Florida Senate - 2019 COMMITTEE AMENDMENT Bill No. PCS (712656) for CS for SB 1528 Ì858228AÎ858228 LEGISLATIVE ACTION Senate . House Comm: RCS . 04/18/2019 . . . . ————————————————————————————————————————————————————————————————— ————————————————————————————————————————————————————————————————— The Committee on Appropriations (Bean) recommended the following: 1 Senate Amendment (with title amendment) 2 3 Delete everything after the enacting clause 4 and insert: 5 Section 1. Section 381.02035, Florida Statutes, is created 6 to read: 7 381.02035 Canadian Prescription Drug Importation Program.— 8 (1) PROGRAM ESTABLISHED.—The Agency for Health Care 9 Administration shall establish the Canadian Prescription Drug 10 Importation Program for the importation of safe and effective 11 prescription drugs from Canada which have the highest potential 12 for cost savings to the state. 13 (2) DEFINITIONS.—As used in this section, the term: 14 (a) “Agency” means the Agency for Health Care 15 Administration. 16 (b) “Canadian supplier” means a manufacturer, wholesale 17 distributor, or pharmacy appropriately licensed or permitted 18 under Canadian law to manufacture, distribute, or dispense 19 prescription drugs. 20 (c) “County health department” means a health care facility 21 established under part I of chapter 154. 22 (d) “Department” means the Department of Health. 23 (e) “Drug” or “prescription drug” has the same meaning as 24 “prescription drug” in s. 499.003, but is limited to drugs 25 intended for human use. 26 (f) “Federal act” means the Federal Food, Drug, and 27 Cosmetic Act, 21 U.S.C. ss. 301 et seq.; 52 Stat. 1040 et seq. 28 as amended by the Drug Quality and Security Act, 21 U.S.C. 351 29 et seq. 30 (g)“Free clinic” means a clinic that delivers only medical 31 diagnostic services or nonsurgical medical treatment free of 32 charge to low-income recipients. 33 (h) “Medicaid pharmacy” means a pharmacy licensed under 34 chapter 465 that has a Medicaid provider agreement in effect 35 with the agency and is in good standing with the agency. 36 (i) “Pharmacist” means a person who holds an active and 37 unencumbered license to practice pharmacy pursuant to chapter 38 465. 39 (j) “Program” means the Canadian Prescription Drug 40 Importation Program. 41 (k) “Track-and-trace” means the product-tracing process for 42 the components of the pharmaceutical distribution supply chain 43 as described in Title II of the Drug Quality and Security Act, 44 Drug Supply Chain Security Act, 21 U.S.C. 351 et seq. 45 (l) “Vendor” means the entity contracted by the agency to 46 manage specified functions of the program. 47 (3) IMPORTATION PROCESS.— 48 (a) The agency shall contract with a vendor to provide 49 services under the program. 50 (b) By December 1, 2019, and each year thereafter, the 51 vendor shall develop a Wholesale Prescription Drug Importation 52 List identifying the prescription drugs that have the highest 53 potential for cost savings to the state. In developing the list, 54 the vendor shall consider, at a minimum, which prescription 55 drugs will provide the greatest cost savings to state programs, 56 including prescriptions drugs for which there are shortages, 57 specialty prescription drugs, and high volume prescription 58 drugs. The agency, in consultation with the department, shall 59 review the Wholesale Prescription Drug Importation List every 3 60 months to ensure that it continues to meet the requirements of 61 the programs and may direct the vendor to revise the list, as 62 necessary. 63 (c) The vendor shall submit evidence of a surety bond with 64 any bid or initial contract negotiation documents and shall 65 maintain documentation of evidence of such a bond with the 66 agency throughout the contract term. The surety bond may be from 67 this state or any other state in the United States for at least 68 $25,000. The surety bond or comparable security arrangement must 69 include the State of Florida as a beneficiary. In lieu of the 70 surety bond, the vendor may provide a comparable security 71 agreement, such as an irrevocable letter of credit or a deposit 72 into a trust account or financial institution, which includes 73 the State of Florida as a beneficiary, payable to the State of 74 Florida. The purposes of the bond or other security arrangement 75 for the program are to: 76 1. Ensure payment of any administrative penalties imposed 77 by the agency or any other state agency under the contract, if 78 the vendor fails to pay within 30 days after assessment; 79 2. Ensure that the vendor meets contractual and statutory 80 obligations through use of a surety bond or other comparable 81 security arrangements to pay any other costs or fees incurred by 82 the agency, the state, or other entities acting on behalf of the 83 state if the vendor fails to meet its contractual and statutory 84 obligations. If the vendor is assessed a penalty under the 85 program and fails to pay within 30 days after that assessment, 86 the agency, the state, or an entity acting on behalf of the 87 state may file a claim for reimbursement against the bond or 88 other comparable security arrangement; and 89 3. Allow for claims to be made against the bond or other 90 comparable security arrangements for up to 1 year after the 91 vendor’s contract under the program has ended with the agency or 92 the state or the program has ended, whichever occurs last. 93 94 A surety bond or comparable document is required, regardless of 95 the type of bid or negotiation process the agency used or the 96 type of final contract or agreement executed for services. 97 (d) The eligible vendor must submit evidence at the time of 98 contract award and throughout the contract term of a surety bond 99 or comparable security arrangement from this state or any other 100 state in the United States in an amount no less than $25,000. 101 The surety bond or comparable security arrangement must include 102 the State of Florida as a beneficiary. In lieu of the surety 103 bond, the vendor may provide a comparable security arrangement 104 such as an irrevocable letter of credit or a deposit into a 105 trust account or financial institution which names the State of 106 Florida as a beneficiary. The purposes of the bond or other 107 security arrangements for the program are to: 108 1. Ensure participation of the vendor in any civil or 109 criminal legal action by the state, the agency, any other state 110 agency, or private individuals or entities against the vendor 111 because of the vendor’s failure to perform under the contract, 112 including, but not limited to causes of actions for personal 113 injury, negligence, and wrongful death; 114 2. Ensure payment by the vendor through the use of a bond 115 or other comparable security arrangements of legal judgements 116 and claims that have been awarded to the agency, the state, 117 other entities acting on behalf of the state, individuals, or 118 organizations if the vendor is assessed a final judgement or 119 other monetary penalty in a court of law for a civil or criminal 120 action under the program. The bond or comparable security 121 arrangement will be accessed if the vendor fails to pay any 122 judgement or claim within 60 days after final judgement; and 123 3. Allow for civil and criminal litigation claims to be 124 made against the bond or other comparable security arrangements 125 for up to 1 year after the vendor’s contract under the program 126 has ended with the agency or the state, the vendor’s license is 127 no longer valid, or the program has ended, whichever occurs 128 last. 129 (e) The vendor shall identify Canadian suppliers that are 130 in full compliance with relevant Canadian federal and provincial 131 laws and regulations and the federal act and who have agreed to 132 export drugs identified on the list at prices that will provide 133 cost savings to the state. The vendor must verify that such 134 Canadian suppliers meet all of the requirements of the program, 135 while meeting or exceeding the federal and state track-and-trace 136 laws and regulations. 137 (f) The vendor shall contract with such eligible Canadian 138 suppliers, or facilitate contracts between eligible importers 139 and Canadian suppliers, to import drugs under the program. 140 (g) The vendor shall maintain a list of all registered 141 importers that participate in the program. 142 (h) The vendor shall ensure compliance with Title II of the 143 federal Drug Quality and Security Act, Pub. L. No. 113-54, by 144 all suppliers, importers and other distributors, and 145 participants in the program. 146 (i) The vendor shall assist the agency in the preparation 147 of the annual report required by subsection (11), including the 148 timely provision of any information requested by the agency. 149 (j) The vendor shall provide an annual financial audit of 150 its operations to the agency as required by the agency. The 151 vendor shall also provide quarterly financial reports specific 152 to the program and shall include information on the performance 153 of its subcontractors and vendors. The agency shall determine 154 the format and contents of the reports. 155 (4) ELIGIBLE PRESCRIPTION DRUGS.—Eligible importers may 156 import a drug from an eligible Canadian supplier if: 157 (a) The drug meets the United States Food and Drug 158 Administration’s standards related to safety, effectiveness, 159 misbranding, and adulteration; 160 (b) Importing the drug would not violate federal patent 161 laws; 162 (c) Importing the drug is expected to generate cost 163 savings; and 164 (d) The drug is not: 165 1. A controlled substance as defined in 21 U.S.C. s. 802; 166 2. A biological product as defined in 42 U.S.C. s. 262; 167 3. An infused drug; 168 4. An intravenously injected drug; 169 5. A drug that is inhaled during surgery; or 170 6. A drug that is a parenteral drug, the importation of 171 which is determined by the United States Secretary of Health and 172 Human Services to pose a threat to the public health. 173 (5) ELIGIBLE CANADIAN SUPPLIERS.—A Canadian supplier may 174 export prescription drugs into the state under the program if 175 the supplier is: 176 (a) In full compliance with relevant Canadian federal and 177 provincial laws and regulations; and 178 (b) Identified by the vendor as eligible to participate in 179 the program. 