Florida Senate - 2019 SB 1452 By Senator Gruters 23-01430-19 20191452__ 1 A bill to be entitled 2 An act relating to prescription drug importation 3 programs; creating s. 381.02035, F.S.; establishing 4 the Canadian Prescription Drug Importation Program 5 within the Agency for Health Care Administration for a 6 specified purpose; defining terms; requiring the 7 agency to contract with a vendor to facilitate 8 wholesale prescription drug importation under the 9 program; providing responsibilities for the vendor; 10 providing eligibility criteria for prescription drugs, 11 for Canadian suppliers, and for importers under the 12 program; requiring participating Canadian suppliers 13 and importers to comply with specified federal 14 requirements in distributing prescription drugs 15 imported under the program; prohibiting Canadian 16 suppliers and importers from distributing, dispensing, 17 or selling prescription drugs imported under the 18 program outside of this state; requiring the agency to 19 request federal approval of the program; providing 20 requirements for such request; requiring the agency to 21 begin operating the program within a specified 22 timeframe after receiving federal approval; requiring 23 the agency, in consultation with the vendor, to submit 24 an annual report to the Governor and the Legislature 25 by a specified date; providing requirements for such 26 report; requiring the agency to adopt rules; creating 27 s. 499.0285, F.S.; requiring the Department of 28 Business and Professional Regulation to establish the 29 International Prescription Drug Importation Program 30 for a specified purpose; defining terms; providing 31 eligibility criteria for prescription drugs, 32 exporters, and importers under the program; requiring 33 participating importers to submit certain 34 documentation to the department for prescription drugs 35 imported under the program; requiring the department 36 to immediately suspend the importation of a specific 37 prescription drug or the importation by a specific 38 importer if a violation has occurred under the 39 program; authorizing the department to revoke such 40 suspension under certain circumstances; requiring the 41 department to adopt rules; creating s. 465.0157, F.S.; 42 establishing an international export pharmacy permit 43 for participation in the International Prescription 44 Drug Importation Program; providing requirements for 45 permit application and renewal; amending s. 465.017, 46 F.S.; authorizing the department to inspect 47 international export pharmacy permittees; amending s. 48 499.01, F.S.; requiring nonresident prescription drug 49 manufacturers to register with the department to 50 participate in the program; providing an exception; 51 establishing an international prescription drug 52 wholesale distributor permit; providing requirements 53 for such permit; amending s. 499.012, F.S.; providing 54 permit application requirements for international 55 prescription drug wholesale distributors and 56 nonresident prescription drug manufacturers to 57 participate in the program; amending ss. 499.005, 58 499.0051, and 499.015, F.S.; conforming provisions to 59 changes made by the act; amending s. 499.065, F.S.; 60 requiring the department to inspect international 61 prescription drug wholesale distributor establishments 62 and to require the immediate closure of such 63 establishments under certain circumstances; requiring 64 the Department of Business and Professional 65 Regulation, in collaboration with the Department of 66 Health, to negotiate a federal arrangement to operate 67 a pilot program for importing prescription drugs into 68 this state; providing that implementation of the act 69 is contingent upon such federal arrangement or 70 obtaining federal guidance; providing an effective 71 date. 72 73 Be It Enacted by the Legislature of the State of Florida: 74 75 Section 1. Section 381.02035, Florida Statutes, is created 76 to read: 77 381.02035 Canadian Prescription Drug Importation Program.— 78 (1) PROGRAM ESTABLISHED.—The agency shall establish a 79 program for the importation of safe and effective prescription 80 drugs from Canada which have the highest potential for cost 81 savings to the state. 82 (2) DEFINITIONS.—As used in this section, the term: 83 (a) “Agency” means the Agency for Health Care 84 Administration. 85 (b) “Canadian supplier” means a manufacturer, a wholesale 86 distributor, or a pharmacy appropriately licensed or permitted 87 under Canadian law to manufacture, distribute, or dispense 88 prescription drugs. 89 (c) “County health department” means a health care facility 90 established under part I of chapter 154. 91 (d) “Department” means the Department of Health. 92 (e) “Free clinic” means a clinic that delivers medical 93 diagnostic services or nonsurgical medical treatment free of 94 charge to low-income recipients. 95 (f) “Medicaid pharmacy” means a pharmacy licensed under 96 chapter 465 which has a Medicaid provider agreement in effect 97 with the agency and is in good standing with the agency. 98 (g) “Pharmacist” means a person who holds an active and 99 unencumbered license to practice pharmacy pursuant to chapter 100 465. 101 (h) “Prescription drug” has the same meaning as in s. 102 499.003. 103 (i) “Program” means the Canadian Prescription Drug 104 Importation Program. 105 (3) IMPORTATION PROCESS.— 106 (a) The agency shall contract with a vendor to provide 107 services under the program. 108 (b) The vendor shall develop by December 1, 2019, and each 109 year thereafter revise, a Wholesale Prescription Drug 110 Importation List identifying the prescription drugs that have 111 the highest potential for cost savings to the state. In 112 developing the list, the vendor shall consider, at a minimum, 113 which prescription drugs will provide the greatest cost savings 114 to state programs, including prescription drugs for which there 115 are shortages, specialty prescription drugs, and high-volume 116 prescription drugs. The agency, in consultation with the 117 department, shall review the Wholesale Prescription Drug 118 Importation List every 3 months to ensure that it continues to 119 meet the requirements of the program, and may direct the vendor 120 to revise the list, as necessary. 121 (c) The vendor shall identify Canadian suppliers that are 122 in full compliance with relevant Canadian federal and provincial 123 laws and regulations and who have agreed to export prescription 124 drugs identified on the list. The vendor must verify that such 125 Canadian suppliers meet all of the requirements of the program 126 and will export prescription drugs at prices that will provide 127 cost savings to the state. The vendor shall contract with such 128 eligible Canadian suppliers, or facilitate contracts between 129 eligible importers and Canadian suppliers, to import 130 prescription drugs under the program. 