| 1 | The Health Care Regulation Committee recommends the following: |
| 2 |
|
| 3 | Council/Committee Substitute |
| 4 | Remove the entire bill and insert: |
| 5 | A bill to be entitled |
| 6 | An act relating to veterinary drug distribution; amending |
| 7 | s. 499.006, F.S.; providing that a drug is adulterated if |
| 8 | it is a certain prescription drug that has been returned |
| 9 | by a veterinarian to a limited prescription drug |
| 10 | veterinary wholesaler; amending s. 499.01, F.S.; requiring |
| 11 | a limited prescription drug veterinary wholesaler to |
| 12 | obtain a permit for operation from the Department of |
| 13 | Health; providing that a permit for a limited prescription |
| 14 | drug veterinary wholesaler may not be issued to the |
| 15 | address of certain health care entities; amending s. |
| 16 | 499.012, F.S.; revising permit requirements for a |
| 17 | veterinary prescription drug wholesaler that distributes |
| 18 | prescription drugs; establishing a permit for a limited |
| 19 | prescription drug veterinary wholesaler; providing |
| 20 | requirements; providing an exception; amending s. |
| 21 | 499.0122, F.S.; redefining the term "veterinary legend |
| 22 | drug retail establishment"; amending s. 499.041, F.S.; |
| 23 | requiring the department to assess an annual fee within a |
| 24 | certain monetary range for a limited prescription drug |
| 25 | veterinary wholesaler permit; amending s. 499.065, F.S.; |
| 26 | requiring the department to inspect each limited |
| 27 | prescription drug veterinary wholesaler establishment; |
| 28 | authorizing the department to determine that a limited |
| 29 | prescription drug veterinary wholesaler establishment is |
| 30 | an imminent danger to the public; providing an effective |
| 31 | date. |
| 32 |
|
| 33 | Be It Enacted by the Legislature of the State of Florida: |
| 34 |
|
| 35 | Section 1. Section 499.006, Florida Statutes, is amended |
| 36 | to read: |
| 37 | 499.006 Adulterated drug or device.--A drug or device is |
| 38 | adulterated: |
| 39 | (1) If it consists in whole or in part of any filthy, |
| 40 | putrid, or decomposed substance; |
| 41 | (2) If it has been produced, prepared, packed, or held |
| 42 | under conditions whereby it could have been contaminated with |
| 43 | filth or rendered injurious to health; |
| 44 | (3) If it is a drug and the methods used in, or the |
| 45 | facilities or controls used for, its manufacture, processing, |
| 46 | packing, or holding do not conform to, or are not operated or |
| 47 | administered in conformity with, current good manufacturing |
| 48 | practices to assure that the drug meets the requirements of ss. |
| 49 | 499.001-499.081 and that the drug has the identity and strength, |
| 50 | and meets the standard of quality and purity, which it purports |
| 51 | or is represented to possess; |
| 52 | (4) If it is a drug and its container is composed, in |
| 53 | whole or in part, of any poisonous or deleterious substance |
| 54 | which could render the contents injurious to health; |
| 55 | (5) If it is a drug and it bears or contains, for the |
| 56 | purpose of coloring only, a color additive that is unsafe within |
| 57 | the meaning of the federal act; or, if it is a color additive, |
| 58 | the intended use of which in or on drugs is for the purpose of |
| 59 | coloring only, and it is unsafe within the meaning of the |
| 60 | federal act; |
| 61 | (6) If it purports to be, or is represented as, a drug the |
| 62 | name of which is recognized in the official compendium, and its |
| 63 | strength differs from, or its quality or purity falls below, the |
| 64 | standard set forth in such compendium. The determination as to |
| 65 | strength, quality, or purity must be made in accordance with the |
| 66 | tests or methods of assay set forth in such compendium, or, when |
| 67 | such tests or methods of assay are absent or inadequate, in |
| 68 | accordance with those tests or methods of assay prescribed under |
| 69 | authority of the federal act. A drug defined in the official |
| 70 | compendium is not adulterated under this subsection merely |
| 71 | because it differs from the standard of strength, quality, or |
| 72 | purity set forth for that drug in such compendium if its |
| 73 | difference in strength, quality, or purity from such standard is |
| 74 | plainly stated on its label; |
| 75 | (7) If it is not subject to subsection (6) and its |
| 76 | strength differs from, or its purity or quality falls below the |
| 77 | standard of, that which it purports or is represented to |
| 78 | possess; |
| 79 | (8) If it is a drug: |
