Florida Senate - 2019 SB 104 By Senator Book 32-00169-19 2019104__ 1 A bill to be entitled 2 An act relating to the Prescription Drug Donation 3 Repository Program; creating s. 465.1902, F.S.; 4 providing a short title; defining terms; creating the 5 Prescription Drug Donation Repository Program within 6 the Department of Health; specifying the purpose of 7 the program; authorizing the department to contract 8 with a third-party vendor to administer the program; 9 specifying entities that are eligible donors; 10 providing criteria and procedures for eligible 11 donations; prohibiting donations to specific patients; 12 providing that certain prescription drugs eligible for 13 return to stock must be credited to Medicaid and may 14 not be donated under the program; prohibiting the 15 donation of certain drugs pursuant to federal 16 restrictions; clarifying that a repository is not 17 required to accept donations of prescription drugs or 18 supplies; providing inspection, inventory, and storage 19 requirements for centralized and local repositories; 20 requiring inspection of donated prescription drugs and 21 supplies by a licensed pharmacist; requiring a local 22 repository to notify the centralized repository within 23 a specified timeframe after receiving a donation of 24 prescription drugs or supplies; authorizing the 25 centralized repository to redistribute prescription 26 drugs or supplies; authorizing a local repository to 27 transfer prescription drugs or supplies to another 28 local repository with authorization from the 29 centralized repository; requiring a local repository 30 to notify the department of its intent to participate 31 in the program; providing notification requirements; 32 providing a procedure for a local repository to 33 withdraw from participation in the program; requiring 34 the department to adopt rules regarding the 35 disposition of prescription drugs and supplies of a 36 withdrawing local repository; specifying conditions 37 for dispensing donated prescription drugs and supplies 38 to eligible patients; providing intake collection form 39 requirements; requiring a local repository to issue an 40 eligible patient who completes an intake collection 41 form a program identification card; prohibiting the 42 sale of donated prescription drugs and supplies under 43 the program; authorizing a repository to charge the 44 patient a nominal handling fee for the preparation and 45 dispensing of prescription drugs or supplies under the 46 program; requiring repositories to establish a 47 protocol for notifying recipients of a prescription 48 drug recall; providing for destruction of donated 49 prescription drugs under certain circumstances; 50 providing recordkeeping requirements; requiring the 51 centralized repository to submit an annual report to 52 the department; requiring the department or contractor 53 to establish, maintain, and publish a registry of 54 participating local repositories and available donated 55 prescription drugs and supplies; requiring the 56 department to publish certain information and forms on 57 its website; providing immunity from civil and 58 criminal liability and from professional disciplinary 59 action for participants under certain circumstances; 60 providing immunity to pharmaceutical manufacturers, 61 under certain circumstances, from any claim or injury 62 arising from the donation of any prescription drug or 63 supply under the program; requiring dispensers to 64 provide certain notice to patients; authorizing the 65 department to establish a direct-support organization 66 to provide assistance, funding, and promotional 67 support for program activities; providing 68 organizational requirements for a direct-support 69 organization; specifying direct-support organization 70 purposes and objectives; prohibiting the direct 71 support organization from lobbying; specifying that 72 the direct-support organization is not a lobbying 73 firm; prohibiting the direct-support organization from 74 possessing prescription drugs on behalf of the 75 program; providing limitations on expenditures of such 76 direct-support organizations; specifying that the 77 direct-support organization must operate under 78 contract with the department; specifying required 79 contract terms; providing for the direct-support 80 organization board of directors; specifying the 81 board’s membership requirements; specifying 82 requirements and requiring the department to adopt 83 rules relating to a direct-support organization’s use 84 of department property; specifying requirements for 85 the deposit and use of funds by the direct-support 86 organization; providing for annual audits of a direct 87 support organization; providing for future legislative 88 review and repeal of provisions relating to the 89 direct-support organization; requiring the department 90 to adopt rules; amending s. 252.36, F.S.; authorizing 91 the Governor to waive program patient eligibility 92 requirements during a declared state of emergency; 93 providing an effective date. 94 95 Be It Enacted by the Legislature of the State of Florida: 96 97 Section 1. Section 465.1902, Florida Statutes, is created 98 to read: 99 465.1902 Prescription Drug Donation Repository Program.