131 (d) The vendor shall assist the agency with the annual 132 report required in subsection (9) and shall provide any 133 information requested by the agency for such report. 134 (4) ELIGIBLE PRESCRIPTION DRUGS.—Eligible importers may 135 import a prescription drug from an eligible Canadian supplier 136 if: 137 (a) The drug meets the United States Food and Drug 138 Administration’s standards relating to safety, effectiveness, 139 misbranding, and adulteration; 140 (b) Importing the drug would not violate the patent laws of 141 the United States; 142 (c) Importing the drug is expected to generate cost 143 savings; and 144 (d) The drug is not: 145 1. A controlled substance as defined in 21 U.S.C. s. 802; 146 2. A biological product as defined in 42 U.S.C. s. 262; 147 3. An infused drug; 148 4. An intravenously injected drug; 149 5. A drug that is inhaled during surgery; or 150 6. A drug that is a parenteral drug, the importation of 151 which is determined by the United States Secretary of Health and 152 Human Services to pose a threat to the public health. 153 (5) ELIGIBLE CANADIAN SUPPLIERS.—A Canadian supplier may 154 export prescription drugs into this state under the program if 155 the supplier is: 156 (a) In full compliance with relevant Canadian federal and 157 provincial laws and regulations; and 158 (b) Identified by the vendor as eligible to participate in 159 the program. 160 (6) ELIGIBLE IMPORTERS.—The following entities may import 161 prescription drugs from a Canadian supplier under the program: 162 (a) A pharmacist or wholesaler employed by or under 163 contract with the department’s central pharmacy, for 164 distribution to a county health department or free clinic for 165 dispensing to clients treated in such department or such clinic. 166 (b) A pharmacist or wholesaler employed by or under 167 contract with a Medicaid pharmacy, for dispensing to the 168 pharmacy’s Medicaid recipients. 169 (c) A pharmacist or wholesaler employed by or under 170 contract with the Department of Corrections, for dispensing to 171 inmates in the custody of the Department of Corrections. 172 (d) A pharmacist or wholesaler employed by or under 173 contract with a developmental disabilities center, as defined in 174 s. 393.063, for dispensing to clients treated in such center. 175 (e) A pharmacist or wholesaler employed by or under 176 contract with a treatment facility, as defined in s. 394.455, 177 for dispensing to patients treated in such a facility. 178 (7) DISTRIBUTION REQUIREMENTS.—Eligible Canadian suppliers 179 and importers participating under the program: 180 (a) Must comply with the tracking and tracing requirements 181 of 21 U.S.C. ss. 360eee et seq. 182 (b) May not distribute, dispense, or sell prescription 183 drugs imported under the program outside of this state. 184 (8) FEDERAL APPROVAL.—By July 1, 2020, the agency shall 185 submit a request to the United States Secretary of Health and 186 Human Services for approval of the program under 21 U.S.C. s. 187 384(l). The agency shall begin operating the program within 6 188 months after receiving such approval. The request must, at a 189 minimum: 190 (a) Describe the agency’s plan for operating the program; 191 (b) Demonstrate how the prescription drugs imported into 192 this state under the program will meet the applicable federal 193 and state standards for safety and effectiveness; 194 (c) Include a list of prescription drugs that have the 195 highest potential for cost savings to the state through 196 importation at the time that the request is submitted; 197 (d) Estimate the total cost savings attributable to the 198 program; and 199 (e) Include a list of potential Canadian suppliers from 200 which the state would import prescription drugs and demonstrate 201 that the suppliers are in full compliance with relevant Canadian 202 federal and provincial laws and regulations. 203 (9) ANNUAL REPORTING.—By December 1 of each year, the 204 agency shall submit a report to the Governor, the President of 205 the Senate, and the Speaker of the House of Representatives on 206 the operation of the program during the previous fiscal year. 207 The report must include, at a minimum: 208 (a) A list of the prescription drugs that were imported 209 under the program; 210 (b) The number of participating entities; 211 (c) The number of prescriptions dispensed through the 212 program; 213 (d) The estimated cost savings during the previous fiscal 214 year and to date; 215 (e) A description of the methodology used to determine 216 which prescription drugs may be included on the Wholesale 217 Prescription Drug Importation List; and 218 (f) Documentation demonstrating how the program ensures 219 that: 220 1. Canadian suppliers participating in the program are of 221 high quality, of high performance, and in full compliance with 222 relevant Canadian federal and provincial laws and regulations; 223 2. Prescription drugs imported under the program are not 224 shipped, sold, or dispensed outside of this state once in the 225 possession of the importer; 226 3. Prescription drugs imported under the program are pure, 227 unadulterated, potent, and safe; 228 4. The program does not put consumers at a higher health 229 and safety risk than if the program did not exist; and 230 5. The program provides cost savings to the state on 231 imported prescription drugs. 232 (10) RULEMAKING AUTHORITY.—The agency shall adopt rules 233 necessary to implement this section. 234 Section 2. Section 499.0285, Florida Statutes, is created 235 to read: 236 499.0285 International Prescription Drug Importation 237 Program.— 238 (1) PROGRAM ESTABLISHED.—The department shall establish a 239 program for the importation of safe and effective prescription 240 drugs from foreign nations with whom the United States has 241 current mutual recognition agreements, cooperation agreements, 242 memoranda of understanding, or other federal mechanisms 243 recognizing their adherence to current good manufacturing 244 practices for pharmaceutical products. 245 (2) DEFINITIONS.—As used in this section, the term: 246 (a) “Exporter” means an international prescription drug 247 wholesale distributor, a nonresident prescription drug 248 manufacturer registered to participate in the program, or an 249 international export pharmacy that exports prescription drugs 250 into this state under the program. 