HB 1257

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

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