary medicine;
8 c. Regularly and lawfully engaged in law enforcement
9 activities;
10 d. For use in research not involving clinical use; or
11 e. For use in chemical analysis or physical testing or
12 for purposes of instruction in law enforcement activities,
13 research, or testing; or.
14 f. Holding a veterinary prescription drug wholesaler
15 permit, limited prescription drug veterinary wholesaler
16 permit, a substantially equivalent authorization, permit, or
17 license issued by another state, or an authorization, license,
18 or permit to engage in the wholesale distribution of
19 prescription drugs issued by another state that does not issue
20 a substantially equivalent permit.
21 2. No more than 30 percent of total annual
22 prescription drug sales may be prescription drugs approved for
23 human use which are subject to, defined by, or described by s.
24 503(b) of the Federal Food, Drug, and Cosmetic Act.
25 3. The person is not permitted, licensed, or otherwise
26 authorized in any state to wholesale prescription drugs
27 subject to, defined by, or described by s. 503(b) of the
28 Federal Food, Drug, and Cosmetic Act to any person who is
29 authorized to sell, distribute, purchase, trade, or use these
30 drugs on or for humans.
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Florida Senate - 2007 SB 2122
20-1330A-07
1 3.4. A limited prescription drug veterinary 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 4.5. A limited prescription drug veterinary 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 5.6. A limited prescription drug veterinary wholesaler
23 must comply with the requirements for wholesale distributors
24 under s. 499.0121, except that a limited prescription drug
25 veterinary wholesaler is not required to provide a pedigree
26 paper as required by s. 499.0121(6)(f) upon the wholesale
27 distribution of a prescription drug to a veterinarian.
28 6.7. A limited prescription drug veterinary wholesaler
29 may not return to inventory for subsequent wholesale
30 distribution any prescription drug subject to, defined by, or
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Florida Senate - 2007 SB 2122
20-1330A-07
1 described by s. 503(b) of the Federal Food, Drug, and Cosmetic
2 Act which has been returned by a veterinarian.
3 7.8. An out-of-state prescription drug wholesaler's
4 permit or a limited prescription drug veterinary wholesaler
5 permit is not required for an intracompany sale or transfer of
6 a prescription drug from an out-of-state establishment that is
7 duly licensed to engage in the wholesale distribution of
8 prescription drugs in its state of residence to a licensed
9 limited prescription drug veterinary wholesaler in this state
10 if both wholesalers conduct wholesale distributions of
11 prescription drugs under the same business name. The
12 recordkeeping requirements of s. 499.0121(6) must be followed
13 for this transaction.
14 Section 2. This act shall take effect upon becoming a
15 law.
16
17 *****************************************
18 SENATE SUMMARY
19 Revises the list of certain persons who are required to
have a limited prescription drug veterinary wholesaler
20 permit. Deletes a provision that requires certain persons
to have a limited prescription drug veterinary wholesaler
21 permit.
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CODING: Words stricken are deletions; words underlined are additions.