| 1 | A bill to be entitled |
| 2 | An act relating to prescription drugs; creating s. |
| 3 | 499.0295, F.S.; providing a short title; creating the Drug |
| 4 | Donation Program for the state correctional system; |
| 5 | providing a purpose; providing definitions; providing |
| 6 | conditions for the donation of drugs and supplies to the |
| 7 | program; providing conditions for the acceptance of drugs |
| 8 | and supplies into the program, inspection of drugs and |
| 9 | supplies, and dispensing of drugs and supplies to eligible |
| 10 | prisoners; requiring a participant facility that accepts |
| 11 | donated drugs and supplies through the program to comply |
| 12 | with certain state and federal laws; authorizing a |
| 13 | participant facility to charge fees under certain |
| 14 | conditions; requiring the Department of Health, upon |
| 15 | recommendation of the Department of Corrections and the |
| 16 | Board of Pharmacy, to adopt certain rules; requiring the |
| 17 | Department of Health to establish and maintain a |
| 18 | participant facility registry; providing for the contents |
| 19 | and availability of the participant facility registry; |
| 20 | providing immunity from civil and criminal liability for |
| 21 | the Department of Corrections, donors, and pharmaceutical |
| 22 | manufacturers in certain circumstances; providing that the |
| 23 | provisions of the act control in the event of a conflict |
| 24 | between provisions of the act and provisions in ch. 465 or |
| 25 | ch. 499, F.S.; authorizing a position and providing an |
| 26 | appropriation; providing an effective date. |
| 27 |
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| 28 | Be It Enacted by the Legislature of the State of Florida: |
| 29 |
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| 30 | Section 1. Section 499.0295, Florida Statutes, is created |
| 31 | to read: |
| 32 | 499.0295 Drug Donation Program.-- |
| 33 | (1) This section may be cited as the "Drug Donation |
| 34 | Program Act." |
| 35 | (2) There is created a Drug Donation Program within the |
| 36 | Department of Health for the purpose of authorizing and |
| 37 | facilitating the donation of drugs to the Department of |
| 38 | Corrections. |
| 39 | (3) As used in this section, the term: |
| 40 | (a) "Closed drug delivery system" means a system in which |
| 41 | the actual control of the unit-dose medication package is |
| 42 | maintained by the facility rather than by the individual |
| 43 | patient. |
| 44 | (b) "Donor" means a patient or patient representative who |
| 45 | donates drugs or supplies needed to administer drugs that have |
| 46 | been maintained within a closed drug delivery system; health |
| 47 | care facilities, nursing homes, hospices, or hospitals that have |
| 48 | closed drug delivery systems; or pharmacies, drug manufacturers, |
| 49 | medical device manufacturers or suppliers, or wholesalers of |
| 50 | drugs or supplies, in accordance with this section. The term |
| 51 | includes a physician licensed under chapter 458 or chapter 459 |
| 52 | who receives drugs directly from a drug manufacturer, wholesale |
| 53 | distributor, or pharmacy. |
| 54 | (c) "Drug" means a prescription drug that has been |
| 55 | approved under s. 505 of the Federal Food, Drug, and Cosmetic |
| 56 | Act. The term does not include a substance listed in Schedule |
| 57 | II, Schedule III, Schedule IV, or Schedule V of s. 893.03. |
| 58 | (d) "Eligible prisoner" means a prisoner who the |
| 59 | Department of Corrections determines is eligible to receive |
| 60 | drugs from the program. |
| 61 | (e) "Participant facility" means a class II hospital |
| 62 | pharmacy that has elected to participate in the program and that |
| 63 | accepts donated drugs and supplies under the rules adopted by |
| 64 | the department for the program. |
| 65 | (f) "Prescribing practitioner" means a physician licensed |
| 66 | under chapter 458 or chapter 459 or any other medical |
| 67 | professional who is authorized under state law to prescribe |
| 68 | medication. |
| 69 | (g) "Prisoner" means any person committed to or detained |
| 70 | in any state prison, prison farm, or penitentiary, or to the |
| 71 | custody of the Department of Corrections under lawful authority. |
| 72 | (h) "Program" means the Drug Donation Program created by |
| 73 | this section. |
| 74 | (i) "Supplies" means any supplies used in the |
| 75 | administration of a drug. |
| 76 | (4) Any donor may donate drugs or supplies to a |
| 77 | participant facility that elects to participate in the program |
| 78 | and meets criteria established by the Department of Health for |
| 79 | such participation. Drugs or supplies may not be donated to a |
| 80 | specific prisoner, and donated drugs or supplies may not be |
| 81 | resold by the program. Drugs billed to and paid for by Medicaid |
| 82 | in long-term care facilities that are eligible for return to |
| 83 | stock under federal Medicaid regulations shall be credited to |
| 84 | Medicaid and are not eligible for donation under the program. A |
| 85 | participant facility shall provide dispensing and consulting |
| 86 | services to the Department of Corrections. |
| 87 | (5) The drugs or supplies donated to the program may be |
| 88 | prescribed only by a prescribing practitioner for use by an |
| 89 | eligible prisoner and may be dispensed only by a pharmacist. |
| 90 | (6)(a) A drug may be accepted or dispensed under the |
| 91 | program only if the drug is in its original, unopened, and |
| 92 | sealed container, or in tamper-evident and unit-dose packaging, |
