S 1638

Florida Senate - 2026  SB 1638
By Senator Jones
34-00322-26  20261638__
1A bill to be entitled
2An act relating to prohibitions against discriminatory
3practices relating to 340B entities and 340B drugs;
4providing a short title; creating s. 499.061, F.S.;
5providing definitions; prohibiting drug manufacturers
6from engaging in certain acts relating to the
7acquisition of 340B drugs by and the delivery of such
8drugs to specified pharmacies; providing an exception;
9prohibiting drug manufacturers from interfering with
10pharmacies’ rights to contract with 340B entities;
11providing that each commission of certain acts
12constitutes a violation of the Florida Deceptive and
13Unfair Trade Practices Act and subjects the violator
14to certain actions and penalties; providing
15construction and applicability; creating s. 626.8829,
16F.S.; providing definitions; prohibiting health
17insurance issuers, pharmacy benefit managers, and
18other third-party payors, and agents thereof, from
19engaging in certain discriminatory acts relating to
20reimbursement to 340B entities for 340B drugs;
21providing applicability; providing that each
22commission of certain acts constitutes a violation of
23the Florida Deceptive and Unfair Trade Practices Act
24and subjects the violator to certain actions and
25penalties; providing construction; creating ss.
26627.64743, 627.65733, and 641.31543, F.S.; providing
27definitions; prohibiting individual health insurers,
28group, blanket, and franchise health insurers, and
29health maintenance organizations, respectively, and
30pharmacy benefit managers on behalf of such insurers
31and health maintenance organizations, from engaging in
32certain discriminatory acts relating to reimbursement
33to 340B entities for 340B drugs; providing
34applicability; providing that each commission of
35certain acts constitutes a violation of the Florida
36Deceptive and Unfair Trade Practices Act and subjects
37the violator to certain actions and penalties;
38providing construction; providing an effective date.
39
40Be It Enacted by the Legislature of the State of Florida:
41
42Section 1. This act may be cited as the “Defending
43Affordable Prescription Drug Costs Act.”
44Section 2. Section 499.061, Florida Statutes, is created to
45read:
46499.061Prohibitions against manufacturers’ discriminatory
47practices relating to 340B drugs and 340B entities.—
48(1)As used in this section, the term:
49(a)“340B drug” means a drug that has been subject to any
50offer for reduced prices by a manufacturer pursuant to 42 U.S.C.
51s. 256b and is purchased by a covered entity as defined in 42
52U.S.C. s. 256b(a)(4).
53(b)“340B entity” means an entity participating or
54authorized to participate in the 340B Drug Pricing Program, as
55described in 42 U.S.C. s. 256b, including its pharmacy, or any
56pharmacy contracted with the participating entity to dispense
57drugs purchased through the 340B Drug Pricing Program.
58(2)A manufacturer may not:
59(a)Deny, restrict, prohibit, or otherwise interfere with,
60directly or indirectly, the acquisition of a 340B drug by, or
61delivery of a 340B drug to, a pharmacy that is under contract
62with a 340B entity and is authorized under such contract to
63receive and dispense 340B drugs on behalf of the covered entity
64unless such receipt is prohibited by the United States
65Department of Health and Human Services; or
66(b)Interfere with a pharmacy’s right to contract with a
67340B entity.
68(3)The commission of any act prohibited by this section is
69a deceptive and unfair trade practice and constitutes a
70violation of the Florida Deceptive and Unfair Trade Practices
71Act under part II of chapter 501, and subjects the violator to
72all actions, including, but not limited to, investigative
73demands, remedies, and penalties, provided for in the Florida
74Deceptive and Unfair Trade Practices Act.
75(4)This section may not be construed to be less
76restrictive than federal law for a person or entity to which
77this section applies. This section may not be construed to be in
78conflict with any of the following:
79(a)Applicable federal law or regulations.
80(b)Other laws of this state which are compatible with
81applicable federal law.