180 (6) ELIGIBLE IMPORTERS.—The following entities may import 181 prescription drugs from a Canadian supplier under the program: 182 (a) A pharmacist or wholesaler employed by or under 183 contract with the department’s central pharmacy, for 184 distribution to a county health department or free clinic for 185 dispensing to clients treated in such department or clinic. 186 (b) A pharmacist or wholesaler employed by or under 187 contract with a Medicaid pharmacy, for dispensing to the 188 pharmacy’s Medicaid recipients. 189 (c) A pharmacist or wholesaler employed by or under 190 contract with the Department of Corrections, for dispensing to 191 inmates in the custody of the Department of Corrections. 192 (d) A pharmacist or wholesaler employed by or under 193 contract with a developmental disabilities center, as defined in 194 s. 393.063, for dispensing to clients treated in such center. 195 (e) A pharmacist or wholesaler employed by or under 196 contract with a treatment facility, as defined in s. 394.455, 197 for dispensing to patients treated in such facility. 198 (7) DISTRIBUTION REQUIREMENTS.—Eligible Canadian suppliers 199 and importers participating under the program: 200 (a) Must comply with the tracking and tracing requirements 201 of 21 U.S.C. ss. 360eee et seq. 202 (b) May not distribute, dispense, or sell prescription 203 drugs imported under the program outside of the state. 204 (8) FEDERAL APPROVAL.—By July 1, 2020, the agency shall 205 submit a request to the United States Secretary of Health and 206 Human Services for approval of the program under 21 U.S.C. s. 207 384(l). The agency shall begin operating the program within 6 208 months after receiving such approval. The request must, at a 209 minimum: 210 (a) Describe the agency’s plan for operating the program. 211 (b) Demonstrate how the prescription drugs imported into 212 this state under the program will meet the applicable federal 213 and state standards for safety and effectiveness. 214 (c) Demonstrate how the drugs imported into this state 215 under the program will comply with federal tracing procedures. 216 (d) Include a list of proposed prescription drugs that have 217 the highest potential for cost savings to the state through 218 importation at the time that the request is submitted. 219 (e) Estimate the total cost savings attributable to the 220 program. 221 (f) Provide the costs of program implementation to the 222 state. 223 (g) Include a list of potential Canadian suppliers from 224 which the state would import drugs and demonstrate that the 225 suppliers are in full compliance with relevant Canadian federal 226 and provincial laws and regulations as well as all applicable 227 federal and state laws and regulations. 228 (9) PRESCRIPTION DRUG SUPPLY CHAIN DOCUMENTATION.— 229 (a) The vendor shall ensure the safety and quality of drugs 230 imported under the program. The vendor shall: 231 1. For an initial imported shipment, ensure that each batch 232 of the drug in the shipment is statistically sampled and tested 233 for authenticity and degradation in a manner consistent with the 234 federal act. 235 2. For any subsequent imported shipment, ensure that a 236 statistically valid sample of the shipment was tested for 237 authenticity and degradation in a manner consistent with the 238 federal act. 239 3. Certify that the drug: 240 a. Is approved for marketing in the United States and is 241 not adulterated or misbranded; and 242 b. Meets all of the labeling requirements under 21 U.S.C. 243 s. 352. 244 4. Maintain qualified laboratory records, including 245 complete data derived from all tests necessary to ensure that 246 the drug is in compliance with the requirements of this section. 247 5. Maintain documentation demonstrating that the testing 248 required by this section was conducted at a qualified laboratory 249 in accordance with the federal act and any other applicable 250 federal and state laws and regulations governing laboratory 251 qualifications. 252 (b) All testing required by this section must be conducted 253 in a qualified laboratory that meets the standards under the 254 federal act and any other applicable federal and state laws and 255 regulations governing laboratory qualifications for drug 256 testing. 257 (c) The vendor shall maintain information and documentation 258 submitted under this section for a period of at least 7 years. 259 (d) A participating importer must submit the all of 260 following information to the vendor: 261 1. The name and quantity of the active ingredient of the 262 drug. 263 2. A description of the dosage form of the drug. 264 3. The date on which the drug is received. 265 4. The quantity of the drug that is received. 266 5. The point of origin and destination of the drug. 267 6. The price paid by the importer for the drug. 268 (e) A participating Canadian supplier must submit the 269 following information and documentation to the vendor specifying 270 all of the following: 271 1. The original source of the drug, including: 272 a. The name of the manufacturer of the drug. 273 b. The date on which the drug was manufactured. 274 c. The location (country, state or province, and city) 275 where the drug was manufactured. 276 2. The date on which the drug is shipped. 277 3. The quantity of the drug that is shipped. 278 4. The quantity of each lot of the drug originally received 279 and from which source. 280 5. The lot or control number and the batch number assigned 281 to the drug by the manufacturer. 282 (f) The agency may require that the vendor collect any 283 other information necessary to ensure the protection of the 284 public health. 285 (10) IMMEDIATE SUSPENSION.—The agency shall immediately 286 suspend the importation of a specific drug or the importation of 287 drugs by a specific importer if it discovers that any drug or 288 activity is in violation of this section or any federal or state 289 law or regulation. The agency may revoke the suspension if, 290 after conducting an investigation, it determines that the public 291 is adequately protected from counterfeit or unsafe drugs being 292 imported into this state. 293 (11) ANNUAL REPORT.—By December 1 of each year, the agency 294 shall submit a report to the Governor, the President of the 295 Senate, and the Speaker of the House of Representatives on the 296 operation of the program during the previous fiscal year. The 297 report must include, at a minimum: 298 (a) A list of the prescription drugs that were imported 299 under the program; 300 (b) The number of participating entities; 301 (c) The number of prescriptions dispensed through the 302 program; 303 (d) The estimated cost savings during the previous fiscal 304 year and to date attributable the program; 305 (e) A description of the methodology used to determine 306 which drugs should be included on the Wholesale Prescription 307 Drug Importation List; and 308 (f) Documentation as to how the program ensures the 309 following: 310 1. That Canadian suppliers participating in the program are 311 of high quality, high performance, and in full compliance with 312 relevant Canadian federal and provincial laws and regulations as 313 well as all federal laws and regulations and state laws and 314 rules; 315 2. That prescription drugs imported under the program are 316 not shipped, sold, or dispensed outside of this state once in 317 the possession of the importer; 318 3. That prescription drugs imported under the program are 319 pure, unadulterated, potent, and safe; 320 4. That the program does not put consumers at a higher 321 health and safety risk than if the consumer did not participate; 322 and 323 5. That the program provides cost savings to the state on 324 imported prescription drugs. 325 (12) NOTIFICATION OF FEDERAL APPROVAL.—Upon receipt of 326 federal approval of the program, the agency shall notify the 327 President of the Senate, the Speaker of the House of 328 Representatives, and the relevant committees of the Senate and 329 the House of Representatives. After approval is received and 330 before the start of the next regular session of the Legislature 331 in which the proposal could be funded, the agency shall submit 332 to all parties a proposal for program implementation and program 333 funding. 334 (13) RULEMAKING.—The agency shall adopt rules necessary to 335 implement this section. 336 Section 2. Section 465.0157, Florida Statutes, is created 337 to read: 338 465.0157 International export pharmacy permit.— 339 (1) To participate as an exporter of prescription drugs 340 into the state under the International Prescription Drug 341 Importation Program established in s. 499.0285, a pharmacy 342 located outside of the United States must hold an international 343 export pharmacy permit. 344 (2) An international export pharmacy shall maintain at all 345 times an active and unencumbered license or permit to operate 346 the pharmacy in compliance with the laws of the jurisdiction in 347 which the dispensing facility is located and from which the 348 prescription drugs will be exported. Such jurisdiction must be 349 in a country with which the United States has a current mutual 350 recognition agreement, cooperation agreement, memorandum of 351 understanding, or other federal mechanism recognizing the 352 country’s adherence to current good manufacturing practices for 353 pharmaceutical products. 354 (3) An application for an international export pharmacy 355 permit must be submitted on a form developed and provided by the 356 board. The board may require an applicant to provide any 357 information it deems reasonably necessary to carry out the 358 purposes of this section. 359 (4) An applicant shall submit the following to the board to 360 obtain an initial permit, or to the department to renew a 361 permit: 362 (a) Proof of an active and unencumbered license or permit 363 to operate the pharmacy in compliance with the laws of the 364 jurisdiction in which the dispensing facility is located and 365 from which the prescription drugs will be exported. 