Florida Senate - 2025 SB 668 By Senator Burgess 23-00484A-25 2025668__ 1 A bill to be entitled 2 An act relating to storage and disposal of 3 prescription drugs and sharps; requiring the 4 Department of Health and the Department of 5 Environmental Protection to conduct a study of the 6 safe collection and proper disposal of sharps; 7 requiring the departments to make a specified 8 assessment of the use of sharps in the home; 9 establishing the collection methods to be considered 10 in conducting the study; authorizing the departments 11 to work or contract with counties, municipalities, and 12 private entities; requiring the departments to submit 13 a specified report to the Governor and the Legislature 14 by a certain date; providing for an appropriation; 15 amending s. 499.0121, F.S.; providing applicability; 16 providing requirements for establishments that store, 17 warehouse, or hold certain prescription drugs solely 18 for the purpose of destruction; amending ss. 465.022, 19 499.003, 499.0051, 499.01, 499.012, 499.01201, 499.05, 20 and 499.067, F.S.; conforming cross-references; 21 providing an effective date. 22 23 Be It Enacted by the Legislature of the State of Florida: 24 25 Section 1.(1)The Department of Health, in partnership 26 with the Department of Environmental Protection, shall conduct a 27 study of the safe collection and proper disposal of sharps, as 28 defined in s. 381.0098(2)(d), Florida Statutes, used by 29 individuals to self-administer prescription drugs in the home. 30 (a)The departments shall assess the risk of injury to 31 patients, health care professionals, caregivers, family members, 32 and waste industry workers from the use of sharps in the home. 33 (b)In conducting the study, the departments shall consider 34 at least the following two methods of safe collection in both 35 rural and urban environments: 36 1.Sharps disposal by mail. 37 2.Sharps disposal at drop-off locations such as pharmacies 38 or other health-care-related sites. 39 (2)The departments may work or contract with counties and 40 municipalities and private entities that wish to participate in 41 the study. 42 (3)By July 1, 2026, the departments shall submit a report 43 of their findings and recommendations to the Governor, the 44 President of the Senate, and the Speaker of the House of 45 Representatives. The report must contain, at a minimum, all of 46 the following: 47 (a)An evaluation of the sharps collection methods, 48 including consideration of cost, convenience, safety, consumer 49 preference, and effectiveness. 50 (b)Information regarding the current local government 51 sharps collection methods practiced in this state, 52 recommendations for improving existing sharps collection 53 programs, and whether such programs have been updated or adopted 54 based on the findings of the study. 55 (c)Recommendations for safely collecting sharps used by 56 individuals to self-administer prescription drugs in the home, 57 including the estimated costs associated with statewide adoption 58 of one or more sharps collection methods. 59 (d)Information regarding current sharps collection methods 60 practiced by health care and home health agency professionals 61 performing services in a patients home, and any recommendations 62 for improving current practices. 63 (4)For the 2025-2026 fiscal year, the nonrecurring sum of 64 $200,000 from the Solid Waste Management Trust Fund is 65 appropriated to the Department of Health and the Department of 66 Environmental Protection to implement this section. 67 Section 2.Section 499.0121, Florida Statutes, is amended 68 to read: 69 499.0121Storage and handling of prescription drugs; 70 recordkeeping. 71 (1)AUTHORITY TO PRESCRIBE RULES. 72 (a)The department shall adopt rules to implement this 73 section as necessary to protect the public health, safety, and 74 welfare. Such rules shall include, but not be limited to, 75 requirements for the storage and handling of prescription drugs 76 and for the establishment and maintenance of prescription drug 77 distribution records. 78 (b)This section does not apply to Schedule IV, Schedule V, 79 and nonscheduled prescription drugs pursuant to s. 893.03, or 80 prescription drugs collected under a program authorized by 21 81 C.F.R. s. 1317, subpart B, which are stored, warehoused, or held 82 solely for the purpose of destruction, except as provided in 83 subsection (7). 84 (2)(1)ESTABLISHMENTS.An establishment at which 85 prescription drugs are stored, warehoused, handled, held, 86 offered, marketed, or displayed must: 87 (a)Be of suitable size and construction to facilitate 88 cleaning, maintenance, and proper operations; 89 (b)Have storage areas designed to provide adequate 90 lighting, ventilation, temperature, sanitation, humidity, space, 91 equipment, and security conditions; 92 (c)Have a quarantine area for storage of prescription 93 drugs that are outdated, damaged, deteriorated, misbranded, or 94 adulterated, or that are in immediate or sealed, secondary 95 containers that have been opened; 96 (d)Be maintained in a clean and orderly condition; and 97 (e)Be free from infestation by insects, rodents, birds, or 98 vermin of any kind. 99 (3)(2)SECURITY. 100 (a)An establishment that is used for wholesale drug 101 distribution must be secure from unauthorized entry. 102 1.Access from outside the premises must be kept to a 103 minimum and be well controlled. 104 2.The outside perimeter of the premises must be well 105 lighted. 106 3.Entry into areas where prescription drugs are held must 107 be limited to authorized personnel. 108 (b)An establishment that is used for wholesale drug 109 distribution must be equipped with: 110 1.An alarm system to detect entry after hours; however, 111 the department may exempt by rule establishments that only hold 112 a permit as prescription drug wholesale distributor-brokers; and 113 2.A security system that will provide suitable protection 114 against theft and diversion. When appropriate, the security 115 system must provide protection against theft or diversion that 116 is facilitated or hidden by tampering with computers or 117 electronic records. 