Florida Senate - 2006 SENATOR AMENDMENT
Bill No. HB 371, 1st Eng.
Barcode 690302
CHAMBER ACTION
Senate House
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05/03/2006 06:21 PM .
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11 Senator Peaden moved the following amendment:
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13 Senate Amendment (with title amendment)
14 Between lines 205 and 206,
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16 insert:
17 Section 3. Subsection (31) of section 499.003, Florida
18 Statutes, is amended to read:
19 499.003 Definitions of terms used in ss.
20 499.001-499.081.--As used in ss. 499.001-499.081, the term:
21 (31) "Pedigree paper" means:
22 (a) A document required pursuant to s. 499.0121(6)(d)
23 or (e); or
24 (b) Effective July 1, 2006, a document or electronic
25 form approved by the Department of Health and containing
26 information that records each distribution of any given legend
27 drug, from sale by a pharmaceutical manufacturer, through
28 acquisition and sale by any wholesaler or repackager, until
29 final sale to a pharmacy or other person administering or
30 dispensing the drug. The information required to be included
31 on a legend drug's pedigree paper must at least detail the
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1 amount of the legend drug; its dosage form and strength; its
2 lot numbers; the name and address of each owner of the legend
3 drug and his or her signature; its shipping information,
4 including the name and address of each person certifying
5 delivery or receipt of the legend drug; an invoice number, a
6 shipping document number, or another number uniquely
7 identifying the transaction; and a certification that the
8 recipient wholesaler has authenticated the pedigree papers. If
9 the manufacturer or repackager has uniquely serialized the
10 individual legend drug unit, that identifier must also be
11 included on the pedigree. It must also include the name,
12 address, telephone number and, if available, e-mail contact
13 information of each wholesaler involved in the chain of the
14 legend drug's custody. The department shall adopt rules and a
15 form relating to the requirements of this paragraph no later
16 than 90 days after the effective date of this act; or.
17 (c) Effective July 1, 2006, a document or electronic
18 form approved by the Department of Health and containing
19 information that records each distribution of any given legend
20 drug, from sale by a pharmaceutical manufacturer, through
21 acquisition and sale by any wholesaler or repackager, until
22 final sale to a pharmacy or other person administering or
23 dispensing the drug; or, if a specific unit of the legend drug
24 was purchased by a wholesaler, referred to in this paragraph
25 as a "direct purchase wholesaler," directly from the
26 manufacturer, an invoice for the specific unit of the legend
27 drug together with a certificate under oath in written or
28 electronic form stating that:
29 1. If the establishment is not a member of an
30 affiliated group: "This establishment purchased the specific
31 unit of the legend drug directly from the manufacturer."
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1 2. If the establishment is a member of an affiliated
2 group: "This establishment or a member of its affiliated group
3 purchased the specific unit of the legend drug directly from
4 the manufacturer."
5
6 A document or electronic form that meets the requirements of
7 this paragraph shall constitute a sufficient pedigree paper
8 only for the purpose of a single sale or distribution
9 transaction in the specific unit of legend drug by the direct
10 purchase wholesaler to an entity authorized by law to purchase
11 legend drugs. For each transaction of the specific unit of
12 legend drug, the direct purchase wholesaler is required to
13 create a separate pedigree paper that meets the requirements
14 of this paragraph and furnish such pedigree paper to any
15 subsequent purchaser. The pedigree paper shall be prepared and
16 updated for every transfer following the direct purchase
17 wholesaler's receipt of the specific unit of legend drug
18 directly from the manufacturer. The information required to be
19 included on the document or electronic form approved by the
20 department pursuant to this paragraph and required of any
21 subsequent transfers of legend drugs received by a direct
22 purchase wholesaler in a transaction described in this
23 paragraph must at least detail the amount of the legend drug;
24 its dosage form and strength; its lot numbers; the name and
25 address of each owner of the legend drug after it has left the
26 possession of the manufacturer and his or her signature; its
27 shipping information, including the name and address of each
28 person certifying delivery or receipt of the legend drug after
29 it has left the possession of the manufacturer; an invoice
30 number, a shipping document number, or another number uniquely
31 identifying the transaction; and a certification that the
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1 recipient direct purchase wholesaler has authenticated the
2 pedigree papers as required in this paragraph. If the
3 manufacturer or repackager has uniquely serialized the
4 individual legend drug unit, that identifier must also be
5 included on the form approved by the department and is
6 required of any subsequent transfers of prescription drugs
7 received by a direct purchase wholesaler in a transaction
8 governed by this paragraph. The pedigree paper must also
9 include the name, address, telephone number, and, if
10 available, e-mail contact information of each wholesaler
11 involved in the chain of custody of the legend drug. The
12 department shall adopt rules and a form relating to the
13 requirements of this paragraph.
