Florida Senate - 2012                          SENATOR AMENDMENT
       Bill No. HB 5511
       
       
       
       
       
       
                                Barcode 336928                          
       
                              LEGISLATIVE ACTION                        
                    Senate             .             House              
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                Floor: 1/R/2R          .                                
             03/09/2012 06:45 PM       .                                
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       Senator Hays moved the following:
       
    1         Senate Amendment (with title amendment)
    2  
    3         Delete everything after the enacting clause
    4  and insert:
    5         Section 1. Paragraphs (d) through (k) of subsection (2) of
    6  section 20.165, Florida Statutes, are redesignated as paragraphs
    7  (e) through (l), respectively, and a new paragraph (d) is added
    8  to that subsection to read:
    9         20.165 Department of Business and Professional Regulation.
   10  There is created a Department of Business and Professional
   11  Regulation.
   12         (2) The following divisions of the Department of Business
   13  and Professional Regulation are established:
   14         (d) Division of Drugs, Devices, and Cosmetics.
   15         Section 2. Effective November 1, 2012, subsection (8) of
   16  section 455.116, Florida Statutes, is amended to read:
   17         455.116 Regulation trust funds.—The following trust funds
   18  shall be placed in the department:
   19         (8) Florida Drug, Device, and Cosmetic Trust Fund.
   20         Section 3. Subsection (15) and paragraph (a) of subsection
   21  (54) of section 499.003, Florida Statutes, are amended to read:
   22         499.003 Definitions of terms used in this part.—As used in
   23  this part, the term:
   24         (15) “Department” means the Department of Business and
   25  Professional Regulation Health.
   26         (54) “Wholesale distribution” means distribution of
   27  prescription drugs to persons other than a consumer or patient,
   28  but does not include:
   29         (a) Any of the following activities, which is not a
   30  violation of s. 499.005(21) if such activity is conducted in
   31  accordance with s. 499.01(2)(g):
   32         1. The purchase or other acquisition by a hospital or other
   33  health care entity that is a member of a group purchasing
   34  organization of a prescription drug for its own use from the
   35  group purchasing organization or from other hospitals or health
   36  care entities that are members of that organization.
   37         2. The sale, purchase, or trade of a prescription drug or
   38  an offer to sell, purchase, or trade a prescription drug by a
   39  charitable organization described in s. 501(c)(3) of the
   40  Internal Revenue Code of 1986, as amended and revised, to a
   41  nonprofit affiliate of the organization to the extent otherwise
   42  permitted by law.
   43         3. The sale, purchase, or trade of a prescription drug or
   44  an offer to sell, purchase, or trade a prescription drug among
   45  hospitals or other health care entities that are under common
   46  control. For purposes of this subparagraph, “common control”
   47  means the power to direct or cause the direction of the
   48  management and policies of a person or an organization, whether
   49  by ownership of stock, by voting rights, by contract, or
   50  otherwise.
   51         4. The sale, purchase, trade, or other transfer of a
   52  prescription drug from or for any federal, state, or local
   53  government agency or any entity eligible to purchase
   54  prescription drugs at public health services prices pursuant to
   55  Pub. L. No. 102-585, s. 602 to a contract provider or its
   56  subcontractor for eligible patients of the agency or entity
   57  under the following conditions:
   58         a. The agency or entity must obtain written authorization
   59  for the sale, purchase, trade, or other transfer of a
   60  prescription drug under this subparagraph from the Secretary of
   61  Business and Professional Regulation State Surgeon General or
   62  his or her designee.
   63         b. The contract provider or subcontractor must be
   64  authorized by law to administer or dispense prescription drugs.
   65         c. In the case of a subcontractor, the agency or entity
   66  must be a party to and execute the subcontract.
   67         d. A contract provider or subcontractor must maintain
   68  separate and apart from other prescription drug inventory any
   69  prescription drugs of the agency or entity in its possession.