— 100 (1) SHORT TITLE.—This section may be cited as the 101 “Prescription Drug Donation Repository Program Act.” 102 (2) DEFINITIONS.—As used in this section, the term: 103 (a) “Centralized repository” means a distributor permitted 104 under chapter 499 who is approved by the department or the 105 contractor to accept, inspect, inventory, and distribute donated 106 drugs and supplies under this section. 107 (b) “Closed drug delivery system” means a system in which 108 the actual control of the unit-dose medication package is 109 maintained by the facility, rather than by the individual 110 patient. 111 (c) “Contractor” means the third-party vendor approved by 112 the department to implement and administer the program as 113 authorized in subsection (4). 114 (d) “Controlled substance” means any substance listed under 115 Schedule II, Schedule III, Schedule IV, or Schedule V of s. 116 893.03. 117 (e) “Direct-support organization” means the entity created 118 under subsection (15). 119 (f) “Dispenser” means a health care practitioner who, 120 within the scope of his or her practice act, is authorized to 121 dispense medicinal drugs and who does so under this act. 122 (g) “Donor” means an entity specified in subsection (5). 123 (h) “Eligible patient” means a Florida resident who is 124 indigent, uninsured, or underinsured and who has a valid 125 prescription for a prescription drug or supply that may be 126 dispensed under the program. 127 (i) “Free clinic” means a clinic that delivers only medical 128 diagnostic services or nonsurgical medical treatment free of 129 charge to low-income recipients. 130 (j) “Health care practitioner” or “practitioner” means a 131 practitioner licensed under this chapter, chapter 458, chapter 132 459, chapter 461, chapter 463, chapter 464, or chapter 466. 133 (k) “Indigent” means an individual whose family income for 134 the 12 months preceding the determination of income is below 200 135 percent of the federal poverty level as defined by the most 136 recently revised poverty income guidelines published by the 137 United States Department of Health and Human Services. 138 (l) “Local repository” means a health care practitioner’s 139 office, a pharmacy, a hospital with a closed drug delivery 140 system, a nursing home facility with a closed drug delivery 141 system, or a free clinic or nonprofit health clinic that is 142 licensed or permitted to dispense medicinal drugs in the state. 143 (m) “Nonprofit health clinic” means a nonprofit legal 144 entity that provides medical care to patients who are indigent, 145 uninsured, or underinsured. The term includes, but is not 146 limited to, a federally qualified health center as defined in 42 147 U.S.C. s. 1396d(l)(2)(B) and a rural health clinic as defined in 148 42 U.S.C. s. 1396d(l)(1). 149 (n) “Nursing home facility” has the same meaning as in s. 150 400.021. 151 (o) “Prescriber” means a health care practitioner who, 152 within the scope of his or her practice act, is authorized to 153 prescribe medicinal drugs. 154 (p) “Prescription drug” has the same meaning as the term 155 “medicinal drugs” or “drugs,” as those terms are defined in s. 156 465.003(8), but does not include controlled substances or cancer 157 drugs donated under s. 499.029. 158 (q) “Program” means the Prescription Drug Donation 159 Repository Program created by this section. 160 (r) “Supplies” means any supply used in the administration 161 of a prescription drug. 162 (s) “Tamper-evident packaging” means a package that has one 163 or more indicators or barriers to entry which, if breached or 164 missing, can reasonably be expected to provide visible evidence 165 to consumers that tampering has occurred. 166 (t) “Underinsured” means a person who has third-party 167 insurance or is eligible to receive prescription drugs or 168 supplies through the Medicaid program or any other prescription 169 drug program funded in whole or in part by the Federal 170 Government, but who has exhausted these benefits or does not 171 have prescription drug coverage for the drug prescribed. 172 (u) “Uninsured” means a person who has no third-party 173 insurance and is not eligible to receive prescription drugs or 174 supplies through the Medicaid program or any other prescription 175 drug program funded in whole or in part by the Federal 176 Government. 177 (3) PRESCRIPTION DRUG DONATION REPOSITORY PROGRAM; 178 CREATION; PURPOSE.