Florida Senate - 2009 SB 1356
By Senator Bennett
21-01257-09 20091356__
1 A bill to be entitled
2 An act relating to monitoring the dispensing of
3 controlled substances; creating s. 893.055, F.S.;
4 providing definitions; requiring the Department of
5 Health to establish a comprehensive electronic system
6 to monitor the dispensing of certain controlled
7 substances; requiring those who dispense certain
8 controlled substances to submit specified information
9 to the department; providing exceptions to reporting
10 requirements; requiring that information be submitted
11 in an approved electronic format; providing time
12 periods for information submission; providing criminal
13 penalties for violations; requiring rulemaking;
14 providing requirements for system funding; providing
15 an effective date.
16
17 Be It Enacted by the Legislature of the State of Florida:
18
19 Section 1. Section 893.055, Florida Statutes, is created to
20 read:
21 893.055 Electronic monitoring system for the dispensing of
22 certain controlled substances.—
23 (1) As used in this section, the term:
24 (a) “Health care practitioner” or “practitioner” means any
25 practitioner subject to licensure or regulation by the
26 department under chapter 458, chapter 459, chapter 461, or
27 chapter 466.
28 (b) “Pharmacy” means any pharmacy subject to licensure or
29 regulation by the department under chapter 465, or that would be
30 subject to such licensure if it were located in this state, that
31 dispenses a controlled substance listed in Schedule II, Schedule
32 III, or Schedule IV to an individual or address in this state.
33 (2) No later than June 30, 2010, the department shall
34 design and establish a comprehensive electronic system,
35 consistent with standards of the American Society for Automation
36 in Pharmacy, to monitor the prescribing and dispensing of
37 controlled substances listed in Schedule II, Schedule III, and
38 Schedule IV by health care practitioners and the dispensing of
39 such controlled substances to an individual or address in this
40 state by a pharmacy required to be permitted or registered by
41 the Board of Pharmacy or through a dispensing transaction with a
42 pharmacy not located in this state that is otherwise subject to
43 the jurisdiction of this state as to that dispensing
44 transaction. The department may contract with another state
45 agency or with a private vendor to establish and maintain the
46 system.
47 (3) Except as provided in subsection (4), each time a
48 controlled substance listed in Schedule II, Schedule III, or
49 Schedule IV is dispensed to an individual or address in this
50 state, the pharmacy or dispensing practitioner shall report to
51 the department information determined by rule of the department
52 that shall include, but not be limited to, the following:
53 (a)1. The full name, address, date of birth, and social
54 security number of the patient for whom, or the owner of the
55 animal for which, the controlled substance is dispensed.
56 2. If the prescription is for an animal, the species of the
57 animal for which the controlled substance is prescribed.
58 (b) The name, strength, quantity, and National Drug Code
59 (NDC) number of the controlled substance dispensed.
60 (c) The full name, address, and federal controlled
61 substance registry number of the prescribing practitioner.
62 (d) The date the prescription was issued by the prescribing
63 practitioner.
64 (e) The full name, address, and federal controlled
65 substance registry number of the pharmacy or dispensing
66 practitioner.
67 (f) The date the prescription was filled by the pharmacy or
68 dispensing practitioner.
69 (g) The number of the prescription as recorded in the
70 prescription files of the pharmacy in which it is filled.
71 (4) This section does not apply to controlled substances:
72 (a) Administered by a health care practitioner directly to
73 a patient.
74 (b) Dispensed by a health care practitioner authorized to
75 prescribe controlled substances directly to a patient and
76 limited to an amount adequate to treat the patient for a period
77 of not more than 72 hours.
78 (c) Dispensed by a health care practitioner or a pharmacist
79 to an inpatient of a facility that holds an institutional
80 pharmacy permit.
81 (d) Ordered from an institutional pharmacy permitted under
82 s. 465.019 in accordance with the institutional policy for such
83 controlled substances.
84 (e) Administered by a health care practitioner to a patient
85 or resident receiving care from a hospital, nursing home,
86 assisted living facility, home health agency, hospice, or
87 intermediate care facility for the developmentally disabled that
88 is licensed in this state.
89 (5) A practitioner or pharmacist whose dispensing of a
90 controlled substance is required to be reported under this
91 section must submit the information required by this section in
92 an electronic or other format approved by rule of the
93 department. The cost to the practitioner or pharmacist in
94 submitting the information required by this section may not be
95 material or extraordinary.
96 (6) A practitioner or pharmacist who dispenses a controlled
97 substance under this section must, unless an extension is
98 approved by the department for cause, submit the information
99 required by subsection (3) within 14 days after dispensing a
100 controlled substance during the first year of the system's
101 operation and within 7 days after dispensing a controlled
102 substance in each year thereafter.
103 (7) Any person who knowingly fails to report the dispensing
104 of a controlled substance as required by this section commits a
105 misdemeanor of the first degree, punishable as provided in s.
106 775.082 or s. 775.083.
107 (8) The department and the regulatory boards for the health
108 care practitioners subject to this section shall adopt rules
109 pursuant to ss. 120.536(1) and 120.54 to administer this
110 section.
111 (9) All costs incurred by the department in administering
112 the system shall be funded through federal, private, or grant
113 funding. State funds may be used to the extent that they are
114 available.
115 Section 2. This act shall take effect July 1, 2009.