Florida Senate - 2014                        COMMITTEE AMENDMENT
       Bill No. CS for SB 836
       
       
       
       
       
       
                                Ì7711841Î771184                         
       
                              LEGISLATIVE ACTION                        
                    Senate             .             House              
                  Comm: RCS            .                                
                  04/01/2014           .                                
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    1         Senate Amendment to Amendment (181392) 
    2  
    3         Delete lines 789 - 1402
    4  and insert:
    5  otherwise authorized under this chapter.
    6         (b) Medical gas manufacturer permit.—A medical gas
    7  manufacturer permit is required for a person or entity located
    8  in this state which engages in the manufacture of medical gases
    9  by physical air separation, chemical action, purification, or
   10  filling containers by a liquid-to-liquid, liquid-to-gas, or gas
   11  to-gas process and distributes those medical gases within this
   12  state.
   13         1. A permitted medical gas manufacturer may not manufacture
   14  or possess a prescription drug other than a medical gas, unless
   15  otherwise authorized under this chapter.
   16         2. A permitted medical gas manufacturer may not distribute
   17  a medical gas without obtaining the applicable permit, except
   18  that it may engage in wholesale distribution of medical gases
   19  that it manufactured without obtaining a medical gas wholesale
   20  distributor permit if it complies with this part and the rules
   21  adopted under this part that apply to a wholesale distributor.
   22         3. A permitted medical gas manufacturer shall comply with
   23  all of the requirements applicable to a wholesale distributor
   24  under this part and all appropriate state and federal good
   25  manufacturing practices.
   26         (c) Medical oxygen retail establishment permit.—A medical
   27  oxygen retail establishment permit is required for an entity
   28  that is located in the state and that dispenses medical oxygen
   29  directly to patients in this state. The sale and delivery must
   30  be based on a prescription or an order from a practitioner
   31  authorized by law to prescribe. A pharmacy licensed under
   32  chapter 465 does not require a permit as a medical oxygen retail
   33  establishment.
   34         1. A medical oxygen retail establishment may not possess,
   35  purchase, sell, or trade a medical gas other than medical
   36  oxygen, unless otherwise authorized under this chapter.
   37         2. A medical oxygen retail establishment may fill and
   38  deliver medical oxygen to an individual patient based on an
   39  order from a practitioner authorized by law to prescribe. The
   40  medical oxygen retail establishment must comply with all
   41  appropriate state and federal good manufacturing practices.
   42  Medical oxygen sold or delivered by a medical oxygen retail
   43  establishment pursuant to an order from a practitioner may not
   44  be returned into the retail establishment’s inventory.
   45         3. A medical oxygen retail establishment shall comply with
   46  all of the requirements applicable to a wholesale distributor
   47  under this part, except for those requirements that pertain
   48  solely to nitrous oxide.
   49         (3) An out-of-state wholesale distributor that engages in
   50  wholesale distribution into this state must be legally
   51  authorized to engage in the wholesale distribution of medical
   52  gases as a wholesale distributor in the state in which it
   53  resides or is incorporated and provide proof of registration as
   54  set forth in s. 499.93(3), if required.
   55         (4) A wholesale distributor may not operate from a place of
   56  residence, and a place of residence may not be granted a permit
   57  or operate under this part, except for the on-call delivery of
   58  home care oxygen for wholesale distributors that also maintain a
   59  medical oxygen retail establishment permit.
   60         (5) If wholesale distribution is conducted at more than one
   61  location within this state or more than one location
   62  distributing into this state, each location must be permitted by
   63  the department.
   64         Section 16. Section 499.831, Florida Statutes, is created
   65  to read:
   66         499.831Permit application.—
   67         (1) The department shall adopt rules to establish the form
   68  and content of the application to obtain a permit and to renew a
   69  permit listed under this part.
   70         (2) An applicant must be at least 18 years of age or be
   71  managed, controlled, or overseen, directly or indirectly, by a
   72  natural person who is at least 18 years of age.
   73         (3) An application for a permit must be filed with the
   74  department and must include all of the following information:
   75         (a) The trade or business name of the applicant, including
   76  a fictitious name, which may not be identical to a name used by
   77  an unrelated entity permitted in this state to dispense or
   78  distribute medical gas.
   79         (b) The name or names of the owner and operator of the
   80  applicant, if not the same person or entity. The application
   81  must also include:
   82         1. If the applicant is an individual, the applicant’s name,
   83  business address, and date of birth.