—The Prescription Drug Donation Repository 179 Program is created within the department for the purpose of 180 authorizing and facilitating the donation of prescription drugs 181 and supplies to eligible patients. 182 (4) PROGRAM IMPLEMENTATION; ADMINISTRATION.—The department 183 may contract with a third-party vendor to administer the 184 program. 185 (5) DONOR ELIGIBILITY.—The centralized repository or a 186 local repository may accept a donation of a prescription drug or 187 supply only from: 188 (a) Nursing home facilities with closed drug delivery 189 systems. 190 (b) Hospices that have maintained control of a patient’s 191 prescription drugs. 192 (c) Hospitals with closed drug delivery systems. 193 (d) Pharmacies. 194 (e) Drug manufacturers or wholesale distributors. 195 (f) Medical device manufacturers or suppliers. 196 (g) Prescribers who receive prescription drugs or supplies 197 directly from a drug manufacturer, wholesale distributor, or 198 pharmacy. 199 (6) PRESCRIPTION DRUGS AND SUPPLIES ELIGIBLE FOR DONATION; 200 DONATION REQUIREMENTS; PROHIBITED DONATIONS.— 201 (a) Only prescription drugs and supplies that have been 202 approved for medical use in the United States and that meet the 203 criteria for donation established by this section may be 204 accepted for donation under the program. Donations must be made 205 on the premises of the centralized repository or a local 206 repository to a person designated by the repository. A drop box 207 may not be used to accept donations. 208 (b) The centralized repository or a local repository may 209 accept a prescription drug only if: 210 1. The drug is in its original sealed and tamper-evident 211 packaging. Single-unit-dose drugs may be accepted if the single 212 unit-dose packaging is unopened. 213 2. The drug requires storage at normal room temperature per 214 the manufacturer or the United States Pharmacopeia. 215 3. The drug has been stored according to manufacturer or 216 United States Pharmacopeia storage requirements. 217 4. The drug does not have any physical signs of tampering 218 or adulteration and there is no reason to believe that the drug 219 is adulterated. 220 5. The packaging does not have any physical signs of 221 tampering, misbranding, deterioration, compromised integrity, or 222 adulteration. 223 6. The packaging indicates the lot number and expiration 224 date of the drug. If the lot number is not retrievable, all 225 specified medications must be destroyed in the event of a 226 recall. 227 7. The drug has an expiration date that is more than 3 228 months after the date that the drug was donated. 229 (c) The centralized repository or a local repository may 230 accept supplies only if they are in their original, unopened, 231 sealed packaging and have not been tampered with or misbranded. 232 (d) Prescription drugs or supplies may not be donated to a 233 specific patient. 234 (e) Prescription drugs billed to and paid for by Medicaid 235 in long-term care facilities which are eligible for return to 236 stock under federal Medicaid regulations must be credited to 237 Medicaid and may not be donated under the program. 238 (f) Prescription drugs with an approved Federal Food and 239 Drug Administration Risk Evaluation and Mitigation Strategy that 240 includes Elements to Assure Safe Use are not eligible for 241 donation under the program. 242 (g) This section does not require the centralized 243 repository or a local repository to accept a donation of 244 prescription drugs or supplies. 245 (7) INSPECTION AND STORAGE.— 246 (a) A licensed pharmacist employed by or under contract 247 with the centralized repository or a local repository shall 248 inspect donated prescription drugs and supplies to determine 249 whether they meet the requirements of subsections (5) and (6). 250 (b) The inspecting pharmacist must sign an inspection 251 record on a form prescribed by the department by rule which 252 verifies that the prescription drugs and supplies meet the 253 criteria of subsections (5) and (6) and must attach the record 254 to the inventory required by paragraph (d). A local repository 255 that receives drugs and supplies from the centralized repository 256 is not required to reinspect them. 257 (c) The centralized repository and local repositories shall 258 store donated prescription drugs and supplies in a secure 259 storage area under the environmental conditions specified by the 260 manufacturer or the United States Pharmacopeia for the 261 respective prescription drugs or supplies. Donated prescription 262 drugs and supplies may not be stored with other inventory. A 263 local repository shall quarantine donated prescription drugs or 264 supplies until they are inspected and approved for dispensing 265 under this section. 