HB 371

1
A bill to be entitled
2An act relating to prescription drugs; creating s.
3499.029, F.S.; providing a short title; creating the
4Cancer Drug Donation Program; providing a purpose;
5providing definitions; providing conditions for the
6donation of cancer drugs and supplies to the program;
7providing conditions for the acceptance of cancer drugs
8and supplies into the program, inspection of cancer drugs
9and supplies, and dispensing of cancer drugs and supplies
10to eligible patients; requiring a participant facility
11that accepts donated drugs and supplies through the
12program to comply with certain state and federal laws;
13authorizing a participant facility to charge fees under
14certain conditions; requiring the Department of Health,
15upon recommendation of the Board of Pharmacy, to adopt
16certain rules; providing for the ineligibility of certain
17persons to receive donated drugs; requiring the department
18to establish and maintain a participant facility registry;
19providing for the contents and availability of the
20participant facility registry; providing immunity from
21civil and criminal liability for donors or pharmaceutical
22manufacturers in certain circumstances; providing that in
23the event of conflict between the provisions in s.
24499.029, F.S., and provisions in ch. 465 or ch. 499, F.S.,
25the provisions in s. 499.029, F.S., shall control;
26providing an appropriation; amending s. 499.003, F.S.;
27revising the definition of the term "pedigree paper";
28authorizing the Department of Health to adopt rules and
29forms relating to pedigree paper requirements; amending s.
30499.005, F.S.; revising a prohibited acts provision
31relating to pedigree papers; amending s. 499.0121, F.S.;
32requiring certain wholesale distributors taking title to a
33prescription drug to provide an invoice to the recipient
34containing certain information; requiring a recipient of a
35prescription drug to acquire from the manufacturer a
36shipping document containing specified information;
37requiring wholesale distributor to make certain
38information available to the department; providing for
39penalties; authorizing the department to adopt certain
40rules relating to the inventory and return of certain
41prescription drugs; providing an effective date.
42
43Be It Enacted by the Legislature of the State of Florida:
44
45     Section 1.  Section 499.029, Florida Statutes, is created
46to read:
47     499.029  Cancer Drug Donation Program.--
48     (1)  This section may be cited as the "Cancer Drug Donation
49Program Act."
50     (2)  There is created a Cancer Drug Donation Program within
51the Department of Health for the purpose of authorizing and
52facilitating the donation of cancer drugs and supplies to
53eligible patients.
54     (3)  As used in this section:
55     (a)  "Cancer drug" means a prescription drug that has been
56approved under s. 505 of the federal Food, Drug, and Cosmetic
57Act and is used to treat cancer or its side effects or is used
58to treat the side effects of a prescription drug used to treat
59cancer or its side effects. "Cancer drug" does not include a
60substance listed in Schedule II, Schedule III, Schedule IV, or
61Schedule V of s. 893.03.
62     (b)  "Closed drug delivery system" means a system in which
63the actual control of the unit-dose medication package is
64maintained by the facility rather than by the individual
65patient.
66     (c)  "Department" means the Department of Health.
67     (d)  "Donor" means a patient or patient representative who
68donates cancer drugs or supplies needed to administer cancer
69drugs that have been maintained within a closed drug delivery
70system; health care facilities, nursing homes, hospices, or
71hospitals with closed drug delivery systems; or pharmacies, drug
72manufacturers, medical device manufacturers or suppliers, or
73wholesalers of drugs or supplies, in accordance with this
74section. "Donor" includes a physician licensed under chapter 458
75or chapter 459 who receives cancer drugs or supplies directly
76from a drug manufacturer, drug wholesaler, or pharmacy.
77     (e)  "Eligible patient" means a person who the department
78determines is eligible to receive cancer drugs from the program.
79     (f)  "Health care facility" means a health care facility
80licensed under chapter 395.
81     (g)  "Health care clinic" means a health care clinic
82licensed under part XIII of chapter 400.
83     (h)  "Hospice" means a corporation licensed under part VI
84of chapter 400.
85     (i)  "Hospital" means a facility as defined in s. 395.002
86and licensed under chapter 395.
87     (j)  "Nursing home" means a facility licensed under part II
88of chapter 400.
89     (k)  "Participant facility" means a class II hospital
90pharmacy that has elected to participate in the program and that
91accepts donated cancer drugs and supplies under the rules
92adopted by the department for the program.
93     (l)  "Pharmacist" means a person licensed under chapter
94465.
95     (m)  "Pharmacy" means an entity licensed under chapter 465.