251 (b) “Foreign recipient” means an entity other than the 252 original prescription drug manufacturer which receives the 253 prescription drug before its importation into this state under 254 the program. 255 (c) “Good manufacturing practice” refers to the good 256 manufacturing practice regulations in 21 C.F.R. parts 210 and 257 211. 258 (d) “Importer” means a wholesale distributor, a pharmacy, 259 or a pharmacist importing prescription drugs into this state 260 under the program. 261 (e) “International export pharmacy” means a pharmacy 262 located outside of the United States which holds an active and 263 unencumbered permit under chapter 465 to export prescription 264 drugs into this state under the program. 265 (f) “International prescription drug wholesale distributor” 266 means a prescription drug wholesale distributor located outside 267 of the United States which holds an active and unencumbered 268 permit under this part to export and distribute prescription 269 drugs into this state under the program. 270 (g) “Nonresident prescription drug manufacturer” means an 271 entity located outside of the United States which holds an 272 active and unencumbered permit under this part to manufacture 273 prescription drugs and has registered with the department to 274 export and distribute such prescription drugs into this state 275 under the program. 276 (h) “Pharmacist” means a person who holds an active and 277 unencumbered license to practice pharmacy under chapter 465. 278 (i) “Pharmacy” means an entity that holds an active and 279 unencumbered permit under chapter 465. 280 (j) “Program” means the International Prescription Drug 281 Importation Program established under this section. 282 (k) “Qualified laboratory” means a laboratory that has been 283 approved by the department for the purposes of this section. 284 (3) ELIGIBLE PRESCRIPTION DRUGS.—An eligible importer may 285 import a prescription drug from an eligible exporter if: 286 (a) The drug meets the United States Food and Drug 287 Administration’s standards relating to safety, effectiveness, 288 misbranding, and adulteration; 289 (b) Importing the drug would not violate the patent laws of 290 the United States; and 291 (c) The drug is not: 292 1. A controlled substance as defined in 21 U.S.C. s. 802; 293 2. A biological product as defined in 42 U.S.C. s. 262; 294 3. An infused drug; 295 4. An intravenously injected drug; 296 5. A drug that is inhaled during surgery; or 297 6. A drug that is a parenteral drug, the importation of 298 which is determined by the United States Secretary of Health and 299 Human Services to pose a threat to the public health. 300 (4) EXPORTERS.— 301 (a) The following entities may export prescription drugs 302 into this state under the program: 303 1. An international prescription drug wholesale 304 distributor. 305 2. A nonresident prescription drug manufacturer. 306 3. An international export pharmacy. 307 (b) An eligible exporter shall register with the department 308 before exporting prescription drugs into this state under the 309 program. 310 (c) An exporter may not distribute, sell, or dispense 311 prescription drugs imported under the program to any person 312 residing outside of this state. 313 (5) IMPORTERS.— 314 (a) The following entities may import prescription drugs 315 under the program: 316 1. A wholesale distributor. 317 2. A pharmacy. 318 3. A pharmacist. 319 (b) An eligible importer shall register with the department 320 before importing prescription drugs into this state under the 321 program. 322 (c) An importer may not distribute, sell, or dispense 323 prescription drugs imported under the program to any person 324 residing outside of this state. 325 (6) PRESCRIPTION DRUG SUPPLY CHAIN DOCUMENTATION.— 326 (a) A participating importer must submit the following 327 information and documentation to the department: 328 1. The name and the quantity of the active ingredient of 329 the prescription drug. 330 2. A description of the dosage form of the prescription 331 drug. 332 3. The date on which the prescription drug is shipped. 333 4. The quantity of the prescription drug that is shipped. 334 5. The point of origin and destination of the prescription 335 drug. 336 6. The price paid by the importer for the prescription 337 drug. 338 7. Documentation from the exporter specifying: 339 a. The original source of the prescription drug; and 340 b. The quantity of each lot of the prescription drug 341 originally received by the seller from such source. 342 8. The lot or control number assigned to the prescription 343 drug by the manufacturer. 344 9. The name, address, telephone number, and professional 345 license or permit number of the importer. 346 10. In the case of a prescription drug that is shipped 347 directly by the first foreign recipient from the manufacturer: 348 a. Documentation demonstrating that the prescription drug 349 was received by the recipient from the manufacturer and 350 subsequently shipped by the first foreign recipient to the 351 importer. 352 b. Documentation of the quantity of each lot of the 353 prescription drug received by the first foreign recipient 354 demonstrating that the quantity being imported into this state 355 is not more than the quantity that was received by the first 356 foreign recipient. 357 c. For an initial imported shipment, documentation 358 demonstrating that each batch of the prescription drug in the 359 shipment was statistically sampled and tested for authenticity 360 and degradation. 361 d. For any subsequent imported shipment, documentation 362 demonstrating that a statistically valid sample of the shipment 363 was tested for authenticity and degradation. 364 11. In the case of a prescription drug that is not shipped 365 directly from the first foreign recipient, documentation 366 demonstrating that each batch in each shipment offered for 367 importation into the state was statistically sampled and tested 368 for authenticity and degradation. 369 12. Certification from the importer or manufacturer that 370 the prescription drug: 371 a. Is approved for marketing in the United States and is 372 not adulterated or misbranded; and 373 b. Meets all of the labeling requirements under 21 U.S.C. 374 s. 352. 375 13. Qualified laboratory records, including complete data 376 derived from all tests necessary to ensure that the prescription 377 drug is in compliance with the requirements of this section. 378 14. Documentation demonstrating that the testing required 379 by this section was conducted at a qualified laboratory. 