HB 283 2025
CODING: Words stricken are deletions; words underlined are additions.
hb283-00
Page 1 of 33
F L O R I D A H O U S E O F R E P R E S E N T A T I V E S
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 d epartments 10
to work or contract with counties and municipalities 11
and private entities; requiring the departments to 12
submit a specified report to the Governor and the 13
Legislature by a certain date; providing for an 14
appropriation; amending s. 499.0121, F.S.; providing 15
applicability; providing requirements for 16
establishments that store, warehouse, or hold certain 17
prescription drugs solely for the purpose of 18
destruction; amending ss. 465.022, 499.003, 499.0051, 19
499.01, 499.012, 499.01201, 499.05, and 499.067, F. S.; 20
conforming cross-references; providing an effective 21
date. 22
23
Be It Enacted by the Legislature of the State of Florida: 24
25
HB 283 2025
CODING: Words stricken are deletions; words underlined are additions.
hb283-00
Page 2 of 33
F L O R I D A H O U S E O F R E P R E S E N T A T I V E S
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 34
consider at least the following two methods of safe collection 35
in both rural and urban environme nts: 36
1. Sharps disposal by mail. 37
2. Sharps disposal at drop -off locations such as 38
pharmacies 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 i n 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
HB 283 2025
CODING: Words stricken are deletions; words underlined are additions.
hb283-00
Page 3 of 33
F L O R I D A H O U S E O F R E P R E S E N T A T I V E S
(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 60
methods practiced by health care and home health agency 61
professionals performing services in a patient's home, and any 62
recommendations 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
499.0121 Storage 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
HB 283 2025
CODING: Words stricken are deletions; words underlined are additions.
hb283-00
Page 4 of 33
F L O R I D A H O U S E O F R E P R E S E N T A T I V E S
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 79
V, and nonscheduled prescription drugs pursuant to s. 893.03, or 80
prescription drugs collected under a program authoriz ed by 21 81
C.F.R. s. 1317, subpart B, that 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, hel d, 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, 98
or vermin of any kind. 99
(3)(2) SECURITY.— 100
HB 283 2025
CODING: Words stricken are deletions; words underlined are additions.
hb283-00
Page 5 of 33
F L O R I D A H O U S E O F R E P R E S E N T A T I V E S
(a) An establishment that is used for wholesale drug 101
distribution must be secure from unauthor ized 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 perso nnel. 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 wholes ale 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 u nder appropriate conditions in 123
accordance with requirements, if any, in the labeling of such 124
drugs, or with requirements in the official compendium. 125
HB 283 2025
CODING: Words stricken are deletions; words underlined are additions.
hb283-00
Page 6 of 33
F L O R I D A H O U S E O F R E P R E S E N T A T I V E S
(a) If no storage requirements are established for a 126
prescription drug, the drug may be held at "controll ed" 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
HB 283 2025
CODING: Words stricken are deletions; words underlined are additions.
hb283-00
Page 7 of 33
F L O R I D A H O U S E O F R E P R E S E N T A T I V E S
records required und er 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 PRESCRIPTIO N 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 166
sealed outer containers or sealed secondary containers have been 167
opened or used must be identified as such and must be 168
quarantined and physically separated from other prescription 169
drugs until they 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 drug's 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
HB 283 2025
CODING: Words stricken are deletions; words underlined are additions.
hb283-00
Page 8 of 33
F L O R I D A H O U S E O F R E P R E S E N T A T I V E S
of safety, identity, strength, quality, and purity. In 176
determining whether the conditions u nder which a drug has been 177
returned cast doubt on the drug's 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 adult erated 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 Sche dule 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 locat ion from 200
HB 283 2025
CODING: Words stricken are deletions; words underlined are additions.
