Senate Bill sb0926c2
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Florida Senate - 2006 CS for CS for SB 926
By the Committees on Judiciary; Health Care; and Senator
Peaden
590-2484-06
1 A bill to be entitled
2 An act relating to drug distribution; amending
3 s. 499.003, F.S.; amending a definition;
4 requiring the Department of Health to approve a
5 document or electronic form relating to
6 pedigree papers; providing requirements for
7 pedigree papers that record certain
8 distributions of legend drugs; amending s.
9 499.005, F.S.; revising a prohibition relating
10 to pedigree papers; amending s. 499.006, F.S.;
11 providing that a drug is adulterated if it is a
12 certain prescription drug that has been
13 returned by a veterinarian to a limited
14 prescription drug veterinary wholesaler;
15 amending s. 499.01, F.S.; requiring a limited
16 prescription drug veterinary wholesaler to
17 obtain a permit for operation from the
18 Department of Health; providing that a permit
19 for a limited prescription drug veterinary
20 wholesaler may not be issued to the address of
21 certain health care entities; amending s.
22 499.012, F.S.; revising permit requirements for
23 a veterinary prescription drug wholesaler that
24 distributes prescription drugs; establishing a
25 permit for a limited prescription drug
26 veterinary wholesaler; providing requirements;
27 providing an exception; amending s. 499.0121,
28 F.S.; requiring certain wholesale distributors
29 taking title to a prescription drug to provide
30 an invoice to the purchaser containing certain
31 information; requiring a purchaser of a
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1 prescription drug to obtain from the
2 manufacturer a shipping document containing
3 specified information; requiring a manufacturer
4 to make certain information available to the
5 department; authorizing the department to adopt
6 certain rules relating to the inventory and
7 return of certain prescription drugs; amending
8 s. 499.0122, F.S.; redefining the term
9 "veterinary legend drug retail establishment";
10 amending s. 499.041, F.S.; requiring the
11 department to assess an annual fee within a
12 certain monetary range for a limited
13 prescription drug veterinary wholesaler permit;
14 amending s. 499.065, F.S.; requiring the
15 department to inspect each limited prescription
16 drug veterinary wholesaler establishment;
17 authorizing the department to determine that a
18 limited prescription drug veterinary wholesaler
19 establishment is an imminent danger to the
20 public; amending s. 499.0661, F.S.; providing
21 for emergency suspension of a permittee if
22 charged with specified violations; requiring
23 the department to publish a list of certain
24 permittee names; amending s. 499.067, F.S.;
25 prohibiting issuance of permits to specified
26 applicants; requiring revocation of permits of
27 specified permittees; providing an effective
28 date.
29
30 Be It Enacted by the Legislature of the State of Florida:
31
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1 Section 1. Subsection (31) of section 499.003, Florida
2 Statutes, is amended to read:
3 499.003 Definitions of terms used in ss.
4 499.001-499.081.--As used in ss. 499.001-499.081, the term:
5 (31) "Pedigree paper" means:
6 (a) A document required pursuant to s. 499.0121(6)(d)
7 or (e); or
8 (b) Effective July 1, 2006, a document or electronic
9 form approved by the Department of Health and containing
10 information that records each distribution of any given legend
11 drug, from sale by a pharmaceutical manufacturer, through
12 acquisition and sale by any wholesaler or repackager, until
13 final sale to a pharmacy or other person administering or
14 dispensing the drug. The information required to be included
15 on a legend drug's pedigree paper must at least detail the
16 amount of the legend drug; its dosage form and strength; its
17 lot numbers; the name and address of each owner of the legend
18 drug and his or her signature; its shipping information,
19 including the name and address of each person certifying
20 delivery or receipt of the legend drug; an invoice number, a
21 shipping document number, or another number uniquely
22 identifying the transaction; and a certification that the
23 recipient wholesaler has authenticated the pedigree papers. If
24 the manufacturer or repackager has uniquely serialized the
25 individual legend drug unit, that identifier must also be
26 included on the pedigree. It must also include the name,
27 address, telephone number and, if available, e-mail contact
28 information of each wholesaler involved in the chain of the
29 legend drug's custody. The department shall adopt rules and a
30 form relating to the requirements of this paragraph no later
31 than 90 days after the effective date of this act; or.