14 Section 4. Subsection (29) of section 499.005, Florida
15 Statutes, is amended to read:
16 499.005 Prohibited acts.--It is unlawful for a person
17 to perform or cause the performance of any of the following
18 acts in this state:
19 (29) The receipt of a prescription drug pursuant to a
20 wholesale distribution without either first receiving a
21 pedigree paper that was attested to as accurate and complete
22 by the wholesale distributor or complying with the provisions
23 of s. 499.0121(6)(f)6.
24 Section 5. Section 499.006, Florida Statutes, is
25 amended to read:
26 499.006 Adulterated drug or device.--A drug or device
27 is adulterated:
28 (1) If it consists in whole or in part of any filthy,
29 putrid, or decomposed substance;
30 (2) If it has been produced, prepared, packed, or held
31 under conditions whereby it could have been contaminated with
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1 filth or rendered injurious to health;
2 (3) If it is a drug and the methods used in, or the
3 facilities or controls used for, its manufacture, processing,
4 packing, or holding do not conform to, or are not operated or
5 administered in conformity with, current good manufacturing
6 practices to assure that the drug meets the requirements of
7 ss. 499.001-499.081 and that the drug has the identity and
8 strength, and meets the standard of quality and purity, which
9 it purports or is represented to possess;
10 (4) If it is a drug and its container is composed, in
11 whole or in part, of any poisonous or deleterious substance
12 which could render the contents injurious to health;
13 (5) If it is a drug and it bears or contains, for the
14 purpose of coloring only, a color additive that is unsafe
15 within the meaning of the federal act; or, if it is a color
16 additive, the intended use of which in or on drugs is for the
17 purpose of coloring only, and it is unsafe within the meaning
18 of the federal act;
19 (6) If it purports to be, or is represented as, a drug
20 the name of which is recognized in the official compendium,
21 and its strength differs from, or its quality or purity falls
22 below, the standard set forth in such compendium. The
23 determination as to strength, quality, or purity must be made
24 in accordance with the tests or methods of assay set forth in
25 such compendium, or, when such tests or methods of assay are
26 absent or inadequate, in accordance with those tests or
27 methods of assay prescribed under authority of the federal
28 act. A drug defined in the official compendium is not
29 adulterated under this subsection merely because it differs
30 from the standard of strength, quality, or purity set forth
31 for that drug in such compendium if its difference in
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1 strength, quality, or purity from such standard is plainly
2 stated on its label;
3 (7) If it is not subject to subsection (6) and its
4 strength differs from, or its purity or quality falls below
5 the standard of, that which it purports or is represented to
6 possess;
7 (8) If it is a drug:
8 (a) With which any substance has been mixed or packed
9 so as to reduce the quality or strength of the drug; or
10 (b) For which any substance has been substituted
11 wholly or in part;
12 (9) If it is a drug or device for which the expiration
13 date has passed; or
14 (10) If it is a legend drug for which the required
15 pedigree paper is nonexistent, fraudulent, or incomplete under
16 the requirements of ss. 499.001-499.081 or applicable rules,
17 or that has been purchased, held, sold, or distributed at any
18 time by a person not authorized under federal or state law to
19 do so; or.
20 (11) If it is a prescription drug subject to, defined
21 by, or described by s. 503(b) of the Federal Food, Drug, and
22 Cosmetic Act which has been returned by a veterinarian to a
23 limited prescription drug veterinary wholesaler.
24 Section 6. Subsection (1) and paragraph (d) of
25 subsection (2) of section 499.01, Florida Statutes, are
26 amended to read:
27 499.01 Permits; applications; renewal; general
28 requirements.--
29 (1) Prior to operating, a permit is required for each
30 person and establishment that intends to operate as:
31 (a) A prescription drug manufacturer;
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1 (b) A prescription drug repackager;
2 (c) An over-the-counter drug manufacturer;
3 (d) A compressed medical gas manufacturer;
4 (e) A device manufacturer;
5 (f) A cosmetic manufacturer;
6 (g) A prescription drug wholesaler;
7 (h) A veterinary prescription drug wholesaler;
8 (i) A compressed medical gas wholesaler;
9 (j) An out-of-state prescription drug wholesaler;
10 (k) A nonresident prescription drug manufacturer;
11 (l) A freight forwarder;
12 (m) A retail pharmacy drug wholesaler;
13 (n) A veterinary legend drug retail establishment;
14 (o) A medical oxygen retail establishment;
15 (p) A complimentary drug distributor; or
16 (q) A restricted prescription drug distributor; or.
