Florida Senate - 2018 CS for CS for SB 710 By the Committees on Appropriations; and Health Policy; and Senator Book 576-03811-18 2018710c2 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; creating the Prescription 5 Drug Donation Repository Program within the Department 6 of Health; providing a purpose for the program; 7 authorizing the department to contract with a third 8 party to implement and administer the program; 9 providing definitions; specifying entities that are 10 eligible donors; providing criteria 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 under 14 specified conditions and are not program eligible; 15 prohibiting the donation of certain drugs pursuant to 16 federal restrictions; authorizing repositories to 17 refuse 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 a 25 centralized repository to redistribute prescription 26 drugs or supplies; requiring local repositories to 27 notify the department regarding participation in the 28 program; providing conditions for dispensing donated 29 prescription drugs and supplies to eligible patients; 30 requiring repositories to establish a protocol for 31 notifying recipients of a prescription drug recall; 32 providing for destruction of donated prescription 33 drugs in the event of a drug recall; providing 34 recordkeeping requirements; requiring the department 35 to establish, maintain, and publish a registry of 36 participating local repositories and available donated 37 prescription drugs and supplies; providing immunity 38 from civil and criminal liability for participants 39 under certain circumstances; specifying certain notice 40 to patients; authorizing the department to establish a 41 direct-support organization to provide assistance, 42 funding, and promotional support for program 43 activities; specifying direct-support organization 44 purposes and objectives; prohibiting such direct 45 support organization from lobbying and specifying that 46 such direct-support organization is not a lobbying 47 firm; specifying that the direct-support organization 48 must operate under contract with the department; 49 specifying required contract terms; providing for the 50 direct-support organization board of directors; 51 specifying the membership of such board; specifying 52 requirements relating to a direct-support 53 organization’s use of department property; specifying 54 requirements for the deposit and use of funds by the 55 direct-support organization; providing for annual 56 audits of a direct-support organization; providing for 57 future legislative review and repeal; requiring the 58 department to adopt rules; amending s. 252.36, F.S.; 59 authorizing the Governor to waive the patient 60 eligibility requirements of s. 465.1902, F.S., during 61 a declared state of emergency; providing an effective 62 date. 63 64 Be It Enacted by the Legislature of the State of Florida: 65 66 Section 1. Section 465.1902, Florida Statutes, is created 67 to read: 68 465.1902 Prescription Drug Donation Repository Program.— 69 (1) SHORT TITLE.—This section may be cited as the 70 “Prescription Drug Donation Repository Program Act.” 71 (2) PRESCRIPTION DRUG DONATION REPOSITORY PROGRAM.—The 72 Prescription Drug Donation Repository Program is created within 73 the Department of Health for the purpose of authorizing and 74 facilitating the donation of prescription drugs and supplies to 75 eligible patients. The department may contract with a third 76 party to implement and administer the program. 77 (3) DEFINITIONS.—As used in this section, the term: 78 (a) “Centralized repository” means a distributor permitted 79 pursuant to chapter 499 which is approved by the department or 80 the contractor to accept, inspect, inventory, and distribute 81 donated drugs and supplies under this section. 82 (b) “Closed drug delivery system” means a system in which 83 the actual control of the unit-dose medication package is 84 maintained by the facility rather than by the individual 85 patient. 86 (c) “Contractor” means the third-party vendor approved by 87 the department to implement and administer the program. 88 (d) “Controlled substance” means any substance listed under 89 Schedule II, Schedule III, Schedule IV, or Schedule V of s. 90 893.03. 91 (e) “Department” means Department of Health. 92 (f) “Direct-support organization” means an entity that is 93 established pursuant to s. 20.058 and is: 94 1. A Florida corporation not for profit incorporated under 95 chapter 617, exempted from filing fees, and approved by the 96 Department of State. 97 2. Organized and operated to conduct programs and 98 activities; raise funds and request and receive grants, gifts, 99 and bequests of moneys; acquire, receive, hold, and invest, in 100 its own name, securities, funds, objects of value, or other 101 property, either real or personal; and make expenditures or 102 provide funding to or for the direct or indirect benefit of the 103 program. 104 (g) “Dispenser” means a dispensing health care practitioner 105 or pharmacist licensed to dispense medicinal drugs in the state. 106 (h) “Donor” means an entity that meets the requirements of 107 subsection (4). 108 (i) “Eligible patient” means a Florida resident who is 109 indigent, uninsured, or underinsured and who has a valid 110 prescription for a prescription drug or supply that is eligible 111 for dispensing under the program. 