82(5)Limited distribution of a drug that is subject to a
83risk evaluation and mitigation strategy under 21 U.S.C. s. 355-1
84is not a violation of this section.
85Section 3. Section 626.8829, Florida Statutes, is created
86to read:
87626.8829Reimbursement to 340B entities for 340B drugs.—
88(1)As used in this section, the term:
89(a)“340B drug” means a drug that has been subject to any
90offer for reduced prices by a manufacturer pursuant to 42 U.S.C.
91s. 256b and is purchased by a covered entity as defined in 42
92U.S.C. s. 256b(a)(4).
93(b)“340B entity” means an entity participating or
94authorized to participate in the 340B Drug Pricing Program, as
95described in 42 U.S.C. s. 256b, including its pharmacy, or any
96pharmacy contracted with the participating entity to dispense
97drugs purchased through the 340B Drug Pricing Program.
98(c)“Health insurance issuer” means an entity subject to
99the insurance laws and regulations of this state, or subject to
100the jurisdiction of the Commissioner of Insurance Regulation,
101which contracts, offers to contract, or enters into an agreement
102to provide, deliver, arrange for, pay for, or reimburse any of
103the costs of health care services. The term includes an accident
104and sickness insurance company, a health maintenance
105organization, a preferred provider organization or any similar
106entity, or any other entity providing a plan of health insurance
107or health benefits.
108(d)“Pharmacy” has the same meaning as in s. 465.003.
109(2)With respect to reimbursement to a 340B entity for a
110340B drug, a health insurance issuer, pharmacy benefit manager,
111or other third-party payor, or its agents, may not do any of the
112following:
113(a)Reimburse the 340B entity for the 340B drug at a rate
114lower than that paid for the same drug to non-340B entities or
115to entities owned or operated by the pharmacy benefit manager on
116the basis that the claim is for a 340B drug.
117(b)Impose any terms or conditions on the 340B entity which
118differ from such terms or conditions applied to non-340B
119entities on the basis that the entity participates in the 340B
120Drug Pricing Program set forth in 42 U.S.C. s. 256b or that the
121drug is a 340B drug, including, but not limited to, any of the
122following terms or conditions:
1231.Fees, charges, clawbacks, or other adjustments or
124assessments. As used in this subparagraph, the term “other
125adjustments” includes, but is not limited to, placing any
126additional requirements, restrictions, or unnecessary burdens on
127the 340B entity which result in administrative costs or fees to
128the 340B entity and which are not placed on non-340B entities,
129including affiliate pharmacies of the health insurance issuer,
130pharmacy benefit manager, or other third-party payor.
1312.Dispensing fees that are less than dispensing fees for
132non-340B entities.
1333.Restrictions or requirements regarding participation in
134standard or preferred pharmacy networks.
1354.Requirements relating to the frequency or scope of
136audits of inventory management systems.
1375.Requirements that a claim for a drug include any
138identification, billing modifier, attestation, or other
139indication that a drug is a 340B drug in order to be processed
140or resubmitted unless it is required by the Centers for Medicare
141and Medicaid Services or the Agency for Health Care
142Administration for the administration of the Medicaid program.
1436.Any other restrictions, conditions, practices, or
144policies that are not imposed on non-340B entities.
145(c)Require the 340B entity to reverse, resubmit, or
146clarify a claim after the initial adjudication unless such
147actions are in the normal course of pharmacy business and not
148related to 340B drug pricing.
