| 1 | Representative(s) Homan offered the following: |
| 2 |
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| 3 | Amendment (with title amendment) |
| 4 | Remove everything after the enacting clause and insert: |
| 5 | Section 1. Subsections (28) and (31) of section 499.003, |
| 6 | Florida Statutes, are amended to read: |
| 7 | 499.003 Definitions of terms used in ss. 499.001- |
| 8 | 499.081.--As used in ss. 499.001-499.081, the term: |
| 9 | (28) "Manufacturer" means a person who prepares, derives, |
| 10 | manufactures, or produces a drug, device, or cosmetic. The term |
| 11 | excludes pharmacies that are operating in compliance with |
| 12 | pharmacy practice standards as defined in chapter 465 and rules |
| 13 | adopted under that chapter. This term also means the holder of |
| 14 | an approved new drug application, abbreviated new drug |
| 15 | application, or new animal drug application; a private label |
| 16 | distributor if the private label distributor's prescription |
| 17 | drugs are originally manufactured and labeled for the |
| 18 | distributor and have not been repackaged; or the distribution |
| 19 | point establishment for the manufacturer, contract manufacturer, |
| 20 | or private label distributor, whether the establishment is a |
| 21 | member of the manufacturer's affiliated group or is a contract |
| 22 | distribution site, only to the extent that the contract |
| 23 | distribution distributes the drugs of the manufacturer. |
| 24 | (31) "Pedigree paper" means: |
| 25 | (a) A document required pursuant to s. 499.0121(6)(d) or |
| 26 | (e); or |
| 27 | (b)1. Effective July 1, 2006, a document or electronic |
| 28 | form approved by the Department of Health and containing |
| 29 | information that records each distribution of any given legend |
| 30 | drug, from sale by a pharmaceutical manufacturer, through |
| 31 | acquisition and sale by any wholesaler or repackager, until |
| 32 | final sale to a pharmacy or other person administering or |
| 33 | dispensing the drug; or. |
| 34 | 2. Effective July 1, 2006, a statement, under oath, in |
| 35 | written or electronic form, given when a wholesale distribution |
| 36 | company purchases and receives the specific unit of the |
| 37 | prescription drug directly from the manufacturer of the |
| 38 | prescription drug, and distributes the prescription drug |
| 39 | directly to a chain pharmacy warehouse or a person authorized by |
| 40 | law to purchase prescription drugs, for the purpose of |
| 41 | administering or dispensing the drug pursuant to s. 465.003. |
| 42 | a. For purposes of this subparagraph, the term "wholesale |
| 43 | distribution company" means a wholesale distributor, as defined |
| 44 | in s. 499.012(1)(b) that performs intracompany transfers of |
| 45 | specific units of prescription drugs to another wholesale |
| 46 | distributor that is a member of its affiliated group as |
| 47 | described in s. 499.012(1)(d)2.b. |
| 48 | b. For purposes of this subparagraph, the term |
| 49 | "intracompany transfers" may not include transfers of |
| 50 | prescription drugs if those specific units of the prescription |
| 51 | drugs were not purchased directly from the manufacturer. |
| 52 | c. For purposes of this subparagraph, "chain pharmacy |
| 53 | warehouse" means a wholesale distributor permitted pursuant to |
| 54 | s. 499.012 that maintains a physical location for prescription |
| 55 | drugs that functions solely as a central warehouse to perform |
| 56 | intra-company transfers of such drugs to a member of its |
| 57 | affiliated group, as described in s. 499.0121(6)(h)1. |
| 58 | (c) The information required to be included on the form |
| 59 | approved by the department pursuant to subparagraph (b)1. a |
| 60 | legend drug's pedigree paper must at least detail the amount of |
| 61 | the legend drug; its dosage form and strength; its lot numbers; |
| 62 | the name and address of each owner of the legend drug and his or |
| 63 | her signature; its shipping information, including the name and |
| 64 | address of each person certifying delivery or receipt of the |
| 65 | legend drug; an invoice number, a shipping document number, or |
| 66 | another number uniquely identifying the transaction; and a |
| 67 | certification that the recipient wholesaler has authenticated |
| 68 | the pedigree papers. If the manufacturer or repackager has |
| 69 | uniquely serialized the individual legend drug unit, that |
| 70 | identifier must also be included on the form approved by the |