380 15. Any other information the department determines is 381 necessary to ensure the protection of the public health. 382 (b) All testing required by this section must be conducted 383 in a qualified laboratory. 384 (c) The department shall maintain information and 385 documentation submitted under this section for a period of at 386 least 4 years. 387 (7) IMMEDIATE SUSPENSION.—The department shall immediately 388 suspend the importation of a specific prescription drug or the 389 importation of prescription drugs by a specific importer if the 390 department discovers that any prescription drug or any activity 391 is in violation of this section. The department may revoke the 392 suspension if, after conducting an investigation, it determines 393 that the public is adequately protected from counterfeit or 394 unsafe prescription drugs being imported into this state. 395 (8) RULEMAKING AUTHORITY.—The department shall adopt rules 396 necessary to implement this section. 397 Section 3. Section 465.0157, Florida Statutes, is created 398 to read: 399 465.0157 International export pharmacy permit.— 400 (1) To participate as an exporter of prescription drugs 401 into this state under the International Prescription Drug 402 Importation Program established in s. 499.0285, a pharmacy 403 located outside of the United States must hold an international 404 export pharmacy permit. 405 (2) An international export pharmacy must maintain at all 406 times an active and unencumbered license or a permit to operate 407 the pharmacy in compliance with the laws of the jurisdiction in 408 which the dispensing facility is located and from which the 409 prescription drugs must be exported. Such jurisdiction must be 410 in a country with whom the United States has a current mutual 411 recognition agreement, cooperation agreement, memorandum of 412 understanding, or other federal mechanism recognizing the 413 country’s adherence to current good manufacturing practices for 414 pharmaceutical products. 415 (3) An application for an international export pharmacy 416 permit must be submitted on a form developed and provided by the 417 board. The board may require an applicant to provide any 418 information it deems reasonably necessary to carry out the 419 purposes of this section. 420 (4) An applicant must submit the following to the board to 421 obtain an initial permit, or to the department to renew a 422 permit: 423 (a) Proof of an active and unencumbered license or permit 424 to operate the pharmacy in compliance with the laws of the 425 jurisdiction in which the dispensing facility is located and 426 from which the prescription drugs must be exported. 427 (b) Documentation demonstrating that the country in which 428 the pharmacy operates has a current mutual recognition 429 agreement, cooperation agreement, memorandum of understanding, 430 or other federal mechanism recognizing the country’s adherence 431 to current good manufacturing practices for pharmaceutical 432 products. 433 (c) The locations, names, and titles of all principal 434 corporate officers and of the pharmacist who serves as the 435 prescription department manager for prescription drugs exported 436 into this state under the International Prescription Drug 437 Importation Program. 438 (d) Written attestation by an owner or an officer of the 439 applicant, and by the applicant’s prescription department 440 manager, that: 441 1. The attestor has read and understands the laws and rules 442 governing the manufacturing, distributing, and dispensing of 443 prescription drugs in this state. 444 2. A prescription drug shipped, mailed, or delivered into 445 this state meets or exceeds this state’s standards for safety 446 and efficacy. 447 3. A prescription drug product shipped, mailed, or 448 delivered into this state may not have been, and may not be, 449 manufactured or distributed in violation of the laws and rules 450 of the jurisdiction in which the applicant is located and from 451 which the prescription drugs must be exported. 452 (e) A current inspection report from an inspection 453 conducted by the regulatory agency or the licensing agency of 454 the jurisdiction in which the applicant is located. The 455 inspection report must reflect compliance with this section. An 456 inspection report is current if the inspection was conducted 457 within 6 months before the date of submitting the application 458 for the initial permit or within 1 year before the date of 459 submitting an application for the permit renewal. If the 460 applicant is unable to submit a current inspection report 461 conducted by the regulatory agency or the licensing agency of 462 the jurisdiction in which the applicant is located and from 463 which the prescription drugs must be exported, due to acceptable 464 circumstances, as established by rule, or if an inspection has 465 not been performed, the department shall: 466 1. Conduct, or contract with an entity to conduct, an 467 onsite inspection for which all costs must be borne by the 468 applicant; 469 2. Accept a current and satisfactory inspection report, as 470 determined by rule, from an entity approved by the board; or 471 3. Accept a current inspection report from the United 472 States Food and Drug Administration conducted pursuant to the 473 federal Drug Quality and Security Act, Pub. L. No. 113-54. 474 Section 4. Subsection (2) of section 465.017, Florida 475 Statutes, is amended to read: 476 465.017 Authority to inspect; disposal.— 477 (2) Duly authorized agents and employees of the department 478 may inspect a nonresident pharmacy registered under s. 465.0156, 479 an international export pharmacy permittee under s. 465.0157, or 480 a nonresident sterile compounding permittee under s. 465.0158 481 pursuant to this section. The costs of such inspections shall be 482 borne by such pharmacy or permittee. 483 Section 5. Subsection (1) and paragraph (c) of subsection 484 (2) of section 499.01, Florida Statutes, are amended, and 485 paragraph (s) is added to subsection (2) of that section, to 486 read: 487 499.01 Permits.— 488 (1) Before operating, a permit is required for each person 489 and establishment that intends to operate as: 490 (a) A prescription drug manufacturer; 491 (b) A prescription drug repackager; 492 (c) A nonresident prescription drug manufacturer; 493 (d) A nonresident prescription drug repackager; 494 (e) A prescription drug wholesale distributor; 495 (f) An out-of-state prescription drug wholesale 496 distributor; 497 (g) A retail pharmacy drug wholesale distributor; 498 (h) A restricted prescription drug distributor; 499 (i) A complimentary drug distributor; 500 (j) A freight forwarder; 501 (k) A veterinary prescription drug retail establishment; 502 (l) A veterinary prescription drug wholesale distributor; 503 (m) A limited prescription drug veterinary wholesale 504 distributor; 505 (n) An over-the-counter drug manufacturer; 506 (o) A device manufacturer; 507 (p) A cosmetic manufacturer; 508 (q) A third party logistics provider;