   70         e. The contract provider and subcontractor must maintain
   71  and produce immediately for inspection all records of movement
   72  or transfer of all the prescription drugs belonging to the
   73  agency or entity, including, but not limited to, the records of
   74  receipt and disposition of prescription drugs. Each contractor
   75  and subcontractor dispensing or administering these drugs must
   76  maintain and produce records documenting the dispensing or
   77  administration. Records that are required to be maintained
   78  include, but are not limited to, a perpetual inventory itemizing
   79  drugs received and drugs dispensed by prescription number or
   80  administered by patient identifier, which must be submitted to
   81  the agency or entity quarterly.
   82         f. The contract provider or subcontractor may administer or
   83  dispense the prescription drugs only to the eligible patients of
   84  the agency or entity or must return the prescription drugs for
   85  or to the agency or entity. The contract provider or
   86  subcontractor must require proof from each person seeking to
   87  fill a prescription or obtain treatment that the person is an
   88  eligible patient of the agency or entity and must, at a minimum,
   89  maintain a copy of this proof as part of the records of the
   90  contractor or subcontractor required under sub-subparagraph e.
   91         g. In addition to the departmental inspection authority set
   92  forth in s. 499.051, the establishment of the contract provider
   93  and subcontractor and all records pertaining to prescription
   94  drugs subject to this subparagraph shall be subject to
   95  inspection by the agency or entity. All records relating to
   96  prescription drugs of a manufacturer under this subparagraph
   97  shall be subject to audit by the manufacturer of those drugs,
   98  without identifying individual patient information.
   99         Section 4. Subsection (2) of section 499.01211, Florida
  100  Statutes, is amended to read:
  101         499.01211 Drug Wholesale Distributor Advisory Council.—
  102         (2) The Secretary of Business and Professional Regulation
  103  State Surgeon General, or his or her designee, and the Secretary
  104  of Health Care Administration, or her or his designee, shall be
  105  members of the council. The Secretary of Business and
  106  Professional Regulation State Surgeon General shall appoint nine
  107  additional members to the council who shall be appointed to a
  108  term of 4 years each, as follows:
  109         (a) Three different persons each of whom is employed by a
  110  different prescription drug wholesale distributor licensed under
  111  this part which operates nationally and is a primary wholesale
  112  distributor, as defined in s. 499.003(47).
  113         (b) One person employed by a prescription drug wholesale
  114  distributor licensed under this part which is a secondary
  115  wholesale distributor, as defined in s. 499.003(52).
  116         (c) One person employed by a retail pharmacy chain located
  117  in this state.
  118         (d) One person who is a member of the Board of Pharmacy and
  119  is a pharmacist licensed under chapter 465.
  120         (e) One person who is a physician licensed pursuant to
  121  chapter 458 or chapter 459.
  122         (f) One person who is an employee of a hospital licensed
  123  pursuant to chapter 395 and is a pharmacist licensed pursuant to
  124  chapter 465.
  125         (g) One person who is an employee of a pharmaceutical
  126  manufacturer.
  127         Section 5. Section 499.024, Florida Statutes, is amended to
  128  read:
  129         499.024 Drug product classification.—The department State
  130  Surgeon General shall adopt rules to classify drug products
  131  intended for use by humans which the United States Food and Drug
  132  Administration has not classified in the federal act or the Code
  133  of Federal Regulations.
  134         (1) Drug products must be classified as proprietary,
  135  prescription, or investigational drugs.
  136         (2) If a product is distributed without required labeling,
  137  it is misbranded while held for sale.
  138         (3) Any product that falls under the definition of drug in
  139  s. 499.003(19) may be classified under the authority of this
  140  section. This section does not subject portable emergency oxygen
  141  inhalators to classification; however, this section does not
  142  exempt any person from ss. 499.01 and 499.015.
  143         (4) Any product classified under the authority of this
  144  section reverts to the federal classification, if different,
  145  upon the federal regulation or act becoming effective.
  146         (5) The department may by rule reclassify drugs subject to
  147  this part when such classification action is necessary to
  148  protect the public health.
  149         (6) The department may adopt rules that exempt from any
  150  labeling or packaging requirements of this part drugs classified
  151  under this section if those requirements are not necessary to
  152  protect the public health.