366 (b) Documentation demonstrating that the country in which 367 the pharmacy operates has a current mutual recognition 368 agreement, cooperation agreement, memorandum of understanding, 369 or other federal mechanism recognizing the country’s adherence 370 to current good manufacturing practices for pharmaceutical 371 products. 372 (c) Evidence of a surety bond with any application or 373 filing for pharmacy permit under this section and shall maintain 374 documentation of evidence of such a bond with the Department of 375 Business and Professional Regulation throughout the permit term. 376 The surety bond may be from this state or any other state in the 377 United States for no less than $25,000. The surety bond or 378 comparable security arrangement must include the State of 379 Florida as a beneficiary. In lieu of the surety bond, the 380 pharmacy may provide a comparable security agreement, such as an 381 irrevocable letter of credit or a deposit into a trust account 382 or financial institution which includes the State of Florida as 383 a beneficiary, payable to the State of Florida. The purposes of 384 the bond or other security arrangement for the program are to: 385 1. Ensure payment of any administrative penalties imposed 386 by the department or any other state agency under the contract 387 when the pharmacy fails to pay within 30 days after assessment; 388 2. Ensure that the pharmacy meets contractual and statutory 389 obligations through use of a surety bond or other comparable 390 security arrangements to pay any other costs or fees incurred by 391 the Department of Business of Professional Regulation, the 392 state, or other entities acting on behalf of the state if the 393 pharmacy fails to meet its obligations. If the pharmacy is 394 assessed a penalty under the program and fails to pay within 30 395 days after that assessment, the Department of Business and 396 Professional Regulation, the state, or an entity acting on 397 behalf of the state may file a claim for reimbursement against 398 the bond or other comparable security arrangement; and 399 3. Allow for claims to be made against the bond or other 400 comparable security arrangements for up to 1 year after the 401 pharmacy’s permit under the program has ended with this section 402 or the program has ended, whichever occurs last. 403 (b) The eligible pharmacy must submit evidence at the time 404 of application and throughout the permit term of a surety bond 405 or comparable security arrangement from this state or any other 406 state in the United States in an amount no less than $25,000. 407 The surety bond or comparable security arrangement must include 408 the State of Florida as a beneficiary. In lieu of the surety 409 bond, the pharmacy may provide a comparable security arrangement 410 such as an irrevocable letter of credit or a deposit into a 411 trust account or financial institution which names the State of 412 Florida as a beneficiary. The purposes of the bond or other 413 security arrangements for the program are to: 414 1. Ensure participation of the pharmacy in any civil or 415 criminal legal action by the state, the Department of Business 416 of Professional Regulation, any other state agency, or private 417 individuals or entities against the pharmacy or because of the 418 pharmacy’s failure to perform under the contract, including, but 419 not limited to causes of actions for personal injury, 420 negligence, and wrongful death; 421 2. Ensure payment by the pharmacy through the use of a bond 422 or other comparable security arrangements of legal judgements 423 and claims that have been awarded to the Department of Business 424 and Professional Regulation, the state, other entities acting on 425 behalf of the state, individuals, or organizations if the 426 pharmacy is assessed a final judgement or other monetary penalty 427 in a court of law for a civil or criminal action under the 428 program. The bond or comparable security arrangement will be 429 accessed if the pharmacy fails to pay any judgement or claim 430 within 60 days after final judgement; and 431 3. Allow for civil and criminal litigation claims to be 432 made against the bond or other comparable security arrangements 433 for up to 1 year after the pharmacy’s contract under the program 434 has ended with the agency or the state, the pharmacy’s license 435 is no longer valid, or the program has ended, whichever occurs 436 last. 437 (c) The location, names, and titles of all principal 438 corporate officers and the pharmacist who serves as the 439 prescription department manager for prescription drugs exported 440 into this state under the International Prescription Drug 441 Importation Program. 442 (d) Written attestation by an owner or officer of the 443 applicant, and by the applicant’s prescription department 444 manager, that: 445 1. The attestor has read and understands the laws and rules 446 governing the manufacture, distribution, and dispensing of 447 prescription drugs in this state. 448 2. A prescription drug shipped, mailed, or delivered into 449 this state meets or exceeds this state’s standards for safety 450 and efficacy. 451 3. A prescription drug product shipped, mailed, or 452 delivered into this state must not have been, and may not be, 453 manufactured or distributed in violation of the laws and rules 454 of the jurisdiction in which the applicant is located and from 455 which the prescription drugs shall be exported. 456 (e) A current inspection report from an inspection 457 conducted by the regulatory or licensing agency of the 458 jurisdiction in which the applicant is located. The inspection 459 report must reflect compliance with this section. An inspection 460 report is current if the inspection was conducted within 6 461 months before the date of submitting the application for the 462 initial permit or within 1 year before the date of submitting an 463 application for permit renewal. If the applicant is unable to 464 submit a current inspection report conducted by the regulatory 465 or licensing agency of the jurisdiction in which the applicant 466 is located and from which the prescription drugs will be 467 exported, due to acceptable circumstances, as established by 468 rule, or if an inspection has not been performed, the department 469 must: 470 1. Conduct, or contract with an entity to conduct, an 471 onsite inspection, with all related costs borne by the 472 applicant; 473 2. Accept a current and satisfactory inspection report, as 474 determined by rule, from an entity approved by the board; or 475 3. Accept a current inspection report from the United 476 States Food and Drug Administration conducted pursuant to the 477 federal Drug Quality and Security Act, Pub. L. No. 113-54. 478 Section 3. Subsection (2) of section 465.017, Florida 479 Statutes, is amended to read: 480 465.017 Authority to inspect; disposal.— 481 (2) Duly authorized agents and employees of the department 482 may inspect a nonresident pharmacy registered under s. 465.0156, 483 an international export pharmacy permittee under s. 465.0157, or 484 a nonresident sterile compounding permittee under s. 465.0158 485 pursuant to this section. The costs of such inspections shall be 486 borne by such pharmacy or permittee. 487 Section 4. Subsection (20) of section 499.005, Florida 488 Statutes, is amended to read: 489 499.005 Prohibited acts.—It is unlawful for a person to 490 perform or cause the performance of any of the following acts in 491 this state: 492 (20) The importation of a prescription drug except as 493 provided by s. 801(d) of the Federal Food, Drug, and Cosmetic 494 Act or s. 499.0285. 495 Section 5. Paragraph (e) of subsection (12) of section 496 499.0051, Florida Statutes, is amended to read: 497 499.0051 Criminal acts.— 498 (12) REFUSAL TO ALLOW INSPECTION; SELLING, PURCHASING, OR 499 TRADING DRUG SAMPLES; FAILURE TO MAINTAIN RECORDS RELATING TO 500 PRESCRIPTION DRUGS.—Any person who violates any of the following 501 provisions commits a felony of the third degree, punishable as 502 provided in s. 775.082, s. 775.083, or s. 775.084, or as 503 otherwise provided in this part: 504 (e) The importation of a prescription drug for wholesale 505 distribution, except as provided by s. 801(d) of the Federal 506 Food, Drug, and Cosmetic Act or s. 499.0285. 507 Section 6. Subsection (1) and paragraph (c) of subsection 508 (2) of section 499.01, Florida Statutes, are amended, and 509 paragraph (s) is added to subsection (2) of that section, to 510 read: 511 499.01 Permits.— 512 (1) Before operating, a permit is required for each person 513 and establishment that intends to operate as: 514 (a) A prescription drug manufacturer; 515 (b) A prescription drug repackager; 516 (c) A nonresident prescription drug manufacturer; 517 (d) A nonresident prescription drug repackager; 518 (e) A prescription drug wholesale distributor; 519 (f) An out-of-state prescription drug wholesale 520 distributor; 521 (g) A retail pharmacy drug wholesale distributor; 522 (h) A restricted prescription drug distributor; 523 (i) A complimentary drug distributor; 524 (j) A freight forwarder; 525 (k) A veterinary prescription drug retail establishment; 526 (l) A veterinary prescription drug wholesale distributor; 527 (m) A limited prescription drug veterinary wholesale 528 distributor; 529 (n) An over-the-counter drug manufacturer; 530 (o) A device manufacturer; 531 (p) A cosmetic manufacturer; 532 (q) A third party logistics provider;or533 (r) A health care clinic establishment 534 (s) An international prescription drug wholesale 535 distributor. 536 (2) The following permits are established: 537 (c) Nonresident prescription drug manufacturer permit.—A 538 nonresident prescription drug manufacturer permit is required 539 for any person that is a manufacturer of prescription drugs, 540 unless permitted as a third party logistics provider, located 541 outside of this state or outside the United States and that 542 engages in the distribution in this state of such prescription 543 drugs. Each such manufacturer must be permitted by the 544 department and comply with all of the provisions required of a 545 prescription drug manufacturer under this part. The department 546 shall adopt rules for issuing a virtual nonresident prescription 547 drug manufacturer permit to a person who engages in the 548 manufacture of prescription drugs but does not make or take 549 physical possession of any prescription drugs. The rules adopted 550 by the department under this section may exempt virtual 551 nonresident manufacturers from certain establishment, security, 552 and storage requirements set forth in s. 499.0121. 