Amendment
Bill No. HB 331

Amendment No. 791535

CHAMBER ACTION
Senate		House
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1	Representative Skidmore offered the following:
2
3	Amendment (with title amendment)
4	Between lines 267 and 268, insert:
5
6	Section 5.  Section 499.029, Florida Statutes, is amended
7	to read:
8	499.029  Prescription Cancer Drug Donation Program.--
9	(1)  This section may be cited as the "Prescription Cancer
10	Drug Donation Program Act."
11	(2)  There is created a Prescription Cancer Drug Donation
12	Program within the department for the purpose of authorizing and
13	facilitating the donation of prescription cancer drugs and
14	supplies to eligible patients.
15	(3)  As used in this section, the term:
16	(a)  "Cancer drug" means a prescription drug that has been
17	approved under s. 505 of the federal Food, Drug, and Cosmetic
18	Act and is used to treat cancer or its side effects or is used
19	to treat the side effects of a prescription drug used to treat
20	cancer or its side effects. "Cancer drug" does not include a
21	substance listed in Schedule II, Schedule III, Schedule IV, or
22	Schedule V of s. 893.03.
23	(a)(b)  "Closed drug delivery system" means a system in
24	which the actual control of the unit-dose medication package is
25	maintained by the facility rather than by the individual
26	patient.
27	(b)  "Dispensing practitioner" means a practitioner
28	registered under s. 465.0276.
29	(c)  "Donor" means a patient or patient representative who
30	donates prescription cancer drugs or supplies needed to
31	administer prescription cancer drugs that have been maintained
32	within a closed drug delivery system; health care facilities,
33	nursing homes, hospices, or hospitals with closed drug delivery
34	systems; or pharmacies, prescription drug manufacturers, medical
35	device manufacturers or suppliers, or wholesalers of
36	prescription drugs or supplies, in accordance with this section.
37	The term "Donor" includes a physician licensed under chapter 458
38	or chapter 459 who receives prescription cancer drugs or
39	supplies directly from a prescription drug manufacturer,
40	wholesale distributor, or pharmacy.
41	(d)  "Eligible patient" means a person who the department
42	determines is eligible to receive prescription cancer drugs from
43	the program.
44	(e)  "Participant facility" means a class II hospital
45	pharmacy or dispensing practitioner that has elected to
46	participate in the program and that accepts donated prescription
47	cancer drugs and supplies under the rules adopted by the
48	department for the program.
49	(f)  "Prescribing practitioner" means a physician licensed
50	under chapter 458 or chapter 459 or any other medical
51	professional with authority under state law to prescribe drugs
52	cancer medication.
53	(g)  "Prescription drug" does not include a substance
54	listed in Schedule II, Schedule III, Schedule IV, or Schedule V
55	of s. 893.03.
56	(h)(g)  "Program" means the Prescription Cancer Drug
57	Donation Program created by this section.
58	(i)(h)  "Supplies" means any supplies used in the
59	administration of a prescription cancer drug.
60	(4)  Any donor may donate prescription cancer drugs or
61	supplies to a participant facility that elects to participate in
62	the program and meets criteria established by the department for
63	such participation. Prescription Cancer drugs or supplies may
64	not be donated to a specific cancer patient, and donated
65	prescription drugs or supplies may not be resold by the
66	participant program. Prescription Cancer drugs billed to and
67	paid for by Medicaid in long-term care facilities that are
68	eligible for return to stock under federal Medicaid regulations
69	shall be credited to Medicaid and are not eligible for donation
70	under the program. A participant facility may provide dispensing
71	and counseling consulting services to an eligible patient
72	individuals who is are not a patient patients of the participant
73	hospital.
74	(5)  The prescription cancer drugs or supplies donated to
75	the program may be prescribed only by a prescribing practitioner
76	for use by an eligible patient and may be dispensed only by a
77	pharmacist or dispensing practitioner.
78	(6)(a)  A prescription cancer drug may only be accepted or
79	dispensed under the program if the drug is in its original,
80	unopened, sealed container, or in a tamper-evident unit-dose
81	packaging, except that a prescription cancer drug packaged in
82	single-unit doses may be accepted and dispensed if the outside
83	packaging is opened but the single-unit-dose packaging is
84	unopened with tamper-resistant packaging intact.
85	(b)  A prescription cancer drug may not be accepted or
86	dispensed under the program if the drug bears an expiration date
87	that is less than 6 months after the date the drug was donated
88	or if the drug appears to have been tampered with or mislabeled
89	as determined in paragraph (c).
90	(c)  Before Prior to being dispensed to an eligible
91	patient, the prescription cancer drug or supplies donated under
92	the program shall be inspected by a pharmacist or dispensing
93	practitioner to determine that the drug and supplies do not
94	appear to have been tampered with or mislabeled.
95	(d)  A dispenser of donated prescription cancer drugs or
96	supplies may not submit a claim or otherwise seek reimbursement
97	from any public or private third-party payor for donated
