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THE BILL ITSELF

SB 262

Storage and Disposal of Prescription Drugs and Sharps

VERSION S 262 Filed · BACK TO THE SUMMARY · OFFICIAL RECORD

underlined language is being added; struck language is being deleted. Line numbers are the Legislature's own — the same ones amendments cite.

Florida Senate - 2026 SB 262 By Senator Burgess 23-00201B-26 2026262__
1 A bill to be entitled
2 An act relating to storage and disposal of
3 prescription drugs and sharps; amending s. 499.0121,
4 F.S.; exempting an establishment that stores,
5 warehouses, or holds noncontrolled prescription drugs
6 solely for the purpose of arranging for their
7 destruction from compliance with specified provisions;
8 requiring such establishments to maintain certain
9 information; making a technical change; providing an
10 effective date.
12 Be It Enacted by the Legislature of the State of Florida:
14 Section 1. Section 499.0121, Florida Statutes, is amended
15 to read:
16 499.0121 Storage and handling of prescription drugs;
17 recordkeeping.— The department shall adopt rules to implement
18 this section as necessary to protect the public health, safety,
19 and welfare. Such rules shall include, but not be limited to,
20 requirements for the storage and handling of prescription drugs
21 and for the establishment and maintenance of prescription drug
22 distribution records.
23 (1) ESTABLISHMENTS.—An establishment at which prescription
24 drugs are stored, warehoused, handled, held, offered, marketed,
25 or displayed must:
26 (a) Be of suitable size and construction to facilitate
27 cleaning, maintenance, and proper operations;
28 (b) Have storage areas designed to provide adequate
29 lighting, ventilation, temperature, sanitation, humidity, space,
30 equipment, and security conditions;
31 (c) Have a quarantine area for storage of prescription
32 drugs that are outdated, damaged, deteriorated, misbranded, or
33 adulterated, or that are in immediate or sealed, secondary
34 containers that have been opened;
35 (d) Be maintained in a clean and orderly condition; and
36 (e) Be free from infestation by insects, rodents, birds, or
37 vermin of any kind.
38 (2) SECURITY.—
39 (a) An establishment that is used for wholesale drug
40 distribution must be secure from unauthorized entry.
41 1. Access from outside the premises must be kept to a
42 minimum and be well controlled.
43 2. The outside perimeter of the premises must be well
44 lighted.
45 3. Entry into areas where prescription drugs are held must
46 be limited to authorized personnel.
47 (b) An establishment that is used for wholesale drug
48 distribution must be equipped with:
49 1. An alarm system to detect entry after hours; however,
50 the department may exempt by rule establishments that only hold
51 a permit as prescription drug wholesale distributor-brokers; and
52 2. A security system that will provide suitable protection
53 against theft and diversion. When appropriate, the security
54 system must provide protection against theft or diversion that
55 is facilitated or hidden by tampering with computers or
56 electronic records.
57 (c) Any vehicle that contains prescription drugs must be
58 secure from unauthorized access to the prescription drugs in the
59 vehicle.
60 (3) STORAGE.—All prescription drugs shall be stored at
61 appropriate temperatures and under appropriate conditions in
62 accordance with requirements, if any, in the labeling of such
63 drugs, or with requirements in the official compendium.
64 (a) If no storage requirements are established for a
65 prescription drug, the drug may be held at “controlled” room
66 temperature, as defined in the official compendium, to help
67 ensure that its identity, strength, quality, and purity are not
68 adversely affected.
69 (b) Appropriate manual, electromechanical, or electronic
70 temperature and humidity recording equipment, devices, or logs
71 must be used to document proper storage of prescription drugs.
72 (c) The recordkeeping requirements in subsection (6) must
73 be followed for all stored prescription drugs.
74 (4) EXAMINATION OF MATERIALS AND RECORDS.—
75 (a) Upon receipt, each outside shipping container must be
76 visually examined for identity and to prevent the acceptance of
77 contaminated prescription drugs that are otherwise unfit for
78 distribution. This examination must be adequate to reveal
79 container damage that would suggest possible contamination or
80 other damage to the contents.
81 (b) Each outgoing shipment must be carefully inspected for
82 identity of the prescription drug products and to ensure that
83 there is no delivery of prescription drugs that have expired or
84 been damaged in storage or held under improper conditions.
85 (c) The recordkeeping requirements in subsection (6) must
86 be followed for all incoming and outgoing prescription drugs.
