| 1 | The Committee on Health Care recommends the following: |
| 2 |
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| 3 | Committee Substitute |
| 4 | Remove the entire bill and insert: |
| 5 | A bill to be entitled |
| 6 | An act relating to the Florida Pharmacy Act; amending s. |
| 7 | 465.015, F.S.; providing that it is unlawful for a person, |
| 8 | firm, or corporation that is not licensed or registered |
| 9 | under the act to use certain terms implying that the |
| 10 | person, firm, or corporation is so licensed or registered, |
| 11 | or to hold himself, herself, or itself out as licensed or |
| 12 | registered to practice pharmacy in this state; providing |
| 13 | penalties; amending s. 465.003, F.S.; defining the term |
| 14 | "automated pharmacy system"; creating s. 465.0235, F.S.; |
| 15 | authorizing a pharmacy to provide services to a long-term |
| 16 | care facility, hospice, or state correctional institution |
| 17 | through an automated pharmacy system; providing that drugs |
| 18 | dispensed from an automated pharmacy system are considered |
| 19 | to have been dispensed by the pharmacy that services a |
| 20 | long-term care facility, hospice, or correctional |
| 21 | institution; requiring that the operation of an automated |
| 22 | pharmacy system be under the supervision of a Florida- |
| 23 | licensed pharmacist; providing duties of such pharmacist; |
| 24 | providing legislative intent relating to automated |
| 25 | pharmacy systems; requiring the Board of Pharmacy to adopt |
| 26 | rules; amending s. 465.026, F.S.; authorizing mail-order |
| 27 | pharmacies that use a common database to perform automated |
| 28 | prescription filling or dispensing functions to process |
| 29 | prescriptions for controlled substances using that common |
| 30 | database in compliance with federal law and regulation; |
| 31 | providing an effective date. |
| 32 |
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| 33 | Be It Enacted by the Legislature of the State of Florida: |
| 34 |
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| 35 | Section 1. Paragraph (c) is added to subsection (3) of |
| 36 | section 465.015, Florida Statutes, and subsection (4) of said |
| 37 | section is amended, to read: |
| 38 | 465.015 Violations and penalties.-- |
| 39 | (3) |
| 40 | (c) It is unlawful for a person, firm, or corporation that |
| 41 | is not licensed or registered under this chapter to: |
| 42 | 1. Use in a trade name, sign, letter, or advertisement any |
| 43 | term, including "drug," "pharmacy," "prescription drugs," "Rx," |
| 44 | or "apothecary," that implies that the person, firm, or |
| 45 | corporation is licensed or registered to practice pharmacy in |
| 46 | this state. |
| 47 | 2. Hold himself, herself, or itself out to others as a |
| 48 | person, firm, or corporation licensed or registered to practice |
| 49 | pharmacy in this state. |
| 50 | (4) Any person who violates any provision of subsection |
| 51 | (1) or subsection (3) commits is guilty of a misdemeanor of the |
| 52 | first degree, punishable as provided in s. 775.082 or s. |
| 53 | 775.083. Any person who violates any provision of subsection (2) |
| 54 | commits is guilty of a felony of the third degree, punishable as |
| 55 | provided in s. 775.082, s. 775.083, or s. 775.084. In any |
| 56 | warrant, information, or indictment, it shall not be necessary |
| 57 | to negative any exceptions, and the burden of any exception |
| 58 | shall be upon the defendant. |
| 59 | Section 2. Subsection (17) is added to section 465.003, |
| 60 | Florida Statutes, to read: |
| 61 | 465.003 Definitions.--As used in this chapter, the term: |
| 62 | (17) "Automated pharmacy system" means a mechanical system |
| 63 | that dispenses prescription drugs received from a Florida- |
| 64 | licensed pharmacy and maintains related transaction information. |
| 65 | Section 3. Section 465.0235, Florida Statutes, is created |
| 66 | to read: |
| 67 | 465.0235 Automated pharmacy systems used by long-term care |
| 68 | facilities, hospices, or state correctional institutions.-- |
| 69 | (1) A pharmacy may provide pharmacy services to a long- |
| 70 | term care facility or hospice licensed under chapter 400 or a |
| 71 | state correctional institution operated under chapter 944 |
| 72 | through the use of an automated pharmacy system that need not be |
| 73 | located at the same location as the pharmacy. |
| 74 | (2) Medicinal drugs stored in bulk or unit of use in an |
| 75 | automated pharmacy system servicing a long-term care facility, |
| 76 | hospice, or correctional institution are part of the inventory |
| 77 | of the pharmacy providing pharmacy services to that facility, |
| 78 | hospice, or institution, and drugs dispensed from the automated |
| 79 | pharmacy system are considered to have been dispensed by that |
| 80 | pharmacy. |
| 81 | (3) The operation of an automated pharmacy system must be |
| 82 | under the supervision of a Florida-licensed pharmacist. To |
| 83 | qualify as a supervisor for an automated pharmacy system, the |
| 84 | pharmacist need not be physically present at the site of the |
| 85 | automated pharmacy system and may supervise the system |
| 86 | electronically. The Florida-licensed pharmacist shall be |
| 87 | required to develop and implement policies and procedures |
| 88 | designed to verify that the prescriptions filled by the |
| 89 | automated pharmacy system are accurate and valid and that the |
| 90 | machine is properly restocked. |
| 91 | (4) The Legislature does not intend this section to limit |
| 92 | the current practice of pharmacy in this state. This section is |