| 80 | (a) With which any substance has been mixed or packed so |
| 81 | as to reduce the quality or strength of the drug; or |
| 82 | (b) For which any substance has been substituted wholly or |
| 83 | in part; |
| 84 | (9) If it is a drug or device for which the expiration |
| 85 | date has passed; or |
| 86 | (10) If it is a legend drug for which the required |
| 87 | pedigree paper is nonexistent, fraudulent, or incomplete under |
| 88 | the requirements of ss. 499.001-499.081 or applicable rules, or |
| 89 | that has been purchased, held, sold, or distributed at any time |
| 90 | by a person not authorized under federal or state law to do so; |
| 91 | or. |
| 92 | (11) If it is a prescription drug subject to, defined by, |
| 93 | or described by s. 503(b) of the Federal Food, Drug, and |
| 94 | Cosmetic Act which has been returned by a veterinarian to a |
| 95 | limited prescription drug veterinary wholesaler. |
| 96 | Section 2. Subsection (1) and paragraph (d) of subsection |
| 97 | (2) of section 499.01, Florida Statutes, are amended to read: |
| 98 | 499.01 Permits; applications; renewal; general |
| 99 | requirements.-- |
| 100 | (1) Prior to operating, a permit is required for each |
| 101 | person and establishment that intends to operate as: |
| 102 | (a) A prescription drug manufacturer; |
| 103 | (b) A prescription drug repackager; |
| 104 | (c) An over-the-counter drug manufacturer; |
| 105 | (d) A compressed medical gas manufacturer; |
| 106 | (e) A device manufacturer; |
| 107 | (f) A cosmetic manufacturer; |
| 108 | (g) A prescription drug wholesaler; |
| 109 | (h) A veterinary prescription drug wholesaler; |
| 110 | (i) A compressed medical gas wholesaler; |
| 111 | (j) An out-of-state prescription drug wholesaler; |
| 112 | (k) A nonresident prescription drug manufacturer; |
| 113 | (l) A freight forwarder; |
| 114 | (m) A retail pharmacy drug wholesaler; |
| 115 | (n) A veterinary legend drug retail establishment; |
| 116 | (o) A medical oxygen retail establishment; |
| 117 | (p) A complimentary drug distributor; or |
| 118 | (q) A restricted prescription drug distributor; or. |
| 119 | (r) A limited prescription drug veterinary wholesaler. |
| 120 | (2) |
| 121 | (d) A permit for a prescription drug manufacturer, |
| 122 | prescription drug repackager, prescription drug wholesaler, |
| 123 | limited prescription drug veterinary wholesaler, or retail |
| 124 | pharmacy wholesaler may not be issued to the address of a health |
| 125 | care entity or to a pharmacy licensed under chapter 465, except |
| 126 | as provided in this paragraph. The department may issue a |
| 127 | prescription drug manufacturer permit to an applicant at the |
| 128 | same address as a licensed nuclear pharmacy, which is a health |
| 129 | care entity, for the purpose of manufacturing prescription drugs |
| 130 | used in positron emission tomography or other |
| 131 | radiopharmaceuticals, as listed in a rule adopted by the |
| 132 | department pursuant to this paragraph. The purpose of this |
| 133 | exemption is to assure availability of state-of-the-art |
| 134 | pharmaceuticals that would pose a significant danger to the |
| 135 | public health if manufactured at a separate establishment |
| 136 | address from the nuclear pharmacy from which the prescription |
| 137 | drugs are dispensed. The department may also issue a retail |
| 138 | pharmacy wholesaler permit to the address of a community |
| 139 | pharmacy licensed under chapter 465 which does not meet the |
| 140 | definition of a closed pharmacy in s. 499.003. |
| 141 | Section 3. Paragraph (g) of subsection (2) of section |
| 142 | 499.012, Florida Statutes, is amended, and paragraph (h) is |
| 143 | added to that subsection, to read: |
| 144 | 499.012 Wholesale distribution; definitions; permits; |
| 145 | applications; general requirements.-- |
| 146 | (2) The following types of wholesaler permits are |
| 147 | established: |
| 148 | (g) A veterinary prescription drug wholesaler permit.--A |
| 149 | veterinary prescription drug wholesaler permit is required for |
| 150 | any person that engages in the distribution of veterinary |
| 151 | prescription drugs in or into this state. A veterinary |
| 152 | prescription drug wholesaler that also distributes prescription |
| 153 | drugs subject to, defined by, or described by s. 503(b) of the |
| 154 | Federal Food, Drug, and Cosmetic Act which it did not |
| 155 | manufacture must obtain a permit as a prescription drug |
| 156 | wholesaler, an or out-of-state prescription drug wholesaler, or |
| 157 | a limited prescription drug veterinary wholesaler in lieu of the |
