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