149(d)Base an action or contract requirement solely on the
150basis that the entity is a participant in the 340B Drug Pricing
151Program in such a manner that prevents or interferes with any
152patient’s choice to receive such drugs from the 340B entity or
153its contracted pharmacy, including the creation of a restriction
154or additional charge on a patient who chooses to receive drugs
155from a 340B entity or its contracted pharmacy through direct
156dispensing, delivery, mail order, or administration of such
157drugs, regardless of the type of insurance coverage or
158medication. For purposes of this paragraph, it is considered a
159prohibited practice that prevents or interferes with a patient’s
160choice to receive drugs from a 340B entity or its contracted
161pharmacy if a health insurance issuer, pharmacy benefit manager,
162or other third-party payor places any additional requirements,
163restrictions, or unnecessary burdens on the 340B entity or its
164contracted pharmacy beyond that of any other pharmacy dispensing
165medications within the scope of general law, including, but not
166limited to, requiring a claim for a drug to include any
167identification, billing modifier, attestation, or other
168indication that a drug is a 340B drug in order to be processed
169or resubmitted, unless it is required by the Centers for
170Medicare and Medicaid Services or the Agency for Health Care
171Administration in administration of the Medicaid program.
172(e)Require or compel the submission of ingredient costs or
173pricing data pertaining to 340B drugs to any health insurance
174issuer, pharmacy benefit manager, or other third-party payor.
175(f)Exclude the 340B entity from the network of the health
176insurance issuer, pharmacy benefit manager, or other third-party
177payor on the basis that the 340B entity dispenses drugs subject
178to an agreement under 42 U.S.C. s. 256b, or refuse to contract
179with the 340B entity for reasons other than those that apply
180equally to non-340B entities.
181(3)Subsection (2) does not apply to the Medicaid program
182as payor when Medicaid provides reimbursement for covered
183outpatient drugs as defined in 42 U.S.C. s. 1396r-8(k).
184(4)The commission of any act prohibited by this section is
185a deceptive and unfair trade practice, constitutes a violation
186of the Florida Deceptive and Unfair Trade Practices Act under
187part II of chapter 501, and subjects the violator to all
188actions, including, but not limited to, investigative demands,
189remedies, and penalties, provided for in the Florida Deceptive
190and Unfair Trade Practices Act.
191(5)This section may not be construed to be less
192restrictive than federal law for a person or entity to which
193this section applies. This section may not be construed to be in
194conflict with any of the following:
195(a)Applicable federal law or regulations.
196(b)Other laws of this state that are compatible with
197applicable federal law.
198(6)Limited distribution of a drug that is subject to a
199risk evaluation and mitigation strategy under 21 U.S.C. s. 355-1
200is not a violation of this section.
201Section 4. Section 627.64743, Florida Statutes, is created
202to read:
203627.64743Reimbursement to 340B entities for 340B drugs.—
204(1)As used in this section, the term:
205(a)“340B drug” means a drug that has been subject to any
206offer for reduced prices by a manufacturer pursuant to 42 U.S.C.
207s. 256b and is purchased by a covered entity as defined in 42
208U.S.C. s. 256b(a)(4).
209(b)“340B entity” means an entity participating or
210authorized to participate in the 340B Drug Pricing Program, as
211described in 42 U.S.C. s. 256b, including its pharmacy, or any
212pharmacy contracted with the participating entity to dispense
213drugs purchased through the 340B Drug Pricing Program.
214(c)“Pharmacy” has the same meaning as in s. 465.003.
215(d)“Pharmacy benefit manager” has the same meaning as in
216s. 627.64741(1).
217(2)With respect to reimbursement to a 340B entity for a
218340B drug, an insurer issuing, delivering, or renewing an
219individual health insurance policy in this state which provides
220prescription drug coverage, or a pharmacy benefit manager on
221behalf of such insurer, may not do any of the following:
222(a)Reimburse the 340B entity for the 340B drug at a rate
223lower than that paid for the same drug to non-340B entities on
224the basis that the claim is for a 340B drug.
