| 1 | Representative(s) Coley offered the following: |
| 2 |
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| 3 | Amendment (with title amendment) |
| 4 | On page 3, between line(s) 19 and 20, |
| 5 |
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| 6 | insert: |
| 7 | Section 3. Section 499.006, Florida Statutes, is amended |
| 8 | to read: |
| 9 | 499.006 Adulterated drug or device.--A drug or device is |
| 10 | adulterated: |
| 11 | (1) If it consists in whole or in part of any filthy, |
| 12 | putrid, or decomposed substance; |
| 13 | (2) If it has been produced, prepared, packed, or held |
| 14 | under conditions whereby it could have been contaminated with |
| 15 | filth or rendered injurious to health; |
| 16 | (3) If it is a drug and the methods used in, or the |
| 17 | facilities or controls used for, its manufacture, processing, |
| 18 | packing, or holding do not conform to, or are not operated or |
| 19 | administered in conformity with, current good manufacturing |
| 20 | practices to assure that the drug meets the requirements of ss. |
| 21 | 499.001-499.081 and that the drug has the identity and strength, |
| 22 | and meets the standard of quality and purity, which it purports |
| 23 | or is represented to possess; |
| 24 | (4) If it is a drug and its container is composed, in |
| 25 | whole or in part, of any poisonous or deleterious substance |
| 26 | which could render the contents injurious to health; |
| 27 | (5) If it is a drug and it bears or contains, for the |
| 28 | purpose of coloring only, a color additive that is unsafe within |
| 29 | the meaning of the federal act; or, if it is a color additive, |
| 30 | the intended use of which in or on drugs is for the purpose of |
| 31 | coloring only, and it is unsafe within the meaning of the |
| 32 | federal act; |
| 33 | (6) If it purports to be, or is represented as, a drug the |
| 34 | name of which is recognized in the official compendium, and its |
| 35 | strength differs from, or its quality or purity falls below, the |
| 36 | standard set forth in such compendium. The determination as to |
| 37 | strength, quality, or purity must be made in accordance with the |
| 38 | tests or methods of assay set forth in such compendium, or, when |
| 39 | such tests or methods of assay are absent or inadequate, in |
| 40 | accordance with those tests or methods of assay prescribed under |
| 41 | authority of the federal act. A drug defined in the official |
| 42 | compendium is not adulterated under this subsection merely |
| 43 | because it differs from the standard of strength, quality, or |
| 44 | purity set forth for that drug in such compendium if its |
| 45 | difference in strength, quality, or purity from such standard is |
| 46 | plainly stated on its label; |
| 47 | (7) If it is not subject to subsection (6) and its |
| 48 | strength differs from, or its purity or quality falls below the |
| 49 | standard of, that which it purports or is represented to |
| 50 | possess; |
| 51 | (8) If it is a drug: |
| 52 | (a) With which any substance has been mixed or packed so |
| 53 | as to reduce the quality or strength of the drug; or |
| 54 | (b) For which any substance has been substituted wholly or |
| 55 | in part; |
| 56 | (9) If it is a drug or device for which the expiration |
| 57 | date has passed; or |
| 58 | (10) If it is a legend drug for which the required |
| 59 | pedigree paper is nonexistent, fraudulent, or incomplete under |
| 60 | the requirements of ss. 499.001-499.081 or applicable rules, or |
| 61 | that has been purchased, held, sold, or distributed at any time |
| 62 | by a person not authorized under federal or state law to do so; |
| 63 | or. |
| 64 | (11) If it is a prescription drug subject to, defined by, |
| 65 | or described by s. 503(b) of the Federal Food, Drug, and |
| 66 | Cosmetic Act which has been returned by a veterinarian to a |
| 67 | limited prescription drug veterinary wholesaler. |
| 68 | Section 4. Subsection (1) and paragraph (d) of subsection |
| 69 | (2) of section 499.01, Florida Statutes, are amended to read: |
| 70 | 499.01 Permits; applications; renewal; general |
| 71 | requirements.-- |
| 72 | (1) Prior to operating, a permit is required for each |
| 73 | person and establishment that intends to operate as: |
| 74 | (a) A prescription drug manufacturer; |
| 75 | (b) A prescription drug repackager; |
| 76 | (c) An over-the-counter drug manufacturer; |
| 77 | (d) A compressed medical gas manufacturer; |
| 78 | (e) A device manufacturer; |
| 79 | (f) A cosmetic manufacturer; |
| 80 | (g) A prescription drug wholesaler; |
| 81 | (h) A veterinary prescription drug wholesaler; |
| 82 | (i) A compressed medical gas wholesaler; |
| 83 | (j) An out-of-state prescription drug wholesaler; |