  153         Section 6. Subsection (2) of section 499.065, Florida
  154  Statutes, is amended to read:
  155         499.065 Inspections; imminent danger.—
  156         (2) To protect the public from prescription drugs that are
  157  adulterated or otherwise unfit for human or animal consumption,
  158  the department may examine, sample, seize, and stop the sale or
  159  use of prescription drugs to determine the condition of those
  160  drugs. The department may immediately seize and remove any
  161  prescription drugs if the Secretary of Business and Professional
  162  Regulation State Surgeon General or his or her designee
  163  determines that the prescription drugs represent a threat to the
  164  public health. The owner of any property seized under this
  165  section may, within 10 days after the seizure, apply to a court
  166  of competent jurisdiction for whatever relief is appropriate. At
  167  any time after 10 days, the department may destroy the drugs as
  168  contraband.
  169         Section 7. Subsection (2) of section 499.601, Florida
  170  Statutes, is amended to read:
  171         499.601 Legislative intent; construction.—
  172         (2) The provisions of this part are cumulative and shall
  173  not be construed as repealing or affecting any powers, duties,
  174  or authority of the department of Health under any other law of
  175  this state; except that, with respect to the regulation of ether
  176  as herein provided, in instances in which the provisions of this
  177  part may conflict with any other such law, the provisions of
  178  this part shall control.
  179         Section 8. Subsection (2) of section 499.61, Florida
  180  Statutes, is amended to read:
  181         499.61 Definitions.—As used in this part:
  182         (2) “Department” means the Department of Business and
  183  Professional Regulation Health.
  184         Section 9. Effective November 1, 2012, section 499.0031,
  185  Florida Statutes, is repealed.
  186         Section 10. (1) The Florida Drug, Device, and Cosmetic
  187  Trust Fund within the Department of Business and Professional
  188  Regulation, FLAIR number 20-2-173005, is terminated.
  189         (2) The current balance remaining in, and all revenues of,
  190  the Florida Drug, Device, and Cosmetic Trust Fund shall be
  191  transferred to the Professional Regulation Trust Fund.
  192         (3) The Department of Business and Professional Regulation
  193  shall pay any outstanding debts or obligations of the Florida
  194  Drug, Device, and Cosmetic Trust Fund as soon as practicable,
  195  and the Chief Financial Officer shall close out and remove the
  196  terminated fund from the various state accounting systems using
  197  generally accepted accounting principles concerning warrants
  198  outstanding, assets, and liabilities.
  199         (4) This section shall take effect November 1, 2012.
  200         Section 11. Paragraphs (d), (e), and (l) of subsection (2)
  201  of section 499.01, Florida Statutes, are amended to read:
  202         499.01 Permits.—
  203         (2) The following permits are established:
  204         (d) Prescription drug wholesale distributor permit.—A
  205  prescription drug wholesale distributor is a wholesale
  206  distributor that may engage in the wholesale distribution of
  207  prescription drugs. A prescription drug wholesale distributor
  208  that applies to the department for a new permit or the renewal
  209  of a permit must submit a bond of $100,000, or other equivalent
  210  means of security acceptable to the department, such as an
  211  irrevocable letter of credit or a deposit in a trust account or
  212  financial institution, payable to the Professional Regulation
  213  Florida Drug, Device, and Cosmetic Trust Fund. The purpose of
  214  the bond is to secure payment of any administrative penalties
  215  imposed by the department and any fees and costs incurred by the
  216  department regarding that permit which are authorized under
  217  state law and which the permittee fails to pay 30 days after the
  218  fine or costs become final. The department may make a claim
  219  against such bond or security until 1 year after the permittee’s
  220  license ceases to be valid or until 60 days after any
  221  administrative or legal proceeding authorized in this part which
  222  involves the permittee is concluded, including any appeal,
  223  whichever occurs later. The department may adopt rules for
  224  issuing a prescription drug wholesale distributor-broker permit
  225  to a person who engages in the wholesale distribution of
  226  prescription drugs and does not take physical possession of any
  227  prescription drugs.