or509 (r) A health care clinic establishment; or 510 (s) An international prescription drug wholesale 511 distributor. 512 (2) The following permits are established: 513 (c) Nonresident prescription drug manufacturer permit.—A 514 nonresident prescription drug manufacturer permit is required 515 for any person that is a manufacturer of prescription drugs, 516 unless permitted as a third party logistics provider, located 517 outside of this state or outside the United States and that 518 engages in the distribution in this state of such prescription 519 drugs. Each such manufacturer must be permitted by the 520 department and comply with all of the provisions required of a 521 prescription drug manufacturer under this part. To participate 522 as an exporter of prescription drugs into this state under the 523 International Prescription Drug Importation Program established 524 in s. 499.0285, a nonresident prescription drug manufacturer 525 located outside of the United States must register with the 526 department before engaging in any activities under that section. 527 Such manufacturer must be licensed or permitted in a country 528 with whom the United States has a current mutual recognition 529 agreement, cooperation agreement, memorandum of understanding, 530 or other federal mechanism recognizing the country’s adherence 531 to current good manufacturing practices for pharmaceutical 532 products. The department shall adopt rules for issuing a virtual 533 nonresident prescription drug manufacturer permit to a person 534 who engages in the manufacture of prescription drugs but does 535 not make or take physical possession of any prescription drugs. 536 The rules adopted by the department under this section may 537 exempt virtual nonresident manufacturers from certain 538 establishment, security, and storage requirements set forth in 539 s. 499.0121. 540 1. A person that distributes prescription drugs for which 541 the person is not the manufacturer must also obtain an out-of 542 state prescription drug wholesale distributor permit, 543 international prescription drug wholesale distributor permit, or 544 third party logistics provider permit pursuant to this section 545 to engage in the distribution of such prescription drugs when 546 required by this part. This subparagraph does not apply to a 547 manufacturer that distributes prescription drugs only for the 548 manufacturer of the prescription drugs where both manufacturers 549 are affiliates. 550 2. Any such person must comply with the licensing or 551 permitting requirements of the jurisdiction in which the 552 establishment is located and the federal act, and any 553 prescription drug distributed into this state must comply with 554 this part. If a person intends to import prescription drugs from 555 a foreign country into this state, the nonresident prescription 556 drug manufacturer must provide to the department a list 557 identifying each prescription drug it intends to import and 558 document approval by the United States Food and Drug 559 Administration for such importation. A nonresident prescription 560 drug manufacturer that has registered to participate in the 561 International Prescription Drug Importation Program pursuant to 562 this section is not required to provide such documentation for 563 prescription drugs imported under that program. 564 (s) International prescription drug wholesale distributor. 565 A wholesale distributor located outside of the United States 566 must obtain an international prescription drug wholesale 567 distributor permit to engage in the wholesale exportation and 568 the distribution of prescription drugs in this state under the 569 International Prescription Drug Importation Program established 570 in s. 499.0285. The wholesale distributor must be licensed or 571 permitted to operate in a country with whom the United States 572 has a mutual recognition agreement, cooperation agreement, 573 memorandum of understanding, or other federal mechanism 574 recognizing the country’s adherence to current good 575 manufacturing practices for pharmaceutical products. The 576 wholesale distributor must maintain at all times a license or 577 permit to engage in the wholesale distribution of prescription 578 drugs in compliance with the laws of the jurisdiction in which 579 it operates. An international prescription drug wholesale 580 distributor permit may not be issued to a wholesale distributor 581 if the jurisdiction in which the wholesale distributor operates 582 does not require a license to engage in the wholesale 583 distribution of prescription drugs. 584 Section 6. Subsection (2), paragraph (a) of subsection (4), 585 subsections (8), (10), (11), and (14), and paragraphs (a), (b), 586 and (f) of subsection (15) of section 499.012, Florida Statutes, 587 are amended to read: 588 499.012 Permit application requirements.— 589 (2) Notwithstanding subsection (6), a permitted person in 590 good standing may change the type of permit issued to that 591 person by completing a new application for the requested permit, 592 paying the amount of the difference in the permit fees if the 593 fee for the new permit is more than the fee for the original 594 permit, and meeting the applicable permitting conditions for the 595 new permit type. The new permit expires on the expiration date 596 of the original permit being changed; however, a new permit for 597 a prescription drug wholesale distributor, an out-of-state 598 prescription drug wholesale distributor, an international 599 prescription drug wholesale distributor, or a retail pharmacy 600 drug wholesale distributor shall expire on the expiration date 601 of the original permit or 1 year after the date of issuance of 602 the new permit, whichever is earlier. A refund may not be issued 603 if the fee for the new permit is less than the fee that was paid 604 for the original permit. 