87 (d) Upon receipt, a wholesale distributor must review
88 records required under this section for the acquisition of
89 prescription drugs for accuracy and completeness, considering
90 the total facts and circumstances surrounding the transactions
91 and the wholesale distributors involved.
92 (5) RETURNED, DAMAGED, OR OUTDATED PRESCRIPTION DRUGS.—
93 (a)1. Prescription drugs that are outdated, damaged,
94 deteriorated, misbranded, or adulterated must be quarantined and
95 physically separated from other prescription drugs until they
96 are destroyed or returned to their supplier. A quarantine
97 section must be separate and apart from other sections where
98 prescription drugs are stored so that prescription drugs in this
99 section are not confused with usable prescription drugs.
100 2. Prescription drugs must be examined at least every 12
101 months, and drugs for which the expiration date has passed must
102 be removed and quarantined.
103 (b) Any prescription drugs of which the immediate or sealed
104 outer containers or sealed secondary containers have been opened
105 or used must be identified as such and must be quarantined and
106 physically separated from other prescription drugs until they
107 are destroyed or returned to the supplier.
108 (c) If the conditions under which a prescription drug has
109 been returned cast doubt on the drug’s safety, identity,
110 strength, quality, or purity, the drug must be destroyed or
111 returned to the supplier, unless examination, testing, or other
112 investigation proves that the drug meets appropriate standards
113 of safety, identity, strength, quality, and purity. In
114 determining whether the conditions under which a drug has been
115 returned cast doubt on the drug’s safety, identity, strength,
116 quality, or purity, the wholesale distributor must consider,
117 among other things, the conditions under which the drug has been
118 held, stored, or shipped before or during its return and the
119 conditions of the drug and its container, carton, or labeling,
120 as a result of storage or shipping.
121 (d) The recordkeeping requirements in subsection (6) must
122 be followed for all outdated, damaged, deteriorated, misbranded,
123 or adulterated prescription drugs.
124 (6) RECORDKEEPING.—The department shall adopt rules that
125 require keeping such records of prescription drugs, including
126 active pharmaceutical ingredients, as are necessary for the
127 protection of the public health.
128 (a) The following persons must maintain business records
129 that include the information specified in paragraph (b):
130 1. Persons permitted or required to be permitted under this
131 chapter to engage in the manufacture, repackaging, or
132 distribution of active pharmaceutical ingredients or
133 prescription drugs.
134 2. Persons other than those set forth in subparagraph 1.
135 that engage in the receipt of active pharmaceutical ingredients
136 or prescription drugs.
137 (b) Business records for persons specified in paragraph (a)
138 must include:
139 1. The name and address of the seller, and the Florida
140 permit number of the seller if such seller is not exempt from
141 Florida permitting requirements, of the active pharmaceutical
142 ingredient or prescription drug.
143 2. The address of the location the active pharmaceutical
144 ingredient or prescription drug was shipped from.
145 3. The distribution date of the active pharmaceutical
146 ingredient or prescription drug.
147 4. The name, strength, and quantity, and the National Drug
148 Code if such code has been assigned, of the distributed active
149 pharmaceutical ingredient or prescription drug.
150 5. The name and Florida permit number of the person that
151 purchased the active pharmaceutical ingredient or prescription
152 drug.
153 6. The financial data, including the unit type and unit
154 price, for the distributions involving active pharmaceutical
155 ingredients or prescription drugs.
156 7. The date and method of disposition of the active
157 pharmaceutical ingredient or prescription drug.
158 (c) Each manufacturer or repackager of medical devices,
159 over-the-counter drugs, or cosmetics must maintain business
160 records that include:
161 1. The name and address of the seller or transferor of the
162 product.
163 2. The address of the location the product was shipped
164 from.
165 3. The date of the sale or distribution of the product.
166 4. The name and quantity of the product involved.
167 5. The name and address of the person who purchased the
168 product.
169 (d) Persons permitted, or required to be permitted, under
170 this chapter to engage in the manufacture, repackaging, or
171 distribution of active pharmaceutical ingredients or
172 prescription drugs; or the manufacture or repackaging of medical
173 devices, over-the-counter drugs, and cosmetics; must establish,
174 maintain, or have the capability to create a current inventory
175 of the active pharmaceutical ingredients, prescription drugs,
176 over-the-counter drugs, cosmetics, and devices at an
177 establishment where activities specified in this paragraph are
178 undertaken and must be able to produce such inventory for
179 inspection by the department within 2 business days.