266 (d) The centralized repository and local repositories shall 267 maintain an inventory of all donated prescription drugs or 268 supplies. Such inventory at local repositories shall be recorded 269 on a form prescribed by the department by rule. 270 (e) A local repository shall notify the centralized 271 repository within 5 days after receipt of any donation of 272 prescription drugs or supplies to the program. The notification 273 must be on a form prescribed by the department by rule. 274 (f) The centralized repository may redistribute 275 prescription drugs and supplies by transferring them to or from 276 the centralized repository and a local repository, as needed. A 277 local repository that receives donated prescription drugs or 278 supplies may, with authorization from the centralized 279 repository, distribute the prescription drugs or supplies to 280 another local repository. 281 (8) PROGRAM PARTICIPATION.— 282 (a) A practitioner, pharmacy, facility, or clinic must 283 notify the department of its intent to participate in the 284 program as a local repository before accepting or dispensing any 285 prescription drugs or supplies pursuant to this section. The 286 notification must be made on a form prescribed by the department 287 by rule and must, at a minimum, include: 288 1. The name, street address, website, and telephone number 289 of the intended local repository and any license or registration 290 number issued by the state to the intended local repository, 291 including the name of the issuing agency. 292 2. The name and telephone number of the pharmacist employed 293 by or under contract with the intended local repository who is 294 responsible for the inspection of donated prescription drugs and 295 supplies. 296 3. A signed and dated statement by the responsible 297 pharmacist affirming that the intended local repository meets 298 the eligibility requirements of this section. 299 (b) A local repository may withdraw from participation in 300 the program at any time by providing written notice to the 301 department or contractor, as appropriate, on a form prescribed 302 by the department by rule. The department shall adopt rules 303 addressing the disposition of prescription drugs and supplies in 304 the possession of the withdrawing local repository. 305 (9) DISPENSING REQUIREMENTS; PROHIBITIONS.— 306 (a) Each eligible patient without a program identification 307 card must submit an intake collection form to a local repository 308 before receiving prescription drugs or supplies under the 309 program. The department shall prescribe a form by rule, which 310 must include at least all of the following: 311 1. The name, street address, and telephone number of the 312 eligible patient. 313 2. The basis for eligibility, which must specify that the 314 patient is indigent, uninsured, or underinsured. 315 3. A statement signed and dated by the eligible patient 316 affirming that he or she meets the eligibility requirements of 317 this section. 318 (b) Upon receipt of a completed and signed intake 319 collection form, the local repository shall issue him or her a 320 program identification card, which is valid for 1 year after its 321 date of issuance. The card must be in a form prescribed by the 322 department by rule. 323 (c) The local repository shall send a summary of each 324 intake collection form to the centralized pharmacy within 5 days 325 after receiving it. 326 (d) A dispenser may dispense donated prescription drugs or 327 supplies only to an eligible patient who has a program 328 identification card or who has submitted a completed intake 329 collection form. 330 (e) A dispenser shall inspect the donated prescription 331 drugs or supplies before dispensing them. 332 (f) A dispenser may provide dispensing and consulting 333 services to an eligible patient. 334 (g) Donated prescription drugs and supplies may not be sold 335 or resold under the program. 336 (h) A dispenser of donated prescription drugs or supplies 337 may not submit a claim or otherwise seek reimbursement from any 338 public or private third-party payor for donated prescription 339 drugs or supplies dispensed under this program. However, a 340 repository may charge the patient a nominal handling fee, 341 established by department rule, for the preparation and 342 dispensing of prescription drugs or supplies under the program. 343 (10) RECALLED PRESCRIPTION DRUGS AND SUPPLIES.— 344 (a) The centralized repository and each local repository 345 shall establish and follow a protocol for notifying recipients 346 in the event of a prescription drug recall. 347 (b) Local repositories shall destroy all recalled or 348 expired prescription drugs and all prescription drugs that are 349 not suitable for dispensing in the repository. Local 350 repositories must complete a destruction information form for 351 all such drugs, in accordance with department rule. 352 (11) RECORDKEEPING.— 353 (a) Local repositories shall maintain records of 354 prescription drugs and supplies that are accepted, donated, 355 dispensed, distributed, or destroyed under the program. 