17 (r) A limited prescription drug veterinary wholesaler.
18 (2)
19 (d) A permit for a prescription drug manufacturer,
20 prescription drug repackager, prescription drug wholesaler,
21 limited prescription drug veterinary wholesaler, or retail
22 pharmacy wholesaler may not be issued to the address of a
23 health care entity or to a pharmacy licensed under chapter
24 465, except as provided in this paragraph. The department may
25 issue a prescription drug manufacturer permit to an applicant
26 at the same address as a licensed nuclear pharmacy, which is a
27 health care entity, for the purpose of manufacturing
28 prescription drugs used in positron emission tomography or
29 other radiopharmaceuticals, as listed in a rule adopted by the
30 department pursuant to this paragraph. The purpose of this
31 exemption is to assure availability of state-of-the-art
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1 pharmaceuticals that would pose a significant danger to the
2 public health if manufactured at a separate establishment
3 address from the nuclear pharmacy from which the prescription
4 drugs are dispensed. The department may also issue a retail
5 pharmacy wholesaler permit to the address of a community
6 pharmacy licensed under chapter 465 which does not meet the
7 definition of a closed pharmacy in s. 499.003.
8 Section 7. Paragraph (g) of subsection (2) of section
9 499.012, Florida Statutes, is amended, and paragraph (h) is
10 added to that subsection, to read:
11 499.012 Wholesale distribution; definitions; permits;
12 applications; general requirements.--
13 (2) The following types of wholesaler permits are
14 established:
15 (g) A veterinary prescription drug wholesaler
16 permit.--A veterinary prescription drug wholesaler permit is
17 required for any person that engages in the distribution of
18 veterinary prescription drugs in or into this state. A
19 veterinary prescription drug wholesaler that also distributes
20 prescription drugs subject to, defined by, or described by s.
21 503(b) of the Federal Food, Drug, and Cosmetic Act which it
22 did not manufacture must obtain a permit as a prescription
23 drug wholesaler, an or out-of-state prescription drug
24 wholesaler, or a limited prescription drug veterinary
25 wholesaler in lieu of the veterinary prescription drug
26 wholesaler permit. A veterinary prescription drug wholesaler
27 must comply with the requirements for wholesale distributors
28 under s. 499.0121, except those set forth in s.
29 499.0121(6)(d), (e), or (f).
30 (h) Limited prescription drug veterinary wholesaler
31 permit.--Unless engaging in the activities of and permitted as
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1 a prescription drug manufacturer, nonresident prescription
2 drug manufacturer, prescription drug wholesaler, or
3 out-of-state prescription drug wholesaler, a limited
4 prescription drug veterinary wholesaler permit is required for
5 any person that engages in the distribution in or into this
6 state of veterinary prescription drugs and prescription drugs
7 subject to, defined by, or described by s. 503(b) of the
8 Federal Food, Drug, and Cosmetic Act to veterinarians under
9 the following conditions:
10 1. The person is engaged in the business of
11 wholesaling prescription and veterinary legend drugs to
12 persons:
13 a. Licensed as veterinarians practicing on a full-time
14 basis;
15 b. Regularly and lawfully engaged in instruction in
16 veterinary medicine;
17 c. Regularly and lawfully engaged in law enforcement;
18 d. For use in research, not involving clinical use; or
19 e. For use in chemical analysis or physical testing,
20 for the purposes of instruction in law enforcement, research,
21 or testing.
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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1 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 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 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 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
31 described by s. 503(b) of the Federal Food, Drug, and Cosmetic
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1 Act which has been returned by a veterinarian.
2 8. An out-of-state prescription drug wholesaler's
3 permit or a limited prescription drug veterinary wholesaler
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 to engage in the wholesale distribution of
7 prescription drugs in its state of residence to a licensed
8 limited prescription drug veterinary wholesaler in this state
9 if both wholesalers conduct wholesale distributions of
10 prescription drugs under the same business name. The
11 recordkeeping requirements of s. 499.0121(6) must be followed
12 for this transaction.