605 (4)(a) Except for a permit for a prescription drug 606 wholesale distributor, an international prescription drug 607 wholesale distributor, or an out-of-state prescription drug 608 wholesale distributor, an application for a permit must include: 609 1. The name, full business address, and telephone number of 610 the applicant; 611 2. All trade or business names used by the applicant; 612 3. The address, telephone numbers, and the names of contact 613 persons for each facility used by the applicant for the storage, 614 handling, and distribution of prescription drugs; 615 4. The type of ownership or operation, such as a 616 partnership, corporation, or sole proprietorship; and 617 5. The names of the owner and the operator of the 618 establishment, including: 619 a. If an individual, the name of the individual; 620 b. If a partnership, the name of each partner and the name 621 of the partnership; 622 c. If a corporation, the name and title of each corporate 623 officer and director, the corporate names, and the name of the 624 state of incorporation; 625 d. If a sole proprietorship, the full name of the sole 626 proprietor and the name of the business entity; 627 e. If a limited liability company, the name of each member, 628 the name of each manager, the name of the limited liability 629 company, and the name of the state in which the limited 630 liability company was organized; and 631 f. Any other relevant information that the department 632 requires. 633 (8) An application for a permit or to renew a permit for a 634 prescription drug wholesale distributor, an international 635 prescription drug wholesale distributor, or an out-of-state 636 prescription drug wholesale distributor submitted to the 637 department must include: 638 (a) The name, full business address, and telephone number 639 of the applicant. 640 (b) All trade or business names used by the applicant. 641 (c) The address, telephone numbers, and the names of 642 contact persons for each facility used by the applicant for the 643 storage, handling, and distribution of prescription drugs. 644 (d) The type of ownership or operation, such as a 645 partnership, corporation, or sole proprietorship. 646 (e) The names of the owner and the operator of the 647 establishment, including: 648 1. If an individual, the name of the individual. 649 2. If a partnership, the name of each partner and the name 650 of the partnership. 651 3. If a corporation: 652 a. The name, address, and title of each corporate officer 653 and director. 654 b. The name and address of the corporation, resident agent 655 of the corporation, the resident agent’s address, and the 656 corporation’s state of incorporation. 657 c. The name and address of each shareholder of the 658 corporation that owns 5 percent or more of the outstanding stock 659 of the corporation. 660 4. If a sole proprietorship, the full name of the sole 661 proprietor and the name of the business entity. 662 5. If a limited liability company: 663 a. The name and address of each member. 664 b. The name and address of each manager. 665 c. The name and address of the limited liability company, 666 the resident agent of the limited liability company, and the 667 name of the state in which the limited liability company was 668 organized. 669 (f) If applicable, the name and address of each affiliate 670 of the applicant. 671 (g) The applicant’s gross annual receipts attributable to 672 prescription drug wholesale distribution activities for the 673 previous tax year. 674 (h) The tax year of the applicant. 675 (i) A copy of the deed for the property on which 676 applicant’s establishment is located, if the establishment is 677 owned by the applicant, or a copy of the applicant’s lease for 678 the property on which applicant’s establishment is located that 679 has an original term of not less than 1 calendar year, if the 680 establishment is not owned by the applicant. 681 (j) A list of all licenses and permits issued to the 682 applicant by any other state or other jurisdiction which 683 authorize the applicant to purchase or possess prescription 684 drugs. 685 (k) The name of the manager of the establishment that is 686 applying for the permit or to renew the permit, the next four 687 highest ranking employees responsible for prescription drug 688 wholesale operations for the establishment, and the name of all 689 affiliated parties for the establishment, together with the 690 personal information statement and fingerprints required 691 pursuant to subsection (9) for each of such persons. 692 (l) The name of each of the applicant’s designated 693 representatives as required by subsection (15), together with 694 the personal information statement and fingerprints required 695 pursuant to subsection (9) for each such person. 696 (m) Evidence of a surety bond in this state or any other 697 state in the United States in the amount of $100,000. If the 698 annual gross receipts of the applicant’s previous tax year are 699 $10 million or less, evidence of a surety bond in the amount of 700 $25,000. The specific language of the surety bond must include 701 the State of Florida as a beneficiary, payable to the 702 Professional Regulation Trust Fund. In lieu of the surety bond, 703 the applicant may provide other equivalent security such as an 704 irrevocable letter of credit, or a deposit in a trust account or 705 financial institution, which includes the State of Florida as a 706 beneficiary, payable to the Professional Regulation Trust Fund. 707 The purpose of the bond or other security is to secure payment 708 of any administrative penalties imposed by the department and 709 any fees and costs incurred by the department regarding that 710 permit which are authorized under state law and which the 711 permittee fails to pay 30 days after the fine or costs become 712 final. The department may make a claim against such bond or 713 security until 1 year after the permittee’s license ceases to be 714 valid or until 60 days after any administrative or legal 715 proceeding authorized in this part which involves the permittee 716 is concluded, including any appeal, whichever occurs later. 717 (n) For establishments used in wholesale distribution, 718 proof of an inspection conducted by the department, the United 719 States Food and Drug Administration, or another governmental 720 entity charged with the regulation of good manufacturing 721 practices related to wholesale distribution of prescription 722 drugs, within timeframes set forth by the department in 723 departmental rules, which demonstrates substantial compliance 724 with current good manufacturing practices applicable to 725 wholesale distribution of prescription drugs. The department may 726 recognize another state’s or jurisdiction’s inspection of a 727 wholesale distributor located in that state or jurisdiction if 728 such state’s or jurisdiction’s laws are deemed to be 729 substantially equivalent to the law of this state by the 730 department. The department may accept an inspection by a third 731 party accreditation or inspection service which meets the 732 criteria set forth in department rule. 733 (o) Any other relevant information that the department 734 requires. 