118 (c)Any vehicle that contains prescription drugs must be 119 secure from unauthorized access to the prescription drugs in the 120 vehicle. 121 (4)(3)STORAGE.All prescription drugs shall be stored at 122 appropriate temperatures and under appropriate conditions in 123 accordance with requirements, if any, in the labeling of such 124 drugs, or with requirements in the official compendium. 125 (a)If no storage requirements are established for a 126 prescription drug, the drug may be held at controlled room 127 temperature, as defined in the official compendium, to help 128 ensure that its identity, strength, quality, and purity are not 129 adversely affected. 130 (b)Appropriate manual, electromechanical, or electronic 131 temperature and humidity recording equipment, devices, or logs 132 must be used to document proper storage of prescription drugs. 133 (c)The recordkeeping requirements in subsection (8) (6) 134 must be followed for all stored prescription drugs. 135 (5)(4)EXAMINATION OF MATERIALS AND RECORDS. 136 (a)Upon receipt, each outside shipping container must be 137 visually examined for identity and to prevent the acceptance of 138 contaminated prescription drugs that are otherwise unfit for 139 distribution. This examination must be adequate to reveal 140 container damage that would suggest possible contamination or 141 other damage to the contents. 142 (b)Each outgoing shipment must be carefully inspected for 143 identity of the prescription drug products and to ensure that 144 there is no delivery of prescription drugs that have expired or 145 been damaged in storage or held under improper conditions. 146 (c)The recordkeeping requirements in subsection (8) (6) 147 must be followed for all incoming and outgoing prescription 148 drugs. 149 (d)Upon receipt, a wholesale distributor must review 150 records required under this section for the acquisition of 151 prescription drugs for accuracy and completeness, considering 152 the total facts and circumstances surrounding the transactions 153 and the wholesale distributors involved. 154 (6)(5)RETURNED, DAMAGED, OR OUTDATED PRESCRIPTION DRUGS. 155 (a)1.Prescription drugs that are outdated, damaged, 156 deteriorated, misbranded, or adulterated must be quarantined and 157 physically separated from other prescription drugs until they 158 are destroyed or returned to their supplier. A quarantine 159 section must be separate and apart from other sections where 160 prescription drugs are stored so that prescription drugs in this 161 section are not confused with usable prescription drugs. 162 2.Prescription drugs must be examined at least every 12 163 months, and drugs for which the expiration date has passed must 164 be removed and quarantined. 165 (b)Any prescription drugs of which the immediate or sealed 166 outer containers or sealed secondary containers have been opened 167 or used must be identified as such and must be quarantined and 168 physically separated from other prescription drugs until they 169 are destroyed or returned to the supplier. 170 (c)If the conditions under which a prescription drug has 171 been returned cast doubt on the drugs safety, identity, 172 strength, quality, or purity, the drug must be destroyed or 173 returned to the supplier, unless examination, testing, or other 174 investigation proves that the drug meets appropriate standards 175 of safety, identity, strength, quality, and purity. In 176 determining whether the conditions under which a drug has been 177 returned cast doubt on the drugs safety, identity, strength, 178 quality, or purity, the wholesale distributor must consider, 179 among other things, the conditions under which the drug has been 180 held, stored, or shipped before or during its return and the 181 conditions of the drug and its container, carton, or labeling, 182 as a result of storage or shipping. 183 (d)The recordkeeping requirements in subsection (8) (6) 184 must be followed for all outdated, damaged, deteriorated, 185 misbranded, or adulterated prescription drugs. 186 (7)DESTRUCTION OF SCHEDULE IV, SCHEDULE V, AND 187 NONSCHEDULED PRESCRIPTION DRUGS OR PRESCRIPTION DRUGS COLLECTED 188 UNDER A PROGRAM AUTHORIZED BY 21 C.F.R. S. 1317, SUBPART B.An 189 establishment that stores, warehouses, or holds Schedule IV, 190 Schedule V, and nonscheduled prescription drugs pursuant to s. 191 893.03, or prescription drugs collected under a program 192 authorized by 21 C.F.R. s. 1317, subpart B, solely for the 193 purpose of arranging for their destruction, shall only be 194 required to: 195 (a)Secure the establishment that is used for activities 196 related to destruction against unauthorized entry or 197 unauthorized access to the prescription drugs when establishment 198 personnel are not present. 199 (b)Maintain records of the address of the location from 200 which the prescription drugs were collected and a formulary or 201 description of that locations prescription drugs, or 202 documentation that the prescription drugs were collected under a 203 program authorized by 21 C.F.R. s. 1317, subpart B, and the 204 address at which the prescription drugs were destroyed. 205 (c)Operate in compliance with applicable federal laws and 206 regulations. 207 (8)(6)RECORDKEEPING.The department shall adopt rules that 208 require keeping such records of prescription drugs, including 209 active pharmaceutical ingredients, as are necessary for the 210 protection of the public health. 211 (a)The following persons must maintain business records 212 that include the information specified in paragraph (b): 213 1.Persons permitted or required to be permitted under this 214 chapter to engage in the manufacture, repackaging, or 215 distribution of active pharmaceutical ingredients or 216 prescription drugs. 