356 (b) All required records must be maintained in accordance 357 with any applicable practice act. Local repositories shall 358 submit these records quarterly to the centralized repository for 359 data collection, and the centralized repository shall submit 360 these records and the collected data in annual reports to the 361 department. 362 (12) REGISTRIES; PUBLICATION OF FORMS.— 363 (a) The department or contractor shall establish and 364 maintain registries of all local repositories and of 365 prescription drugs and supplies available under the program. The 366 registry of local repositories must include each repository’s 367 name, address, website, and telephone number. The registry of 368 available prescription drugs and supplies must include the name, 369 strength, available quantity, and expiration date of the 370 prescription drug or supplies and the name and contact 371 information of each repository where such drug or supplies are 372 available. The department shall publish the registries on its 373 website. 374 (b) The department shall publish all forms required by this 375 section on its website. 376 (13) IMMUNITY FROM LIABILITY, DISCIPLINARY ACTION.— 377 (a) Any donor of prescription drugs or supplies and any 378 participant in the program who exercises reasonable care in 379 donating, accepting, distributing, or dispensing prescription 380 drugs or supplies under the program is immune from civil or 381 criminal liability and from professional disciplinary action by 382 the state for any injury, death, or loss to person or property 383 relating to such activities. 384 (b) A pharmaceutical manufacturer who exercises reasonable 385 care is not liable for any claim or injury arising from the 386 donation of any prescription drug or supply under this section, 387 including, but not limited to, liability for failure to transfer 388 or communicate product or consumer information regarding the 389 donated prescription drug, including its expiration date. 390 (14) NOTICE TO PATIENTS.—Before dispensing a donated 391 prescription drug under the program, the dispenser must provide 392 written notification to the eligible patient or his or her legal 393 representative, receipt of which must be acknowledged in 394 writing, of all of the following information: 395 (a) The prescription drug was donated to the program. 396 (b) The donors and participants in the program are immune 397 from civil or criminal liability or disciplinary action. 398 (c) The eligible patient is not required to pay for the 399 prescription drug, but may be required to pay a nominal handling 400 fee, which may not exceed the amount established by department 401 rule. 402 (15) DIRECT-SUPPORT ORGANIZATION.—The department may 403 establish a direct-support organization to provide assistance, 404 funding, and promotional support for the activities authorized 405 under the act. 406 (a) Entity organization.—The direct-support organization 407 must operate in accordance with s. 20.058 and is: 408 1. A Florida corporation not for profit incorporated under 409 chapter 617, exempted from filing fees, and approved by the 410 Department of State. 411 2. Organized and operated to conduct programs and 412 activities; raise funds and request and receive grants, gifts, 413 and bequests of moneys; acquire, receive, hold, and invest, in 414 its own name, securities, funds, objects of value, or other 415 property, either real or personal; and make expenditures or 416 provide funding to or for the direct or indirect benefit of the 417 program. 418 (b) Purposes and objectives.—The purposes and objectives of 419 the direct-support organization must be consistent with the 420 goals of the department, in the best interest of the state, and 421 in accordance with the adopted goals and the mission of the 422 department. 423 (c) Prohibition against lobbying.—The direct-support 424 organization is not considered a lobbying firm, as that term is 425 defined in s. 11.045(1). All expenditures of the direct-support 426 organization must be directly related to program administration 427 within the requirements of this section. Funds of the direct 428 support organization may not be used for the purpose of 429 lobbying, as that term is defined in s. 11.045(1). 430 (d) Possession of prescription drugs.—The direct-support 431 organization may not possess any prescription drugs on behalf of 432 the program. 433 (e) Contract.—The direct-support organization shall operate 434 under a written contract with the department. 435 1. The contract must require the direct-support 436 organization to submit to the department, annually by August 1, 437 the following information, which must be posted on the websites 438 of the direct-support organization and the department: 439 a. The articles of incorporation and bylaws of the direct 440 support organization, as approved by the department. 