HB 7063

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; providing an effective date.
10
11	Be It Enacted by the Legislature of the State of Florida:
12
13	Section 1.  Section 499.029, Florida Statutes, is amended
14	to read:
15	499.029  Prescription Cancer Drug Donation Program.--
16	(1)  This section may be cited as the "Prescription Cancer
17	Drug Donation Program Act."
18	(2)  There is created a Prescription Cancer Drug Donation
19	Program within the department of Health for the purpose of
20	authorizing and facilitating the donation of prescription cancer
21	drugs and supplies to eligible patients.
22	(3)  As used in this section:
23	(a)  "Cancer drug" means a prescription drug that has been
24	approved under s. 505 of the federal Food, Drug, and Cosmetic
25	Act and is used to treat cancer or its side effects or is used
26	to treat the side effects of a prescription drug used to treat
27	cancer or its side effects. "Cancer drug" does not include a
28	substance listed in Schedule II, Schedule III, Schedule IV, or
29	Schedule V of s. 893.03.
30	(a)(b)  "Closed drug delivery system" means a system in
31	which the actual control of the unit-dose medication package is
32	maintained by the facility rather than by the individual
33	patient.
34	(b)  "Dispensing practitioner" means a practitioner
35	registered under s. 465.0276.
36	(c)  "Department" means the Department of Health.
37	(c)(d)  "Donor" means a patient or patient representative
38	who donates prescription cancer drugs or supplies needed to
39	administer prescription cancer drugs that have been maintained
40	within a closed drug delivery system; health care facilities,
41	nursing homes, hospices, or hospitals with closed drug delivery
42	systems; or pharmacies, prescription drug manufacturers, medical
43	device manufacturers or suppliers, or wholesalers of
44	prescription drugs or supplies, in accordance with this section.
45	"Donor" includes a physician licensed under chapter 458 or
46	chapter 459 who receives prescription cancer drugs or supplies
47	directly from a prescription drug manufacturer, wholesale
48	distributor drug wholesaler, or pharmacy.
49	(d)(e)  "Eligible patient" means a person who the
50	department determines is eligible to receive prescription cancer
51	drugs from the program.
52	(e)(f)  "Health care facility" means a health care facility
53	licensed under chapter 395.
54	(g)  "Health care clinic" means a health care clinic
55	licensed under part X of chapter 400.
56	(f)(h)  "Hospice" means a corporation licensed under part
57	IV of chapter 400.
58	(g)(i)  "Hospital" means a facility as defined in s.
59	395.002 and licensed under chapter 395.
60	(h)(j)  "Nursing home" means a facility licensed under part
61	II of chapter 400.
62	(i)(k)  "Participant facility" means a class II hospital
63	pharmacy or dispensing practitioner that has elected to
64	participate in the program and that accepts donated prescription
65	cancer drugs and supplies under the rules adopted by the
66	department for the program.
67	(j)(l)  "Pharmacist" means a person licensed under chapter
68	465.
69	(k)(m)  "Pharmacy" means an entity licensed under chapter
70	465.
71	(l)(n)  "Prescribing practitioner" means a physician
72	licensed under chapter 458 or chapter 459 or any other medical
73	professional with authority under state law to prescribe drugs
74	cancer medication.
75	(m)(o)  "Prescription drug" does not include a substance
76	listed in Schedule II, Schedule III, Schedule IV, or Schedule V
77	of s. 893.03 means a drug as defined in s. 465.003(8).
78	(n)(p)  "Program" means the Prescription Cancer Drug
79	Donation Program created by this section.
80	(o)(q)  "Supplies" means any supplies used in the
81	administration of a prescription cancer drug.
82	(4)  Any donor may donate prescription cancer drugs or
83	supplies to a participant facility that elects to participate in
84	the program and meets criteria established by the department for
85	such participation. Prescription Cancer drugs or supplies may
86	not be donated to a specific cancer patient, and donated
87	prescription drugs or supplies may not be resold by the
88	participant program. Prescription Cancer drugs billed to and
89	paid for by Medicaid in long-term care facilities that are
90	eligible for return to stock under federal Medicaid regulations
91	shall be credited to Medicaid and are not eligible for donation
92	under the program. A participant facility may provide dispensing
93	and counseling consulting services to an eligible patient
94	individuals who is are not a patient patients of the participant
95	hospital.
96	(5)  The prescription cancer drugs or supplies donated to
97	the program may be prescribed only by a prescribing practitioner
98	for use by an eligible patient and may be dispensed only by a
99	pharmacist or a dispensing practitioner.
