Florida Senate - 2012                                    SB 1980
       
       
       
       By the Committee on Budget
       
       
       
       
       576-03460-12                                          20121980__
    1                        A bill to be entitled                      
    2         An act relating to the Department of Business and
    3         Professional Regulation; amending s. 20.165, F.S.;
    4         creating the Division of Drugs, Devices, and Cosmetics
    5         within the Department of Business and Professional
    6         Regulation; amending s. 455.116, F.S.; deleting the
    7         Florida Drug, Device, and Cosmetic Trust Fund from the
    8         list of trust funds placed in the department, to
    9         conform; amending ss. 499.003, 499.01211, 499.024,
   10         499.065, 499.601, and 499.61, F.S.; conforming
   11         provisions to the transfer by s. 27, chapter 2010-161,
   12         Laws of Florida, of regulatory authority for ch. 499,
   13         F.S., from the Department of Health to the Department
   14         of Business and Professional Regulation; repealing s.
   15         499.0031, F.S., relating to the Florida Drug, Device,
   16         and Cosmetic Trust Fund; terminating the Florida Drug,
   17         Device, and Cosmetic Trust Fund; providing for the
   18         disposition of balances in and revenues of such trust
   19         fund; prescribing procedures for the termination of
   20         such trust fund; amending ss. 499.01, 499.028, 499.04,
   21         499.057, 499.062, 499.066, 499.62, 499.72, and 499.79,
   22         F.S.; conforming provisions; requiring the Department
   23         of Business and Professional Regulation to submit a
   24         report to the Legislature by a specified date;
   25         providing for future expiration; providing effective
   26         dates.
   27  
   28  Be It Enacted by the Legislature of the State of Florida:
   29  
   30         Section 1. Paragraphs (d) through (k) of subsection (2) of
   31  section 20.165, Florida Statutes, are redesignated as paragraphs
   32  (e) through (l), respectively, and a new paragraph (d) is added
   33  to that subsection to read:
   34         20.165 Department of Business and Professional Regulation.
   35  There is created a Department of Business and Professional
   36  Regulation.
   37         (2) The following divisions of the Department of Business
   38  and Professional Regulation are established:
   39         (d) Division of Drugs, Devices, and Cosmetics.
   40         Section 2. Effective November 1, 2012, subsection (8) of
   41  section 455.116, Florida Statutes, is amended to read:
   42         455.116 Regulation trust funds.—The following trust funds
   43  shall be placed in the department:
   44         (8) Florida Drug, Device, and Cosmetic Trust Fund.
   45         Section 3. Subsection (15) and paragraph (a) of subsection
   46  (54) of section 499.003, Florida Statutes, are amended to read:
   47         499.003 Definitions of terms used in this part.—As used in
   48  this part, the term:
   49         (15) “Department” means the Department of Business and
   50  Professional Regulation Health.
   51         (54) “Wholesale distribution” means distribution of
   52  prescription drugs to persons other than a consumer or patient,
   53  but does not include:
   54         (a) Any of the following activities, which is not a
   55  violation of s. 499.005(21) if such activity is conducted in
   56  accordance with s. 499.01(2)(g):
   57         1. The purchase or other acquisition by a hospital or other
   58  health care entity that is a member of a group purchasing
   59  organization of a prescription drug for its own use from the
   60  group purchasing organization or from other hospitals or health
   61  care entities that are members of that organization.
   62         2. The sale, purchase, or trade of a prescription drug or
   63  an offer to sell, purchase, or trade a prescription drug by a
   64  charitable organization described in s. 501(c)(3) of the
   65  Internal Revenue Code of 1986, as amended and revised, to a
   66  nonprofit affiliate of the organization to the extent otherwise
   67  permitted by law.
   68         3. The sale, purchase, or trade of a prescription drug or
   69  an offer to sell, purchase, or trade a prescription drug among
   70  hospitals or other health care entities that are under common
   71  control. For purposes of this subparagraph, “common control”
   72  means the power to direct or cause the direction of the
   73  management and policies of a person or an organization, whether
   74  by ownership of stock, by voting rights, by contract, or
   75  otherwise.