  228         (e) Out-of-state prescription drug wholesale distributor
  229  permit.—An out-of-state prescription drug wholesale distributor
  230  is a wholesale distributor located outside this state which
  231  engages in the wholesale distribution of prescription drugs into
  232  this state and which must be permitted by the department and
  233  comply with all the provisions required of a wholesale
  234  distributor under this part. An out-of-state prescription drug
  235  wholesale distributor that applies to the department for a new
  236  permit or the renewal of a permit must submit a bond of
  237  $100,000, or other equivalent means of security acceptable to
  238  the department, such as an irrevocable letter of credit or a
  239  deposit in a trust account or financial institution, payable to
  240  the Professional Regulation Florida Drug, Device, and Cosmetic
  241  Trust Fund. The purpose of the bond is to secure payment of any
  242  administrative penalties imposed by the department and any fees
  243  and costs incurred by the department regarding that permit which
  244  are authorized under state law and which the permittee fails to
  245  pay 30 days after the fine or costs become final. The department
  246  may make a claim against such bond or security until 1 year
  247  after the permittee’s license ceases to be valid or until 60
  248  days after any administrative or legal proceeding authorized in
  249  this part which involves the permittee is concluded, including
  250  any appeal, whichever occurs later.
  251         1. The out-of-state prescription drug wholesale distributor
  252  must maintain at all times a license or permit to engage in the
  253  wholesale distribution of prescription drugs in compliance with
  254  laws of the state in which it is a resident.
  255         2. An out-of-state prescription drug wholesale distributor
  256  permit is not required for an intracompany sale or transfer of a
  257  prescription drug from an out-of-state establishment that is
  258  duly licensed as a prescription drug wholesale distributor, in
  259  its state of residence, to a licensed prescription drug
  260  wholesale distributor in this state, if both wholesale
  261  distributors conduct wholesale distributions of prescription
  262  drugs under the same business name. The recordkeeping
  263  requirements of ss. 499.0121(6) and 499.01212 must be followed
  264  for this transaction.
  265         (l) Limited prescription drug veterinary wholesale
  266  distributor permit.—Unless engaging in the activities of and
  267  permitted as a prescription drug manufacturer, nonresident
  268  prescription drug manufacturer, prescription drug wholesale
  269  distributor, or out-of-state prescription drug wholesale
  270  distributor, a limited prescription drug veterinary wholesale
  271  distributor permit is required for any person that engages in
  272  the distribution in or into this state of veterinary
  273  prescription drugs and prescription drugs subject to, defined
  274  by, or described by s. 503(b) of the Federal Food, Drug, and
  275  Cosmetic Act under the following conditions:
  276         1. The person is engaged in the business of wholesaling
  277  prescription and veterinary prescription drugs to persons:
  278         a. Licensed as veterinarians practicing on a full-time
  279  basis;
  280         b. Regularly and lawfully engaged in instruction in
  281  veterinary medicine;
  282         c. Regularly and lawfully engaged in law enforcement
  283  activities;
  284         d. For use in research not involving clinical use; or
  285         e. For use in chemical analysis or physical testing or for
  286  purposes of instruction in law enforcement activities, research,
  287  or testing.
  288         2. No more than 30 percent of total annual prescription
  289  drug sales may be prescription drugs approved for human use
  290  which are subject to, defined by, or described by s. 503(b) of
  291  the Federal Food, Drug, and Cosmetic Act.
  292         3. The person does not distribute in any jurisdiction
  293  prescription drugs subject to, defined by, or described by s.
  294  503(b) of the Federal Food, Drug, and Cosmetic Act to any person
  295  who is authorized to sell, distribute, purchase, trade, or use
  296  these drugs on or for humans.