hb283-00
Page 9 of 33
F L O R I D A H O U S E O F R E P R E S E N T A T I V E S
which the prescription drugs were collected and a formulary or 201
description of that location's 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 208
that require keeping such records of prescription drugs, 209
including active pharmaceutical ingredients, as are necessary 210
for the 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 und er 214
this 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 ingredient s 219
or prescription drugs. 220
(b) Business records for persons specified in paragraph 221
(a) 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
HB 283 2025
CODING: Words stricken are deletions; words underlined are additions.
hb283-00
Page 10 of 33
F L O R I D A H O U S E O F R E P R E S E N T A T I V E S
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 pha rmaceutical 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
HB 283 2025
CODING: Words stricken are deletions; words underlined are additions.
hb283-00
Page 11 of 33
F L O R I D A H O U S E O F R E P R E S E N T A T I V E S
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 p aragraph 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
HB 283 2025
CODING: Words stricken are deletions; words underlined are additions.
hb283-00
Page 12 of 33
F L O R I D A H O U S E O F R E P R E S E N T A T I V E S
(f) Records required to be kept pursuant to this 276
subsection must be maintained as specified for a period of not 277
less than 6 years from the date of disposition of the active 278
pharmaceutical ingredients, prescription drugs, over -the-counter 279
drugs, medical devices, or cosmetics. 280
(g) To the extent that prescription drugs are also 281
products as defined in the federal act, as amended, and the 282
information required by the business rec ords requirements of 283
this section are also included in the tracking and tracing 284
requirements of the federal act, as amended, and departmental 285
rules, the manufacturer, wholesale distributor, repackager, or 286
dispenser must follow both the requirements of the federal act, 287
as 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 polic ies and procedures for identifying, 300
HB 283 2025
CODING: Words stricken are deletions; words underlined are additions.
hb283-00
Page 13 of 33
F L O R I D A H O U S E O F R E P R E S E N T A T I V E S
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 prescript ion 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 312
Drug 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 imp roved 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 lo cal, state, or national 325
HB 283 2025
CODING: Words stricken are deletions; words underlined are additions.
hb283-00
Page 14 of 33
F L O R I D A H O U S E O F R E P R E S E N T A T I V E S
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 o f 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, man agers, 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 a nd 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
HB 283 2025
CODING: Words stricken are deletions; words underlined are additions.
hb283-00
Page 15 of 33
F L O R I D A H O U S E O F R E P R E S E N T A T I V E S
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 sco pe 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 re cipient 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
HB 283 2025
CODING: Words stricken are deletions; words underlined are additions.
hb283-00
Page 16 of 33
F L O R I D A H O U S E O F R E P R E S E N T A T I V E S
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 i n this state, a copy of the 398
selling wholesale distributor's licenses or permits, and 399
background information concerning the ownership of the selling 400
HB 283 2025
CODING: Words stricken are deletions; words underlined are additions.
hb283-00
Page 17 of 33
F L O R I D A H O U S E O F R E P R E S E N T A T I V E S
wholesale distributor, including the experience of the wholesale 401
distributor in the wholesale distribution o f prescription drugs. 402
(d) Verify that the selling wholesale distributor's 403
Florida permit is valid. 404
(e) Inspect the selling wholesale distributor's licensed 405
establishment to document that it has a policies and procedures 406
manual relating to the distribut ion 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 ar e 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
HB 283 2025
CODING: Words stricken are deletions; words underlined are additions.
hb283-00
Page 18 of 33
F L O R I D A H O U S E O F R E P R E S E N T A T I V E S
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 rep ort 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 o f 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
HB 283 2025
CODING: Words stricken are deletions; words underlined are additions.
hb283-00
Page 19 of 33
F L O R I D A H O U S E O F R E P R E S E N T A T I V E S
distributed or from which the drugs ar e 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 pu rchasing to identify purchasing 463
levels that are inconsistent with the purchasing entity's 464
clinical needs. The Department of Law Enforcement shall 465
investigate purchases at levels that are inconsistent with the 466
purchasing entity's 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 establi sh 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
HB 283 2025
CODING: Words stricken are deletions; words underlined are additions.