| 71 | department pursuant to subparagraph (b)1. pedigree. It must also |
| 72 | include the name, address, telephone number and, if available, |
| 73 | e-mail contact information of each wholesaler involved in the |
| 74 | chain of the legend drug's custody. The department shall adopt |
| 75 | rules and a form relating to the requirements of this paragraph |
| 76 | no later than 90 days after the effective date of this act. |
| 77 | (d)1. The information required to be included pursuant to |
| 78 | subparagraph (b)2. must include: |
| 79 | a. A written statement that states: "This wholesale |
| 80 | distribution company purchased the specific unit of the |
| 81 | prescription drug directly from the manufacturer." |
| 82 | b. The manufacturer's National Drug Code identifier that |
| 83 | provides the name of the manufacturer and the name and address |
| 84 | of the wholesaler and the purchaser of the prescription drug. |
| 85 | c. The name of the prescription drug as it was provided by |
| 86 | the manufacturer. |
| 87 | d. The quantity, dosage form, and strength of the |
| 88 | prescription drug. |
| 89 | 2. The wholesale distribution company shall also maintain |
| 90 | and make available to the department, upon request, the name and |
| 91 | shipping address of the manufacturer from whom the prescription |
| 92 | drugs were purchased; the dates of shipment and invoice numbers |
| 93 | from the manufacturer to the wholesale distribution company for |
| 94 | such prescription drugs; lot numbers of such prescription drugs |
| 95 | received by the wholesale distribution company; and any records |
| 96 | of any intracompany transfers within the wholesale distribution |
| 97 | company of such prescription drugs. |
| 98 | (e) The department may adopt rules and forms relating to |
| 99 | the requirements of this subsection. |
| 100 | Section 2. Subsection (29) of section 499.005, Florida |
| 101 | Statutes, is amended to read: |
| 102 | 499.005 Prohibited acts.--It is unlawful for a person to |
| 103 | perform or cause the performance of any of the following acts in |
| 104 | this state: |
| 105 | (29) The receipt of a prescription drug pursuant to a |
| 106 | wholesale distribution without either first receiving a pedigree |
| 107 | paper that was attested to as accurate and complete by the |
| 108 | wholesale distributor or complying with the provisions of s. |
| 109 | 499.0121(6)(f)6. |
| 110 | Section 3. Section 499.006, Florida Statutes, is amended |
| 111 | to read: |
| 112 | 499.006 Adulterated drug or device.--A drug or device is |
| 113 | adulterated: |
| 114 | (1) If it consists in whole or in part of any filthy, |
| 115 | putrid, or decomposed substance; |
| 116 | (2) If it has been produced, prepared, packed, or held |
| 117 | under conditions whereby it could have been contaminated with |
| 118 | filth or rendered injurious to health; |
| 119 | (3) If it is a drug and the methods used in, or the |
| 120 | facilities or controls used for, its manufacture, processing, |
| 121 | packing, or holding do not conform to, or are not operated or |
| 122 | administered in conformity with, current good manufacturing |
| 123 | practices to assure that the drug meets the requirements of ss. |
| 124 | 499.001-499.081 and that the drug has the identity and strength, |
| 125 | and meets the standard of quality and purity, which it purports |
| 126 | or is represented to possess; |
| 127 | (4) If it is a drug and its container is composed, in |
| 128 | whole or in part, of any poisonous or deleterious substance |
| 129 | which could render the contents injurious to health; |
| 130 | (5) If it is a drug and it bears or contains, for the |
| 131 | purpose of coloring only, a color additive that is unsafe within |
| 132 | the meaning of the federal act; or, if it is a color additive, |
| 133 | the intended use of which in or on drugs is for the purpose of |
| 134 | coloring only, and it is unsafe within the meaning of the |
| 135 | federal act; |
| 136 | (6) If it purports to be, or is represented as, a drug the |
| 137 | name of which is recognized in the official compendium, and its |
| 138 | strength differs from, or its quality or purity falls below, the |
| 139 | standard set forth in such compendium. The determination as to |
| 140 | strength, quality, or purity must be made in accordance with the |
| 141 | tests or methods of assay set forth in such compendium, or, when |
| 142 | such tests or methods of assay are absent or inadequate, in |