| 84 | (k) A nonresident prescription drug manufacturer; |
| 85 | (l) A freight forwarder; |
| 86 | (m) A retail pharmacy drug wholesaler; |
| 87 | (n) A veterinary legend drug retail establishment; |
| 88 | (o) A medical oxygen retail establishment; |
| 89 | (p) A complimentary drug distributor; or |
| 90 | (q) A restricted prescription drug distributor; or. |
| 91 | (r) A limited prescription drug veterinary wholesaler. |
| 92 | (2) |
| 93 | (d) A permit for a prescription drug manufacturer, |
| 94 | prescription drug repackager, prescription drug wholesaler, |
| 95 | limited prescription drug veterinary wholesaler, or retail |
| 96 | pharmacy wholesaler may not be issued to the address of a health |
| 97 | care entity or to a pharmacy licensed under chapter 465, except |
| 98 | as provided in this paragraph. The department may issue a |
| 99 | prescription drug manufacturer permit to an applicant at the |
| 100 | same address as a licensed nuclear pharmacy, which is a health |
| 101 | care entity, for the purpose of manufacturing prescription drugs |
| 102 | used in positron emission tomography or other |
| 103 | radiopharmaceuticals, as listed in a rule adopted by the |
| 104 | department pursuant to this paragraph. The purpose of this |
| 105 | exemption is to assure availability of state-of-the-art |
| 106 | pharmaceuticals that would pose a significant danger to the |
| 107 | public health if manufactured at a separate establishment |
| 108 | address from the nuclear pharmacy from which the prescription |
| 109 | drugs are dispensed. The department may also issue a retail |
| 110 | pharmacy wholesaler permit to the address of a community |
| 111 | pharmacy licensed under chapter 465 which does not meet the |
| 112 | definition of a closed pharmacy in s. 499.003. |
| 113 | Section 5. Paragraph (g) of subsection (2) of section |
| 114 | 499.012, Florida Statutes, is amended, and paragraph (h) is |
| 115 | added to that subsection, to read: |
| 116 | 499.012 Wholesale distribution; definitions; permits; |
| 117 | applications; general requirements.-- |
| 118 | (2) The following types of wholesaler permits are |
| 119 | established: |
| 120 | (g) A veterinary prescription drug wholesaler permit.--A |
| 121 | veterinary prescription drug wholesaler permit is required for |
| 122 | any person that engages in the distribution of veterinary |
| 123 | prescription drugs in or into this state. A veterinary |
| 124 | prescription drug wholesaler that also distributes prescription |
| 125 | drugs subject to, defined by, or described by s. 503(b) of the |
| 126 | Federal Food, Drug, and Cosmetic Act which it did not |
| 127 | manufacture must obtain a permit as a prescription drug |
| 128 | wholesaler, an or out-of-state prescription drug wholesaler, or |
| 129 | a limited prescription drug veterinary wholesaler in lieu of the |
| 130 | veterinary prescription drug wholesaler permit. A veterinary |
| 131 | prescription drug wholesaler must comply with the requirements |
| 132 | for wholesale distributors under s. 499.0121, except those set |
| 133 | forth in s. 499.0121(6)(d), (e), or (f). |
| 134 | (h) Limited prescription drug veterinary wholesaler |
| 135 | permit.--Unless engaging in the activities of and permitted as a |
| 136 | prescription drug manufacturer, nonresident prescription drug |
| 137 | manufacturer, prescription drug wholesaler, or out-of-state |
| 138 | prescription drug wholesaler, a limited prescription drug |
| 139 | veterinary wholesaler permit is required for any person that |
| 140 | engages in the distribution in or into this state of veterinary |
| 141 | prescription drugs and prescription drugs subject to, defined |
| 142 | by, or described by s. 503(b) of the Federal Food, Drug, and |
| 143 | Cosmetic Act under the following conditions: |
| 144 | 1. The person is engaged in the business of wholesaling |
| 145 | prescription and veterinary legend drugs to persons: |
| 146 | a. Licensed as veterinarians practicing on a full-time |
| 147 | basis; |
| 148 | b. Regularly and lawfully engaged in instruction in |
| 149 | veterinary medicine; |
| 150 | c. Regularly and lawfully engaged in law enforcement |
| 151 | activities; |
| 152 | d. For use in research not involving clinical use; or |
| 153 | e. For use in chemical analysis or physical testing or for |
| 154 | purposes of instruction in law enforcement activities, research, |
| 155 | or testing. |
| 156 | 2. No more than 30 percent of total annual prescription |
| 157 | drug sales may be prescription drugs approved for human use |
| 158 | which are subject to, defined by, or described by s. 503(b) of |
| 159 | the Federal Food, Drug, and Cosmetic Act. |
| 160 | 3. The person is not permitted, licensed, or otherwise |
| 161 | authorized in any state to wholesale prescription drugs subject |