  297         4. A limited prescription drug veterinary wholesale
  298  distributor that applies to the department for a new permit or
  299  the renewal of a permit must submit a bond of $20,000, or other
  300  equivalent means of security acceptable to the department, such
  301  as an irrevocable letter of credit or a deposit in a trust
  302  account or financial institution, payable to the Professional
  303  Regulation Florida Drug, Device, and Cosmetic Trust Fund. The
  304  purpose of the bond is to secure payment of any administrative
  305  penalties imposed by the department and any fees and costs
  306  incurred by the department regarding that permit which are
  307  authorized under state law and which the permittee fails to pay
  308  30 days after the fine or costs become final. The department may
  309  make a claim against such bond or security until 1 year after
  310  the permittee’s license ceases to be valid or until 60 days
  311  after any administrative or legal proceeding authorized in this
  312  part which involves the permittee is concluded, including any
  313  appeal, whichever occurs later.
  314         5. A limited prescription drug veterinary wholesale
  315  distributor must maintain at all times a license or permit to
  316  engage in the wholesale distribution of prescription drugs in
  317  compliance with laws of the state in which it is a resident.
  318         6. A limited prescription drug veterinary wholesale
  319  distributor must comply with the requirements for wholesale
  320  distributors under ss. 499.0121 and 499.01212, except that a
  321  limited prescription drug veterinary wholesale distributor is
  322  not required to provide a pedigree paper as required by s.
  323  499.01212 upon the wholesale distribution of a prescription drug
  324  to a veterinarian.
  325         7. A limited prescription drug veterinary wholesale
  326  distributor may not return to inventory for subsequent wholesale
  327  distribution any prescription drug subject to, defined by, or
  328  described by s. 503(b) of the Federal Food, Drug, and Cosmetic
  329  Act which has been returned by a veterinarian.
  330         8. A limited prescription drug veterinary wholesale
  331  distributor permit is not required for an intracompany sale or
  332  transfer of a prescription drug from an out-of-state
  333  establishment that is duly licensed to engage in the wholesale
  334  distribution of prescription drugs in its state of residence to
  335  a licensed limited prescription drug veterinary wholesale
  336  distributor in this state if both wholesale distributors conduct
  337  wholesale distributions of prescription drugs under the same
  338  business name. The recordkeeping requirements of ss. 499.0121(6)
  339  and 499.01212 must be followed for this transaction.
  340         Section 12. Subsection (13) of section 499.028, Florida
  341  Statutes, is amended to read:
  342         499.028 Drug samples or complimentary drugs; starter packs;
  343  permits to distribute.—
  344         (13) The department may, pursuant to chapter 120, impose an
  345  administrative fine, not to exceed $5,000 per violation per day,
  346  for the violation of this section or rules adopted under this
  347  section. Each day such violation continues constitutes a
  348  separate violation, and each such separate violation is subject
  349  to a separate fine. All amounts collected under this section
  350  shall be deposited into the Professional Regulation Drug,
  351  Device, and Cosmetic Trust Fund. In determining the amount of
  352  fine to be levied for a violation, the following factors must be
  353  considered:
  354         (a) The severity of the violation.
  355         (b) Any actions taken by the permittee to correct the
  356  violation or to remedy complaints.
  357         (c) Any previous violations.
  358         Section 13. Section 499.04, Florida Statutes, is amended to
  359  read:
  360         499.04 Fee authority.—The department may collect fees for
  361  all drug, device, and cosmetic applications, permits, product
  362  registrations, and free-sale certificates. The total amount of
  363  fees collected from all permits, applications, product
  364  registrations, and free-sale certificates must be adequate to
  365  fund the expenses incurred by the department in carrying out
  366  this part. The department shall, by rule, establish a schedule
  367  of fees that are within the ranges provided in this section and
  368  shall adjust those fees from time to time based on the costs
  369  associated with administering this part. The fees are payable to
  370  the department to be deposited into the Professional Regulation
  371  Florida Drug, Device, and Cosmetic Trust Fund for the sole
  372  purpose of carrying out the provisions of this part.
  373         Section 14. Section 499.057, Florida Statutes, is amended
  374  to read:
  375         499.057 Expenses and salaries.—Except as otherwise provided
  376  in the General Appropriations Act, all expenses and salaries
  377  shall be paid out of the Professional Regulation Trust Fund.