   84         2. If the applicant is a sole proprietorship, the business
   85  address of the sole proprietor and the name and federal employer
   86  identification number of the business entity.
   87         3. If the applicant is a partnership, the name, business
   88  address, date of birth of each partner, the name of the
   89  partnership, and the partnership’s federal employer
   90  identification number.
   91         4. If the applicant is a limited liability company, the
   92  name, business address, and title of each company officer, the
   93  name of the limited liability company and federal employer
   94  identification number, and the name of the state in which the
   95  limited liability company was organized.
   96         5. If the applicant is a corporation, the name, business
   97  address, and title of each corporate officer and director, the
   98  corporate names, the state of incorporation, the federal
   99  employer identification number, and, if applicable, the name and
  100  business address of the parent company.
  101         (c) A list of disciplinary actions pertinent to wholesale
  102  distributors, manufacturers, and retailers of prescription drugs
  103  or controlled substances by a state or federal agency against
  104  the applicant seeking to distribute into this state and any such
  105  disciplinary actions against such applicant’s principals,
  106  owners, directors, or officers.
  107         (d) A complete disclosure of all of the applicant’s past
  108  felony convictions.
  109         (e) An address and description of each facility and
  110  warehouse, including all locations used for medical gas storage
  111  or wholesale distribution including a description of each
  112  facility’s security system.
  113         (4) An applicant shall attest in writing that the
  114  information contained in its application is complete and
  115  accurate.
  116         (5) An applicant must submit a reasonable fee, to be
  117  determined by the department, in order to obtain a permit.
  118         (a) The fee for a medical gas wholesale distributor permit
  119  may not be less than $200 or more than $300 annually.
  120         (b) The fee for a medical gas manufacturer permit may not
  121  be less than $400 or more than $500 annually.
  122         (c) The fee for a medical oxygen retail establishment
  123  permit may not be less than $200 or more than $300 annually.
  124         (6) Upon approval of the application by the department and
  125  payment of the required fee, the department shall issue a permit
  126  to the applicant pursuant to the rules adopted under this part.
  127         Section 17. Section 499.832, Florida Statutes, is created
  128  to read:
  129         499.832 Expiration and renewal of a permit.—
  130         (1) A permit issued under this part automatically expires 2
  131  years after the last day of the month in which the permit was
  132  originally issued.
  133         (2) A permit issued under this part may be renewed by
  134  submitting an application for renewal on a form furnished by the
  135  department and paying the appropriate fee. The application for
  136  renewal must contain a statement by the applicant attesting that
  137  the information is true and correct. Upon approval of a renewal
  138  application by the department and payment of the required
  139  renewal fee, the department shall renew a permit issued under
  140  this part pursuant to the rules adopted under this part.
  141         (3) A renewal application may be accepted up to 60 days
  142  after the expiration date of the permit if, along with the
  143  permit renewal fee, the applicant submits an additional renewal
  144  delinquent fee of $100. A permit that expired more than 60 days
  145  before a renewal application was submitted or postmarked may not
  146  be renewed.
  147         (4) Failure to renew a permit in accordance with this
  148  section precludes future renewal. If a permit has expired and
  149  cannot be renewed, the person, entity, or establishment holding
  150  the permit must cease all permit related activities. In order to
  151  engage in activities that require a permit the person, entity,
  152  or establishment must submit an application for a new permit,
  153  pay the applicable application fee, the initial permit fee, and
  154  all applicable penalties, and be issued a new permit by the
  155  department before engaging in an activity that requires a permit
  156  under this part.
  157         (5) The department shall adopt rules to administer this
  158  section, including setting a reasonable fee for a renewal
  159  application.
  160         Section 18. Section 499.833, Florida Statutes, is created
  161  to read:
  162         499.833Permitholder changes.—
  163         (1) A permit issued under this part is valid only for the
  164  person or entity to which it is issued and is not subject to
  165  sale, assignment, or other transfer, voluntarily or
  166  involuntarily.
  167         (2) A permit issued under this part is not valid for an
  168  establishment other than the establishment for which it was
  169  originally issued.
  170         (3) The department may approve the following permit
  171  changes:
  172         (a)Change of location.A person or entity permitted under
  173  this part must notify and receive approval from the department
  174  before changing location. The department shall set a change-of
  175  location fee not to exceed $100.