| 162 | to, defined by, or described by s. 503(b) of the Federal Food, |
| 163 | Drug, and Cosmetic Act to any person who is authorized to sell, |
| 164 | distribute, purchase, trade, or use these drugs on or for |
| 165 | humans. |
| 166 | 4. A limited prescription drug veterinary wholesaler that |
| 167 | applies to the department for a new permit or the renewal of a |
| 168 | permit must submit a bond of $20,000, or other equivalent means |
| 169 | of security acceptable to the department, such as an irrevocable |
| 170 | letter of credit or a deposit in a trust account or financial |
| 171 | institution, payable to the Florida Drug, Device, and Cosmetic |
| 172 | Trust Fund. The purpose of the bond is to secure payment of any |
| 173 | administrative penalties imposed by the department and any fees |
| 174 | and costs incurred by the department regarding that permit which |
| 175 | are authorized under state law and which the permittee fails to |
| 176 | pay 30 days after the fine or costs become final. The department |
| 177 | may make a claim against such bond or security until 1 year |
| 178 | after the permittee's license ceases to be valid or until 60 |
| 179 | days after any administrative or legal proceeding authorized in |
| 180 | ss. 499.001-499.081 which involves the permittee is concluded, |
| 181 | including any appeal, whichever occurs later. |
| 182 | 5. A limited prescription drug veterinary wholesaler must |
| 183 | maintain at all times a license or permit to engage in the |
| 184 | wholesale distribution of prescription drugs in compliance with |
| 185 | laws of the state in which it is a resident. |
| 186 | 6. A limited prescription drug veterinary wholesaler must |
| 187 | comply with the requirements for wholesale distributors under s. |
| 188 | 499.0121, except that a limited prescription drug veterinary |
| 189 | wholesaler is not required to provide a pedigree paper as |
| 190 | required by s. 499.0121(6)(f) upon the wholesale distribution of |
| 191 | a prescription drug to a veterinarian. |
| 192 | 7. A limited prescription drug veterinary wholesaler may |
| 193 | not return to inventory for subsequent wholesale distribution |
| 194 | any prescription drug subject to, defined by, or described by s. |
| 195 | 503(b) of the Federal Food, Drug, and Cosmetic Act which has |
| 196 | been returned by a veterinarian. |
| 197 | 8. An out-of-state prescription drug wholesaler's permit |
| 198 | or a limited prescription drug veterinary wholesaler permit is |
| 199 | not required for an intracompany sale or transfer of a |
| 200 | prescription drug from an out-of-state establishment that is |
| 201 | duly licensed to engage in the wholesale distribution of |
| 202 | prescription drugs in its state of residence to a licensed |
| 203 | limited prescription drug veterinary wholesaler in this state if |
| 204 | both wholesalers conduct wholesale distributions of prescription |
| 205 | drugs under the same business name. The recordkeeping |
| 206 | requirements of s. 499.0121(6) must be followed for this |
| 207 | transaction. |
| 208 | Section 6. Paragraph (d) of subsection (1) of section |
| 209 | 499.0122, Florida Statutes, is amended to read: |
| 210 | 499.0122 Medical oxygen and veterinary legend drug retail |
| 211 | establishments; definitions, permits, general requirements.-- |
| 212 | (1) As used in this section, the term: |
| 213 | (d) "Veterinary legend drug retail establishment" means a |
| 214 | person permitted to sell veterinary legend drugs to the public |
| 215 | or to veterinarians, but does not include a pharmacy licensed |
| 216 | under chapter 465. |
| 217 | 1. The sale to the public must be based on a valid written |
| 218 | order from a veterinarian licensed in this state who has a valid |
| 219 | client-veterinarian relationship with the purchaser's animal. |
| 220 | 2. Veterinary legend drugs may not be sold in excess of |
| 221 | the amount clearly indicated on the order or beyond the date |
| 222 | indicated on the order. |
| 223 | 3. An order may not be valid for more than 1 year. |
| 224 | 4. A veterinary legend drug retail establishment may not |
| 225 | purchase, sell, trade, or possess human prescription drugs or |
| 226 | any controlled substance as defined in chapter 893. |
| 227 | 5. A veterinary legend drug retail establishment must sell |
| 228 | a veterinary legend drug in the original, sealed manufacturer's |
| 229 | container with all labeling intact and legible. The department |
| 230 | may adopt by rule additional labeling requirements for the sale |
| 231 | of a veterinary legend drug. |
| 232 | Section 7. Paragraph (h) is added to subsection (2) of |
| 233 | section 499.041, Florida Statutes, to read: |