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1 (c) Effective July 1, 2006, a document or electronic
2 form approved by the Department of Health and containing
3 information that records each distribution of any given legend
4 drug, from sale by a pharmaceutical manufacturer, through
5 acquisition and sale by any wholesaler or repackager, until
6 final sale to a pharmacy or other person administering or
7 dispensing the drug; or, if a specific unit of the legend drug
8 was purchased by a wholesaler, referred to in this paragraph
9 as a "direct purchase wholesaler," directly from the
10 manufacturer, an invoice for the specific unit of the legend
11 drug together with a certificate under oath in written or
12 electronic form stating that:
13 1. If the establishment is not a member of an
14 affiliated group: "This establishment purchased the specific
15 unit of the legend drug directly from the manufacturer."
16 2. If the establishment is a member of an affiliated
17 group: "This establishment or a member of its affiliated group
18 purchased the specific unit of the legend drug directly from
19 the manufacturer."
20
21 A document or electronic form that meets the requirements of
22 this paragraph shall constitute a sufficient pedigree paper
23 only for the purpose of a single sale or distribution
24 transaction in the specific unit of legend drug by the direct
25 purchase wholesaler to an entity authorized by law to purchase
26 legend drugs. For each transaction of the specific unit of
27 legend drug, the direct purchase wholesaler is required to
28 create a separate pedigree paper that meets the requirements
29 of this paragraph and furnish such pedigree paper to any
30 subsequent purchaser. The pedigree paper shall be prepared and
31 updated for every transfer following the direct purchase
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1 wholesaler's receipt of the specific unit of legend drug
2 directly from the manufacturer. The information required to be
3 included on the document or electronic form approved by the
4 department pursuant to this paragraph and required of any
5 subsequent transfers of legend drugs received by a direct
6 purchase wholesaler in a transaction described in this
7 paragraph must at least detail the amount of the legend drug;
8 its dosage form and strength; its lot numbers; the name and
9 address of each owner of the legend drug after it has left the
10 possession of the manufacturer and his or her signature; its
11 shipping information, including the name and address of each
12 person certifying delivery or receipt of the legend drug after
13 it has left the possession of the manufacturer; an invoice
14 number, a shipping document number, or another number uniquely
15 identifying the transaction; and a certification that the
16 recipient direct purchase wholesaler has authenticated the
17 pedigree papers as required in this paragraph. If the
18 manufacturer or repackager has uniquely serialized the
19 individual legend drug unit, that identifier must also be
20 included on the form approved by the department and is
21 required of any subsequent transfers of prescription drugs
22 received by a direct purchase wholesaler in a transaction
23 governed by this paragraph. The pedigree paper must also
24 include the name, address, telephone number, and, if
25 available, e-mail contact information of each wholesaler
26 involved in the chain of custody of the legend drug. The
27 department shall adopt rules and a form relating to the
28 requirements of this paragraph.
29 Section 2. Subsection (29) of section 499.005, Florida
30 Statutes, is amended to read:
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1 499.005 Prohibited acts.--It is unlawful for a person
2 to perform or cause the performance of any of the following
3 acts in this state:
4 (29) The receipt of a prescription drug pursuant to a
5 wholesale distribution without either first receiving a
6 pedigree paper that was attested to as accurate and complete
7 by the wholesale distributor or complying with the provisions
8 of s. 499.0121(6)(f)6.