180 (e) Business records required to be kept pursuant to this
181 section, and that are kept at the inspection site or can be
182 immediately retrieved by computer or other electronic means,
183 must be readily available for authorized inspection during the
184 retention period. Records kept at a central location outside of
185 this state which are not electronically retrievable must be made
186 available for inspection within 2 working days after a request
187 by an authorized official of a federal, state, or local law
188 enforcement agency. Records maintained at a central location
189 within this state must be maintained at an establishment that is
190 permitted pursuant to this part, and such records must be
191 readily available for inspection.
192 (f) Records required to be kept pursuant to this subsection
193 must be maintained as specified for a period of not less than 6
194 years from the date of disposition of the active pharmaceutical
195 ingredients, prescription drugs, over-the-counter drugs, medical
196 devices, or cosmetics.
197 (g) To the extent that prescription drugs are also products
198 as defined in the federal act, as amended, and the information
199 required by the business records requirements of this section
200 are also included in the tracking and tracing requirements of
201 the federal act, as amended, and departmental rules, the
202 manufacturer, wholesale distributor, repackager, or dispenser
203 must follow both the requirements of the federal act, as
204 amended, and departmental rules.
205 (7) PRESCRIPTION DRUG PURCHASE LIST.—Each wholesale
206 distributor, except for a manufacturer, shall annually provide
207 the department with a written list of all wholesale distributors
208 and manufacturers from whom the wholesale distributor purchases
209 prescription drugs. A wholesale distributor, except a
210 manufacturer, shall notify the department not later than 10 days
211 after any change to either list.
212 (8) WRITTEN POLICIES AND PROCEDURES.—Wholesale distributors
213 must establish, maintain, and adhere to written policies and
214 procedures, which must be followed for the receipt, security,
215 storage, inventory, and distribution of prescription drugs,
216 including policies and procedures for identifying, recording,
217 and reporting losses or thefts, and for correcting all errors
218 and inaccuracies in inventories. Wholesale distributors must
219 include in their written policies and procedures:
220 (a) A procedure whereby the oldest approved stock of a
221 prescription drug product is distributed first. The procedure
222 may permit deviation from this requirement, if the deviation is
223 temporary and appropriate.
224 (b) A procedure to be followed for handling recalls and
225 withdrawals of prescription drugs. Such procedure must be
226 adequate to deal with recalls and withdrawals due to:
227 1. Any action initiated at the request of the Food and Drug
228 Administration or any other federal, state, or local law
229 enforcement or other government agency, including the
230 department.
231 2. Any voluntary action by the manufacturer or repackager
232 to remove defective or potentially defective drugs from the
233 market; or
234 3. Any action undertaken to promote public health and
235 safety by replacing existing merchandise with an improved
236 product or new package design.
237 (c) A procedure to ensure that wholesale distributors
238 prepare for, protect against, and handle any crisis that affects
239 security or operation of any facility if a strike, fire, flood,
240 or other natural disaster, or a local, state, or national
241 emergency, occurs.
242 (d) A procedure to ensure that any outdated prescription
243 drugs are segregated from other drugs and returned to the
244 manufacturer or repackager or destroyed. This procedure must
245 provide for written documentation of the disposition of outdated
246 prescription drugs. This documentation must be maintained for 2
247 years after disposition of the outdated drugs.
248 (9) RESPONSIBLE PERSONS.—Wholesale distributors must
249 establish and maintain lists of officers, directors, managers,
250 designated representatives, and other persons in charge of
251 wholesale drug distribution, storage, and handling, including a
252 description of their duties and a summary of their
253 qualifications.
254 (10) COMPLIANCE WITH FEDERAL, STATE, AND LOCAL LAW.—A
255 wholesale distributor must operate in compliance with applicable
256 federal, state, and local laws and regulations.
257 (a) A wholesale distributor must allow the department and
258 authorized federal, state, and local officials to enter and
259 inspect its premises and delivery vehicles, and to audit its
260 records and written operating procedures, at reasonable times
261 and in a reasonable manner, to the extent authorized by law.
262 (b) A wholesale distributor that deals in controlled
263 substances must register with the Drug Enforcement
264 Administration and must comply with all applicable state, local,
265 and federal laws. A wholesale distributor that distributes any
266 substance controlled under chapter 893 must notify the
267 department when registering with the Drug Enforcement
268 Administration pursuant to that chapter and must provide the
269 department with its DEA number.
270 (11) SALVAGING AND REPROCESSING.—A wholesale distributor is
271 subject to any applicable federal, state, or local laws or
272 regulations that relate to prescription drug product salvaging
273 or reprocessing.
