Florida Senate - 2009 SB 462
By Senator Fasano
11-00424-09 2009462__
1 A bill to be entitled
2 An act relating to controlled substances; creating s.
3 893.055, F.S.; providing definitions; requiring the
4 Agency for Health Care Administration to establish a
5 statewide, comprehensive electronic system to monitor
6 the prescribing and dispensing of controlled
7 substances listed in Schedule II, Schedule III, or
8 Schedule IV; providing reporting requirements;
9 requiring the agency to notify certain dispensers and
10 prescribers of the implementation date for the
11 reporting of controlled substances; specifying
12 circumstances under which a pharmacy or practitioner
13 is exempt from participating in the system; requiring
14 prescribing or dispensing pharmacists and
15 practitioners to submit information in a certain
16 format; providing a penalty; requiring that the
17 department and regulatory boards adopt rules;
18 requiring that all costs incurred by the agency be
19 paid through federal, private, or grant funding
20 sources; providing an effective date.
21
22 Be It Enacted by the Legislature of the State of Florida:
23
24 Section 1. Section 893.055, Florida Statutes, is created to
25 read:
26 893.055 Electronic-monitoring system for prescription of
27 controlled substances listed in Schedule II, Schedule III, or
28 Schedule IV.—
29 (1) As used in this section, the term:
30 (a) “Agency” means the Agency for Health Care
31 Administration.
32 (b) “Department” means the Department of Health.
33 (c) “Pharmacy” means any pharmacy that is subject to
34 licensure or regulation by the department pursuant to chapter
35 465 and that dispenses or delivers a controlled substance
36 included in Schedule II, Schedule III, or Schedule IV in s.
37 893.03 to a patient in this state.
38 (2) By June 30, 2010, the agency shall design and establish
39 an electronic system consistent with standards of the American
40 Society for Automation in Pharmacy to monitor the prescribing of
41 controlled substances listed in Schedule II, Schedule III, or
42 Schedule IV in s. 893.03 by health care practitioners and the
43 dispensing of such controlled substances to an individual by a
44 dispensing practitioner pursuant to chapter 465 or a pharmacy
45 permitted or registered by the Board of Pharmacy pursuant to
46 chapter 465.
47 (3) Each time a controlled substance listed in Schedule II,
48 Schedule III, or Schedule IV is dispensed to an individual, the
49 controlled substance must be reported to the agency through the
50 system as soon thereafter as possible, but not more than 15 days
51 after the date the controlled substance is dispensed. A pharmacy
52 or dispensing practitioner may meet the reporting requirements
53 of this section by providing to the agency in written or any
54 electronic or magnetic format, including, but not limited to,
55 electronic submission via the Internet or magnetic disc or tape,
56 each controlled substance listed in Schedule II, Schedule III,
57 or Schedule IV which it dispenses.
58 (4) The agency shall notify each dispenser and prescriber
59 subject to the reporting requirements in this section of the
60 implementation date for the reporting requirements as set forth
61 in the rules of the agency.
62 (5) This section does not apply to controlled substances:
63 (a) Administered by a health care practitioner directly to
64 a patient.
65 (b) Dispensed by a health care practitioner authorized to
66 prescribe controlled substances directly to a patient and
67 limited to an amount adequate to treat the patient for a period
68 of not more than 72 hours.
69 (c) Dispensed by a health care practitioner or a pharmacist
70 to an inpatient of a facility that holds an institutional
71 pharmacy permit.
72 (d) Ordered from an institutional pharmacy permitted under
73 s. 465.019 in accordance with the institutional policy for such
74 controlled substances or drugs.
75 (e) Dispensed by a pharmacist or administered by a health
76 care practitioner to a patient or resident receiving care from a
77 hospital, nursing home, assisted living facility, home health
78 agency, hospice, or intermediate care facility for the
79 developmentally disabled which is licensed in this state.
80 (6) The data required to be reported under this section
81 shall be determined by the department by rule and may include,
82 but is not limited to, any data required under s. 893.04.
83 (7) A practitioner or pharmacist who dispenses a controlled
84 substance listed in Schedule II, Schedule III, or Schedule IV in
85 s. 893.03 must submit the information required by this section
86 in an electronic or other format approved by rule of the agency.
87 The cost to the dispenser in submitting the information required
88 by this section may not be material or extraordinary. Costs not
89 considered to be material or extraordinary include, but are not
90 limited to, regular postage, compact discs, zip-drive storage,
91 regular electronic mail, magnetic tapes, diskettes, and
92 facsimile charges. The information submitted to the agency under
93 this section may be transmitted to any person or agency
94 authorized to receive it pursuant to chapter 119, and that
95 person or agency may maintain the information received for up to
96 24 months before purging the information from its records. All
97 transmissions required by this subsection must comply with
98 relevant privacy and security laws of the state and federal
99 government. However, any authorized agency receiving such
100 information may maintain it for longer than 24 months if the
101 information is pertinent to an ongoing investigation or
102 prosecution.
103 (8) Any person who knowingly fails to report the dispensing
104 of a controlled substance listed in Schedule II, Schedule III,
105 or Schedule IV as required by this section commits a misdemeanor
106 of the first degree, punishable as provided in s. 775.082 or s.
107 775.083.
108 (9) The department and the regulatory boards for the health
109 care practitioners subject to this section shall adopt rules to
110 administer this section.
111 (10) All costs incurred by the agency in administering the
112 prescription-monitoring system shall be through federal,
113 private, or grant funding applied for by the state. The agency
114 and state government shall cooperate in seeking grant funds at
115 no cost to the agency.
116 Section 2. This act shall take effect July 1, 2009.