| 143 | accordance with those tests or methods of assay prescribed under |
| 144 | authority of the federal act. A drug defined in the official |
| 145 | compendium is not adulterated under this subsection merely |
| 146 | because it differs from the standard of strength, quality, or |
| 147 | purity set forth for that drug in such compendium if its |
| 148 | difference in strength, quality, or purity from such standard is |
| 149 | plainly stated on its label; |
| 150 | (7) If it is not subject to subsection (6) and its |
| 151 | strength differs from, or its purity or quality falls below the |
| 152 | standard of, that which it purports or is represented to |
| 153 | possess; |
| 154 | (8) If it is a drug: |
| 155 | (a) With which any substance has been mixed or packed so |
| 156 | as to reduce the quality or strength of the drug; or |
| 157 | (b) For which any substance has been substituted wholly or |
| 158 | in part; |
| 159 | (9) If it is a drug or device for which the expiration |
| 160 | date has passed; or |
| 161 | (10) If it is a legend drug for which the required |
| 162 | pedigree paper is nonexistent, fraudulent, or incomplete under |
| 163 | the requirements of ss. 499.001-499.081 or applicable rules, or |
| 164 | that has been purchased, held, sold, or distributed at any time |
| 165 | by a person not authorized under federal or state law to do so; |
| 166 | or. |
| 167 | (11) If it is a prescription drug subject to, defined by, |
| 168 | or described by s. 503(b) of the Federal Food, Drug, and |
| 169 | Cosmetic Act which has been returned by a veterinarian to a |
| 170 | limited prescription drug veterinary wholesaler. |
| 171 | Section 4. Subsection (1) and paragraph (d) of subsection |
| 172 | (2) of section 499.01, Florida Statutes, are amended to read: |
| 173 | 499.01 Permits; applications; renewal; general |
| 174 | requirements.-- |
| 175 | (1) Prior to operating, a permit is required for each |
| 176 | person and establishment that intends to operate as: |
| 177 | (a) A prescription drug manufacturer; |
| 178 | (b) A prescription drug repackager; |
| 179 | (c) An over-the-counter drug manufacturer; |
| 180 | (d) A compressed medical gas manufacturer; |
| 181 | (e) A device manufacturer; |
| 182 | (f) A cosmetic manufacturer; |
| 183 | (g) A prescription drug wholesaler; |
| 184 | (h) A veterinary prescription drug wholesaler; |
| 185 | (i) A compressed medical gas wholesaler; |
| 186 | (j) An out-of-state prescription drug wholesaler; |
| 187 | (k) A nonresident prescription drug manufacturer; |
| 188 | (l) A freight forwarder; |
| 189 | (m) A retail pharmacy drug wholesaler; |
| 190 | (n) A veterinary legend drug retail establishment; |
| 191 | (o) A medical oxygen retail establishment; |
| 192 | (p) A complimentary drug distributor; or |
| 193 | (q) A restricted prescription drug distributor; or. |
| 194 | (r) A limited prescription drug veterinary wholesaler. |
| 195 | (2) |
| 196 | (d) A permit for a prescription drug manufacturer, |
| 197 | prescription drug repackager, prescription drug wholesaler, |
| 198 | limited prescription drug veterinary wholesaler, or retail |
| 199 | pharmacy wholesaler may not be issued to the address of a health |
| 200 | care entity or to a pharmacy licensed under chapter 465, except |
| 201 | as provided in this paragraph. The department may issue a |
| 202 | prescription drug manufacturer permit to an applicant at the |
| 203 | same address as a licensed nuclear pharmacy, which is a health |
| 204 | care entity, for the purpose of manufacturing prescription drugs |
| 205 | used in positron emission tomography or other |
| 206 | radiopharmaceuticals, as listed in a rule adopted by the |
| 207 | department pursuant to this paragraph. The purpose of this |
| 208 | exemption is to assure availability of state-of-the-art |
| 209 | pharmaceuticals that would pose a significant danger to the |
| 210 | public health if manufactured at a separate establishment |
| 211 | address from the nuclear pharmacy from which the prescription |
| 212 | drugs are dispensed. The department may also issue a retail |
| 213 | pharmacy wholesaler permit to the address of a community |
| 214 | pharmacy licensed under chapter 465 which does not meet the |
| 215 | definition of a closed pharmacy in s. 499.003. |
| 216 | Section 5. Paragraph (g) of subsection (2) of section |
| 217 | 499.012, Florida Statutes, is amended, and paragraph (h) is |
| 218 | added to that subsection, to read: |
| 219 | 499.012 Wholesale distribution; definitions; permits; |