112 (j) “Free clinic” means a clinic that delivers only medical 113 diagnostic services or nonsurgical medical treatment free of 114 charge to all low-income recipients. 115 (k) “Health care practitioner” or “practitioner” means a 116 practitioner licensed under chapter 458, chapter 459, chapter 117 461, chapter 463, chapter 464, chapter 465, or chapter 466. 118 (l) “Indigent” means a person with an income that is below 119 200 percent of the federal poverty level as defined by the most 120 recently revised poverty income guidelines published by the 121 United States Department of Health and Human Services. 122 (m) “Local repository” means a health care practitioner’s 123 office, a pharmacy, a hospital with a closed drug delivery 124 system, a nursing home facility with a closed drug delivery 125 system, a free clinic, or a nonprofit health clinic that is 126 licensed or permitted to dispense medicinal drugs in the state. 127 (n) “Nonprofit health clinic” means a nonprofit legal 128 entity that provides medical care to patients who are indigent, 129 uninsured, or underinsured, including, but not limited to, a 130 federally qualified health center as defined in 42 U.S.C. s. 131 1396d(l)(2)(B) and a rural health clinic as defined in 42 U.S.C. 132 s. 1396d(l)(1). 133 (o) “Nursing home facility” has the same meaning as in s. 134 400.021(12). 135 (p) “Prescriber” means a prescribing physician, prescribing 136 practitioner, or other health care practitioner authorized by 137 the laws of this state to prescribe medicinal drugs. 138 (q) “Prescription drug” has the same meaning as defined in 139 s. 465.003(8), but does not include controlled substances or 140 cancer drugs donated under s. 499.029. 141 (r) “Program” means the Prescription Drug Donation 142 Repository Program created by this section. 143 (s) “Supplies” means any supply used in the administration 144 of a prescription drug. 145 (t) “Tamper-evident packaging” means a package that has one 146 or more indicators or barriers to entry which, if breached or 147 missing, can reasonably be expected to provide visible evidence 148 to consumers that tampering has occurred. 149 (u) “Underinsured” means a person who has third-party 150 insurance or is eligible to receive prescription drugs or 151 supplies through the Medicaid program or any other prescription 152 drug program funded in whole or in part by the Federal 153 Government, but has exhausted these benefits or does not have 154 prescription drug coverage for the drug prescribed. 155 (v) “Uninsured” means a person who has no third-party 156 insurance and is not eligible to receive prescription drugs or 157 supplies through the Medicaid program or any other prescription 158 drug program funded in whole or in part by the Federal 159 Government. 160 (4) DONOR ELIGIBILITY.—The program may only accept a 161 donation of a prescription drug or supply from: 162 (a) Nursing home facilities with closed drug delivery 163 systems. 164 (b) Hospices that have maintained control of a patient’s 165 prescription drug. 166 (c) Hospitals with closed drug delivery systems. 167 (d) Pharmacies. 168 (e) Drug manufacturers or wholesale distributors. 169 (f) Medical device manufacturers or suppliers. 170 (g) Prescribers who receive prescription drugs or supplies 171 directly from a drug manufacturer, wholesale distributor, or 172 pharmacy. 173 (5) PRESCRIPTION DRUGS AND SUPPLIES ELIGIBLE FOR DONATION.— 174 (a) All prescription drugs and supplies that have been 175 approved for medical use in the United States and meet the 176 criteria for donation established by this section may be 177 accepted for donation under the program. 178 (b) The centralized repository or a local repository may 179 accept a prescription drug only if: 180 1. The drug is in its original sealed and tamper-evident 181 packaging. Single-unit-dose drugs may be accepted if the single 182 unit-dose packaging is unopened. 183 2. The drug requires storage at normal room temperature per 184 the manufacturer or the United States Pharmacopeia. 185 3. The drug has been stored according to manufacturer or 186 United States Pharmacopeia storage requirements. 187 4. The drug does not have any physical signs of tampering 188 or adulteration and there is no reason to believe that the drug 189 is adulterated. 190 5. The packaging does not have any physical signs of 191 tampering, misbranding, deterioration, compromised integrity, or 192 adulteration. 193 6. The packaging contains the lot number and expiration 194 date of the drug. If the lot number is not retrievable, all 195 specified medications must be destroyed in the event of a 196 recall. 197 7. The drug has an expiration date that is more than 3 198 months after the date that the drug was donated. 199 (c) The central repository or a local repository may only 200 accept supplies that are in their original, unopened, sealed 201 packaging and have not been adulterated or misbranded. 202 (d) Prescription drugs and supplies may be donated on the 203 premises of the centralized repository or a local repository to 204 a person designated by the repository. A drop box may not be 205 used to accept donations. 206 (e) Prescription drugs or supplies may not be donated to a 207 specific patient. 208 (f) Prescription drugs billed to and paid for by Medicaid 209 in long-term care facilities which are eligible for return to 210 stock under federal Medicaid regulations must be credited to 211 Medicaid and are not eligible for donation under the program. 