13 Section 8. Paragraph (f) of subsection (6) of section
14 499.0121, Florida Statutes, is amended to read:
15 499.0121 Storage and handling of prescription drugs;
16 recordkeeping.--The department shall adopt rules to implement
17 this section as necessary to protect the public health,
18 safety, and welfare. Such rules shall include, but not be
19 limited to, requirements for the storage and handling of
20 prescription drugs and for the establishment and maintenance
21 of prescription drug distribution records.
22 (6) RECORDKEEPING.--The department shall adopt rules
23 that require keeping such records of prescription drugs as are
24 necessary for the protection of the public health.
25 (f)1. Effective July 1, 2006, each person who is
26 engaged in the wholesale distribution of a prescription drug
27 and who is not the manufacturer of that drug must, before each
28 wholesale distribution of such drug, provide to the person who
29 receives the drug a pedigree paper as defined in s.
30 499.003(31).
31 2. A repackager must comply with this paragraph.
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1 3. The pedigree paper requirements in this paragraph
2 do not apply to compressed medical gases or veterinary legend
3 drugs.
4 4. Each wholesale distributor of prescription drugs
5 must maintain separate and distinct from other required
6 records all statements that are required under subparagraph 1.
7 5. In order to verify compliance with subparagraph
8 (d)1., each manufacturer of a prescription drug sold in this
9 state must make available upon request distribution
10 documentation related to its sales of prescription drugs,
11 regardless of whether the prescription drug was sold directly
12 by the manufacturer to a person in Florida.
13 6. Subparagraph 1. does not apply to a wholesale
14 distributor that takes title to, but not possession of, a
15 prescription drug and the prescription drug's manufacturer
16 ships the prescription drug directly to a person authorized by
17 law to administer or dispense prescription drugs or a member
18 of an affiliated group, except a repackager, described in
19 paragraph (h).
20 a. The wholesale distributor must send an invoice to
21 the purchaser of the prescription drug that contains a clear
22 cross-reference to the shipping document sent by the
23 manufacturer to the purchaser of the prescription drug.
24 b. The purchaser of the prescription drug must obtain
25 a shipping document from the manufacturer that contains, at a
26 minimum:
27 (I) The name and address of the manufacturer,
28 including the point of origin of the shipment; the wholesaler;
29 and the purchaser.
30 (II) The name of the prescription drug as it appears
31 on the label.
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1 (III) The quantity, dosage form, and strength of the
2 prescription drug.
3 (IV) The date of the shipment.
4 c. The manufacturer must also make available to the
5 department, upon request, the lot number of the prescription
6 drug if the lot number is not contained in the shipping
7 document received by the purchaser.
8 7. The department may by rule define alternatives to
9 compliance with subparagraph 1. for a prescription drug in the
10 inventory of a permitted prescription drug wholesaler as of
11 June 30, 2006, and the return of a prescription drug purchased
12 prior to July 1, 2006. The department may specify time limits
13 for such alternatives.
14 Section 9. Paragraph (d) of subsection (1) of section
15 499.0122, Florida Statutes, is amended to read:
16 499.0122 Medical oxygen and veterinary legend drug
17 retail establishments; definitions, permits, general
18 requirements.--
19 (1) As used in this section, the term:
20 (d) "Veterinary legend drug retail establishment"
21 means a person permitted to sell veterinary legend drugs to
22 the public or to veterinarians, but does not include a
23 pharmacy licensed under chapter 465.
24 1. The sale to the public must be based on a valid
25 written order from a veterinarian licensed in this state who
26 has a valid client-veterinarian relationship with the
27 purchaser's animal.
28 2. Veterinary legend drugs may not be sold in excess
29 of the amount clearly indicated on the order or beyond the
30 date indicated on the order.
31 3. An order may not be valid for more than 1 year.
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1 4. A veterinary legend drug retail establishment may
2 not purchase, sell, trade, or possess human prescription drugs
3 or any controlled substance as defined in chapter 893.
4 5. A veterinary legend drug retail establishment must
5 sell a veterinary legend drug in the original, sealed
6 manufacturer's container with all labeling intact and legible.
7 The department may adopt by rule additional labeling
8 requirements for the sale of a veterinary legend drug.
9 Section 10. Paragraph (h) is added to subsection (2)
10 of section 499.041, Florida Statutes, to read:
11 499.041 Schedule of fees for drug, device, and
12 cosmetic applications and permits, product registrations, and
13 free-sale certificates.--
14 (2) The department shall assess an applicant that is
15 required to have a wholesaling permit an annual fee within the
16 ranges established in this section for the specific type of
17 wholesaling.