100	(6)(a)  A prescription cancer drug may only be accepted or
101	dispensed under the program if the drug is in its original,
102	unopened, sealed container, or in a tamper-evident unit-dose
103	packaging, except that a prescription cancer drug packaged in
104	single-unit doses may be accepted and dispensed if the outside
105	packaging is opened but the single-unit-dose packaging is
106	unopened with tamper-resistant packaging intact.
107	(b)  A prescription cancer drug may not be accepted or
108	dispensed under the program if the drug bears an expiration date
109	that is less than 6 months after the date the drug was donated
110	or if the drug appears to have been tampered with or mislabeled
111	as determined in paragraph (c).
112	(c)  Prior to being dispensed to an eligible patient, the
113	prescription cancer drug or supplies donated under the program
114	shall be inspected by a pharmacist or dispensing practitioner to
115	determine that the drug and supplies do not appear to have been
116	tampered with or mislabeled.
117	(d)  A dispenser of donated prescription cancer drugs or
118	supplies may not submit a claim or otherwise seek reimbursement
119	from any public or private third-party payor for donated
120	prescription cancer drugs or supplies dispensed to any patient
121	under the program, and a public or private third-party payor is
122	not required to provide reimbursement to a dispenser for donated
123	prescription cancer drugs or supplies dispensed to any patient
124	under the program.
125	(7)(a)  A donation of prescription cancer drugs or supplies
126	shall be made only at a participant's participant facility. A
127	participant facility may decline to accept a donation. A
128	participant facility that accepts donated prescription cancer
129	drugs or supplies under the program shall comply with all
130	applicable provisions of state and federal law relating to the
131	storage and dispensing of the donated prescription cancer drugs
132	or supplies.
133	(b)  A participant facility that voluntarily takes part in
134	the program may charge a handling fee sufficient to cover the
135	cost of preparation and dispensing of prescription cancer drugs
136	or supplies under the program. The fee shall be established in
137	rules adopted by the department.
138	(8)  The department, upon the recommendation of the Board
139	of Pharmacy, shall adopt rules to carry out the provisions of
140	this section. Initial rules under this section shall be adopted
141	no later than 90 days after the effective date of this act. The
142	rules shall include, but not be limited to:
143	(a)  Eligibility criteria, including a method to determine
144	priority of eligible patients under the program.
145	(b)  Standards and procedures for participants participant
146	facilities that accept, store, distribute, or dispense donated
147	prescription cancer drugs or supplies.
148	(c)  Necessary forms for administration of the program,
149	including, but not limited to, forms for use by entities that
150	donate, accept, distribute, or dispense prescription cancer
151	drugs or supplies under the program.
152	(d)  The maximum handling fee that may be charged by a
153	participant facility that accepts and distributes or dispenses
154	donated prescription cancer drugs or supplies.
155	(e)  Categories of prescription cancer drugs and supplies
156	that the program will accept for dispensing; however, the
157	department may exclude any drug based on its therapeutic
158	effectiveness or high potential for abuse or diversion.
159	(f)  Maintenance and distribution of the participant
160	facility registry established in subsection (10).
161	(9)  A person who is eligible to receive prescription
162	cancer drugs or supplies under the state Medicaid program or
163	under any other prescription drug program funded in whole or in
164	part by the state, by any other prescription drug program funded
165	in whole or in part by the Federal Government, or by any other
166	prescription drug program offered by a third-party insurer,
167	unless benefits have been exhausted, or a certain prescription
168	cancer drug or supply is not covered by the prescription drug
169	program, is ineligible to participate in the program created
170	under this section.
171	(10)  The department shall establish and maintain a
172	participant facility registry for the program. The participant
173	facility registry shall include the participant's participant
174	facility's name, address, and telephone number. The department
175	shall make the participant facility registry available on the
176	department's website to any donor wishing to donate prescription
177	cancer drugs or supplies to the program. The department's
178	website shall also contain links to prescription cancer drug
179	manufacturers that offer drug assistance programs or free
180	medication.
181	(11)  Any donor of prescription cancer drugs or supplies,
182	or any participant in the program, who exercises reasonable care
183	in donating, accepting, distributing, or dispensing prescription
184	cancer drugs or supplies under the program and the rules adopted
185	under this section shall be immune from civil or criminal
186	liability and from professional disciplinary action of any kind
187	for any injury, death, or loss to person or property relating to
188	such activities.
189	(12)  A pharmaceutical manufacturer is not liable for any
190	claim or injury arising from the transfer of any prescription
191	cancer drug under this section, including, but not limited to,
192	liability for failure to transfer or communicate product or
193	consumer information regarding the transferred drug, as well as
194	the expiration date of the transferred drug.
195	(13)  If any conflict exists between the provisions in this
196	section and the provisions in this chapter or chapter 465, the
197	provisions in this section shall control the operation of the
198	Cancer Drug Donation program.
199	Section 2.  This act shall take effect July 1, 2008.

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