   76         4. The sale, purchase, trade, or other transfer of a
   77  prescription drug from or for any federal, state, or local
   78  government agency or any entity eligible to purchase
   79  prescription drugs at public health services prices pursuant to
   80  Pub. L. No. 102-585, s. 602 to a contract provider or its
   81  subcontractor for eligible patients of the agency or entity
   82  under the following conditions:
   83         a. The agency or entity must obtain written authorization
   84  for the sale, purchase, trade, or other transfer of a
   85  prescription drug under this subparagraph from the Secretary of
   86  Business and Professional Regulation State Surgeon General or
   87  his or her designee.
   88         b. The contract provider or subcontractor must be
   89  authorized by law to administer or dispense prescription drugs.
   90         c. In the case of a subcontractor, the agency or entity
   91  must be a party to and execute the subcontract.
   92         d. A contract provider or subcontractor must maintain
   93  separate and apart from other prescription drug inventory any
   94  prescription drugs of the agency or entity in its possession.
   95         e. The contract provider and subcontractor must maintain
   96  and produce immediately for inspection all records of movement
   97  or transfer of all the prescription drugs belonging to the
   98  agency or entity, including, but not limited to, the records of
   99  receipt and disposition of prescription drugs. Each contractor
  100  and subcontractor dispensing or administering these drugs must
  101  maintain and produce records documenting the dispensing or
  102  administration. Records that are required to be maintained
  103  include, but are not limited to, a perpetual inventory itemizing
  104  drugs received and drugs dispensed by prescription number or
  105  administered by patient identifier, which must be submitted to
  106  the agency or entity quarterly.
  107         f. The contract provider or subcontractor may administer or
  108  dispense the prescription drugs only to the eligible patients of
  109  the agency or entity or must return the prescription drugs for
  110  or to the agency or entity. The contract provider or
  111  subcontractor must require proof from each person seeking to
  112  fill a prescription or obtain treatment that the person is an
  113  eligible patient of the agency or entity and must, at a minimum,
  114  maintain a copy of this proof as part of the records of the
  115  contractor or subcontractor required under sub-subparagraph e.
  116         g. In addition to the departmental inspection authority set
  117  forth in s. 499.051, the establishment of the contract provider
  118  and subcontractor and all records pertaining to prescription
  119  drugs subject to this subparagraph shall be subject to
  120  inspection by the agency or entity. All records relating to
  121  prescription drugs of a manufacturer under this subparagraph
  122  shall be subject to audit by the manufacturer of those drugs,
  123  without identifying individual patient information.
  124         Section 4. Subsection (2) of section 499.01211, Florida
  125  Statutes, is amended to read:
  126         499.01211 Drug Wholesale Distributor Advisory Council.—
  127         (2) The Secretary of Business and Professional Regulation
  128  State Surgeon General, or his or her designee, and the Secretary
  129  of Health Care Administration, or her or his designee, shall be
  130  members of the council. The Secretary of Business and
  131  Professional Regulation State Surgeon General shall appoint nine
  132  additional members to the council who shall be appointed to a
  133  term of 4 years each, as follows:
  134         (a) Three different persons each of whom is employed by a
  135  different prescription drug wholesale distributor licensed under
  136  this part which operates nationally and is a primary wholesale
  137  distributor, as defined in s. 499.003(47).
  138         (b) One person employed by a prescription drug wholesale
  139  distributor licensed under this part which is a secondary
  140  wholesale distributor, as defined in s. 499.003(52).
  141         (c) One person employed by a retail pharmacy chain located
  142  in this state.
  143         (d) One person who is a member of the Board of Pharmacy and
  144  is a pharmacist licensed under chapter 465.
  145         (e) One person who is a physician licensed pursuant to
  146  chapter 458 or chapter 459.