9 Section 3. Section 499.006, Florida Statutes, is
10 amended to read:
11 499.006 Adulterated drug or device.--A drug or device
12 is adulterated:
13 (1) If it consists in whole or in part of any filthy,
14 putrid, or decomposed substance;
15 (2) If it has been produced, prepared, packed, or held
16 under conditions whereby it could have been contaminated with
17 filth or rendered injurious to health;
18 (3) If it is a drug and the methods used in, or the
19 facilities or controls used for, its manufacture, processing,
20 packing, or holding do not conform to, or are not operated or
21 administered in conformity with, current good manufacturing
22 practices to assure that the drug meets the requirements of
23 ss. 499.001-499.081 and that the drug has the identity and
24 strength, and meets the standard of quality and purity, which
25 it purports or is represented to possess;
26 (4) If it is a drug and its container is composed, in
27 whole or in part, of any poisonous or deleterious substance
28 which could render the contents injurious to health;
29 (5) If it is a drug and it bears or contains, for the
30 purpose of coloring only, a color additive that is unsafe
31 within the meaning of the federal act; or, if it is a color
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1 additive, the intended use of which in or on drugs is for the
2 purpose of coloring only, and it is unsafe within the meaning
3 of the federal act;
4 (6) If it purports to be, or is represented as, a drug
5 the name of which is recognized in the official compendium,
6 and its strength differs from, or its quality or purity falls
7 below, the standard set forth in such compendium. The
8 determination as to strength, quality, or purity must be made
9 in accordance with the tests or methods of assay set forth in
10 such compendium, or, when such tests or methods of assay are
11 absent or inadequate, in accordance with those tests or
12 methods of assay prescribed under authority of the federal
13 act. A drug defined in the official compendium is not
14 adulterated under this subsection merely because it differs
15 from the standard of strength, quality, or purity set forth
16 for that drug in such compendium if its difference in
17 strength, quality, or purity from such standard is plainly
18 stated on its label;
19 (7) If it is not subject to subsection (6) and its
20 strength differs from, or its purity or quality falls below
21 the standard of, that which it purports or is represented to
22 possess;
23 (8) If it is a drug:
24 (a) With which any substance has been mixed or packed
25 so as to reduce the quality or strength of the drug; or
26 (b) For which any substance has been substituted
27 wholly or in part;
28 (9) If it is a drug or device for which the expiration
29 date has passed; or
30 (10) If it is a legend drug for which the required
31 pedigree paper is nonexistent, fraudulent, or incomplete under
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1 the requirements of ss. 499.001-499.081 or applicable rules,
2 or that has been purchased, held, sold, or distributed at any
3 time by a person not authorized under federal or state law to
4 do so; or.
5 (11) If it is a prescription drug subject to, defined
6 by, or described by s. 503(b) of the Federal Food, Drug, and
7 Cosmetic Act which has been returned by a veterinarian to a
8 limited prescription drug veterinary wholesaler.
9 Section 4. Subsection (1) and paragraph (d) of
10 subsection (2) of section 499.01, Florida Statutes, are
11 amended to read:
12 499.01 Permits; applications; renewal; general
13 requirements.--
14 (1) Prior to operating, a permit is required for each
15 person and establishment that intends to operate as:
16 (a) A prescription drug manufacturer;
17 (b) A prescription drug repackager;
18 (c) An over-the-counter drug manufacturer;
19 (d) A compressed medical gas manufacturer;
20 (e) A device manufacturer;
21 (f) A cosmetic manufacturer;
22 (g) A prescription drug wholesaler;
23 (h) A veterinary prescription drug wholesaler;
24 (i) A compressed medical gas wholesaler;
25 (j) An out-of-state prescription drug wholesaler;
26 (k) A nonresident prescription drug manufacturer;
27 (l) A freight forwarder;
28 (m) A retail pharmacy drug wholesaler;
29 (n) A veterinary legend drug retail establishment;
30 (o) A medical oxygen retail establishment;
31 (p) A complimentary drug distributor; or
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1 (q) A restricted prescription drug distributor; or.
2 (r) A limited prescription drug veterinary wholesaler.
3 (2)
4 (d) A permit for a prescription drug manufacturer,
5 prescription drug repackager, prescription drug wholesaler,
6 limited prescription drug veterinary wholesaler, or retail
7 pharmacy wholesaler may not be issued to the address of a
8 health care entity or to a pharmacy licensed under chapter
9 465, except as provided in this paragraph. The department may
10 issue a prescription drug manufacturer permit to an applicant
11 at the same address as a licensed nuclear pharmacy, which is a
12 health care entity, for the purpose of manufacturing
13 prescription drugs used in positron emission tomography or
14 other radiopharmaceuticals, as listed in a rule adopted by the
15 department pursuant to this paragraph. The purpose of this
16 exemption is to assure availability of state-of-the-art
17 pharmaceuticals that would pose a significant danger to the
18 public health if manufactured at a separate establishment
19 address from the nuclear pharmacy from which the prescription
20 drugs are dispensed. The department may also issue a retail
21 pharmacy wholesaler permit to the address of a community
22 pharmacy licensed under chapter 465 which does not meet the
23 definition of a closed pharmacy in s. 499.003.