  176         (b)Change in ownership.—If a majority of the ownership or
  177  controlling interest of a permitted establishment is transferred
  178  or assigned or if a lessee agrees to undertake or provide
  179  services such that legal liability for operation of the
  180  establishment will rest with the lessee, an application for a
  181  new permit is required. Such application must be submitted and
  182  approved by the department before the change of ownership takes
  183  place. However, if a permitted wholesale distributor or
  184  manufacturer is changing ownership and the new owner has held
  185  another permit that allows the wholesale distribution of medical
  186  gas under this chapter for the preceding 18 months without
  187  having been found in violation of the provisions of this chapter
  188  relating to medical gases, then the new owner may operate under
  189  the permit of the acquired entity if the new owner submits the
  190  application for a new permit by the first business day after
  191  ownership is transferred or assigned. A new owner operating
  192  under the original permit is responsible for compliance with all
  193  laws and regulations governing medical gas. If the application
  194  is denied, the new owner shall immediately cease operation at
  195  the establishment until a permit is issued to the new owner.
  196         (c)Change of name.—A permitholder may make a change of
  197  business name without submitting a new permit application.
  198  However, the permitholder must notify the department before
  199  making the name change.
  200         (d)Closure.—If an establishment permitted under this part
  201  closes, the owner must notify the department, in writing, before
  202  the effective date of the closure and must:
  203         1. Return the permit to the department; and
  204         2. Indicate the disposition of any medical gas authorized
  205  to be distributed or dispensed under the permit, including the
  206  name, address, and inventory, and provide the name and address
  207  of a person to contact regarding access to the records that are
  208  required to be maintained under this part. Transfer of ownership
  209  of medical gas may be made only to persons authorized to receive
  210  medical gas pursuant to this part.
  211         (e) Change in information.—Any change in the information
  212  required under this part, other than the changes in paragraphs
  213  (a)-(d), shall be submitted to the department within 30 days
  214  after such change occurs.
  215         (4) A permitholder in good standing may change the type of
  216  permit issued by completing a new application for the requested
  217  permit, meeting the applicable permitting requirements for the
  218  new permit type, and paying any difference between the permit
  219  fees. A refund may not be issued if the fee for the new permit
  220  is less than the fee that was paid for the original permit. The
  221  new permit retains the expiration date of the original permit.
  222         Section 19. Section 499.834, Florida Statutes, is created
  223  to read:
  224         499.834Minimum qualifications.—The department shall
  225  consider all of the following factors in determining eligibility
  226  for, and renewal of, a permit for a person or entity under this
  227  part:
  228         (1) A finding by the department that the applicant has
  229  violated or been disciplined by a regulatory agency in any state
  230  for violating a federal, state, or local law relating to
  231  prescription drugs.
  232         (2) Felony convictions of the applicant under a federal,
  233  state, or local law.
  234         (3) The applicant’s past experience in the manufacture,
  235  retail, or distribution of medical gases.
  236         (4) False or fraudulent material provided by the applicant
  237  in an application made in connection with the manufacturing,
  238  retailing, or distribution of prescription drugs.
  239         (5) Any suspension, sanction, or revocation by a federal,
  240  state, or local government against a license or permit currently
  241  or previously held by the applicant or its owners for violations
  242  of a federal, state, or local law regarding prescription drugs.
  243         (6) Compliance with previously granted licenses or permits.
  244         (7) Compliance with the requirements that distributors or
  245  retailers of medical gases maintain records and make records
  246  available to the department licensing authority or federal,
  247  state, or local law enforcement officials.
  248         (8) Other factors or qualifications the department
  249  considers relevant to and consistent with the public health and
  250  safety.
  251         Section 20. Section 499.84, Florida Statutes, is created to
  252  read:
  253         499.84Minimum requirements for the storage and handling of
  254  medical gases.—
  255         (1) A facility where a medical gas is received, stored,
  256  warehoused, handled, held, offered, marketed, displayed, or
  257  transported, to avoid any negative effect on the identity,
  258  strength, quality, or purity of the medical gas, must:
  259         (a) Be of suitable construction to ensure that medical
  260  gases are maintained in accordance with the product labeling of
  261  the medical gas or in compliance with the USP-NF;
  262         (b) Be of suitable size and construction to facilitate
  263  cleaning, maintenance, and proper permitted operations;
  264         (c) Have adequate storage areas with appropriate lighting,
  265  ventilation, space, equipment, and security conditions.
