Florida Senate - 2006                        SENATOR AMENDMENT
    Bill No. HB 371, 1st Eng.
                        Barcode 690302
                            CHAMBER ACTION
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       05/03/2006 06:21 PM         .                    
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11  Senator Peaden moved the following amendment:
12  
13         Senate Amendment (with title amendment) 
14         Between lines 205 and 206,
15  
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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Florida Senate - 2006 SENATOR AMENDMENT Bill No. HB 371, 1st Eng. Barcode 690302 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." 2 5:29 PM 05/03/06 h037105e1c-02-11a
Florida Senate - 2006 SENATOR AMENDMENT Bill No. HB 371, 1st Eng. Barcode 690302 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 3 5:29 PM 05/03/06 h037105e1c-02-11a
Florida Senate - 2006 SENATOR AMENDMENT Bill No. HB 371, 1st Eng. Barcode 690302 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 4 5:29 PM 05/03/06 h037105e1c-02-11a
Florida Senate - 2006 SENATOR AMENDMENT Bill No. HB 371, 1st Eng. Barcode 690302 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 5 5:29 PM 05/03/06 h037105e1c-02-11a
Florida Senate - 2006 SENATOR AMENDMENT Bill No. HB 371, 1st Eng. Barcode 690302 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; 6 5:29 PM 05/03/06 h037105e1c-02-11a
Florida Senate - 2006 SENATOR AMENDMENT Bill No. HB 371, 1st Eng. Barcode 690302 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 7 5:29 PM 05/03/06 h037105e1c-02-11a
Florida Senate - 2006 SENATOR AMENDMENT Bill No. HB 371, 1st Eng. Barcode 690302 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 8 5:29 PM 05/03/06 h037105e1c-02-11a
Florida Senate - 2006 SENATOR AMENDMENT Bill No. HB 371, 1st Eng. Barcode 690302 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. 9 5:29 PM 05/03/06 h037105e1c-02-11a
Florida Senate - 2006 SENATOR AMENDMENT Bill No. HB 371, 1st Eng. Barcode 690302 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 10 5:29 PM 05/03/06 h037105e1c-02-11a
Florida Senate - 2006 SENATOR AMENDMENT Bill No. HB 371, 1st Eng. Barcode 690302 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. 11 5:29 PM 05/03/06 h037105e1c-02-11a
Florida Senate - 2006 SENATOR AMENDMENT Bill No. HB 371, 1st Eng. Barcode 690302 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. 12 5:29 PM 05/03/06 h037105e1c-02-11a
Florida Senate - 2006 SENATOR AMENDMENT Bill No. HB 371, 1st Eng. Barcode 690302 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. 13 5:29 PM 05/03/06 h037105e1c-02-11a
Florida Senate - 2006 SENATOR AMENDMENT Bill No. HB 371, 1st Eng. Barcode 690302 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 14 5:29 PM 05/03/06 h037105e1c-02-11a
Florida Senate - 2006 SENATOR AMENDMENT Bill No. HB 371, 1st Eng. Barcode 690302 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. 15 5:29 PM 05/03/06 h037105e1c-02-11a
Florida Senate - 2006 SENATOR AMENDMENT Bill No. HB 371, 1st Eng. Barcode 690302 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 16 5:29 PM 05/03/06 h037105e1c-02-11a
Florida Senate - 2006 SENATOR AMENDMENT Bill No. HB 371, 1st Eng. Barcode 690302 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, 17 5:29 PM 05/03/06 h037105e1c-02-11a
Florida Senate - 2006 SENATOR AMENDMENT Bill No. HB 371, 1st Eng. Barcode 690302 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; 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 20 5:29 PM 05/03/06 h037105e1c-02-11a