212 (g) Prescription drugs that are subject to a Federal Food 213 and Drug Administration Risk Evaluation and Mitigation Strategy 214 with Elements to Assure Safe Use are not eligible for donation 215 under the program. 216 (h) Nothing in this section requires the central repository 217 or a local repository to accept a donation of a prescription 218 drug or supplies. 219 (6) INSPECTION AND STORAGE.— 220 (a) A licensed pharmacist employed by or under contract 221 with the centralized repository or a local repository shall 222 inspect donated prescription drugs and supplies to determine 223 whether the donated prescription drugs or supplies: 224 1. Are eligible for donation under the program; 225 2. Have been adulterated or misbranded; and 226 3. Are safe and suitable for dispensing. 227 (b) The pharmacist who inspects the donated prescription 228 drugs or supplies shall sign an inspection record on a form 229 prescribed by the department and adopted in rule verifying that 230 the criteria of paragraph (a) have been met and attach such 231 record to the copy of the inventory record. If a local 232 repository receives drugs and supplies from the centralized 233 repository, the local repository is not required to reinspect 234 the drugs and supplies. 235 (c) The centralized repository and local repositories shall 236 store donated prescription drugs and supplies in a secure 237 storage area under the environmental conditions specified by the 238 manufacturer or United States Pharmacopeia for the prescription 239 drugs or supplies being stored. Donated prescription drugs and 240 supplies may not be stored with nondonated inventory. A local 241 repository shall quarantine any donated prescription drugs or 242 supplies from all dispensing stock until the donated 243 prescription drugs or supplies are inspected and approved for 244 dispensing under the program. 245 (d) A local repository shall maintain an inventory of all 246 donated prescription drugs or supplies it receives. Such 247 inventory shall be recorded on a form prescribed by the 248 department and adopted in rule. 249 (e) A local repository shall notify the centralized 250 repository within 5 days after receipt of any donation of 251 prescription drugs or supplies to the program. The notification 252 shall be on a form prescribed by the department and adopted by 253 rule. 254 (f) The centralized repository shall maintain an inventory 255 of all prescription drugs and supplies donated to the program. 256 (g) The centralized repository may redistribute 257 prescription drugs and supplies to facilitate dispensing to 258 either the centralized repository or to a local repository, as 259 needed. 260 (7) LOCAL REPOSITORY NOTICE OF PARTICIPATION.— 261 (a) A local repository must notify the department of its 262 intent to participate in the program before accepting or 263 dispensing any prescription drugs or supplies pursuant to this 264 section. The notification shall be on a form prescribed by the 265 department and adopted by rule and must, at a minimum, include: 266 1. The name, street address, website, and telephone number 267 of the local repository and any state-issued license or 268 registration number issued to the local repository, including 269 the name of the issuing agency. 270 2. The name and telephone number of the pharmacist employed 271 by or under contract with the local repository who is 272 responsible for the inspection of donated prescription drugs and 273 supplies. 274 3. A statement signed and dated by the responsible 275 pharmacist affirming that the local repository meets the 276 eligibility requirements of this section. 277 (b) A local repository may withdraw from participation in 278 the program at any time by providing written notice to the 279 department or contractor on a form prescribed by the department 280 and adopted by rule. The department shall adopt rules addressing 281 the disposition of any prescription drugs in the possession of 282 the local repository. 283 (8) DISPENSING.— 284 (a) Each eligible patient without a program identification 285 card must submit an intake collection form to a local repository 286 before receiving prescription drugs or supplies under the 287 program. The form shall be prescribed by the department and 288 adopted by rule and, at a minimum, must include: 289 1. The name, street address, and telephone number of the 290 eligible patient. 291 2. The basis for eligibility, which must specify that the 292 patient is indigent, uninsured, or underinsured. 293 3. A statement signed and dated by the eligible patient 294 affirming that he or she meets the eligibility requirements of 295 this section. 296 (b) A local repository shall collect a signed and dated 297 intake collection form from each eligible patient receiving 298 prescription drugs or supplies under the program. The local 299 repository must issue a program identification card upon receipt 300 of a duly executed intake collection form. The program 301 identification card is valid for 1 year after issuance and must 302 be in a form prescribed by the department and adopted in rule. 303 (c) A local repository must send a summary of the intake 304 collection form data to the centralized pharmacy within 5 days 305 after receipt of a duly executed intake collection form. 306 (d) A dispenser may only dispense a donated prescription 307 drug or supplies, if available, to an eligible patient with a 308 program identification card or a duly executed intake collection 309 form. 310 (e) A dispenser shall inspect the donated prescription 311 drugs or supplies prior to dispensing such drugs or supplies. 