96     (n)  "Prescribing practitioner" means a physician licensed
97under chapter 458 or any other medical professional with
98authority under state law to prescribe cancer medication.
99     (o)  "Prescription drug" means a drug as defined in s.
100465.003(8).
101     (p)  "Program" means the Cancer Drug Donation Program
102created by this section.
103     (q)  "Supplies" means any supplies used in the
104administration of a cancer drug.
105     (4)  Any donor may donate cancer drugs or supplies to a
106participant facility that elects to participate in the program
107and meets criteria established by the department for such
108participation. Cancer drugs or supplies may not be donated to a
109specific cancer patient, and donated drugs or supplies may not
110be resold by the program. Cancer drugs billed to and paid for by
111Medicaid in long-term care facilities that are eligible for
112return to stock under federal Medicaid regulations shall be
113credited to Medicaid and are not eligible for donation under the
114program. A participant facility may provide dispensing and
115consulting services to individuals who are not patients of the
116hospital.
117     (5)  The cancer drugs or supplies donated to the program
118may be prescribed only by a prescribing practitioner for use by
119an eligible patient and may be dispensed only by a pharmacist.
120     (6)(a)  A cancer drug may only be accepted or dispensed
121under the program if the drug is in its original, unopened,
122sealed container, or in a tamper-evident unit-dose packaging,
123except that a cancer drug packaged in single-unit doses may be
124accepted and dispensed if the outside packaging is opened but
125the single-unit-dose packaging is unopened with tamper-resistant
126packaging intact.
127     (b)  A cancer drug may not be accepted or dispensed under
128the program if the drug bears an expiration date that is less
129than 6 months after the date the drug was donated or if the drug
130appears to have been tampered with or mislabeled as determined
131in paragraph (c).
132     (c)  Prior to being dispensed to an eligible patient, the
133cancer drug or supplies donated under the program shall be
134inspected by a pharmacist to determine that the drug and
135supplies do not appear to have been tampered with or mislabeled.
136     (d)  A dispenser of donated cancer drugs or supplies may
137not submit a claim or otherwise seek reimbursement from any
138public or private third-party payor for donated cancer drugs or
139supplies dispensed to any patient under the program, and a
140public or private third-party payor is not required to provide
141reimbursement to a dispenser for donated cancer drugs or
142supplies dispensed to any patient under the program.
143     (7)(a)  A donation of cancer drugs or supplies shall be
144made only at a participant facility. A participant facility may
145decline to accept a donation. A participant facility that
146accepts donated cancer drugs or supplies under the program shall
147comply with all applicable provisions of state and federal law
148relating to the storage and dispensing of the donated cancer
149drugs or supplies.
150     (b)  A participant facility that voluntarily takes part in
151the program may charge a handling fee sufficient to cover the
152cost of preparation and dispensing of cancer drugs or supplies
153under the program. The fee shall be established in rules adopted
154by the department.
155     (8)  The department, upon the recommendation of the Board
156of Pharmacy, shall adopt rules to carry out the provisions of
157this section. Initial rules under this section shall be adopted
158no later than 90 days after the effective date of this act. The
159rules shall include, but not be limited to:
160     (a)  Eligibility criteria, including a method to determine
161priority of eligible patients under the program.
162     (b)  Standards and procedures for participant facilities
163that accept, store, distribute, or dispense donated cancer drugs
164or supplies.
165     (c)  Necessary forms for administration of the program,
166including, but not limited to, forms for use by entities that
167donate, accept, distribute, or dispense cancer drugs or supplies
168under the program.
169     (d)  The maximum handling fee that may be charged by a
170participant facility that accepts and distributes or dispenses
171donated cancer drugs or supplies.
172     (e)  Categories of cancer drugs and supplies that the
173program will accept for dispensing; however, the department may
174exclude any drug based on its therapeutic effectiveness or high
175potential for abuse or diversion.
176     (f)  Maintenance and distribution of the participant
177facility registry established in subsection (10).
178     (9)  A person who is eligible to receive cancer drugs or
179supplies under the state Medicaid program or under any other
180prescription drug program funded in whole or in part by the
181state, by any other prescription drug program funded in whole or
182in part by the Federal Government, or by any other prescription
183drug program offered by a third-party insurer, unless benefits
184have been exhausted, or a certain cancer drug or supply is not
185covered by the prescription drug program, is ineligible to
186participate in the program created under this section.
187     (10)  The department shall establish and maintain a
188participant facility registry for the program. The participant
189facility registry shall include the participant facility's name,
190address, and telephone number. The department shall make the
191participant facility registry available on the department's
192website to any donor wishing to donate cancer drugs or supplies
193to the program. The department's website shall also contain
194links to cancer drug manufacturers that offer drug assistance
195programs or free medication.