hb283-00
Page 20 of 33
F L O R I D A H O U S E O F R E P R E S E N T A T I V E S
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 entity's history of Schedul e 485
II and Schedule III controlled substance purchasing from the 486
wholesale distributor. 487
3. A determination that the receiving entity's Schedule II 488
and Schedule III controlled substance purchasing history, if 489
any, is consistent with and reasonable for that entity's 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 na ture. 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 substanc e in 499
any one month to determine whether the purchase is reasonable. 500
HB 283 2025
CODING: Words stricken are deletions; words underlined are additions.
hb283-00
Page 21 of 33
F L O R I D A H O U S E O F R E P R E S E N T A T I V E S
In making such assessments, a wholesale distributor may consider 501
the purchasing entity's clinical business needs, location, and 502
population served, in addition to other factors established in 503
the distributor's 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 tha t 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, regardl ess 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
465.022 Pharmacies; 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
HB 283 2025
CODING: Words stricken are deletions; words underlined are additions.
hb283-00
Page 22 of 33
F L O R I D A H O U S E O F R E P R E S E N T A T I V E S
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
499.003 Definitions 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
HB 283 2025
CODING: Words stricken are deletions; words underlined are additions.
hb283-00
Page 23 of 33
F L O R I D A H O U S E O F R E P R E S E N T A T I V E S
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
provider's 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 i n which the 573
person handling the reverse distribution or destruction receives 574
the drug. 575
HB 283 2025
CODING: Words stricken are deletions; words underlined are additions.
hb283-00
Page 24 of 33
F L O R I D A H O U S E O F R E P R E S E N T A T I V E S
6. The distribution of a prescription drug by a hospital 576
or other health care entity to a person licensed under this part 577
to repackage prescription drugs for the purpo se of repackaging 578
the prescription drug for use by that hospital, or other health 579
care 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 di screpancies 586
in a timely manner. 587
Section 5. Subsection (15) of section 499.0051, Florida 588
Statutes, is amended to read: 589
499.0051 Criminal acts. — 590
(15) FALSE REPORT.—Any person who submits a report 591
required by s. 499.0121(16) s. 499.0121(14) knowing that such 592
report contains a false statement commits a felony of the third 593
degree, punishable as provided in s. 775.082, s. 775.083, or s. 594
775.084. 595
Section 6. Paragraph (m) of subsection (2), subsection 596
(3), and paragraphs (a), (b), and (c) of subsection (4) of 597
section 499.01, Florida Statutes, are amended to read: 598
499.01 Permits.— 599
(2) The following permits are established: 600
HB 283 2025
CODING: Words stricken are deletions; words underlined are additions.
hb283-00
Page 25 of 33
F L O R I D A H O U S E O F R E P R E S E N T A T I V E S
(m) Limited prescription drug veterinary wholesale 601
distributor permit.—Unless engaging in the activities of and 602
permitted as a prescription drug manufacturer, nonresident 603
prescription drug manufacturer, prescription drug wholesale 604
distributor, or out-of-state prescription drug wholesale 605
distributor, a limited prescription drug veterinary wholesale 606
distributor permit is required for any person that engages in 607
the distribution in or into this state of veterinary 608
prescription drugs and prescription drugs subject to, defined 609
by, or described by s. 503(b) of the Federal Food, Drug, and 610
Cosmetic Act under the following conditions: 611
1. The person is engaged in the business of wholesaling 612
prescription and veterinary prescription drugs to persons: 613
a. Licensed as veterinarians practicing on a full -time 614
basis; 615
b. Regularly and lawfully engaged in instruction in 616
veterinary medicine; 617
c. Regularly and lawfully engaged in law enforcement 618
activities; 619
d. For use in research not involving clinical use; or 620
e. For use in chemical analysis or physical testing or for 621
purposes of instruction in law enforcement activities, research, 622
or testing. 623
2. No more than 30 percent of total annual prescription 624
drug sales may be prescription drugs approved for human use 625
HB 283 2025
CODING: Words stricken are deletions; words underlined are additions.