  266         (d) Have a quarantined area for storage of medical gases
  267  that are suspected of being misbranded, adulterated, or
  268  otherwise unfit for distribution;
  269         (e) Be maintained in an orderly condition;
  270         (f) Be located in a commercial location and not in a
  271  personal dwelling or residence location, except that a personal
  272  dwelling location used for on-call delivery of oxygen USP for
  273  homecare use if the person providing on-call delivery is
  274  employed by or acting under a written contract with an entity
  275  that holds a medical oxygen retailer permit;
  276         (g) Provide for the secure and confidential storage of
  277  patient information, if applicable, with restricted access and
  278  policies and procedures to protect the integrity and
  279  confidentiality of patient information; and
  280         (h) Provide and maintain appropriate inventory controls to
  281  detect and document any theft of nitrous oxide.
  282         (2) Medical gas shall be stored under appropriate
  283  conditions in accordance with the manufacturer’s recommendations
  284  on product labeling and department rules or, in the absence of
  285  rules, in accordance with applicable industry standards.
  286         (3) Medical gas shall be packaged in accordance with
  287  official compendium standards, such as the USP-NF.
  288         Section 21. Section 499.85, Florida Statutes, is created to
  289  read:
  290         499.85Security.—
  291         (1) A permitholder that has a facility used for the
  292  distribution or retailing of medical gases shall protect such
  293  gases from unauthorized access by implementing all of the
  294  following security measures:
  295         (a) Keeping access from outside the premises well
  296  controlled and to a minimum.
  297         (b) Ensuring the outside perimeter of the premises is well
  298  lit.
  299         (c) Limiting access into areas where medical gases are held
  300  to authorized personnel.
  301         (d) Equipping all facilities with a fence or other system
  302  to detect or deter entry after hours.
  303         (2) A facility used for distributing or retailing medical
  304  gases shall be equipped with a system that provides suitable
  305  protection against theft, including if appropriate, protection
  306  against theft of computers or electronic records and the
  307  protection of the integrity and confidentiality of data and
  308  documents.
  309         (3) A facility used for wholesale distribution of medical
  310  gases shall be equipped with inventory management and control
  311  systems that protect against, detect, and document any instances
  312  of theft of nitrous oxide.
  313         (4) If a wholesale distributor uses electronic distribution
  314  records, the wholesale distributor shall employ, train, and
  315  document the training of personnel in the proper use of such
  316  technology and equipment.
  317         (5) Vehicles used for on-call delivery of oxygen USP and
  318  oxygen-related equipment for home care use by home care
  319  providers may be parked at a place of residence and must be
  320  locked and equipped with an audible alarm when not attended.
  321         (6) The department shall adopt rules that govern the
  322  distribution of medical oxygen for emergency use by persons
  323  authorized to receive emergency use oxygen. Unless the laws of
  324  this state specifically direct otherwise, such rules must be
  325  consistent with federal regulations, including the labeling
  326  requirements of oxygen under the federal act.
  327         Section 22. Section 499.86, Florida Statutes, is created to
  328  read:
  329         499.86Examination of materials.—
  330         (1) A wholesale distributor must visually examine a medical
  331  gas container upon receipt from the manufacturer in order to
  332  identify the medical gas stored within and to determine if the
  333  container has been damaged or is otherwise unfit for
  334  distribution. Such examination must occur in a manner that would
  335  reveal damage to the container which could suggest possible
  336  adulteration or misbranding.
  337         (2) A medical gas container that is found to be damaged or
  338  otherwise unfit pursuant to subsection (1) must be quarantined
  339  from the stock of medical gas until a determination is made that
  340  the medical gas in question is not misbranded or adulterated.
  341         (3) An outgoing shipment must be inspected to identify the
  342  medical gases in the shipment to ensure that medical gas
  343  containers that have been damaged in storage or held under
  344  improper conditions are not distributed or dispensed.
  345         (4) A wholesale distributor must review records documenting
  346  the acquisition of medical gas upon receipt for accuracy and
  347  completeness.
  348         Section 23. Section 499.87, Florida Statutes, is created to
  349  read:
  350         499.87Returned, damaged, and outdated medical gas.—
  351         (1) A medical gas that has left the control of the
  352  wholesale distributor may be returned to the wholesale
  353  distributor or manufacturer from which it was acquired, but may
  354  not be resold as a medical gas unless it is reprocessed by a
  355  manufacturer using proper and adequate controls to ensure the
  356  identity, strength, quality, and purity of the reprocessed
  357  medical gas.