217 2.Persons other than those set forth in subparagraph 1. 218 that engage in the receipt of active pharmaceutical ingredients 219 or prescription drugs. 220 (b)Business records for persons specified in paragraph (a) 221 must include: 222 1.The name and address of the seller, and the Florida 223 permit number of the seller if such seller is not exempt from 224 Florida permitting requirements, of the active pharmaceutical 225 ingredient or prescription drug. 226 2.The address of the location the active pharmaceutical 227 ingredient or prescription drug was shipped from. 228 3.The distribution date of the active pharmaceutical 229 ingredient or prescription drug. 230 4.The name, strength, and quantity, and the National Drug 231 Code if such code has been assigned, of the distributed active 232 pharmaceutical ingredient or prescription drug. 233 5.The name and Florida permit number of the person that 234 purchased the active pharmaceutical ingredient or prescription 235 drug. 236 6.The financial data, including the unit type and unit 237 price, for the distributions involving active pharmaceutical 238 ingredients or prescription drugs. 239 7.The date and method of disposition of the active 240 pharmaceutical ingredient or prescription drug. 241 (c)Each manufacturer or repackager of medical devices, 242 over-the-counter drugs, or cosmetics must maintain business 243 records that include: 244 1.The name and address of the seller or transferor of the 245 product. 246 2.The address of the location the product was shipped 247 from. 248 3.The date of the sale or distribution of the product. 249 4.The name and quantity of the product involved. 250 5.The name and address of the person who purchased the 251 product. 252 (d)Persons permitted, or required to be permitted, under 253 this chapter to engage in the manufacture, repackaging, or 254 distribution of active pharmaceutical ingredients or 255 prescription drugs; or the manufacture or repackaging of medical 256 devices, over-the-counter drugs, and cosmetics; must establish, 257 maintain, or have the capability to create a current inventory 258 of the active pharmaceutical ingredients, prescription drugs, 259 over-the-counter drugs, cosmetics, and devices at an 260 establishment where activities specified in this paragraph are 261 undertaken and must be able to produce such inventory for 262 inspection by the department within 2 business days. 263 (e)Business records required to be kept pursuant to this 264 section, and that are kept at the inspection site or can be 265 immediately retrieved by computer or other electronic means, 266 must be readily available for authorized inspection during the 267 retention period. Records kept at a central location outside of 268 this state which are not electronically retrievable must be made 269 available for inspection within 2 working days after a request 270 by an authorized official of a federal, state, or local law 271 enforcement agency. Records maintained at a central location 272 within this state must be maintained at an establishment that is 273 permitted pursuant to this part, and such records must be 274 readily available for inspection. 275 (f)Records required to be kept pursuant to this subsection 276 must be maintained as specified for a period of not less than 6 277 years from the date of disposition of the active pharmaceutical 278 ingredients, prescription drugs, over-the-counter drugs, medical 279 devices, or cosmetics. 280 (g)To the extent that prescription drugs are also products 281 as defined in the federal act, as amended, and the information 282 required by the business records requirements of this section 283 are also included in the tracking and tracing requirements of 284 the federal act, as amended, and departmental rules, the 285 manufacturer, wholesale distributor, repackager, or dispenser 286 must follow both the requirements of the federal act, as 287 amended, and departmental rules. 288 (9)(7)PRESCRIPTION DRUG PURCHASE LIST.Each wholesale 289 distributor, except for a manufacturer, shall annually provide 290 the department with a written list of all wholesale distributors 291 and manufacturers from whom the wholesale distributor purchases 292 prescription drugs. A wholesale distributor, except a 293 manufacturer, shall notify the department not later than 10 days 294 after any change to either list. 295 (10)(8)WRITTEN POLICIES AND PROCEDURES.Wholesale 296 distributors must establish, maintain, and adhere to written 297 policies and procedures, which must be followed for the receipt, 298 security, storage, inventory, and distribution of prescription 299 drugs, including policies and procedures for identifying, 300 recording, and reporting losses or thefts, and for correcting 301 all errors and inaccuracies in inventories. Wholesale 302 distributors must include in their written policies and 303 procedures: 304 (a)A procedure whereby the oldest approved stock of a 305 prescription drug product is distributed first. The procedure 306 may permit deviation from this requirement, if the deviation is 307 temporary and appropriate. 308 (b)A procedure to be followed for handling recalls and 309 withdrawals of prescription drugs. Such procedure must be 310 adequate to deal with recalls and withdrawals due to: 311 1.Any action initiated at the request of the Food and Drug 312 Administration or any other federal, state, or local law 313 enforcement or other government agency, including the 314 department. 315 2.Any voluntary action by the manufacturer or repackager 316 to remove defective or potentially defective drugs from the 317 market; or 318 3.Any action undertaken to promote public health and 319 safety by replacing existing merchandise with an improved 320 product or new package design. 321 (c)A procedure to ensure that wholesale distributors 322 prepare for, protect against, and handle any crisis that affects 323 security or operation of any facility if a strike, fire, flood, 324 or other natural disaster, or a local, state, or national 325 emergency, occurs. 