225(b)Impose any terms or conditions on the 340B entity which
226differ from such terms or conditions applied to non-340B
227entities on the basis that the entity participates in the 340B
228Drug Pricing Program set forth in 42 U.S.C. s. 256b or that the
229drug is a 340B drug, including, but not limited to, any of the
230following terms or conditions:
2311.Fees, charges, clawbacks, or other adjustments or
232assessments. As used in this subparagraph, the term “other
233adjustments” includes, but is not limited to, placing any
234additional requirements, restrictions, or unnecessary burdens on
235the 340B entity which result in administrative costs or fees to
236the 340B entity and which are not placed on non-340B entities,
237including affiliate pharmacies or in-network pharmacies of the
238insurer or of the pharmacy benefit manager.
2392.Dispensing fees that are less than dispensing fees for
240non-340B entities.
2413.Restrictions or requirements regarding participation in
242standard or preferred pharmacy networks.
2434.Requirements relating to the frequency or scope of
244audits of inventory management systems.
2455.Requirements that a claim for a drug include any
246identification, billing modifier, attestation, or other
247indication that a drug is a 340B drug in order to be processed
248or resubmitted unless it is required by the Centers for Medicare
249and Medicaid Services or the Agency for Health Care
250Administration for the administration of the Medicaid program.
2516.Any other restrictions, conditions, practices, or
252policies that are not imposed on non-340B entities.
253(c)Require the 340B entity to reverse, resubmit, or
254clarify a claim after the initial adjudication unless such
255actions are in the normal course of pharmacy business and not
256related to 340B drug pricing.
257(d)Base an action or a contract requirement solely on the
258basis that the entity is a participant in the 340B Drug Pricing
259Program in such a manner that prevents or interferes with a
260patient’s choice to receive such drugs from the 340B entity or
261its contracted pharmacy, including the creation of a restriction
262or an additional charge on a patient who chooses to receive
263drugs from a 340B entity or its contracted pharmacy through
264direct dispensing, delivery, mail order, or administration of
265such drugs, regardless of the type of insurance coverage or
266medication. For purposes of this paragraph, it is considered a
267prohibited practice that prevents or interferes with a patient’s
268choice to receive drugs from a 340B entity or its contracted
269pharmacy if the insurer, or the pharmacy benefit manager on
270behalf of the insurer, places any additional requirements,
271restrictions, or unnecessary burdens on the 340B entity or its
272contracted pharmacy beyond that of any other pharmacy dispensing
273medications within the scope of general law, including, but not
274limited to, requiring a claim for a drug to include any
275identification, billing modifier, attestation, or other
276indication that a drug is a 340B drug in order to be processed
277or resubmitted, unless it is required by the Centers for
278Medicare and Medicaid Services or the Agency for Health Care
279Administration in administration of the Medicaid program.
280(e)Require or compel the submission of ingredient costs or
281pricing data pertaining to 340B drugs to the insurer or the
282pharmacy benefit manager.
283(f)Exclude the 340B entity from the network of the insurer
284or pharmacy benefit manager on the basis that the 340B entity
285dispenses drugs subject to an agreement under 42 U.S.C. s. 256b,
286or refuse to contract with the 340B entity for reasons other
287than those that apply equally to non-340B entities.
288(3)Subsection (2) does not apply to the Medicaid program
289as payor when Medicaid provides reimbursement for covered
290outpatient drugs as defined in 42 U.S.C. s. 1396r-8(k).
291(4)The commission of any act prohibited by this section is
292a deceptive and unfair trade practice, constitutes a violation
293of the Florida Deceptive and Unfair Trade Practices Act under
294part II of chapter 501, and subjects the violator to all
295actions, including, but not limited to, investigative demands,
296remedies, and penalties, provided for in the Florida Deceptive
297and Unfair Trade Practices Act. Each commission of a prohibited
298act constitutes a violation of the Florida Deceptive and Unfair
299Trade Practices Act.
300(5)This section may not be construed to be less
301restrictive than federal law for a person or entity to which
302this section applies. This section may not be construed to be in
303conflict with any of the following:
304(a)Applicable federal law or federal regulations.
305(b)Other laws of this state that are compatible with
306applicable federal law.
