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