Florida Senate - 2012                                    SB 1364
       
       
       
       By Senator Hays
       
       
       
       
       20-00600A-12                                          20121364__
    1                        A bill to be entitled                      
    2         An act relating to controlled substances; amending s.
    3         893.13, F.S.; prohibiting the knowing use of a
    4         Schedule II controlled substance in a form or manner
    5         other than that in which the manufacturer or
    6         prescriber intended it to be used; providing criminal
    7         penalties; amending ss. 893.055, 893.0551, and
    8         921.0022, F.S.; conforming cross-references; providing
    9         definitions; requiring the Board of Pharmacy to create
   10         a list of opioid analgesic drugs that incorporate a
   11         tamper-resistance technology and have been approved by
   12         a specified agency; prohibiting substitution for such
   13         an opioid analgesic drug with another opioid analgesic
   14         drug without meeting specified requirements; providing
   15         an effective date.
   16  
   17  Be It Enacted by the Legislature of the State of Florida:
   18  
   19         Section 1. Subsection (7) of section 893.13, Florida
   20  Statutes, is amended to read:
   21         893.13 Prohibited acts; penalties.—
   22         (7)(a) A person may not:
   23         1. Distribute or dispense a controlled substance in
   24  violation of this chapter.
   25         2. Refuse or fail to make, keep, or furnish any record,
   26  notification, order form, statement, invoice, or information
   27  required under this chapter.
   28         3. Refuse entry into any premises for any inspection or
   29  refuse to allow any inspection authorized by this chapter.
   30         4. Distribute a controlled substance named or described in
   31  s. 893.03(1) or (2) except pursuant to an order form as required
   32  by s. 893.06.
   33         5. Keep or maintain any store, shop, warehouse, dwelling,
   34  building, vehicle, boat, aircraft, or other structure or place
   35  which is resorted to by persons using controlled substances in
   36  violation of this chapter for the purpose of using these
   37  substances, or which is used for keeping or selling them in
   38  violation of this chapter.
   39         6. Use to his or her own personal advantage, or reveal, any
   40  information obtained in enforcement of this chapter except in a
   41  prosecution or administrative hearing for a violation of this
   42  chapter.
   43         7. Possess a prescription form which has not been completed
   44  and signed by the practitioner whose name appears printed
   45  thereon, unless the person is that practitioner, is an agent or
   46  employee of that practitioner, is a pharmacist, or is a supplier
   47  of prescription forms who is authorized by that practitioner to
   48  possess those forms.
   49         8. Knowingly use a Schedule II controlled substance in a
   50  form or manner other than that in which the manufacturer or
   51  prescriber intended it to be used.
   52         9.8. Withhold information from a practitioner from whom the
   53  person seeks to obtain a controlled substance or a prescription
   54  for a controlled substance that the person making the request
   55  has received a controlled substance or a prescription for a
   56  controlled substance of like therapeutic use from another
   57  practitioner within the previous 30 days.
   58         10.9. Acquire or obtain, or attempt to acquire or obtain,
   59  possession of a controlled substance by misrepresentation,
   60  fraud, forgery, deception, or subterfuge.
   61         11.10. Affix any false or forged label to a package or
   62  receptacle containing a controlled substance.
   63         12.11. Furnish false or fraudulent material information in,
   64  or omit any material information from, any report or other
   65  document required to be kept or filed under this chapter or any
   66  record required to be kept by this chapter.
   67         13.12. Store anhydrous ammonia in a container that is not
   68  approved by the United States Department of Transportation to
   69  hold anhydrous ammonia or is not constructed in accordance with
   70  sound engineering, agricultural, or commercial practices.
   71         14.13. With the intent to obtain a controlled substance or
   72  combination of controlled substances that are not medically
   73  necessary for the person or an amount of a controlled substance
   74  or substances that is not medically necessary for the person,
   75  obtain or attempt to obtain from a practitioner a controlled
   76  substance or a prescription for a controlled substance by
   77  misrepresentation, fraud, forgery, deception, subterfuge, or
   78  concealment of a material fact. For purposes of this
   79  subparagraph, a material fact includes whether the person has an
   80  existing prescription for a controlled substance issued for the
   81  same period of time by another practitioner or as described in
   82  subparagraph 9. 8.
