| 1 | A bill to be entitled |
| 2 | An act relating to the pharmaceutical take-back program |
| 3 | pilot project; creating s. 499.0295, F.S.; providing that |
| 4 | a manufacturer of a drug may not sell the drug or allow |
| 5 | the drug to be sold in the pilot project area unless the |
| 6 | manufacturer operates a pharmaceutical take-back program |
| 7 | approved by the Department of Health; providing |
| 8 | requirements for such programs; providing requirements for |
| 9 | submission of such a plan and its review by the |
| 10 | department; requiring retail pharmacies to post a sign to |
| 11 | inform consumers of the availability of pharmaceutical |
| 12 | take-back programs; requiring the department to adopt a |
| 13 | sample sign and post it on the Internet; providing civil |
| 14 | penalties for violations; providing for an application |
| 15 | fee; authorizing rulemaking; creating the Advisory |
| 16 | Committee on Pharmaceutical Take-Back Programs; providing |
| 17 | for membership; providing for duties; providing for |
| 18 | reimbursement of member travel and other expenses; |
| 19 | requiring reports; providing for termination of the pilot |
| 20 | project and repeal of provisions; providing for the terms |
| 21 | of initial committee members; providing that the |
| 22 | requirement to have a plan registered with the department |
| 23 | applies to manufacturers whose drugs are sold in the pilot |
| 24 | project area on or after a specified date; providing an |
| 25 | effective date. |
| 26 |
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| 27 | Be It Enacted by the Legislature of the State of Florida: |
| 28 |
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| 29 | Section 1. Section 499.0295, Florida Statutes, is created |
| 30 | to read: |
| 31 | 499.0295 Pharmaceutical take-back program pilot project.-- |
| 32 | (1) PROGRAM REQUIREMENTS.-- |
| 33 | (a) The department shall develop a pilot project in Pasco |
| 34 | and Hernando counties under which a manufacturer of a drug may |
| 35 | not sell the drug or allow the drug to be sold in those counties |
| 36 | unless the manufacturer operates in each county a pharmaceutical |
| 37 | take-back program approved by the department. The pharmaceutical |
| 38 | take-back program must do the following: |
| 39 | 1. Accept all drugs presented to the program by consumers, |
| 40 | including residents of long-term care facilities and persons |
| 41 | enrolled in hospice, palliative care, and home health programs. |
| 42 | 2. Accept all drugs sold regardless of the manufacturer. |
| 43 | 3. Offer pharmaceutical take-back services at no cost to |
| 44 | the consumer, either at the time of sale of the drug or at the |
| 45 | time of collection of the drug. |
| 46 | 4. Be convenient and adequate to serve consumers in urban |
| 47 | and rural areas. |
| 48 | 5. Dispose of collected drugs by incineration or hazardous |
| 49 | waste disposal. |
| 50 | 6. Include an education and outreach program to inform |
| 51 | consumers, retail pharmacies, health practitioners, county |
| 52 | health departments, hospitals, hospice care providers, and long- |
| 53 | term care facilities of the availability of the program. |
| 54 | 7. Include a method for evaluation and improvement of the |
| 55 | program. |
| 56 | (b) A manufacturer may operate its pharmaceutical take- |
| 57 | back program individually or collectively with other |
| 58 | manufacturers. |
| 59 | (2) PLAN APPROVAL.-- |
| 60 | (a) A manufacturer that sells drugs in the pilot project |
| 61 | area shall submit a plan describing the manufacturer's proposed |
| 62 | pharmaceutical take-back program to the department for approval. |
| 63 | The proposed plan must: |
| 64 | 1. Describe how the program meets the requirements of |
| 65 | subsection (1). |
| 66 | 2. Include recovery goals for the first, second, and third |
| 67 | years of the program, expressed as pounds of drugs recovered per |
| 68 | capita, and a plan for action if the recovery goals are not met. |
| 69 | 3. Describe the proposed method for disposal of the |
| 70 | collected drugs. |
| 71 | 4. Describe how the manufacturer will coordinate with |
| 72 | other manufacturers to minimize consumer confusion about |
| 73 | different pharmaceutical take-back programs. |
| 74 | 5. Meet other requirements established by rule by the |
| 75 | department. |
| 76 | 6. Be accompanied by a fee determined by the department |
| 77 | under subsection (5). |
| 78 | (b) The department shall review the disposal proposal in |
| 79 | the plan in consultation with the Department of Environmental |
| 80 | Protection. |
| 81 | (c) Within 60 days after a manufacturer submits a plan |
| 82 | under paragraph (a), the department must approve or reject the |
| 83 | plan. If the plan is rejected, the department shall provide the |
| 84 | manufacturer with a written statement of the reasons for the |
| 85 | rejection and the manufacturer may submit a revised plan within |
| 86 | 60 days after the date of the written statement of rejection. |
| 87 | The department must approve or reject the revised plan within 60 |
| 88 | days after its submission. |
| 89 | (d) A manufacturer shall submit an updated plan to the |
| 90 | department annually, on or before the anniversary of the |
| 91 | approval of the original plan. The department shall review the |
