ENROLLED
       2014 Legislature             CS for CS for SB 836, 1st Engrossed
       
       
       
       
       
       
                                                              2014836er
    1  
    2         An act relating to medical gas; amending s. 499.001,
    3         F.S.; conforming provisions to changes made by this
    4         act; amending s. 499.003, F.S.; revising terms;
    5         amending ss. 499.01 and 499.0121, F.S.; conforming
    6         provisions to changes made by this act; amending s.
    7         499.01211, F.S.; adding a member to the Drug Wholesale
    8         Distributor Advisory Council; authorizing the
    9         Compressed Gas Association to recommend one person to
   10         the council for appointment; amending ss. 499.041,
   11         499.05, 499.051, 499.066, 499.0661, and 499.067, F.S.;
   12         conforming provisions to changes made by this act;
   13         creating part III of ch. 499, F.S., entitled “Medical
   14         Gas”; creating s. 499.81, F.S.; providing for the
   15         administration and enforcement of this part; creating
   16         s. 499.82, F.S.; defining terms; creating s. 499.83,
   17         F.S.; requiring a person or entity that intends to
   18         distribute medical gas within or into this state to
   19         obtain an applicable permit before operating;
   20         establishing categories of permits and setting
   21         requirements for each; creating s. 499.831, F.S.;
   22         requiring the Department of Business and Professional
   23         Regulation to establish the form and content of an
   24         application; authorizing the department to set fees
   25         within certain parameters; creating s. 499.832, F.S.;
   26         providing that a permit expires 2 years after the last
   27         day of the month in which the permit was originally
   28         issued; providing requirements for the renewal of a
   29         permit; requiring the department to adopt rules for
   30         the renewal of permits; creating s. 499.833, F.S.;
   31         authorizing the department to approve certain
   32         permitholder changes; creating s. 499.834, F.S.;
   33         authorizing the department to consider certain factors
   34         in determining the eligibility of an applicant;
   35         creating s. 499.84, F.S.; setting the minimum
   36         requirements for the storage and handling of medical
   37         gas; creating s. 499.85, F.S.; setting facility
   38         requirements for security purposes; authorizing a
   39         vehicle used for on-call delivery of oxygen USP and
   40         oxygen-related equipment to be parked at a place of
   41         residence; requiring the department to adopt rules
   42         governing the distribution of medical oxygen; creating
   43         s. 499.86, F.S.; requiring a wholesale distributor of
   44         medical gases to visually examine a medical gas
   45         container upon receipt in order to identify the
   46         medical gas stored within and to determine if the
   47         container has been damaged or is otherwise unfit for
   48         distribution; requiring a medical gas container that
   49         is damaged or otherwise unfit for distribution to be
   50         quarantined; requiring outgoing shipments of medical
   51         gas to be inspected; requiring wholesale distributors
   52         to review certain records; creating s. 499.87, F.S.;
   53         authorizing the return of medical gas that has left
   54         the control of a wholesale distributor; requiring that
   55         medical gas that is damaged, misbranded, or
   56         adulterated be quarantined from other medical gases
   57         until it is destroyed or returned to the manufacturer
   58         or wholesale distributor from which it was acquired;
   59         creating s. 499.88, F.S.; requiring a wholesale
   60         distributor to obtain certain information before the
   61         initial acquisition of a medical gas; providing
   62         certain exemptions; creating s. 499.89, F.S.;
   63         requiring a permitholder under this part to establish
   64         and maintain transactional records; providing a
   65         retention period for certain records and requiring
   66         that such records be available for inspection during
   67         that period; creating s. 499.90, F.S.; requiring a
   68         wholesale distributor to establish, maintain, and
   69         adhere to certain written policies and procedures;
   70         creating s. 499.91, F.S.; prohibiting certain acts;
   71         creating s. 499.92, F.S.; establishing criminal
   72         penalties; authorizing property or assets subject to
   73         forfeiture to be seized pursuant to a warrant;
   74         creating s. 499.93, F.S.; authorizing the department
   75         to require a facility that engages in the manufacture,
   76         retail sale, or wholesale distribution of medical gas
   77         to undergo an inspection; authorizing the department
   78         to authorize a third party to inspect such facilities;
   79         creating s. 499.931, F.S.; providing that trade secret
   80         information required to be submitted pursuant to this
   81         part must be maintained by the department; creating s.
   82         499.94, F.S.; requiring fees collected pursuant to
   83         this part to be deposited into the Professional
   84         Regulation Trust Fund; amending ss. 409.9201, 460.403,
   85         465.0265, 499.01212, 499.015, and 499.024, F.S.;
   86         conforming cross-references; providing an effective
   87         date.
   88          
   89  Be It Enacted by the Legislature of the State of Florida:
   90  
   91         Section 1. Section 499.001, Florida Statutes, is amended to
   92  read:
   93         499.001 Florida Drug and Cosmetic Act; short title.
   94  Sections 499.001-499.94 499.001-499.081 may be cited as the
   95  “Florida Drug and Cosmetic Act.”
   96         Section 2. Subsections (12) through (32) and subsections
   97  (47) through (55) of section 499.003, Florida Statutes, are
   98  renumbered as subsections (11) through (31) and subsections (46)
   99  through (54), respectively, and present subsections (11), (43),
  100  and (46) of that section are amended, to read:
  101         499.003 Definitions of terms used in this part.—As used in
  102  this part, the term:
  103         (32)(11) “Compressed Medical gas” means any liquefied or
  104  vaporized gas that is a prescription drug, whether it is alone
  105  or in combination with other gases, and as defined in the
  106  federal act.
  107         (43) “Prescription drug” means a prescription, medicinal,
  108  or legend drug, including, but not limited to, finished dosage
  109  forms or active pharmaceutical ingredients subject to, defined
  110  by, or described by s. 503(b) of the federal Food, Drug, and
  111  Cosmetic act or s. 465.003(8), s. 499.007(13), or subsection
  112  (32) (11), subsection (46), or subsection (52) (53), except that
  113  an active pharmaceutical ingredient is a prescription drug only
  114  if substantially all finished dosage forms in which it may be
  115  lawfully dispensed or administered in this state are also
  116  prescription drugs.
  117         (46) “Prescription medical oxygen” means oxygen USP which
  118  is a drug that can only be sold on the order or prescription of
  119  a practitioner authorized by law to prescribe. The label of
  120  prescription medical oxygen must comply with current labeling
  121  requirements for oxygen under the Federal Food, Drug, and
  122  Cosmetic Act.
  123         Section 3. Subsection (1), paragraphs (a), (c), (g), (m),
  124  (n), and (o) of subsection (2), and subsection (5) of section
  125  499.01, Florida Statutes, are amended to read:
  126         499.01 Permits.—
  127         (1) Prior to operating, a permit is required for each
  128  person and establishment that intends to operate as:
  129         (a) A prescription drug manufacturer;
  130         (b) A prescription drug repackager;
  131         (c) A nonresident prescription drug manufacturer;
  132         (d) A prescription drug wholesale distributor;
  133         (e) An out-of-state prescription drug wholesale
  134  distributor;
  135         (f) A retail pharmacy drug wholesale distributor;
  136         (g) A restricted prescription drug distributor;
  137         (h) A complimentary drug distributor;
  138         (i) A freight forwarder;
  139         (j) A veterinary prescription drug retail establishment;
  140         (k) A veterinary prescription drug wholesale distributor;
  141         (l) A limited prescription drug veterinary wholesale
  142  distributor;
  143         (m)A medical oxygen retail establishment;
  144         (n)A compressed medical gas wholesale distributor;
  145         (o)A compressed medical gas manufacturer;
  146         (m)(p) An over-the-counter drug manufacturer;
  147         (n)(q) A device manufacturer;
  148         (o)(r) A cosmetic manufacturer;
  149         (p)(s) A third party logistics provider; or
  150         (q)(t) A health care clinic establishment.
  151         (2) The following permits are established:
  152         (a) Prescription drug manufacturer permit.—A prescription
  153  drug manufacturer permit is required for any person that is a
  154  manufacturer of a prescription drug and that manufactures or
  155  distributes such prescription drugs in this state.
  156         1. A person that operates an establishment permitted as a
  157  prescription drug manufacturer may engage in wholesale
  158  distribution of prescription drugs manufactured at that
  159  establishment and must comply with all of the provisions of this
  160  part, except s. 499.01212, and the rules adopted under this
  161  part, except s. 499.01212, which apply to a wholesale
  162  distributor.
  163         2. A prescription drug manufacturer must comply with all
  164  appropriate state and federal good manufacturing practices.
  165         3. A blood establishment, as defined in s. 381.06014,
  166  operating in a manner consistent with the provisions of 21
  167  C.F.R. parts 211 and 600-640, and manufacturing only the
  168  prescription drugs described in s. 499.003(53)(d) s.
  169  499.003(54)(d) is not required to be permitted as a prescription
  170  drug manufacturer under this paragraph or to register products
  171  under s. 499.015.
  172         (c) Nonresident prescription drug manufacturer permit.—A
  173  nonresident prescription drug manufacturer permit is required
  174  for any person that is a manufacturer of prescription drugs,
  175  unless permitted as a third party logistics provider, located
  176  outside of this state or outside the United States and that
  177  engages in the wholesale distribution in this state of such
  178  prescription drugs. Each such manufacturer must be permitted by
  179  the department and comply with all of the provisions required of
  180  a wholesale distributor under this part, except s. 499.01212.
  181         1. A person that distributes prescription drugs for which
  182  the person is not the manufacturer must also obtain an out-of
  183  state prescription drug wholesale distributor permit or third
  184  party logistics provider permit pursuant to this section to
  185  engage in the wholesale distribution of such prescription drugs.
  186  This subparagraph does not apply to a manufacturer as defined in
  187  s. 499.003(30)(e) s. 499.003(31)(e).
  188         2. Any such person must comply with the licensing or
  189  permitting requirements of the jurisdiction in which the
  190  establishment is located and the federal act, and any product
  191  wholesaled into this state must comply with this part. If a
  192  person intends to import prescription drugs from a foreign
  193  country into this state, the nonresident prescription drug
  194  manufacturer must provide to the department a list identifying
  195  each prescription drug it intends to import and document
  196  approval by the United States Food and Drug Administration for
  197  such importation.
  198         (g) Restricted prescription drug distributor permit.—
  199         1. A restricted prescription drug distributor permit is
  200  required for:
  201         a. Any person located in this state who engages in the
  202  distribution of a prescription drug, which distribution is not
  203  considered “wholesale distribution” under s. 499.003(53)(a) s.