274 (12) SHIPPING AND TRANSPORTATION.—The person responsible
275 for shipment and transportation of a prescription drug in a
276 wholesale distribution may use a common carrier; its own vehicle
277 or employee acting within the scope of employment if authorized
278 under s. 499.03 for the possession of prescription drugs in this
279 state; or, in the case of a prescription drug intended for
280 domestic distribution, an independent contractor who must be the
281 agent of the authorized seller or recipient responsible for
282 shipping and transportation as set forth in a written contract
283 between the parties. A person selling a prescription drug for
284 export must obtain documentation, such as a validated airway
285 bill, bill of lading, or other appropriate documentation that
286 the prescription drug was exported. A person responsible for
287 shipping or transporting prescription drugs is not required to
288 maintain documentation from a common carrier that the designated
289 recipient received the prescription drugs; however, the person
290 must obtain such documentation from the common carrier and make
291 it available to the department upon request of the department.
292 (13) DUE DILIGENCE OF SUPPLIERS.—Prior to purchasing any
293 prescription drugs from another wholesale distributor, a
294 prescription drug wholesale distributor, an out-of-state
295 prescription drug wholesale distributor, or a prescription drug
296 repackager must:
297 (a) Enter an agreement with the selling wholesale
298 distributor by which the selling wholesale distributor will
299 indemnify the purchasing wholesale distributor for any loss
300 caused to the purchasing wholesale distributor related to the
301 purchase of drugs from the selling wholesale distributor which
302 are determined to be counterfeit or to have been distributed in
303 violation of any federal or state law governing the distribution
304 of drugs.
305 (b) Determine that the selling wholesale distributor has
306 insurance coverage of not less than the greater of 1 percent of
307 the amount of total dollar volume of the prescription drug sales
308 reported to the department under s. 499.012(8)(g) or $500,000;
309 however the coverage need not exceed $2 million.
310 (c) Obtain information from the selling wholesale
311 distributor, including the length of time the selling wholesale
312 distributor has been licensed in this state, a copy of the
313 selling wholesale distributor’s licenses or permits, and
314 background information concerning the ownership of the selling
315 wholesale distributor, including the experience of the wholesale
316 distributor in the wholesale distribution of prescription drugs.
317 (d) Verify that the selling wholesale distributor’s Florida
318 permit is valid.
319 (e) Inspect the selling wholesale distributor’s licensed
320 establishment to document that it has a policies and procedures
321 manual relating to the distribution of drugs, the appropriate
322 temperature controlled environment for drugs requiring
323 temperature control, an alarm system, appropriate access
324 restrictions, and procedures to ensure that records related to
325 the wholesale distribution of prescription drugs are maintained
326 as required by law:
327 1. Before purchasing any drug from the wholesale
328 distributor, and at least once each subsequent year; or
329 2. Before purchasing any drug from the wholesale
330 distributor, and each subsequent year obtain a complete copy of
331 the most recent inspection report for the establishment which
332 was prepared by the department or the regulatory authority
333 responsible for wholesale distributors in the state in which the
334 establishment is located.
335 (14) DISTRIBUTION REPORTING.—Each prescription drug
336 wholesale distributor, out-of-state prescription drug wholesale
337 distributor, retail pharmacy drug wholesale distributor,
338 manufacturer, or repackager that engages in the wholesale
339 distribution of controlled substances as defined in s. 893.02
340 shall submit a report to the department of its receipts and
341 distributions of controlled substances listed in Schedule II,
342 Schedule III, Schedule IV, or Schedule V as provided in s.
343 893.03. Wholesale distributor facilities located within this
344 state shall report all transactions involving controlled
345 substances, and wholesale distributor facilities located outside
346 this state shall report all distributions to entities located in
347 this state. If the prescription drug wholesale distributor, out
348 of-state prescription drug wholesale distributor, retail
349 pharmacy drug wholesale distributor, manufacturer, or repackager
350 does not have any controlled substance distributions for the
351 month, a report shall be sent indicating that no distributions
352 occurred in the period. The report shall be submitted monthly by
353 the 20th of the next month, in the electronic format used for
354 controlled substance reporting to the Automation of Reports and
355 Consolidated Orders System division of the federal Drug
356 Enforcement Administration. Submission of electronic data must
357 be made in a secured Internet environment that allows for manual
358 or automated transmission. Upon successful transmission, an
359 acknowledgment page must be displayed to confirm receipt. The
360 report must contain the following information:
361 (a) The federal Drug Enforcement Administration
362 registration number of the wholesale distributing location.