735 (p) Documentation of the credentialing policies and 736 procedures required by s. 499.0121(15). 737 (q) For international prescription drug wholesale 738 distributors and nonresident prescription drug manufacturers to 739 participate in the International Prescription Drug Importation 740 Program established under s. 499.0285, documentation 741 demonstrating that the applicant is appropriately licensed or 742 permitted by a country with whom the United States has a mutual 743 recognition agreement, cooperation agreement, memorandum of 744 understanding, or other mechanism recognizing the country’s 745 adherence to current good manufacturing practices for 746 pharmaceutical products. 747 (10) The department may deny an application for a permit or 748 refuse to renew a permit for a prescription drug wholesale 749 distributor, an international prescription drug wholesale 750 distributor, or an out-of-state prescription drug wholesale 751 distributor if: 752 (a) The applicant has not met the requirements for the 753 permit. 754 (b) The management, officers, or directors of the applicant 755 or any affiliated party are found by the department to be 756 incompetent or untrustworthy. 757 (c) The applicant is so lacking in experience in managing a 758 wholesale distributor as to make the issuance of the proposed 759 permit hazardous to the public health. 760 (d) The applicant is so lacking in experience in managing a 761 wholesale distributor as to jeopardize the reasonable promise of 762 successful operation of the wholesale distributor. 763 (e) The applicant is lacking in experience in the 764 distribution of prescription drugs. 765 (f) The applicant’s past experience in manufacturing or 766 distributing prescription drugs indicates that the applicant 767 poses a public health risk. 768 (g) The applicant is affiliated directly or indirectly 769 through ownership, control, or other business relations, with 770 any person or persons whose business operations are or have been 771 detrimental to the public health. 772 (h) The applicant, or any affiliated party, has been found 773 guilty of or has pleaded guilty or nolo contendere to any felony 774 or crime punishable by imprisonment for 1 year or more under the 775 laws of the United States, any state, or any other country, 776 regardless of whether adjudication of guilt was withheld. 777 (i) The applicant or any affiliated party has been charged 778 with a felony in a state or federal court and the disposition of 779 that charge is pending during the application review or renewal 780 review period. 781 (j) The applicant has furnished false or fraudulent 782 information or material in any application made in this state or 783 any other state in connection with obtaining a permit or license 784 to manufacture or distribute drugs, devices, or cosmetics. 785 (k) That a federal, state, or local government permit 786 currently or previously held by the applicant, or any affiliated 787 party, for the manufacture or distribution of any drugs, 788 devices, or cosmetics has been disciplined, suspended, or 789 revoked and has not been reinstated. 790 (l) The applicant does not possess the financial or 791 physical resources to operate in compliance with the permit 792 being sought, this chapter, and the rules adopted under this 793 chapter. 794 (m) The applicant or any affiliated party receives, 795 directly or indirectly, financial support and assistance from a 796 person who was an affiliated party of a permittee whose permit 797 was subject to discipline or was suspended or revoked, other 798 than through the ownership of stock in a publicly traded company 799 or a mutual fund. 800 (n) The applicant or any affiliated party receives, 801 directly or indirectly, financial support and assistance from a 802 person who has been found guilty of any violation of this part 803 or chapter 465, chapter 501, or chapter 893, any rules adopted 804 under this part or those chapters, any federal or state drug 805 law, or any felony where the underlying facts related to drugs, 806 regardless of whether the person has been pardoned, had her or 807 his civil rights restored, or had adjudication withheld, other 808 than through the ownership of stock in a publicly traded company 809 or a mutual fund. 810 (o) The applicant for renewal of a permit under s. 811 499.01(2)(e) or (f) has not actively engaged in the wholesale 812 distribution of prescription drugs, as demonstrated by the 813 regular and systematic distribution of prescription drugs 814 throughout the year as evidenced by not fewer than 12 wholesale 815 distributions in the previous year and not fewer than three 816 wholesale distributions in the previous 6 months. 817 (p) Information obtained in response to s. 499.01(2)(e) or 818 (f) demonstrates it would not be in the best interest of the 819 public health, safety, and welfare to issue a permit. 820 (q) The applicant does not possess the financial standing 821 and business experience for the successful operation of the 822 applicant. 823 (r) The applicant or any affiliated party has failed to 824 comply with the requirements for manufacturing or distributing 825 prescription drugs under this part, similar federal laws, 826 similar laws in other states, or the rules adopted under such 827 laws. 828 (11) Upon approval of the application by the department and 829 payment of the required fee, the department shall issue or renew 830 a prescription drug wholesale distributor, an international 831 prescription drug wholesale distributor, or an out-of-state 832 prescription drug wholesale distributor permit to the applicant. 833 (14) The name of a permittee or establishment on a 834 prescription drug wholesale distributor permit, an international 835 prescription drug wholesale distributor permit, or an out-of 836 state prescription drug wholesale distributor permit may not 837 include any indicia of attainment of any educational degree, any 838 indicia that the permittee or establishment possesses a 839 professional license, or any name or abbreviation that the 840 department determines is likely to cause confusion or mistake or 841 that the department determines is deceptive, including that of 842 any other entity authorized to purchase prescription drugs. 