  358         (2) A medical gas that has been subjected to improper
  359  conditions, such as a fire, accident, or natural disaster, may
  360  not be salvaged or reprocessed.
  361         (3) A medical gas, including its container, which is
  362  damaged, misbranded, or adulterated must be quarantined from
  363  other medical gases until it is destroyed or returned to the
  364  manufacturer or wholesale distributor from which it was
  365  acquired. External contamination of a medical gas container or
  366  closure system which does not impact the integrity of the
  367  medical gas is not considered damaged or adulterated for
  368  purposes of this subsection. If a medical gas is adulterated or
  369  misbranded or suspected of being adulterated or misbranded,
  370  notice shall be provided to the manufacturer or wholesale
  371  distributor from which the medical gas was acquired and to the
  372  appropriate boards and federal regulatory bodies.
  373         (4) A medical gas container that has been opened or used
  374  but is not adulterated or misbranded is considered empty and
  375  must be quarantined from nonempty medical gas containers and
  376  returned to the manufacturer or wholesale distributor from which
  377  it was acquired for destruction or reprocessing.
  378         (5) A medical gas, its container, or its associated
  379  documentation or labeling that is suspected of being used in
  380  criminal activity must be retained until its disposition is
  381  authorized by the department or an applicable law enforcement
  382  agency.
  383         Section 24. Section 499.88, Florida Statutes, is created to
  384  read:
  385         499.88Due diligence.
  386         (1) A wholesale distributor shall obtain, before the
  387  initial acquisition of medical gas, the following information
  388  from the supplying wholesale distributor or manufacturer:
  389         (a) If a manufacturer is distributing to a wholesale
  390  distributor, evidence that the manufacturer is registered and
  391  the medical gas is listed with the United States Food and Drug
  392  Administration;
  393         (b) If a wholesale distributor is distributing to a
  394  wholesale distributor, evidence that the wholesale distributor
  395  supplying the medical gas is legally authorized to distribute
  396  medical gas within or into the state;
  397         (c) The name of the responsible facility contact person for
  398  the supplying manufacturer or wholesale distributor; and
  399         (d) Certification that the manufacturer’s or wholesale
  400  distributor’s policies and procedures comply with this part.
  401         (2) A wholesale distributor is exempt from obtaining the
  402  information from a manufacturer, as required under subsection
  403  (1), if the manufacturer is registered with the United States
  404  Food and Drug Administration in accordance with s. 510 of the
  405  federal act and the manufacturer provides:
  406         (a) Proof of such registration; and
  407         (b) Proof of inspection by the United States Food and Drug
  408  Administration or other regulatory body within the past 3 years
  409  demonstrating substantial compliance with current good
  410  manufacturing practices applicable to medical gases.
  411         (3) A manufacturer or wholesale distributor that
  412  distributes to or acquires medical gas from another wholesale
  413  distributor shall provide to or obtain from the distributing or
  414  acquiring manufacturer or distributor the information required
  415  by s. 499.89(1), as applicable.
  416         Section 25. Section 499.89, Florida Statutes, is created to
  417  read:
  418         499.89Recordkeeping.—
  419         (1) A permitholder under this part shall establish and
  420  maintain a record of transactions regarding the receipt and the
  421  distribution, or other disposition, of medical gases, as
  422  applicable. Such records constitute an audit trail and must
  423  contain information sufficient to perform a recall of medical
  424  gas in compliance with 21 C.F.R. s. 211.196 and 21 C.F.R. s.
  425  820.160(b). Such records must include all of the following
  426  information, which may be kept in two separate documents one
  427  related to the distribution of medical gas and the other related
  428  to the receipt of medical gas:
  429         (a) The dates of receipt and distribution or other
  430  disposition of the medical gas.
  431         (b) The name, address, license or permit number and its
  432  expiration date for the person or entity purchasing the medical
  433  gas from the wholesale distributor.
  434         (c) The name, address, license or permit number and its
  435  expiration date for the person or entity receiving the medical
  436  gas, if different from the information required under paragraph
  437  (b).
  438         (d) Information sufficient to perform a recall of all
  439  medical gas received, distributed, or dispensed.
  440         (2) Such records shall be made available for inspection and
  441  copying by an authorized official of any federal, state, or
  442  local governmental agency for a period of:
  443         (a) Three years following the distribution date of high
  444  pressure medical gases.