hb283-00
Page 26 of 33
F L O R I D A H O U S E O F R E P R E S E N T A T I V E S
which are subject to, defined by, or described by s. 503(b) of 626
the Federal Food, Drug, and Cosmetic Act. 627
3. The person does not distribute in any jurisdiction 628
prescription drugs subject to, defined by, or described by s. 629
503(b) of the Federal Food, Drug, and Cosmetic Act to any person 630
who is authorized to sell, distribute, purchase, trade, or use 631
these drugs on or for humans. 632
4. A limited prescription drug veterinary wholesale 633
distributor that applies to the department for a new permit or 634
the renewal of a permit must submit a bond of $20,000, or other 635
equivalent means of security acceptable to the department, such 636
as an irrevocable letter o f credit or a deposit in a trust 637
account or financial institution, payable to the Professional 638
Regulation Trust Fund. The purpose of the bond is to secure 639
payment of any administrative penalties imposed by the 640
department and any fees and costs incurred by the department 641
regarding that permit which are authorized under state law and 642
which the permittee fails to pay 30 days after the fine or costs 643
become final. The department may make a claim against such bond 644
or security until 1 year after the permittee's li cense ceases to 645
be valid or until 60 days after any administrative or legal 646
proceeding authorized in this part which involves the permittee 647
is concluded, including any appeal, whichever occurs later. 648
5. A limited prescription drug veterinary wholesale 649
distributor must maintain at all times a license or permit to 650
HB 283 2025
CODING: Words stricken are deletions; words underlined are additions.
hb283-00
Page 27 of 33
F L O R I D A H O U S E O F R E P R E S E N T A T I V E S
engage in the wholesale distribution of prescription drugs in 651
compliance with laws of the state in which it is a resident. 652
6. A limited prescription drug veterinary wholesale 653
distributor must comply with the requirements for wholesale 654
distributors under s. 499.0121. 655
7. A limited prescription drug veterinary wholesale 656
distributor may not return to inventory for subsequent wholesale 657
distribution any prescription drug subject to, defined by, or 658
described by s. 503(b) of the Federal Food, Drug, and Cosmetic 659
Act which has been returned by a veterinarian. 660
8. A limited prescription drug veterinary wholesale 661
distributor permit is not required for an intracompany sale or 662
transfer of a prescription drug from an out-of-state 663
establishment that is duly licensed to engage in the wholesale 664
distribution of prescription drugs in its state of residence to 665
a licensed limited prescription drug veterinary wholesale 666
distributor in this state if both wholesale distr ibutors conduct 667
wholesale distributions of prescription drugs under the same 668
business name. The recordkeeping requirements of s. 499.0121(8) 669
s. 499.0121(6) must be followed for this transaction. 670
(3) A nonresident prescription drug manufacturer permit is 671
not required for a manufacturer to distribute a prescription 672
drug active pharmaceutical ingredient that it manufactures to a 673
prescription drug manufacturer permitted in this state intended 674
for research and development and not for resale or human use 675
HB 283 2025
CODING: Words stricken are deletions; words underlined are additions.