  204  499.003(54)(a).
  205         b. Any person located in this state who engages in the
  206  receipt or distribution of a prescription drug in this state for
  207  the purpose of processing its return or its destruction if such
  208  person is not the person initiating the return, the prescription
  209  drug wholesale supplier of the person initiating the return, or
  210  the manufacturer of the drug.
  211         c. A blood establishment located in this state which
  212  collects blood and blood components only from volunteer donors
  213  as defined in s. 381.06014 or pursuant to an authorized
  214  practitioner’s order for medical treatment or therapy and
  215  engages in the wholesale distribution of a prescription drug not
  216  described in s. 499.003(53)(d) s. 499.003(54)(d) to a health
  217  care entity. A mobile blood unit operated by a blood
  218  establishment permitted under this sub-subparagraph is not
  219  required to be separately permitted. The health care entity
  220  receiving a prescription drug distributed under this sub
  221  subparagraph must be licensed as a closed pharmacy or provide
  222  health care services at that establishment. The blood
  223  establishment must operate in accordance with s. 381.06014 and
  224  may distribute only:
  225         (I) Prescription drugs indicated for a bleeding or clotting
  226  disorder or anemia;
  227         (II) Blood-collection containers approved under s. 505 of
  228  the federal act;
  229         (III) Drugs that are blood derivatives, or a recombinant or
  230  synthetic form of a blood derivative;
  231         (IV) Prescription drugs that are identified in rules
  232  adopted by the department and that are essential to services
  233  performed or provided by blood establishments and authorized for
  234  distribution by blood establishments under federal law; or
  235         (V) To the extent authorized by federal law, drugs
  236  necessary to collect blood or blood components from volunteer
  237  blood donors; for blood establishment personnel to perform
  238  therapeutic procedures under the direction and supervision of a
  239  licensed physician; and to diagnose, treat, manage, and prevent
  240  any reaction of a volunteer blood donor or a patient undergoing
  241  a therapeutic procedure performed under the direction and
  242  supervision of a licensed physician,
  243  
  244  as long as all of the health care services provided by the blood
  245  establishment are related to its activities as a registered
  246  blood establishment or the health care services consist of
  247  collecting, processing, storing, or administering human
  248  hematopoietic stem cells or progenitor cells or performing
  249  diagnostic testing of specimens if such specimens are tested
  250  together with specimens undergoing routine donor testing. The
  251  blood establishment may purchase and possess the drugs described
  252  in this sub-subparagraph without a health care clinic
  253  establishment permit.
  254         2. Storage, handling, and recordkeeping of these
  255  distributions by a person required to be permitted as a
  256  restricted prescription drug distributor must be in accordance
  257  with the requirements for wholesale distributors under s.
  258  499.0121, but not those set forth in s. 499.01212 if the
  259  distribution occurs pursuant to sub-subparagraph 1.a. or sub
  260  subparagraph 1.b.
  261         3. A person who applies for a permit as a restricted
  262  prescription drug distributor, or for the renewal of such a
  263  permit, must provide to the department the information required
  264  under s. 499.012.
  265         4. The department may adopt rules regarding the
  266  distribution of prescription drugs by hospitals, health care
  267  entities, charitable organizations, other persons not involved
  268  in wholesale distribution, and blood establishments, which rules
  269  are necessary for the protection of the public health, safety,
  270  and welfare.
  271         (m) Medical oxygen retail establishment permit.—A medical
  272  oxygen retail establishment permit is required for any person
  273  that sells medical oxygen to patients only. The sale must be
  274  based on an order from a practitioner authorized by law to
  275  prescribe. The term does not include a pharmacy licensed under
  276  chapter 465.
  277         1. A medical oxygen retail establishment may not possess,
  278  purchase, sell, or trade any prescription drug other than
  279  medical oxygen.
  280         2. A medical oxygen retail establishment may refill medical
  281  oxygen for an individual patient based on an order from a
  282  practitioner authorized by law to prescribe. A medical oxygen
  283  retail establishment that refills medical oxygen must comply
  284  with all appropriate state and federal good manufacturing
  285  practices.
  286         3. A medical oxygen retail establishment must comply with
  287  all of the wholesale distribution requirements of s. 499.0121.
  288         4. Prescription medical oxygen sold by a medical oxygen
  289  retail establishment pursuant to a practitioner’s order may not
  290  be returned into the retail establishment’s inventory.
  291         (n) Compressed medical gas wholesale distributor permit.—A
  292  compressed medical gas wholesale distributor is a wholesale
  293  distributor that is limited to the wholesale distribution of
  294  compressed medical gases to other than the consumer or patient.
  295  The compressed medical gas must be in the original sealed
  296  container that was purchased by that wholesale distributor. A
  297  compressed medical gas wholesale distributor may not possess or
  298  engage in the wholesale distribution of any prescription drug
  299  other than compressed medical gases. The department shall adopt
  300  rules that govern the wholesale distribution of prescription
  301  medical oxygen for emergency use. With respect to the emergency
  302  use of prescription medical oxygen, those rules may not be
  303  inconsistent with rules and regulations of federal agencies
  304  unless the Legislature specifically directs otherwise.
  305         (o) Compressed medical gas manufacturer permit.—A
  306  compressed medical gas manufacturer permit is required for any
  307  person that engages in the manufacture of compressed medical
  308  gases or repackages compressed medical gases from one container
  309  to another.
  310         1. A compressed medical gas manufacturer may not
  311  manufacture or possess any prescription drug other than
  312  compressed medical gases.
  313         2. A compressed medical gas manufacturer may engage in
  314  wholesale distribution of compressed medical gases manufactured
  315  at that establishment and must comply with all the provisions of
  316  this part and the rules adopted under this part that apply to a
  317  wholesale distributor.
  318         3. A compressed medical gas manufacturer must comply with
  319  all appropriate state and federal good manufacturing practices.
  320         (5) A prescription drug repackager permit issued under this
  321  part is not required for a restricted prescription drug
  322  distributor permitholder that is a health care entity to
  323  repackage prescription drugs in this state for its own use or
  324  for distribution to hospitals or other health care entities in
  325  the state for their own use, pursuant to s. 499.003(53)(a)3. s.
  326  499.003(54)(a)3., if:
  327         (a) The prescription drug distributor notifies the
  328  department, in writing, of its intention to engage in
  329  repackaging under this exemption, 30 days before engaging in the
  330  repackaging of prescription drugs at the permitted
  331  establishment;
  332         (b) The prescription drug distributor is under common
  333  control with the hospitals or other health care entities to
  334  which the prescription drug distributor is distributing
  335  prescription drugs. As used in this paragraph, “common control”
  336  means the power to direct or cause the direction of the
  337  management and policies of a person or an organization, whether
  338  by ownership of stock, voting rights, contract, or otherwise;
  339         (c) The prescription drug distributor repackages the
  340  prescription drugs in accordance with current state and federal
  341  good manufacturing practices; and
  342         (d) The prescription drug distributor labels the
  343  prescription drug it repackages in accordance with state and
  344  federal laws and rules.
  345  
  346  The prescription drug distributor is exempt from the product
  347  registration requirements of s. 499.015 with regard to the
  348  prescription drugs that it repackages and distributes under this
  349  subsection.
  350         Section 4. Paragraph (b) of subsection (2) of section
  351  499.0121, Florida Statutes, is amended to read:
  352         499.0121 Storage and handling of prescription drugs;
  353  recordkeeping.—The department shall adopt rules to implement
  354  this section as necessary to protect the public health, safety,
  355  and welfare. Such rules shall include, but not be limited to,
  356  requirements for the storage and handling of prescription drugs
  357  and for the establishment and maintenance of prescription drug
  358  distribution records.
  359         (2) SECURITY.—
  360         (b) An establishment that is used for wholesale drug
  361  distribution must be equipped with:
  362         1. An alarm system to detect entry after hours; however,
  363  the department may exempt by rule establishments that only hold
  364  a permit as prescription drug wholesale distributor-brokers and
  365  establishments that only handle medical oxygen; and
  366         2. A security system that will provide suitable protection
  367  against theft and diversion. When appropriate, the security
  368  system must provide protection against theft or diversion that
  369  is facilitated or hidden by tampering with computers or
  370  electronic records.
  371         Section 5. Subsections (1) and (2) of section 499.01211,
  372  Florida Statutes, are amended to read:
  373         499.01211 Drug Wholesale Distributor Advisory Council.—
  374         (1) There is created the Drug Wholesale Distributor
  375  Advisory Council within the department. The council shall meet
  376  at least once each calendar quarter. Staff for the council shall
  377  be provided by the department. The council shall consist of 12
  378  11 members who shall serve without compensation. The council
  379  shall elect a chairperson and a vice chairperson annually.
  380         (2) The Secretary of Business and Professional Regulation
  381  or his or her designee and the Secretary of Health Care
  382  Administration or her or his designee shall be members of the
  383  council. The Secretary of Business and Professional Regulation
  384  shall appoint 10 nine additional members to the council who
  385  shall be appointed to a term of 4 years each, as follows:
  386         (a) Three different persons, each of whom is employed by a
  387  different prescription drug wholesale distributor permitted
  388  licensed under this part which operates nationally and is a
  389  primary wholesale distributor, as defined in s. 499.003 s.
  390  499.003(47).
  391         (b) One person employed by a prescription drug wholesale
  392  distributor permitted licensed under this part which is a
  393  secondary wholesale distributor, as defined in s. 499.003 s.
  394  499.003(52).
  395         (c) One person employed by a retail pharmacy chain located
  396  in this state.
  397         (d) One person who is a member of the Board of Pharmacy and
  398  is a pharmacist licensed under chapter 465.
  399         (e) One person who is a physician licensed pursuant to
  400  chapter 458 or chapter 459.
  401         (f) One person who is an employee of a hospital licensed
  402  pursuant to chapter 395 and is a pharmacist licensed pursuant to
  403  chapter 465.
  404         (g) One person who is an employee of a pharmaceutical
  405  manufacturer.
  406         (h) One person who is an employee of a permitted medical
  407  gas manufacturer or medical gas wholesale distributor and who
  408  has been recommended by the Compressed Gas Association.