  445         (b) Two years following the distribution date for cryogenic
  446  or refrigerated liquid medical gases.
  447         (3) Records kept at the inspection site or that can be
  448  immediately retrieved by computer or other electronic means
  449  shall be readily available for authorized inspection during the
  450  retention period. Records kept at a central location apart from
  451  the inspection site and not electronically retrievable shall be
  452  made available for inspection within 2 working days of a request
  453  by an authorized official of any state or federal governmental
  454  agency charged with enforcement of these rules.
  455         (4) A pedigree paper is not required for distributing or
  456  dispensing medical gas.
  457         (5) A wholesale distributor shall maintain records
  458  sufficient to aid in the mandatory reporting of any theft,
  459  suspected theft, or other significant loss of nitrous oxide to
  460  the department and other appropriate law enforcement agencies.
  461         Section 26. Section 499.90, Florida Statutes, is created to
  462  read:
  463         499.90Policies and procedures.—A wholesale distributor
  464  shall establish, maintain, and adhere to written policies and
  465  procedures for the receipt, security, storage, transport,
  466  shipping, and distribution of medical gases and shall establish,
  467  maintain, and adhere to procedures for maintaining inventories;
  468  for identifying, recording, and reporting losses or thefts; and
  469  for correcting all errors and inaccuracies in inventories
  470  associated with nitrous oxide. A wholesale distributor shall
  471  include in its written policies and procedures the following:
  472         (1) A procedure for handling recalls and withdrawals of
  473  medical gas. Such procedure must deal with recalls and
  474  withdrawals due to:
  475         (a) Action initiated at the request of the United States
  476  Food and Drug Administration or any federal, state, or local law
  477  enforcement or other government agency, including the
  478  department; or
  479         (b) Voluntary action by a manufacturer of medical gases to
  480  remove defective or potentially defective medical gases from the
  481  market.
  482         (2) A procedure that includes preparation for, protection
  483  against, and responding to a crisis that affects the security or
  484  operation of a facility that stores medical gases in the event
  485  of a strike; a fire, flood, or other natural disaster; or other
  486  local, state, or national emergency.
  487         (3) A procedure for reporting criminal or suspected
  488  criminal activity involving the inventory of nitrous oxide to
  489  the department and to applicable law enforcement agencies within
  490  3 business days after becoming aware of the criminal or
  491  suspected criminal activity.
  492         Section 27. Section 499.91, Florida Statutes, is created to
  493  read:
  494         499.91Prohibited acts.—A person may not perform or cause
  495  the performance of, or aid and abet in, any of the following
  496  acts:
  497         (1) The manufacture, sale, or delivery, or the holding or
  498  offering for sale, of a medical gas that is adulterated,
  499  misbranded, or is otherwise unfit for distribution.
  500         (2) The adulteration or misbranding of a medical gas.
  501         (3) The receipt of a medical gas that is adulterated,
  502  misbranded, stolen, or obtained by fraud or deceit, and the
  503  delivery or proffered delivery of such medical gas for pay or
  504  otherwise.
  505         (4) The alteration, mutilation, destruction, obliteration,
  506  or removal of all or any part of the product labeling of a
  507  medical gas, or the willful commission of any other act with
  508  respect to a medical gas that results in it being misbranded.
  509         (5) The purchase or receipt of a medical gas from a person
  510  not authorized to distribute or dispense medical gas or who is
  511  not exempted from permitting requirements to wholesale
  512  distribute medical gas to such purchaser or recipient.
  513         (6) The knowing and willful sale or transfer of a medical
  514  gas to a recipient who is not legally authorized to receive a
  515  medical gas, except that a violation does not exist if a
  516  permitted wholesale distributor provides oxygen to a permitted
  517  medical oxygen retail establishment that is out of compliance
  518  with the notice of location change requirements of s. 499.834,
  519  provided that the wholesale distributor with knowledge of the
  520  violation notifies the department of the transaction by the next
  521  business day.
  522         (7) The failure to maintain or provide records required
  523  under this part and the rules adopted under this part.
  524         (8) Providing the department or any of its representatives
  525  or any state or federal official with false or fraudulent
  526  records or making false or fraudulent statements regarding this
  527  part or the rules adopted under this part.
  528         (9) The distribution of a medical gas that was:
  529         (a)Purchased by a public or private hospital or other
  530  health care entity, except for the physical distribution of such
  531  medical gas to an authorized recipient at the direction of a
  532  hospital or other health care entity;
  533         (b) Donated or supplied at a reduced price to a charitable
  534  organization; or
  535         (c) Stolen or obtained by fraud or deceit.