hb283-00
Page 28 of 33
F L O R I D A H O U S E O F R E P R E S E N T A T I V E S
other than lawful clinical trials and biostudies authorized and 676
regulated by federal law. A manufacturer claiming to be exempt 677
from the permit requirements of this subsection and the 678
prescription drug manufacturer purchasing and receiving the 679
active pharmaceutical ingredient shall comply with the 680
recordkeeping requirements of s. 499.0121(8) s. 499.0121(6). The 681
prescription drug manufacturer purchasing and receiving the 682
active pharmaceutical ingredient shall maintain on file a record 683
of the FDA registration number ; if available, the out -of-state 684
license, permit, or registration number; and, if available, a 685
copy of the most current FDA inspection report, for all 686
manufacturers from whom they purchase active pharmaceutical 687
ingredients under this section. The failure t o comply with the 688
requirements of this subsection, or rules adopted by the 689
department to administer this subsection, for the purchase of 690
prescription drug active pharmaceutical ingredients is a 691
violation of s. 499.005(14), and a knowing failure is a 692
violation of s. 499.0051(3). 693
(a) The immediate package or container of a prescription 694
drug active pharmaceutical ingredient distributed into the state 695
that is intended for research and development under this 696
subsection shall bear a label prominently displaying the 697
statement: "Caution: Research and Development Only —Not for 698
Manufacturing, Compounding, or Resale." 699
(b) A prescription drug manufacturer that obtains a 700
HB 283 2025
CODING: Words stricken are deletions; words underlined are additions.
hb283-00
Page 29 of 33
F L O R I D A H O U S E O F R E P R E S E N T A T I V E S
prescription drug active pharmaceutical ingredient under this 701
subsection for use in clinical trial s and or biostudies 702
authorized and regulated by federal law must create and maintain 703
records detailing the specific clinical trials or biostudies for 704
which the prescription drug active pharmaceutical ingredient was 705
obtained. 706
(4)(a) A permit issued under this part is not required to 707
distribute a prescription drug active pharmaceutical ingredient 708
from an establishment located in the United States to an 709
establishment located in this state permitted as a prescription 710
drug manufacturer under this part for use by the recipient in 711
preparing, deriving, processing, producing, or fabricating a 712
prescription drug finished dosage form at the establishment in 713
this state where the product is received under an approved and 714
otherwise valid New Drug Approval Application, Ab breviated New 715
Drug Application, New Animal Drug Application, or Therapeutic 716
Biologic Application, provided that the application, active 717
pharmaceutical ingredient, or finished dosage form has not been 718
withdrawn or removed from the market in this country for public 719
health reasons. 720
1. Any distributor claiming exemption from permitting 721
requirements pursuant to this paragraph shall maintain a 722
license, permit, or registration to engage in the wholesale 723
distribution of prescription drugs under the laws of the st ate 724
from which the product is distributed. If the state from which 725
HB 283 2025
CODING: Words stricken are deletions; words underlined are additions.
hb283-00
Page 30 of 33
F L O R I D A H O U S E O F R E P R E S E N T A T I V E S
the prescription drugs are distributed does not require a 726
license to engage in the wholesale distribution of prescription 727
drugs, the distributor must be licensed as a wholesale 728
distributor as required by the federal act. 729
2. Any distributor claiming exemption from permitting 730
requirements pursuant to this paragraph and the prescription 731
drug manufacturer purchasing and receiving the active 732
pharmaceutical ingredient shall comply with the recor dkeeping 733
requirements of s. 499.0121(8) s. 499.0121(6). 734
(b) A permit issued under this part is not required to 735
distribute a prescription drug that has not been repackaged from 736
an establishment located in the United States to an 737
establishment located in t his state permitted as a prescription 738
drug manufacturer under this part for research and development 739
or to a holder of a letter of exemption issued by the department 740
under s. 499.03(4) for research, teaching, or testing. 741
1. Any distributor claiming exemp tion from permitting 742
requirements pursuant to this paragraph shall maintain a 743
license, permit, or registration to engage in the wholesale 744
distribution of prescription drugs under the laws of the state 745
from which the product is distributed. If the state fro m which 746
the prescription drugs are distributed does not require a 747
license to engage in the wholesale distribution of prescription 748
drugs, the distributor must be licensed as a wholesale 749
distributor as required by the federal act. 750
HB 283 2025
CODING: Words stricken are deletions; words underlined are additions.