24 Section 5. Paragraph (g) of subsection (2) of section
25 499.012, Florida Statutes, is amended, and paragraph (h) is
26 added to that subsection, to read:
27 499.012 Wholesale distribution; definitions; permits;
28 applications; general requirements.--
29 (2) The following types of wholesaler permits are
30 established:
31
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1 (g) A veterinary prescription drug wholesaler
2 permit.--A veterinary prescription drug wholesaler permit is
3 required for any person that engages in the distribution of
4 veterinary prescription drugs in or into this state. A
5 veterinary prescription drug wholesaler that also distributes
6 prescription drugs subject to, defined by, or described by s.
7 503(b) of the Federal Food, Drug, and Cosmetic Act which it
8 did not manufacture must obtain a permit as a prescription
9 drug wholesaler, an or out-of-state prescription drug
10 wholesaler, or a limited prescription drug veterinary
11 wholesaler in lieu of the veterinary prescription drug
12 wholesaler permit. A veterinary prescription drug wholesaler
13 must comply with the requirements for wholesale distributors
14 under s. 499.0121, except those set forth in s.
15 499.0121(6)(d), (e), or (f).
16 (h) Limited prescription drug veterinary wholesaler
17 permit.--Unless engaging in the activities of and permitted as
18 a prescription drug manufacturer, nonresident prescription
19 drug manufacturer, prescription drug wholesaler, or
20 out-of-state prescription drug wholesaler, a limited
21 prescription drug veterinary wholesaler permit is required for
22 any person that engages in the distribution in or into this
23 state of veterinary prescription drugs and prescription drugs
24 subject to, defined by, or described by s. 503(b) of the
25 Federal Food, Drug, and Cosmetic Act to veterinarians under
26 the following conditions:
27 1. The person is engaged in the business of
28 wholesaling prescription and veterinary legend drugs to
29 persons:
30 a. Licensed as veterinarians practicing on a full-time
31 basis;
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1 b. Regularly and lawfully engaged in instruction in
2 veterinary medicine;
3 c. Regularly and lawfully engaged in law enforcement;
4 d. For use in research, not involving clinical use; or
5 e. For use in chemical analysis or physical testing,
6 for the purposes of instruction in law enforcement, research,
7 or testing.
8 2. No more than 30 percent of prescription drug sales
9 may be prescription drugs approved for human use which are
10 subject to, defined by, or described by s. 503(b) of the
11 Federal Food, Drug, and Cosmetic Act.
12 3. The person is not permitted, licensed, or otherwise
13 authorized in any state to wholesale prescription drugs
14 subject to, defined by, or described by s. 503(b) of the
15 Federal Food, Drug, and Cosmetic Act to any person who is
16 authorized to sell, distribute, purchase, trade, or use these
17 drugs on or for humans.
18 4. A limited prescription drug veterinary wholesaler
19 that applies to the department for a new permit or the renewal
20 of a permit must submit a bond of $20,000, or other equivalent
21 means of security acceptable to the department, such as an
22 irrevocable letter of credit or a deposit in a trust account
23 or financial institution, payable to the Florida Drug, Device,
24 and Cosmetic Trust Fund. The purpose of the bond is to secure
25 payment of any administrative penalties imposed by the
26 department and any fees and costs incurred by the department
27 regarding that permit which are authorized under state law and
28 which the permittee fails to pay 30 days after the fine or
29 costs become final. The department may make a claim against
30 such bond or security until 1 year after the permittee's
31 license ceases to be valid or until 60 days after any
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1 administrative or legal proceeding authorized in ss.
2 499.001-499.081 which involves the permittee is concluded,
3 including any appeal, whichever occurs later.
4 5. A limited prescription drug veterinary wholesaler
5 must maintain at all times a license or permit to engage in
6 the wholesale distribution of prescription drugs in compliance
7 with laws of the state in which it is a resident.