326 (d)A procedure to ensure that any outdated prescription 327 drugs are segregated from other drugs and returned to the 328 manufacturer or repackager or destroyed. This procedure must 329 provide for written documentation of the disposition of outdated 330 prescription drugs. This documentation must be maintained for 2 331 years after disposition of the outdated drugs. 332 (11)(9)RESPONSIBLE PERSONS.Wholesale distributors must 333 establish and maintain lists of officers, directors, managers, 334 designated representatives, and other persons in charge of 335 wholesale drug distribution, storage, and handling, including a 336 description of their duties and a summary of their 337 qualifications. 338 (12)(10)COMPLIANCE WITH FEDERAL, STATE, AND LOCAL LAW.A 339 wholesale distributor must operate in compliance with applicable 340 federal, state, and local laws and regulations. 341 (a)A wholesale distributor must allow the department and 342 authorized federal, state, and local officials to enter and 343 inspect its premises and delivery vehicles, and to audit its 344 records and written operating procedures, at reasonable times 345 and in a reasonable manner, to the extent authorized by law. 346 (b)A wholesale distributor that deals in controlled 347 substances must register with the Drug Enforcement 348 Administration and must comply with all applicable state, local, 349 and federal laws. A wholesale distributor that distributes any 350 substance controlled under chapter 893 must notify the 351 department when registering with the Drug Enforcement 352 Administration pursuant to that chapter and must provide the 353 department with its DEA number. 354 (13)(11)SALVAGING AND REPROCESSING.A wholesale 355 distributor is subject to any applicable federal, state, or 356 local laws or regulations that relate to prescription drug 357 product salvaging or reprocessing. 358 (14)(12)SHIPPING AND TRANSPORTATION.The person 359 responsible for shipment and transportation of a prescription 360 drug in a wholesale distribution may use a common carrier; its 361 own vehicle or employee acting within the scope of employment if 362 authorized under s. 499.03 for the possession of prescription 363 drugs in this state; or, in the case of a prescription drug 364 intended for domestic distribution, an independent contractor 365 who must be the agent of the authorized seller or recipient 366 responsible for shipping and transportation as set forth in a 367 written contract between the parties. A person selling a 368 prescription drug for export must obtain documentation, such as 369 a validated airway bill, bill of lading, or other appropriate 370 documentation that the prescription drug was exported. A person 371 responsible for shipping or transporting prescription drugs is 372 not required to maintain documentation from a common carrier 373 that the designated recipient received the prescription drugs; 374 however, the person must obtain such documentation from the 375 common carrier and make it available to the department upon 376 request of the department. 377 (15)(13)DUE DILIGENCE OF SUPPLIERS.Prior to purchasing 378 any prescription drugs from another wholesale distributor, a 379 prescription drug wholesale distributor, an out-of-state 380 prescription drug wholesale distributor, or a prescription drug 381 repackager must: 382 (a)Enter an agreement with the selling wholesale 383 distributor by which the selling wholesale distributor will 384 indemnify the purchasing wholesale distributor for any loss 385 caused to the purchasing wholesale distributor related to the 386 purchase of drugs from the selling wholesale distributor which 387 are determined to be counterfeit or to have been distributed in 388 violation of any federal or state law governing the distribution 389 of drugs. 390 (b)Determine that the selling wholesale distributor has 391 insurance coverage of not less than the greater of 1 percent of 392 the amount of total dollar volume of the prescription drug sales 393 reported to the department under s. 499.012(8)(g) or $500,000; 394 however the coverage need not exceed $2 million. 395 (c)Obtain information from the selling wholesale 396 distributor, including the length of time the selling wholesale 397 distributor has been licensed in this state, a copy of the 398 selling wholesale distributors licenses or permits, and 399 background information concerning the ownership of the selling 400 wholesale distributor, including the experience of the wholesale 401 distributor in the wholesale distribution of prescription drugs. 402 (d)Verify that the selling wholesale distributors Florida 403 permit is valid. 404 (e)Inspect the selling wholesale distributors licensed 405 establishment to document that it has a policies and procedures 406 manual relating to the distribution of drugs, the appropriate 407 temperature controlled environment for drugs requiring 408 temperature control, an alarm system, appropriate access 409 restrictions, and procedures to ensure that records related to 410 the wholesale distribution of prescription drugs are maintained 411 as required by law: 412 1.Before purchasing any drug from the wholesale 413 distributor, and at least once each subsequent year; or 414 2.Before purchasing any drug from the wholesale 415 distributor, and each subsequent year obtain a complete copy of 416 the most recent inspection report for the establishment which 417 was prepared by the department or the regulatory authority 418 responsible for wholesale distributors in the state in which the 419 establishment is located. 