18 (h) The fee for a limited prescription drug veterinary
19 wholesaler's permit may not be less than $300 or more than
20 $500 annually.
21 Section 11. Subsections (1) and (3) of section
22 499.065, Florida Statutes, are amended to read:
23 499.065 Imminent danger.--
24 (1) Notwithstanding s. 499.051, the department shall
25 inspect each prescription drug wholesale establishment,
26 prescription drug repackager establishment, veterinary
27 prescription drug wholesale establishment, limited
28 prescription drug veterinary wholesaler establishment, and
29 retail pharmacy drug wholesaler establishment that is required
30 to be permitted under this chapter as often as necessary to
31 ensure compliance with applicable laws and rules. The
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1 department shall have the right of entry and access to these
2 facilities at any reasonable time.
3 (3) The department may determine that a prescription
4 drug wholesale establishment, prescription drug repackager
5 establishment, veterinary prescription drug wholesale
6 establishment, limited prescription drug veterinary wholesaler
7 establishment, or retail pharmacy drug wholesaler
8 establishment that is required to be permitted under this
9 chapter is an imminent danger to the public health and shall
10 require its immediate closure if the establishment fails to
11 comply with applicable laws and rules and, because of the
12 failure, presents an imminent threat to the public's health,
13 safety, or welfare. Any establishment so deemed and closed
14 shall remain closed until allowed by the department or by
15 judicial order to reopen.
16
17 For purposes of this section, a refusal to allow entry to the
18 department for inspection at reasonable times, or a failure or
19 refusal to provide the department with required documentation
20 for purposes of inspection, constitutes an imminent danger to
21 the public health.
22 Section 12. Paragraph (e) of subsection (3) of section
23 499.0661, Florida Statutes, is amended to read:
24 499.0661 Cease and desist orders; removal of certain
25 persons.--
26 (3) REMOVAL OF AFFILIATED PARTIES BY THE DEPARTMENT.--
27 (e)1. The chief executive officer, designated
28 representative, or the person holding the equivalent office,
29 of a permittee shall promptly notify the department if she or
30 he has actual knowledge that any affiliated party is charged
31 with a felony in a state or federal court.
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1 2. Whenever any affiliated party is charged with a
2 felony in a state or federal court or with the equivalent of a
3 felony in the courts of any foreign country with which the
4 United States maintains diplomatic relations, and the charge
5 alleges violation of any law involving prescription drugs,
6 pharmaceuticals, fraud, theft, or moral turpitude, the
7 department may enter an emergency order suspending the
8 affiliated party or restricting or prohibiting participation
9 by the affiliated party in the affairs of the particular
10 permittee or of any other permittee upon service of the order
11 upon the permittee and the affiliated party charged. The order
12 must contain notice of opportunity for a hearing pursuant to
13 ss. 120.569 and 120.57, where the affiliated party may request
14 a postsuspension hearing to show that continued service to or
15 participation in the affairs of the permittee does not pose a
16 threat to the public health or the interests of the permittee
17 and does not threaten to impair public confidence in the
18 permittee. In accordance with applicable departmental rules,
19 the department shall notify the affiliated party whether the
20 order suspending or prohibiting the person from participation
21 in the affairs of a permittee will be rescinded or otherwise
22 modified. The emergency order remains in effect, unless
23 otherwise modified by the department, until the criminal
24 charge is disposed of. The acquittal of the person charged, or
25 the final, unappealed dismissal of all charges against the
26 person, dissolves the emergency order but does not prohibit
27 the department from instituting proceedings under paragraph
28 (a). If the person charged is convicted or pleads guilty or
29 nolo contendere, whether or not an adjudication of guilt is
30 entered by the court, the emergency order shall become final.
31 3. Whenever a permittee is charged with violation of
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1 s. 499.0051 or s. 499.0052, the department may enter an
2 emergency order suspending the permittee's permit. The order
3 must contain notice of opportunity for a hearing pursuant to
4 ss. 120.569 and 120.57, where a permittee may request a
5 postsuspension hearing to show that continued operation by the
6 permittee under his or her permit does not pose a threat to
7 the public health and does not threaten to impair public
8 confidence in the permittee. In accordance with applicable
9 departmental rules, the department shall notify the permittee
10 whether the order suspending the permit of the permittee will
11 be rescinded or otherwise modified. The emergency order
12 remains in effect, unless otherwise modified by the
13 department, until the criminal charge is disposed of. The
14 acquittal of the permittee charged, or the final, unappealed
15 dismissal of all charges against the permittee, dissolves the
16 emergency order but does not prohibit the department from
17 instituting proceedings under paragraph (a). If a permittee
18 charged with a violation of s. 499.0051 or s. 499.0052 is
19 convicted or pleads guilty or nolo contendere, whether or not
20 an adjudication of guilt is entered by the court, the
21 emergency order shall become final.
