| 1 | A bill to be entitled |
| 2 | An act relating to monitoring the dispensing of controlled |
| 3 | substances; creating s. 893.055, F.S.; providing |
| 4 | definitions; requiring the Department of Health to |
| 5 | establish a comprehensive electronic system to monitor the |
| 6 | dispensing of certain controlled substances; requiring |
| 7 | those who dispense certain controlled substances to submit |
| 8 | specified information to the department; providing |
| 9 | exceptions to reporting requirements; requiring that |
| 10 | information be submitted in an approved electronic format; |
| 11 | providing time periods for information submission; |
| 12 | providing criminal penalties for violations; requiring |
| 13 | rulemaking; providing requirements for system funding; |
| 14 | providing an effective date. |
| 15 |
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| 16 | Be It Enacted by the Legislature of the State of Florida: |
| 17 |
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| 18 | Section 1. Section 893.055, Florida Statutes, is created |
| 19 | to read: |
| 20 | 893.055 Electronic monitoring system for the dispensing of |
| 21 | certain controlled substances.-- |
| 22 | (1) As used in this section, the term: |
| 23 | (a) "Health care practitioner" or "practitioner" means any |
| 24 | practitioner subject to licensure or regulation by the |
| 25 | department under chapter 458, chapter 459, chapter 461, or |
| 26 | chapter 466. |
| 27 | (b) "Pharmacy" means any pharmacy subject to licensure or |
| 28 | regulation by the department under chapter 465, or that would be |
| 29 | subject to such licensure if it were located in this state, that |
| 30 | dispenses a controlled substance listed in Schedule II, Schedule |
| 31 | III, or Schedule IV to an individual or address in this state. |
| 32 | (2) No later than June 30, 2010, the department shall |
| 33 | design and establish a comprehensive electronic system, |
| 34 | consistent with standards of the American Society for Automation |
| 35 | in Pharmacy, to monitor the prescribing and dispensing of |
| 36 | controlled substances listed in Schedule II, Schedule III, and |
| 37 | Schedule IV by health care practitioners and the dispensing of |
| 38 | such controlled substances to an individual or address in this |
| 39 | state by a pharmacy required to be permitted or registered by |
| 40 | the Board of Pharmacy or through a dispensing transaction with a |
| 41 | pharmacy not located in this state that is otherwise subject to |
| 42 | the jurisdiction of this state as to that dispensing |
| 43 | transaction. The department may contract with another state |
| 44 | agency or with a private vendor to establish and maintain the |
| 45 | system. |
| 46 | (3) Except as provided in subsection (4), each time a |
| 47 | controlled substance listed in Schedule II, Schedule III, or |
| 48 | Schedule IV is dispensed to an individual or address in this |
| 49 | state, the pharmacy or dispensing practitioner shall report to |
| 50 | the department information determined by rule of the department |
| 51 | that shall include, but not be limited to, the following: |
| 52 | (a)1. The full name, address, date of birth, and social |
| 53 | security number of the patient for whom, or the owner of the |
| 54 | animal for which, the controlled substance is dispensed. |
| 55 | 2. If the prescription is for an animal, the species of |
| 56 | the animal for which the controlled substance is prescribed. |
| 57 | (b) The name, strength, quantity, and National Drug Code |
| 58 | (NDC) number of the controlled substance dispensed. |
| 59 | (c) The full name, address, and federal controlled |
| 60 | substance registry number of the prescribing practitioner. |
| 61 | (d) The date the prescription was issued by the |
| 62 | prescribing practitioner. |
| 63 | (e) The full name, address, and federal controlled |
| 64 | substance registry number of the pharmacy or dispensing |
| 65 | practitioner. |
| 66 | (f) The date the prescription was filled by the pharmacy |
| 67 | or dispensing practitioner. |
| 68 | (g) The number of the prescription as recorded in the |
| 69 | prescription files of the pharmacy in which it is filled. |
| 70 | (4) This section does not apply to controlled substances: |
| 71 | (a) Administered by a health care practitioner directly to |
| 72 | a patient. |
| 73 | (b) Dispensed by a health care practitioner authorized to |
| 74 | prescribe controlled substances directly to a patient and |
| 75 | limited to an amount adequate to treat the patient for a period |
| 76 | of not more than 72 hours. |
| 77 | (c) Dispensed by a health care practitioner or a |
| 78 | pharmacist to an inpatient of a facility that holds an |
| 79 | institutional pharmacy permit. |
| 80 | (d) Ordered from an institutional pharmacy permitted under |
| 81 | s. 465.019 in accordance with the institutional policy for such |
| 82 | controlled substances. |
| 83 | (e) Administered by a health care practitioner to a |
| 84 | patient or resident receiving care from a hospital, nursing |
| 85 | home, assisted living facility, home health agency, hospice, or |
| 86 | intermediate care facility for the developmentally disabled that |
| 87 | is licensed in this state. |
| 88 | (5) A practitioner or pharmacist whose dispensing of a |
| 89 | controlled substance is required to be reported under this |
| 90 | section must submit the information required by this section in |
| 91 | an electronic or other format approved by rule of the |
| 92 | department. The cost to the practitioner or pharmacist in |
| 93 | submitting the information required by this section may not be |
| 94 | material or extraordinary. |
| 95 | (6) A practitioner or pharmacist who dispenses a |
| 96 | controlled substance under this section must, unless an |
| 97 | extension is approved by the department for cause, submit the |
| 98 | information required by subsection (3) within 14 days after |
| 99 | dispensing a controlled substance during the first year of the |
| 100 | system's operation and within 7 days after dispensing a |
| 101 | controlled substance in each year thereafter. |
| 102 | (7) Any person who knowingly fails to report the |
| 103 | dispensing of a controlled substance as required by this section |
| 104 | commits a misdemeanor of the first degree, punishable as |
| 105 | provided in s. 775.082 or s. 775.083. |
| 106 | (8) The department and the regulatory boards for the |
| 107 | health care practitioners subject to this section shall adopt |
| 108 | rules pursuant to ss. 120.536(1) and 120.54 to administer this |
| 109 | section. |
| 110 | (9) All costs incurred by the department in administering |
| 111 | the system shall be funded through federal, private, or grant |
| 112 | funding. State funds may be used to the extent that they are |
| 113 | available. |
| 114 | Section 2. This act shall take effect July 1, 2009. |