| 93 | except that a drug packaged in single-unit doses may be accepted |
| 94 | and dispensed if the outside packaging is opened but the single- |
| 95 | unit-dose packaging is unopened and the tamper-resistant |
| 96 | packaging is intact. |
| 97 | (b) A drug may not be accepted or dispensed under the |
| 98 | program if the drug bears an expiration date that is less than 6 |
| 99 | months after the date the drug was donated or if the drug |
| 100 | appears to have been tampered with or mislabeled as determined |
| 101 | in paragraph (c). |
| 102 | (c) Before being dispensed to an eligible prisoner, the |
| 103 | drug or supplies donated under the program shall be inspected by |
| 104 | a pharmacist to determine if the drug and supplies appear to |
| 105 | have been tampered with or mislabeled. |
| 106 | (d) A dispenser of donated drugs or supplies may not |
| 107 | submit a claim or otherwise seek reimbursement from the |
| 108 | Department of Corrections or any public or private third-party |
| 109 | payor for donated drugs or supplies dispensed to any prisoner |
| 110 | under the program, and a public or private third-party payor or |
| 111 | the Department of Corrections is not required to provide |
| 112 | reimbursement to a dispenser for donated drugs or supplies |
| 113 | dispensed to any prisoner under the program. |
| 114 | (7)(a) A donation of drugs or supplies shall be made only |
| 115 | at a participant facility. A participant facility may decline to |
| 116 | accept a donation. A participant facility that accepts donated |
| 117 | drugs or supplies under the program shall comply with all |
| 118 | applicable provisions of state and federal law relating to the |
| 119 | storage and dispensing of the donated drugs or supplies. |
| 120 | (b) A participant facility that voluntarily takes part in |
| 121 | the program may charge a handling fee sufficient to cover the |
| 122 | cost of preparation and dispensing of drugs or supplies under |
| 123 | the program. The fee shall be established in rules adopted by |
| 124 | the department. |
| 125 | (8) Upon the recommendation of the Board of Pharmacy and |
| 126 | the Department of Corrections, the Department of Health shall |
| 127 | adopt rules to administer this section. Initial rules under this |
| 128 | section must be adopted by October 1, 2009. The rules must |
| 129 | include, but need not be limited to: |
| 130 | (a) Eligibility criteria, including a method to determine |
| 131 | priority of eligible prisoners under the program. |
| 132 | (b) Standards and procedures for participant facilities |
| 133 | that accept, store, distribute, or dispense donated drugs or |
| 134 | supplies. |
| 135 | (c) Necessary forms for administration of the program, |
| 136 | including, but not limited to, forms for use by entities that |
| 137 | donate, accept, distribute, or dispense drugs or supplies under |
| 138 | the program. |
| 139 | (d) The maximum handling fee that may be charged by a |
| 140 | participant facility that accepts and distributes or dispenses |
| 141 | donated drugs or supplies. |
| 142 | (e) Categories of drugs and supplies which the program |
| 143 | will accept for dispensing; however, the department may exclude |
| 144 | any drug based on its therapeutic effectiveness or high |
| 145 | potential for abuse or diversion. |
| 146 | (f) Maintenance and distribution of the participant |
| 147 | facility registry established in subsection (9). |
| 148 | (9) The Department of Health shall establish and maintain |
| 149 | a participant facility registry for the program. The participant |
| 150 | facility registry shall include a participant facility's name, |
| 151 | address, and telephone number. The department shall make the |
| 152 | participant facility registry available on the department's |
| 153 | website to any donor wishing to donate drugs or supplies to the |
| 154 | program. The department's website must also contain links to |
| 155 | drug manufacturers that offer drug assistance programs or free |
| 156 | medication. |
| 157 | (10) The Department of Corrections, any donor of drugs or |
| 158 | supplies, or any participant in the program who exercises |
| 159 | reasonable care in donating, accepting, distributing, or |
| 160 | dispensing drugs or supplies under the program and the rules |
| 161 | adopted under this section is immune from civil or criminal |
| 162 | liability and from professional disciplinary action of any kind |
| 163 | for any injury, death, or loss to person or property relating to |
| 164 | such activities. |
| 165 | (11) A pharmaceutical manufacturer is not liable for any |
| 166 | claim or injury arising from the transfer of any drug under this |
| 167 | section, including, but not limited to, liability for failure to |
| 168 | transfer or communicate product or consumer information |
| 169 | regarding the transferred drug, as well as the expiration date |
| 170 | of the transferred drug. |
| 171 | (12) If any conflict exists between the provisions in this |
| 172 | section and the provisions in this chapter or chapter 465, the |
| 173 | provisions in this section control the operation of the Drug |
| 174 | Donation Program. |
| 175 | Section 2. One full-time equivalent position at a salary |
| 176 | rate of 42,715 is authorized and recurring funding from the |
| 177 | Florida Drug, Device, and Cosmetic Trust Fund pursuant to s. |
| 178 | 499.057, Florida Statutes, in the sum of $65,308 is appropriated |
| 179 | for the 2009-2010 fiscal year for the purpose of implementing |
| 180 | the Drug Donation Program as created by this act. |
| 181 | Section 3. This act shall take effect July 1, 2009. |