hb283-00
Page 31 of 33
F L O R I D A H O U S E O F R E P R E S E N T A T I V E S
2. All purchasers and rec ipients of any prescription drugs 751
distributed pursuant to this paragraph shall ensure that the 752
products are not resold or used, directly or indirectly, on 753
humans except in lawful clinical trials and biostudies 754
authorized and regulated by federal law. 755
3. Any distributor claiming exemption from permitting 756
requirements pursuant to this paragraph, and the purchaser and 757
recipient of the prescription drug, shall comply with the 758
recordkeeping requirements of s. 499.0121(8) s. 499.0121(6). 759
4. The immediate pack age or container of any active 760
pharmaceutical ingredient distributed into the state that is 761
intended for teaching, testing, research, and development shall 762
bear a label prominently displaying the statement: "Caution: 763
Research, Teaching, or Testing Only – Not for Manufacturing, 764
Compounding, or Resale." 765
(c) An out-of-state prescription drug wholesale 766
distributor permit is not required for an intracompany sale or 767
transfer of a prescription drug from an out -of-state 768
establishment that is duly licensed as a pr escription drug 769
wholesale distributor in its state of residence to a licensed 770
prescription drug wholesale distributor in this state, if both 771
wholesale distributors conduct wholesale distributions of 772
prescription drugs under the same business name. The 773
recordkeeping requirements of s. 499.0121(8) s. 499.0121(6) must 774
be followed for such transactions. 775
HB 283 2025
CODING: Words stricken are deletions; words underlined are additions.
hb283-00
Page 32 of 33
F L O R I D A H O U S E O F R E P R E S E N T A T I V E S
Section 7. Paragraph (p) of subsection (8) of section 776
499.012, Florida Statutes, is amended to read: 777
499.012 Permit application requirements. — 778
(8) An application for a permit or to renew a permit for a 779
prescription drug wholesale distributor or an out -of-state 780
prescription drug wholesale distributor submitted to the 781
department must include: 782
(p) Documentation of the credentialing policies and 783
procedures required by s. 499.0121(17) s. 499.0121(15). 784
Section 8. Section 499.01201, Florida Statutes, is amended 785
to read: 786
499.01201 Agency for Health Care Administration review and 787
use of statute and rule violation or compliance data. —788
Notwithstanding any ot her provision of law, the Agency for 789
Health Care Administration may not: 790
(1) Review or use any violation or alleged violation of s. 791
499.0121(8) s. 499.0121(6), or any rules adopted under that 792
section, as a ground for denying or withholding any payment of a 793
Medicaid reimbursement to a pharmacy licensed under chapter 465; 794
or 795
(2) Review or use compliance with s. 499.0121(8) s. 796
499.0121(6), or any rules adopted under that section, as the 797
subject of any audit of Medicaid -related records held by a 798
pharmacy licensed under chapter 465. 799
Section 9. Paragraphs (m) and (n) of subsection (1) of 800
HB 283 2025
CODING: Words stricken are deletions; words underlined are additions.
hb283-00
Page 33 of 33
F L O R I D A H O U S E O F R E P R E S E N T A T I V E S
section 499.05, Florida Statutes, are amended to read: 801
499.05 Rules.— 802
(1) The department shall adopt rules to implement and 803
enforce this chapter with respect to: 804
(m) Wholesale distributor reporting requirements of s. 805
499.0121(16) s. 499.0121(14). 806
(n) Wholesale distributor credentialing and distribution 807
requirements of s. 499.0121(17) s. 499.0121(15). 808
Section 10. Subsections (8) and (9) of section 499.067, 809
Florida Statutes, are amended to read: 810
499.067 Denial, suspension, or revocation of permit, 811
certification, or registration. — 812
(8) The department may deny, suspend, or revoke a permit 813
under this part if it finds the permittee has not complied with 814
the credentialing requirements of s. 499.0121(17) s. 815
499.0121(15). 816
(9) The department may deny, suspend, or revoke a permit 817
under this part if it finds the permittee has not complied with 818
the reporting requirements of, or knowingly made a false 819
statement in a report required by, s. 499.0121(16) s. 820
499.0121(14). 821
Section 11. This act shall take effect July 1, 2025. 822