| 158 | veterinary prescription drug wholesaler permit. A veterinary |
| 159 | prescription drug wholesaler must comply with the requirements |
| 160 | for wholesale distributors under s. 499.0121, except those set |
| 161 | forth in s. 499.0121(6)(d), (e), or (f). |
| 162 | (h) Limited prescription drug veterinary wholesaler |
| 163 | permit.--Unless engaging in the activities of and permitted as a |
| 164 | prescription drug manufacturer, nonresident prescription drug |
| 165 | manufacturer, prescription drug wholesaler, or out-of-state |
| 166 | prescription drug wholesaler, a limited prescription drug |
| 167 | veterinary wholesaler permit is required for any person that |
| 168 | engages in the distribution in or into this state of veterinary |
| 169 | prescription drugs and prescription drugs subject to, defined |
| 170 | by, or described by s. 503(b) of the Federal Food, Drug, and |
| 171 | Cosmetic Act to veterinarians under the following conditions: |
| 172 | 1. The person is engaged in the business of wholesaling |
| 173 | prescription and veterinary legend drugs to persons: |
| 174 | a. Licensed as veterinarians practicing on a full-time |
| 175 | basis; |
| 176 | b. Regularly and lawfully engaged in instruction in |
| 177 | veterinary medicine; |
| 178 | c. Regularly and lawfully engaged in law enforcement; |
| 179 | d. For use in research, not involving clinical use; or |
| 180 | e. For use in chemical analysis or physical testing, for |
| 181 | the purposes of instruction in law enforcement, research, or |
| 182 | testing. |
| 183 | 2. No more than 30 percent of prescription drug sales may |
| 184 | be prescription drugs approved for human use which are subject |
| 185 | to, defined by, or described by s. 503(b) of the Federal Food, |
| 186 | Drug, and Cosmetic Act. |
| 187 | 3. The person is not permitted, licensed, or otherwise |
| 188 | authorized in any state to wholesale prescription drugs subject |
| 189 | to, defined by, or described by s. 503(b) of the Federal Food, |
| 190 | Drug, and Cosmetic Act to any person who is authorized to sell, |
| 191 | distribute, purchase, trade, or use these drugs on or for |
| 192 | humans. |
| 193 | 4. A limited prescription drug veterinary wholesaler that |
| 194 | applies to the department for a new permit or the renewal of a |
| 195 | permit must submit a bond of $20,000, or other equivalent means |
| 196 | of security acceptable to the department, such as an irrevocable |
| 197 | letter of credit or a deposit in a trust account or financial |
| 198 | institution, payable to the Florida Drug, Device, and Cosmetic |
| 199 | Trust Fund. The purpose of the bond is to secure payment of any |
| 200 | administrative penalties imposed by the department and any fees |
| 201 | and costs incurred by the department regarding that permit which |
| 202 | are authorized under state law and which the permittee fails to |
| 203 | pay 30 days after the fine or costs become final. The department |
| 204 | may make a claim against such bond or security until 1 year |
| 205 | after the permittee's license ceases to be valid or until 60 |
| 206 | days after any administrative or legal proceeding authorized in |
| 207 | ss. 499.001-499.081 which involves the permittee is concluded, |
| 208 | including any appeal, whichever occurs later. |
| 209 | 5. A limited prescription drug veterinary wholesaler must |
| 210 | maintain at all times a license or permit to engage in the |
| 211 | wholesale distribution of prescription drugs in compliance with |
| 212 | laws of the state in which it is a resident. |
| 213 | 6. A limited prescription drug veterinary wholesaler must |
| 214 | comply with the requirements for wholesale distributors under s. |
| 215 | 499.0121, except that a limited prescription drug veterinary |
| 216 | wholesaler is not required to provide a pedigree paper as |
| 217 | required by s. 499.0121(6)(f) upon the wholesale distribution of |
| 218 | a prescription drug to a veterinarian. |
| 219 | 7. A limited prescription drug veterinary wholesaler may |
| 220 | not return to inventory for subsequent wholesale distribution |
| 221 | any prescription drug subject to, defined by, or described by s. |
| 222 | 503(b) of the Federal Food, Drug, and Cosmetic Act which has |
| 223 | been returned by a veterinarian. |
| 224 | 8. An out-of-state prescription drug wholesaler's permit |
| 225 | or a limited prescription drug veterinary wholesaler permit is |
| 226 | not required for an intracompany sale or transfer of a |
| 227 | prescription drug from an out-of-state establishment that is |
