Florida Senate - 2009 SB 2650
By Senator Fasano
11-00340A-09 20092650__
1 A bill to be entitled
2 An act relating to pharmaceutical take-back programs;
3 creating s. 499.0295, F.S.; requiring drug
4 manufacturers who sell drugs in this state to
5 establish a take-back program that accepts and
6 disposes of pharmaceuticals turned in by consumers by
7 a certain date; provides program requirements;
8 requires the manufacturer to submit a program plan to
9 the Department of Health, which must review and
10 approve or reject the plan; requiring retail
11 pharmacies to post a sign informing consumers about
12 the take-back program; requiring a manufacturer to pay
13 a fee to the department designed to cover the
14 department's administrative costs for the program;
15 authorizing the department to impose administrative
16 fines for violations; establishing an advisory
17 committee to advise the department on issues relating
18 to take-back programs; providing for member
19 appointment, terms, selection of a chairperson, number
20 of meetings, and reimbursement for expenses;
21 authorizing the department to adopt rules; providing
22 an effective date.
23
24 Be It Enacted by the Legislature of the State of Florida:
25
26 Section 1. Section 499.0295, Florida Statutes, is created
27 to read:
28 499.0295 Pharmaceutical take-back program.—
29 (1) Effective July 1, 2011, a manufacturer of a drug may
30 not sell the drug or allow the drug to be sold in this state
31 unless the manufacturer operates a pharmaceutical take-back
32 program approved by the department. The take-back program must:
33 (a) Accept prescription and proprietary drugs presented to
34 the program by consumers, including residents of long-term care
35 facilities and persons enrolled in hospice and home health
36 programs;
37 (b) Accept all prescription and proprietary drugs sold in
38 this state regardless of manufacturer;
39 (c) Offer pharmaceutical take-back services at no cost to
40 the consumer at the time of sale of the drug or at the time of
41 collection of the drug;
42 (d) Be convenient and adequate to serve consumers in urban
43 and rural areas;
44 (e) Dispose of collected drugs by incineration or hazardous
45 waste disposal;
46 (f) Include an education and outreach program to inform
47 consumers, retail pharmacies, health practitioners, county
48 health departments, hospitals, hospice care providers, and long
49 term care facilities of the availability of the program; and
50 (g) Include a method for evaluation and improvement of the
51 program.
52 (2) A manufacturer may operate its pharmaceutical take-back
53 program individually or collectively with other manufacturers.
54 (3) A manufacturer that sells drugs in this state shall
55 submit a plan describing the manufacturer's proposed
56 pharmaceutical take-back program to the department for approval.
57 The plan must:
58 (a) Describe how the program meets the requirements of
59 subsection (1);
60 (b) Include recovery goals for the first 3 years of the
61 program, expressed as pounds per capita, and a plan for action
62 if the recovery goals are not met;
63 (c) Describe the proposed method for disposal of the
64 collected drugs;
65 (d) Describe how the manufacturer will coordinate with
66 other manufacturers to minimize consumer confusion about
67 different pharmaceutical take-back programs;
68 (e) Meet other requirements established by rule of the
69 department; and
70 (f) Be accompanied by a fee determined by the department
71 under subsection (9).
72 (4) Within 60 days after a manufacturer submits a plan
73 under subsection (3), the department shall approve or reject the
74 plan. If the plan is rejected, the department shall provide the
75 manufacturer with a written statement of the reasons for the
76 rejection, and the manufacturer may submit a revised plan within
77 60 days after the date of the written statement of rejection.
78 The department shall approve or reject the revised plan within
79 60 days after its submission.
80 (5) Following department approval, the manufacturer shall
81 submit an updated plan to the department annually, on or before
82 the anniversary of the approval of the original plan. The
83 department shall review the disposal proposal in the updated
84 plan, and shall approve or reject the updated plan as provided
85 in subsection (4).
86 (6) If at the time the plan is due for submission to the
87 department there is no legal method for a manufacturer to accept
88 all prescription and proprietary drugs through the
89 pharmaceutical take-back program, a manufacturer may apply to
90 the department for an extension of the time to submit the plan.
91 The department may grant an extension for up to 1 year.
92 (7) The department may withdraw approval of a plan if a
93 manufacturer does not operate the manufacturer's pharmaceutical
94 take-back program in accordance with the approved plan.
95 (8) Retail pharmacies must post a sign informing consumers
96 of the availability of pharmaceutical take-back programs. The
97 department shall make an example of the sign available on the
98 department's website.
99 (9) The department shall adopt rules establishing the
100 application fee for submission of a pharmaceutical take-back
101 program plan. The application fee may not exceed the costs
102 incurred by the department in regulating pharmaceutical take
103 back programs, including the cost of any full-time employees
104 necessary to administer the program.
105 (10) The department may impose administrative penalties for
106 violations of this section as established by rule which may not
107 exceed $500 per violation.
108 (11) Moneys received under subsections (9) and (10) shall
109 be used to support the program.
110 (12) There is created the Advisory Committee on
111 Pharmaceutical Take-Back Programs, consisting of seven members
112 appointed by the State Health Officer who shall serve at the
113 pleasure of the officer. The advisory committee shall advise the
114 department on issues relating to pharmaceutical take-back
115 programs.
116 (a) The term of office of each member is 3 years except
117 that some members of the first council may serve shorter terms
118 in order to establish staggered terms. A member is eligible for
119 reappointment for one additional term.
120 (b) The advisory committee shall elect one of its members
121 to serve as chairperson.
122 (c) The advisory committee shall meet at least four times
123 per year, at times and places specified by the call of the
124 chairperson or of a majority of the members of the advisory
125 committee.
126 (d) A member of the committee shall serve without
127 compensation, but is entitled to reimbursement for per diem and
128 travel expenses incurred in the performance of duties related to
129 the committee in accordance with s. 112.061.
130 (e) All state agencies are directed to assist the advisory
131 committee in the performance of its duties and to furnish such
132 information and advice as the members of the advisory committee
133 consider necessary to perform their duties.
134 (13) The department may adopt rules to administer this
135 section.
136 Section 2. This act shall take effect July 1, 2009.