307(6)Limited distribution of a drug that is subject to a
308risk evaluation and mitigation strategy under 21 U.S.C. s. 355-1
309is not a violation of this section.
310Section 5. Section 627.65733, Florida Statutes, is created
311to read:
312627.65733Reimbursement to 340B entities for 340B drugs.—
313(1)As used in this section, the term:
314(a)“340B drug” means a drug that has been subject to any
315offer for reduced prices by a manufacturer pursuant to 42 U.S.C.
316s. 256b and is purchased by a covered entity as defined in 42
317U.S.C. s. 256b(a)(4).
318(b)“340B entity” means an entity participating or
319authorized to participate in the 340B Drug Pricing Program, as
320described in 42 U.S.C. s. 256b, including its pharmacy, or any
321pharmacy contracted with the participating entity to dispense
322drugs purchased through the 340B Drug Pricing Program.
323(c)“Pharmacy” has the same meaning as in s. 465.003.
324(d)“Pharmacy benefit manager” has the same meaning as in
325s. 627.6572(1).
326(2)With respect to reimbursement to a 340B entity for 340B
327drugs, an insurer issuing, delivering, or renewing a group,
328blanket, or franchise health insurance policy in this state
329which provides prescription drug coverage, or a pharmacy benefit
330manager on behalf of such insurer, may not do any of the
331following:
332(a)Reimburse the 340B entity for 340B drugs at a rate
333lower than that paid for the same drug to non-340B entities on
334the basis that the claim is for a 340B drug.
335(b)Impose any terms or conditions on the 340B entity which
336differ from such terms or conditions applied to non-340B
337entities on the basis that the entity participates in the 340B
338Drug Pricing Program set forth in 42 U.S.C. s. 256b or that a
339drug is a 340B drug, including, but not limited to, any of the
340following terms or conditions:
3411.Fees, charges, clawbacks, or other adjustments or
342assessments. As used in this subparagraph, the term “other
343adjustments” includes, but is not limited to, placing any
344additional requirements, restrictions, or unnecessary burdens on
345the 340B entity which result in administrative costs or fees to
346the 340B entity and which are not placed on non-340B entities,
347including affiliate pharmacies or in-network pharmacies of the
348insurer or of the pharmacy benefit manager.
3492.Dispensing fees that are less than dispensing fees for
350non-340B entities.
3513.Restrictions or requirements regarding participation in
352standard or preferred pharmacy networks.
3534.Requirements relating to the frequency or scope of
354audits of inventory management systems.
3555.Requirements that a claim for a drug include any
356identification, billing modifier, attestation, or other
357indication that a drug is a 340B drug in order to be processed
358or resubmitted unless it is required by the Centers for Medicare
359and Medicaid Services or the Agency for Health Care
360Administration for the administration of the Medicaid program.
3616.Any other restrictions, conditions, practices, or
362policies that are not imposed on non-340B entities.
363(c)Require the 340B entity to reverse, resubmit, or
364clarify a claim after the initial adjudication unless such
365actions are in the normal course of pharmacy business and not
366related to 340B drug pricing.
367(d)Base an action or contract requirement solely on the
368basis that the entity is a participant in the 340B Drug Pricing
369Program in such a manner that prevents or interferes with any
370patient’s choice to receive such drugs from the 340B entity or
371its contracted pharmacy, including the creation of a restriction
372or additional charge on a patient who chooses to receive drugs
373from a 340B entity or its contracted pharmacy through direct
374dispensing, delivery, mail order, or administration of such
375drugs, regardless of the type of insurance coverage or
376medication. For purposes of this paragraph, it is considered a
377prohibited practice that prevents or interferes with a patient’s
378choice to receive drugs from a 340B entity or its contracted
379pharmacy if the insurer, or the pharmacy benefit manager on
380behalf of the insurer, places any additional requirements,
381restrictions, or unnecessary burdens on the 340B entity beyond
382that of any other pharmacy dispensing medications within the
383scope of general law, including, but not limited to, requiring a
384claim for a drug to include any identification, billing
385modifier, attestation, or other indication that a drug is a 340B
386drug in order to be processed or resubmitted, unless it is
387required by the Centers for Medicare and Medicaid Services or
388the Agency for Health Care Administration in administration of
389the Medicaid program.