  409         Section 6. Paragraph (e) of subsection (1), paragraph (b)
  410  of subsection (2), and paragraph (b) of subsection (3) of
  411  section 499.041, Florida Statutes, are amended to read:
  412         499.041 Schedule of fees for drug, device, and cosmetic
  413  applications and permits, product registrations, and free-sale
  414  certificates.—
  415         (1) The department shall assess applicants requiring a
  416  manufacturing permit an annual fee within the ranges established
  417  in this section for the specific type of manufacturer.
  418         (e) The fee for a compressed medical gas manufacturer
  419  permit may not be less than $400 or more than $500 annually.
  420         (2) The department shall assess an applicant that is
  421  required to have a wholesaling permit an annual fee within the
  422  ranges established in this section for the specific type of
  423  wholesaling.
  424         (b) The fee for a compressed medical gas wholesale
  425  distributor permit may not be less than $200 or more than $300
  426  annually.
  427         (3) The department shall assess an applicant that is
  428  required to have a retail establishment permit an annual fee
  429  within the ranges established in this section for the specific
  430  type of retail establishment.
  431         (b) The fee for a medical oxygen retail establishment
  432  permit may not be less than $200 or more than $300 annually.
  433         Section 7. Section 499.05, Florida Statutes, is amended to
  434  read:
  435         499.05 Rules.—
  436         (1) The department shall adopt rules to implement and
  437  enforce this chapter part with respect to:
  438         (a) The definition of terms used in this chapter part, and
  439  used in the rules adopted under this chapter part, when the use
  440  of the term is not its usual and ordinary meaning.
  441         (b) Labeling requirements for drugs, devices, and
  442  cosmetics.
  443         (c) The establishment of fees authorized in this chapter
  444  part.
  445         (d) The identification of permits that require an initial
  446  application and onsite inspection or other prerequisites for
  447  permitting which demonstrate that the establishment and person
  448  are in compliance with the requirements of this chapter part.
  449         (e) The application processes and forms for product
  450  registration.
  451         (f) Procedures for requesting and issuing certificates of
  452  free sale.
  453         (g) Inspections and investigations conducted under s.
  454  499.051 or s. 499.93, and the identification of information
  455  claimed to be a trade secret and exempt from the public records
  456  law as provided in s. 499.051(7).
  457         (h) The establishment of a range of penalties, as provided
  458  in s. 499.066; requirements for notifying persons of the
  459  potential impact of a violation of this chapter part; and a
  460  process for the uncontested settlement of alleged violations.
  461         (i) Additional conditions that qualify as an emergency
  462  medical reason under s. 499.003(53)(b)2. or s. 499.82 s.
  463  499.003(54)(b)2.
  464         (j) Procedures and forms relating to the pedigree paper
  465  requirement of s. 499.01212.
  466         (k) The protection of the public health, safety, and
  467  welfare regarding good manufacturing practices that
  468  manufacturers and repackagers must follow to ensure the safety
  469  of the products.
  470         (l) Information required from each retail establishment
  471  pursuant to s. 499.012(3) or s. 499.83(2)(c), including
  472  requirements for prescriptions or orders.
  473         (m) The recordkeeping, storage, and handling with respect
  474  to each of the distributions of prescription drugs specified in
  475  s. 499.003(53)(a)-(d) or s. 499.82(14) s. 499.003(54)(a)-(d).
  476         (n) Alternatives to compliance with s. 499.01212 for a
  477  prescription drug in the inventory of a permitted prescription
  478  drug wholesale distributor as of June 30, 2006, and the return
  479  of a prescription drug purchased prior to July 1, 2006. The
  480  department may specify time limits for such alternatives.
  481         (o) Wholesale distributor reporting requirements of s.
  482  499.0121(14).
  483         (p) Wholesale distributor credentialing and distribution
  484  requirements of s. 499.0121(15).
  485         (2) With respect to products in interstate commerce, those
  486  rules must not be inconsistent with rules and regulations of
  487  federal agencies unless specifically otherwise directed by the
  488  Legislature.
  489         (3) The department shall adopt rules regulating
  490  recordkeeping for and the storage, handling, and distribution of
  491  medical devices and over-the-counter drugs to protect the public
  492  from adulterated products.
  493         Section 8. Subsections (1) through (4) of section 499.051,
  494  Florida Statutes, are amended to read:
  495         499.051 Inspections and investigations.—
  496         (1) The agents of the department and of the Department of
  497  Law Enforcement, after they present proper identification, may
  498  inspect, monitor, and investigate any establishment permitted
  499  pursuant to this chapter part during business hours for the
  500  purpose of enforcing this chapter part, chapters 465, 501, and
  501  893, and the rules of the department that protect the public
  502  health, safety, and welfare.
  503         (2) In addition to the authority set forth in subsection
  504  (1), the department and any duly designated officer or employee
  505  of the department may enter and inspect any other establishment
  506  for the purpose of determining compliance with this chapter part
  507  and rules adopted under this chapter part regarding any drug,
  508  device, or cosmetic product.
  509         (3) Any application for a permit or product registration or
  510  for renewal of such permit or registration made pursuant to this
  511  chapter part and rules adopted under this chapter part
  512  constitutes permission for any entry or inspection of the
  513  premises in order to verify compliance with this chapter part
  514  and rules; to discover, investigate, and determine the existence
  515  of compliance; or to elicit, receive, respond to, and resolve
  516  complaints and violations.
  517         (4) Any application for a permit made pursuant to s.
  518  499.012 or s. 499.831 and rules adopted under those sections
  519  that section constitutes permission for agents of the department
  520  and the Department of Law Enforcement, after presenting proper
  521  identification, to inspect, review, and copy any financial
  522  document or record related to the manufacture, repackaging, or
  523  distribution of a drug as is necessary to verify compliance with
  524  this chapter part and the rules adopted by the department to
  525  administer this chapter part, in order to discover, investigate,
  526  and determine the existence of compliance, or to elicit,
  527  receive, respond to, and resolve complaints and violations.
  528         Section 9. Subsections (1) through (4) of section 499.066,
  529  Florida Statutes, are amended to read:
  530         499.066 Penalties; remedies.—In addition to other penalties
  531  and other enforcement provisions:
  532         (1) The department may institute such suits or other legal
  533  proceedings as are required to enforce any provision of this
  534  chapter part. If it appears that a person has violated any
  535  provision of this chapter part for which criminal prosecution is
  536  provided, the department may provide the appropriate state
  537  attorney or other prosecuting agency having jurisdiction with
  538  respect to such prosecution with the relevant information in the
  539  department’s possession.
  540         (2) If any person engaged in any activity covered by this
  541  chapter part violates any provision of this chapter part, any
  542  rule adopted under this chapter part, or a cease and desist
  543  order as provided by this chapter part, the department may
  544  obtain an injunction in the circuit court of the county in which
  545  the violation occurred or in which the person resides or has its
  546  principal place of business, and may apply in that court for
  547  such temporary and permanent orders as the department considers
  548  necessary to restrain the person from engaging in any such
  549  activities until the person complies with this chapter part, the
  550  rules adopted under this chapter part, and the orders of the
  551  department authorized by this chapter part or to mandate
  552  compliance with this chapter part, the rules adopted under this
  553  chapter part, and any order or permit issued by the department
  554  under this chapter part.
  555         (3) The department may impose an administrative fine, not
  556  to exceed $5,000 per violation per day, for the violation of any
  557  provision of this chapter part or rules adopted under this
  558  chapter part. Each day a violation continues constitutes a
  559  separate violation, and each separate violation is subject to a
  560  separate fine. All amounts collected pursuant to this section
  561  shall be deposited into the Professional Regulation Trust Fund
  562  and are appropriated for the use of the department in
  563  administering this chapter part. In determining the amount of
  564  the fine to be levied for a violation, the department shall
  565  consider:
  566         (a) The severity of the violation;
  567         (b) Any actions taken by the person to correct the
  568  violation or to remedy complaints; and
  569         (c) Any previous violations.
  570         (4) The department shall deposit any rewards, fines, or
  571  collections that are due the department and which derive from
  572  joint enforcement activities with other state and federal
  573  agencies which relate to this chapter part, chapter 893, or the
  574  federal act, into the Professional Regulation Trust Fund. The
  575  proceeds of those rewards, fines, and collections are
  576  appropriated for the use of the department in administering this
  577  chapter part.
  578         Section 10. Paragraph (a) of subsection (1) and paragraph
  579  (a) of subsection (2) of section 499.0661, Florida Statutes, are
  580  amended to read:
  581         499.0661 Cease and desist orders; removal of certain
  582  persons.—
  583         (1) CEASE AND DESIST ORDERS.—
  584         (a) In addition to any authority otherwise provided in this
  585  chapter, the department may issue and serve a complaint stating
  586  charges upon a any permittee or upon an any affiliated party,
  587  whenever the department has reasonable cause to believe that the
  588  person or individual named therein is engaging in or has engaged
  589  in conduct that is:
  590         1. An act that demonstrates a lack of fitness or
  591  trustworthiness to engage in the business authorized under the
  592  permit issued pursuant to this chapter part, is hazardous to the
  593  public health, or constitutes business operations that are a
  594  detriment to the public health;
  595         2. A violation of a any provision of this chapter part;
  596         3. A violation of a any rule of the department;
  597         4. A violation of an any order of the department; or
  598         5. A breach of a any written agreement with the department.
  599         (2) REMOVAL OF AFFILIATED PARTIES BY THE DEPARTMENT.—
  600         (a) The department may issue and serve a complaint stating
  601  charges upon an any affiliated party and upon the permittee
  602  involved whenever the department has reason to believe that an
  603  affiliated party is engaging in or has engaged in conduct that
  604  constitutes:
  605         1. An act that demonstrates a lack of fitness or
  606  trustworthiness to engage in the business authorized under the
  607  permit issued pursuant to this chapter part, is hazardous to the
  608  public health, or constitutes business operations that are a
  609  detriment to the public health;
  610         2. A willful violation of this chapter part; however, if
  611  the violation constitutes a misdemeanor, a complaint may not be
  612  served as provided in this section until the affiliated party is
  613  notified in writing of the matter of the violation and has been
  614  afforded a reasonable period of time, as set forth in the
  615  notice, to correct the violation and has failed to do so;
  616         3. A violation of a any other law involving fraud or moral
  617  turpitude which constitutes a felony;
  618         4. A willful violation of a any rule of the department;
  619         5. A willful violation of an any order of the department;
  620  or
  621         6. A material misrepresentation of fact, made knowingly and
  622  willfully or made with reckless disregard for the truth of the
  623  matter.
  624         Section 11. Section 499.067, Florida Statutes, is amended
  625  to read:
  626         499.067 Denial, suspension, or revocation of permit,
  627  certification, or registration.—
  628         (1)(a) The department may deny, suspend, or revoke a permit
  629  if it finds that there has been a substantial failure to comply
  630  with this chapter part or chapter 465, chapter 501, or chapter
  631  893, the rules adopted under this part or those chapters, any
  632  final order of the department, or applicable federal laws or
  633  regulations or other state laws or rules governing drugs,
  634  devices, or cosmetics.
  635         (b) The department may deny an application for a permit or
  636  certification, or suspend or revoke a permit or certification,
  637  if the department finds that:
  638         1. The applicant is not of good moral character or that it
  639  would be a danger or not in the best interest of the public
  640  health, safety, and welfare if the applicant were issued a
  641  permit or certification.
  642         2. The applicant has not met the requirements for the
  643  permit or certification.
  644         3. The applicant is not eligible for a permit or
  645  certification for any of the reasons enumerated in s. 499.012.
  646         4. The applicant, permittee, or person certified under s.
  647  499.012(16) demonstrates any of the conditions enumerated in s.
  648  499.012.
  649         5. The applicant, permittee, or person certified under s.
  650  499.012(16) has committed any violation of this chapter ss.
  651  499.005-499.0054.
  652         (2) The department may deny, suspend, or revoke any
  653  registration required by the provisions of this chapter part for
  654  the violation of any provision of this chapter part or of any
  655  rules adopted under this chapter part.
  656         (3) The department may revoke or suspend a permit:
  657         (a) If the permit was obtained by misrepresentation or
  658  fraud or through a mistake of the department;
  659         (b) If the permit was procured, or attempted to be
  660  procured, for any other person by making or causing to be made
  661  any false representation; or
  662         (c) If the permittee has violated any provision of this
  663  chapter part or rules adopted under this chapter part.
  664         (4) If a any permit issued under this chapter part is
  665  revoked or suspended, the owner, manager, operator, or
  666  proprietor of the establishment shall cease to operate as the
  667  permit authorized, from the effective date of the suspension or
  668  revocation until the person is again registered with the
  669  department and possesses the required permit. If a permit is
  670  revoked or suspended, the owner, manager, or proprietor shall
  671  remove all signs and symbols that identify the operation as
  672  premises permitted as a drug wholesaling establishment; drug,
  673  device, or cosmetic manufacturing establishment; or retail
  674  establishment. The department shall determine the length of time
  675  for which the permit is to be suspended. If a permit is revoked,
  676  the person that owns or operates the establishment may not apply
  677  for a any permit under this chapter part for a period of 1 year
  678  after the date of the revocation. A revocation of a permit may
  679  be permanent if the department considers that to be in the best
  680  interest of the public health.
  681         (5) The department may deny, suspend, or revoke a permit
  682  issued under this chapter part which authorizes the permittee to
  683  purchase prescription drugs if an any owner, officer, employee,
  684  or other person who participates in administering or operating
  685  the establishment has been found guilty of a any violation of
  686  this chapter part or chapter 465, chapter 501, or chapter 893,
  687  any rules adopted under this part or those chapters, or any
  688  federal or state drug law, regardless of whether the person has
  689  been pardoned, had her or his civil rights restored, or had
  690  adjudication withheld.
  691         (6) The department shall deny, suspend, or revoke the
  692  permit of a any person or establishment if the assignment, sale,
  693  transfer, or lease of an establishment permitted under this
  694  chapter part will avoid an administrative penalty, civil action,
  695  or criminal prosecution.
  696         (7) Notwithstanding s. 120.60(5), if a permittee fails to
  697  comply with s. 499.012(6) or s. 499.833, as applicable, the
  698  department may revoke the permit of the permittee and shall
  699  provide notice of the intended agency action by posting a notice
  700  at the department’s headquarters and by mailing a copy of the
  701  notice of intended agency action by certified mail to the most
  702  recent mailing address on record with the department and, if the
  703  permittee is not a natural person, to the permittee’s registered
  704  agent on file with the Department of State.
  705         (8) The department may deny, suspend, or revoke a permit
  706  under this part if it finds the permittee has not complied with
  707  the credentialing requirements of s. 499.0121(15).
  708         (9) The department may deny, suspend, or revoke a permit
  709  under this part if it finds the permittee has not complied with
  710  the reporting requirements of, or knowingly made a false
  711  statement in a report required by, s. 499.0121(14).
  712         Section 12. Part III of chapter 499, Florida Statutes,
  713  consisting of ss. 499.81-499.94, Florida Statutes, is created
  714  and entitled “Medical Gas.”
  715         Section 13. Section 499.81, Florida Statutes, is created to
  716  read:
  717         499.81 Administration and enforcement.—
  718         (1) This part is cumulative and shall be construed and
  719  applied as being in addition to, and not in substitution for or
  720  limiting any powers, duties, or authority of the department
  721  under any other law of this state; except that, with respect to
  722  the regulation of medical gas, this part controls over any
  723  conflicting provisions.
  724         (2) The department shall administer and enforce this part
  725  to prevent fraud, adulteration, misbranding, or false
  726  advertising in the manufacture and distribution of medical
  727  gases.
  728         (3) For the purpose of an investigation or proceeding
  729  conducted by the department under this part, the department may
  730  administer oaths, take depositions, subpoena witnesses, and
  731  compel the production of books, papers, documents, or other
  732  records. Challenges to, and enforcement of, subpoenas and orders
  733  shall be handled as provided in s. 120.569.
  734         (4) Each state attorney, county attorney, or municipal
  735  attorney to whom the department or its designated agent reports
  736  a violation of this part shall cause appropriate proceedings to
  737  be instituted in the proper courts without delay and prosecuted
  738  as required by law.
  739         (5) This part does not require the department to report,
  740  for the purpose of instituting proceedings under this part,
  741  minor violations of this part when the department believes that
  742  the public interest will be adequately served by a written
  743  notice or warning.
  744         Section 14. Section 499.82, Florida Statutes, is created to
  745  read:
  746         499.82Definitions.—As used in this part, the term:
  747         (1) “Adulterated,” means a medical gas that:
  748         (a) Consists, in whole or in part, of impurities or
  749  deleterious substances exceeding normal specifications;
  750         (b) Is produced, prepared, packed, or held under conditions
  751  whereby the medical gas may have been contaminated causing it to
  752  be rendered injurious to health; or if the methods used in, or
  753  the facilities or controls used for, its manufacture,
  754  processing, packing, or holding do not conform to or are not
  755  operated or administered in conformity with current good
  756  manufacturing practices to ensure that the medical gas meets the
  757  requirements of this part as to safety and has the identity and
  758  strength and meets the quality and purity characteristics that
  759  the medical gas is represented to possess;
  760         (c) Is held in a container with an interior that is
  761  composed in whole or in part of a poisonous or deleterious
  762  substance that may render the contents injurious to health; or
  763         (d) Is represented as having a strength differing from, or
  764  quality or purity falling below, the standard set forth in the
  765  USP-NF. A medical gas defined in USP-NF may not be deemed to be
  766  adulterated under this paragraph merely because it differs from
  767  the standard of strength, quality, or purity set forth in the
  768  USP-NF if its difference in strength, quality, or purity from
  769  that standard is plainly stated on its label. The determination
  770  as to strength, quality, or purity shall be made:
  771         1. In accordance with the tests or methods of assay in the
  772  USP-NF or its validated equivalent; or
  773         2. In the absence or inadequacy of such tests or methods of
  774  assay, in accordance with the tests or methods of assay
  775  prescribed under the federal act.
  776         (2) “Department” means the Department of Business and
  777  Professional Regulation.
  778         (3) “Distribute” or “distribution” means to sell; offer to
  779  sell; deliver; offer to deliver; transfer by either the passage
  780  of title, physical movement, or both; broker; or give away a
  781  medical gas. The term does not include:
  782         (a) The dispensing or administration of a medical gas;
  783         (b) The delivery of, or an offer to deliver, a medical gas
  784  by a common carrier in its usual course of business; or
  785         (c) Sales activities taking place in a location owned,
  786  controlled, or staffed by persons employed by a person or entity
  787  permitted in this state to distribute a medical gas, if that
  788  location is not used to physically store or move a medical gas.
  789         (4) “Emergency medical reasons” include:
  790         (a) Transfers between wholesale distributors or between a
  791  wholesale distributor and a retail pharmacy or health care
  792  entity to alleviate a temporary shortage of a medical gas
  793  arising from a long-term delay or interruption of regular
  794  distribution schedules.
  795         (b) Sales, purchases, trades, transfers, or use of a
  796  medical gas acquired by a medical director or licensed emergency
  797  medical services provider for use by the emergency medical
  798  services provider and its permitted transport and nontransport
  799  vehicles in accordance with the provider’s license under part
  800  III of chapter 401.
  801         (c) The provision of emergency supplies of medical gases to
  802  nursing homes during the hours of the day when necessary medical
  803  gases cannot normally be obtained from the nursing home’s
  804  regular distributors.
  805         (d) The transfer of medical gases between retail pharmacies
  806  to alleviate a temporary shortage.
  807         (5) “Emergency use oxygen” means oxygen USP administered in
  808  emergency situations without a prescription for oxygen
  809  deficiency and resuscitation. The container must be labeled in
  810  accordance with requirements of the United States Food and Drug
  811  Administration.
  812         (6) “Federal act” means the Federal Food, Drug, and
  813  Cosmetic Act.
  814         (7) “Medical gas” means a liquefied or vaporized gas that
  815  is a prescription drug, whether alone or in combination with
  816  other gases, and as defined in the federal act.
  817         (8) “Medical gas-related equipment” means a device used as
  818  a component part or accessory used to contain or control the
  819  flow, delivery, or pressure during the administration of a
  820  medical gas, such as liquid oxygen base and portable units,
  821  pressure regulators and flow meters, and oxygen concentrators.
  822         (9) “Misbranded” means having a label that is false or
  823  misleading; a label without the name and address of the
  824  manufacturer, packer, or distributor and without an accurate
  825  statement of the quantities of active ingredients; or a label
  826  without an accurate monograph for the medical gas, except in the
  827  case of mixtures of designated medical gases where the label
  828  identifies the component percentages of each designated medical
  829  gas used to make the mixture.
  830         (10) “Medical oxygen” means oxygen USP which must be
  831  labeled in compliance with labeling requirements for oxygen
  832  under the federal act.
  833         (11) “Product labeling” means the labels and other written,
  834  printed, or graphic matter upon an article, or the containers or
  835  wrappers that accompany an article, except for letters, numbers,
  836  and symbols stamped into the container as required by the
  837  federal Department of Transportation.
  838         (12) “USP” means the United States Pharmacopeia.
  839         (13) “USP-NF” means the United States Pharmacopeia-National
  840  Formulary.
  841         (14) “Wholesale distribution” means the distribution of
  842  medical gas to a person other than a consumer or patient.
  843  Wholesale distribution of medical gases does not include:
  844         (a) The sale, purchase, or trade of a medical gas; an offer
  845  to sell, purchase, or trade a medical gas; or the dispensing of
  846  a medical gas pursuant to a prescription;
  847         (b) Activities exempt from the definition of wholesale
  848  distribution in s. 499.003;
  849         (c) The sale, purchase, or trade of a medical gas or an
  850  offer to sell, purchase, or trade a medical gas for emergency
  851  medical reasons; or
  852         (d) Other transactions excluded from the definition of
  853  wholesale distribution under the federal act or regulations
  854  implemented under the federal act related to medical gas.
  855         (15) “Wholesale distributor” means any person or entity
  856  engaged in wholesale distribution of medical gas within or into
  857  this state, including, but not limited to, manufacturers; own
  858  label distributors; private-label distributors; warehouses,
  859  including manufacturers’ and distributors’ warehouses; and
  860  wholesale medical gas warehouses.
  861         Section 15. Section 499.83, Florida Statutes, is created to
  862  read:
  863         499.83 Permits.—
  864         (1) A person or entity that intends to distribute medical
  865  gas within or into this state, unless exempted under this part,
  866  must obtain the applicable permit before operating as:
  867         (a) A medical gas wholesale distributor;
  868         (b) A medical gas manufacturer; or
  869         (c) A medical oxygen retail establishment.
  870         (2) The following permits are established:
  871         (a) Medical gas wholesale distributor permit.—A medical gas
  872  wholesale distributor permit is required for wholesale
  873  distribution, whether within or into this state. A medical gas
  874  must remain in the original container obtained by the wholesale
  875  distributor and the wholesale distributor may not engage in
  876  further manufacturing operations unless it possesses a medical
  877  gas manufacturer permit. A medical gas wholesale distributor may
  878  not possess or engage in the wholesale distribution of a
  879  prescription drug that is not a medical gas or distribute a
  880  medical gas other than by wholesale distribution unless
  881  otherwise authorized under this chapter.
  882         (b) Medical gas manufacturer permit.—A medical gas
  883  manufacturer permit is required for a person or entity located
  884  in this state which engages in the manufacture of medical gases
  885  by physical air separation, chemical action, purification, or
  886  filling containers by a liquid-to-liquid, liquid-to-gas, or gas
  887  to-gas process and distributes those medical gases within this
  888  state.
  889         1. A permitted medical gas manufacturer may not manufacture
  890  or possess a prescription drug other than a medical gas, unless
  891  otherwise authorized under this chapter.
  892         2. A permitted medical gas manufacturer may not distribute
  893  a medical gas without obtaining the applicable permit, except
  894  that it may engage in wholesale distribution of medical gases
  895  that it manufactured without obtaining a medical gas wholesale
  896  distributor permit if it complies with this part and the rules
  897  adopted under this part that apply to a wholesale distributor.
  898         3. A permitted medical gas manufacturer shall comply with
  899  all of the requirements applicable to a wholesale distributor
  900  under this part and all appropriate state and federal good
  901  manufacturing practices.
  902         (c) Medical oxygen retail establishment permit.—A medical
  903  oxygen retail establishment permit is required for an entity
  904  that is located in the state and that sells or delivers medical
  905  oxygen directly to patients in this state. The sale and delivery
  906  must be based on a prescription or an order from a practitioner
  907  authorized by law to prescribe. A pharmacy licensed under
  908  chapter 465 does not require a permit as a medical oxygen retail
  909  establishment.
  910         1. A medical oxygen retail establishment may not possess,
  911  purchase, sell, or trade a medical gas other than medical
  912  oxygen, unless otherwise authorized under this chapter.
  913         2. A medical oxygen retail establishment may fill and
  914  deliver medical oxygen to an individual patient based on an
  915  order from a practitioner authorized by law to prescribe. The
  916  medical oxygen retail establishment must comply with all
  917  appropriate state and federal good manufacturing practices.
  918  Medical oxygen sold or delivered by a medical oxygen retail
  919  establishment pursuant to an order from a practitioner may not
  920  be returned into the retail establishment’s inventory.
  921         3. A medical oxygen retail establishment shall comply with
  922  all of the requirements applicable to a wholesale distributor
  923  under this part, except for those requirements that pertain
  924  solely to nitrous oxide.
  925         (3) An out-of-state wholesale distributor that engages in
  926  wholesale distribution into this state must be legally
  927  authorized to engage in the wholesale distribution of medical
  928  gases as a wholesale distributor in the state in which it
  929  resides and provide proof of registration as set forth in s.
  930  499.93(3), if required.
  931         (4) A wholesale distributor may not operate from a place of
  932  residence, and a place of residence may not be granted a permit
  933  or operate under this part, except for the on-call delivery of
  934  home care oxygen for wholesale distributors that also maintain a
  935  medical oxygen retail establishment permit.
  936         (5) If wholesale distribution is conducted at more than one
  937  location within this state or more than one location
  938  distributing into this state, each location must be permitted by
  939  the department.
  940         Section 16. Section 499.831, Florida Statutes, is created
  941  to read:
  942         499.831 Permit application.—
  943         (1) The department shall adopt rules to establish the form
  944  and content of the application to obtain a permit and to renew a
  945  permit listed under this part.
  946         (2) An applicant must be at least 18 years of age or be
  947  managed, controlled, or overseen, directly or indirectly, by a
  948  natural person who is at least 18 years of age.
  949         (3) An application for a permit must be filed with the
  950  department and must include all of the following information:
  951         (a) The trade or business name of the applicant, including
  952  current and former fictitious names, which may not be identical
  953  to a name used by an unrelated entity permitted in this state to
  954  dispense or distribute medical gas.
  955         (b) The name or names of the owner and operator of the
  956  applicant, if not the same person or entity. The application
  957  must also include:
  958         1. If the applicant is an individual, the applicant’s name,
  959  business address, and date of birth.
  960         2. If the applicant is a sole proprietorship, the business
  961  address of the sole proprietor and the name and federal employer
  962  identification number of the business entity.
  963         3. If the applicant is a partnership, the name, business
  964  address, date of birth of each partner, the name of the
  965  partnership, and the partnership’s federal employer
  966  identification number.
  967         4. If the applicant is a limited liability company, the
  968  name, business address, and title of each company officer, the
  969  name of the limited liability company and federal employer
  970  identification number, and the name of the state in which the
  971  limited liability company was organized.
  972         5. If the applicant is a corporation, the name, business
  973  address, and title of each corporate officer and director, the
  974  corporate names, the state of incorporation, the federal
  975  employer identification number, and, if applicable, the name and
  976  business address of the parent company.
  977         (c) A list of disciplinary actions pertinent to wholesale
  978  distributors, manufacturers, and retailers of prescription drugs
  979  or controlled substances by a state or federal agency against
  980  the applicant seeking to distribute into this state and any such
  981  disciplinary actions against such applicant’s principals,
  982  owners, directors, or officers.
  983         (d) A complete disclosure of all of the applicant’s past
  984  felony convictions.
  985         (e) An address and description of each facility and
  986  warehouse, including all locations used for medical gas storage
  987  or wholesale distribution including a description of each
  988  facility’s security system.
  989         (4) An applicant shall attest in writing that the
  990  information contained in its application is complete and
  991  accurate.
  992         (5) An applicant must submit a reasonable fee, to be
  993  determined by the department, in order to obtain a permit.
  994         (a) The fee for a medical gas wholesale distributor permit
  995  may not be less than $200 or more than $300 annually.
  996         (b) The fee for a medical gas manufacturer permit may not
  997  be less than $400 or more than $500 annually.
  998         (c) The fee for a medical oxygen retail establishment
  999  permit may not be less than $200 or more than $300 annually.
 1000         (6) Upon approval of the application by the department and
 1001  payment of the required fee, the department shall issue a permit
 1002  to the applicant pursuant to the rules adopted under this part.
 1003         Section 17. Section 499.832, Florida Statutes, is created
 1004  to read:
 1005         499.832 Expiration and renewal of a permit.—
 1006         (1) A permit issued under this part automatically expires 2
 1007  years after the last day of the month in which the permit was
 1008  originally issued.
 1009         (2) A permit issued under this part may be renewed by
 1010  submitting an application for renewal on a form furnished by the
 1011  department and paying the appropriate fee. The application for
 1012  renewal must contain a statement by the applicant attesting that
 1013  the information is true and correct. Upon approval of a renewal
 1014  application by the department and payment of the required
 1015  renewal fee, the department shall renew a permit issued under
 1016  this part pursuant to the rules adopted under this part.
 1017         (3) A renewal application may be accepted up to 60 days
 1018  after the expiration date of the permit if, along with the
 1019  permit renewal fee, the applicant submits an additional renewal
 1020  delinquent fee of $100. A permit that expired more than 60 days
 1021  before a renewal application was submitted or postmarked may not
 1022  be renewed.
 1023         (4) Failure to renew a permit in accordance with this
 1024  section precludes future renewal. If a permit has expired and
 1025  cannot be renewed, the person, entity, or establishment holding
 1026  the permit must cease all permit related activities. In order to
 1027  engage in such activities, the person, entity, or establishment
 1028  must submit an application for a new permit, pay the applicable
 1029  application fee, the initial permit fee, and all applicable
 1030  penalties, and be issued a new permit by the department before
 1031  engaging in an activity that requires a permit under this part.
 1032         (5) The department shall adopt rules to administer this
 1033  section, including setting a reasonable fee for a renewal
 1034  application.
 1035         Section 18. Section 499.833, Florida Statutes, is created
 1036  to read:
 1037         499.833 Permitholder changes.—
 1038         (1) A permit issued under this part is valid only for the
 1039  person or entity to which it is issued and is not subject to
 1040  sale, assignment, or other transfer, voluntarily or
 1041  involuntarily.
 1042         (2) A permit issued under this part is not valid for an
 1043  establishment other than the establishment for which it was
 1044  originally issued.
 1045         (3) The department may approve the following permit
 1046  changes:
 1047         (a) Change of location.—A person or entity permitted under
 1048  this part must notify and receive approval from the department
 1049  before changing location. The department shall set a change-of
 1050  location fee not to exceed $100.
 1051         (b) Change in ownership.—If a majority of the ownership or
 1052  controlling interest of a permitted establishment is transferred
 1053  or assigned or if a lessee agrees to undertake or provide
 1054  services such that legal liability for operation of the
 1055  establishment will rest with the lessee, an application for a
 1056  new permit is required. Such application must be submitted and
 1057  approved by the department before the change of ownership takes
 1058  place. However, if a permitted wholesale distributor or
 1059  manufacturer is changing ownership and the new owner has held
 1060  another permit that allows the wholesale distribution of medical
 1061  gas under this chapter for the preceding 18 months without
 1062  having been found in violation of the provisions of this chapter
 1063  relating to medical gases, then the new owner may operate under
 1064  the permit of the acquired entity if the new owner submits the
 1065  application for a new permit by the first business day after
 1066  ownership is transferred or assigned. A new owner operating
 1067  under the original permit is responsible for compliance with all
 1068  laws and regulations governing medical gas. If the application
 1069  is denied, the new owner shall immediately cease operation at
 1070  the establishment until a permit is issued to the new owner.
 1071         (c) Change of name.—A permitholder may make a change of
 1072  business name without submitting a new permit application.
 1073  However, the permitholder must notify the department before
 1074  making the name change.
 1075         (d) Closure.—If an establishment permitted under this part
 1076  closes, the owner must notify the department, in writing, before
 1077  the effective date of the closure and must:
 1078         1. Return the permit to the department; and
 1079         2. Indicate the disposition of any medical gas authorized
 1080  to be distributed or dispensed under the permit, including the
 1081  name, address, and inventory, and provide the name and address
 1082  of a person to contact regarding access to the records that are
 1083  required to be maintained under this part. Transfer of ownership
 1084  of medical gas may be made only to persons authorized to receive
 1085  medical gas pursuant to this part.
 1086         (e) Change in information.—Any change in the information
 1087  required under this part, other than the changes in paragraphs
 1088  (a)-(d), shall be submitted to the department within 30 days
 1089  after such change occurs.
 1090         (4) A permitholder in good standing may change the type of
 1091  permit issued by completing a new application for the requested
 1092  permit, meeting the applicable permitting requirements for the
 1093  new permit type, and paying any difference between the permit
 1094  fees. A refund may not be issued if the fee for the new permit
 1095  is less than the fee that was paid for the original permit. The
 1096  new permit retains the expiration date of the original permit.
 1097         Section 19. Section 499.834, Florida Statutes, is created
 1098  to read:
 1099         499.834 Minimum qualifications.—The department shall
 1100  consider all of the following factors in determining eligibility
 1101  for, and renewal of, a permit for a person or entity under this
 1102  part:
 1103         (1) A finding by the department that the applicant has
 1104  violated or been disciplined by a regulatory agency in any state
 1105  for violating a federal, state, or local law relating to
 1106  prescription drugs.
 1107         (2) Felony convictions of the applicant under a federal,
 1108  state, or local law.
 1109         (3) The applicant’s past experience in the manufacture,
 1110  retail, or distribution of medical gases.
 1111         (4) False or fraudulent material provided by the applicant
 1112  in an application made in connection with the manufacturing,
 1113  retailing, or distribution of prescription drugs.
 1114         (5) Any suspension, sanction, or revocation by a federal,
 1115  state, or local government against a license or permit currently
 1116  or previously held by the applicant or its owners for violations
 1117  of a federal, state, or local law regarding prescription drugs.
 1118         (6) Compliance with previously granted licenses or permits.
 1119         (7) Compliance with the requirements that distributors or
 1120  retailers of medical gases maintain records and make records
 1121  available to the department licensing authority or federal,
 1122  state, or local law enforcement officials.
 1123         (8) Other factors or qualifications the department has
 1124  established in rule that are relevant to and consistent with the
 1125  public health and safety.
 1126         Section 20. Section 499.84, Florida Statutes, is created to
 1127  read:
 1128         499.84 Minimum requirements for the storage and handling of
 1129  medical gases.—
 1130         (1) A facility where a medical gas is received, stored,
 1131  warehoused, handled, held, offered, marketed, displayed, or
 1132  transported, to avoid any negative effect on the identity,
 1133  strength, quality, or purity of the medical gas, must:
 1134         (a) Be of suitable construction to ensure that medical
 1135  gases are maintained in accordance with the product labeling of
 1136  the medical gas or in compliance with the USP-NF;
 1137         (b) Be of suitable size and construction to facilitate
 1138  cleaning, maintenance, and proper permitted operations;
 1139         (c) Have adequate storage areas with appropriate lighting,
 1140  ventilation, space, equipment, and security conditions;
 1141         (d) Have a quarantined area for storage of medical gases
 1142  that are suspected of being misbranded, adulterated, or
 1143  otherwise unfit for distribution;
 1144         (e) Be maintained in an orderly condition;
 1145         (f) Be located in a commercial location and not in a
 1146  personal dwelling or residence location, except that a personal
 1147  dwelling location used for on-call delivery of oxygen USP for
 1148  homecare use if the person providing on-call delivery is
 1149  employed by or acting under a written contract with an entity
 1150  that holds a medical oxygen retailer permit;
 1151         (g) Provide for the secure and confidential storage of
 1152  patient information, if applicable, with restricted access and
 1153  policies and procedures to protect the integrity and
 1154  confidentiality of patient information; and
 1155         (h) Provide and maintain appropriate inventory controls to
 1156  detect and document any theft of nitrous oxide.
 1157         (2) Medical gas shall be stored under appropriate
 1158  conditions in accordance with the manufacturer’s recommendations
 1159  on product labeling and department rules or, in the absence of
 1160  rules, in accordance with applicable industry standards.
 1161         (3) Medical gas shall be packaged in accordance with
 1162  official compendium standards, such as the USP-NF.
 1163         Section 21. Section 499.85, Florida Statutes, is created to
 1164  read:
 1165         499.85 Security.—
 1166         (1) A permitholder that has a facility used for the
 1167  distribution or retailing of medical gases shall protect such
 1168  gases from unauthorized access by implementing all of the
 1169  following security measures:
 1170         (a) Keeping access from outside the premises well
 1171  controlled and to a minimum.
 1172         (b) Ensuring the outside perimeter of the premises is well
 1173  lit.
 1174         (c) Limiting access into areas where medical gases are held
 1175  to authorized personnel.
 1176         (d) Equipping all facilities with a fence or other system
 1177  to detect or deter entry after hours.
 1178         (2) A facility used for distributing or retailing medical
 1179  gases shall be equipped with a system that provides suitable
 1180  protection against theft, including if appropriate, protection
 1181  against theft of computers or electronic records and the
 1182  protection of the integrity and confidentiality of data and
 1183  documents.
 1184         (3) A facility used for wholesale distribution of medical
 1185  gases shall be equipped with inventory management and control
 1186  systems that protect against, detect, and document any instances
 1187  of theft of nitrous oxide.
 1188         (4) If a wholesale distributor uses electronic distribution
 1189  records, the wholesale distributor shall employ, train, and
 1190  document the training of personnel in the proper use of such
 1191  technology and equipment.
 1192         (5) Vehicles used for on-call delivery of oxygen USP and
 1193  oxygen-related equipment for home care use by home care
 1194  providers may be parked at a place of residence and must be
 1195  locked and equipped with an audible alarm when not attended.
 1196         (6) The department shall adopt rules that govern the
 1197  distribution of medical oxygen for emergency use by persons
 1198  authorized to receive emergency use oxygen. Unless the laws of
 1199  this state specifically direct otherwise, such rules must be
 1200  consistent with federal regulations, including the labeling
 1201  requirements of oxygen under the federal act. Such rules may not
 1202  be inconsistent with part III of chapter 401 or rules adopted
 1203  thereunder.
 1204         Section 22. Section 499.86, Florida Statutes, is created to
 1205  read:
 1206         499.86 Examination of materials.—
 1207         (1) A wholesale distributor must visually examine a medical
 1208  gas container upon receipt from the manufacturer in order to
 1209  identify the medical gas stored within and to determine if the
 1210  container has been damaged or is otherwise unfit for
 1211  distribution. Such examination must occur in a manner that would
 1212  reveal damage to the container which could suggest possible
 1213  adulteration or misbranding.
 1214         (2) A medical gas container that is found to be damaged or
 1215  otherwise unfit pursuant to subsection (1) must be quarantined
 1216  from the stock of medical gas until a determination is made that
 1217  the medical gas in question is not misbranded or adulterated.
 1218         (3) An outgoing shipment must be inspected to identify the
 1219  medical gases in the shipment to ensure that medical gas
 1220  containers that have been damaged in storage or held under
 1221  improper conditions are not distributed or dispensed.
 1222         (4) A wholesale distributor must review records documenting
 1223  the acquisition of medical gas upon receipt for accuracy and
 1224  completeness.
 1225         Section 23. Section 499.87, Florida Statutes, is created to
 1226  read:
 1227         499.87 Returned, damaged, and outdated medical gas.—
 1228         (1) A medical gas that has left the control of the
 1229  wholesale distributor may be returned to the wholesale
 1230  distributor or manufacturer from which it was acquired, but may
 1231  not be resold as a medical gas unless it is reprocessed by a
 1232  manufacturer using proper and adequate controls to ensure the
 1233  identity, strength, quality, and purity of the reprocessed
 1234  medical gas.
 1235         (2) A medical gas that has been subjected to improper
 1236  conditions, such as a fire, accident, or natural disaster, may
 1237  not be salvaged or reprocessed.
 1238         (3) A medical gas, including its container, which is
 1239  damaged, misbranded, or adulterated must be quarantined from
 1240  other medical gases until it is destroyed or returned to the
 1241  manufacturer or wholesale distributor from which it was
 1242  acquired. External contamination of a medical gas container or
 1243  closure system which does not impact the integrity of the
 1244  medical gas is not considered damaged or adulterated for
 1245  purposes of this subsection. If a medical gas is adulterated or
 1246  misbranded or suspected of being adulterated or misbranded,
 1247  notice shall be provided to the manufacturer or wholesale
 1248  distributor from which the medical gas was acquired and to the
 1249  appropriate boards and federal regulatory bodies.
 1250         (4) A medical gas container that has been opened or used
 1251  but is not adulterated or misbranded is considered empty and
 1252  must be quarantined from nonempty medical gas containers and
 1253  returned to the manufacturer or wholesale distributor from which
 1254  it was acquired for destruction or reprocessing.
 1255         (5) A medical gas, its container, or its associated
 1256  documentation or labeling that is suspected of being used in
 1257  criminal activity must be retained until its disposition is
 1258  authorized by the department or an applicable law enforcement
 1259  agency.
 1260         Section 24. Section 499.88, Florida Statutes, is created to
 1261  read:
 1262         499.88 Due diligence.—
 1263         (1) A wholesale distributor shall obtain, before the
 1264  initial acquisition of medical gas, the following information
 1265  from the supplying wholesale distributor or manufacturer:
 1266         (a) If a manufacturer is distributing to a wholesale
 1267  distributor, evidence that the manufacturer is registered and
 1268  the medical gas is listed with the United States Food and Drug
 1269  Administration;
 1270         (b) If a wholesale distributor is distributing to a
 1271  wholesale distributor, evidence that the wholesale distributor
 1272  supplying the medical gas is legally authorized to distribute
 1273  medical gas within or into the state;
 1274         (c) The name of the responsible facility contact person for
 1275  the supplying manufacturer or wholesale distributor; and
 1276         (d) Certification that the manufacturer’s or wholesale
 1277  distributor’s policies and procedures comply with this part.
 1278         (2) A wholesale distributor is exempt from obtaining the
 1279  information from a manufacturer, as required under subsection
 1280  (1), if the manufacturer is registered with the United States
 1281  Food and Drug Administration in accordance with s. 510 of the
 1282  federal act and the manufacturer provides:
 1283         (a) Proof of such registration; and
 1284         (b) Proof of inspection by the United States Food and Drug
 1285  Administration or other regulatory body within the past 3 years
 1286  demonstrating substantial compliance with current good
 1287  manufacturing practices applicable to medical gases.
 1288         (3) A manufacturer or wholesale distributor that
 1289  distributes to or acquires medical gas from another wholesale
 1290  distributor shall provide to or obtain from the distributing or
 1291  acquiring manufacturer or distributor the information required
 1292  by s. 499.89(1), as applicable.
 1293         Section 25. Section 499.89, Florida Statutes, is created to
 1294  read:
 1295         499.89 Recordkeeping.—
 1296         (1) A permitholder under this part shall establish and
 1297  maintain a record of transactions regarding the receipt and the
 1298  distribution, or other disposition, of medical gases, as
 1299  applicable. Such records constitute an audit trail and must
 1300  contain information sufficient to perform a recall of medical
 1301  gas in compliance with 21 C.F.R. s. 211.196 and 21 C.F.R. s.
 1302  820.160(b). Such records must include all of the following
 1303  information, which may be kept in two separate documents one
 1304  related to the distribution of medical gas and the other related
 1305  to the receipt of medical gas:
 1306         (a) The dates of receipt and distribution or other
 1307  disposition of the medical gas.
 1308         (b) The name, address, license or permit number and its
 1309  expiration date for the person or entity purchasing the medical
 1310  gas from the wholesale distributor.
 1311         (c) The name, address, license or permit number and its
 1312  expiration date for the person or entity receiving the medical
 1313  gas, if different from the information required under paragraph
 1314  (b).
 1315         (d) Information sufficient to perform a recall of all
 1316  medical gas received, distributed, or dispensed.
 1317         (2) Such records shall be made available for inspection and
 1318  copying by an authorized official of any federal, state, or
 1319  local governmental agency for a period of:
 1320         (a) Three years following the distribution date of high
 1321  pressure medical gases.
 1322         (b) Two years following the distribution date for cryogenic
 1323  or refrigerated liquid medical gases.
 1324         (3) Records kept at the inspection site or that can be
 1325  immediately retrieved by computer or other electronic means
 1326  shall be readily available for authorized inspection during the
 1327  retention period. Records kept at a central location apart from
 1328  the inspection site and not electronically retrievable shall be
 1329  made available for inspection within 2 working days of a request
 1330  by an authorized official of any state or federal governmental
 1331  agency charged with enforcement of these rules.
 1332         (4) A pedigree paper is not required for distributing or
 1333  dispensing medical gas.
 1334         (5) A wholesale distributor shall maintain records
 1335  sufficient to aid in the mandatory reporting of any theft,
 1336  suspected theft, or other significant loss of nitrous oxide to
 1337  the department and other appropriate law enforcement agencies.
 1338         Section 26. Section 499.90, Florida Statutes, is created to
 1339  read:
 1340         499.90 Policies and procedures.—A wholesale distributor
 1341  shall establish, maintain, and adhere to written policies and
 1342  procedures for the receipt, security, storage, transport,
 1343  shipping, and distribution of medical gases and shall establish,
 1344  maintain, and adhere to procedures for maintaining inventories;
 1345  for identifying, recording, and reporting losses or thefts; and
 1346  for correcting all errors and inaccuracies in inventories
 1347  associated with nitrous oxide. A wholesale distributor shall
 1348  include in its written policies and procedures all of the
 1349  following:
 1350         (1) A procedure for handling recalls and withdrawals of
 1351  medical gas. Such procedure must deal with recalls and
 1352  withdrawals due to:
 1353         (a) Action initiated at the request of the United States
 1354  Food and Drug Administration or any federal, state, or local law
 1355  enforcement or other government agency, including the
 1356  department; or
 1357         (b) Voluntary action by a manufacturer of medical gases to
 1358  remove defective or potentially defective medical gases from the
 1359  market.
 1360         (2) A procedure that includes preparation for, protection
 1361  against, and responding to a crisis that affects the security or
 1362  operation of a facility that stores medical gases in the event
 1363  of a strike; a fire, flood, or other natural disaster; or other
 1364  local, state, or national emergency.
 1365         (3) A procedure for reporting criminal or suspected
 1366  criminal activity involving the inventory of nitrous oxide to
 1367  the department and to applicable law enforcement agencies within
 1368  3 business days after becoming aware of the criminal or
 1369  suspected criminal activity.
 1370         Section 27. Section 499.91, Florida Statutes, is created to
 1371  read:
 1372         499.91 Prohibited acts.—A person may not perform or cause
 1373  the performance of, or aid and abet in, any of the following
 1374  acts:
 1375         (1) The manufacture, sale, or delivery, or the holding or
 1376  offering for sale, of a medical gas that is adulterated,
 1377  misbranded, or is otherwise unfit for distribution.
 1378         (2) The adulteration or misbranding of a medical gas.
 1379         (3) The receipt of a medical gas that is adulterated,
 1380  misbranded, stolen, or obtained by fraud or deceit, and the
 1381  delivery or proffered delivery of such medical gas for pay or
 1382  otherwise.
 1383         (4) The alteration, mutilation, destruction, obliteration,
 1384  or removal of all or any part of the product labeling of a
 1385  medical gas, or the willful commission of any other act with
 1386  respect to a medical gas that results in it being misbranded.
 1387         (5) The purchase or receipt of a medical gas from a person
 1388  not authorized to distribute or dispense medical gas or who is
 1389  not exempted from permitting requirements to wholesale
 1390  distribute medical gas to such purchaser or recipient.
 1391         (6) The knowing and willful sale or transfer of a medical
 1392  gas to a recipient who is not legally authorized to receive a
 1393  medical gas, except that a violation does not exist if a
 1394  permitted wholesale distributor provides oxygen to a permitted
 1395  medical oxygen retail establishment that is out of compliance
 1396  with the notice of location change requirements of s. 499.834,
 1397  provided that the wholesale distributor with knowledge of the
 1398  violation notifies the department of the transaction by the next
 1399  business day.
 1400         (7) The failure to maintain or provide records required
 1401  under this part and the rules adopted under this part.
 1402         (8) Providing the department or any of its representatives
 1403  or any state or federal official with false or fraudulent
 1404  records or making false or fraudulent statements regarding this
 1405  part or the rules adopted under this part.
 1406         (9) The distribution of a medical gas that was:
 1407         (a) Purchased by a public or private hospital or other
 1408  health care entity, except for the physical distribution of such
 1409  medical gas to an authorized recipient at the direction of a
 1410  hospital or other health care entity;
 1411         (b) Donated or supplied at a reduced price to a charitable
 1412  organization; or
 1413         (c) Stolen or obtained by fraud or deceit.
 1414         (10) The failure to obtain a license or permit or operating
 1415  without a valid license or permit, if one is required.
 1416         (11) The obtaining of, or attempt to obtain, a medical gas
 1417  by fraud, deceit, or misrepresentation or engaging in
 1418  misrepresentation or fraud in the distribution of a medical gas.
 1419         (12) Except for emergency use oxygen, the distribution of a
 1420  medical gas to a patient without a prescription from a
 1421  practitioner authorized by law to prescribe a medical gas.
 1422         (13) The distribution or dispensing of a medical gas that
 1423  was previously dispensed by a pharmacy or a practitioner
 1424  authorized by law to prescribe.
 1425         (14) The distribution or dispensing of a medical gas or
 1426  medical gas-related equipment to a patient, unless the patient
 1427  has been provided with the appropriate information and
 1428  counseling on the use, storage, and disposal of the medical gas.
 1429         (15) Failure to report an act prohibited under this part or
 1430  the rules adopted under this part.
 1431         (16) Failure to exercise due diligence as provided in s.
 1432  499.88.
 1433         Section 28. Section 499.92, Florida Statutes, is created to
 1434  read:
 1435         499.92 Criminal acts.—
 1436         (1) A person commits a felony of the third degree,
 1437  punishable as provided in s. 775.082, s. 775.083, or s. 775.084,
 1438  if he or she:
 1439         (a) Adulterates or misbrands a medical gas with intent to
 1440  defraud or deceive;
 1441         (b) Knowingly purchases or receives a medical gas from a
 1442  person not legally authorized to distribute or dispense medical
 1443  gas;
 1444         (c) Knowingly engages in the wholesale distribution of, or
 1445  sells, barters, brokers, or transfers, a medical gas to a person
 1446  not legally authorized to purchase or receive medical gas in the
 1447  jurisdiction in which the person receives the medical gas. A
 1448  permitted wholesale distributor that provides oxygen to a
 1449  permitted medical oxygen retail establishment that is out of
 1450  compliance with only the change of location notice requirement
 1451  under s. 499.834, does not commit a violation of this paragraph
 1452  if the wholesale distributor notifies the department of the
 1453  transaction no later than the next business day; or
 1454         (d) Knowingly falsely creates a label for a medical gas or
 1455  knowingly misrepresents a factual matter contained in a label
 1456  for a medical gas.
 1457         (2) A person found guilty of an offense under this section,
 1458  under the authority of the court convicting and sentencing the
 1459  person, shall be ordered to forfeit to the state any real or
 1460  personal property:
 1461         (a) Used or intended to be used to commit, to facilitate,
 1462  or to promote the commission of such offense; and
 1463         (b) Constituting, derived from, or traceable to the gross
 1464  proceeds that the defendant obtained directly or indirectly as a
 1465  result of the offense.
 1466         (3) Property or assets subject to forfeiture under
 1467  subsection (2) may be seized pursuant to a warrant obtained in
 1468  the same manner as a search warrant or as otherwise authorized
 1469  by law, and held until the case against a defendant is
 1470  adjudicated. Monies ordered forfeited, or proceeds from the sale
 1471  of other assets ordered forfeited, shall be equitably divided
 1472  between the department and other agencies involved in the
 1473  investigation and prosecution that led to the conviction. Other
 1474  property ordered forfeited after conviction of a defendant may,
 1475  at the discretion of the investigating agencies, be placed into
 1476  official use by the department or the agencies involved in the
 1477  investigation and prosecution that led to the conviction.
 1478         Section 29. Section 499.93, Florida Statutes, is created to
 1479  read:
 1480         499.93Inspections.—
 1481         (1) The department may require a facility that engages in
 1482  the manufacture, retail sale, or wholesale distribution of
 1483  medical gas to undergo an inspection in accordance with a
 1484  schedule to be determined by the department, including
 1485  inspections for initial permitting, permit renewal, and a
 1486  permitholder’s change of location. The department may recognize
 1487  a third party to inspect wholesale distributors in this state or
 1488  other states pursuant to a schedule to be determined by the
 1489  department.
 1490         (2) The department may recognize another state’s
 1491  inspections of a manufacturer or wholesale distributor located
 1492  in that state if such state’s laws are deemed to be
 1493  substantially equivalent to the laws of this state by the
 1494  department.
 1495         (3) A manufacturing facility of medical gases is exempt
 1496  from routine inspection by the department if:
 1497         (a) The manufacturing facility is currently registered with
 1498  the United States Food and Drug Administration under s. 510 of
 1499  the federal act and can provide proof of registration, such as a
 1500  copy of the Internet verification page; and
 1501         (b) The manufacturing facility can provide proof of
 1502  inspection by the Food and Drug Administration, or if the
 1503  facility is located in another state, inspection by the Food and
 1504  Drug Administration or other governmental entity charged with
 1505  regulation of good manufacturing practices related to medical
 1506  gases in that state within the past 3 years, which demonstrates
 1507  substantial compliance with current good manufacturing practices
 1508  applicable to medical gases.
 1509         (4) A permitholder under this part shall exhibit or have
 1510  readily available its state permits and its most recent
 1511  inspection report administered by the department.
 1512         Section 30. Section 499.931, Florida Statutes, is created
 1513  to read:
 1514         499.931 Trade secret information.—Information required to
 1515  be submitted under this part which is a trade secret as defined
 1516  in s. 812.081(1)(c) and designated as a trade secret by an
 1517  applicant or permitholder must be maintained as required under
 1518  s. 499.051.
 1519         Section 31. Section 499.94, Florida Statutes, is created to
 1520  read:
 1521         499.94Fees.—A fee collected for a permit under this part
 1522  shall be deposited into the Professional Regulation Trust Fund.
 1523  Moneys collected under this part shall be used for administering
 1524  this part. The department shall maintain a separate account in
 1525  the trust fund for the Drugs, Devices, and Cosmetics program.
 1526         Section 32. Paragraph (a) of subsection (1) of section
 1527  409.9201, Florida Statutes, is amended to read:
 1528         409.9201 Medicaid fraud.—
 1529         (1) As used in this section, the term:
 1530         (a) “Prescription drug” means any drug, including, but not
 1531  limited to, finished dosage forms or active ingredients that are
 1532  subject to, defined in by, or described in by s. 503(b) of the
 1533  Federal Food, Drug, and Cosmetic Act or in by s. 465.003(8), s.
 1534  499.003(52), s. 499.003(46) or (53) or s. 499.007(13), or s.
 1535  499.82(10).
 1536  
 1537  The value of individual items of the legend drugs or goods or
 1538  services involved in distinct transactions committed during a
 1539  single scheme or course of conduct, whether involving a single
 1540  person or several persons, may be aggregated when determining
 1541  the punishment for the offense.
 1542         Section 33. Paragraph (c) of subsection (9) of section
 1543  460.403, Florida Statutes, is amended to read:
 1544         460.403 Definitions.—As used in this chapter, the term:
 1545         (9)
 1546         (c)1. Chiropractic physicians may adjust, manipulate, or
 1547  treat the human body by manual, mechanical, electrical, or
 1548  natural methods; by the use of physical means or physiotherapy,
 1549  including light, heat, water, or exercise; by the use of
 1550  acupuncture; or by the administration of foods, food
 1551  concentrates, food extracts, and items for which a prescription
 1552  is not required and may apply first aid and hygiene, but
 1553  chiropractic physicians are expressly prohibited from
 1554  prescribing or administering to any person any legend drug
 1555  except as authorized under subparagraph 2., from performing any
 1556  surgery except as stated herein, or from practicing obstetrics.
 1557         2. Notwithstanding the prohibition against prescribing and
 1558  administering legend drugs under subparagraph 1. or s.
 1559  499.83(2)(c) s. 499.01(2)(m), pursuant to board rule
 1560  chiropractic physicians may order, store, and administer, for
 1561  emergency purposes only at the chiropractic physician’s office
 1562  or place of business, prescription medical oxygen and may also
 1563  order, store, and administer the following topical anesthetics
 1564  in aerosol form:
 1565         a. Any solution consisting of 25 percent ethylchloride and
 1566  75 percent dichlorodifluoromethane.
 1567         b. Any solution consisting of 15 percent
 1568  dichlorodifluoromethane and 85 percent
 1569  trichloromonofluoromethane.
 1570  
 1571  However, this paragraph does not authorize a chiropractic
 1572  physician to prescribe medical oxygen as defined in chapter 499.
 1573         Section 34. Subsection (3) of section 465.0265, Florida
 1574  Statutes, is amended to read:
 1575         465.0265 Centralized prescription filling.—
 1576         (3) The filling, delivery, and return of a prescription by
 1577  one pharmacy for another pursuant to this section shall not be
 1578  construed as the filling of a transferred prescription as
 1579  described set forth in s. 465.026 or as a wholesale distribution
 1580  as defined set forth in s. 499.003 s. 499.003(54).
 1581         Section 35. Paragraph (b) of subsection (2) of section
 1582  499.01212, Florida Statutes, is amended to read:
 1583         499.01212 Pedigree paper.—
 1584         (2) FORMAT.—A pedigree paper must contain the following
 1585  information:
 1586         (b) For all other wholesale distributions of prescription
 1587  drugs:
 1588         1. The quantity, dosage form, and strength of the
 1589  prescription drugs.
 1590         2. The lot numbers of the prescription drugs.
 1591         3. The name and address of each owner of the prescription
 1592  drug and his or her signature.
 1593         4. Shipping information, including the name and address of
 1594  each person certifying delivery or receipt of the prescription
 1595  drug.
 1596         5. An invoice number, a shipping document number, or
 1597  another number uniquely identifying the transaction.
 1598         6. A certification that the recipient wholesale distributor
 1599  has authenticated the pedigree papers.
 1600         7. The unique serialization of the prescription drug, if
 1601  the manufacturer or repackager has uniquely serialized the
 1602  individual prescription drug unit.
 1603         8. The name, address, telephone number, and, if available,
 1604  e-mail contact information of each wholesale distributor
 1605  involved in the chain of the prescription drug’s custody.
 1606  
 1607  When an affiliated group member obtains title to a prescription
 1608  drug before distributing the prescription drug as the
 1609  manufacturer as defined in s. 499.003(30)(e) under s.
 1610  499.003(31)(e), information regarding the distribution between
 1611  those affiliated group members may be omitted from a pedigree
 1612  paper required under this paragraph for subsequent distributions
 1613  of that prescription drug.
 1614         Section 36. Paragraph (a) of subsection (1) and subsection
 1615  (3) of section 499.015, Florida Statutes, are amended to read:
 1616         499.015 Registration of drugs, devices, and cosmetics;
 1617  issuance of certificates of free sale.—
 1618         (1)(a) Except for those persons exempted from the
 1619  definition of manufacturer in s. 499.003 s. 499.003(31), any
 1620  person who manufactures, packages, repackages, labels, or
 1621  relabels a drug, device, or cosmetic in this state must register
 1622  such drug, device, or cosmetic biennially with the department;
 1623  pay a fee in accordance with the fee schedule provided by s.
 1624  499.041; and comply with this section. The registrant must list
 1625  each separate and distinct drug, device, or cosmetic at the time
 1626  of registration.
 1627         (3) Except for those persons exempted from the definition
 1628  of manufacturer in s. 499.003 s. 499.003(31), a person may not
 1629  sell any product that he or she has failed to register in
 1630  conformity with this section. Such failure to register subjects
 1631  such drug, device, or cosmetic product to seizure and
 1632  condemnation as provided in s. 499.062, and subjects such person
 1633  to the penalties and remedies provided in this part.
 1634         Section 37. Subsection (3) of section 499.024, Florida
 1635  Statutes, is amended to read:
 1636         499.024 Drug product classification.—The department shall
 1637  adopt rules to classify drug products intended for use by humans
 1638  which the United States Food and Drug Administration has not
 1639  classified in the federal act or the Code of Federal
 1640  Regulations.
 1641         (3) Any product that falls under the definition of drug in
 1642  s. 499.003 s. 499.003(19) may be classified under the authority
 1643  of this section. This section does not subject portable
 1644  emergency oxygen inhalators to classification; however, this
 1645  section does not exempt any person from ss. 499.01 and 499.015.
 1646         Section 38. This act shall take effect October 1, 2014.