| 92 | disposal proposal in the updated plan, in consultation with the |
| 93 | Department of Environmental Protection, and shall approve or |
| 94 | reject the updated plan as provided in paragraph (c). |
| 95 | (e) If at the time the plan is due for submission to the |
| 96 | department there is no legal method for a manufacturer to accept |
| 97 | all prescription and nonprescription drugs through the |
| 98 | pharmaceutical take-back program, a manufacturer may apply to |
| 99 | the department for an extension of the time to submit the plan. |
| 100 | The department may grant an extension not to exceed 1 year. |
| 101 | (f) The department may withdraw approval of a plan if a |
| 102 | manufacturer does not operate the pharmaceutical take-back |
| 103 | program in accordance with the approved plan. The department |
| 104 | shall comply with chapter 120 in withdrawing approval of a plan. |
| 105 | (3) SIGNS.--The department shall require retail pharmacies |
| 106 | to post a sign to inform consumers of the availability of |
| 107 | pharmaceutical take-back programs. The department shall adopt an |
| 108 | example of such a sign and post the example on the Internet. |
| 109 | (4) PENALTIES.--In addition to any other liability or |
| 110 | penalty provided by law, the department may impose a civil |
| 111 | penalty on a person for violation of this section or of the |
| 112 | rules adopted to implement this section of up to $250 for each |
| 113 | violation. Civil penalties under this section shall be imposed |
| 114 | as provided in s. 499.066. |
| 115 | (5) FEES.--The department shall set an application fee for |
| 116 | submission of a pharmaceutical take-back program plan under |
| 117 | subsection (2) not to exceed $100. The application fee must be |
| 118 | designed to recover the cost to the department of regulating |
| 119 | pharmaceutical take-back programs. |
| 120 | (6) RULEMAKING.--The department may adopt rules pursuant |
| 121 | to ss. 120.536(1) and 120.54 to implement this section. |
| 122 | (7) ADVISORY COMMITTEE.-- |
| 123 | (a) There is created the Advisory Committee on |
| 124 | Pharmaceutical Take-Back Programs, consisting of 11 members |
| 125 | appointed by the State Surgeon General. The term of office of |
| 126 | each member is 3 years, but a member serves at the pleasure of |
| 127 | the State Surgeon General. Before the expiration of the term of |
| 128 | a member, the State Surgeon General shall appoint a successor |
| 129 | whose term begins immediately upon the expiration of the term of |
| 130 | the current member. A member is eligible for reappointment for |
| 131 | one additional term. If there is a vacancy for any cause, the |
| 132 | director shall make an appointment to become effective |
| 133 | immediately. |
| 134 | (b) The advisory committee shall advise the department on |
| 135 | issues relating to pharmaceutical take-back programs. |
| 136 | (c) A majority of the members of the advisory committee |
| 137 | constitutes a quorum for the transaction of business. Official |
| 138 | action by the advisory committee requires the approval of a |
| 139 | majority of the members of the advisory committee. The advisory |
| 140 | committee shall elect one of its members to serve as |
| 141 | chairperson. |
| 142 | (d) The advisory committee shall meet at least four times |
| 143 | per year at times and places specified by the call of the |
| 144 | chairperson or of a majority of the members of the advisory |
| 145 | committee. |
| 146 | (e) The advisory committee may adopt rules necessary for |
| 147 | its operation. |
| 148 | (f) A member of the advisory committee is not entitled to |
| 149 | compensation, but in the discretion of the department may be |
| 150 | reimbursed from funds available to the department for actual and |
| 151 | necessary travel and other expenses incurred by the member in |
| 152 | the performance of the member's official duties as provided in |
| 153 | s. 112.061. |
| 154 | (8) REPORTS.--The department shall submit a preliminary |
| 155 | report to President of the Senate and the Speaker of the House |
| 156 | of Representatives by January 31, 2011, and a final report by |
| 157 | January 31, 2012, concerning the effectiveness of the pilot |
| 158 | project in meeting its recovery goals. In addition, the final |
| 159 | report shall make recommendations on expanding the project to |
| 160 | other parts of the state. |
| 161 | (9) TERMINATION AND REPEAL.--Unless renewed by the |
| 162 | Legislature, the pilot project shall terminate December 31, |
| 163 | 2012, and this section is repealed on that date. |
| 164 | Section 2. Notwithstanding the term of office specified by |
| 165 | s. 499.0295, Florida Statutes, as created by this act, for the |
| 166 | members first appointed to the Advisory Committee on |
| 167 | Pharmaceutical Take-Back Programs: |
| 168 | (1) Three members shall serve for a term ending June 30, |
| 169 | 2010. |
| 170 | (2) Four members shall serve for a term ending June 30, |
| 171 | 2011. |
| 172 | (3) Four members shall serve for a term ending June 30, |
| 173 | 2012. |
| 174 | Section 3. The registration requirements contained in s. |
| 175 | 499.0295, Florida Statutes, as created by this act, apply to |
| 176 | manufacturers whose drugs are sold in the pilot project area on |
| 177 | or after January 1, 2010. |
| 178 | Section 4. This act shall take effect July 1, 2009. |