  147         (f) One person who is an employee of a hospital licensed
  148  pursuant to chapter 395 and is a pharmacist licensed pursuant to
  149  chapter 465.
  150         (g) One person who is an employee of a pharmaceutical
  151  manufacturer.
  152         Section 5. Section 499.024, Florida Statutes, is amended to
  153  read:
  154         499.024 Drug product classification.—The department State
  155  Surgeon General shall adopt rules to classify drug products
  156  intended for use by humans which the United States Food and Drug
  157  Administration has not classified in the federal act or the Code
  158  of Federal Regulations.
  159         (1) Drug products must be classified as proprietary,
  160  prescription, or investigational drugs.
  161         (2) If a product is distributed without required labeling,
  162  it is misbranded while held for sale.
  163         (3) Any product that falls under the definition of drug in
  164  s. 499.003(19) may be classified under the authority of this
  165  section. This section does not subject portable emergency oxygen
  166  inhalators to classification; however, this section does not
  167  exempt any person from ss. 499.01 and 499.015.
  168         (4) Any product classified under the authority of this
  169  section reverts to the federal classification, if different,
  170  upon the federal regulation or act becoming effective.
  171         (5) The department may by rule reclassify drugs subject to
  172  this part when such classification action is necessary to
  173  protect the public health.
  174         (6) The department may adopt rules that exempt from any
  175  labeling or packaging requirements of this part drugs classified
  176  under this section if those requirements are not necessary to
  177  protect the public health.
  178         Section 6. Subsection (2) of section 499.065, Florida
  179  Statutes, is amended to read:
  180         499.065 Inspections; imminent danger.—
  181         (2) To protect the public from prescription drugs that are
  182  adulterated or otherwise unfit for human or animal consumption,
  183  the department may examine, sample, seize, and stop the sale or
  184  use of prescription drugs to determine the condition of those
  185  drugs. The department may immediately seize and remove any
  186  prescription drugs if the Secretary of Business and Professional
  187  Regulation State Surgeon General or his or her designee
  188  determines that the prescription drugs represent a threat to the
  189  public health. The owner of any property seized under this
  190  section may, within 10 days after the seizure, apply to a court
  191  of competent jurisdiction for whatever relief is appropriate. At
  192  any time after 10 days, the department may destroy the drugs as
  193  contraband.
  194         Section 7. Subsection (2) of section 499.601, Florida
  195  Statutes, is amended to read:
  196         499.601 Legislative intent; construction.—
  197         (2) The provisions of this part are cumulative and shall
  198  not be construed as repealing or affecting any powers, duties,
  199  or authority of the department of Health under any other law of
  200  this state; except that, with respect to the regulation of ether
  201  as herein provided, in instances in which the provisions of this
  202  part may conflict with any other such law, the provisions of
  203  this part shall control.
  204         Section 8. Subsection (2) of section 499.61, Florida
  205  Statutes, is amended to read:
  206         499.61 Definitions.—As used in this part:
  207         (2) “Department” means the Department of Business and
  208  Professional Regulation Health.
  209         Section 9. Effective November 1, 2012, section 499.0031,
  210  Florida Statutes, is repealed.
  211         Section 10. (1) The Florida Drug, Device, and Cosmetic
  212  Trust Fund within the Department of Business and Professional
  213  Regulation, FLAIR number 20-2-173005, is terminated.
  214         (2) The current balance remaining in, and all revenues of,
  215  the Florida Drug, Device, and Cosmetic Trust Fund shall be
  216  transferred to the Professional Regulation Trust Fund.
  217         (3) The Department of Business and Professional Regulation
  218  shall pay any outstanding debts or obligations of the Florida
  219  Drug, Device, and Cosmetic Trust Fund as soon as practicable,
  220  and the Chief Financial Officer shall close out and remove the
  221  terminated fund from the various state accounting systems using
  222  generally accepted accounting principles concerning warrants
  223  outstanding, assets, and liabilities.
  224         (4) This section shall take effect November 1, 2012.