553 1. A person that distributes prescription drugs for which 554 the person is not the manufacturer must also obtain an out-of 555 state prescription drug wholesale distributor permit, an 556 international prescription drug wholesale distributor permit, or 557 third party logistics provider permit pursuant to this section 558 to engage in the distribution of such prescription drugs when 559 required by this part. This subparagraph does not apply to a 560 manufacturer that distributes prescription drugs only for the 561 manufacturer of the prescription drugs where both manufacturers 562 are affiliates. 563 2. Any such person must comply with the licensing or 564 permitting requirements of the jurisdiction in which the 565 establishment is located and the federal act, and any 566 prescription drug distributed into this state must comply with 567 this part. If a person intends to import prescription drugs from 568 a foreign country into this state, the nonresident prescription 569 drug manufacturer must provide to the department a list 570 identifying each prescription drug it intends to import and 571 document approval by the United States Food and Drug 572 Administration for such importation. 573 3.a. A nonresident prescription drug manufacturer that has 574 registered to participate in the International Prescription Drug 575 Importation Program pursuant to this section is not required to 576 provide the list and approval required by subparagraph 2. for 577 prescription drugs imported under that program. 578 b. To participate as an exporter of prescription drugs into 579 the state under the International Prescription Drug Importation 580 Program established under s. 499.0285, a nonresident 581 prescription drug manufacturer located outside of the United 582 States must register with the Department of Business and 583 Professional Regulation before engaging in any activities under 584 that section. Such manufacturer must be licensed or permitted in 585 a country with which the United States has a current mutual 586 recognition agreement, cooperation agreement, memorandum of 587 understanding, or other federal mechanism recognizing the 588 country’s adherence to current good manufacturing practices for 589 pharmaceutical products. 590 c. The nonresident prescription drug manufacturer shall 591 submit evidence of a surety bond with any application or filing 592 for registration under this section and shall maintain 593 documentation of evidence of such a bond with the Department of 594 Business and Professional Regulation throughout the registration 595 term. The surety bond may be from this state or any other state 596 in the United States in an amount equal to 10 percent of the 597 manufacturer’s annual sales or $1 million, whichever is higher. 598 The surety bond or comparable security arrangement must include 599 the State of Florida as a beneficiary. In lieu of the surety 600 bond, the manufacturer may provide a comparable security 601 agreement, such as an irrevocable letter of credit or a deposit 602 into a trust account or financial institution which includes the 603 State of Florida as a beneficiary, payable to the State of 604 Florida. The purposes of the bond or other security arrangement 605 for the program are to: 606 (I) Ensure payment of any administrative penalties imposed 607 by the Department of Business and Professional Regulation or any 608 other state agency under the contract when the manufacturer 609 fails to pay within 30 days after assessment; 610 (II) Ensure that if the manufacturer fails to meets its 611 obligations through use of a surety bond or other comparable 612 security arrangements to pay any other costs or fees incurred by 613 the Department of Business of Professional Regulation, the 614 state, or other entities acting on behalf of the state if the 615 manufacturer fails to meet its obligations. If the manufacturer 616 is assessed a penalty under the program and fails to pay within 617 30 days after that assessment, the Department of Business and 618 Professional Regulation, the state, or an entity acting on 619 behalf of the state may file a claim for reimbursement against 620 the bond or other comparable security arrangement; and 621 (III) Allow for claims to be made against the bond or other 622 comparable security arrangements for up to 1 year after the 623 manufacturer’s permit under the program has ended with this 624 section or the program has ended, whichever occurs last. 625 (b) The eligible manufacturer must submit evidence at the 626 time of application and throughout the permit term of a surety 627 bond or comparable security arrangement from this state or any 628 other state in the United States in an amount equal to 10 629 percent of the manufacturer’s annual sales or $1 million, 630 whichever is greater. The surety bond or comparable security 631 arrangement must include the State of Florida as a beneficiary. 632 In lieu of the surety bond, the manufacturer may provide a 633 comparable security arrangement such as an irrevocable letter of 634 credit or a deposit into a trust account or financial 635 institution which names the State of Florida as a beneficiary. 636 The purposes of the bond or other security arrangements for the 637 program are to: 638 1. Ensure participation of the manufacturer in any civil or 639 criminal legal action by the state, the Department of Business 640 of Professional Regulation, any other state agency, or private 641 individuals or entities against the manufacturer or because of 642 the manufacturer’s failure to perform according to the contract, 643 permit, or federal or state law and regulations, including, but 644 not limited to causes of actions for personal injury, 645 negligence, and wrongful death; 646 2. Ensure payment by the manufacturer through the use of a 647 bond or other comparable security arrangements of legal 648 judgements and claims that have been awarded to the Department 649 of Business and Professional Regulation, the state, other 650 entities acting on behalf of the state, individuals, or 651 organizations if the pharmacy is assessed a final judgement or 652 other monetary penalty in a court of law for a civil or criminal 653 action under the program. The bond or comparable security 654 arrangement will be accessed if the manufacturer fails to pay 655 any judgement or claim within 60 days after final judgement; and 656 3. Allow for civil and criminal litigation claims to be 657 made against the bond or other comparable security arrangements 658 for up to 1 year after the manufacturer’s permit under the 659 program has ended with the Department of Professional and 660 Business Regulation or the state, the manufacturer’s permit or 661 comparable legal document is no longer valid, or the program has 662 ended, whichever occurs last. 663 (s) International prescription drug wholesale distributor.— 664 1. A wholesale distributor located outside of the United 665 States must obtain an international prescription drug wholesale 666 distributor permit to engage in the wholesale exportation and 667 distribution of prescription drugs in the state under the 668 International Prescription Drug Importation Program established 669 in s. 499.0285. The wholesale distributor must be licensed or 670 permitted to operate in a country with which the United States 671 has a mutual recognition agreement, cooperation agreement, 672 memorandum of understanding, or other federal mechanism 673 recognizing the country’s adherence to current good 674 manufacturing practices for pharmaceutical products. The 675 wholesale distributor must maintain at all times a license or 676 permit to engage in the wholesale distribution of prescription 677 drugs in compliance with the laws of the jurisdiction in which 678 it operates. An international prescription drug wholesale 679 distributor permit may not be issued to a wholesale distributor 680 if the jurisdiction in which the wholesale distributor operates 681 does not require a license to engage in the wholesale 682 distribution of prescription drugs. 683 2. In order to participate in the International 684 Prescription Drug Importation Program established under s. 685 499.0285, the international wholesale distributor shall submit 686 evidence of a surety bond with any application or filing for a 687 permit under this section and shall maintain documentation of 688 evidence of such a bond with the Department of Business and 689 Professional Regulation throughout the permit term. The surety 690 bond may be from this state or any other state in the United 691 States in an amount equal to 10 percent of the international 692 wholesale distributor’s annual sales or $1 million, whichever is 693 greater. The surety bond or comparable security arrangement must 694 include the State of Florida as a beneficiary. In lieu of the 695 surety bond, the wholesale distributor may provide a comparable 696 security agreement, such as an irrevocable letter of credit or a 697 deposit into a trust account or financial institution which 698 names the State of Florida as a beneficiary. The purposes of the 699 bond or other security arrangement for the program are to: 700 a. Ensure payment of any administrative penalties imposed 701 by the Department of Business and Professional Regulation or any 702 other state agency under the contract when the wholesale 703 distributor fails to pay within 30 days after assessment; 704 b. Ensure that the wholesale distributor meets contractual 705 and statutory obligations through use of a surety bond or other 706 comparable security arrangements to pay any other costs or fees 707 incurred by the Department of Business of Professional 708 Regulation, the state, or other entities acting on behalf of the 709 state if the wholesale distributor fails to meet its 710 obligations. If the wholesale distributor is assessed a penalty 711 under the program and fails to pay within 30 days after that 712 assessment, the Department of Business