420 (16)(14)DISTRIBUTION REPORTING.Each prescription drug 421 wholesale distributor, out-of-state prescription drug wholesale 422 distributor, retail pharmacy drug wholesale distributor, 423 manufacturer, or repackager that engages in the wholesale 424 distribution of controlled substances as defined in s. 893.02 425 shall submit a report to the department of its receipts and 426 distributions of controlled substances listed in Schedule II, 427 Schedule III, Schedule IV, or Schedule V as provided in s. 428 893.03. Wholesale distributor facilities located within this 429 state shall report all transactions involving controlled 430 substances, and wholesale distributor facilities located outside 431 this state shall report all distributions to entities located in 432 this state. If the prescription drug wholesale distributor, out 433 of-state prescription drug wholesale distributor, retail 434 pharmacy drug wholesale distributor, manufacturer, or repackager 435 does not have any controlled substance distributions for the 436 month, a report shall be sent indicating that no distributions 437 occurred in the period. The report shall be submitted monthly by 438 the 20th of the next month, in the electronic format used for 439 controlled substance reporting to the Automation of Reports and 440 Consolidated Orders System division of the federal Drug 441 Enforcement Administration. Submission of electronic data must 442 be made in a secured Internet environment that allows for manual 443 or automated transmission. Upon successful transmission, an 444 acknowledgment page must be displayed to confirm receipt. The 445 report must contain the following information: 446 (a)The federal Drug Enforcement Administration 447 registration number of the wholesale distributing location. 448 (b)The federal Drug Enforcement Administration 449 registration number of the entity to which the drugs are 450 distributed or from which the drugs are received. 451 (c)The transaction code that indicates the type of 452 transaction. 453 (d)The National Drug Code identifier of the product and 454 the quantity distributed or received. 455 (e)The Drug Enforcement Administration Form 222 number or 456 Controlled Substance Ordering System Identifier on all Schedule 457 II transactions. 458 (f)The date of the transaction. 459 460 The department must share the reported data with the Department 461 of Law Enforcement and local law enforcement agencies upon 462 request and must monitor purchasing to identify purchasing 463 levels that are inconsistent with the purchasing entitys 464 clinical needs. The Department of Law Enforcement shall 465 investigate purchases at levels that are inconsistent with the 466 purchasing entitys clinical needs to determine whether 467 violations of chapter 893 have occurred. 468 (17)(15)DUE DILIGENCE OF PURCHASERS. 469 (a)Each prescription drug wholesale distributor, out-of 470 state prescription drug wholesale distributor, and retail 471 pharmacy drug wholesale distributor must establish and maintain 472 policies and procedures to credential physicians licensed under 473 chapter 458, chapter 459, chapter 461, or chapter 466 and 474 pharmacies that purchase or otherwise receive from the wholesale 475 distributor controlled substances listed in Schedule II or 476 Schedule III as provided in s. 893.03. The prescription drug 477 wholesale distributor, out-of-state prescription drug wholesale 478 distributor, or retail pharmacy drug wholesale distributor shall 479 maintain records of such credentialing and make the records 480 available to the department upon request. Such credentialing 481 must, at a minimum, include: 482 1.A determination of the clinical nature of the receiving 483 entity, including any specialty practice area. 484 2.A review of the receiving entitys history of Schedule 485 II and Schedule III controlled substance purchasing from the 486 wholesale distributor. 487 3.A determination that the receiving entitys Schedule II 488 and Schedule III controlled substance purchasing history, if 489 any, is consistent with and reasonable for that entitys 490 clinical business needs. 491 (b)A wholesale distributor must take reasonable measures 492 to identify its customers, understand the normal and expected 493 transactions conducted by those customers, and identify those 494 transactions that are suspicious in nature. A wholesale 495 distributor must establish internal policies and procedures for 496 identifying suspicious orders and preventing suspicious 497 transactions. A wholesale distributor must assess orders for 498 more than 7,500 unit doses of any one controlled substance in 499 any one month to determine whether the purchase is reasonable. 500 In making such assessments, a wholesale distributor may consider 501 the purchasing entitys clinical business needs, location, and 502 population served, in addition to other factors established in 503 the distributors policies and procedures. A wholesale 504 distributor must report to the department any regulated 505 transaction involving an extraordinary quantity of a listed 506 chemical, an uncommon method of payment or delivery, or any 507 other circumstance that the regulated person believes may 508 indicate that the listed chemical will be used in violation of 509 the law. The wholesale distributor shall maintain records that 510 document the report submitted to the department in compliance 511 with this paragraph. 512 (c)A wholesale distributor may not distribute controlled 513 substances to an entity if any criminal history record check for 514 any person associated with that entity shows that the person has 515 been convicted of, or entered a plea of guilty or nolo 516 contendere to, regardless of adjudication, a crime in any 517 jurisdiction related to controlled substances, the practice of 518 pharmacy, or the dispensing of medicinal drugs. 519 Section 3.Paragraph (b) of subsection (3) of section 520 465.022, Florida Statutes, is amended to read: 521 465.022Pharmacies; general requirements; fees. 522 (3)Any person or business entity, before engaging in the 523 operation of a pharmacy, shall file with the board a sworn 524 application on forms provided by the department. For purposes of 525 this section, any person required to provide fingerprints under 526 this subsection is an affiliated person within the meaning of s. 527 465.023(1). 