  225         Section 11. Paragraphs (d), (e), and (l) of subsection (2)
  226  of section 499.01, Florida Statutes, are amended to read:
  227         499.01 Permits.—
  228         (2) The following permits are established:
  229         (d) Prescription drug wholesale distributor permit.—A
  230  prescription drug wholesale distributor is a wholesale
  231  distributor that may engage in the wholesale distribution of
  232  prescription drugs. A prescription drug wholesale distributor
  233  that applies to the department for a new permit or the renewal
  234  of a permit must submit a bond of $100,000, or other equivalent
  235  means of security acceptable to the department, such as an
  236  irrevocable letter of credit or a deposit in a trust account or
  237  financial institution, payable to the Professional Regulation
  238  Florida Drug, Device, and Cosmetic Trust Fund. The purpose of
  239  the bond is to secure payment of any administrative penalties
  240  imposed by the department and any fees and costs incurred by the
  241  department regarding that permit which are authorized under
  242  state law and which the permittee fails to pay 30 days after the
  243  fine or costs become final. The department may make a claim
  244  against such bond or security until 1 year after the permittee’s
  245  license ceases to be valid or until 60 days after any
  246  administrative or legal proceeding authorized in this part which
  247  involves the permittee is concluded, including any appeal,
  248  whichever occurs later. The department may adopt rules for
  249  issuing a prescription drug wholesale distributor-broker permit
  250  to a person who engages in the wholesale distribution of
  251  prescription drugs and does not take physical possession of any
  252  prescription drugs.
  253         (e) Out-of-state prescription drug wholesale distributor
  254  permit.—An out-of-state prescription drug wholesale distributor
  255  is a wholesale distributor located outside this state which
  256  engages in the wholesale distribution of prescription drugs into
  257  this state and which must be permitted by the department and
  258  comply with all the provisions required of a wholesale
  259  distributor under this part. An out-of-state prescription drug
  260  wholesale distributor that applies to the department for a new
  261  permit or the renewal of a permit must submit a bond of
  262  $100,000, or other equivalent means of security acceptable to
  263  the department, such as an irrevocable letter of credit or a
  264  deposit in a trust account or financial institution, payable to
  265  the Professional Regulation Florida Drug, Device, and Cosmetic
  266  Trust Fund. The purpose of the bond is to secure payment of any
  267  administrative penalties imposed by the department and any fees
  268  and costs incurred by the department regarding that permit which
  269  are authorized under state law and which the permittee fails to
  270  pay 30 days after the fine or costs become final. The department
  271  may make a claim against such bond or security until 1 year
  272  after the permittee’s license ceases to be valid or until 60
  273  days after any administrative or legal proceeding authorized in
  274  this part which involves the permittee is concluded, including
  275  any appeal, whichever occurs later.
  276         1. The out-of-state prescription drug wholesale distributor
  277  must maintain at all times a license or permit to engage in the
  278  wholesale distribution of prescription drugs in compliance with
  279  laws of the state in which it is a resident.
  280         2. An out-of-state prescription drug wholesale distributor
  281  permit is not required for an intracompany sale or transfer of a
  282  prescription drug from an out-of-state establishment that is
  283  duly licensed as a prescription drug wholesale distributor, in
  284  its state of residence, to a licensed prescription drug
  285  wholesale distributor in this state, if both wholesale
  286  distributors conduct wholesale distributions of prescription
  287  drugs under the same business name. The recordkeeping
  288  requirements of ss. 499.0121(6) and 499.01212 must be followed
  289  for this transaction.