   83         (b) A health care practitioner, with the intent to provide
   84  a controlled substance or combination of controlled substances
   85  that are not medically necessary to his or her patient or an
   86  amount of controlled substances that is not medically necessary
   87  for his or her patient, may not provide a controlled substance
   88  or a prescription for a controlled substance by
   89  misrepresentation, fraud, forgery, deception, subterfuge, or
   90  concealment of a material fact. For purposes of this paragraph,
   91  a material fact includes whether the patient has an existing
   92  prescription for a controlled substance issued for the same
   93  period of time by another practitioner or as described in
   94  subparagraph (a)9. (a)8.
   95         (c) Any person who violates the provisions of subparagraphs
   96  (a)1.-8. (a)1.-7. commits a misdemeanor of the first degree,
   97  punishable as provided in s. 775.082 or s. 775.083; except that,
   98  upon a second or subsequent violation, the person commits a
   99  felony of the third degree, punishable as provided in s.
  100  775.082, s. 775.083, or s. 775.084.
  101         (d) Any person who violates the provisions of subparagraphs
  102  (a)9.-13. (a)8.-12. commits a felony of the third degree,
  103  punishable as provided in s. 775.082, s. 775.083, or s. 775.084.
  104         (e) A person or health care practitioner who violates the
  105  provisions of subparagraph (a)14. (a)13. or paragraph (b)
  106  commits a felony of the third degree, punishable as provided in
  107  s. 775.082, s. 775.083, or s. 775.084, if any controlled
  108  substance that is the subject of the offense is listed in
  109  Schedule II, Schedule III, or Schedule IV.
  110         Section 2. Paragraph (a) of subsection (1), paragraph (b)
  111  of subsection (2), and paragraph (f) of subsection (7) of
  112  section 893.055, Florida Statutes, are amended to read:
  113         893.055 Prescription drug monitoring program.—
  114         (1) As used in this section, the term:
  115         (a) “Patient advisory report” or “advisory report” means
  116  information provided by the department in writing, or as
  117  determined by the department, to a prescriber, dispenser,
  118  pharmacy, or patient concerning the dispensing of controlled
  119  substances. All advisory reports are for informational purposes
  120  only and impose no obligations of any nature or any legal duty
  121  on a prescriber, dispenser, pharmacy, or patient. The patient
  122  advisory report shall be provided in accordance with s.
  123  893.13(7)(a)9. 893.13(7)(a)8. The advisory reports issued by the
  124  department are not subject to discovery or introduction into
  125  evidence in any civil or administrative action against a
  126  prescriber, dispenser, pharmacy, or patient arising out of
  127  matters that are the subject of the report; and a person who
  128  participates in preparing, reviewing, issuing, or any other
  129  activity related to an advisory report may not be permitted or
  130  required to testify in any such civil action as to any findings,
  131  recommendations, evaluations, opinions, or other actions taken
  132  in connection with preparing, reviewing, or issuing such a
  133  report.
  134         (2)
  135         (b) The department, when the direct support organization
  136  receives at least $20,000 in nonstate moneys or the state
  137  receives at least $20,000 in federal grants for the prescription
  138  drug monitoring program, shall adopt rules as necessary
  139  concerning the reporting, accessing the database, evaluation,
  140  management, development, implementation, operation, security,
  141  and storage of information within the system, including rules
  142  for when patient advisory reports are provided to pharmacies and
  143  prescribers. The patient advisory report shall be provided in
  144  accordance with s. 893.13(7)(a)9. 893.13(7)(a)8. The department
  145  shall work with the professional health care licensure boards,
  146  such as the Board of Medicine, the Board of Osteopathic
  147  Medicine, and the Board of Pharmacy; other appropriate
  148  organizations, such as the Florida Pharmacy Association, the
  149  Florida Medical Association, the Florida Retail Federation, and
  150  the Florida Osteopathic Medical Association, including those
  151  relating to pain management; and the Attorney General, the
  152  Department of Law Enforcement, and the Agency for Health Care
  153  Administration to develop rules appropriate for the prescription
  154  drug monitoring program.