528 (b)The department shall annually submit the fingerprints 529 provided by the applicant to the Department of Law Enforcement 530 for a state criminal history records check. The Department of 531 Law Enforcement shall annually forward the fingerprints to the 532 Federal Bureau of Investigation for a national criminal history 533 records check. The department shall report the results of annual 534 criminal history records checks to wholesale distributors 535 permitted under chapter 499 for the purposes of s. 499.0121(17) 536 s. 499.0121(15). 537 Section 4.Paragraph (b) of subsection (48) of section 538 499.003, Florida Statutes, is amended to read: 539 499.003Definitions of terms used in this part.As used in 540 this part, the term: 541 (48)Wholesale distribution means the distribution of a 542 prescription drug to a person other than a consumer or patient, 543 or the receipt of a prescription drug by a person other than the 544 consumer or patient, but does not include: 545 (b)Any of the following activities, which is not a 546 violation of s. 499.005(21) if such activity is conducted in 547 accordance with rules established by the department: 548 1.The distribution of a prescription drug among federal, 549 state, or local government health care entities that are under 550 common control and are authorized to purchase such prescription 551 drug. 552 2.The distribution of a prescription drug or offer to 553 distribute a prescription drug for emergency medical reasons, 554 which may include transfers of prescription drugs by a retail 555 pharmacy to another retail pharmacy to alleviate a temporary 556 shortage. For purposes of this subparagraph, a drug shortage not 557 caused by a public health emergency does not constitute an 558 emergency medical reason. 559 3.The distribution of a prescription drug acquired by a 560 medical director on behalf of a licensed emergency medical 561 services provider to that emergency medical services provider 562 and its transport vehicles for use in accordance with the 563 providers license under chapter 401. 564 4.The donation of a prescription drug by a health care 565 entity to a charitable organization that has been granted an 566 exemption under s. 501(c)(3) of the Internal Revenue Code of 567 1986, as amended, and that is authorized to possess prescription 568 drugs. 569 5.The distribution of a prescription drug by a person 570 authorized to purchase or receive prescription drugs to a person 571 licensed or permitted to handle reverse distributions or 572 destruction under the laws of the jurisdiction in which the 573 person handling the reverse distribution or destruction receives 574 the drug. 575 6.The distribution of a prescription drug by a hospital or 576 other health care entity to a person licensed under this part to 577 repackage prescription drugs for the purpose of repackaging the 578 prescription drug for use by that hospital, or other health care 579 entity and other health care entities that are under common 580 control, if ownership of the prescription drugs remains with the 581 hospital or other health care entity at all times. In addition 582 to the recordkeeping requirements of s. 499.0121(8) s. 583 499.0121(6), the hospital or health care entity that distributes 584 prescription drugs pursuant to this subparagraph must reconcile 585 all drugs distributed and returned and resolve any discrepancies 586 in a timely manner. 587 Section 5.Subsections (15) and (16) of section 499.0051, 588 Florida Statutes, are amended to read: 589 499.0051Criminal acts. 590 (15)FALSE REPORT.Any person who submits a report required 591 by s. 499.0121(16) s. 499.0121(14) knowing that such report 592 contains a false statement commits a felony of the third degree, 593 punishable as provided in s. 775.082, s. 775.083, or s. 775.084. 594 (16)CONTROLLED SUBSTANCE DISTRIBUTION.Any person who 595 engages in the wholesale distribution of prescription drugs and 596 who knowingly distributes controlled substances in violation of 597 s. 499.0121(16) s. 499.0121(14) commits a felony of the third 598 degree, punishable as provided in s. 775.082, s. 775.083, or s. 599 775.084. In addition to any other fine that may be imposed, a 600 person convicted of such a violation may be sentenced to pay a 601 fine that does not exceed three times the gross monetary value 602 gained from such violation, plus court costs and the reasonable 603 costs of investigation and prosecution. 604 Section 6.Paragraph (m) of subsection (2), subsection (3), 605 and paragraphs (a), (b), and (c) of subsection (4) of section 606 499.01, Florida Statutes, are amended to read: 607 499.01Permits. 608 (2)The following permits are established: 609 (m)Limited prescription drug veterinary wholesale 610 distributor permit.Unless engaging in the activities of and 611 permitted as a prescription drug manufacturer, nonresident 612 prescription drug manufacturer, prescription drug wholesale 613 distributor, or out-of-state prescription drug wholesale 614 distributor, a limited prescription drug veterinary wholesale 615 distributor permit is required for any person that engages in 616 the distribution in or into this state of veterinary 617 prescription drugs and prescription drugs subject to, defined 618 by, or described by s. 503(b) of the Federal Food, Drug, and 619 Cosmetic Act under the following conditions: 620 1.The person is engaged in the business of wholesaling 621 prescription and veterinary prescription drugs to persons: 622 a.Licensed as veterinarians practicing on a full-time 623 basis; 624 b.Regularly and lawfully engaged in instruction in 625 veterinary medicine; 626 c.Regularly and lawfully engaged in law enforcement 627 activities; 628 d.For use in research not involving clinical use; or 629 e.For use in chemical analysis or physical testing or for 630 purposes of instruction in law enforcement activities, research, 631 or testing. 