| 220 | applications; general requirements.-- |
| 221 | (2) The following types of wholesaler permits are |
| 222 | established: |
| 223 | (g) A veterinary prescription drug wholesaler permit.--A |
| 224 | veterinary prescription drug wholesaler permit is required for |
| 225 | any person that engages in the distribution of veterinary |
| 226 | prescription drugs in or into this state. A veterinary |
| 227 | prescription drug wholesaler that also distributes prescription |
| 228 | drugs subject to, defined by, or described by s. 503(b) of the |
| 229 | Federal Food, Drug, and Cosmetic Act which it did not |
| 230 | manufacture must obtain a permit as a prescription drug |
| 231 | wholesaler, an or out-of-state prescription drug wholesaler, or |
| 232 | a limited prescription drug veterinary wholesaler in lieu of the |
| 233 | veterinary prescription drug wholesaler permit. A veterinary |
| 234 | prescription drug wholesaler must comply with the requirements |
| 235 | for wholesale distributors under s. 499.0121, except those set |
| 236 | forth in s. 499.0121(6)(d), (e), or (f). |
| 237 | (h) Limited prescription drug veterinary wholesaler |
| 238 | permit.--Unless engaging in the activities of and permitted as a |
| 239 | prescription drug manufacturer, nonresident prescription drug |
| 240 | manufacturer, prescription drug wholesaler, or out-of-state |
| 241 | prescription drug wholesaler, a limited prescription drug |
| 242 | veterinary wholesaler permit is required for any person that |
| 243 | engages in the distribution in or into this state of veterinary |
| 244 | prescription drugs and prescription drugs subject to, defined |
| 245 | by, or described by s. 503(b) of the Federal Food, Drug, and |
| 246 | Cosmetic Act to veterinarians under the following conditions: |
| 247 | 1. The person is engaged in the business of wholesaling |
| 248 | prescription and veterinary legend drugs to persons: |
| 249 | a. Licensed as veterinarians practicing on a full-time |
| 250 | basis; |
| 251 | b. Regularly and lawfully engaged in instruction in |
| 252 | veterinary medicine; |
| 253 | c. Regularly and lawfully engaged in law enforcement; |
| 254 | d. For use in research, not involving clinical use; or |
| 255 | e. For use in chemical analysis or physical testing, for |
| 256 | the purposes of instruction in law enforcement, research, or |
| 257 | testing. |
| 258 | 2. No more than 30 percent of prescription drug sales may |
| 259 | be prescription drugs approved for human use which are subject |
| 260 | to, defined by, or described by s. 503(b) of the Federal Food, |
| 261 | Drug, and Cosmetic Act. |
| 262 | 3. The person is not permitted, licensed, or otherwise |
| 263 | authorized in any state to wholesale prescription drugs subject |
| 264 | to, defined by, or described by s. 503(b) of the Federal Food, |
| 265 | Drug, and Cosmetic Act to any person who is authorized to sell, |
| 266 | distribute, purchase, trade, or use these drugs on or for |
| 267 | humans. |
| 268 | 4. A limited prescription drug veterinary wholesaler that |
| 269 | applies to the department for a new permit or the renewal of a |
| 270 | permit must submit a bond of $20,000, or other equivalent means |
| 271 | of security acceptable to the department, such as an irrevocable |
| 272 | letter of credit or a deposit in a trust account or financial |
| 273 | institution, payable to the Florida Drug, Device, and Cosmetic |
| 274 | Trust Fund. The purpose of the bond is to secure payment of any |
| 275 | administrative penalties imposed by the department and any fees |
| 276 | and costs incurred by the department regarding that permit which |
| 277 | are authorized under state law and which the permittee fails to |
| 278 | pay 30 days after the fine or costs become final. The department |
| 279 | may make a claim against such bond or security until 1 year |
| 280 | after the permittee's license ceases to be valid or until 60 |
| 281 | days after any administrative or legal proceeding authorized in |
| 282 | ss. 499.001-499.081 which involves the permittee is concluded, |
| 283 | including any appeal, whichever occurs later. |
| 284 | 5. A limited prescription drug veterinary wholesaler must |
| 285 | maintain at all times a license or permit to engage in the |
| 286 | wholesale distribution of prescription drugs in compliance with |
| 287 | laws of the state in which it is a resident. |
| 288 | 6. A limited prescription drug veterinary wholesaler must |