390(e)Require or compel the submission of ingredient costs or
391pricing data pertaining to 340B drugs to the insurer or the
392pharmacy benefit manager.
393(f)Exclude the 340B entity from the network of the insurer
394or pharmacy benefit manager on the basis that the 340B entity
395dispenses drugs subject to an agreement under 42 U.S.C. s. 256b,
396or refuse to contract with the 340B entity for reasons other
397than those that apply equally to non-340B entities.
398(3)Subsection (2) does not apply to the Medicaid program
399as payor when Medicaid provides reimbursement for covered
400outpatient drugs as defined in 42 U.S.C. s. 1396r-8(k).
401(4)The commission of any act prohibited by this section is
402a deceptive and unfair trade practice, constitutes a violation
403of the Florida Deceptive and Unfair Trade Practices Act under
404part II of chapter 501, and subjects the violator to all
405actions, including, but not limited to, investigative demands,
406remedies, and penalties, provided for in the Florida Deceptive
407and Unfair Trade Practices Act. Each commission of a prohibited
408act constitutes a violation of the Florida Deceptive and Unfair
409Trade Practices Act.
410(5)This section may not be construed to be less
411restrictive than federal law for a person or entity to which
412this section applies. This section may not be construed to be in
413conflict with any of the following:
414(a)Applicable federal law or regulations.
415(b)Other laws of this state that are compatible with
416applicable federal law.
417(6)Limited distribution of a drug that is subject to a
418risk evaluation and mitigation strategy under 21 U.S.C. s. 355-1
419is not a violation of this section.
420Section 6. Section 641.31543, Florida Statutes, is created
421to read:
422641.31543Reimbursement to 340B entities for 340B drugs.—
423(1)As used in this section, the term:
424(a)“340B drug” means a drug that has been subject to any
425offer for reduced prices by a manufacturer pursuant to 42 U.S.C.
426s. 256b and is purchased by a covered entity as defined in 42
427U.S.C. s. 256b(a)(4).
428(b)“340B entity” means an entity participating or
429authorized to participate in the 340B Drug Pricing Program, as
430described in 42 U.S.C. s. 256b, including its pharmacy, or any
431pharmacy contracted with the participating entity to dispense
432drugs purchased through the 340B Drug Pricing Program.
433(c)“Pharmacy” has the same meaning as in s. 465.003.
434(d)“Pharmacy benefit manager” has the same meaning as in
435s. 641.314(1).
436(2)With respect to reimbursement to a 340B entity for a
437340B drug, a health maintenance organization issuing,
438delivering, or renewing a health maintenance contract in this
439state which provides prescription drug coverage, or a pharmacy
440benefit manager on behalf of such health maintenance
441organization, may not do any of the following:
442(a)Reimburse the 340B entity for the 340B drug at a rate
443lower than that paid for the same drug to non-340B entities on
444the basis that the claim is for a 340B drug.
445(b)Impose any terms or conditions on the 340B entity which
446differ from such terms or conditions applied to non-340B
447entities on the basis that the entity participates in the 340B
448Drug Pricing Program set forth in 42 U.S.C. s. 256b or that a
449drug is a 340B drug, including, but not limited to, any of the
450following terms or conditions:
4511.Fees, charges, clawbacks, or other adjustments or
452assessments. For purposes of this subparagraph, the term “other
453adjustments” includes, but is not limited to, placing any
454additional requirements, restrictions, or unnecessary burdens on
455the 340B entity which result in administrative costs or fees to
456the 340B entity which are not placed on non-340B entities,
457including affiliate pharmacies or in-network pharmacies of the
458health maintenance organization or of the pharmacy benefit
459manager.