632 2.No more than 30 percent of total annual prescription 633 drug sales may be prescription drugs approved for human use 634 which are subject to, defined by, or described by s. 503(b) of 635 the Federal Food, Drug, and Cosmetic Act. 636 3.The person does not distribute in any jurisdiction 637 prescription drugs subject to, defined by, or described by s. 638 503(b) of the Federal Food, Drug, and Cosmetic Act to any person 639 who is authorized to sell, distribute, purchase, trade, or use 640 these drugs on or for humans. 641 4.A limited prescription drug veterinary wholesale 642 distributor that applies to the department for a new permit or 643 the renewal of a permit must submit a bond of $20,000, or other 644 equivalent means of security acceptable to the department, such 645 as an irrevocable letter of credit or a deposit in a trust 646 account or financial institution, payable to the Professional 647 Regulation Trust Fund. The purpose of the bond is to secure 648 payment of any administrative penalties imposed by the 649 department and any fees and costs incurred by the department 650 regarding that permit which are authorized under state law and 651 which the permittee fails to pay 30 days after the fine or costs 652 become final. The department may make a claim against such bond 653 or security until 1 year after the permittees license ceases to 654 be valid or until 60 days after any administrative or legal 655 proceeding authorized in this part which involves the permittee 656 is concluded, including any appeal, whichever occurs later. 657 5.A limited prescription drug veterinary wholesale 658 distributor must maintain at all times a license or permit to 659 engage in the wholesale distribution of prescription drugs in 660 compliance with laws of the state in which it is a resident. 661 6.A limited prescription drug veterinary wholesale 662 distributor must comply with the requirements for wholesale 663 distributors under s. 499.0121. 664 7.A limited prescription drug veterinary wholesale 665 distributor may not return to inventory for subsequent wholesale 666 distribution any prescription drug subject to, defined by, or 667 described by s. 503(b) of the Federal Food, Drug, and Cosmetic 668 Act which has been returned by a veterinarian. 669 8.A limited prescription drug veterinary wholesale 670 distributor permit is not required for an intracompany sale or 671 transfer of a prescription drug from an out-of-state 672 establishment that is duly licensed to engage in the wholesale 673 distribution of prescription drugs in its state of residence to 674 a licensed limited prescription drug veterinary wholesale 675 distributor in this state if both wholesale distributors conduct 676 wholesale distributions of prescription drugs under the same 677 business name. The recordkeeping requirements of s. 499.0121(8) 678 s. 499.0121(6) must be followed for this transaction. 679 (3)A nonresident prescription drug manufacturer permit is 680 not required for a manufacturer to distribute a prescription 681 drug active pharmaceutical ingredient that it manufactures to a 682 prescription drug manufacturer permitted in this state intended 683 for research and development and not for resale or human use 684 other than lawful clinical trials and biostudies authorized and 685 regulated by federal law. A manufacturer claiming to be exempt 686 from the permit requirements of this subsection and the 687 prescription drug manufacturer purchasing and receiving the 688 active pharmaceutical ingredient shall comply with the 689 recordkeeping requirements of s. 499.0121(8) s. 499.0121(6). The 690 prescription drug manufacturer purchasing and receiving the 691 active pharmaceutical ingredient shall maintain on file a record 692 of the FDA registration number; if available, the out-of-state 693 license, permit, or registration number; and, if available, a 694 copy of the most current FDA inspection report, for all 695 manufacturers from whom they purchase active pharmaceutical 696 ingredients under this section. The failure to comply with the 697 requirements of this subsection, or rules adopted by the 698 department to administer this subsection, for the purchase of 699 prescription drug active pharmaceutical ingredients is a 700 violation of s. 499.005(14), and a knowing failure is a 701 violation of s. 499.0051(3). 702 (a)The immediate package or container of a prescription 703 drug active pharmaceutical ingredient distributed into the state 704 that is intended for research and development under this 705 subsection shall bear a label prominently displaying the 706 statement: Caution: Research and Development OnlyNot for 707 Manufacturing, Compounding, or Resale. 708 (b)A prescription drug manufacturer that obtains a 709 prescription drug active pharmaceutical ingredient under this 710 subsection for use in clinical trials and or biostudies 711 authorized and regulated by federal law must create and maintain 712 records detailing the specific clinical trials or biostudies for 713 which the prescription drug active pharmaceutical ingredient was 714 obtained. 715 (4)(a)A permit issued under this part is not required to 716 distribute a prescription drug active pharmaceutical ingredient 717 from an establishment located in the United States to an 718 establishment located in this state permitted as a prescription 719 drug manufacturer under this part for use by the recipient in 720 preparing, deriving, processing, producing, or fabricating a 721 prescription drug finished dosage form at the establishment in 722 this state where the product is received under an approved and 723 otherwise valid New Drug Approval Application, Abbreviated New 724 Drug Application, New Animal Drug Application, or Therapeutic 725 Biologic Application, provided that the application, active 726 pharmaceutical ingredient, or finished dosage form has not been 727 withdrawn or removed from the market in this country for public 728 health reasons. 