| 228 | duly licensed to engage in the wholesale distribution of |
| 229 | prescription drugs in its state of residence to a licensed |
| 230 | limited prescription drug veterinary wholesaler in this state if |
| 231 | both wholesalers conduct wholesale distributions of prescription |
| 232 | drugs under the same business name. The recordkeeping |
| 233 | requirements of s. 499.0121(6) must be followed for this |
| 234 | transaction. |
| 235 | Section 4. Paragraph (d) of subsection (1) of section |
| 236 | 499.0122, Florida Statutes, is amended to read: |
| 237 | 499.0122 Medical oxygen and veterinary legend drug retail |
| 238 | establishments; definitions, permits, general requirements.-- |
| 239 | (1) As used in this section, the term: |
| 240 | (d) "Veterinary legend drug retail establishment" means a |
| 241 | person permitted to sell veterinary legend drugs to the public |
| 242 | or to veterinarians, but does not include a pharmacy licensed |
| 243 | under chapter 465. |
| 244 | 1. The sale to the public must be based on a valid written |
| 245 | order from a veterinarian licensed in this state who has a valid |
| 246 | client-veterinarian relationship with the purchaser's animal. |
| 247 | 2. Veterinary legend drugs may not be sold in excess of |
| 248 | the amount clearly indicated on the order or beyond the date |
| 249 | indicated on the order. |
| 250 | 3. An order may not be valid for more than 1 year. |
| 251 | 4. A veterinary legend drug retail establishment may not |
| 252 | purchase, sell, trade, or possess human prescription drugs or |
| 253 | any controlled substance as defined in chapter 893. |
| 254 | 5. A veterinary legend drug retail establishment must sell |
| 255 | a veterinary legend drug in the original, sealed manufacturer's |
| 256 | container with all labeling intact and legible. The department |
| 257 | may adopt by rule additional labeling requirements for the sale |
| 258 | of a veterinary legend drug. |
| 259 | Section 5. Paragraph (h) is added to subsection (2) of |
| 260 | section 499.041, Florida Statutes, to read: |
| 261 | 499.041 Schedule of fees for drug, device, and cosmetic |
| 262 | applications and permits, product registrations, and free-sale |
| 263 | certificates.-- |
| 264 | (2) The department shall assess an applicant that is |
| 265 | required to have a wholesaling permit an annual fee within the |
| 266 | ranges established in this section for the specific type of |
| 267 | wholesaling. |
| 268 | (h) The fee for a limited prescription drug veterinary |
| 269 | wholesaler's permit may not be less than $300 or more than $500 |
| 270 | annually. |
| 271 | Section 6. Subsections (1) and (3) of section 499.065, |
| 272 | Florida Statutes, are amended to read: |
| 273 | 499.065 Imminent danger.-- |
| 274 | (1) Notwithstanding s. 499.051, the department shall |
| 275 | inspect each prescription drug wholesale establishment, |
| 276 | prescription drug repackager establishment, veterinary |
| 277 | prescription drug wholesale establishment, limited prescription |
| 278 | drug veterinary wholesaler establishment, and retail pharmacy |
| 279 | drug wholesaler establishment that is required to be permitted |
| 280 | under this chapter as often as necessary to ensure compliance |
| 281 | with applicable laws and rules. The department shall have the |
| 282 | right of entry and access to these facilities at any reasonable |
| 283 | time. |
| 284 | (3) The department may determine that a prescription drug |
| 285 | wholesale establishment, prescription drug repackager |
| 286 | establishment, veterinary prescription drug wholesale |
| 287 | establishment, limited prescription drug veterinary wholesaler |
| 288 | establishment, or retail pharmacy drug wholesaler establishment |
| 289 | that is required to be permitted under this chapter is an |
| 290 | imminent danger to the public health and shall require its |
| 291 | immediate closure if the establishment fails to comply with |
| 292 | applicable laws and rules and, because of the failure, presents |
| 293 | an imminent threat to the public's health, safety, or welfare. |
| 294 | Any establishment so deemed and closed shall remain closed until |
| 295 | allowed by the department or by judicial order to reopen. |
| 296 |
|
| 297 | For purposes of this section, a refusal to allow entry to the |
| 298 | department for inspection at reasonable times, or a failure or |
| 299 | refusal to provide the department with required documentation |
| 300 | for purposes of inspection, constitutes an imminent danger to |
| 301 | the public health. |
| 302 | Section 7. This act shall take effect July 1, 2006. |