843 (15)(a) Each establishment that is issued an initial or 844 renewal permit as a prescription drug wholesale distributor, an 845 international prescription drug wholesale distributor, or an 846 out-of-state prescription drug wholesale distributor must 847 designate in writing to the department at least one natural 848 person to serve as the designated representative of the 849 wholesale distributor. Such person must have an active 850 certification as a designated representative from the 851 department. 852 (b) To be certified as a designated representative, a 853 natural person must: 854 1. Submit an application on a form furnished by the 855 department and pay the appropriate fees. 856 2. Be at least 18 years of age. 857 3. Have at least 2 years of verifiable full-time: 858 a. Work experience in a pharmacy licensed in this state or 859 another state or jurisdiction, where the person’s 860 responsibilities included, but were not limited to, 861 recordkeeping for prescription drugs; 862 b. Managerial experience with a prescription drug wholesale 863 distributor licensed in this state or in another state or 864 another jurisdiction; or 865 c. Managerial experience with the United States Armed 866 Forces, where the person’s responsibilities included, but were 867 not limited to, recordkeeping, warehousing, distributing, or 868 other logistics services pertaining to prescription drugs. 869 4. Receive a passing score of at least 75 percent on an 870 examination given by the department regarding federal laws 871 governing distribution of prescription drugs and this part and 872 the rules adopted by the department governing the wholesale 873 distribution of prescription drugs. This requirement shall be 874 effective 1 year after the results of the initial examination 875 are mailed to the persons that took the examination. The 876 department shall offer such examinations at least four times 877 each calendar year. 878 5. Provide the department with a personal information 879 statement and fingerprints pursuant to subsection (9). 880 (f) A wholesale distributor may not operate under a 881 prescription drug wholesale distributor permit, an international 882 prescription drug wholesale distributor permit, or an out-of 883 state prescription drug wholesale distributor permit for more 884 than 10 business days after the designated representative leaves 885 the employ of the wholesale distributor, unless the wholesale 886 distributor employs another designated representative and 887 notifies the department within 10 business days after ofthe 888 identity of the new designated representative. 889 Section 7. Subsection (20) of section 499.005, Florida 890 Statutes, is amended to read: 891 499.005 Prohibited acts.—It is unlawful for a person to 892 perform or cause the performance of any of the following acts in 893 this state: 894 (20) The importation of a prescription drug except as 895 provided by s. 801(d) of the Federal Food, Drug, and Cosmetic 896 Act or s. 499.0285. 897 Section 8. Paragraph (e) of subsection (12) of section 898 499.0051, Florida Statutes, is amended to read: 899 499.0051 Criminal acts.— 900 (12) REFUSAL TO ALLOW INSPECTION; SELLING, PURCHASING, OR 901 TRADING DRUG SAMPLES; FAILURE TO MAINTAIN RECORDS RELATING TO 902 PRESCRIPTION DRUGS.—Any person who violates any of the following 903 provisions commits a felony of the third degree, punishable as 904 provided in s. 775.082, s. 775.083, or s. 775.084, or as 905 otherwise provided in this part: 906 (e) The importation of a prescription drug for wholesale 907 distribution, except as provided by s. 801(d) of the Federal 908 Food, Drug, and Cosmetic Act or s. 499.0285. 909 Section 9. Paragraph (c) is added to subsection (1) of 910 section 499.015, Florida Statutes, to read: 911 499.015 Registration of drugs and devices; issuance of 912 certificates of free sale.— 913 (1) 914 (c) Registration under this section is not required for 915 prescription drugs imported under the International Prescription 916 Drug Importation Program established in s. 499.0285. 917 Section 10. Subsections (1) and (3) of section 499.065, 918 Florida Statutes, are amended to read: 919 499.065 Inspections; imminent danger.— 920 (1) Notwithstanding s. 499.051, the department shall 921 inspect each prescription drug wholesale distributor 922 establishment, international prescription drug wholesale 923 distributor establishment, prescription drug repackager 924 establishment, veterinary prescription drug wholesale 925 distributor establishment, limited prescription drug veterinary 926 wholesale distributor establishment, and retail pharmacy drug 927 wholesale distributor establishment that is required to be 928 permitted under this part as often as necessary to ensure 929 compliance with applicable laws and rules. The department shall 930 have the right of entry and access to these facilities at any 931 reasonable time. 932 (3) The department may determine that a prescription drug 933 wholesale distributor establishment, international prescription 934 drug wholesale distributor establishment, prescription drug 935 repackager establishment, veterinary prescription drug wholesale 936 distributor establishment, limited prescription drug veterinary 937 wholesale distributor establishment, or retail pharmacy drug 938 wholesale distributor establishment that is required to be 939 permitted under this part is an imminent danger to the public 940 health and shall require its immediate closure if the 941 establishment fails to comply with applicable laws and rules 942 and, because of the failure, presents an imminent threat to the 943 public’s health, safety, or welfare. Any establishment so deemed 944 and closed shall remain closed until allowed by the department 945 or by judicial order to reopen. 946 Section 11. Notwithstanding the Federal Food, Drug, and 947 Cosmetic Act, the Department of Business and Professional 948 Regulation, in collaboration with the Department of Health, 949 shall negotiate a federal arrangement to operate a pilot program 950 for importing prescription drugs into this state. The proposal 951 to operate such a pilot program must demonstrate that the 952 program sets safety standards consistent with the current 953 federal requirements for the manufacturing and distributing of 954 prescription drugs; limits the importation of prescription drugs 955 to entities licensed or permitted by the state to manufacture, 956 distribute, or dispense prescription drugs; and includes 957 inspection and enforcement authority. Implementation of sections 958 2 through 11 of this act is contingent upon such federal 959 arrangement or upon obtaining federal guidance. 960 Section 12. This act shall take effect July 1, 2019.