| 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 veterinary prescription drugs; amending |
| 7 | s. 499.003, F.S.; providing a definition; amending s. |
| 8 | 499.01, F.S.; requiring a person or establishment to |
| 9 | obtain a permit in order to operate as a veterinary |
| 10 | prescription drug wholesaler; amending s. 499.012, F.S.; |
| 11 | requiring a person to have a veterinary prescription drug |
| 12 | wholesaler permit to distribute veterinary prescription |
| 13 | drugs in or into this state; requiring a veterinary |
| 14 | prescription drug wholesaler who also distributes human |
| 15 | prescription drugs that it did not manufacture to obtain a |
| 16 | prescription drug wholesaler or out-of-state prescription |
| 17 | drug wholesaler permit in lieu of the veterinary |
| 18 | prescription drug wholesaler permit; amending s. 499.0121, |
| 19 | F.S.; requiring certain prescription wholesalers and |
| 20 | repackagers to use due diligence when purchasing |
| 21 | prescription drugs from certain distributors; amending s. |
| 22 | 499.041, F.S.; requiring an annual fee for a veterinary |
| 23 | prescription drug wholesaler's permit; amending s. |
| 24 | 499.065, F.S.; requiring the Department of Health to |
| 25 | inspect veterinary prescription drug wholesale |
| 26 | establishments; authorizing the department to close the |
| 27 | establishment if it creates an imminent danger to the |
| 28 | public health; providing an effective date. |
| 29 |
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| 30 | Be It Enacted by the Legislature of the State of Florida: |
| 31 |
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| 32 | Section 1. Subsection (40) is added to section 499.003, |
| 33 | Florida Statutes, to read: |
| 34 | 499.003 Definitions of terms used in ss. 499.001- |
| 35 | 499.081.--As used in ss. 499.001-499.081, the term: |
| 36 | (40) "Veterinary prescription drug wholesaler" means any |
| 37 | person engaged in wholesale distribution of veterinary |
| 38 | prescription drugs in or into this state. |
| 39 | Section 2. Subsection (1) of section 499.01, Florida |
| 40 | Statutes, is amended to read: |
| 41 | 499.01 Permits; applications; renewal; general |
| 42 | requirements.-- |
| 43 | (1) Prior to operating, a permit is required for each |
| 44 | person and establishment that intends to operate as: |
| 45 | (a) A prescription drug manufacturer; |
| 46 | (b) A prescription drug repackager; |
| 47 | (c) An over-the-counter drug manufacturer; |
| 48 | (d) A compressed medical gas manufacturer; |
| 49 | (e) A device manufacturer; |
| 50 | (f) A cosmetic manufacturer; |
| 51 | (g) A prescription drug wholesaler; |
| 52 | (h) A veterinary prescription drug wholesaler; |
| 53 | (i)(h) A compressed medical gas wholesaler; |
| 54 | (j)(i) An out-of-state prescription drug wholesaler; |
| 55 | (k)(j) A nonresident prescription drug manufacturer; |
| 56 | (l)(k) A freight forwarder; |
| 57 | (m)(l) A retail pharmacy drug wholesaler; |
| 58 | (n)(m) A veterinary legend drug retail establishment; |
| 59 | (o)(n) A medical oxygen retail establishment; |
| 60 | (p)(o) A complimentary drug distributor; or |
| 61 | (q)(p) A restricted prescription drug distributor. |
| 62 | Section 3. Paragraph (g) is added to subsection (2) of |
| 63 | section 499.012, Florida Statutes, to read: |
| 64 | 499.012 Wholesale distribution; definitions; permits; |
| 65 | applications; general requirements.-- |
| 66 | (2) The following types of wholesaler permits are |
| 67 | established: |
| 68 | (g) A veterinary prescription drug wholesaler permit. A |
| 69 | veterinary prescription drug wholesaler permit is required for |
| 70 | any person who engages in the distribution of veterinary |
| 71 | prescription drugs in or into this state. A veterinary |
| 72 | prescription drug wholesaler who also distributes prescription |
| 73 | drugs subject to, defined by, or described by s. 503(b) of the |
| 74 | Federal Food, Drug, and Cosmetic Act that it did not manufacture |
| 75 | must obtain a permit as a prescription drug wholesaler or out- |
| 76 | of-state prescription drug wholesaler in lieu of the veterinary |
| 77 | prescription drug wholesaler permit. A veterinary prescription |
| 78 | drug wholesaler must comply with the requirements for wholesale |
| 79 | distributors under s. 499.0121, except those set forth in s. |
| 80 | 499.0121(6)(d), (e), and (f). |
| 81 | Section 4. Subsection (12) of section 499.0121, Florida |
| 82 | Statutes, is amended to read: |
| 83 | 499.0121 Storage and handling of prescription drugs; |
| 84 | recordkeeping.--The department shall adopt rules to implement |
| 85 | this section as necessary to protect the public health, safety, |
| 86 | and welfare. Such rules shall include, but not be limited to, |
| 87 | requirements for the storage and handling of prescription drugs |
| 88 | and for the establishment and maintenance of prescription drug |
| 89 | distribution records. |
| 90 | (12) DUE DILIGENCE OF SUPPLIERS.--Prior to purchasing any |
| 91 | prescription drugs from another wholesale drug distributor, a |
| 92 | wholesale drug distributor, a prescription drug wholesaler, an |
| 93 | out-of-state prescription drug wholesaler, or a prescription |
| 94 | drug repackager must: |
| 95 | (a) Enter an agreement with the selling wholesale drug |
| 96 | distributor by which the selling wholesale drug distributor will |
| 97 | indemnify the purchasing wholesale drug distributor for any loss |
| 98 | caused to the purchasing wholesale drug distributor related to |
| 99 | the purchase of drugs from the selling wholesale drug |