196     (11)  Any donor of cancer drugs or supplies, or any
197participant in the program, who exercises reasonable care in
198donating, accepting, distributing, or dispensing cancer drugs or
199supplies under the program and the rules adopted under this
200section shall be immune from civil or criminal liability and
201from professional disciplinary action of any kind for any
202injury, death, or loss to person or property relating to such
203activities.
204     (12)  A pharmaceutical manufacturer is not liable for any
205claim or injury arising from the transfer of any cancer drug
206under this section, including, but not limited to, liability for
207failure to transfer or communicate product or consumer
208information regarding the transferred drug, as well as the
209expiration date of the transferred drug.
210     (13)  If any conflict exists between the provisions in this
211section and the provisions in this chapter or chapter 465, the
212provisions in this section shall control the operation of the
213Cancer Drug Donation Program.
214     Section 2.  There is hereby appropriated one full-time
215equivalent position at salary rate 42,715 and recurring funding
216from the Florida Drug, Device, and Cosmetic Trust Fund pursuant
217to s. 499.057, Florida Statutes, in the sum of $65,308 for
218fiscal year 2006-2007, for the purpose of implementing the
219Cancer Drug Donation Program under s. 499.029, Florida Statutes,
220as created by this act.
221     Section 3.  Subsection (31) of section 499.003, Florida
222Statutes, is amended to read:
223     499.003  Definitions of terms used in ss. 499.001-
224499.081.--As used in ss. 499.001-499.081, the term:
225     (31)  "Pedigree paper" means:
226     (a)  A document required pursuant to s. 499.0121(6)(d) or
227(e); or
228     (b)1.  Effective July 1, 2006, a document or electronic
229form approved by the Department of Health and containing
230information that records each distribution of any given legend
231drug, from sale by a pharmaceutical manufacturer, through
232acquisition and sale by any wholesaler or repackager, until
233final sale to a pharmacy or other person administering or
234dispensing the drug. The information required to be included on
235the form approved by the department pursuant to this
236subparagraph a legend drug's pedigree paper must at least detail
237the amount of the legend drug; its dosage form and strength; its
238lot numbers; the name and address of each owner of the legend
239drug and his or her signature; its shipping information,
240including the name and address of each person certifying
241delivery or receipt of the legend drug; an invoice number, a
242shipping document number, or another number uniquely identifying
243the transaction; and a certification that the recipient
244wholesaler has authenticated the pedigree papers. If the
245manufacturer or repackager has uniquely serialized the
246individual legend drug unit, that identifier must also be
247included on the form approved pursuant to this subparagraph
248pedigree. It must also include the name, address, telephone
249number and, if available, e-mail contact information of each
250wholesaler involved in the chain of the legend drug's custody;
251or
252     2.  A statement, under oath, in written or electronic
253form, confirming that a wholesale distributor purchases and
254receives the specific unit of the prescription drug directly
255from the manufacturer of the prescription drug and distributes
256the prescription drug directly, or through an intracompany
257transfer, to a chain pharmacy warehouse or a person authorized
258by law to purchase prescription drugs for the purpose of
259administering or dispensing the drug, as defined in s. 465.003.
260For purposes of this paragraph, the term "chain pharmacy
261warehouse" means a wholesale distributor permitted pursuant to
262s. 499.01 that maintains a physical location for prescription
263drugs that functions solely as a central warehouse to perform
264intracompany transfers of such drugs to a member of its
265affiliated group as described in s. 499.0121(6)(h)1.
266     a.  The information required to be included pursuant to
267this subparagraph must include:
268     (I)  The following statement: "This wholesale distributor
269purchased the specific unit of the prescription drug directly
270from the manufacturer."
271     (II)  The manufacturers' national drug code identifier and
272the name and address of the wholesaler and the purchaser of the
273prescription drug.
274     (III)  The name of the prescription drug as it appears on
275the label.
276     (IV)  The quantity, dosage form, and strength of the
277prescription drug.
278     b.  The wholesale distributor must also maintain and make
279available to the department, upon request, the point of origin
280of the prescription drugs, including intracompany transfers; the
281date of the shipment from the manufacturer to the wholesale
282distributor; the lot numbers of such drugs; and the invoice
283numbers from the manufacturer.
284
285The department may shall adopt rules and forms a form relating
286to the requirements of this subsection paragraph no later than
28790 days after the effective date of this act.