| 289 | comply with the requirements for wholesale distributors under s. |
| 290 | 499.0121, except that a limited prescription drug veterinary |
| 291 | wholesaler is not required to provide a pedigree paper as |
| 292 | required by s. 499.0121(6)(f) upon the wholesale distribution of |
| 293 | a prescription drug to a veterinarian. |
| 294 | 7. A limited prescription drug veterinary wholesaler may |
| 295 | not return to inventory for subsequent wholesale distribution |
| 296 | any prescription drug subject to, defined by, or described by s. |
| 297 | 503(b) of the Federal Food, Drug, and Cosmetic Act which has |
| 298 | been returned by a veterinarian. |
| 299 | 8. An out-of-state prescription drug wholesaler's permit |
| 300 | or a limited prescription drug veterinary wholesaler permit is |
| 301 | not required for an intracompany sale or transfer of a |
| 302 | prescription drug from an out-of-state establishment that is |
| 303 | duly licensed to engage in the wholesale distribution of |
| 304 | prescription drugs in its state of residence to a licensed |
| 305 | limited prescription drug veterinary wholesaler in this state if |
| 306 | both wholesalers conduct wholesale distributions of prescription |
| 307 | drugs under the same business name. The recordkeeping |
| 308 | requirements of s. 499.0121(6) must be followed for this |
| 309 | transaction. |
| 310 | Section 6. Paragraph (f) of subsection (6) of section |
| 311 | 499.0121, Florida Statutes, is amended to read: |
| 312 | 499.0121 Storage and handling of prescription drugs; |
| 313 | recordkeeping.--The department shall adopt rules to implement |
| 314 | this section as necessary to protect the public health, safety, |
| 315 | and welfare. Such rules shall include, but not be limited to, |
| 316 | requirements for the storage and handling of prescription drugs |
| 317 | and for the establishment and maintenance of prescription drug |
| 318 | distribution records. |
| 319 | (6) RECORDKEEPING.--The department shall adopt rules that |
| 320 | require keeping such records of prescription drugs as are |
| 321 | necessary for the protection of the public health. |
| 322 | (f)1. Effective July 1, 2006, each person who is engaged |
| 323 | in the wholesale distribution of a prescription drug and who is |
| 324 | not the manufacturer of that drug must, before each wholesale |
| 325 | distribution of such drug, provide to the person who receives |
| 326 | the drug a pedigree paper as defined in s. 499.003(31). |
| 327 | 2. A repackager must comply with this paragraph. |
| 328 | 3. The pedigree paper requirements in this paragraph do |
| 329 | not apply to compressed medical gases or veterinary legend |
| 330 | drugs. |
| 331 | 4. Each wholesale distributor of prescription drugs must |
| 332 | maintain separate and distinct from other required records all |
| 333 | statements that are required under subparagraph 1. |
| 334 | 5. In order to verify compliance with subparagraph (d)1., |
| 335 | each manufacturer of a prescription drug sold in this state must |
| 336 | make available upon request distribution documentation related |
| 337 | to its sales of prescription drugs, regardless of whether the |
| 338 | prescription drug was sold directly by the manufacturer to a |
| 339 | person in Florida. |
| 340 | 6. The provisions of subparagraph (f)1. are satisfied when |
| 341 | a wholesale distributor takes title to, but not possession of, a |
| 342 | prescription drug, and the prescription drug's manufacturer |
| 343 | ships the prescription drug directly to a person authorized by |
| 344 | law to purchase prescription drugs for the purpose of |
| 345 | administering or dispensing the drug pursuant to s. 465.003 or a |
| 346 | member of an affiliated group, as described in subparagraph |
| 347 | (h)1. |
| 348 | a. The wholesale distributor must deliver to the recipient |
| 349 | of the prescription drug, within 14 days of the shipment |
| 350 | notification from the manufacturer, an invoice and that the |
| 351 | following sworn statement: "This wholesale distribution company |
| 352 | purchased the specific unit of the prescription drug, listed on |
| 353 | the invoice, directly from the manufacturer and has been |
| 354 | notified by the manufacturer that the specific unit of |
| 355 | prescription drug was shipped by the manufacturer directly to a |
| 356 | person authorized by law to administer or dispense the legend |
| 357 | drug pursuant to s. 465.003, Florida Statutes, or a member of an |
| 358 | affiliated group, as described in s. 499.0121(6)(h)1., Florida |