| 100 | distributor which are determined to be counterfeit or to have |
| 101 | been distributed in violation of any federal or state law |
| 102 | governing the distribution of drugs. |
| 103 | (b) Determine that the selling wholesale drug distributor |
| 104 | has insurance coverage of not less than the greater of 1 percent |
| 105 | of the amount of total dollar volume of the prescription drug |
| 106 | sales reported to the department under pursuant to s. |
| 107 | 499.012(3)(g) or $500,000; however the coverage need not exceed |
| 108 | $2 million. |
| 109 | (c) Obtain information from the selling wholesale drug |
| 110 | distributor, including the length of time the selling wholesale |
| 111 | drug distributor has been licensed in this state, a copy of the |
| 112 | selling wholesale drug distributor's licenses or permits, and |
| 113 | background information concerning the ownership of the selling |
| 114 | wholesale drug distributor, including the experience of the |
| 115 | wholesale distributor in the wholesale distribution of |
| 116 | prescription drugs. |
| 117 | (d) Verify that the selling wholesale drug distributor's |
| 118 | Florida permit is valid. |
| 119 | (e) Inspect the selling wholesale drug distributor's |
| 120 | licensed establishment to document that it has a policies and |
| 121 | procedures manual relating to the distribution of drugs, the |
| 122 | appropriate temperature controlled environment for drugs |
| 123 | requiring temperature control, an alarm system, appropriate |
| 124 | access restrictions, and procedures to ensure that records |
| 125 | related to the wholesale distribution of prescription drugs are |
| 126 | maintained as required by law: |
| 127 | 1. Before purchasing any drug from the wholesale drug |
| 128 | distributor, and at least once each subsequent year; or |
| 129 | 2. Before purchasing any drug from the wholesale drug |
| 130 | distributor, and each subsequent year obtain a complete copy of |
| 131 | the most recent inspection report for the establishment which |
| 132 | was prepared by the department or the regulatory authority |
| 133 | responsible for wholesale drug distributors in the state in |
| 134 | which the establishment is located. |
| 135 | Section 5. Paragraph (g) is added to subsection (2) of |
| 136 | section 499.041, Florida Statutes, to read: |
| 137 | 499.041 Schedule of fees for drug, device, and cosmetic |
| 138 | applications and permits, product registrations, and free-sale |
| 139 | certificates.-- |
| 140 | (2) The department shall assess an applicant that is |
| 141 | required to have a wholesaling permit an annual fee within the |
| 142 | ranges established in this section for the specific type of |
| 143 | wholesaling. |
| 144 | (g) The fee for a veterinary prescription drug |
| 145 | wholesaler's permit may not be less than $300 nor more than $500 |
| 146 | annually. |
| 147 | Section 6. Section 499.065, Florida Statutes, is amended |
| 148 | to read: |
| 149 | 499.065 Imminent danger.-- |
| 150 | (1) Notwithstanding s. 499.051, the department shall |
| 151 | inspect each prescription drug wholesale establishment, |
| 152 | prescription drug repackager establishment, veterinary |
| 153 | prescription drug wholesale establishment, and retail pharmacy |
| 154 | drug wholesaler establishment that is required to be permitted |
| 155 | under this chapter as often as necessary to ensure compliance |
| 156 | with applicable laws and rules. The department shall have the |
| 157 | right of entry and access to these facilities at any reasonable |
| 158 | time. |
| 159 | (2) To protect the public from prescription drugs that are |
| 160 | adulterated or otherwise unfit for human or animal consumption, |
| 161 | the department may examine, sample, seize, and stop the sale or |
| 162 | use of prescription drugs to determine the condition of those |
| 163 | drugs. The department may immediately seize and remove any |
| 164 | prescription drugs if the Secretary of Health or his or her |
| 165 | designee determines that the such prescription drugs represent a |
| 166 | threat to the public health. The owner of any property seized |
| 167 | under this section may, within 10 days after the seizure, apply |
| 168 | to a court of competent jurisdiction for whatever relief is |
| 169 | appropriate. At any time after 10 days, the department may |
| 170 | destroy the drugs as contraband. |
| 171 | (3) The department may determine that a prescription drug |
| 172 | wholesale establishment, prescription drug repackager |
| 173 | establishment, veterinary prescription drug wholesale |
| 174 | establishment, or retail pharmacy drug wholesaler establishment |
| 175 | that is required to be permitted under this chapter is an |
| 176 | imminent danger to the public health and shall require its |
| 177 | immediate closure if the such establishment fails to comply with |
| 178 | applicable laws and rules and, because of the such failure, |
| 179 | presents an imminent threat to the public's health, safety, or |
| 180 | welfare. Any establishment so deemed and closed shall remain |
| 181 | closed until allowed by the department or by judicial order to |
| 182 | reopen. |
| 183 |
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| 184 | For purposes of this section, a refusal to allow entry to the |
| 185 | department for inspection at reasonable times, or a failure or |
| 186 | refusal to provide the department with required documentation |
| 187 | for purposes of inspection, constitutes an imminent danger to |
| 188 | the public health. |
| 189 | Section 7. This act shall take effect July 1, 2004. |