312 (f) A dispenser may provide dispensing and consulting 313 services to an eligible patient. 314 (g) Donated prescription drugs and supplies may not be sold 315 or resold under this program. 316 (h) A dispenser of donated prescription drugs or supplies 317 may not submit a claim or otherwise seek reimbursement from any 318 public or private third-party payor for donated prescription 319 drugs or supplies dispensed to any patient under this program. 320 However, a repository may charge a nominal handling fee, 321 established by department rule, for the preparation and 322 dispensing of prescription drugs or supplies under the program. 323 (i) A local repository that receives donated prescription 324 drugs or supplies may, with authorization from the centralized 325 repository, distribute the prescription drugs or supplies to 326 another local repository. 327 (9) RECALL AND DESTRUCTION OF PRESCRIPTION DRUGS AND 328 SUPPLIES.— 329 (a) The centralized repository and a local repository shall 330 be responsible for drug recalls and shall have an established 331 protocol to notify recipients in the event of a prescription 332 drug recall. 333 (b) Local repositories shall destroy all of the recalled or 334 expired prescription drugs or prescription drugs that are not 335 suitable for dispensing in the repository and complete a 336 destruction information form for all donated prescription drugs 337 destroyed, in accordance with rules adopted by the department. 338 (10) RECORDKEEPING.— 339 (a) Local repositories shall maintain records of 340 prescription drugs and supplies that were accepted, donated, 341 dispensed, distributed, or destroyed under the program. 342 (b) All records required to be maintained as a part of the 343 program shall be maintained in accordance with any applicable 344 practice acts. Local repositories shall submit these records 345 quarterly to the centralized repository for data collection, and 346 the centralized repository shall submit these records and the 347 collected data in annual reports to the department. 348 (11) REGISTRIES AND FORMS.— 349 (a) The department shall establish and maintain registries 350 of all local repositories and available drugs and supplies under 351 the program. The registry of local repositories must include the 352 repository’s name, address, website, and telephone number. The 353 registry of available drugs and supplies must include the name, 354 strength, available quantity, and expiration date of the drug or 355 supply and the name and contact information of the repositories 356 where such drug or supply is available. The department shall 357 publish the registries on its website. 358 (b) The department shall publish all forms required by this 359 section on its website. 360 (12) IMMUNITY.— 361 (a) Any donor of prescription drugs or supplies, or any 362 participant in the program, who exercises reasonable care in 363 donating, accepting, distributing, or dispensing prescription 364 drugs or supplies under the program, and the rules adopted 365 pursuant thereto, is immune from civil or criminal liability and 366 from professional disciplinary action of any kind for any 367 injury, death, or loss to person or property relating to such 368 activities. 369 (b) A pharmaceutical manufacturer who exercises reasonable 370 care is not liable for any claim or injury arising from the 371 transfer of any prescription drug under this section, including 372 but not limited to, liability for failure to transfer or 373 communicate product or consumer information regarding the 374 transferred drug, including the expiration date of the 375 transferred drug. 376 (13) NOTICE TO PATIENTS.–Before dispensing a prescription 377 drug that has been donated under this program, the dispenser 378 must provide written notification to the patient, or to his or 379 her legal representative, receipt of which must be acknowledged 380 in writing, that: 381 (a) The prescription drug was donated to the program; 382 (b) The donors and participants in the program are granted 383 certain immunities as described in subsection (12); and 384 (c) The patient may not be required to pay for the 385 prescription drug, except for a nominal handling fee which may 386 not exceed the amount established by department rule. 387 (14) DIRECT-SUPPORT ORGANIZATION.-The department may 388 establish a direct-support organization to provide assistance, 389 funding, and promotional support for the activities authorized 390 for the program. 391 (a) Purposes and objectives.-The purposes and objectives of 392 the direct-support organization of the program must be 393 consistent with the goals of the department, in the best 394 interest of the state, and in accordance with the adopted goals 395 and mission of the department. 396 (b) Prohibition against lobbying.–The direct-support 397 organization is not considered a lobbying firm within the 398 meaning of s. 11.045. All expenditures of the direct-support 399 organization must be used for the program. No expenditures of 400 the direct-support organization may be used for the purpose of 401 lobbying as defined in s. 11.045. 402 (c) Contract.