729 1.Any distributor claiming exemption from permitting 730 requirements pursuant to this paragraph shall maintain a 731 license, permit, or registration to engage in the wholesale 732 distribution of prescription drugs under the laws of the state 733 from which the product is distributed. If the state from which 734 the prescription drugs are distributed does not require a 735 license to engage in the wholesale distribution of prescription 736 drugs, the distributor must be licensed as a wholesale 737 distributor as required by the federal act. 738 2.Any distributor claiming exemption from permitting 739 requirements pursuant to this paragraph and the prescription 740 drug manufacturer purchasing and receiving the active 741 pharmaceutical ingredient shall comply with the recordkeeping 742 requirements of s. 499.0121(8) s. 499.0121(6). 743 (b)A permit issued under this part is not required to 744 distribute a prescription drug that has not been repackaged from 745 an establishment located in the United States to an 746 establishment located in this state permitted as a prescription 747 drug manufacturer under this part for research and development 748 or to a holder of a letter of exemption issued by the department 749 under s. 499.03(4) for research, teaching, or testing. 750 1.Any distributor claiming exemption from permitting 751 requirements pursuant to this paragraph shall maintain a 752 license, permit, or registration to engage in the wholesale 753 distribution of prescription drugs under the laws of the state 754 from which the product is distributed. If the state from which 755 the prescription drugs are distributed does not require a 756 license to engage in the wholesale distribution of prescription 757 drugs, the distributor must be licensed as a wholesale 758 distributor as required by the federal act. 759 2.All purchasers and recipients of any prescription drugs 760 distributed pursuant to this paragraph shall ensure that the 761 products are not resold or used, directly or indirectly, on 762 humans except in lawful clinical trials and biostudies 763 authorized and regulated by federal law. 764 3.Any distributor claiming exemption from permitting 765 requirements pursuant to this paragraph, and the purchaser and 766 recipient of the prescription drug, shall comply with the 767 recordkeeping requirements of s. 499.0121(8) s. 499.0121(6). 768 4.The immediate package or container of any active 769 pharmaceutical ingredient distributed into the state that is 770 intended for teaching, testing, research, and development shall 771 bear a label prominently displaying the statement: Caution: 772 Research, Teaching, or Testing Only Not for Manufacturing, 773 Compounding, or Resale. 774 (c)An out-of-state prescription drug wholesale distributor 775 permit is not required for an intracompany sale or transfer of a 776 prescription drug from an out-of-state establishment that is 777 duly licensed as a prescription drug wholesale distributor in 778 its state of residence to a licensed prescription drug wholesale 779 distributor in this state, if both wholesale distributors 780 conduct wholesale distributions of prescription drugs under the 781 same business name. The recordkeeping requirements of s. 782 499.0121(8) s. 499.0121(6) must be followed for such 783 transactions. 784 Section 7.Paragraph (p) of subsection (8) of section 785 499.012, Florida Statutes, is amended to read: 786 499.012Permit application requirements. 787 (8)An application for a permit or to renew a permit for a 788 prescription drug wholesale distributor or an out-of-state 789 prescription drug wholesale distributor submitted to the 790 department must include: 791 (p)Documentation of the credentialing policies and 792 procedures required by s. 499.0121(17) s. 499.0121(15). 793 Section 8.Section 499.01201, Florida Statutes, is amended 794 to read: 795 499.01201Agency for Health Care Administration review and 796 use of statute and rule violation or compliance data. 797 Notwithstanding any other provision of law, the Agency for 798 Health Care Administration may not: 799 (1)Review or use any violation or alleged violation of s. 800 499.0121(8) s. 499.0121(6), or any rules adopted under that 801 section, as a ground for denying or withholding any payment of a 802 Medicaid reimbursement to a pharmacy licensed under chapter 465; 803 or 804 (2)Review or use compliance with s. 499.0121(8) s. 805 499.0121(6), or any rules adopted under that section, as the 806 subject of any audit of Medicaid-related records held by a 807 pharmacy licensed under chapter 465. 808 Section 9.Paragraphs (m) and (n) of subsection (1) of 809 section 499.05, Florida Statutes, are amended to read: 810 499.05Rules. 811 (1)The department shall adopt rules to implement and 812 enforce this chapter with respect to: 813 (m)Wholesale distributor reporting requirements of s. 814 499.0121(16) s. 499.0121(14). 815 (n)Wholesale distributor credentialing and distribution 816 requirements of s. 499.0121(17) s. 499.0121(15). 817 Section 10.Subsections (8) and (9) of section 499.067, 818 Florida Statutes, are amended to read: 819 499.067Denial, suspension, or revocation of permit, 820 certification, or registration. 821 (8)The department may deny, suspend, or revoke a permit 822 under this part if it finds the permittee has not complied with 823 the credentialing requirements of s. 499.0121(17) s. 824 499.0121(15). 825 (9)The department may deny, suspend, or revoke a permit 826 under this part if it finds the permittee has not complied with 827 the reporting requirements of, or knowingly made a false 828 statement in a report required by, s. 499.0121(16) s. 829 499.0121(14). 830 Section 11.This act shall take effect July 1, 2025.