  290         (l) Limited prescription drug veterinary wholesale
  291  distributor permit.—Unless engaging in the activities of and
  292  permitted as a prescription drug manufacturer, nonresident
  293  prescription drug manufacturer, prescription drug wholesale
  294  distributor, or out-of-state prescription drug wholesale
  295  distributor, a limited prescription drug veterinary wholesale
  296  distributor permit is required for any person that engages in
  297  the distribution in or into this state of veterinary
  298  prescription drugs and prescription drugs subject to, defined
  299  by, or described by s. 503(b) of the Federal Food, Drug, and
  300  Cosmetic Act under the following conditions:
  301         1. The person is engaged in the business of wholesaling
  302  prescription and veterinary prescription drugs to persons:
  303         a. Licensed as veterinarians practicing on a full-time
  304  basis;
  305         b. Regularly and lawfully engaged in instruction in
  306  veterinary medicine;
  307         c. Regularly and lawfully engaged in law enforcement
  308  activities;
  309         d. For use in research not involving clinical use; or
  310         e. For use in chemical analysis or physical testing or for
  311  purposes of instruction in law enforcement activities, research,
  312  or testing.
  313         2. No more than 30 percent of total annual prescription
  314  drug sales may be prescription drugs approved for human use
  315  which are subject to, defined by, or described by s. 503(b) of
  316  the Federal Food, Drug, and Cosmetic Act.
  317         3. The person does not distribute in any jurisdiction
  318  prescription drugs subject to, defined by, or described by s.
  319  503(b) of the Federal Food, Drug, and Cosmetic Act to any person
  320  who is authorized to sell, distribute, purchase, trade, or use
  321  these drugs on or for humans.
  322         4. A limited prescription drug veterinary wholesale
  323  distributor that applies to the department for a new permit or
  324  the renewal of a permit must submit a bond of $20,000, or other
  325  equivalent means of security acceptable to the department, such
  326  as an irrevocable letter of credit or a deposit in a trust
  327  account or financial institution, payable to the Professional
  328  Regulation Florida Drug, Device, and Cosmetic Trust Fund. The
  329  purpose of the bond is to secure payment of any administrative
  330  penalties imposed by the department and any fees and costs
  331  incurred by the department regarding that permit which are
  332  authorized under state law and which the permittee fails to pay
  333  30 days after the fine or costs become final. The department may
  334  make a claim against such bond or security until 1 year after
  335  the permittee’s license ceases to be valid or until 60 days
  336  after any administrative or legal proceeding authorized in this
  337  part which involves the permittee is concluded, including any
  338  appeal, whichever occurs later.
  339         5. A limited prescription drug veterinary wholesale
  340  distributor must maintain at all times a license or permit to
  341  engage in the wholesale distribution of prescription drugs in
  342  compliance with laws of the state in which it is a resident.
  343         6. A limited prescription drug veterinary wholesale
  344  distributor must comply with the requirements for wholesale
  345  distributors under ss. 499.0121 and 499.01212, except that a
  346  limited prescription drug veterinary wholesale distributor is
  347  not required to provide a pedigree paper as required by s.
  348  499.01212 upon the wholesale distribution of a prescription drug
  349  to a veterinarian.
  350         7. A limited prescription drug veterinary wholesale
  351  distributor may not return to inventory for subsequent wholesale
  352  distribution any prescription drug subject to, defined by, or
  353  described by s. 503(b) of the Federal Food, Drug, and Cosmetic
  354  Act which has been returned by a veterinarian.
  355         8. A limited prescription drug veterinary wholesale
  356  distributor permit is not required for an intracompany sale or
  357  transfer of a prescription drug from an out-of-state
  358  establishment that is duly licensed to engage in the wholesale
  359  distribution of prescription drugs in its state of residence to
  360  a licensed limited prescription drug veterinary wholesale
  361  distributor in this state if both wholesale distributors conduct
  362  wholesale distributions of prescription drugs under the same
  363  business name. The recordkeeping requirements of ss. 499.0121(6)
  364  and 499.01212 must be followed for this transaction.
  365         Section 12. Subsection (13) of section 499.028, Florida
  366  Statutes, is amended to read:
  367         499.028 Drug samples or complimentary drugs; starter packs;
  368  permits to distribute.—
  369         (13) The department may, pursuant to chapter 120, impose an
  370  administrative fine, not to exceed $5,000 per violation per day,
  371  for the violation of this section or rules adopted under this
  372  section. Each day such violation continues constitutes a
  373  separate violation, and each such separate violation is subject
  374  to a separate fine. All amounts collected under this section
  375  shall be deposited into the Professional Regulation Drug,
  376  Device, and Cosmetic Trust Fund. In determining the amount of
  377  fine to be levied for a violation, the following factors must be
  378  considered:
  379         (a) The severity of the violation.