363 (b) The federal Drug Enforcement Administration
364 registration number of the entity to which the drugs are
365 distributed or from which the drugs are received.
366 (c) The transaction code that indicates the type of
367 transaction.
368 (d) The National Drug Code identifier of the product and
369 the quantity distributed or received.
370 (e) The Drug Enforcement Administration Form 222 number or
371 Controlled Substance Ordering System Identifier on all Schedule
372 II transactions.
373 (f) The date of the transaction.
375 The department must share the reported data with the Department
376 of Law Enforcement and local law enforcement agencies upon
377 request and must monitor purchasing to identify purchasing
378 levels that are inconsistent with the purchasing entity’s
379 clinical needs. The Department of Law Enforcement shall
380 investigate purchases at levels that are inconsistent with the
381 purchasing entity’s clinical needs to determine whether
382 violations of chapter 893 have occurred.
383 (15) DUE DILIGENCE OF PURCHASERS.—
384 (a) Each prescription drug wholesale distributor, out-of
385 state prescription drug wholesale distributor, and retail
386 pharmacy drug wholesale distributor must establish and maintain
387 policies and procedures to credential physicians licensed under
388 chapter 458, chapter 459, chapter 461, or chapter 466 and
389 pharmacies that purchase or otherwise receive from the wholesale
390 distributor controlled substances listed in Schedule II or
391 Schedule III as provided in s. 893.03. The prescription drug
392 wholesale distributor, out-of-state prescription drug wholesale
393 distributor, or retail pharmacy drug wholesale distributor shall
394 maintain records of such credentialing and make the records
395 available to the department upon request. Such credentialing
396 must, at a minimum, include:
397 1. A determination of the clinical nature of the receiving
398 entity, including any specialty practice area.
399 2. A review of the receiving entity’s history of Schedule
400 II and Schedule III controlled substance purchasing from the
401 wholesale distributor.
402 3. A determination that the receiving entity’s Schedule II
403 and Schedule III controlled substance purchasing history, if
404 any, is consistent with and reasonable for that entity’s
405 clinical business needs.
406 (b) A wholesale distributor must take reasonable measures
407 to identify its customers, understand the normal and expected
408 transactions conducted by those customers, and identify those
409 transactions that are suspicious in nature. A wholesale
410 distributor must establish internal policies and procedures for
411 identifying suspicious orders and preventing suspicious
412 transactions. A wholesale distributor must assess orders for
413 more than 7,500 unit doses of any one controlled substance in
414 any one month to determine whether the purchase is reasonable.
415 In making such assessments, a wholesale distributor may consider
416 the purchasing entity’s clinical business needs, location, and
417 population served, in addition to other factors established in
418 the distributor’s policies and procedures. A wholesale
419 distributor must report to the department any regulated
420 transaction involving an extraordinary quantity of a listed
421 chemical, an uncommon method of payment or delivery, or any
422 other circumstance that the regulated person believes may
423 indicate that the listed chemical will be used in violation of
424 the law. The wholesale distributor shall maintain records that
425 document the report submitted to the department in compliance
426 with this paragraph.
427 (c) A wholesale distributor may not distribute controlled
428 substances to an entity if any criminal history record check for
429 any person associated with that entity shows that the person has
430 been convicted of, or entered a plea of guilty or nolo
431 contendere to, regardless of adjudication, a crime in any
432 jurisdiction related to controlled substances, the practice of
433 pharmacy, or the dispensing of medicinal drugs.
434 (16) EXEMPTIONS AND REQUIREMENTS FOR CERTAIN
435 ESTABLISHMENTS.—An establishment that stores, warehouses, or
436 holds noncontrolled prescription drugs solely for the purpose of
437 arranging for their destruction is not required to comply with
438 paragraph (1)(c), subsection (3), subsection (4), subsection
439 (5), subsection (6), paragraphs (8)(a), (b), and (d), or
440 subsection (13) with respect to those noncontrolled prescription
441 drugs, but shall maintain records of the locations from which
442 the prescription drugs were collected, a formulary or
443 description of that location’s prescription drugs, an estimate
444 of the amount of the prescription drugs collected, and the
445 manner, date, and location of destruction of the prescription
446 drugs.
447 (17) RULEMAKING.—The department shall adopt rules to
448 implement this section as necessary to protect the public
449 health, safety, and welfare. Such rules must include, but need
450 not be limited to, requirements for the storage and handling of
451 prescription drugs and for the establishment and maintenance of
452 prescription drug distribution records.
453 Section 2. This act shall take effect July 1, 2026.