and Professional 713 Regulation, the state, or an entity acting on behalf of the 714 state may file a claim for reimbursement against the bond or 715 other comparable security arrangement; and 716 c. Allow for claims to be made against the bond or other 717 comparable security arrangements for up to 1 year after the 718 wholesale distributor’s permit under the program has ended with 719 this section or the program has ended, whichever occurs last. 720 3. The eligible wholesale distributor must submit evidence 721 at the time of application and throughout the permit term of a 722 surety bond or comparable security arrangement from this state 723 or any other state in the United States in an amount equal to 10 724 percent of the international wholesale distributor’s annual 725 sales or $1 million, whichever is greater. The surety bond or 726 comparable security arrangement must include the State of 727 Florida as a beneficiary. In lieu of the surety bond, the 728 wholesale distributor may provide a comparable security 729 arrangement such as an irrevocable letter of credit or a deposit 730 into a trust account or financial institution which names the 731 State of Florida as a beneficiary. The purposes of the bond or 732 other security arrangements for the program are to: 733 a. Ensure participation of the wholesale distributor in any 734 civil or criminal legal action by the state, the Department of 735 Business of Professional Regulation, any other state agency, or 736 private individuals or entities against the wholesale 737 distributor or because of the wholesale distributor’s failure to 738 perform under the contract, including, but not limited to causes 739 of actions for personal injury, negligence, and wrongful death; 740 b. Ensure payment by the wholesale distributor through the 741 use of a bond or other comparable security arrangements of legal 742 judgements and claims that have been awarded to the Department 743 of Business and Professional Regulation, the state, other 744 entities acting on behalf of the state, individuals, or 745 organizations if the wholesale distributor is assessed a final 746 judgement or other monetary penalty in a court of law for a 747 civil or criminal action under the program. The bond or 748 comparable security arrangement will be accessed if the 749 wholesale distributor fails to pay any judgement or claim within 750 60 days after final judgement; and 751 c. Allow for civil and criminal litigation claims to be 752 made against the bond or other comparable security arrangements 753 for up to 1 year after the wholesale distributor’s permit under 754 the program has ended with the agency or the state, the 755 pharmacy’s permit or comparable legal document is no longer 756 valid, or the program has ended, whichever occurs last. 757 Section 7. Subsection (2), paragraph (a) of subsection (4), 758 subsections (8), (10), (11), and (14), and paragraphs (a), (b), 759 and (f) of subsection (15) of section 499.012, Florida Statutes, 760 are amended to read: 761 499.012 Permit application requirements.— 762 (2) Notwithstanding subsection (6), a permitted person in 763 good standing may change the type of permit issued to that 764 person by completing a new application for the requested permit, 765 paying the amount of the difference in the permit fees if the 766 fee for the new permit is more than the fee for the original 767 permit, and meeting the applicable permitting conditions for the 768 new permit type. The new permit expires on the expiration date 769 of the original permit being changed; however, a new permit for 770 a prescription drug wholesale distributor, an out-of-state 771 prescription drug wholesale distributor, an international 772 prescription drug wholesale distributor, or a retail pharmacy 773 drug wholesale distributor shall expire on the expiration date 774 of the original permit or 1 year after the date of issuance of 775 the new permit, whichever is earlier. A refund may not be issued 776 if the fee for the new permit is less than the fee that was paid 777 for the original permit. 778 (4)(a) Except for a permit for a prescription drug 779 wholesale distributor, an international prescription drug 780 wholesale distributor, or an out-of-state prescription drug 781 wholesale distributor, an application for a permit must include: 782 1. The name, full business address, and telephone number of 783 the applicant; 784 2. All trade or business names used by the applicant; 785 3. The address, telephone numbers, and the names of contact 786 persons for each facility used by the applicant for the storage, 787 handling, and distribution of prescription drugs; 788 4. The type of ownership or operation, such as a 789 partnership, corporation, or sole proprietorship; and 790 5. The names of the owner and the operator of the 791 establishment, including: 792 a. If an individual, the name of the individual; 793 b. If a partnership, the name of each partner and the name 794 of the partnership; 795 c. If a corporation, the name and title of each corporate 796 officer and director, the corporate names, and the name of the 797 state of incorporation; 798 d. If a sole proprietorship, the full name of the sole 799 proprietor and the name of the business entity; 800 e. If a limited liability company, the name of each member, 801 the name of each manager, the name of the limited liability 802 company, and the name of the state in which the limited 803 liability company was organized; and 804 f. Any other relevant information that the department 805 requires. 806 (8) An application for a permit or to renew a permit for a 807 prescription drug wholesale distributor, an international 808 prescription drug wholesale distributor, or an out-of-state 809 prescription drug wholesale distributor submitted to the 810 department must include: 811 (a) The name, full business address, and telephone number 812 of the applicant. 813 (b) All trade or business names used by the applicant. 814 (c) The address, telephone numbers, and the names of 815 contact persons for each facility used by the applicant for the 816 storage, handling, and distribution of prescription drugs. 817 (d) The type of ownership or operation, such as a 818 partnership, corporation, or sole proprietorship. 819 (e) The names of the owner and the operator of the 820 establishment, including: 821 1. If an individual, the name of the individual. 822 2. If a partnership, the name of each partner and the name 823 of the partnership. 824 3. If a corporation: 825 a. The name, address, and title of each corporate officer 826 and director. 827 b. The name and address of the corporation, resident agent 828 of the corporation, the resident agent’s address, and the 829 corporation’s state of incorporation. 830 c. The name and address of each shareholder of the 831 corporation that owns 5 percent or more of the outstanding stock 832 of the corporation. 833 4. If a sole proprietorship, the full name of the sole 834 proprietor and the name of the business entity. 835 5. If a limited liability company: 836 a. The name and address of each member. 837 b. The name and address of each manager. 838 c. The name and address of the limited liability company, 839 the resident agent of the limited liability company, and the 840 name of the state in which the limited liability company was 841 organized. 842 (f) If applicable, the name and address of each affiliate 843 of the applicant. 844 (g) The applicant’s gross annual receipts attributable to 845 prescription drug wholesale distribution activities for the 846 previous tax year. 847 (h) The tax year of the applicant. 848 (i) A copy of the deed for the property on which 849 applicant’s establishment is located, if the establishment is 850 owned by the applicant, or a copy of the applicant’s lease for 851 the property on which applicant’s establishment is located that 852 has an original term of not less than 1 calendar year, if the 853 establishment is not owned by the applicant. 854 (j) A list of all licenses and permits issued to the 855 applicant by any other state or jurisdiction which authorize the 856 applicant to purchase or possess prescription drugs. 857 (k) The name of the manager of the establishment that is 858 applying for the permit or to renew the permit, the next four 859 highest ranking employees responsible for prescription drug 860 wholesale operations for the establishment, and the name of all 861 affiliated parties for the establishment, together with the 862 personal information statement and fingerprints required 863 pursuant to subsection (9) for each of such persons. 864 (l) The name of each of the applicant’s designated 865 representatives as required by subsection (15), together with 866 the personal information statement and fingerprints required 867 pursuant to subsection (9) for each such person. 868 (m) Evidence of a surety bond in this state or any other 869 state in the United States in the amount of $100,000. If the 870 annual gross receipts of the applicant’s previous tax year are 871 $10 million or less, evidence of a surety bond in the amount of 872 $25,000. The specific language of the surety bond must include 873 the State of Florida as a beneficiary, payable to the 874 Professional Regulation Trust Fund. In lieu of the surety bond, 875 the applicant may provide other equivalent security such as an 876 irrevocable letter of credit, or a deposit in a trust account or 877 financial institution, which includes the State of Florida as a 878 beneficiary, payable to the Professional Regulation Trust Fund. 879 The purpose of the bond or other security is to secure payment 880 of any administrative penalties imposed by the department and 881 any fees and costs incurred by the department regarding that 882 permit which are authorized under state law and which the 883 permittee fails to pay 30 days after the fine or costs become 884 final. The department may make a claim against such bond or 885 security until 1 year after the permittee’s license ceases to be 886 valid or until 60 days after any administrative or legal 887 proceeding authorized in this part which involves the permittee 888 is concluded, including any appeal, whichever occurs later. 