| 359 | Statutes." The invoice must contain a clear cross-reference to |
| 360 | the shipping document sent by the manufacturer to the recipient |
| 361 | of the prescription drug. |
| 362 | b. The recipient of the prescription drug must acquire, |
| 363 | within 14 days of receipt of the prescription drug, a shipping |
| 364 | document from the manufacturer that contains, at a minimum: |
| 365 | (I) The name and address of the manufacturer, including |
| 366 | the point of origin of the shipment, the wholesaler, and such |
| 367 | purchaser. |
| 368 | (II) The name of the prescription drug as it appears on |
| 369 | the label. |
| 370 | (III) The quantity, dosage form, and strength of the |
| 371 | prescription drug. |
| 372 | (IV) The date of the shipment from the manufacturer. |
| 373 | c. The wholesale distributor must also maintain and make |
| 374 | available to the department, upon request, the lot number of |
| 375 | such drug if the applicable lot numbers are provided to the |
| 376 | wholesale distributor by the manufacturer and are not contained |
| 377 | in the shipping document received by such recipient. |
| 378 | 7. Failure of the purchaser to acquire, or the wholesale |
| 379 | distributor or manufacturer to deliver, the documentation |
| 380 | required under subparagraph (f)6. shall constitute failure to |
| 381 | acquire or deliver a pedigree paper under s. 499.0051. Forgery |
| 382 | by the purchaser, wholesale distributor, or manufacturer of the |
| 383 | documentation required to be acquired or delivered under |
| 384 | subparagraph (f)6. shall constitute forgery of a pedigree paper |
| 385 | under s. 499.0051. |
| 386 | 8. The department may by rule define alternatives to |
| 387 | compliance with subparagraph (f)1. for a prescription drug in |
| 388 | the inventory of a permitted prescription drug wholesaler as of |
| 389 | June 30, 2006, and the return of a prescription drug purchased |
| 390 | prior to July 1, 2006. The department may specify time limits |
| 391 | for such alternatives. |
| 392 | Section 7. Paragraph (d) of subsection (1) of section |
| 393 | 499.0122, Florida Statutes, is amended to read: |
| 394 | 499.0122 Medical oxygen and veterinary legend drug retail |
| 395 | establishments; definitions, permits, general requirements.-- |
| 396 | (1) As used in this section, the term: |
| 397 | (d) "Veterinary legend drug retail establishment" means a |
| 398 | person permitted to sell veterinary legend drugs to the public |
| 399 | or to veterinarians, but does not include a pharmacy licensed |
| 400 | under chapter 465. |
| 401 | 1. The sale to the public must be based on a valid written |
| 402 | order from a veterinarian licensed in this state who has a valid |
| 403 | client-veterinarian relationship with the purchaser's animal. |
| 404 | 2. Veterinary legend drugs may not be sold in excess of |
| 405 | the amount clearly indicated on the order or beyond the date |
| 406 | indicated on the order. |
| 407 | 3. An order may not be valid for more than 1 year. |
| 408 | 4. A veterinary legend drug retail establishment may not |
| 409 | purchase, sell, trade, or possess human prescription drugs or |
| 410 | any controlled substance as defined in chapter 893. |
| 411 | 5. A veterinary legend drug retail establishment must sell |
| 412 | a veterinary legend drug in the original, sealed manufacturer's |
| 413 | container with all labeling intact and legible. The department |
| 414 | may adopt by rule additional labeling requirements for the sale |
| 415 | of a veterinary legend drug. |
| 416 | Section 8. Paragraph (h) is added to subsection (2) of |
| 417 | section 499.041, Florida Statutes, to read: |
| 418 | 499.041 Schedule of fees for drug, device, and cosmetic |
| 419 | applications and permits, product registrations, and free-sale |
| 420 | certificates.-- |
| 421 | (2) The department shall assess an applicant that is |
| 422 | required to have a wholesaling permit an annual fee within the |
| 423 | ranges established in this section for the specific type of |
| 424 | wholesaling. |
| 425 | (h) The fee for a limited prescription drug veterinary |
| 426 | wholesaler's permit may not be less than $300 or more than $500 |
| 427 | annually. |
| 428 | Section 9. Subsections (1) and (3) of section 499.065, |
| 429 | Florida Statutes, are amended to read: |
| 430 | 499.065 Imminent danger.-- |
| 431 | (1) Notwithstanding s. 499.051, the department shall |
| 432 | inspect each prescription drug wholesale establishment, |