8 6. A limited prescription drug veterinary wholesaler
9 must comply with the requirements for wholesale distributors
10 under s. 499.0121, except that a limited prescription drug
11 veterinary wholesaler is not required to provide a pedigree
12 paper as required by s. 499.0121(6)(f) upon the wholesale
13 distribution of a prescription drug to a veterinarian.
14 7. A limited prescription drug veterinary 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 or a limited prescription drug veterinary wholesaler
21 permit is not required for an intracompany sale or transfer of
22 a prescription drug from an out-of-state establishment that is
23 duly licensed to engage in the wholesale distribution of
24 prescription drugs in its state of residence to a licensed
25 limited prescription drug veterinary wholesaler in this state
26 if both wholesalers conduct wholesale distributions of
27 prescription drugs under the same business name. The
28 recordkeeping requirements of s. 499.0121(6) must be followed
29 for this transaction.
30 Section 6. Paragraph (f) of subsection (6) of section
31 499.0121, Florida Statutes, is amended to read:
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1 499.0121 Storage and handling of prescription drugs;
2 recordkeeping.--The department shall adopt rules to implement
3 this section as necessary to protect the public health,
4 safety, and welfare. Such rules shall include, but not be
5 limited to, requirements for the storage and handling of
6 prescription drugs and for the establishment and maintenance
7 of prescription drug distribution records.
8 (6) RECORDKEEPING.--The department shall adopt rules
9 that require keeping such records of prescription drugs as are
10 necessary for the protection of the public health.
11 (f)1. Effective July 1, 2006, each person who is
12 engaged in the wholesale distribution of a prescription drug
13 and who is not the manufacturer of that drug must, before each
14 wholesale distribution of such drug, provide to the person who
15 receives the drug a pedigree paper as defined in s.
16 499.003(31).
17 2. A repackager must comply with this paragraph.
18 3. The pedigree paper requirements in this paragraph
19 do not apply to compressed medical gases or veterinary legend
20 drugs.
21 4. Each wholesale distributor of prescription drugs
22 must maintain separate and distinct from other required
23 records all statements that are required under subparagraph 1.
24 5. In order to verify compliance with subparagraph
25 (d)1., each manufacturer of a prescription drug sold in this
26 state must make available upon request distribution
27 documentation related to its sales of prescription drugs,
28 regardless of whether the prescription drug was sold directly
29 by the manufacturer to a person in Florida.
30 6. Subparagraph 1. does not apply to a wholesale
31 distributor that takes title to, but not possession of, a
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1 prescription drug and the prescription drug's manufacturer
2 ships the prescription drug directly to a person authorized by
3 law to administer or dispense prescription drugs or a member
4 of an affiliated group, except a repackager, described in
5 paragraph (h).
6 a. The wholesale distributor must send an invoice to
7 the purchaser of the prescription drug that contains a clear
8 cross-reference to the shipping document sent by the
9 manufacturer to the purchaser of the prescription drug.
10 b. The purchaser of the prescription drug must obtain
11 a shipping document from the manufacturer that contains, at a
12 minimum:
13 (I) The name and address of the manufacturer,
14 including the point of origin of the shipment; the wholesaler;
15 and the purchaser.
16 (II) The name of the prescription drug as it appears
17 on the label.
18 (III) The quantity, dosage form, and strength of the
19 prescription drug.
20 (IV) The date of the shipment.
21 c. The manufacturer must also make available to the
22 department, upon request, the lot number of the prescription
23 drug if the lot number is not contained in the shipping
24 document received by the purchaser.
25 7. The department may by rule define alternatives to
26 compliance with subparagraph 1. for a prescription drug in the
27 inventory of a permitted prescription drug wholesaler as of
28 June 30, 2006, and the return of a prescription drug purchased
29 prior to July 1, 2006. The department may specify time limits
30 for such alternatives.
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1 Section 7. Paragraph (d) of subsection (1) of section
2 499.0122, Florida Statutes, is amended to read:
3 499.0122 Medical oxygen and veterinary legend drug
4 retail establishments; definitions, permits, general
5 requirements.--
6 (1) As used in this section, the term:
7 (d) "Veterinary legend drug retail establishment"
8 means a person permitted to sell veterinary legend drugs to
9 the public or to veterinarians, but does not include a
10 pharmacy licensed under chapter 465.