  378  special fund hereby created in the office of the Chief Financial
  379  Officer, which fund is to be known as the “Florida Drug, Device,
  380  and Cosmetic Trust Fund.”
  381         Section 15. Paragraph (a) of subsection (2) of section
  382  499.062, Florida Statutes, is amended to read:
  383         499.062 Seizure and condemnation of drugs, devices, or
  384  cosmetics.—
  385         (2) Whenever a duly authorized officer or employee of the
  386  department finds cause, or has probable cause to believe that
  387  cause exists, for the seizure of any drug, device, or cosmetic,
  388  as set out in this part, he or she shall affix to the article a
  389  tag, stamp, or other appropriate marking, giving notice that the
  390  article is, or is suspected of being, subject to seizure under
  391  this part and that the article has been detained and seized by
  392  the department. Such officer or employee shall also warn all
  393  persons not to remove or dispose of the article, by sale or
  394  otherwise, until permission is given by the department or the
  395  court. Any person who violates this subsection is guilty of a
  396  felony of the second degree, punishable as provided in s.
  397  775.082, s. 775.083, or s. 775.084.
  398         (a) When any article detained or seized under this
  399  subsection has been found by the department to be subject to
  400  seizure and condemnation, the department shall petition the
  401  court for an order of condemnation or sale, as the court
  402  directs. The proceeds of the sale of drugs, devices, and
  403  cosmetics, less the legal costs and charges, shall be deposited
  404  into the Professional Regulation Florida Drug, Device, and
  405  Cosmetic Trust Fund.
  406         Section 16. Subsections (3) and (4) of section 499.066,
  407  Florida Statutes, are amended to read:
  408         499.066 Penalties; remedies.—In addition to other penalties
  409  and other enforcement provisions:
  410         (3) The department may impose an administrative fine, not
  411  to exceed $5,000 per violation per day, for the violation of any
  412  provision of this part or rules adopted under this part. Each
  413  day a violation continues constitutes a separate violation, and
  414  each separate violation is subject to a separate fine. All
  415  amounts collected pursuant to this section shall be deposited
  416  into the Professional Regulation Florida Drug, Device, and
  417  Cosmetic Trust Fund and are appropriated for the use of the
  418  department in administering this part. In determining the amount
  419  of the fine to be levied for a violation, the department shall
  420  consider:
  421         (a) The severity of the violation;
  422         (b) Any actions taken by the person to correct the
  423  violation or to remedy complaints; and
  424         (c) Any previous violations.
  425         (4) The department shall deposit any rewards, fines, or
  426  collections that are due the department and which derive from
  427  joint enforcement activities with other state and federal
  428  agencies which relate to this part, chapter 893, or the federal
  429  act, into the Professional Regulation Florida Drug, Device, and
  430  Cosmetic Trust Fund. The proceeds of those rewards, fines, and
  431  collections are appropriated for the use of the department in
  432  administering this part.
  433         Section 17. Subsection (7) of section 499.62, Florida
  434  Statutes, is amended to read:
  435         499.62 License or permit required of manufacturer,
  436  distributor, dealer, or purchaser of ether.—
  437         (7) A licensed or permitted facility shall renew its
  438  license or permit prior to its expiration date. If a renewal
  439  application and fee are not filed by the expiration date of any
  440  year, the permit may be reinstated only upon payment of a
  441  delinquent fee of $50, plus the required renewal fee, within 30
  442  days after the date of expiration. If any person who is subject
  443  to the requirements of this part fails to comply with the
  444  renewal, the department shall have the authority to seize all
  445  ether products and dispose of them as of November 1 of the year
  446  the license or permit expires. Any funds collected from the
  447  disposal shall be placed in the Professional Regulation Florida
  448  Drug, Device, and Cosmetic Trust Fund.
  449         Section 18. Subsection (2) of section 499.72, Florida
  450  Statutes, is amended to read:
  451         499.72 Administrative fines.—
  452         (2) All such fines, monetary penalties, and costs received
  453  by the department in connection with this part shall be
  454  deposited in the Professional Regulation Florida Drug, Device,
  455  and Cosmetic Trust Fund.