4602.Dispensing of fees that are less than dispensing fees
461for non-340B entities.
4623.Restrictions or requirements regarding participation in
463standard or preferred pharmacy networks.
4644.Requirements relating to the frequency or scope of
465audits of inventory management systems.
4665.Requirements that a claim for a drug include any
467identification, billing modifier, attestation, or other
468indication that a drug is a 340B drug in order to be processed
469or resubmitted unless it is required by the Centers for Medicare
470and Medicaid Services or the Agency for Health Care
471Administration for the administration of the Medicaid program.
4726.Any other restrictions, conditions, practices, or
473policies that are not imposed on non-340B entities.
474(c)Require the 340B entity to reverse, resubmit, or
475clarify a claim after the initial adjudication unless such
476actions are in the normal course of pharmacy business and not
477related to 340B drug pricing.
478(d)Base an action or contract requirement solely on the
479basis that the entity is a participant in the 340B Drug Pricing
480Program in such a manner that prevents or interferes with any
481patient’s choice to receive such drugs from the 340B entity or
482its contracted pharmacy, including the creation of a restriction
483or additional charge on a patient who chooses to receive drugs
484from a 340B entity or its contracted pharmacy through direct
485dispensing, delivery, mail order, or administration of such
486drugs, regardless of the type of insurance coverage or
487medication. For purposes of this paragraph, it is considered a
488prohibited practice that prevents or interferes with a patient’s
489choice to receive drugs from a 340B entity or its contracted
490pharmacy if the health maintenance organization, or the pharmacy
491benefit manager on behalf of the health maintenance
492organization, places any additional requirements, restrictions,
493or unnecessary burdens on the 340B entity or its contracted
494pharmacy beyond that of any other pharmacy dispensing
495medications within the scope of general law, including, but not
496limited to, requiring a claim for a drug to include any
497identification, billing modifier, attestation, or other
498indication that a drug is a 340B drug in order to be processed
499or resubmitted, unless it is required by the Centers for
500Medicare and Medicaid Services or the Agency for Health Care
501Administration in administration of the Medicaid program.
502(e)Require or compel the submission of ingredient costs or
503pricing data pertaining to 340B drugs to the health maintenance
504organization or the pharmacy benefit manager.
505(f)Exclude the 340B entity from the network of the health
506maintenance organization or pharmacy benefit manager on the
507basis that the 340B entity dispenses drugs subject to an
508agreement under 42 U.S.C. s. 256b, or refuse to contract with
509the 340B entity for reasons other than those that apply equally
510to non-340B entities.
511(3)Subsection (2) does not apply to the Medicaid program
512as payor when Medicaid provides reimbursement for covered
513outpatient drugs as defined in 42 U.S.C. s. 1396r-8(k).
514(4)The commission of any act prohibited by this section is
515a deceptive and unfair trade practice, constitutes a violation
516of the Florida Deceptive and Unfair Trade Practices Act under
517part II of chapter 501, and subjects the violator to all
518actions, including, but not limited to, investigative demands,
519remedies, and penalties, provided for in the Florida Deceptive
520and Unfair Trade Practices Act. Each commission of a prohibited
521act constitutes a violation of the Florida Deceptive and Unfair
522Trade Practices Act.
523(5)This section may not be construed to be less
524restrictive than federal law for a person or entity to which
525this section applies. This section may not be construed to be in
526conflict with any of the following:
527(a)Applicable federal law or regulations.
528(b)Other laws of this state that are compatible with
529applicable federal law.
530(6)Limited distribution of a drug that is subject to a
531risk evaluation and mitigation strategy under 21 U.S.C. s. 355-1
532is not a violation of this section.
533Section 7. This act shall take effect July 1, 2026.