288     Section 4.  Subsection (29) of section 499.005, Florida
289Statutes, is amended to read:
290     499.005  Prohibited acts.--It is unlawful for a person to
291perform or cause the performance of any of the following acts in
292this state:
293     (29)  The receipt of a prescription drug pursuant to a
294wholesale distribution without either first receiving a pedigree
295paper that was attested to as accurate and complete by the
296wholesale distributor or complying with the provisions of s.
297499.0121(6)(f)6.
298     Section 5.  Paragraph (f) of subsection (6) of section
299499.0121, Florida Statutes, is amended to read:
300     499.0121  Storage and handling of prescription drugs;
301recordkeeping.--The department shall adopt rules to implement
302this section as necessary to protect the public health, safety,
303and welfare. Such rules shall include, but not be limited to,
304requirements for the storage and handling of prescription drugs
305and for the establishment and maintenance of prescription drug
306distribution records.
307     (6)  RECORDKEEPING.--The department shall adopt rules that
308require keeping such records of prescription drugs as are
309necessary for the protection of the public health.
310     (f)1.  Effective July 1, 2006, each person who is engaged
311in the wholesale distribution of a prescription drug and who is
312not the manufacturer of that drug must, before each wholesale
313distribution of such drug, provide to the person who receives
314the drug a pedigree paper as defined in s. 499.003(31).
315     2.  A repackager must comply with this paragraph.
316     3.  The pedigree paper requirements in this paragraph do
317not apply to compressed medical gases or veterinary legend
318drugs.
319     4.  Each wholesale distributor of prescription drugs must
320maintain separate and distinct from other required records all
321statements that are required under subparagraph 1.
322     5.  In order to verify compliance with subparagraph (d)1.,
323each manufacturer of a prescription drug sold in this state must
324make available upon request distribution documentation related
325to its sales of prescription drugs, regardless of whether the
326prescription drug was sold directly by the manufacturer to a
327person in Florida.
328     6.  Subparagraph 1. is satisfied when a wholesale
329distributor takes title to, but not possession of, a
330prescription drug and the prescription drug's manufacturer ships
331the prescription drug directly to a person authorized by law to
332purchase prescription drugs for the purpose of administering or
333dispensing the drug, as defined in s. 465.003, or a member of an
334affiliated group, as described in paragraph (h), with the
335exception of a repackager.
336     a.  The wholesale distributor must deliver to the recipient
337of the prescription drug, within 14 days after the shipment
338notification from the manufacturer, an invoice and the following
339sworn statement: "This wholesale distributor purchased the
340specific unit of the prescription drug listed on the invoice
341directly from the manufacturer, and the specific unit of
342prescription drug was shipped by the manufacturer directly to a
343person authorized by law to administer or dispense the legend
344drug, as defined in s. 465.003, Florida Statutes, or a member of
345an affiliated group, as described in s. 499.0121(6)(h), Florida
346Statutes, with the exception of a repackager." The invoice must
347contain a unique cross-reference to the shipping document sent
348by the manufacturer to the recipient of the prescription drug.
349     b.  The manufacturer of the prescription drug shipped
350directly to the recipient under this section must provide and
351the recipient of the prescription drug must acquire, within 14
352days after receipt of the prescription drug, a shipping document
353from the manufacturer that contains, at a minimum:
354     (I)  The name and address of the manufacturer, including
355the point of origin of the shipment, and the names and addresses
356of the wholesaler and the purchaser.
357     (II)  The name of the prescription drug as it appears on
358the label.
359     (III)  The quantity, dosage form, and strength of the
360prescription drug.
361     (IV)  The date of the shipment from the manufacturer.
362     c.  The wholesale distributor must also maintain and make
363available to the department, upon request, the lot number of
364such drug if not contained in the shipping document acquired by
365the recipient.
366     7.  Failure of the manufacturer to provide, the recipient
367to acquire, or the wholesale distributor to deliver, the
368documentation required under subparagraph 6. shall constitute
369failure to acquire or deliver a pedigree paper under s.
370499.0051. Forgery by the manufacturer, the recipient or the
371wholesale distributor of the documentation required to be
372acquired or delivered under subparagraph 6. shall constitute
373forgery of a pedigree paper under s. 499.0051.
374     8.  The department may, by rule, specify alternatives to
375compliance with subparagraph 1. for a prescription drug in the
376inventory of a permitted prescription drug wholesaler as of June
37730, 2006, and the return of a prescription drug purchased prior
378to July 1, 2006. The department may specify time limits for such
379alternatives.
380     Section 6.  This act shall take effect July 1, 2006.


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