889 (n) For establishments used in wholesale distribution, 890 proof of an inspection conducted by the department, the United 891 States Food and Drug Administration, or another governmental 892 entity charged with the regulation of good manufacturing 893 practices related to wholesale distribution of prescription 894 drugs, within timeframes set forth by the department in 895 departmental rules, which demonstrates substantial compliance 896 with current good manufacturing practices applicable to 897 wholesale distribution of prescription drugs. The department may 898 recognize another state’s or jurisdiction’s inspection of a 899 wholesale distributor located in that state or jurisdiction if 900 such state’s or jurisdiction’s laws are deemed to be 901 substantially equivalent to the law of this state by the 902 department. The department may accept an inspection by a third 903 party accreditation or inspection service which meets the 904 criteria set forth in department rule. 905 (o) Any other relevant information that the department 906 requires. 907 (p) Documentation of the credentialing policies and 908 procedures required by s. 499.0121(15). 909 (q) For international prescription drug wholesale 910 distributors and nonresident prescription drug manufacturers to 911 participate in the International Prescription Drug Importation 912 Program established under s. 499.0285, documentation 913 demonstrating that the applicant is appropriately licensed or 914 permitted by a country with which the United States has a mutual 915 recognition agreement, cooperation agreement, memorandum of 916 understanding, or other mechanism recognizing the country’s 917 adherence to current good manufacturing practices for 918 pharmaceutical products. 919 (10) The department may deny an application for a permit or 920 refuse to renew a permit for a prescription drug wholesale 921 distributor, an international prescription drug wholesale 922 distributor, or an out-of-state prescription drug wholesale 923 distributor if: 924 (a) The applicant has not met the requirements for the 925 permit. 926 (b) The management, officers, or directors of the applicant 927 or any affiliated party are found by the department to be 928 incompetent or untrustworthy. 929 (c) The applicant is so lacking in experience in managing a 930 wholesale distributor as to make the issuance of the proposed 931 permit hazardous to the public health. 932 (d) The applicant is so lacking in experience in managing a 933 wholesale distributor as to jeopardize the reasonable promise of 934 successful operation of the wholesale distributor. 935 (e) The applicant is lacking in experience in the 936 distribution of prescription drugs. 937 (f) The applicant’s past experience in manufacturing or 938 distributing prescription drugs indicates that the applicant 939 poses a public health risk. 940 (g) The applicant is affiliated directly or indirectly 941 through ownership, control, or other business relations, with 942 any person or persons whose business operations are or have been 943 detrimental to the public health. 944 (h) The applicant, or any affiliated party, has been found 945 guilty of or has pleaded guilty or nolo contendere to any felony 946 or crime punishable by imprisonment for 1 year or more under the 947 laws of the United States, any state, or any other country, 948 regardless of whether adjudication of guilt was withheld. 949 (i) The applicant or any affiliated party has been charged 950 with a felony in a state or federal court and the disposition of 951 that charge is pending during the application review or renewal 952 review period. 953 (j) The applicant has furnished false or fraudulent 954 information or material in any application made in this state or 955 any other state in connection with obtaining a permit or license 956 to manufacture or distribute drugs, devices, or cosmetics. 957 (k) That a federal, state, or local government permit 958 currently or previously held by the applicant, or any affiliated 959 party, for the manufacture or distribution of any drugs, 960 devices, or cosmetics has been disciplined, suspended, or 961 revoked and has not been reinstated. 962 (l) The applicant does not possess the financial or 963 physical resources to operate in compliance with the permit 964 being sought, this chapter, and the rules adopted under this 965 chapter. 966 (m) The applicant or any affiliated party receives, 967 directly or indirectly, financial support and assistance from a 968 person who was an affiliated party of a permittee whose permit 969 was subject to discipline or was suspended or revoked, other 970 than through the ownership of stock in a publicly traded company 971 or a mutual fund. 972 (n) The applicant or any affiliated party receives, 973 directly or indirectly, financial support and assistance from a 974 person who has been found guilty of any violation of this part 975 or chapter 465, chapter 501, or chapter 893, any rules adopted 976 under this part or those chapters, any federal or state drug 977 law, or any felony where the underlying facts related to drugs, 978 regardless of whether the person has been pardoned, had her or 979 his civil rights restored, or had adjudication withheld, other 980 than through the ownership of stock in a publicly traded company 981 or a mutual fund. 982 (o) The applicant for renewal of a permit under s. 983 499.01(2)(e) or (f) has not actively engaged in the wholesale 984 distribution of prescription drugs, as demonstrated by the 985 regular and systematic distribution of prescription drugs 986 throughout the year as evidenced by not fewer than 12 wholesale 987 distributions in the previous year and not fewer than three 988 wholesale distributions in the previous 6 months. 989 (p) Information obtained in response to s. 499.01(2)(e) or 990 (f) demonstrates it would not be in the best interest of the 991 public health, safety, and welfare to issue a permit. 992 (q) The applicant does not possess the financial standing 993 and business experience for the successful operation of the 994 applicant. 995 (r) The applicant or any affiliated party has failed to 996 comply with the requirements for manufacturing or distributing 997 prescription drugs under this part, similar federal laws, 998 similar laws in other states, or the rules adopted under such 999 laws. 1000 (11) Upon approval of the application by the department and 1001 payment of the required fee, the department shall issue or renew 1002 a prescription drug wholesale distributor, an international 1003 prescription drug wholesale distributor, or an out-of-state 1004 prescription drug wholesale distributor permit to the applicant. 1005 (14) The name of a permittee or establishment on a 1006 prescription drug wholesale distributor permit, an international 1007 prescription drug wholesale distributor permit, or an out-of 1008 state prescription drug wholesale distributor permit may not 1009 include any indicia of attainment of any educational degree, any 1010 indicia that the permittee or establishment possesses a 1011 professional license, or any name or abbreviation that the 1012 department determines is likely to cause confusion or mistake or 1013 that the department determines is deceptive, including that of 1014 any other entity authorized to purchase prescription drugs. 1015 (15)(a) Each establishment that is issued an initial or 1016 renewal permit as a prescription drug wholesale distributor, an 1017 international prescription drug wholesale distributor, or an 1018 out-of-state prescription drug wholesale distributor must 1019 designate in writing to the department at least one natural 1020 person to serve as the designated representative of the 1021 wholesale distributor. Such person must have an active 1022 certification as a designated representative from the 1023 department. 1024 (b) To be certified as a designated representative, a 1025 natural person must: 1026 1. Submit an application on a form furnished by the 1027 department and pay the appropriate fees. 1028 2. Be at least 18 years of age. 1029 3. Have at least 2 years of verifiable full-time: 1030 a. Work experience in a pharmacy licensed in this state or 1031 another state or jurisdiction, where the person’s 1032 responsibilities included, but were not limited to, 1033 recordkeeping for prescription drugs; 1034 b. Managerial experience with a prescription drug wholesale 1035 distributor licensed in this state or in another state or 1036 jurisdiction; or 1037 c. Managerial experience with the United States Armed 1038 Forces, where the person’s responsibilities included, but were 1039 not limited to, recordkeeping, warehousing, distributing, or 1040 other logistics services pertaining to prescription drugs. 1041 4. Receive a passing score of at least 75 percent on an 1042 examination given by the department regarding federal laws 1043 governing distribution of prescription drugs and this part and 1044 the rules adopted by the department governing the wholesale 1045 distribution of prescription drugs. This requirement shall be 1046 effective 1 year after the results of the initial examination 1047 are mailed to the persons that took the examination. The 1048 department shall offer such examinations at least four times 1049 each calendar year. 1050 5. Provide the department with a personal information 1051 statement and fingerprints pursuant to subsection (9). 1052 (f) A wholesale distributor may not operate under a 1053 prescription drug wholesale distributor permit, an international 1054 prescription drug wholesale distributor permit, or an out-of 1055 state prescription drug wholesale distributor permit for more 1056 than 10 business days after the designated representative leaves 1057 the employ of the wholesale distributor, unless the wholesale 1058 distributor employs another designated representative and 1059 notifies the department within 10 business days of the identity 1060 of the new designated representative. 1061 Section 8. Subsection (1) of section 499.015, Florida 1062 Statutes, is amended to read: 1063 499.015 Registration of drugs and devices; issuance of 1064 certificates of free sale.