  155         (7)
  156         (f) The program manager, upon determining a pattern
  157  consistent with the rules established under paragraph (2)(d) and
  158  having cause to believe a violation of s. 893.13(7)(a)9.
  159  893.13(7)(a)8., (8)(a), or (8)(b) has occurred, may provide
  160  relevant information to the applicable law enforcement agency.
  161         Section 3. Subsection (4) of section 893.0551, Florida
  162  Statutes, is amended to read:
  163         893.0551 Public records exemption for the prescription drug
  164  monitoring program.—
  165         (4) The department shall disclose such confidential and
  166  exempt information to the applicable law enforcement agency in
  167  accordance with s. 893.055(7)(f). The law enforcement agency may
  168  disclose the confidential and exempt information received from
  169  the department to a criminal justice agency as defined in s.
  170  119.011 as part of an active investigation that is specific to a
  171  violation of s. 893.13(7)(a)9. 893.13(7)(a)8., s. 893.13(8)(a),
  172  or s. 893.13(8)(b).
  173         Section 4. Paragraph (c) of subsection (3) of section
  174  921.0022, Florida Statutes, is amended to read:
  175         921.0022 Criminal Punishment Code; offense severity ranking
  176  chart.—
  177         (3) OFFENSE SEVERITY RANKING CHART
  178         (c) LEVEL 3
  179  FloridaStatute   FelonyDegree                Description                 
  180  119.10(2)(b)       3rd   Unlawful use of confidential information from police reports.
  181  316.066 (3)(b)-(d)  3rd   Unlawfully obtaining or using confidential crash reports.
  182  316.193(2)(b)      3rd   Felony DUI, 3rd conviction.                 
  183  316.1935(2)        3rd   Fleeing or attempting to elude law enforcement officer in patrol vehicle with siren and lights activated.
  184  319.30(4)          3rd   Possession by junkyard of motor vehicle with identification number plate removed.
  185  319.33(1)(a)       3rd   Alter or forge any certificate of title to a motor vehicle or mobile home.
  186  319.33(1)(c)       3rd   Procure or pass title on stolen vehicle.    
  187  319.33(4)          3rd   With intent to defraud, possess, sell, etc., a blank, forged, or unlawfully obtained title or registration.
  188  327.35(2)(b)       3rd   Felony BUI.                                 
  189  328.05(2)          3rd   Possess, sell, or counterfeit fictitious, stolen, or fraudulent titles or bills of sale of vessels.
  190  328.07(4)          3rd   Manufacture, exchange, or possess vessel with counterfeit or wrong ID number.
  191  376.302(5)         3rd   Fraud related to reimbursement for cleanup expenses under the Inland Protection Trust Fund.
  192  379.2431 (1)(e)5.  3rd   Taking, disturbing, mutilating, destroying, causing to be destroyed, transferring, selling, offering to sell, molesting, or harassing marine turtles, marine turtle eggs, or marine turtle nests in violation of the Marine Turtle Protection Act.
  193  379.2431 (1)(e)6.  3rd   Soliciting to commit or conspiring to commit a violation of the Marine Turtle Protection Act.
  194  400.9935(4)        3rd   Operating a clinic without a license or filing false license application or other required information.
  195  440.1051(3)        3rd   False report of workers’ compensation fraud or retaliation for making such a report.
  196  501.001(2)(b)      2nd   Tampers with a consumer product or the container using materially false/misleading information.
  197  624.401(4)(a)      3rd   Transacting insurance without a certificate of authority.
  198  624.401(4)(b)1.    3rd   Transacting insurance without a certificate of authority; premium collected less than $20,000.
  199  626.902(1)(a) & (b)  3rd   Representing an unauthorized insurer.       