| 234 | 499.041 Schedule of fees for drug, device, and cosmetic |
| 235 | applications and permits, product registrations, and free-sale |
| 236 | certificates.-- |
| 237 | (2) The department shall assess an applicant that is |
| 238 | required to have a wholesaling permit an annual fee within the |
| 239 | ranges established in this section for the specific type of |
| 240 | wholesaling. |
| 241 | (h) The fee for a limited prescription drug veterinary |
| 242 | wholesaler's permit may not be less than $300 or more than $500 |
| 243 | annually. |
| 244 | Section 8. Subsections (1) and (3) of section 499.065, |
| 245 | Florida Statutes, are amended to read: |
| 246 | 499.065 Imminent danger.-- |
| 247 | (1) Notwithstanding s. 499.051, the department shall |
| 248 | inspect each prescription drug wholesale establishment, |
| 249 | prescription drug repackager establishment, veterinary |
| 250 | prescription drug wholesale establishment, limited prescription |
| 251 | drug veterinary wholesaler establishment, and retail pharmacy |
| 252 | drug wholesaler establishment that is required to be permitted |
| 253 | under this chapter as often as necessary to ensure compliance |
| 254 | with applicable laws and rules. The department shall have the |
| 255 | right of entry and access to these facilities at any reasonable |
| 256 | time. |
| 257 | (3) The department may determine that a prescription drug |
| 258 | wholesale establishment, prescription drug repackager |
| 259 | establishment, veterinary prescription drug wholesale |
| 260 | establishment, limited prescription drug veterinary wholesaler |
| 261 | establishment, or retail pharmacy drug wholesaler establishment |
| 262 | that is required to be permitted under this chapter is an |
| 263 | imminent danger to the public health and shall require its |
| 264 | immediate closure if the establishment fails to comply with |
| 265 | applicable laws and rules and, because of the failure, presents |
| 266 | an imminent threat to the public's health, safety, or welfare. |
| 267 | Any establishment so deemed and closed shall remain closed until |
| 268 | allowed by the department or by judicial order to reopen. |
| 269 |
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| 270 | For purposes of this section, a refusal to allow entry to the |
| 271 | department for inspection at reasonable times, or a failure or |
| 272 | refusal to provide the department with required documentation |
| 273 | for purposes of inspection, constitutes an imminent danger to |
| 274 | the public health. |
| 275 |
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| 276 |
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| 277 | ========= T I T L E A M E N D M E N T ========= |
| 278 | On page 1, line(s) 2-10, |
| 279 | remove: all of said lines |
| 280 |
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| 281 | and insert: |
| 282 | An act relating to pharmacy; amending s. 465.026, F.S.; deleting |
| 283 | a provision authorizing certain community pharmacies to transfer |
| 284 | prescriptions for Schedule II medicinal drugs under certain |
| 285 | conditions; creating s. 465.0266, F.S.; authorizing the |
| 286 | dispensing or refilling of a prescription without a transferred |
| 287 | prescription under specified conditions; amending s. 499.006, |
| 288 | F.S.; providing that a drug is adulterated if it is a certain |
| 289 | prescription drug that has been returned by a veterinarian to a |
| 290 | limited prescription drug veterinary wholesaler; amending s. |
| 291 | 499.01, F.S.; requiring a limited prescription drug veterinary |
| 292 | wholesaler to obtain a permit for operation from the Department |
| 293 | of Health; providing that a permit for a limited prescription |
| 294 | drug veterinary wholesaler may not be issued to the address of |
| 295 | certain health care entities; amending s. 499.012, F.S.; |
| 296 | revising permit requirements for a veterinary prescription drug |
| 297 | wholesaler that distributes prescription drugs; establishing a |
| 298 | permit for a limited prescription drug veterinary wholesaler; |
| 299 | providing requirements; providing an exception; amending s. |
| 300 | 499.0122, F.S.; redefining the term "veterinary legend drug |
| 301 | retail establishment"; amending s. 499.041, F.S.; requiring the |
| 302 | department to assess an annual fee within a certain monetary |
| 303 | range for a limited prescription drug veterinary wholesaler |
| 304 | permit; amending s. 499.065, F.S.; requiring the department to |
| 305 | inspect each limited prescription drug veterinary wholesaler |
| 306 | establishment; authorizing the department to determine that a |
| 307 | limited prescription drug veterinary wholesaler establishment is |
| 308 | an imminent danger to the public; providing an effective |