— 1065 (1)(a) Except for those persons exempted from the 1066 definition of manufacturer in s. 499.003, any person who 1067 manufactures, packages, repackages, labels, or relabels a drug 1068 or device in this state must register such drug or device 1069 biennially with the department; pay a fee in accordance with the 1070 fee schedule provided by s. 499.041; and comply with this 1071 section. The registrant must list each separate and distinct 1072 drug or device at the time of registration. 1073 (b) The department may not register any product that does 1074 not comply with the Federal Food, Drug, and Cosmetic Act, as 1075 amended, or Title 21 C.F.R. Registration of a product by the 1076 department does not mean that the product does in fact comply 1077 with all provisions of the Federal Food, Drug, and Cosmetic Act, 1078 as amended. 1079 (c) Registration under this section is not required for 1080 prescription drugs imported under the International Prescription 1081 Drug Importation Program established in s. 499.0285. 1082 Section 9. Subsections (1) and (3) of section 499.065, 1083 Florida Statutes, are amended to read: 1084 499.065 Inspections; imminent danger.— 1085 (1) Notwithstanding s. 499.051, the department shall 1086 inspect each prescription drug wholesale distributor 1087 establishment, international prescription drug wholesale 1088 distributor establishment, prescription drug repackager 1089 establishment, veterinary prescription drug wholesale 1090 distributor establishment, limited prescription drug veterinary 1091 wholesale distributor establishment, and retail pharmacy drug 1092 wholesale distributor establishment that is required to be 1093 permitted under this part as often as necessary to ensure 1094 compliance with applicable laws and rules. The department shall 1095 have the right of entry and access to these facilities at any 1096 reasonable time. 1097 (3) The department may determine that a prescription drug 1098 wholesale distributor establishment, international prescription 1099 drug wholesale distributor establishment, prescription drug 1100 repackager establishment, veterinary prescription drug wholesale 1101 distributor establishment, limited prescription drug veterinary 1102 wholesale distributor establishment, or retail pharmacy drug 1103 wholesale distributor establishment that is required to be 1104 permitted under this part is an imminent danger to the public 1105 health and shall require its immediate closure if the 1106 establishment fails to comply with applicable laws and rules 1107 and, because of the failure, presents an imminent threat to the 1108 public’s health, safety, or welfare. Any establishment so deemed 1109 and closed shall remain closed until allowed by the department 1110 or by judicial order to reopen. 1111 Section 10. Section 499.0285, Florida Statutes, is created 1112 to read: 1113 499.0285 International Prescription Drug Importation 1114 Program.— 1115 (1) PROGRAM ESTABLISHED.—The department shall establish a 1116 program for the importation of safe and effective prescription 1117 drugs from foreign nations with which the United States has 1118 current mutual recognition agreements, cooperation agreements, 1119 memoranda of understanding, or other federal mechanisms 1120 recognizing their adherence to current good manufacturing 1121 practices for pharmaceutical products. The program shall be open 1122 to individual Florida residents and to those participating in 1123 the Canadian Drug Importation Program under s. 381.02035. 1124 (2) DEFINITIONS.—As used in this section, the term: 1125 (a) “Exporter” means an international prescription drug 1126 wholesale distributor, a nonresident prescription drug 1127 manufacturer registered to participate in the program, or an 1128 international export pharmacy that exports prescription drugs 1129 into the state under the program. 1130 (b) “Federal Act” means the Federal Food, Drug, and 1131 Cosmetic Act, 21 U.S.C. ss. 301 et seq.; 52 Stat. 1040 et seq. 1132 as amended by the Drug Quality and Security Act, 21 U.S.C. 351 1133 et seq. 1134 (c) “Foreign recipient” means an entity other than the 1135 original prescription drug manufacturer which receives the 1136 prescription drug before its importation into the state under 1137 the program. 1138 (d) “Good manufacturing practice” refers to the good 1139 manufacturing practice regulations in 21 C.F.R. parts 210 and 1140 211. 1141 (e) “Importer” means a wholesale distributor, pharmacy, or 1142 pharmacist importing prescription drugs into the state under the 1143 program. 1144 (f) “International export pharmacy” means a pharmacy 1145 located outside of the United States which holds an active and 1146 unencumbered permit under chapter 465 to export prescription 1147 drugs into the state under the program. 1148 (g) “International prescription drug wholesale distributor” 1149 means a prescription drug wholesale distributor located outside 1150 of the United States which holds an active and unencumbered 1151 permit under this part to export and distribute prescription 1152 drugs into the state under the program. 1153 (h) “Nonresident prescription drug manufacturer” means an 1154 entity located outside of the United States which holds an 1155 active and unencumbered permit under this part to manufacture 1156 prescription drugs and has registered with the department to 1157 export and distribute such prescription drugs into the state 1158 under the program. 1159 (i) “Pharmacist” means a person who holds an active and 1160 unencumbered license to practice pharmacy under chapter 465. 1161 (j) “Pharmacy” means an entity that holds an active and 1162 unencumbered permit under chapter 465. 1163 (k) “Prescription drug” has the same meaning as defined in 1164 this part, but is limited to drugs intended for human use. 1165 (l) “Program” means the International Prescription Drug 1166 Importation Program established under this section. 1167 (m) “Qualified laboratory” means a laboratory that has been 1168 approved by the department for the purposes of this section. 1169 (3) ELIGIBLE PRESCRIPTION DRUGS.—An eligible importer may 1170 import a prescription drug from an eligible exporter if: 1171 (a) The drug meets the United States Food and Drug 1172 Administration’s standards related to safety, effectiveness, 1173 misbranding, and adulteration; 1174 (b) Importing the drug would not violate the patent laws of 1175 the United States; and 1176 (c) The drug is not: 1177 1. A controlled substance as defined in 21 U.S.C. s. 802; 1178 2. A biological product as defined in 42 U.S.C. s. 262; 1179 3. An infused drug; 1180 4. An intravenously injected drug; 1181 5. A drug that is inhaled during surgery; or 1182 6. A drug that is a parenteral drug, the importation of 1183 which is determined by the United States Secretary of Health and 1184 Human Services to pose a threat to the public health. 1185 (4) EXPORTERS.— 1186 (a) The following entities may export prescription drugs 1187 into the state under the program: 1188 1. An international prescription drug wholesale 1189 distributor. 1190 2. A nonresident prescription drug manufacturer. 1191 3. An international export pharmacy. 1192 (b) An eligible exporter must register with the department 1193 before exporting prescription drugs into the state under the 1194 program. 1195 (c) An exporter may not distribute, sell, or dispense 1196 prescription drugs imported under the program to any person 1197 residing outside of the state. 1198 (5) IMPORTERS.— 1199 (a) The following entities may import prescription drugs 1200 under the program: 1201 1. A wholesale distributor. 1202 2. A pharmacy. 1203 3. A pharmacist. 1204 (b) An eligible importer must register with the department 1205 before importing prescription drugs into the state under the 1206 program. 1207 (c) An importer may not distribute, sell, or dispense 1208 prescription drugs imported under the program to any person 1209 residing outside of the state. 1210 (6) PRESCRIPTION DRUG SUPPLY CHAIN DOCUMENTATION.— 1211 (a) A participating importer must submit the following 1212 information and documentation to the department: 1213 1. The name and quantity of the active ingredient of the 1214 prescription drug. 1215 2. A description of the dosage form of the prescription 1216 drug. 1217 3. The date on which the prescription drug is shipped. 1218 4. The quantity of the prescription drug that is shipped. 1219 5. The point of origin and destination of the prescription 1220 drug. 1221 6. The price paid by the importer for the prescription 1222 drug. 1223 7. Documentation from the exporter specifying: 1224 a. The original source of the prescription drug; and 1225 b. The quantity of each lot of the prescription drug 1226 originally received by the seller from that source. 1227 8. The lot or control number assigned to the prescription 1228 drug by the manufacturer. 1229 9. The name, address, telephone number, and professional 1230 license or permit number of the importer. 1231 10. In the case of a prescription drug that is shipped 1232 directly by the first foreign recipient from the manufacturer: 1233 a. Documentation demonstrating that the prescription drug 1234 was received by the recipient from the manufacturer and 1235 subsequently shipped by the first foreign recipient to the 1236 importer. 1237 b. Documentation of the quantity of each lot of the 1238 prescription drug received by the first foreign recipient 1239 demonstrating that the quantity being imported into the state is 1240 not more than the quantity that was received by the first 1241 foreign recipient. 1242 c. For an initial imported shipment, documentation 1243 demonstrating that each batch of the prescription drug in the 1244 shipment was statistically sampled and tested for authenticity 1245 and degradation. 1246 11. In the case of a prescription drug that is not shipped 1247 directly from the first foreign recipient, documentation 1248 demonstrating that each batch in each shipment offered for 1249 importation into the state was statistically sampled and tested 1250 for authenticity and degradation. 1251 12. For an initial imported shipment, the agency shall 1252 ensure that each batch of the drug in the shipment is 1253 statistically sampled and tested for authenticity and 1254 degradation in a manner consistent with the federal act. The 1255 agency may contract with a vendor for these functions. 