98	prescription cancer drugs or supplies dispensed to any patient
99	under the program, and a public or private third-party payor is
100	not required to provide reimbursement to a dispenser for donated
101	prescription cancer drugs or supplies dispensed to any patient
102	under the program.
103	(7)(a)  A donation of prescription cancer drugs or supplies
104	shall be made only at a participant's participant facility. A
105	participant facility may decline to accept a donation. A
106	participant facility that accepts donated prescription cancer
107	drugs or supplies under the program shall comply with all
108	applicable provisions of state and federal law relating to the
109	storage and dispensing of the donated prescription cancer drugs
110	or supplies.
111	(b)  A participant facility that voluntarily takes part in
112	the program may charge a handling fee sufficient to cover the
113	cost of preparation and dispensing of prescription cancer drugs
114	or supplies under the program. The fee shall be established in
115	rules adopted by the department.
116	(8)  The department, upon the recommendation of the Board
117	of Pharmacy, shall adopt rules to carry out the provisions of
118	this section. Initial rules under this section shall be adopted
119	no later than 90 days after the effective date of this act. The
120	rules shall include, but not be limited to:
121	(a)  Eligibility criteria, including a method to determine
122	priority of eligible patients under the program.
123	(b)  Standards and procedures for participants participant
124	facilities that accept, store, distribute, or dispense donated
125	prescription cancer drugs or supplies.
126	(c)  Necessary forms for administration of the program,
127	including, but not limited to, forms for use by entities that
128	donate, accept, distribute, or dispense prescription cancer
129	drugs or supplies under the program.
130	(d)  The maximum handling fee that may be charged by a
131	participant facility that accepts and distributes or dispenses
132	donated prescription cancer drugs or supplies.
133	(e)  Categories of prescription cancer drugs and supplies
134	that the program will accept for dispensing; however, the
135	department may exclude any drug based on its therapeutic
136	effectiveness or high potential for abuse or diversion.
137	(f)  Maintenance and distribution of the participant
138	facility registry established in subsection (10).
139	(9)  A person who is eligible to receive prescription
140	cancer drugs or supplies under the state Medicaid program or
141	under any other prescription drug program funded in whole or in
142	part by the state, by any other prescription drug program funded
143	in whole or in part by the Federal Government, or by any other
144	prescription drug program offered by a third-party insurer,
145	unless benefits have been exhausted, or a certain prescription
146	cancer drug or supply is not covered by the prescription drug
147	program, is ineligible to participate in the program created
148	under this section.
149	(10)  The department shall establish and maintain a
150	participant facility registry for the program. The participant
151	facility registry shall include the participant's participant
152	facility's name, address, and telephone number. The department
153	shall make the participant facility registry available on the
154	department's website to any donor wishing to donate prescription
155	cancer drugs or supplies to the program. The department's
156	website shall also contain links to prescription cancer drug
157	manufacturers that offer drug assistance programs or free
158	medication.
159	(11)  Any donor of prescription cancer drugs or supplies,
160	or any participant in the program, who exercises reasonable care
161	in donating, accepting, distributing, or dispensing prescription
162	cancer drugs or supplies under the program and the rules adopted
163	under this section is shall be immune from civil or criminal
164	liability and from professional disciplinary action of any kind
165	for any injury, death, or loss to person or property relating to
166	such activities.
167	(12)  A pharmaceutical manufacturer is not liable for any
168	claim or injury arising from the transfer of any prescription
169	cancer drug under this section, including, but not limited to,
170	liability for failure to transfer or communicate product or
171	consumer information regarding the transferred drug, as well as
172	the expiration date of the transferred drug.
173	(13)  If any conflict exists between the provisions in this
174	section and the provisions in this chapter or chapter 465, the
175	provisions in this section shall control the operation of the
176	Cancer Drug Donation program.
177	Section 6.  This act shall take effect July 1, 2009.
178
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180	T I T L E  A M E N D M E N T
181	Remove line 11 and insert:
182	381.981, F.S.; conforming terminology; amending s. 499.029,
183	F.S.; renaming the Cancer Drug Donation Program as the
184	Prescription Drug Donation Program; revising definitions;
185	expanding the drugs and supplies that may be donated under the
186	program; expanding the types of facilities and practitioners
187	that may participate in the program; conforming provisions to
188	changes in terminology; removing obsolete language relating to
189	the adoption of initial rules; providing an

CODING: Words stricken are deletions; words underlined are additions.