  456         Section 19. Section 499.79, Florida Statutes, is amended to
  457  read:
  458         499.79 Deposit of fees.—All fees collected for licenses and
  459  permits required by this part shall be deposited in the
  460  Professional Regulation Florida Drug, Device, and Cosmetic Trust
  461  Fund created by s. 499.057, and all moneys collected under the
  462  provisions of this part and deposited in the such trust fund
  463  shall be used by are hereby appropriated for the use of the
  464  department in the administration of this part.
  465         Section 20. (1)(a)The Department of Business and
  466  Professional Regulation shall maintain a separate account in the
  467  Professional Regulation Trust Fund for the Drugs, Devices, and
  468  Cosmetics Program.
  469         (b) The Drugs, Devices, and Cosmetics Program protects the
  470  public health, safety, and welfare by preventing fraud,
  471  adulteration, misbranding, and false advertising in the
  472  manufacture, repackaging, or distribution of drugs, devices, and
  473  cosmetics. The program promotes consistency between state and
  474  federal laws governing drugs, devices, and cosmetics by
  475  licensing manufacturers, repackagers, distributors, and certain
  476  retailers as required by federal law, and regulating persons and
  477  entities engaged in related activities, including, but not
  478  limited to, licensees, practitioners, pharmacies, clinics, and
  479  hospitals.
  480         (2) By January 15, 2013, the Department of Business and
  481  Professional Regulation shall submit a report to the chairs of
  482  the Senate Budget Subcommittee on General Government
  483  Appropriations, the Senate Committee on Regulated Industries,
  484  the House Government Operations Appropriations Subcommittee, and
  485  the House of Representatives Subcommittee on Business and
  486  Consumer Affairs regarding the operation of the Drugs, Devices,
  487  and Cosmetics Program. The report must provide detailed options
  488  and recommendations to the Legislature relating to:
  489         (a) Eliminating the program’s operating deficit through
  490  operational changes or improved efficiencies;
  491         (b)The cost-efficient alignment of the licensure renewal
  492  process under the program with other professions; and
  493         (c)Regulating the program under chapter 455, Florida
  494  Statutes.
  495         (d) This subsection expires July 1, 2013.
  496         Section 21. Except as otherwise expressly provided in this
  497  act, this act shall take effect July 1, 2012.
  498  
  499  ================= T I T L E  A M E N D M E N T ================
  500         And the title is amended as follows:
  501         Delete everything before the enacting clause
  502  and insert:
  503                        A bill to be entitled                      
  504         An act relating to the Department of Business and
  505         Professional Regulation; amending s. 20.165, F.S.;
  506         creating the Division of Drugs, Devices, and Cosmetics
  507         within the Department of Business and Professional
  508         Regulation; amending s. 455.116, F.S.; deleting the
  509         Florida Drug, Device, and Cosmetic Trust Fund from the
  510         list of trust funds placed in the department, to
  511         conform; amending ss. 499.003, 499.01211, 499.024,
  512         499.065, 499.601, and 499.61, F.S.; conforming
  513         provisions to the transfer by s. 27, chapter 2010-161,
  514         Laws of Florida, of regulatory authority for ch. 499,
  515         F.S., from the Department of Health to the Department
  516         of Business and Professional Regulation; repealing s.
  517         499.0031, F.S., relating to the Florida Drug, Device,
  518         and Cosmetic Trust Fund; terminating the Florida Drug,
  519         Device, and Cosmetic Trust Fund; providing for the
  520         disposition of balances in and revenues of such trust
  521         fund; prescribing procedures for the termination of
  522         such trust fund; amending ss. 499.01, 499.028, 499.04,
  523         499.057, 499.062, 499.066, 499.62, 499.72, and 499.79,
  524         F.S.; conforming provisions; requiring the Department
  525         of Business and Professional Regulation to submit a
  526         report to the Legislature by a specified date;
  527         providing for future expiration; providing effective
  528         dates.