11 1. The sale to the public must be based on a valid
12 written order from a veterinarian licensed in this state who
13 has a valid client-veterinarian relationship with the
14 purchaser's animal.
15 2. Veterinary legend drugs may not be sold in excess
16 of the amount clearly indicated on the order or beyond the
17 date indicated on the order.
18 3. An order may not be valid for more than 1 year.
19 4. A veterinary legend drug retail establishment may
20 not purchase, sell, trade, or possess human prescription drugs
21 or any controlled substance as defined in chapter 893.
22 5. A veterinary legend drug retail establishment must
23 sell a veterinary legend drug in the original, sealed
24 manufacturer's container with all labeling intact and legible.
25 The department may adopt by rule additional labeling
26 requirements for the sale of a veterinary legend drug.
27 Section 8. Paragraph (h) is added to subsection (2) of
28 section 499.041, Florida Statutes, to read:
29 499.041 Schedule of fees for drug, device, and
30 cosmetic applications and permits, product registrations, and
31 free-sale certificates.--
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1 (2) The department shall assess an applicant that is
2 required to have a wholesaling permit an annual fee within the
3 ranges established in this section for the specific type of
4 wholesaling.
5 (h) The fee for a limited prescription drug veterinary
6 wholesaler's permit may not be less than $300 or more than
7 $500 annually.
8 Section 9. Subsections (1) and (3) of section 499.065,
9 Florida Statutes, are amended to read:
10 499.065 Imminent danger.--
11 (1) Notwithstanding s. 499.051, the department shall
12 inspect each prescription drug wholesale establishment,
13 prescription drug repackager establishment, veterinary
14 prescription drug wholesale establishment, limited
15 prescription drug veterinary wholesaler establishment, and
16 retail pharmacy drug wholesaler establishment that is required
17 to be permitted under this chapter as often as necessary to
18 ensure compliance with applicable laws and rules. The
19 department shall have the right of entry and access to these
20 facilities at any reasonable time.
21 (3) The department may determine that a prescription
22 drug wholesale establishment, prescription drug repackager
23 establishment, veterinary prescription drug wholesale
24 establishment, limited prescription drug veterinary wholesaler
25 establishment, or retail pharmacy drug wholesaler
26 establishment that is required to be permitted under this
27 chapter is an imminent danger to the public health and shall
28 require its immediate closure if the establishment fails to
29 comply with applicable laws and rules and, because of the
30 failure, presents an imminent threat to the public's health,
31 safety, or welfare. Any establishment so deemed and closed
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1 shall remain closed until allowed by the department or by
2 judicial order to reopen.
3
4 For purposes of this section, a refusal to allow entry to the
5 department for inspection at reasonable times, or a failure or
6 refusal to provide the department with required documentation
7 for purposes of inspection, constitutes an imminent danger to
8 the public health.
9 Section 10. Paragraph (e) of subsection (3) of section
10 499.0661, Florida Statutes, is amended to read:
11 499.0661 Cease and desist orders; removal of certain
12 persons.--
13 (3) REMOVAL OF AFFILIATED PARTIES BY THE DEPARTMENT.--
14 (e)1. The chief executive officer, designated
15 representative, or the person holding the equivalent office,
16 of a permittee shall promptly notify the department if she or
17 he has actual knowledge that any affiliated party is charged
18 with a felony in a state or federal court.