  380         (b) Any actions taken by the permittee to correct the
  381  violation or to remedy complaints.
  382         (c) Any previous violations.
  383         Section 13. Section 499.04, Florida Statutes, is amended to
  384  read:
  385         499.04 Fee authority.—The department may collect fees for
  386  all drug, device, and cosmetic applications, permits, product
  387  registrations, and free-sale certificates. The total amount of
  388  fees collected from all permits, applications, product
  389  registrations, and free-sale certificates must be adequate to
  390  fund the expenses incurred by the department in carrying out
  391  this part. The department shall, by rule, establish a schedule
  392  of fees that are within the ranges provided in this section and
  393  shall adjust those fees from time to time based on the costs
  394  associated with administering this part. The fees are payable to
  395  the department to be deposited into the Professional Regulation
  396  Florida Drug, Device, and Cosmetic Trust Fund for the sole
  397  purpose of carrying out the provisions of this part.
  398         Section 14. Section 499.057, Florida Statutes, is amended
  399  to read:
  400         499.057 Expenses and salaries.—Except as otherwise provided
  401  in the General Appropriations Act, all expenses and salaries
  402  shall be paid out of the Professional Regulation Trust Fund.
  403  special fund hereby created in the office of the Chief Financial
  404  Officer, which fund is to be known as the “Florida Drug, Device,
  405  and Cosmetic Trust Fund.”
  406         Section 15. Paragraph (a) of subsection (2) of section
  407  499.062, Florida Statutes, is amended to read:
  408         499.062 Seizure and condemnation of drugs, devices, or
  409  cosmetics.—
  410         (2) Whenever a duly authorized officer or employee of the
  411  department finds cause, or has probable cause to believe that
  412  cause exists, for the seizure of any drug, device, or cosmetic,
  413  as set out in this part, he or she shall affix to the article a
  414  tag, stamp, or other appropriate marking, giving notice that the
  415  article is, or is suspected of being, subject to seizure under
  416  this part and that the article has been detained and seized by
  417  the department. Such officer or employee shall also warn all
  418  persons not to remove or dispose of the article, by sale or
  419  otherwise, until permission is given by the department or the
  420  court. Any person who violates this subsection is guilty of a
  421  felony of the second degree, punishable as provided in s.
  422  775.082, s. 775.083, or s. 775.084.
  423         (a) When any article detained or seized under this
  424  subsection has been found by the department to be subject to
  425  seizure and condemnation, the department shall petition the
  426  court for an order of condemnation or sale, as the court
  427  directs. The proceeds of the sale of drugs, devices, and
  428  cosmetics, less the legal costs and charges, shall be deposited
  429  into the Professional Regulation Florida Drug, Device, and
  430  Cosmetic Trust Fund.
  431         Section 16. Subsections (3) and (4) of section 499.066,
  432  Florida Statutes, are amended to read:
  433         499.066 Penalties; remedies.—In addition to other penalties
  434  and other enforcement provisions:
  435         (3) The department may impose an administrative fine, not
  436  to exceed $5,000 per violation per day, for the violation of any
  437  provision of this part or rules adopted under this part. Each
  438  day a violation continues constitutes a separate violation, and
  439  each separate violation is subject to a separate fine. All
  440  amounts collected pursuant to this section shall be deposited
  441  into the Professional Regulation Florida Drug, Device, and
  442  Cosmetic Trust Fund and are appropriated for the use of the
  443  department in administering this part. In determining the amount
  444  of the fine to be levied for a violation, the department shall
  445  consider:
  446         (a) The severity of the violation;
  447         (b) Any actions taken by the person to correct the
  448  violation or to remedy complaints; and
  449         (c) Any previous violations.