| 433 | prescription drug repackager establishment, veterinary |
| 434 | prescription drug wholesale establishment, limited prescription |
| 435 | drug veterinary wholesaler establishment, and retail pharmacy |
| 436 | drug wholesaler establishment that is required to be permitted |
| 437 | under this chapter as often as necessary to ensure compliance |
| 438 | with applicable laws and rules. The department shall have the |
| 439 | right of entry and access to these facilities at any reasonable |
| 440 | time. |
| 441 | (3) The department may determine that a prescription drug |
| 442 | wholesale establishment, prescription drug repackager |
| 443 | establishment, veterinary prescription drug wholesale |
| 444 | establishment, limited prescription drug veterinary wholesaler |
| 445 | establishment, or retail pharmacy drug wholesaler establishment |
| 446 | that is required to be permitted under this chapter is an |
| 447 | imminent danger to the public health and shall require its |
| 448 | immediate closure if the establishment fails to comply with |
| 449 | applicable laws and rules and, because of the failure, presents |
| 450 | an imminent threat to the public's health, safety, or welfare. |
| 451 | Any establishment so deemed and closed shall remain closed until |
| 452 | allowed by the department or by judicial order to reopen. |
| 453 |
|
| 454 | For purposes of this section, a refusal to allow entry to the |
| 455 | department for inspection at reasonable times, or a failure or |
| 456 | refusal to provide the department with required documentation |
| 457 | for purposes of inspection, constitutes an imminent danger to |
| 458 | the public health. |
| 459 | Section 10. This act shall take effect July 1, 2006. |
| 460 |
|
| 461 |
|
| 462 | ======= T I T L E A M E N D M E N T ========== |
| 463 | Remove the entire title and insert: |
| 464 | A bill to be entitled |
| 465 | An act relating to drug distribution; amending s. 499.003, |
| 466 | F.S.; amending definitions; requiring the Department of |
| 467 | Health to approve a document or electronic form relating |
| 468 | to pedigree papers; providing requirements for pedigree |
| 469 | papers that record certain distributions of legend drugs; |
| 470 | amending s. 499.005, F.S.; revising a prohibition relating |
| 471 | to pedigree papers; amending s. 499.006, F.S.; providing |
| 472 | that a drug is adulterated if it is a certain prescription |
| 473 | drug that has been returned by a veterinarian to a limited |
| 474 | prescription drug veterinary wholesaler; amending s. |
| 475 | 499.01, F.S.; requiring a limited prescription drug |
| 476 | veterinary wholesaler to obtain a permit for operation |
| 477 | from the Department of Health; providing that a permit for |
| 478 | a limited prescription drug veterinary wholesaler may not |
| 479 | be issued to the address of certain health care entities; |
| 480 | amending s. 499.012, F.S.; revising permit requirements |
| 481 | for a veterinary prescription drug wholesaler that |
| 482 | distributes prescription drugs; establishing a permit for |
| 483 | a limited prescription drug veterinary wholesaler; |
| 484 | providing requirements; providing an exception; amending |
| 485 | s. 499.0121, F.S.; requiring certain wholesale |
| 486 | distributors taking title to a prescription drug to |
| 487 | provide an invoice to the purchaser containing certain |
| 488 | information; requiring a purchaser of a prescription drug |
| 489 | to obtain from the manufacturer a shipping document |
| 490 | containing specified information; requiring a manufacturer |
| 491 | to make certain information available to the department; |
| 492 | providing a penalty; authorizing the department to adopt |
| 493 | certain rules relating to the inventory and return of |
| 494 | certain prescription drugs; amending s. 499.0122, F.S.; |
| 495 | redefining the term "veterinary legend drug retail |
| 496 | establishment"; amending s. 499.041, F.S.; requiring the |
| 497 | department to assess an annual fee within a certain |
| 498 | monetary range for a limited prescription drug veterinary |
| 499 | wholesaler permit; amending s. 499.065, F.S.; requiring |
| 500 | the department to inspect each limited prescription drug |
| 501 | veterinary wholesaler establishment; authorizing the |
| 502 | department to determine that a limited prescription drug |
| 503 | veterinary wholesaler establishment is an imminent danger |
| 504 | to the public; providing an effective date. |