  200  697.08             3rd   Equity skimming.                            
  201  790.15(3)          3rd   Person directs another to discharge firearm from a vehicle.
  202  796.05(1)          3rd   Live on earnings of a prostitute.           
  203  806.10(1)          3rd   Maliciously injure, destroy, or interfere with vehicles or equipment used in firefighting.
  204  806.10(2)          3rd   Interferes with or assaults firefighter in performance of duty.
  205  810.09(2)(c)       3rd   Trespass on property other than structure or conveyance armed with firearm or dangerous weapon.
  206  812.014(2)(c)2.    3rd   Grand theft; $5,000 or more but less than $10,000.
  207  812.0145(2)(c)     3rd   Theft from person 65 years of age or older; $300 or more but less than $10,000.
  208  815.04(4)(b)       2nd   Computer offense devised to defraud or obtain property.
  209  817.034(4)(a)3.    3rd   Engages in scheme to defraud (Florida Communications Fraud Act), property valued at less than $20,000.
  210  817.233            3rd   Burning to defraud insurer.                 
  211  817.234 (8)(b)-(c)  3rd   Unlawful solicitation of persons involved in motor vehicle accidents.
  212  817.234(11)(a)     3rd   Insurance fraud; property value less than $20,000.
  213  817.236            3rd   Filing a false motor vehicle insurance application.
  214  817.2361           3rd   Creating, marketing, or presenting a false or fraudulent motor vehicle insurance card.
  215  817.413(2)         3rd   Sale of used goods as new.                  
  216  817.505(4)         3rd   Patient brokering.                          
  217  828.12(2)          3rd   Tortures any animal with intent to inflict intense pain, serious physical injury, or death.
  218  831.28(2)(a)       3rd   Counterfeiting a payment instrument with intent to defraud or possessing a counterfeit payment instrument.
  219  831.29             2nd   Possession of instruments for counterfeiting drivers’ licenses or identification cards.
  220  838.021(3)(b)      3rd   Threatens unlawful harm to public servant.  
  221  843.19             3rd   Injure, disable, or kill police dog or horse.
  222  860.15(3)          3rd   Overcharging for repairs and parts.         
  223  870.01(2)          3rd   Riot; inciting or encouraging.              
  224  893.13(1)(a)2.     3rd   Sell, manufacture, or deliver cannabis (or other s. 893.03(1)(c), (2)(c)1., (2)(c)2., (2)(c)3., (2)(c)5., (2)(c)6., (2)(c)7., (2)(c)8., (2)(c)9., (3), or (4) drugs).
  225  893.13(1)(d)2.     2nd   Sell, manufacture, or deliver s. 893.03(1)(c), (2)(c)1., (2)(c)2., (2)(c)3., (2)(c)5., (2)(c)6., (2)(c)7., (2)(c)8., (2)(c)9., (3), or (4) drugs within 1,000 feet of university.
  226  893.13(1)(f)2.     2nd   Sell, manufacture, or deliver s. 893.03(1)(c), (2)(c)1., (2)(c)2., (2)(c)3., (2)(c)5., (2)(c)6., (2)(c)7., (2)(c)8., (2)(c)9., (3), or (4) drugs within 1,000 feet of public housing facility.
  227  893.13(6)(a)       3rd   Possession of any controlled substance other than felony possession of cannabis.
  228  893.13(7)(a)9. 893.13(7)(a)8.  3rd   Withhold information from practitioner regarding previous receipt of or prescription for a controlled substance.
  229  893.13(7)(a)10.893.13(7)(a)9.  3rd   Obtain or attempt to obtain controlled substance by fraud, forgery, misrepresentation, etc.
  230  893.13(7)(a)11. 893.13(7)(a)10.  3rd   Affix false or forged label to package of controlled substance.
  231  893.13(7)(a)12. 893.13(7)(a)11.  3rd   Furnish false or fraudulent material information on any document or record required by chapter 893.
  232  893.13(8)(a)1.     3rd   Knowingly assist a patient, other person, or owner of an animal in obtaining a controlled substance through deceptive, untrue, or fraudulent representations in or related to the practitioner’s practice.