| 93 | intended to allow automated pharmacy systems to enhance the |
| 94 | ability of a pharmacist to provide pharmacy services in |
| 95 | locations that do not employ a full-time pharmacist. This |
| 96 | section does not limit or replace the use of a consultant |
| 97 | pharmacist. |
| 98 | (5) The board shall adopt rules governing the use of an |
| 99 | automated pharmacy system by January 1, 2005, which must |
| 100 | specify: |
| 101 | (a) Recordkeeping requirements. |
| 102 | (b) Security requirements. |
| 103 | (c) Labeling requirements that permit the use of unit-dose |
| 104 | medications if the facility, hospice, or institution maintains |
| 105 | medication-administration records that include directions for |
| 106 | use of the medication and the automated pharmacy system |
| 107 | identifies: |
| 108 | 1. The dispensing pharmacy. |
| 109 | 2. The prescription number. |
| 110 | 3. The name of the patient. |
| 111 | 4. The name of the prescribing practitioner. |
| 112 | Section 4. Section 465.026, Florida Statutes, is amended |
| 113 | to read: |
| 114 | 465.026 Filling of certain prescriptions.--Nothing |
| 115 | contained in this chapter shall be construed to prohibit a |
| 116 | pharmacist licensed in this state from filling or refilling a |
| 117 | valid prescription which is on file in a pharmacy located in |
| 118 | this state or in another state and has been transferred from one |
| 119 | pharmacy to another by any means, including any electronic |
| 120 | means, under the following conditions: |
| 121 | (1) Prior to dispensing any transferred prescription, the |
| 122 | dispensing pharmacist must, either verbally or by any electronic |
| 123 | means, do all of the following: |
| 124 | (a) Advise the patient that the prescription on file at |
| 125 | the other pharmacy must be canceled before it may be filled or |
| 126 | refilled. |
| 127 | (b) Determine that the prescription is valid and on file |
| 128 | at the other pharmacy and that the prescription may be filled or |
| 129 | refilled, as requested, in accordance with the prescriber's |
| 130 | intent expressed on the prescription. |
| 131 | (c) Notify the pharmacist or pharmacy where the |
| 132 | prescription is on file that the prescription must be canceled. |
| 133 | (d) Record in writing, or by any electronic means, the |
| 134 | prescription order, the name of the pharmacy at which the |
| 135 | prescription was on file, the prescription number, the name of |
| 136 | the drug and the original amount dispensed, the date of original |
| 137 | dispensing, and the number of remaining authorized refills. |
| 138 | (e) Obtain the consent of the prescriber to the refilling |
| 139 | of the prescription when the prescription, in the dispensing |
| 140 | pharmacist's professional judgment, so requires. Any |
| 141 | interference with the professional judgment of the dispensing |
| 142 | pharmacist by any pharmacist or pharmacy permittee, or its |
| 143 | agents or employees, shall be grounds for discipline. |
| 144 | (2) Upon receipt of a prescription transfer request, if |
| 145 | the pharmacist is satisfied in her or his professional judgment |
| 146 | that the request is valid, or if the request has been validated |
| 147 | by any electronic means, the pharmacist or pharmacy must do all |
| 148 | of the following: |
| 149 | (a) Transfer the information required by paragraph (1)(d) |
| 150 | accurately and completely. |
| 151 | (b) Record on the prescription, or by any electronic |
| 152 | means, the requesting pharmacy and pharmacist and the date of |
| 153 | request. |
| 154 | (c) Cancel the prescription on file by electronic means or |
| 155 | by recording the word "void" on the prescription record. No |
| 156 | further prescription information shall be given or medication |
| 157 | dispensed pursuant to the original prescription. |
| 158 | (3) If a transferred prescription is not dispensed within |
| 159 | a reasonable time, the pharmacist shall, by any means, so notify |
| 160 | the transferring pharmacy. Such notice shall serve to revalidate |
| 161 | the canceled prescription. The pharmacist who has served such |
| 162 | notice shall then cancel the prescription in the same manner as |
| 163 | set forth in paragraph (2)(c). |
| 164 | (4) In the case of a prescription to be transferred from |
| 165 | or to a pharmacy located in another state, it shall be the |
| 166 | responsibility of the pharmacist or pharmacy located in the |
| 167 | State of Florida to verify, whether by electronic means or |
| 168 | otherwise, that the person or entity involved in the transfer is |
| 169 | a licensed pharmacist or pharmacy in the other state. |
| 170 | (5) Electronic transfers of prescriptions are permitted |
| 171 | regardless of whether the transferor or transferee pharmacy is |
| 172 | open for business. |
| 173 | (6) The transfer of a prescription for medicinal drugs |
| 174 | listed in Schedules III, IV, and V appearing in chapter 893 for |
| 175 | the purpose of refill dispensing is permissible, subject to the |
| 176 | requirements of this section and federal law. Compliance with |
| 177 | federal law shall be deemed compliance with the requirements of |
| 178 | this section. |
| 179 | (7) For purposes of this section, a mail-order pharmacy |
| 180 | that uses a common database to perform automated prescription |
| 181 | filling or dispensing functions may process a prescription for a |
| 182 | controlled substance using that common database to perform |
| 183 | prescription filling or dispensing functions in compliance with |
| 184 | federal law and regulation. |
| 185 | Section 5. This act shall take effect upon becoming a law. |