22 4. The department shall publish on its website a list
23 of all permittees against whom an emergency order or a
24 permanent order under this section is entered.
25 Section 13. Subsections (8) and (9) are added to
26 section 499.067, Florida Statutes, to read:
27 499.067 Denial, suspension, or revocation of permit,
28 certification, or registration.--
29 (8) The department shall deny an application for a
30 permit for an establishment if the applicant, any person named
31 pursuant to s. 499.012(3)(k) in the applicant's application,
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1 or the person designated pursuant to s. 499.012(11) by the
2 applicant has been convicted or pleaded guilty or nolo
3 contendere to a violation of s. 499.0051 or s. 499.0052,
4 whether or not an adjudication of guilt is entered by the
5 court.
6 (9) The department shall revoke the permit of an
7 establishment if the permittee, any person named pursuant to
8 s. 499.012(3)(k) in the permittee's application, or the person
9 designated pursuant to s. 499.012(11) by the permittee has
10 been convicted or pleaded guilty or nolo contendere to a
11 violation of s. 499.0051 or s. 499.0052, whether or not an
12 adjudication of guilt is entered by the court.
13
14 (Redesignate subsequent sections.)
15
16
17 ================ T I T L E A M E N D M E N T ===============
18 And the title is amended as follows:
19 On line 26, after the semicolon,
20
21 insert:
22 amending s. 499.003, F.S.; amending a
23 definition; requiring the Department of Health
24 to approve a document or electronic form
25 relating to pedigree papers; providing
26 requirements for pedigree papers that record
27 certain distributions of legend drugs; amending
28 s. 499.005, F.S.; revising a prohibition
29 relating to pedigree papers; amending s.
30 499.006, F.S.; providing that a drug is
31 adulterated if it is a certain prescription
18
5:29 PM 05/03/06 h037105e1c-02-11a
Florida Senate - 2006 SENATOR AMENDMENT
Bill No. HB 371, 1st Eng.
Barcode 690302
1 drug that has been returned by a veterinarian
2 to a limited prescription drug veterinary
3 wholesaler; amending s. 499.01, F.S.; requiring
4 a limited prescription drug veterinary
5 wholesaler to obtain a permit for operation
6 from the Department of Health; providing that a
7 permit for a limited prescription drug
8 veterinary wholesaler may not be issued to the
9 address of certain health care entities;
10 amending s. 499.012, F.S.; revising permit
11 requirements for a veterinary prescription drug
12 wholesaler that distributes prescription drugs;
13 establishing a permit for a limited
14 prescription drug veterinary wholesaler;
15 providing requirements; providing an exception;
16 amending s. 499.0121, F.S.; requiring certain
17 wholesale distributors taking title to a
18 prescription drug to provide an invoice to the
19 purchaser containing certain information;
20 requiring a purchaser of a prescription drug to
21 obtain from the manufacturer a shipping
22 document containing specified information;
23 requiring a manufacturer to make certain
24 information available to the department;
25 authorizing the department to adopt certain
26 rules relating to the inventory and return of
27 certain prescription drugs; amending s.
28 499.0122, F.S.; redefining the term "veterinary
29 legend drug retail establishment"; amending s.
30 499.041, F.S.; requiring the department to
31 assess an annual fee within a certain monetary
19
5:29 PM 05/03/06 h037105e1c-02-11a
Florida Senate - 2006 SENATOR AMENDMENT
Bill No. HB 371, 1st Eng.
Barcode 690302
1 range for a limited prescription drug
2 veterinary wholesaler permit; amending s.
3 499.065, F.S.; requiring the department to
4 inspect each limited prescription drug
5 veterinary wholesaler establishment;
6 authorizing the department to determine that a
7 limited prescription drug veterinary wholesaler
8 establishment is an imminent danger to the
9 public; amending s. 499.0661, F.S.; providing
10 for emergency suspension of a permittee if
11 charged with specified violations; requiring
12 the department to publish a list of certain
13 permittee names; amending s. 499.067, F.S.;
14 prohibiting issuance of permits to specified
15 applicants; requiring revocation of permits of
16 specified permittees;
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24
25
26
27
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31
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5:29 PM 05/03/06 h037105e1c-02-11a