  450         (4) The department shall deposit any rewards, fines, or
  451  collections that are due the department and which derive from
  452  joint enforcement activities with other state and federal
  453  agencies which relate to this part, chapter 893, or the federal
  454  act, into the Professional Regulation Florida Drug, Device, and
  455  Cosmetic Trust Fund. The proceeds of those rewards, fines, and
  456  collections are appropriated for the use of the department in
  457  administering this part.
  458         Section 17. Subsection (7) of section 499.62, Florida
  459  Statutes, is amended to read:
  460         499.62 License or permit required of manufacturer,
  461  distributor, dealer, or purchaser of ether.—
  462         (7) A licensed or permitted facility shall renew its
  463  license or permit prior to its expiration date. If a renewal
  464  application and fee are not filed by the expiration date of any
  465  year, the permit may be reinstated only upon payment of a
  466  delinquent fee of $50, plus the required renewal fee, within 30
  467  days after the date of expiration. If any person who is subject
  468  to the requirements of this part fails to comply with the
  469  renewal, the department shall have the authority to seize all
  470  ether products and dispose of them as of November 1 of the year
  471  the license or permit expires. Any funds collected from the
  472  disposal shall be placed in the Professional Regulation Florida
  473  Drug, Device, and Cosmetic Trust Fund.
  474         Section 18. Subsection (2) of section 499.72, Florida
  475  Statutes, is amended to read:
  476         499.72 Administrative fines.—
  477         (2) All such fines, monetary penalties, and costs received
  478  by the department in connection with this part shall be
  479  deposited in the Professional Regulation Florida Drug, Device,
  480  and Cosmetic Trust Fund.
  481         Section 19. Section 499.79, Florida Statutes, is amended to
  482  read:
  483         499.79 Deposit of fees.—All fees collected for licenses and
  484  permits required by this part shall be deposited in the
  485  Professional Regulation Florida Drug, Device, and Cosmetic Trust
  486  Fund created by s. 499.057, and all moneys collected under the
  487  provisions of this part and deposited in the such trust fund
  488  shall be used by are hereby appropriated for the use of the
  489  department in the administration of this part.
  490         Section 20. (1)(a)The Department of Business and
  491  Professional Regulation shall maintain a separate account in the
  492  Professional Regulation Trust Fund for the Drugs, Devices, and
  493  Cosmetics Program.
  494         (b) The Drugs, Devices, and Cosmetics Program protects the
  495  public health, safety, and welfare by preventing fraud,
  496  adulteration, misbranding, and false advertising in the
  497  manufacture, repackaging, or distribution of drugs, devices, and
  498  cosmetics. The program promotes consistency between state and
  499  federal laws governing drugs, devices, and cosmetics by
  500  licensing manufacturers, repackagers, distributors, and certain
  501  retailers as required by federal law, and regulating persons and
  502  entities engaged in related activities, including, but not
  503  limited to, licensees, practitioners, pharmacies, clinics, and
  504  hospitals.
  505         (2) By January 15, 2013, the Department of Business and
  506  Professional Regulation shall submit a report to the chairs of
  507  the Senate Budget Subcommittee on General Government
  508  Appropriations, the Senate Committee on Regulated Industries,
  509  the House Government Operations Appropriations Subcommittee, and
  510  the House of Representatives Subcommittee on Business and
  511  Consumer Affairs regarding the operation of the Drugs, Devices,
  512  and Cosmetics Program. The report must provide detailed options
  513  and recommendations to the Legislature relating to:
  514         (a) Eliminating the program’s operating deficit through
  515  operational changes or improved efficiencies;
  516         (b)The cost-efficient alignment of the licensure renewal
  517  process under the program with other professions; and
  518         (c)Regulating the program under chapter 455, Florida
  519  Statutes.
  520         (d) This subsection expires July 1, 2013.
  521         Section 21. Except as otherwise expressly provided in this
  522  act, this act shall take effect July 1, 2012.