  536         (10) The failure to obtain a license or permit or operating
  537  without a valid license or permit, if one is required.
  538         (11) The obtaining of, or attempt to obtain, a medical gas
  539  by fraud, deceit, or misrepresentation or engaging in
  540  misrepresentation or fraud in the distribution of a medical gas.
  541         (12) Except for emergency use oxygen, the distribution of a
  542  medical gas to a patient without a prescription from a
  543  practitioner authorized by law to prescribe a medical gas.
  544         (13) The distribution or dispensing of a medical gas that
  545  was previously dispensed by a pharmacy or a practitioner
  546  authorized by law to prescribe.
  547         (14) The distribution or dispensing of a medical gas or
  548  medical gas-related equipment to a patient, unless the patient
  549  has been provided with the appropriate information and
  550  counseling on the use, storage, and disposal of the medical gas.
  551         (15) Failure to report an act prohibited under this part or
  552  the rules adopted under this part.
  553         (16) Failure to exercise due diligence as provided in s.
  554  499.88.
  555         Section 28. Section 499.92, Florida Statutes, is created to
  556  read:
  557         499.92Criminal acts.—
  558         (1) A person commits a felony of the third degree,
  559  punishable as provided in s. 775.082, s. 775.083, or s. 775.084,
  560  if he or she:
  561         (a) Adulterates or misbrands a medical gas with intent to
  562  defraud or deceive;
  563         (b) Knowingly purchases or receives a medical gas from a
  564  person not legally authorized to distribute or dispense medical
  565  gas;
  566         (c) Knowingly engages in the wholesale distribution of, or
  567  sells, barters, brokers, or transfers, a medical gas to a person
  568  not legally authorized to purchase or receive medical gas in the
  569  jurisdiction in which the person receives the medical gas. A
  570  permitted wholesale distributor that, at its location, provides
  571  oxygen to a permitted medical oxygen retail establishment that
  572  is out of compliance with only the change of location notice
  573  requirement under s. 499.834, does not commit a violation of
  574  this subsection if the wholesale distributor notifies the
  575  department of the transaction no later than the next business
  576  day; or
  577         (d) Knowingly falsely creates a label for a medical gas or
  578  knowingly falsely misrepresents a factual matter contained in a
  579  label for a medical gas.
  580         (2) A person found guilty of an offense under this section,
  581  under the authority of the court convicting and sentencing the
  582  person, shall be ordered to forfeit to the state any real or
  583  personal property:
  584         (a) Used or intended to be used to commit, to facilitate,
  585  or to promote the commission of such offense; and
  586         (b) Constituting, derived from, or traceable to the gross
  587  proceeds that the defendant obtained directly or indirectly as a
  588  result of the offense.
  589         (3) Property or assets subject to forfeiture under
  590  subsection (2) may be seized pursuant to a warrant obtained in
  591  the same manner as a search warrant or as otherwise authorized
  592  by law, and held until the case against a defendant is
  593  adjudicated. Monies ordered forfeited, or proceeds from the sale
  594  of other assets ordered forfeited, shall be equitably divided
  595  between the department and other agencies involved in the
  596  investigation and prosecution that led to the conviction. Other
  597  property ordered forfeited after conviction of a defendant may,
  598  at the discretion of the investigating agencies, be placed into
  599  official use by the department or the agencies involved in the
  600  investigation and prosecution that led to the conviction.
  601         Section 29. Section 499.93, Florida Statutes, is created to
  602  read:
  603         499.93Inspections.—
  604         (1) The department may require a facility that engages in
  605  the manufacture, retail sale, or wholesale distribution of
  606  medical gas to undergo an inspection in accordance with a
  607  schedule to be determined by the department, including
  608  inspections for initial permitting, permit renewal, and a
  609  permitholder’s change of location. The department may recognize
  610  a third party to inspect wholesale distributors in this state or
  611  other states pursuant to a schedule to be determined by the
  612  department.
  613         (2) The department may recognize another state’s
  614  inspections of a manufacturer or wholesale distributor located
  615  in that state if such state’s laws are deemed to be
  616  substantially equivalent to the laws of this state by the
  617  department.
  618         (3) A manufacturing facility of medical gases is exempt
  619  from routine inspection by the department if: