Florida Senate - 2014                        COMMITTEE AMENDMENT
       Bill No. CS for SB 836
       
       
       
       
       
       
                                Ì181392.Î181392                         
       
                              LEGISLATIVE ACTION                        
                    Senate             .             House              
                  Comm: RCS            .                                
                  04/01/2014           .                                
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    1         Senate Amendment (with title amendment)
    2  
    3         Delete everything after the enacting clause
    4  and insert:
    5         Section 1. Section 499.001, Florida Statutes, is amended to
    6  read:
    7         499.001 Florida Drug and Cosmetic Act; short title.
    8  Sections 499.001-499.94 499.001-499.081 may be cited as the
    9  “Florida Drug and Cosmetic Act.”
   10         Section 2. Subsections (12) through (32) and subsections
   11  (47) through (55) of section 499.003, Florida Statutes, are
   12  renumbered as subsections (11) through (31) and subsections (46)
   13  through (54), respectively, and present subsections (11), (43),
   14  and (46) of that section are amended, to read:
   15         499.003 Definitions of terms used in this part.—As used in
   16  this part, the term:
   17         (32)(11) “Compressed Medical gas” means any liquefied or
   18  vaporized gas that is a prescription drug, whether it is alone
   19  or in combination with other gases, and as defined in the
   20  federal act.
   21         (43) “Prescription drug” means a prescription, medicinal,
   22  or legend drug, including, but not limited to, finished dosage
   23  forms or active pharmaceutical ingredients subject to, defined
   24  by, or described by s. 503(b) of the federal Food, Drug, and
   25  Cosmetic act or s. 465.003(8), s. 499.007(13), or subsection
   26  (32) (11), subsection (46), or subsection (52) (53), except that
   27  an active pharmaceutical ingredient is a prescription drug only
   28  if substantially all finished dosage forms in which it may be
   29  lawfully dispensed or administered in this state are also
   30  prescription drugs.
   31         (46) “Prescription medical oxygen” means oxygen USP which
   32  is a drug that can only be sold on the order or prescription of
   33  a practitioner authorized by law to prescribe. The label of
   34  prescription medical oxygen must comply with current labeling
   35  requirements for oxygen under the Federal Food, Drug, and
   36  Cosmetic Act.
   37         Section 3. Subsection (1), paragraphs (a), (c), (g), (m),
   38  (n), and (o) of subsection (2), and subsection (5) of section
   39  499.01, Florida Statutes, are amended to read:
   40         499.01 Permits.—
   41         (1) Prior to operating, a permit is required for each
   42  person and establishment that intends to operate as:
   43         (a) A prescription drug manufacturer;
   44         (b) A prescription drug repackager;
   45         (c) A nonresident prescription drug manufacturer;
   46         (d) A prescription drug wholesale distributor;
   47         (e) An out-of-state prescription drug wholesale
   48  distributor;
   49         (f) A retail pharmacy drug wholesale distributor;
   50         (g) A restricted prescription drug distributor;
   51         (h) A complimentary drug distributor;
   52         (i) A freight forwarder;
   53         (j) A veterinary prescription drug retail establishment;
   54         (k) A veterinary prescription drug wholesale distributor;
   55         (l) A limited prescription drug veterinary wholesale
   56  distributor;
   57         (m)A medical oxygen retail establishment;
   58         (n)A compressed medical gas wholesale distributor;
   59         (o)A compressed medical gas manufacturer;
   60         (m)(p) An over-the-counter drug manufacturer;
   61         (n)(q) A device manufacturer;
   62         (o)(r) A cosmetic manufacturer;
   63         (p)(s) A third party logistics provider; or
   64         (q)(t) A health care clinic establishment.
   65         (2) The following permits are established:
   66         (a) Prescription drug manufacturer permit.—A prescription
   67  drug manufacturer permit is required for any person that is a
   68  manufacturer of a prescription drug and that manufactures or
   69  distributes such prescription drugs in this state.
   70         1. A person that operates an establishment permitted as a
   71  prescription drug manufacturer may engage in wholesale
   72  distribution of prescription drugs manufactured at that
   73  establishment and must comply with all of the provisions of this
   74  part, except s. 499.01212, and the rules adopted under this
   75  part, except s. 499.01212, which apply to a wholesale
   76  distributor.
   77         2. A prescription drug manufacturer must comply with all
   78  appropriate state and federal good manufacturing practices.
   79         3. A blood establishment, as defined in s. 381.06014,
   80  operating in a manner consistent with the provisions of 21
   81  C.F.R. parts 211 and 600-640, and manufacturing only the
   82  prescription drugs described in s. 499.003(53)(d) s.
   83  499.003(54)(d) is not required to be permitted as a prescription
   84  drug manufacturer under this paragraph or to register products
   85  under s. 499.015.
   86         (c) Nonresident prescription drug manufacturer permit.—A
   87  nonresident prescription drug manufacturer permit is required
   88  for any person that is a manufacturer of prescription drugs,
   89  unless permitted as a third party logistics provider, located
   90  outside of this state or outside the United States and that
   91  engages in the wholesale distribution in this state of such
   92  prescription drugs. Each such manufacturer must be permitted by
   93  the department and comply with all of the provisions required of
   94  a wholesale distributor under this part, except s. 499.01212.
   95         1. A person that distributes prescription drugs for which
   96  the person is not the manufacturer must also obtain an out-of
   97  state prescription drug wholesale distributor permit or third
   98  party logistics provider permit pursuant to this section to
   99  engage in the wholesale distribution of such prescription drugs.
  100  This subparagraph does not apply to a manufacturer as defined in
  101  s. 499.003(30)(e) s. 499.003(31)(e).
  102         2. Any such person must comply with the licensing or
  103  permitting requirements of the jurisdiction in which the
  104  establishment is located and the federal act, and any product
  105  wholesaled into this state must comply with this part. If a
  106  person intends to import prescription drugs from a foreign
  107  country into this state, the nonresident prescription drug
  108  manufacturer must provide to the department a list identifying
  109  each prescription drug it intends to import and document
  110  approval by the United States Food and Drug Administration for
  111  such importation.
  112         (g) Restricted prescription drug distributor permit.—
  113         1. A restricted prescription drug distributor permit is
  114  required for:
  115         a. Any person located in this state who engages in the
  116  distribution of a prescription drug, which distribution is not
  117  considered “wholesale distribution” under s. 499.003(53)(a) s.
  118  499.003(54)(a).
  119         b. Any person located in this state who engages in the
  120  receipt or distribution of a prescription drug in this state for
  121  the purpose of processing its return or its destruction if such
  122  person is not the person initiating the return, the prescription
  123  drug wholesale supplier of the person initiating the return, or
  124  the manufacturer of the drug.
  125         c. A blood establishment located in this state which
  126  collects blood and blood components only from volunteer donors
  127  as defined in s. 381.06014 or pursuant to an authorized
  128  practitioner’s order for medical treatment or therapy and
  129  engages in the wholesale distribution of a prescription drug not
  130  described in s. 499.003(53)(d) s. 499.003(54)(d) to a health
  131  care entity. A mobile blood unit operated by a blood
  132  establishment permitted under this sub-subparagraph is not
  133  required to be separately permitted. The health care entity
  134  receiving a prescription drug distributed under this sub
  135  subparagraph must be licensed as a closed pharmacy or provide
  136  health care services at that establishment. The blood
  137  establishment must operate in accordance with s. 381.06014 and
  138  may distribute only:
  139         (I) Prescription drugs indicated for a bleeding or clotting
  140  disorder or anemia;
  141         (II) Blood-collection containers approved under s. 505 of
  142  the federal act;
  143         (III) Drugs that are blood derivatives, or a recombinant or
  144  synthetic form of a blood derivative;
  145         (IV) Prescription drugs that are identified in rules
  146  adopted by the department and that are essential to services
  147  performed or provided by blood establishments and authorized for
  148  distribution by blood establishments under federal law; or
  149         (V) To the extent authorized by federal law, drugs
  150  necessary to collect blood or blood components from volunteer
  151  blood donors; for blood establishment personnel to perform
  152  therapeutic procedures under the direction and supervision of a
  153  licensed physician; and to diagnose, treat, manage, and prevent
  154  any reaction of a volunteer blood donor or a patient undergoing
  155  a therapeutic procedure performed under the direction and
  156  supervision of a licensed physician,
  157  
  158  as long as all of the health care services provided by the blood
  159  establishment are related to its activities as a registered
  160  blood establishment or the health care services consist of
  161  collecting, processing, storing, or administering human
  162  hematopoietic stem cells or progenitor cells or performing
  163  diagnostic testing of specimens if such specimens are tested
  164  together with specimens undergoing routine donor testing. The
  165  blood establishment may purchase and possess the drugs described
  166  in this sub-subparagraph without a health care clinic
  167  establishment permit.
  168         2. Storage, handling, and recordkeeping of these
  169  distributions by a person required to be permitted as a
  170  restricted prescription drug distributor must be in accordance
  171  with the requirements for wholesale distributors under s.
  172  499.0121, but not those set forth in s. 499.01212 if the
  173  distribution occurs pursuant to sub-subparagraph 1.a. or sub
  174  subparagraph 1.b.
  175         3. A person who applies for a permit as a restricted
  176  prescription drug distributor, or for the renewal of such a
  177  permit, must provide to the department the information required
  178  under s. 499.012.
  179         4. The department may adopt rules regarding the
  180  distribution of prescription drugs by hospitals, health care
  181  entities, charitable organizations, other persons not involved
  182  in wholesale distribution, and blood establishments, which rules
  183  are necessary for the protection of the public health, safety,
  184  and welfare.
  185         (m) Medical oxygen retail establishment permit.—A medical
  186  oxygen retail establishment permit is required for any person
  187  that sells medical oxygen to patients only. The sale must be
  188  based on an order from a practitioner authorized by law to
  189  prescribe. The term does not include a pharmacy licensed under
  190  chapter 465.
  191         1. A medical oxygen retail establishment may not possess,
  192  purchase, sell, or trade any prescription drug other than
  193  medical oxygen.
  194         2. A medical oxygen retail establishment may refill medical
  195  oxygen for an individual patient based on an order from a
  196  practitioner authorized by law to prescribe. A medical oxygen
  197  retail establishment that refills medical oxygen must comply
  198  with all appropriate state and federal good manufacturing
  199  practices.
  200         3. A medical oxygen retail establishment must comply with
  201  all of the wholesale distribution requirements of s. 499.0121.
  202         4. Prescription medical oxygen sold by a medical oxygen
  203  retail establishment pursuant to a practitioner’s order may not
  204  be returned into the retail establishment’s inventory.
  205         (n) Compressed medical gas wholesale distributor permit.—A
  206  compressed medical gas wholesale distributor is a wholesale
  207  distributor that is limited to the wholesale distribution of
  208  compressed medical gases to other than the consumer or patient.
  209  The compressed medical gas must be in the original sealed
  210  container that was purchased by that wholesale distributor. A
  211  compressed medical gas wholesale distributor may not possess or
  212  engage in the wholesale distribution of any prescription drug
  213  other than compressed medical gases. The department shall adopt
  214  rules that govern the wholesale distribution of prescription
  215  medical oxygen for emergency use. With respect to the emergency
  216  use of prescription medical oxygen, those rules may not be
  217  inconsistent with rules and regulations of federal agencies
  218  unless the Legislature specifically directs otherwise.
  219         (o) Compressed medical gas manufacturer permit.—A
  220  compressed medical gas manufacturer permit is required for any
  221  person that engages in the manufacture of compressed medical
  222  gases or repackages compressed medical gases from one container
  223  to another.
  224         1. A compressed medical gas manufacturer may not
  225  manufacture or possess any prescription drug other than
  226  compressed medical gases.
  227         2. A compressed medical gas manufacturer may engage in
  228  wholesale distribution of compressed medical gases manufactured
  229  at that establishment and must comply with all the provisions of
  230  this part and the rules adopted under this part that apply to a
  231  wholesale distributor.
  232         3. A compressed medical gas manufacturer must comply with
  233  all appropriate state and federal good manufacturing practices.
  234         (5) A prescription drug repackager permit issued under this
  235  part is not required for a restricted prescription drug
  236  distributor permitholder that is a health care entity to
  237  repackage prescription drugs in this state for its own use or
  238  for distribution to hospitals or other health care entities in
  239  the state for their own use, pursuant to s. 499.003(53)(a)3. s.
  240  499.003(54)(a)3., if:
  241         (a) The prescription drug distributor notifies the
  242  department, in writing, of its intention to engage in
  243  repackaging under this exemption, 30 days before engaging in the
  244  repackaging of prescription drugs at the permitted
  245  establishment;
  246         (b) The prescription drug distributor is under common
  247  control with the hospitals or other health care entities to
  248  which the prescription drug distributor is distributing
  249  prescription drugs. As used in this paragraph, “common control”
  250  means the power to direct or cause the direction of the
  251  management and policies of a person or an organization, whether
  252  by ownership of stock, voting rights, contract, or otherwise;
  253         (c) The prescription drug distributor repackages the
  254  prescription drugs in accordance with current state and federal
  255  good manufacturing practices; and
  256         (d) The prescription drug distributor labels the
  257  prescription drug it repackages in accordance with state and
  258  federal laws and rules.
  259  
  260  The prescription drug distributor is exempt from the product
  261  registration requirements of s. 499.015 with regard to the
  262  prescription drugs that it repackages and distributes under this
  263  subsection.
  264         Section 4. Paragraph (b) of subsection (2) of section
  265  499.0121, Florida Statutes, is amended to read:
  266         499.0121 Storage and handling of prescription drugs;
  267  recordkeeping.—The department shall adopt rules to implement
  268  this section as necessary to protect the public health, safety,
  269  and welfare. Such rules shall include, but not be limited to,
  270  requirements for the storage and handling of prescription drugs
  271  and for the establishment and maintenance of prescription drug
  272  distribution records.
  273         (2) SECURITY.—
  274         (b) An establishment that is used for wholesale drug
  275  distribution must be equipped with:
  276         1. An alarm system to detect entry after hours; however,
  277  the department may exempt by rule establishments that only hold
  278  a permit as prescription drug wholesale distributor-brokers. and
  279  establishments that only handle medical oxygen; and
  280         2. A security system that will provide suitable protection
  281  against theft and diversion. When appropriate, the security
  282  system must provide protection against theft or diversion that
  283  is facilitated or hidden by tampering with computers or
  284  electronic records.
  285         Section 5. Subsections (1) and (2) of section 499.01211,
  286  Florida Statutes, are amended to read:
  287         499.01211 Drug Wholesale Distributor Advisory Council.—
  288         (1) There is created the Drug Wholesale Distributor
  289  Advisory Council within the department. The council shall meet
  290  at least once each calendar quarter. Staff for the council shall
  291  be provided by the department. The council shall consist of 12
  292  11 members who shall serve without compensation. The council
  293  shall elect a chairperson and a vice chairperson annually.
  294         (2) The Secretary of Business and Professional Regulation
  295  or his or her designee and the Secretary of Health Care
  296  Administration or her or his designee shall be members of the
  297  council. The Secretary of Business and Professional Regulation
  298  shall appoint 10 nine additional members to the council who
  299  shall be appointed to a term of 4 years each, as follows:
  300         (a) Three different persons, each of whom is employed by a
  301  different prescription drug wholesale distributor permitted
  302  licensed under this part which operates nationally and is a
  303  primary wholesale distributor, as defined in s. 499.003 s.
  304  499.003(47).
  305         (b) One person employed by a prescription drug wholesale
  306  distributor permitted licensed under this part which is a
  307  secondary wholesale distributor, as defined in s. 499.003 s.
  308  499.003(52).
  309         (c) One person employed by a retail pharmacy chain located
  310  in this state.
  311         (d) One person who is a member of the Board of Pharmacy and
  312  is a pharmacist licensed under chapter 465.
  313         (e) One person who is a physician licensed pursuant to
  314  chapter 458 or chapter 459.
  315         (f) One person who is an employee of a hospital licensed
  316  pursuant to chapter 395 and is a pharmacist licensed pursuant to
  317  chapter 465.
  318         (g) One person who is an employee of a pharmaceutical
  319  manufacturer.
  320         (h) One person who is an employee of a permitted medical
  321  gas manufacturer or medical gas wholesale distributor and who
  322  has been recommended by the Compressed Gas Association.
  323         Section 6. Paragraph (e) of subsection (1), paragraph (b)
  324  of subsection (2), and paragraph (b) of subsection (3) of
  325  section 499.041, Florida Statutes, are amended to read:
  326         499.041 Schedule of fees for drug, device, and cosmetic
  327  applications and permits, product registrations, and free-sale
  328  certificates.—
  329         (1) The department shall assess applicants requiring a
  330  manufacturing permit an annual fee within the ranges established
  331  in this section for the specific type of manufacturer.
  332         (e) The fee for a compressed medical gas manufacturer
  333  permit may not be less than $400 or more than $500 annually.
  334         (2) The department shall assess an applicant that is
  335  required to have a wholesaling permit an annual fee within the
  336  ranges established in this section for the specific type of
  337  wholesaling.
  338         (b) The fee for a compressed medical gas wholesale
  339  distributor permit may not be less than $200 or more than $300
  340  annually.
  341         (3) The department shall assess an applicant that is
  342  required to have a retail establishment permit an annual fee
  343  within the ranges established in this section for the specific
  344  type of retail establishment.
  345         (b) The fee for a medical oxygen retail establishment
  346  permit may not be less than $200 or more than $300 annually.
  347         Section 7. Section 499.05, Florida Statutes, is amended to
  348  read:
  349         499.05 Rules.—
  350         (1) The department shall adopt rules to implement and
  351  enforce this chapter part with respect to:
  352         (a) The definition of terms used in this chapter part, and
  353  used in the rules adopted under this chapter part, when the use
  354  of the term is not its usual and ordinary meaning.
  355         (b) Labeling requirements for drugs, devices, and
  356  cosmetics.
  357         (c) The establishment of fees authorized in this chapter
  358  part.
  359         (d) The identification of permits that require an initial
  360  application and onsite inspection or other prerequisites for
  361  permitting which demonstrate that the establishment and person
  362  are in compliance with the requirements of this chapter part.
  363         (e) The application processes and forms for product
  364  registration.
  365         (f) Procedures for requesting and issuing certificates of
  366  free sale.
  367         (g) Inspections and investigations conducted under s.
  368  499.051 or s. 499.93 s. 499.051, and the identification of
  369  information claimed to be a trade secret and exempt from the
  370  public records law as provided in s. 499.051(7).
  371         (h) The establishment of a range of penalties, as provided
  372  in s. 499.066; requirements for notifying persons of the
  373  potential impact of a violation of this chapter part; and a
  374  process for the uncontested settlement of alleged violations.
  375         (i) Additional conditions that qualify as an emergency
  376  medical reason under s. 499.003(53)(b)2. or s. 499.82 s.
  377  499.003(54)(b)2.
  378         (j) Procedures and forms relating to the pedigree paper
  379  requirement of s. 499.01212.
  380         (k) The protection of the public health, safety, and
  381  welfare regarding good manufacturing practices that
  382  manufacturers and repackagers must follow to ensure the safety
  383  of the products.
  384         (l) Information required from each retail establishment
  385  pursuant to s.499.012(3) or s 499.83(2)(c) s. 499.012(3),
  386  including requirements for prescriptions or orders.
  387         (m) The recordkeeping, storage, and handling with respect
  388  to each of the distributions of prescription drugs specified in
  389  s. 499.003(53)(a)-(d) or s. 499.82(14) s. 499.003(54)(a)-(d).
  390         (n) Alternatives to compliance with s. 499.01212 for a
  391  prescription drug in the inventory of a permitted prescription
  392  drug wholesale distributor as of June 30, 2006, and the return
  393  of a prescription drug purchased prior to July 1, 2006. The
  394  department may specify time limits for such alternatives.
  395         (o) Wholesale distributor reporting requirements of s.
  396  499.0121(14).
  397         (p) Wholesale distributor credentialing and distribution
  398  requirements of s. 499.0121(15).
  399         (2) With respect to products in interstate commerce, those
  400  rules must not be inconsistent with rules and regulations of
  401  federal agencies unless specifically otherwise directed by the
  402  Legislature.
  403         (3) The department shall adopt rules regulating
  404  recordkeeping for and the storage, handling, and distribution of
  405  medical devices and over-the-counter drugs to protect the public
  406  from adulterated products.
  407         Section 8. Subsections (1) through (4) of section 499.051,
  408  Florida Statutes, are amended to read:
  409         499.051 Inspections and investigations.—
  410         (1) The agents of the department and of the Department of
  411  Law Enforcement, after they present proper identification, may
  412  inspect, monitor, and investigate any establishment permitted
  413  pursuant to this chapter part during business hours for the
  414  purpose of enforcing this chapter part, chapters 465, 501, and
  415  893, and the rules of the department that protect the public
  416  health, safety, and welfare.
  417         (2) In addition to the authority set forth in subsection
  418  (1), the department and any duly designated officer or employee
  419  of the department may enter and inspect any other establishment
  420  for the purpose of determining compliance with this chapter part
  421  and rules adopted under this chapter part regarding any drug,
  422  device, or cosmetic product.
  423         (3) Any application for a permit or product registration or
  424  for renewal of such permit or registration made pursuant to this
  425  chapter part and rules adopted under this chapter part
  426  constitutes permission for any entry or inspection of the
  427  premises in order to verify compliance with this chapter part
  428  and rules; to discover, investigate, and determine the existence
  429  of compliance; or to elicit, receive, respond to, and resolve
  430  complaints and violations.
  431         (4) Any application for a permit made pursuant to s.
  432  499.012 or s. 499.831 and rules adopted under those sections
  433  that section constitutes permission for agents of the department
  434  and the Department of Law Enforcement, after presenting proper
  435  identification, to inspect, review, and copy any financial
  436  document or record related to the manufacture, repackaging, or
  437  distribution of a drug as is necessary to verify compliance with
  438  this chapter part and the rules adopted by the department to
  439  administer this chapter part, in order to discover, investigate,
  440  and determine the existence of compliance, or to elicit,
  441  receive, respond to, and resolve complaints and violations.
  442         Section 9. Subsections (1) through (4) of section 499.066,
  443  Florida Statutes, are amended to read:
  444         499.066 Penalties; remedies.—In addition to other penalties
  445  and other enforcement provisions:
  446         (1) The department may institute such suits or other legal
  447  proceedings as are required to enforce any provision of this
  448  chapter part. If it appears that a person has violated any
  449  provision of this chapter part for which criminal prosecution is
  450  provided, the department may provide the appropriate state
  451  attorney or other prosecuting agency having jurisdiction with
  452  respect to such prosecution with the relevant information in the
  453  department’s possession.
  454         (2) If any person engaged in any activity covered by this
  455  chapter part violates any provision of this chapter part, any
  456  rule adopted under this chapter part, or a cease and desist
  457  order as provided by this chapter part, the department may
  458  obtain an injunction in the circuit court of the county in which
  459  the violation occurred or in which the person resides or has its
  460  principal place of business, and may apply in that court for
  461  such temporary and permanent orders as the department considers
  462  necessary to restrain the person from engaging in any such
  463  activities until the person complies with this chapter part, the
  464  rules adopted under this chapter part, and the orders of the
  465  department authorized by this chapter part or to mandate
  466  compliance with this chapter part, the rules adopted under this
  467  chapter part, and any order or permit issued by the department
  468  under this chapter part.
  469         (3) The department may impose an administrative fine, not
  470  to exceed $5,000 per violation per day, for the violation of any
  471  provision of this chapter part or rules adopted under this
  472  chapter part. Each day a violation continues constitutes a
  473  separate violation, and each separate violation is subject to a
  474  separate fine. All amounts collected pursuant to this section
  475  shall be deposited into the Professional Regulation Trust Fund
  476  and are appropriated for the use of the department in
  477  administering this chapter part. In determining the amount of
  478  the fine to be levied for a violation, the department shall
  479  consider:
  480         (a) The severity of the violation;
  481         (b) Any actions taken by the person to correct the
  482  violation or to remedy complaints; and
  483         (c) Any previous violations.
  484         (4) The department shall deposit any rewards, fines, or
  485  collections that are due the department and which derive from
  486  joint enforcement activities with other state and federal
  487  agencies which relate to this chapter part, chapter 893, or the
  488  federal act, into the Professional Regulation Trust Fund. The
  489  proceeds of those rewards, fines, and collections are
  490  appropriated for the use of the department in administering this
  491  chapter part.
  492         Section 10. Paragraph (a) of subsection (1) and paragraph
  493  (a) of subsection (2) of section 499.0661, Florida Statutes, are
  494  amended to read:
  495         499.0661 Cease and desist orders; removal of certain
  496  persons.—
  497         (1) CEASE AND DESIST ORDERS.—
  498         (a) In addition to any authority otherwise provided in this
  499  chapter, the department may issue and serve a complaint stating
  500  charges upon a any permittee or upon an any affiliated party,
  501  whenever the department has reasonable cause to believe that the
  502  person or individual named therein is engaging in or has engaged
  503  in conduct that is:
  504         1. An act that demonstrates a lack of fitness or
  505  trustworthiness to engage in the business authorized under the
  506  permit issued pursuant to this chapter part, is hazardous to the
  507  public health, or constitutes business operations that are a
  508  detriment to the public health;
  509         2. A violation of a any provision of this chapter part;
  510         3. A violation of a any rule of the department;
  511         4. A violation of an any order of the department; or
  512         5. A breach of a any written agreement with the department.
  513         (2) REMOVAL OF AFFILIATED PARTIES BY THE DEPARTMENT.—
  514         (a) The department may issue and serve a complaint stating
  515  charges upon an any affiliated party and upon the permittee
  516  involved whenever the department has reason to believe that an
  517  affiliated party is engaging in or has engaged in conduct that
  518  constitutes:
  519         1. An act that demonstrates a lack of fitness or
  520  trustworthiness to engage in the business authorized under the
  521  permit issued pursuant to this chapter part, is hazardous to the
  522  public health, or constitutes business operations that are a
  523  detriment to the public health;
  524         2. A willful violation of this chapter part; however, if
  525  the violation constitutes a misdemeanor, a complaint may not be
  526  served as provided in this section until the affiliated party is
  527  notified in writing of the matter of the violation and has been
  528  afforded a reasonable period of time, as set forth in the
  529  notice, to correct the violation and has failed to do so;
  530         3. A violation of a any other law involving fraud or moral
  531  turpitude which constitutes a felony;
  532         4. A willful violation of a any rule of the department;
  533         5. A willful violation of an any order of the department;
  534  or
  535         6. A material misrepresentation of fact, made knowingly and
  536  willfully or made with reckless disregard for the truth of the
  537  matter.
  538         Section 11. Section 499.067, Florida Statutes, is amended
  539  to read:
  540         499.067 Denial, suspension, or revocation of permit,
  541  certification, or registration.—
  542         (1)(a) The department may deny, suspend, or revoke a permit
  543  if it finds that there has been a substantial failure to comply
  544  with this chapter part or chapter 465, chapter 501, or chapter
  545  893, the rules adopted under this part or those chapters, any
  546  final order of the department, or applicable federal laws or
  547  regulations or other state laws or rules governing drugs,
  548  devices, or cosmetics.
  549         (b) The department may deny an application for a permit or
  550  certification, or suspend or revoke a permit or certification,
  551  if the department finds that:
  552         1. The applicant is not of good moral character or that it
  553  would be a danger or not in the best interest of the public
  554  health, safety, and welfare if the applicant were issued a
  555  permit or certification.
  556         2. The applicant has not met the requirements for the
  557  permit or certification.
  558         3. The applicant is not eligible for a permit or
  559  certification for any of the reasons enumerated in s. 499.012.
  560         4. The applicant, permittee, or person certified under s.
  561  499.012(16) demonstrates any of the conditions enumerated in s.
  562  499.012.
  563         5. The applicant, permittee, or person certified under s.
  564  499.012(16) has committed any violation of this chapter ss.
  565  499.005-499.0054.
  566         (2) The department may deny, suspend, or revoke any
  567  registration required by the provisions of this chapter part for
  568  the violation of any provision of this chapter part or of any
  569  rules adopted under this chapter part.
  570         (3) The department may revoke or suspend a permit:
  571         (a) If the permit was obtained by misrepresentation or
  572  fraud or through a mistake of the department;
  573         (b) If the permit was procured, or attempted to be
  574  procured, for any other person by making or causing to be made
  575  any false representation; or
  576         (c) If the permittee has violated any provision of this
  577  chapter part or rules adopted under this chapter part.
  578         (4) If a any permit issued under this chapter part is
  579  revoked or suspended, the owner, manager, operator, or
  580  proprietor of the establishment shall cease to operate as the
  581  permit authorized, from the effective date of the suspension or
  582  revocation until the person is again registered with the
  583  department and possesses the required permit. If a permit is
  584  revoked or suspended, the owner, manager, or proprietor shall
  585  remove all signs and symbols that identify the operation as
  586  premises permitted as a drug wholesaling establishment; drug,
  587  device, or cosmetic manufacturing establishment; or retail
  588  establishment. The department shall determine the length of time
  589  for which the permit is to be suspended. If a permit is revoked,
  590  the person that owns or operates the establishment may not apply
  591  for a any permit under this chapter part for a period of 1 year
  592  after the date of the revocation. A revocation of a permit may
  593  be permanent if the department considers that to be in the best
  594  interest of the public health.
  595         (5) The department may deny, suspend, or revoke a permit
  596  issued under this part which authorizes the permittee to
  597  purchase prescription drugs if an any owner, officer, employee,
  598  or other person who participates in administering or operating
  599  the establishment has been found guilty of a any violation of
  600  this chapter part or chapter 465, chapter 501, or chapter 893,
  601  any rules adopted under this part or those chapters, or any
  602  federal or state drug law, regardless of whether the person has
  603  been pardoned, had her or his civil rights restored, or had
  604  adjudication withheld.
  605         (6) The department shall deny, suspend, or revoke the
  606  permit of a any person or establishment if the assignment, sale,
  607  transfer, or lease of an establishment permitted under this
  608  chapter part will avoid an administrative penalty, civil action,
  609  or criminal prosecution.
  610         (7) Notwithstanding s. 120.60(5), if a permittee fails to
  611  comply with s. 499.012(6) or s. 499.833, as applicable, the
  612  department may revoke the permit of the permittee and shall
  613  provide notice of the intended agency action by posting a notice
  614  at the department’s headquarters and by mailing a copy of the
  615  notice of intended agency action by certified mail to the most
  616  recent mailing address on record with the department and, if the
  617  permittee is not a natural person, to the permittee’s registered
  618  agent on file with the Department of State.
  619         (8) The department may deny, suspend, or revoke a permit
  620  under this part if it finds the permittee has not complied with
  621  the credentialing requirements of s. 499.0121(15).
  622         (9) The department may deny, suspend, or revoke a permit
  623  under this part if it finds the permittee has not complied with
  624  the reporting requirements of, or knowingly made a false
  625  statement in a report required by, s. 499.0121(14).
  626         Section 12. Part III of chapter 499, Florida Statutes,
  627  consisting of ss. 499.81-499.94, Florida Statutes, is created
  628  and entitled “Medical Gas.”
  629         Section 13. Section 499.81, Florida Statutes, is created to
  630  read:
  631         499.81 Administration and enforcement.—
  632         (1) This part is cumulative and shall be construed and
  633  applied as being in addition to, and not in substitution for or
  634  limiting any powers, duties, or authority of the department
  635  under any other law of this state; except that, with respect to
  636  the regulation of medical gas, this part controls over any
  637  conflicting provisions.
  638         (2) The department shall administer and enforce this part
  639  to prevent fraud, adulteration, misbranding, or false
  640  advertising in the manufacture and distribution of medical
  641  gases.
  642         (3) For the purpose of an investigation or proceeding
  643  conducted by the department under this part, the department may
  644  administer oaths, take depositions, subpoena witnesses, and
  645  compel the production of books, papers, documents, or other
  646  records. Challenges to, and enforcement of, subpoenas and orders
  647  shall be handled as provided in s. 120.569.
  648         (4) Each state attorney, county attorney, or municipal
  649  attorney to whom the department or its designated agent reports
  650  a violation of this part shall cause appropriate proceedings to
  651  be instituted in the proper courts without delay and prosecuted
  652  as required by law.
  653         (5) This part does not require the department to report,
  654  for the purpose of instituting proceedings under this part,
  655  minor violations of this part when the department believes that
  656  the public interest will be adequately served by a written
  657  notice or warning.
  658         Section 14. Section 499.82, Florida Statutes, is created to
  659  read:
  660         499.82Definitions.—As used in this part, the term:
  661         (1) “Adulterated,” means a medical gas that:
  662         (a) Consists, in whole or in part, of impurities or
  663  deleterious substances exceeding normal specifications;
  664         (b) Is produced, prepared, packed, or held under conditions
  665  whereby the medical gas may have been contaminated causing it to
  666  be rendered injurious to health; or if the methods used in, or
  667  the facilities or controls used for, its manufacture,
  668  processing, packing, or holding do not conform to or are not
  669  operated or administered in conformity with current good
  670  manufacturing practices to ensure that the medical gas meets the
  671  requirements of this part as to safety and has the identity and
  672  strength and meets the quality and purity characteristics that
  673  the medical gas is represented to possess;
  674         (c) Is held in a container with an interior that is
  675  composed in whole or in part of a poisonous or deleterious
  676  substance that may render the contents injurious to health; or
  677         (d) Is represented as having a strength differing from, or
  678  quality or purity falling below, the standard set forth in the
  679  USP-NF. A medical gas defined in USP-NF may not be deemed to be
  680  adulterated under this paragraph merely because it differs from
  681  the standard of strength, quality, or purity set forth in the
  682  USP-NF if its difference in strength, quality, or purity from
  683  that standard is plainly stated on its label. The determination
  684  as to strength, quality, or purity shall be made:
  685         1. In accordance with the tests or methods of assay in the
  686  USP-NF or its validated equivalent; or
  687         2. In the absence or inadequacy of such tests or methods of
  688  assay, in accordance with the tests or methods of assay
  689  prescribed under the federal act.
  690         (2) “Department” means the Department of Business and
  691  Professional Regulation.
  692         (3) “Distribute” or “distribution” means to sell; offer to
  693  sell; deliver; offer to deliver; transfer by either the passage
  694  of title, physical movement, or both; broker; or give away a
  695  medical gas. The term does not include:
  696         (a) The dispensing or administration of a medical gas;
  697         (b) The delivery of, or an offer to deliver, a medical gas
  698  by a common carrier in its usual course of business; or
  699         (c) Sales activities taking place in a location owned,
  700  controlled, or staffed by persons employed by a person or entity
  701  permitted in this state to distribute a medical gas, if that
  702  location is not used to physically store or move a medical gas.
  703         (4) “Emergency medical reasons” include:
  704         (a) Transfers between wholesale distributors or between a
  705  wholesale distributor and a retail pharmacy or health care
  706  entity to alleviate a temporary shortage of a medical gas
  707  arising from a long-term delay or interruption of regular
  708  distribution schedules.
  709         (b) Sales or transfers to licensed emergency medical
  710  services in this state, including ambulance companies and
  711  firefighting organizations.
  712         (c) The provision of emergency supplies of medical gases to
  713  nursing homes during the hours of the day when necessary medical
  714  gases cannot normally be obtained from the nursing home’s
  715  regular distributors.
  716         (d) The transfer of medical gases between retail pharmacies
  717  to alleviate a temporary shortage.
  718         (5) “Emergency use oxygen” means oxygen USP administered in
  719  emergency situations without a prescription for oxygen
  720  deficiency and resuscitation. The container must be labeled in
  721  accordance with requirements of the United States Food and Drug
  722  Administration.
  723         (6) “Federal act” means the Federal Food, Drug, and
  724  Cosmetic Act.
  725         (7) “Medical gas” means a liquefied or vaporized gas that
  726  is a prescription drug, whether alone or in combination with
  727  other gases, and as defined in the federal act.
  728         (8) “Medical gas-related equipment” means a device used as
  729  a component part or accessory used to contain or control the
  730  flow, delivery, or pressure during the administration of a
  731  medical gas, such as liquid oxygen base and portable units,
  732  pressure regulators and flow meters, and oxygen concentrators.
  733         (9) “Misbranded” means having a label that is false or
  734  misleading; a label without the name and address of the
  735  manufacturer, repackager, or distributor and without an accurate
  736  statement of the quantities of active ingredients; or a label
  737  without an accurate monograph for the medical gas, except in the
  738  case of mixtures of designated medical gases where the label
  739  identifies the component percentages of each designated medical
  740  gas used to make the mixture.
  741         (10) “Medical oxygen” means oxygen USP which must be
  742  labeled in compliance with labeling requirements for oxygen
  743  under the federal act.
  744         (11) “Product labeling” means the labels and other written,
  745  printed, or graphic matter upon an article, or the containers or
  746  wrappers that accompany an article, except for letters, numbers,
  747  and symbols stamped into the container as required by the
  748  federal Department of Transportation.
  749         (12) “USP” means United States Pharmacopeial Convention.
  750         (13) “USP-NF” means United States Pharmacopeia-National
  751  Formulary.
  752         (14) “Wholesale distribution” means the distribution of
  753  medical gas to a person other than a consumer or patient.
  754  Wholesale distribution of medical gases does not include:
  755         (a) The sale, purchase, or trade of a medical gas; an offer
  756  to sell, purchase, or trade a medical gas; or the dispensing of
  757  a medical gas pursuant to a prescription;
  758         (b) Activities exempt from the definition of wholesale
  759  distribution in s. 499.003; or
  760         (c) Other transactions excluded from the definition of
  761  wholesale distribution under the federal act or regulations
  762  implemented under the federal act related to medical gas.
  763         (15) “Wholesale distributor” means any person or entity
  764  engaged in wholesale distribution of medical gas within or into
  765  this state, including, but not limited to, manufacturers; own
  766  label distributors; private-label distributors; warehouses,
  767  including manufacturers’ and distributors’ warehouses; and
  768  wholesale medical gas warehouses.
  769         Section 15. Section 499.83, Florida Statutes, is created to
  770  read:
  771         499.83Permits.—
  772         (1) A person or entity that intends to distribute medical
  773  gas within or into this state, unless exempted under this part,
  774  must obtain the applicable permit before operating as:
  775         (a) A medical gas wholesale distributor;
  776         (b) A medical gas manufacturer; or
  777         (c) A medical oxygen retail establishment.
  778         (2) The following permits are established:
  779         (a) Medical gas wholesale distributor permit.—A medical gas
  780  wholesale distributor permit is required for wholesale
  781  distribution, whether within or into this state. A medical gas
  782  must remain in the original container obtained by the wholesale
  783  distributor and the wholesale distributor may not engage in
  784  further manufacturing operations unless it possesses a medical
  785  gas manufacturer permit. A medical gas wholesale distributor may
  786  not possess or engage in the wholesale distribution of a
  787  prescription drug that is not a medical gas or distribute a
  788  medical gas other than by wholesale distribution unless
  789  otherwise authorized.
  790         (b) Medical gas manufacturer permit.—A medical gas
  791  manufacturer permit is required for a person or entity located
  792  in this state which engages in the manufacture of medical gases
  793  by physical air separation, chemical action, purification, or
  794  filling containers by a liquid-to-liquid, liquid-to-gas, or gas
  795  to-gas process and distributes those medical gases within this
  796  state.
  797         1. A permitted medical gas manufacturer may not manufacture
  798  or possess a prescription drug other than a medical gas, unless
  799  otherwise authorized.
  800         2. A permitted medical gas manufacturer may not distribute
  801  a medical gas without obtaining the applicable permit, except
  802  that it may engage in wholesale distribution of medical gases
  803  that it manufactured without obtaining a medical gas wholesale
  804  distributor permit if it complies with this part and the rules
  805  adopted under this part that apply to a wholesale distributor.
  806         3. A permitted medical gas manufacturer shall comply with
  807  all of the requirements applicable to a wholesale distributor
  808  under this part and all appropriate state and federal good
  809  manufacturing practices.
  810         (c) Medical oxygen retail establishment permit.—A medical
  811  oxygen retail establishment permit is required for an entity
  812  that is located in the state and that dispenses medical oxygen
  813  directly to patients in this state. The sale and delivery must
  814  be based on an order from a practitioner authorized by law to
  815  prescribe. A pharmacy licensed under chapter 465 does not
  816  require a permit as a medical oxygen retail establishment.
  817         1. A medical oxygen retail establishment may not possess,
  818  purchase, sell, or trade a medical gas other than medical
  819  oxygen, unless otherwise authorized.
  820         2. A medical oxygen retail establishment may fill and
  821  deliver medical oxygen to an individual patient based on an
  822  order from a practitioner authorized by law to prescribe. The
  823  medical oxygen retail establishment must comply with all
  824  appropriate state and federal good manufacturing practices.
  825  Medical oxygen sold or delivered by a medical oxygen retail
  826  establishment pursuant to an order from a practitioner may not
  827  be returned into the retail establishment’s inventory.
  828         3. A medical oxygen retail establishment shall comply with
  829  all of the requirements applicable to a wholesale distributor
  830  under this part, except for those requirements that pertain
  831  solely to nitrous oxide.
  832         (3) An out-of-state wholesale distributor that engages in
  833  wholesale distribution into this state must be legally
  834  authorized to engage in the wholesale distribution of medical
  835  gases as a wholesale distributor in the state in which it
  836  resides or is incorporated and provide proof of registration as
  837  set forth in s. 499.93(3), if required.
  838         (4) A wholesale distributor may not operate from a place of
  839  residence, and a place of residence may not be granted a permit
  840  or operate under this part, except for the on-call delivery of
  841  home care oxygen for wholesale distributors that also maintain a
  842  medical oxygen retail establishment permit.
  843         (5) If wholesale distribution is conducted at more than one
  844  location within this state or more than one location
  845  distributing into this state, each location must be permitted by
  846  the department.
  847         Section 16. Section 499.831, Florida Statutes, is created
  848  to read:
  849         499.831Permit application.—
  850         (1) The department shall adopt rules to establish the form
  851  and content of the application to obtain a permit and to renew a
  852  permit listed under this part.
  853         (2) An applicant must be at least 18 years of age or be
  854  managed, controlled, or overseen, directly or indirectly, by a
  855  natural person who is at least 18 years of age.
  856         (3) An application for a permit must be filed with the
  857  department and must include all of the following information:
  858         (a) The trade or business name of the applicant, including
  859  a fictitious name, which may not be identical to a name used by
  860  an unrelated entity permitted in this state to dispense or
  861  distribute medical gas.
  862         (b) The name or names of the owner and operator of the
  863  applicant, if not the same person or entity. The application
  864  must also include:
  865         1. If the applicant is an individual, the applicant’s name,
  866  business address, and date of birth.
  867         2. If the applicant is a sole proprietorship, the business
  868  address of the sole proprietor and the name and federal employer
  869  identification number of the business entity.
  870         3. If the applicant is a partnership, the name, business
  871  address, date of birth of each partner, the name of the
  872  partnership, and the partnership’s federal employer
  873  identification number.
  874         4. If the applicant is a limited liability company, the
  875  name, business address, and title of each company officer, the
  876  name of the limited liability company and federal employer
  877  identification number, and the name of the state in which the
  878  limited liability company was organized.
  879         5. If the applicant is a corporation, the name, business
  880  address, and title of each corporate officer and director, the
  881  corporate names, the state of incorporation, the federal
  882  employer identification number, and, if applicable, the name and
  883  business address of the parent company.
  884         (c) A list of disciplinary actions pertinent to wholesale
  885  distributors, manufacturers, and retailers of prescription drugs
  886  or controlled substances by a state or federal agency against
  887  the applicant seeking to distribute into this state and any such
  888  disciplinary actions against such applicant’s principals,
  889  owners, directors, or officers.
  890         (d) A complete disclosure of all of the applicant’s past
  891  felony convictions.
  892         (e) An address and description of each facility and
  893  warehouse, including all locations used for medical gas storage
  894  or wholesale distribution including a description of each
  895  facility’s security system.
  896         (4) An applicant shall attest in writing that the
  897  information contained in its application is complete and
  898  accurate.
  899         (5) An applicant must submit a reasonable fee, to be
  900  determined by the department, in order to obtain a permit.
  901         (a) The fee for a medical gas wholesale distributor permit
  902  may not be less than $200 or more than $300 annually.
  903         (b) The fee for a medical gas manufacturer permit may not
  904  be less than $400 or more than $500 annually.
  905         (c) The fee for a medical oxygen retail establishment
  906  permit may not be less than $200 or more than $300 annually.
  907         (6) Upon approval of the application by the department and
  908  payment of the required fee, the department shall issue a permit
  909  to the applicant pursuant to the rules adopted under this part.
  910         Section 17. Section 499.832, Florida Statutes, is created
  911  to read:
  912         499.832 Expiration and renewal of a permit.—
  913         (1) A permit issued under this part automatically expires 2
  914  years after the last day of the month in which the permit was
  915  originally issued.
  916         (2) A permit issued under this part may be renewed by
  917  submitting an application for renewal on a form furnished by the
  918  department and paying the appropriate fee. The application for
  919  renewal must contain a statement by the applicant attesting that
  920  the information is true and correct. Upon approval of a renewal
  921  application by the department and payment of the required
  922  renewal fee, the department shall renew a permit issued under
  923  this part pursuant to the rules adopted under this part.
  924         (3) A renewal application may be accepted up to 60 days
  925  after the expiration date of the permit if, along with the
  926  permit renewal fee, the applicant submits an additional renewal
  927  delinquent fee of $100. A permit that expired more than 60 days
  928  before a renewal application was submitted or postmarked may not
  929  be renewed.
  930         (4) Failure to renew a permit in accordance with this
  931  section precludes future renewal. If a permit has expired and
  932  cannot be renewed, the person, entity, or establishment holding
  933  the permit must cease all permit related activities. In order to
  934  engage in activities that require a permit the person, entity,
  935  or establishment must submit an application for a new permit,
  936  pay the applicable application fee, the initial permit fee, and
  937  all applicable penalties, and be issued a new permit by the
  938  department before engaging in an activity that requires a permit
  939  under this part.
  940         (5) The department shall adopt rules to administer this
  941  section, including setting a reasonable fee for a renewal
  942  application.
  943         Section 18. Section 499.833, Florida Statutes, is created
  944  to read:
  945         499.833Permitholder changes.—
  946         (1) A permit issued under this part is valid only for the
  947  person or entity to which it is issued and is not subject to
  948  sale, assignment, or other transfer, voluntarily or
  949  involuntarily.
  950         (2) A permit issued under this part is not valid for an
  951  establishment other than the establishment for which it was
  952  originally issued.
  953         (3) The department may approve the following permit
  954  changes:
  955         (a)Change of location.A person or entity permitted under
  956  this part must notify and receive approval from the department
  957  before changing location. The department shall set a change-of
  958  location fee not to exceed $100.
  959         (b)Change in ownership.—If a majority of the ownership or
  960  controlling interest of a permitted establishment is transferred
  961  or assigned or if a lessee agrees to undertake or provide
  962  services such that legal liability for operation of the
  963  establishment will rest with the lessee, an application for a
  964  new permit is required. Such application must be submitted and
  965  approved by the department before the change of ownership takes
  966  place. However, if a permitted wholesale distributor or
  967  manufacturer is changing ownership and the new owner has held
  968  another permit that allows the wholesale distribution of medical
  969  gas under this chapter for the preceding 18 months without
  970  having been found in violation of the provisions of this chapter
  971  relating to medical gases, then the new owner may operate under
  972  the permit of the acquired entity if the new owner submits the
  973  application for a new permit by the first business day after
  974  ownership is transferred or assigned. A new owner operating
  975  under the original permit is responsible for compliance with all
  976  laws and regulations governing medical gas. If the application
  977  is denied, the new owner shall immediately cease operation at
  978  the establishment until a permit is issued to the new owner.
  979         (c)Change of name.—A permitholder may make a change of
  980  business name without submitting a new permit application.
  981  However, the permitholder must notify the department before
  982  making the name change.
  983         (d)Closure.—If an establishment permitted under this part
  984  closes, the owner must notify the department, in writing, before
  985  the effective date of the closure and must:
  986         1. Return the permit to the department; and
  987         2. Indicate the disposition of any medical gas authorized
  988  to be distributed or dispensed under the permit, including the
  989  name, address, and inventory, and provide the name and address
  990  of a person to contact regarding access to the records that are
  991  required to be maintained under this part. Transfer of ownership
  992  of medical gas may be made only to persons authorized to receive
  993  medical gas pursuant to this part.
  994         (e) Change in information.—Any change in the information
  995  required under this part, other than the changes in paragraphs
  996  (a)-(d), shall be submitted to the department within 30 days
  997  after such change occurs.
  998         (4) A permitholder in good standing may change the type of
  999  permit issued by completing a new application for the requested
 1000  permit, meeting the applicable permitting requirements for the
 1001  new permit type, and paying any difference between the permit
 1002  fees. A refund may not be issued if the fee for the new permit
 1003  is less than the fee that was paid for the original permit. The
 1004  new permit retains the expiration date of the original permit.
 1005         Section 19. Section 499.834, Florida Statutes, is created
 1006  to read:
 1007         499.834Minimum qualifications.—The department shall
 1008  consider all of the following factors in determining eligibility
 1009  for, and renewal of, a permit for a person or entity under this
 1010  part:
 1011         (1) A finding by the department that the applicant has
 1012  violated or been disciplined by a regulatory agency in any state
 1013  for violating a federal, state, or local law relating to
 1014  prescription drugs.
 1015         (2) Felony convictions of the applicant under a federal,
 1016  state, or local law.
 1017         (3) The applicant’s past experience in the manufacture,
 1018  retail, or distribution of medical gases.
 1019         (4) False or fraudulent material provided by the applicant
 1020  in an application made in connection with the manufacturing,
 1021  retailing, or distribution of prescription drugs.
 1022         (5) Any suspension, sanction, or revocation by a federal,
 1023  state, or local government against a license or permit currently
 1024  or previously held by the applicant or its owners for violations
 1025  of a federal, state, or local law regarding prescription drugs.
 1026         (6) Compliance with previously granted licenses or permits.
 1027         (7) Compliance with the requirements that distributors or
 1028  retailers of medical gases maintain records and make records
 1029  available to the department licensing authority or federal,
 1030  state, or local law enforcement officials.
 1031         (8) Other factors or qualifications the department
 1032  considers relevant to and consistent with the public health and
 1033  safety.
 1034         Section 20. Section 499.84, Florida Statutes, is created to
 1035  read:
 1036         499.84Minimum requirements for the storage and handling of
 1037  medical gases.—
 1038         (1) A facility where a medical gas is received, stored,
 1039  warehoused, handled, held, offered, marketed, displayed, or
 1040  transported, to avoid any negative effect on the identity,
 1041  strength, quality, or purity of the medical gas, must:
 1042         (a) Be of suitable construction to ensure that medical
 1043  gases are maintained in accordance with the product labeling of
 1044  the medical gas or in compliance with the USP-NF;
 1045         (b) Be of suitable size and construction to facilitate
 1046  cleaning, maintenance, and proper permitted operations;
 1047         (c) Have adequate storage areas with appropriate lighting,
 1048  ventilation, space, equipment, and security conditions.
 1049         (d) Have a quarantined area for storage of medical gases
 1050  that are suspected of being misbranded, adulterated, or
 1051  otherwise unfit for distribution;
 1052         (e) Be maintained in an orderly condition;
 1053         (f) Be located in a commercial location and not in a
 1054  personal dwelling or residence location, except that a personal
 1055  dwelling location used for on-call delivery of oxygen USP for
 1056  homecare use if the person providing on-call delivery is
 1057  employed by or acting under a written contract with an entity
 1058  that holds a medical oxygen retailer permit;
 1059         (g) Provide for the secure and confidential storage of
 1060  patient information, if applicable, with restricted access and
 1061  policies and procedures to protect the integrity and
 1062  confidentiality of patient information; and
 1063         (h) Provide and maintain appropriate inventory controls to
 1064  detect and document any theft of nitrous oxide.
 1065         (2) Medical gas shall be stored under appropriate
 1066  conditions in accordance with the manufacturer’s recommendations
 1067  on product labeling and department rules or, in the absence of
 1068  rules, in accordance with applicable industry standards.
 1069         (3) Medical gas shall be packaged in accordance with
 1070  official compendium standards, such as the USP-NF.
 1071         Section 21. Section 499.85, Florida Statutes, is created to
 1072  read:
 1073         499.85Security.—
 1074         (1) A permitholder that has a facility used for the
 1075  distribution or retailing of medical gases shall protect such
 1076  gases from unauthorized access by implementing all of the
 1077  following security measures:
 1078         (a) Keeping access from outside the premises well
 1079  controlled and to a minimum.
 1080         (b) Ensuring the outside perimeter of the premises is well
 1081  lit.
 1082         (c) Limiting access into areas where medical gases are held
 1083  to authorized personnel.
 1084         (d) Equipping all facilities with a fence or other system
 1085  to detect or deter entry after hours.
 1086         (2) A facility used for distributing or retailing medical
 1087  gases shall be equipped with a system that provides suitable
 1088  protection against theft, including if appropriate, protection
 1089  against theft of computers or electronic records and the
 1090  protection of the integrity and confidentiality of data and
 1091  documents.
 1092         (3) A facility used for wholesale distribution of medical
 1093  gases shall be equipped with inventory management and control
 1094  systems that protect against, detect, and document any instances
 1095  of theft of nitrous oxide.
 1096         (4) If a wholesale distributor uses electronic distribution
 1097  records, the wholesale distributor shall employ, train, and
 1098  document the training of personnel in the proper use of such
 1099  technology and equipment.
 1100         (5) Vehicles used for on-call delivery of oxygen USP and
 1101  oxygen-related equipment for home care use by home care
 1102  providers may be parked at a place of residence and must be
 1103  locked and equipped with an audible alarm when not attended.
 1104         (6) The department shall adopt rules that govern the
 1105  distribution of medical oxygen for emergency use by persons
 1106  authorized to receive emergency use oxygen. Unless the laws of
 1107  this state specifically direct otherwise, such rules must be
 1108  consistent with federal regulations, including the labeling
 1109  requirements of oxygen under the federal act.
 1110         Section 22. Section 499.86, Florida Statutes, is created to
 1111  read:
 1112         499.86Examination of materials.—
 1113         (1) A wholesale distributor must visually examine a medical
 1114  gas container upon receipt from the manufacturer in order to
 1115  identify the medical gas stored within and to determine if the
 1116  container has been damaged or is otherwise unfit for
 1117  distribution. Such examination must occur in a manner that would
 1118  reveal damage to the container which could suggest possible
 1119  adulteration or misbranding.
 1120         (2) A medical gas container that is found to be damaged or
 1121  otherwise unfit pursuant to subsection (1) must be quarantined
 1122  from the stock of medical gas until a determination is made that
 1123  the medical gas in question is not misbranded or adulterated.
 1124         (3) An outgoing shipment must be inspected to identify the
 1125  medical gases in the shipment to ensure that medical gas
 1126  containers that have been damaged in storage or held under
 1127  improper conditions are not distributed or dispensed.
 1128         (4) A wholesale distributor must review records documenting
 1129  the acquisition of medical gas upon receipt for accuracy and
 1130  completeness.
 1131         Section 23. Section 499.87, Florida Statutes, is created to
 1132  read:
 1133         499.87Returned, damaged, and outdated medical gas.—
 1134         (1) A medical gas that has left the control of the
 1135  wholesale distributor may be returned to the wholesale
 1136  distributor or manufacturer from which it was acquired, but may
 1137  not be resold as a medical gas unless it is reprocessed by a
 1138  manufacturer using proper and adequate controls to ensure the
 1139  identity, strength, quality, and purity of the reprocessed
 1140  medical gas.
 1141         (2) A medical gas that has been subjected to improper
 1142  conditions, such as a fire, accident, or natural disaster, may
 1143  not be salvaged or reprocessed.
 1144         (3) A medical gas, including its container, which is
 1145  damaged, misbranded, or adulterated must be quarantined from
 1146  other medical gases until it is destroyed or returned to the
 1147  manufacturer or wholesale distributor from which it was
 1148  acquired. External contamination of a medical gas container or
 1149  closure system which does not impact the integrity of the
 1150  medical gas is not considered damaged or adulterated for
 1151  purposes of this subsection. If a medical gas is adulterated or
 1152  misbranded or suspected of being adulterated or misbranded,
 1153  notice shall be provided to the manufacturer or wholesale
 1154  distributor from which the medical gas was acquired and to the
 1155  appropriate boards and federal regulatory bodies.
 1156         (4) A medical gas container that has been opened or used
 1157  but is not adulterated or misbranded is considered empty and
 1158  must be quarantined from nonempty medical gas containers and
 1159  returned to the manufacturer or wholesale distributor from which
 1160  it was acquired for destruction or reprocessing.
 1161         (5) A medical gas, its container, or its associated
 1162  documentation or labeling that is suspected of being used in
 1163  criminal activity must be retained until its disposition is
 1164  authorized by the department or an applicable law enforcement
 1165  agency.
 1166         Section 24. Section 499.88, Florida Statutes, is created to
 1167  read:
 1168         499.88Due diligence.
 1169         (1) A wholesale distributor shall obtain, before the
 1170  initial acquisition of medical gas, the following information
 1171  from the supplying wholesale distributor or manufacturer:
 1172         (a) If a manufacturer is distributing to a wholesale
 1173  distributor, evidence that the manufacturer is registered and
 1174  the medical gas is listed with the United States Food and Drug
 1175  Administration;
 1176         (b) If a wholesale distributor is distributing to a
 1177  wholesale distributor, evidence that the wholesale distributor
 1178  supplying the medical gas is legally authorized to distribute
 1179  medical gas within or into the state;
 1180         (c) The name of the responsible facility contact person for
 1181  the supplying manufacturer or wholesale distributor; and
 1182         (d) Certification that the manufacturer’s or wholesale
 1183  distributor’s policies and procedures comply with this part.
 1184         (2) A wholesale distributor is exempt from obtaining the
 1185  information from a manufacturer, as required under subsection
 1186  (1), if the manufacturer is registered with the United States
 1187  Food and Drug Administration in accordance with s. 510 of the
 1188  federal act and the manufacturer provides:
 1189         (a) Proof of such registration; and
 1190         (b) Proof of inspection by the United States Food and Drug
 1191  Administration or other regulatory body within the past 3 years
 1192  demonstrating substantial compliance with current good
 1193  manufacturing practices applicable to medical gases.
 1194         (3) A manufacturer or wholesale distributor that
 1195  distributes to or acquires medical gas from another wholesale
 1196  distributor shall provide to or obtain from the distributing or
 1197  acquiring manufacturer or distributor the information required
 1198  by s. 499.89(1), as applicable.
 1199         Section 25. Section 499.89, Florida Statutes, is created to
 1200  read:
 1201         499.89Recordkeeping.—
 1202         (1) A permitholder under this part shall establish and
 1203  maintain a record of transactions regarding the receipt and the
 1204  distribution, or other disposition, of medical gases, as
 1205  applicable. Such records constitute an audit trail and must
 1206  contain information sufficient to perform a recall of medical
 1207  gas in compliance with 21 C.F.R. s. 211.196 and 21 C.F.R. s.
 1208  820.160(b). Such records must include all of the following
 1209  information, which may be kept in two separate documents one
 1210  related to the distribution of medical gas and the other related
 1211  to the receipt of medical gas:
 1212         (a) The dates of receipt and distribution or other
 1213  disposition of the medical gas.
 1214         (b) The name, address, license or permit number and its
 1215  expiration date for the person or entity purchasing the medical
 1216  gas from the wholesale distributor.
 1217         (c) The name, address, license or permit number and its
 1218  expiration date for the person or entity receiving the medical
 1219  gas, if different from the information required under paragraph
 1220  (b).
 1221         (d) Information sufficient to perform a recall of all
 1222  medical gas received, distributed, or dispensed.
 1223         (2) Such records shall be made available for inspection and
 1224  copying by an authorized official of any federal, state, or
 1225  local governmental agency for a period of:
 1226         (a) Three years following the distribution date of high
 1227  pressure medical gases.
 1228         (b) Two years following the distribution date for cryogenic
 1229  or refrigerated liquid medical gases.
 1230         (3) Records kept at the inspection site or that can be
 1231  immediately retrieved by computer or other electronic means
 1232  shall be readily available for authorized inspection during the
 1233  retention period. Records kept at a central location apart from
 1234  the inspection site and not electronically retrievable shall be
 1235  made available for inspection within 2 working days of a request
 1236  by an authorized official of any state or federal governmental
 1237  agency charged with enforcement of these rules.
 1238         (4) A pedigree paper is not required for distributing or
 1239  dispensing medical gas.
 1240         (5) A wholesale distributor shall maintain records
 1241  sufficient to aid in the mandatory reporting of any theft,
 1242  suspected theft, or other significant loss of nitrous oxide to
 1243  the department and other appropriate law enforcement agencies.
 1244         Section 26. Section 499.90, Florida Statutes, is created to
 1245  read:
 1246         499.90Policies and procedures.—A wholesale distributor
 1247  shall establish, maintain, and adhere to written policies and
 1248  procedures for the receipt, security, storage, transport,
 1249  shipping, and distribution of medical gases and shall establish,
 1250  maintain, and adhere to procedures for maintaining inventories;
 1251  for identifying, recording, and reporting losses or thefts; and
 1252  for correcting all errors and inaccuracies in inventories
 1253  associated with nitrous oxide. A wholesale distributor shall
 1254  include in its written policies and procedures the following:
 1255         (1) A procedure for handling recalls and withdrawals of
 1256  medical gas. Such procedure must deal with recalls and
 1257  withdrawals due to:
 1258         (a) Action initiated at the request of the United States
 1259  Food and Drug Administration or any federal, state, or local law
 1260  enforcement or other government agency, including the
 1261  department; or
 1262         (b) Voluntary action by a manufacturer of medical gases to
 1263  remove defective or potentially defective medical gases from the
 1264  market.
 1265         (2) A procedure that includes preparation for, protection
 1266  against, and responding to a crisis that affects the security or
 1267  operation of a facility that stores medical gases in the event
 1268  of a strike; a fire, flood, or other natural disaster; or other
 1269  local, state, or national emergency.
 1270         (3) A procedure for reporting criminal or suspected
 1271  criminal activity involving the inventory of nitrous oxide to
 1272  the department and to applicable law enforcement agencies within
 1273  3 business days after becoming aware of the criminal or
 1274  suspected criminal activity.
 1275         Section 27. Section 499.91, Florida Statutes, is created to
 1276  read:
 1277         499.91Prohibited acts.—A person may not perform or cause
 1278  the performance of, or aid and abet in, any of the following
 1279  acts in this state:
 1280         (1) The manufacture, sale, or delivery, or the holding or
 1281  offering for sale, of a medical gas that is adulterated,
 1282  misbranded, or is otherwise unfit for distribution.
 1283         (2) The adulteration or misbranding of a medical gas.
 1284         (3) The receipt of a medical gas that is adulterated,
 1285  misbranded, stolen, or obtained by fraud or deceit, or the
 1286  delivery or proffered delivery of such medical gas for pay or
 1287  otherwise.
 1288         (4) The alteration, mutilation, destruction, obliteration,
 1289  or removal of all or any part of the product labeling of a
 1290  medical gas, or the willful commission of any other act with
 1291  respect to a medical gas that results in it being misbranded.
 1292         (5) The purchase or receipt of a medical gas from a person
 1293  not authorized to distribute or dispense medical gas or who is
 1294  not exempted from permitting requirements to wholesale
 1295  distribute medical gas to such purchaser or recipient.
 1296         (6) The knowing and willful sale or transfer of a medical
 1297  gas to a recipient who is not legally authorized to receive a
 1298  medical gas, except that a violation does not exist if a
 1299  permitted wholesale distributor provides oxygen to a permitted
 1300  medical oxygen retail establishment that is out of compliance
 1301  with the notice of location change requirements of s. 499.834,
 1302  provided that the wholesale distributor with knowledge of the
 1303  violation notifies the department of the transaction by the next
 1304  business day.
 1305         (7) The failure to maintain or provide records required
 1306  under this part and the rules adopted under this part.
 1307         (8) Providing the department or any of its representatives
 1308  or any state or federal official with false or fraudulent
 1309  records or making false or fraudulent statements regarding this
 1310  part or the rules adopted under this part.
 1311         (9) The distribution of a medical gas that was:
 1312         (a)Purchased by a public or private hospital or other
 1313  health care entity, except for the physical distribution of such
 1314  medical gas to an authorized recipient at the direction of a
 1315  hospital or other health care entity;
 1316         (b) Donated or supplied at a reduced price to a charitable
 1317  organization; or
 1318         (c) Stolen or obtained by fraud or deceit.
 1319         (10) The failure to obtain a license or permit or operating
 1320  without a valid license or permit, if one is required.
 1321         (11) The obtaining of, or attempt to obtain, a medical gas
 1322  by fraud, deceit, or misrepresentation or engaging in
 1323  misrepresentation or fraud in the distribution of a medical gas.
 1324         (12) Except for emergency use oxygen, the distribution of a
 1325  medical gas to a patient without a prescription from a
 1326  practitioner authorized by law to prescribe a medical gas.
 1327         (13) The distribution or dispensing of a medical gas that
 1328  was previously dispensed by a pharmacy or a practitioner
 1329  authorized by law to prescribe.
 1330         (14) The distribution or dispensing of a medical gas or
 1331  medical gas-related equipment to a patient, unless the patient
 1332  has been provided with the appropriate information and
 1333  counseling on the use, storage, and disposal the medical gas.
 1334         (15) Failure to report an act prohibited under this part or
 1335  the rules adopted under this part.
 1336         (16) Failure to exercise due diligence as provided in s.
 1337  499.88.
 1338         Section 28. Section 499.92, Florida Statutes, is created to
 1339  read:
 1340         499.92Criminal acts.—
 1341         (1) A person commits a felony of the third degree,
 1342  punishable as provided in s. 775.082, s. 775.083, or s. 775.084,
 1343  if he or she:
 1344         (a) Adulterates or misbrands a medical gas with intent to
 1345  defraud or deceive;
 1346         (b) Knowingly purchases or receives a medical gas from a
 1347  person not legally authorized to distribute or dispense medical
 1348  gas;
 1349         (c) Knowingly engages in the wholesale distribution of, or
 1350  sells, barters, brokers, or transfers, a medical gas to a person
 1351  not legally authorized to purchase or receive medical gas in the
 1352  jurisdiction in which the person receives the medical gas. A
 1353  permitted wholesale distributor that, at its location, provides
 1354  oxygen to a permitted medical oxygen retail establishment that
 1355  is out of compliance with only the change of location notice
 1356  requirement under s. 499.834, does not commit a violation of
 1357  this subsection if the wholesale distributor notifies the
 1358  department of the transaction no later than the next business
 1359  day; or
 1360         (d) Knowingly falsely creates a label for a medical gas or
 1361  knowingly falsely misrepresents a factual matter contained in a
 1362  label for a medical gas.
 1363         (2) A person found guilty of an offense under this section,
 1364  under the authority of the court convicting and sentencing the
 1365  person, shall be ordered to forfeit to the state any real or
 1366  personal property:
 1367         (a) Used or intended to be used to commit, to facilitate,
 1368  or to promote the commission of such offense; and
 1369         (b) Constituting, derived from, or traceable to the gross
 1370  proceeds that the defendant obtained directly or indirectly as a
 1371  result of the offense.
 1372         (3) Property or assets subject to forfeiture under
 1373  subsection (2) may be seized pursuant to a warrant obtained in
 1374  the same manner as a search warrant or as otherwise authorized
 1375  by law, and held until the case against a defendant is
 1376  adjudicated. Monies ordered forfeited, or proceeds from the sale
 1377  of other assets ordered forfeited, shall be equitably divided
 1378  between the department and other agencies involved in the
 1379  investigation and prosecution that led to the conviction. Other
 1380  property ordered forfeited after conviction of a defendant may,
 1381  at the discretion of the investigating agencies, be placed into
 1382  official use by the department or the agencies involved in the
 1383  investigation and prosecution that led to the conviction.
 1384         Section 29. Section 499.93, Florida Statutes, is created to
 1385  read:
 1386         499.93Inspections.—
 1387         (1) The department may require a facility that engages in
 1388  the manufacture, retail sale, or wholesale distribution of
 1389  medical gas to undergo an inspection in accordance with a
 1390  schedule to be determined by the department, including
 1391  inspections for initial permitting, permit renewal, and a
 1392  permitholder’s change of location. The department may recognize
 1393  a third party to inspect wholesale distributors in this state or
 1394  other states pursuant to a schedule to be determined by the
 1395  department.
 1396         (2) The department may recognize another state’s
 1397  inspections of a manufacturer or wholesale distributor located
 1398  in that state if such state’s laws are deemed to be
 1399  substantially equivalent to the laws of this state by the
 1400  department.
 1401         (3) A manufacturing facility of medical gases is exempt
 1402  from inspection by the department if:
 1403         (a) The manufacturing facility is currently registered with
 1404  the United States Food and Drug Administration under s. 510 of
 1405  the federal act and can provide proof of registration, such as a
 1406  copy of the Internet verification page; and
 1407         (b) The manufacturing facility can provide proof of
 1408  inspection by the Food and Drug Administration, or if the
 1409  facility is located in another state, inspection by the Food and
 1410  Drug Administration or other governmental entity charged with
 1411  regulation of good manufacturing practices related to medical
 1412  gases in that state within the past 3 years, which demonstrates
 1413  substantial compliance with current good manufacturing practices
 1414  applicable to medical gases.
 1415         (4) A permitholder under this part shall exhibit or have
 1416  readily available its state permits and its most recent
 1417  inspection report administered by the department.
 1418         Section 30. Section 499.931, Florida Statutes, is created
 1419  to read:
 1420         499.931 Trade secret information.—Information required to
 1421  be submitted under this part which is a trade secret as defined
 1422  in s. 812.081(1)(c) and designated as a trade secret by an
 1423  applicant or permitholder must be maintained as required under
 1424  s. 499.051.
 1425         Section 31. Section 499.94, Florida Statutes, is created to
 1426  read:
 1427         499.94Fees.—A fee collected for a permit under this part
 1428  shall be deposited into the Professional Regulation Trust Fund.
 1429  Moneys collected under this part shall be used for administering
 1430  this part. The department shall maintain a separate account in
 1431  the trust fund for the Drugs, Devices, and Cosmetics program.
 1432         Section 32. Paragraph (a) of subsection (1) of section
 1433  409.9201, Florida Statutes, is amended to read:
 1434         409.9201 Medicaid fraud.—
 1435         (1) As used in this section, the term:
 1436         (a) “Prescription drug” means any drug, including, but not
 1437  limited to, finished dosage forms or active ingredients that are
 1438  subject to, defined in by, or described in by s. 503(b) of the
 1439  Federal Food, Drug, and Cosmetic Act or in by s. 465.003(8), s.
 1440  499.003(52), s. 499.003(46) or (53) or s. 499.007(13), or s.
 1441  499.82(10).
 1442  
 1443  The value of individual items of the legend drugs or goods or
 1444  services involved in distinct transactions committed during a
 1445  single scheme or course of conduct, whether involving a single
 1446  person or several persons, may be aggregated when determining
 1447  the punishment for the offense.
 1448         Section 33. Paragraph (c) of subsection (9) of section
 1449  460.403, Florida Statutes, is amended to read:
 1450         460.403 Definitions.—As used in this chapter, the term:
 1451         (9)
 1452         (c)1. Chiropractic physicians may adjust, manipulate, or
 1453  treat the human body by manual, mechanical, electrical, or
 1454  natural methods; by the use of physical means or physiotherapy,
 1455  including light, heat, water, or exercise; by the use of
 1456  acupuncture; or by the administration of foods, food
 1457  concentrates, food extracts, and items for which a prescription
 1458  is not required and may apply first aid and hygiene, but
 1459  chiropractic physicians are expressly prohibited from
 1460  prescribing or administering to any person any legend drug
 1461  except as authorized under subparagraph 2., from performing any
 1462  surgery except as stated herein, or from practicing obstetrics.
 1463         2. Notwithstanding the prohibition against prescribing and
 1464  administering legend drugs under subparagraph 1. or s.
 1465  499.83(2)(c) s. 499.01(2)(m), pursuant to board rule
 1466  chiropractic physicians may order, store, and administer, for
 1467  emergency purposes only at the chiropractic physician’s office
 1468  or place of business, prescription medical oxygen and may also
 1469  order, store, and administer the following topical anesthetics
 1470  in aerosol form:
 1471         a. Any solution consisting of 25 percent ethylchloride and
 1472  75 percent dichlorodifluoromethane.
 1473         b. Any solution consisting of 15 percent
 1474  dichlorodifluoromethane and 85 percent
 1475  trichloromonofluoromethane.
 1476  
 1477  However, this paragraph does not authorize a chiropractic
 1478  physician to prescribe medical oxygen as defined in chapter 499.
 1479         Section 34. Subsection (3) of section 465.0265, Florida
 1480  Statutes, is amended to read:
 1481         465.0265 Centralized prescription filling.—
 1482         (3) The filling, delivery, and return of a prescription by
 1483  one pharmacy for another pursuant to this section shall not be
 1484  construed as the filling of a transferred prescription as
 1485  described set forth in s. 465.026 or as a wholesale distribution
 1486  as defined set forth in s. 499.003 s. 499.003(54).
 1487         Section 35. Paragraph (b) of subsection (2) of section
 1488  499.01212, Florida Statutes, is amended to read:
 1489         499.01212 Pedigree paper.—
 1490         (2) FORMAT.—A pedigree paper must contain the following
 1491  information:
 1492         (b) For all other wholesale distributions of prescription
 1493  drugs:
 1494         1. The quantity, dosage form, and strength of the
 1495  prescription drugs.
 1496         2. The lot numbers of the prescription drugs.
 1497         3. The name and address of each owner of the prescription
 1498  drug and his or her signature.
 1499         4. Shipping information, including the name and address of
 1500  each person certifying delivery or receipt of the prescription
 1501  drug.
 1502         5. An invoice number, a shipping document number, or
 1503  another number uniquely identifying the transaction.
 1504         6. A certification that the recipient wholesale distributor
 1505  has authenticated the pedigree papers.
 1506         7. The unique serialization of the prescription drug, if
 1507  the manufacturer or repackager has uniquely serialized the
 1508  individual prescription drug unit.
 1509         8. The name, address, telephone number, and, if available,
 1510  e-mail contact information of each wholesale distributor
 1511  involved in the chain of the prescription drug’s custody.
 1512  
 1513  When an affiliated group member obtains title to a prescription
 1514  drug before distributing the prescription drug as the
 1515  manufacturer as defined in s. 499.003(30)(e) under s.
 1516  499.003(31)(e), information regarding the distribution between
 1517  those affiliated group members may be omitted from a pedigree
 1518  paper required under this paragraph for subsequent distributions
 1519  of that prescription drug.
 1520         Section 36. Paragraph (a) of subsection (1) and subsection
 1521  (3) of section 499.015, Florida Statutes, are amended to read:
 1522         499.015 Registration of drugs, devices, and cosmetics;
 1523  issuance of certificates of free sale.—
 1524         (1)(a) Except for those persons exempted from the
 1525  definition of manufacturer in s. 499.003 s. 499.003(31), any
 1526  person who manufactures, packages, repackages, labels, or
 1527  relabels a drug, device, or cosmetic in this state must register
 1528  such drug, device, or cosmetic biennially with the department;
 1529  pay a fee in accordance with the fee schedule provided by s.
 1530  499.041; and comply with this section. The registrant must list
 1531  each separate and distinct drug, device, or cosmetic at the time
 1532  of registration.
 1533         (3) Except for those persons exempted from the definition
 1534  of manufacturer in s. 499.003 s. 499.003(31), a person may not
 1535  sell any product that he or she has failed to register in
 1536  conformity with this section. Such failure to register subjects
 1537  such drug, device, or cosmetic product to seizure and
 1538  condemnation as provided in s. 499.062, and subjects such person
 1539  to the penalties and remedies provided in this part.
 1540         Section 37. Subsection (3) of section 499.024, Florida
 1541  Statutes, is amended to read:
 1542         499.024 Drug product classification.—The department shall
 1543  adopt rules to classify drug products intended for use by humans
 1544  which the United States Food and Drug Administration has not
 1545  classified in the federal act or the Code of Federal
 1546  Regulations.
 1547         (3) Any product that falls under the definition of drug in
 1548  s. 499.003 s. 499.003(19) may be classified under the authority
 1549  of this section. This section does not subject portable
 1550  emergency oxygen inhalators to classification; however, this
 1551  section does not exempt any person from ss. 499.01 and 499.015.
 1552         Section 38. This act shall take effect October 1, 2014.
 1553  
 1554  ================= T I T L E  A M E N D M E N T ================
 1555  And the title is amended as follows:
 1556         Delete everything before the enacting clause
 1557  and insert:
 1558                        A bill to be entitled                      
 1559         An act relating to medical gas; amending s. 499.001,
 1560         F.S.; conforming provisions to changes made by this
 1561         act; amending s. 499.003, F.S.; revising terms;
 1562         amending ss. 499.01 and 499.0121, F.S.; conforming
 1563         provisions to changes made by this act; amending s.
 1564         499.01211, F.S.; adding a member of to the Drug
 1565         Wholesale Distributor Advisory Council; authorizing
 1566         the Compressed Gas Association to recommend one person
 1567         to the council for appointment; amending ss. 499.041,
 1568         499.05, 499.051, 499.066, 499.0661, and 499.067, F.S.;
 1569         conforming provisions to changes made by this act;
 1570         creating part III of ch. 499, F.S., entitled “Medical
 1571         Gas”; creating s. 499.81, F.S.; providing for the
 1572         administration and enforcement of this part; creating
 1573         s. 499.82, F.S.; defining terms; creating s. 499.83,
 1574         F.S.; requiring a person or entity that intends to
 1575         distribute medical gas within or into this state to
 1576         obtain an applicable permit before operating;
 1577         establishing categories of permits and setting
 1578         requirements for each; creating s. 499.831, F.S.;
 1579         requiring the Department of Business and Professional
 1580         Regulation to establish the form and content of an
 1581         application; authorizing the department to set fees
 1582         within certain parameters; creating s. 499.832, F.S.;
 1583         providing that a permit expires 2 years after the last
 1584         day of the month in which the permit was originally
 1585         issued; providing requirements for the renewal of a
 1586         permit; requiring the department to adopt rules for
 1587         the renewal of permits; creating s. 499.833, F.S.;
 1588         authorizing the department to approve certain
 1589         permitholder changes; creating s. 499.834, F.S.;
 1590         authorizing the department to consider certain factors
 1591         in determining the eligibility of an applicant;
 1592         creating s. 499.84, F.S.; setting the minimum
 1593         requirements for the storage and handling of medical
 1594         gas; creating s. 499.85, F.S.; setting facility
 1595         requirements for security purposes; authorizing a
 1596         vehicle used for on-call delivery of oxygen USP and
 1597         oxygen-related equipment to be parked at a place of
 1598         residence; requiring the department to adopt rules
 1599         governing the distribution of medical oxygen; creating
 1600         s. 499.86, F.S.; requiring a wholesale distributor of
 1601         medical gases to visually examine a medical gas
 1602         container upon receipt in order to identify the
 1603         medical gas stored within and to determine if the
 1604         container has been damaged or is otherwise unfit for
 1605         distribution; requiring a medical gas container that
 1606         is damaged or otherwise unfit for distribution to be
 1607         quarantined; requiring outgoing shipments of medical
 1608         gas to be inspected; requiring wholesale distributors
 1609         to review certain records; creating s. 499.87, F.S.;
 1610         authorizing the return of medical gas that has left
 1611         the control of a wholesale distributor; requiring that
 1612         medical gas that is damaged, misbranded, or
 1613         adulterated be quarantined from other medical gases
 1614         until it is destroyed or returned to the manufacturer
 1615         or wholesale distributor from which it was acquired;
 1616         creating s. 499.88, F.S.; requiring a wholesale
 1617         distributor to obtain certain information before the
 1618         initial acquisition of a medical gas; providing
 1619         certain exemptions; creating s. 499.89, F.S.;
 1620         requiring a permitholder under this part to establish
 1621         and maintain transactional records; providing a
 1622         retention period for certain records and requiring
 1623         that such records be available for inspection during
 1624         that period; creating s. 499.90, F.S.; requiring a
 1625         wholesale distributor to establish, maintain, and
 1626         adhere to certain written policies and procedures;
 1627         creating s. 499.91, F.S.; prohibiting certain acts;
 1628         creating s. 499.92, F.S.; establishing criminal
 1629         penalties; authorizing property or assets subject to
 1630         forfeiture to be seized pursuant to a warrant;
 1631         creating s. 499.93, F.S.; authorizing the department
 1632         to require a facility that engages in in the
 1633         manufacture, retail sale, or wholesale distribution of
 1634         medical to undergo an inspection; authorizing the
 1635         department to authorize a third party to inspect such
 1636         facilities; creating s. 499.931, F.S.; providing that
 1637         trade secret information required to be submitted
 1638         pursuant to this part must be maintained by the
 1639         department; creating s. 499.94, F.S.; requiring fees
 1640         collected pursuant to this part to be deposited into
 1641         the Professional Regulation Trust Fund; amending ss.
 1642         409.9201, 460.403, 465.0265, 499.01212, 499.015, and
 1643         499.024, F.S.; conforming cross references; providing
 1644         an effective date.