1256 13. For any subsequent imported shipment, the department 1257 shall ensure that a statistically valid sample of the shipment 1258 was tested for authenticity and degradation in a manner 1259 consistent with the federal act. 1260 14. Certify that the drug: 1261 a. Is approved for marketing in the United States and is 1262 not adulterated or misbranded; and 1263 b. Meets all of the labeling requirements under 21 U.S.C. 1264 s. 352. 1265 15. Maintain qualified laboratory records, including 1266 complete data derived from all tests necessary to ensure that 1267 the drug is in compliance with the requirements of this section. 1268 16. Maintain documentation demonstrating that the testing 1269 required by this section was conducted at a qualified laboratory 1270 in accordance with the federal act and any other applicable 1271 federal and state laws and regulations governing laboratory 1272 qualifications. 1273 (b) All testing required by this section must be conducted 1274 in a qualified laboratory that meets the standards under the 1275 federal act and any other applicable federal and state laws and 1276 regulations governing laboratory qualifications for drug 1277 testing. 1278 (c) The vendor shall maintain information and documentation 1279 submitted under this section for a period of at least 7 years. 1280 (d) A participating importer must submit the all of 1281 following information to the department: 1282 1. The name and quantity of the active ingredient of the 1283 drug. 1284 2. A description of the dosage form of the drug. 1285 3. The date on which the drug is received. 1286 4. The quantity of the drug that is received. 1287 5. The point of origin and destination of the drug. 1288 6. The price paid by the importer for the drug. 1289 (e) A participating International Importation Drug supplier 1290 must submit the following information and documentation to the 1291 agency or the agency’s designated vendor specifying all of the 1292 following: 1293 1. The original source of the drug, including: 1294 a. The name of the manufacturer of the drug. 1295 b. The date on which the drug was manufactured. 1296 c. The location (country, state or province, and city) 1297 where the drug was manufactured. 1298 2. The date on which the drug is shipped. 1299 3. The quantity of the drug that is shipped. 1300 4. The quantity of each lot of the drug originally received 1301 and from which source. 1302 5. The lot or control number and the batch number assigned 1303 to the drug by the manufacturer. 1304 6. The name, address, and telephone number, and 1305 professional license or permit number of the importer. 1306 (f) The department may require any other information 1307 necessary to ensure the protection of the public health. 1308 (7) IMMEDIATE SUSPENSION.—The department shall immediately 1309 suspend the importation of a specific prescription drug or the 1310 importation of prescription drugs by a specific importer if it 1311 discovers that any prescription drug or activity is in violation 1312 of this section. The department may revoke the suspension if, 1313 after conducting an investigation, it determines that the public 1314 is adequately protected from counterfeit or unsafe prescription 1315 drugs being imported into the state. 1316 (8) RULEMAKING AUTHORITY.—The department shall adopt rules 1317 necessary to implement this section. 1318 Section 11. Notwithstanding the Federal Food, Drug, and 1319 Cosmetic Act, the Department of Business and Professional 1320 Regulation, in collaboration with the Department of Health, 1321 shall negotiate a federal arrangement to operate a pilot program 1322 for importing prescription drugs into the state. The proposal to 1323 operate such a pilot program shall demonstrate that the program 1324 sets safety standards consistent with the current federal 1325 requirements for the manufacturing and distribution of 1326 prescription drugs; limits the importation of prescription drugs 1327 under the program to entities licensed or permitted by the state 1328 to manufacture, distribute, or dispense prescription drugs; and 1329 includes inspection and enforcement authority. Implementation of 1330 sections 2 through 11 of this act is contingent upon authority 1331 granted under federal law or rule. The department shall notify 1332 the President of the Senate, the Speaker of the House of 1333 Representatives, and the relevant committees of the Senate and 1334 the House of Representatives prior to implementation of the 1335 pilot program. The department shall submit to all parties a 1336 proposal for program implementation and program funding. 1337 Section 12. This act shall take effect July 1, 2019. 1338 1339 ================= T I T L E A M E N D M E N T ================ 1340 And the title is amended as follows: 1341 Delete everything before the enacting clause 1342 and insert: 1343 A bill to be entitled 1344 An act relating to drug importation programs; creating 1345 s. 381.02035, F.S.; requiring the Agency for Health 1346 Care Administration to establish the Canadian 1347 Prescription Drug Importation Program; defining terms; 1348 requiring the agency to contract with a vendor to 1349 facilitate wholesale prescription drug importation 1350 under the program; providing responsibilities for the 1351 vendor; providing eligibility criteria for 1352 prescription drugs, Canadian suppliers, and importers 1353 under the program; authorizing a Canadian supplier to 1354 export drugs into this state under the program under 1355 certain circumstances; providing eligibility criteria 1356 and requirements for drug importers; requiring 1357 participating Canadian suppliers and importers to 1358 comply with specified federal requirements for 1359 distributing prescription drugs imported under the 1360 program; prohibiting Canadian suppliers and importers 1361 from distributing, dispensing, or selling prescription 1362 drugs imported under the program outside of this 1363 state; requiring the agency to request federal 1364 approval of the program; requiring the request to 1365 include certain information; requiring the agency to 1366 begin operating the program within a specified 1367 timeframe after receiving federal approval; providing 1368 certain documentation requirements; requiring the 1369 agency to suspend the importation of drugs in 1370 violation of this section or any federal or state law 1371 or regulation; authorizing the agency to revoke the 1372 suspension under certain circumstances; requiring the 1373 agency to submit an annual report to the Governor and 1374 the Legislature by a specified date; providing 1375 requirements for such report; requiring the agency to 1376 notify the Legislature upon federal approval of the 1377 program and to submit a proposal to the Legislature 1378 for program implementation and funding before a 1379 certain date; requiring the agency to adopt rules; 1380 creating s. 465.0157, F.S.; establishing an 1381 international export pharmacy permit for participation 1382 in the International Prescription Drug Importation 1383 Program; providing requirements for permit application 1384 and renewal; amending s. 465.017, F.S.; authorizing 1385 the Department of Health to inspect international 1386 export pharmacy permittees; amending s. 499.005, F.S.; 1387 providing that the importation of a prescription drug 1388 under the International Prescription Drug Importation 1389 Program is an exception from a prohibited act; 1390 amending s. 499.0051, F.S.; providing that the 1391 importation of a prescription drug for wholesale 1392 distribution under the International Prescription Drug 1393 Importation Program is an exception from criminal 1394 offenses; amending s. 499.01, F.S.; requiring an 1395 international prescription drug wholesale distributor 1396 to be permitted before operating; requiring 1397 nonresident prescription drug manufacturers to 1398 register with the Department of Business and 1399 Professional Regulation to participate in the program; 1400 providing an exception; establishing an international 1401 prescription drug wholesale distributor drug permit; 1402 providing permit requirements; amending s. 499.012, 1403 F.S.; providing application requirements for 1404 international prescription drug wholesale distributors 1405 and nonresident prescription drug manufacturers to 1406 participate in the program; amending s. 499.015, F.S.; 1407 establishing that prescription drugs imported under 1408 the International Prescription Drug Importation 1409 Program are not required to be registered under a 1410 specified provision; amending s. 499.065, F.S.; 1411 requiring the department to inspect international 1412 prescription drug wholesale distributor 1413 establishments; authorizing the department to 1414 determine that an international prescription drug 1415 wholesale distributor establishment is an imminent 1416 danger to the public and require its immediate closure 1417 under certain conditions; creating s. 499.0285, F.S.; 1418 requiring the Department of Business and Professional 1419 Regulation to establish the International Prescription 1420 Drug Importation Program for a specified purpose; 1421 providing definition; providing eligibility criteria 1422 for prescription drugs, exporters, and importers under 1423 the program; requiring participating importers to 1424 submit certain documentation to the department for 1425 prescription drugs imported under the program; 1426 requiring the department to immediately suspend the 1427 importation of specific prescription drug or 1428 importation by a specific importer if a violation has 1429 occurred under the program; authorizing the department 1430 to revoke such suspension under certain suspension 1431 under certain circumstances; requiring the department 1432 to adopt rules; requiring the agency, in collaboration 1433 with the Department of Business and Professional 1434 Regulation and the Department of Health, to negotiate 1435 a federal arrangement to operate a pilot program for 1436 importing prescription drugs into the state; providing 1437 that implementation of the act is contingent upon the 1438 authority of federal law or regulation; providing an 1439 effective date.