—The direct-support organization shall operate 403 under a written contract with the department. The contract must 404 provide for a submission by the direct-support organization to 405 the department, by each August 1, and posting on the direct 406 support organization’s and department’s websites, the following 407 information: 408 1. The articles of incorporation and bylaws of the direct 409 support organization as approved by the department. 410 2. An annual budget for the approval of the department. 411 3. The code of ethics of the direct-support organization. 412 4. The statutory authority or executive order that created 413 the direct-support organization. 414 5. A brief description of the direct-support organization’s 415 mission and any results obtained by the direct-support 416 organization. 417 6. A brief description of the direct-support organization’s 418 plans for the next 3 fiscal years. 419 7. A copy of the direct-support organization’s most recent 420 federal Internal Revenue Service Return Organization Exempt from 421 Income Tax form (Form 990). 422 8. Certification by the department that the direct-support 423 organization is complying with the terms of the contract and 424 operating in a manner consistent with the goals and purposes of 425 the department and the best interest of the program and the 426 state. Such certification must be made annually and reported in 427 the official minutes of a meeting of the direct-support 428 organization. 429 9. The reversion, without penalty, of moneys and property 430 held in trust by the direct-support organization for the benefit 431 of the program to the state if the department ceases to exist; 432 or reversion to the department if the direct-support 433 organization is no longer approved to operate or ceases to 434 exist. 435 10. The fiscal year of the direct-support organization, 436 which must begin on July 1 of each year and end on June 30 of 437 the following year. 438 11. The disclosure of material provisions of the contract, 439 and the distinction between the department and the direct 440 support organization, to donors of gifts, contributions, or 441 bequests, including such disclosure on all promotional and 442 fundraising publications. 443 12. All prescription drugs solicited by the direct-support 444 organization to be distributed to the centralized repository or 445 a local repository. The direct-support organization may not 446 possess any prescription drugs on behalf of the program. 447 (d) Board of directors.—The State Surgeon General shall 448 appoint a board of directors of the direct-support organization. 449 The board of directors shall consist of at least 5 members, but 450 not more than 15 members, who serve at the pleasure of the State 451 Surgeon General. The board members must elect a chair from among 452 its members. Board members must serve without compensation but 453 may be entitled to reimbursement of travel and per diem expenses 454 in accordance with s. 112.061, if funds are available for this 455 purpose. 456 (e) Use of property.—The department may allow, without 457 charge, appropriate use of fixed property, facilities, and 458 personnel services of the department by the direct-support 459 organization, subject to this subsection. For the purposes of 460 this paragraph, the term “personnel services” includes full-time 461 or part-time personnel, as well as payroll processing services. 462 1. The department may prescribe any condition with which 463 the direct-support organization must comply in order to use 464 fixed property or facilities of the department. 465 2. The department may not permit the use of any fixed 466 property or facilities of the department by the direct-support 467 organization if it does not provide equal membership and 468 employment opportunities to all persons regardless of race, 469 color, religion, sex, age, or national origin. 470 3. The department shall adopt rules prescribing the 471 procedures by which the direct-support organization is governed 472 and any conditions with which a direct-support organization must 473 comply to use property or facilities of the department. 474 (f) Deposit of funds.—Any moneys may be held in a separate 475 depository account in the name of the direct-support 476 organization and subject to the provisions of the contract with 477 the department. 478 (g) Use of funds.-Funds designated for the direct-support 479 organization must be used for the enhancement of the projects of 480 the program and used in a manner consistent with that purpose. 481 Any administrative costs of running and promoting the purposes 482 of the corporation or program must be paid by private funds. 483 (h) Audit.—The direct-support organization shall provide 484 for an annual financial audit in accordance with s. 215.981. 485 (i) Repeal.—This subsection shall stand repealed on October 486 1, 2023, unless reviewed and saved from repeal by the 487 Legislature. 488 (15) RULEMAKING.—The department shall adopt rules necessary 489 to implement the requirements of this section. When applicable, 490 the rules may provide for the use of electronic forms, 491 recordkeeping, and meeting by teleconference. 492 Section 2. Paragraph (o) is added to subsection (5) of 493 section 252.36, Florida Statutes, to read: 494 252.36 Emergency management powers of the Governor.— 495 (5) In addition to any other powers conferred upon the 496 Governor by law, she or he may: 497 (o) Waive the patient eligibility requirements of s. 498 465.1902. 499 Section 3. This act shall take effect July 1, 2018.