441 b. A proposed annual budget for the approval of the 442 department. 443 c. The code of ethics of the direct-support organization. 444 d. The statutory authority or executive order that created 445 the direct-support organization. 446 e. A brief description of the direct-support organization’s 447 mission and any results obtained by the direct-support 448 organization. 449 f. A brief description of the direct-support organization’s 450 annual plan for each of the next 3 fiscal years. 451 g. A copy of the direct-support organization’s most recent 452 federal Internal Revenue Service Return Organization Exempt from 453 Income Tax form (Form 990). 454 h. Certification by the department that the direct-support 455 organization is complying with the terms of the contract and 456 operating in a manner consistent with the goals and purposes of 457 the department and the best interest of the program and the 458 state. Such certification must be made annually and reported in 459 the official minutes of a meeting of the board of directors of 460 the direct-support organization. 461 2. The contract must, at a minimum, provide for: 462 a. The reversion without penalty to the department, or to 463 the state if the department ceases to exist, of all moneys and 464 property held in trust by the direct-support organization for 465 the benefit of the program if the direct-support organization 466 ceases to exist or if the contract is terminated. 467 b. A disclosure of material provisions of the contract and 468 the distinction between the department and the direct-support 469 organization to appear on all promotional and fundraising 470 publications. 471 c. A list of prescription drugs solicited by the direct 472 support organization for distribution to the centralized 473 repository or a local repository. 474 (f) Board of directors.—The State Surgeon General shall 475 appoint the board of directors, which must consist of at least 5 476 members, but not more than 15 members, who serve at his or her 477 pleasure. The board must elect a chair from among its members. 478 Board members must serve without compensation but may be 479 entitled to reimbursement of travel and per diem expenses in 480 accordance with s. 112.061, if funds are available for this 481 purpose. 482 (g) Use of property.—The department may allow, without 483 charge, appropriate use of fixed property, facilities, and 484 personnel services of the department by the direct-support 485 organization for purposes related to the program. For purposes 486 of this paragraph, the term “personnel services” includes full 487 time or part-time personnel, as well as payroll processing 488 services. 489 1. The department may prescribe any condition with which 490 the direct-support organization must comply in order to use 491 fixed property or facilities of the department. 492 2. The department may not allow the use of any fixed 493 property or facilities of the department by the direct-support 494 organization if the organization does not provide equal 495 membership and employment opportunities to all persons 496 regardless of race, color, religion, sex, age, or national 497 origin. 498 3. The department shall adopt rules prescribing the 499 procedures by which the direct-support organization is governed 500 and any conditions with which a direct-support organization must 501 comply to use property or facilities of the department. 502 (h) Deposit of funds.—Any moneys of the direct-support 503 organization may be held in a separate depository account in the 504 name of the organization and subject to the provisions of the 505 organization’s contract with the department. 506 (i) Use of funds.—Funds designated for the direct-support 507 organization must be used for the enhancement of program 508 projects and in a manner consistent with that purpose. Any 509 administrative costs of running and promoting the purposes of 510 the organization or program must be paid by private funds. 511 (j) Audit.—The direct-support organization shall provide 512 for an annual financial audit in accordance with s. 215.981. 513 (k) Repeal.—This subsection is repealed on October 1, 2024, 514 unless reviewed and saved from repeal by the Legislature. 515 (16) RULEMAKING.—The department shall adopt rules necessary 516 to administer this section. When applicable, the rules may 517 provide for the use of electronic forms, recordkeeping, and 518 meeting by teleconference. 519 Section 2. Paragraph (o) is added to subsection (5) of 520 section 252.36, Florida Statutes, to read: 521 252.36 Emergency management powers of the Governor.— 522 (5) In addition to any other powers conferred upon the 523 Governor by law, she or he may: 524 (o) Waive the patient eligibility requirements of s. 525 465.1902. 526 Section 3. This act shall take effect July 1, 2019.