  233  893.13(8)(a)2.     3rd   Employ a trick or scheme in the practitioner’s practice to assist a patient, other person, or owner of an animal in obtaining a controlled substance.
  234  893.13(8)(a)3.     3rd   Knowingly write a prescription for a controlled substance for a fictitious person.
  235  893.13(8)(a)4.     3rd   Write a prescription for a controlled substance for a patient, other person, or an animal if the sole purpose of writing the prescription is a monetary benefit for the practitioner.
  236  918.13(1)(a)       3rd   Alter, destroy, or conceal investigation evidence.
  237  944.47 (1)(a)1.-2.  3rd   Introduce contraband to correctional facility.
  238  944.47(1)(c)       2nd   Possess contraband while upon the grounds of a correctional institution.
  239  985.721            3rd   Escapes from a juvenile facility (secure detention or residential commitment facility).
  240         Section 5. Substitution of opioid analgesic for opioid
  241  analgesic incorporating tamper-resistance technology prohibited;
  242  exceptions.—
  243         (1) As used in this section, the term:
  244         (a) “Interchange or substitution of an opioid analgesic
  245  drug” means the substitution of any opioid analgesic drug, brand
  246  or generic, for the opioid analgesic drug incorporating a
  247  tamper-resistance technology originally prescribed, irrespective
  248  of whether the substituted drug is rated as pharmaceutically and
  249  therapeutically equivalent by the United States Food and Drug
  250  Administration or the Board of Pharmacy or whether the opioid
  251  analgesic drug with tamper-resistance technology bears a
  252  labeling claim with respect to reduction of tampering, abuse, or
  253  abuse potential.
  254         (b) “Opioid analgesic drug” means a drug in the opioid
  255  analgesic drug class prescribed to treat moderate to severe pain
  256  or other conditions, whether in immediate-release or extended
  257  release form and whether or not combined with other drug
  258  substances to form a single tablet or other dosage form.
  259         (c) “Opioid analgesic drug incorporating a tamper
  260  resistance technology” means an opioid analgesic drug listed as
  261  such by the Board of Pharmacy based upon a submission of
  262  evidence by the drug manufacturer or distributor that the drug
  263  incorporates a tamper-resistance technology and has been
  264  approved by the United States Food and Drug Administration
  265  pursuant to an application that includes at least one human
  266  tampering or abuse potential study or a laboratory study
  267  comparing the tamper- or abuse-resistance properties of the drug
  268  to one or more opioid analgesic drugs that have been approved by
  269  the United States Food and Drug Administration and serve as a
  270  positive control.
  271         (2) The Board of Pharmacy shall create a list of opioid
  272  analgesic drugs for which information has been submitted as
  273  described in paragraph (1)(c). Inclusion of a drug on the list
  274  does not require that the drug bear a labeling claim with
  275  respect to reduction of tampering, abuse, or abuse potential at
  276  the time of listing. The list must also include a determination
  277  by the Board of Pharmacy as to which listed opioid analgesic
  278  drugs incorporating tamper-resistance technologies provide
  279  substantially similar tamper-resistance properties, based solely
  280  upon studies submitted by the drug manufacturer consistent with
  281  paragraph (1)(c).
  282         (3) Notwithstanding s. 465.025, Florida Statutes, a
  283  pharmacist may not interchange or substitute an opioid analgesic
  284  drug, whether brand or generic, for an opioid analgesic drug
  285  incorporating a tamper-resistance technology that is listed
  286  pursuant to subsection (2) without:
  287         (a) Verifying that the opioid analgesic drug has been
  288  listed by the Board of Pharmacy under subsection (2) as
  289  providing tamper-resistance properties substantially similar to
  290  the prescribed opioid analgesic drug incorporating a tamper
  291  resistance technology; or
  292         (b) Obtaining written, signed consent from the prescribing
  293  physician for the interchange or substitution.
  294         Section 6. This act shall take effect October 1, 2012.