19 2. Whenever any affiliated party is charged with a
20 felony in a state or federal court or with the equivalent of a
21 felony in the courts of any foreign country with which the
22 United States maintains diplomatic relations, and the charge
23 alleges violation of any law involving prescription drugs,
24 pharmaceuticals, fraud, theft, or moral turpitude, the
25 department may enter an emergency order suspending the
26 affiliated party or restricting or prohibiting participation
27 by the affiliated party in the affairs of the particular
28 permittee or of any other permittee upon service of the order
29 upon the permittee and the affiliated party charged. The order
30 must contain notice of opportunity for a hearing pursuant to
31 ss. 120.569 and 120.57, where the affiliated party may request
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1 a postsuspension hearing to show that continued service to or
2 participation in the affairs of the permittee does not pose a
3 threat to the public health or the interests of the permittee
4 and does not threaten to impair public confidence in the
5 permittee. In accordance with applicable departmental rules,
6 the department shall notify the affiliated party whether the
7 order suspending or prohibiting the person from participation
8 in the affairs of a permittee will be rescinded or otherwise
9 modified. The emergency order remains in effect, unless
10 otherwise modified by the department, until the criminal
11 charge is disposed of. The acquittal of the person charged, or
12 the final, unappealed dismissal of all charges against the
13 person, dissolves the emergency order but does not prohibit
14 the department from instituting proceedings under paragraph
15 (a). If the person charged is convicted or pleads guilty or
16 nolo contendere, whether or not an adjudication of guilt is
17 entered by the court, the emergency order shall become final.
18 3. Whenever a permittee is charged with violation of
19 s. 499.0051 or s. 499.0052, the department may enter an
20 emergency order suspending the permittee's permit. The order
21 must contain notice of opportunity for a hearing pursuant to
22 ss. 120.569 and 120.57, where a permittee may request a
23 postsuspension hearing to show that continued operation by the
24 permittee under his or her permit does not pose a threat to
25 the public health and does not threaten to impair public
26 confidence in the permittee. In accordance with applicable
27 departmental rules, the department shall notify the permittee
28 whether the order suspending the permit of the permittee will
29 be rescinded or otherwise modified. The emergency order
30 remains in effect, unless otherwise modified by the
31 department, until the criminal charge is disposed of. The
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Florida Senate - 2006 CS for CS for SB 926
590-2484-06
1 acquittal of the permittee charged, or the final, unappealed
2 dismissal of all charges against the permittee, dissolves the
3 emergency order but does not prohibit the department from
4 instituting proceedings under paragraph (a). If a permittee
5 charged with a violation of s. 499.0051 or s. 499.0052 is
6 convicted or pleads guilty or nolo contendere, whether or not
7 an adjudication of guilt is entered by the court, the
8 emergency order shall become final.
9 4. The department shall publish on its website a list
10 of all permittees against whom an emergency order or a
11 permanent order under this section is entered.
12 Section 11. Subsections (8) and (9) are added to
13 section 499.067, Florida Statutes, to read:
14 499.067 Denial, suspension, or revocation of permit,
15 certification, or registration.--
16 (8) The department shall deny an application for a
17 permit for an establishment if the applicant, any person named
18 pursuant to s. 499.012(3)(k) in the applicant's application,
19 or the person designated pursuant to s. 499.012(11) by the
20 applicant has been convicted or pleaded guilty or nolo
21 contendere to a violation of s. 499.0051 or s. 499.0052,
22 whether or not an adjudication of guilt is entered by the
23 court.
24 (9) The department shall revoke the permit of an
25 establishment if the permittee, any person named pursuant to
26 s. 499.012(3)(k) in the permittee's application, or the person
27 designated pursuant to s. 499.012(11) by the permittee has
28 been convicted or pleaded guilty or nolo contendere to a
29 violation of s. 499.0051 or s. 499.0052, whether or not an
30 adjudication of guilt is entered by the court.
31 Section 12. This act shall take effect July 1, 2006.
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Florida Senate - 2006 CS for CS for SB 926
590-2484-06
1 STATEMENT OF SUBSTANTIAL CHANGES CONTAINED IN
COMMITTEE SUBSTITUTE FOR
2 CS for Senate Bill 926
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4 The committee substitute changes the underlying committee
substitute in that it:
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-- Requires the use of detailed pedigree papers for
6 redistributions of prescription drugs purchased from a
wholesaler who purchased them directly from a
7 manufacturer;
8 -- Removes provisions pertaining to authorized distributors
of record of prescription drug manufacturers;
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-- Creates a limited prescription drug veterinary wholesaler
10 permit and provides for regulation of permit-holders; and
11 -- Provides that holders of a limited prescription drug
veterinary wholesaler permit generally are not required
12 to use pedigree papers.
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CODING: Words stricken are deletions; words underlined are additions.