HB 0489

CS

CHAMBER ACTION

1	The Health Care Regulation Committee recommends the following:
2
3	Council/Committee Substitute
4	Remove the entire bill and insert:
5	A bill to be entitled
6	An act relating to the sale and distribution of
7	prescription drugs; amending s. 499.003, F.S.; redefining
8	the term "pedigree paper"; amending s. 499.012, F.S.;
9	providing an exemption from wholesale distribution for the
10	transfer of prescription drugs due to a change in the
11	ownership of a pharmacy; amending s. 499.0121, F.S.;
12	abrogating the expiration of recordkeeping provisions for
13	pedigree papers which relate to chain drug entities that
14	are part of an affiliated group; amending to conform to a
15	future effective provision; providing an effective date.
16
17	Be It Enacted by the Legislature of the State of Florida:
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19	Section 1.  Paragraph (b) of subsection (31) of section
20	499.003, Florida Statutes, is amended to read:
21	499.003  Definitions of terms used in ss. 499.001-
22	499.081.--As used in ss. 499.001-499.081, the term:
23	(31)  "Pedigree paper" means:
24	(b)  Effective July 1, 2006, a document or electronic in a
25	form approved by the Department of Health and containing
26	information that records each distribution of any given legend
27	drug, from sale by a pharmaceutical manufacturer, through
28	acquisition and sale by any wholesaler or repackager, until
29	final sale to a pharmacy or other person administering or
30	dispensing the drug. The information required to be included on
31	a legend drug's pedigree paper must at least detail the amount
32	of the legend drug;, its dosage form and strength;, its lot
33	numbers;, the name and address of each owner of the legend drug
34	and his or her signature;, its shipping information, including
35	the name and address of each person certifying delivery or
36	receipt of the legend drug; an invoice number, a shipping
37	document number, or another number uniquely identifying the
38	transaction;, and a certification that each the recipient
39	wholesaler has authenticated the pedigree papers. If the
40	manufacturer or repackager has uniquely serialized the
41	individual legend drug unit, that identifier must also be
42	included on the pedigree. It must also include the name,
43	address, telephone number and, if available, e-mail contact
44	information of each wholesaler involved in the chain of the
45	legend drug's custody. The department shall adopt rules and a
46	form relating to the requirements of this paragraph no later
47	than 90 days after the effective date of this act.
48	Section 2.  Paragraph (a) of subsection (1) of section
49	499.012, Florida Statutes, is amended to read:
50	499.012  Wholesale distribution; definitions; permits;
51	applications; general requirements.--
52	(1)  As used in this section, the term:
53	(a)  "Wholesale distribution" means distribution of
54	prescription drugs to persons other than a consumer or patient,
55	but does not include:
56	1.  Any of the following activities, which is not a
57	violation of s. 499.005(21) if such activity is conducted in
58	accordance with s. 499.014:
59	a.  The purchase or other acquisition by a hospital or
60	other health care entity that is a member of a group purchasing
61	organization of a prescription drug for its own use from the
62	group purchasing organization or from other hospitals or health
63	care entities that are members of that organization.
64	b.  The sale, purchase, or trade of a prescription drug or
65	an offer to sell, purchase, or trade a prescription drug by a
66	charitable organization described in s. 501(c)(3) of the
67	Internal Revenue Code of 1986, as amended and revised, to a
68	nonprofit affiliate of the organization to the extent otherwise
69	permitted by law.
70	c.  The sale, purchase, or trade of a prescription drug or
71	an offer to sell, purchase, or trade a prescription drug among
72	hospitals or other health care entities that are under common
73	control. For purposes of this section, "common control" means
74	the power to direct or cause the direction of the management and
75	policies of a person or an organization, whether by ownership of
76	stock, by voting rights, by contract, or otherwise.
77	d.  The sale, purchase, trade, or other transfer of a
78	prescription drug from or for any federal, state, or local
79	government agency or any entity eligible to purchase
80	prescription drugs at public health services prices pursuant to
81	Pub. L. No. 102-585, s. 602 to a contract provider or its
82	subcontractor for eligible patients of the agency or entity
83	under the following conditions:
84	(I)  The agency or entity must obtain written authorization
85	for the sale, purchase, trade, or other transfer of a
86	prescription drug under this sub-subparagraph from the Secretary
87	of Health or his or her designee.
88	(II)  The contract provider or subcontractor must be
89	authorized by law to administer or dispense prescription drugs.
90	(III)  In the case of a subcontractor, the agency or entity
91	must be a party to and execute the subcontract.
92	(IV)  A contract provider or subcontractor must maintain
93	separate and apart from other prescription drug inventory any
94	prescription drugs of the agency or entity in its possession.
95	(V)  The contract provider and subcontractor must maintain
96	and produce immediately for inspection all records of movement
97	or transfer of all the prescription drugs belonging to the
98	agency or entity, including, but not limited to, the records of
99	receipt and disposition of prescription drugs. Each contractor
100	and subcontractor dispensing or administering these drugs must
101	maintain and produce records documenting the dispensing or
102	administration. Records that are required to be maintained
103	include, but are not limited to, a perpetual inventory itemizing
104	drugs received and drugs dispensed by prescription number or
105	administered by patient identifier, which must be submitted to
106	the agency or entity quarterly.
107	(VI)  The contract provider or subcontractor may administer
108	or dispense the prescription drugs only to the eligible patients
109	of the agency or entity or must return the prescription drugs
110	for or to the agency or entity. The contract provider or
111	subcontractor must require proof from each person seeking to
112	fill a prescription or obtain treatment that the person is an
113	eligible patient of the agency or entity and must, at a minimum,
114	maintain a copy of this proof as part of the records of the
115	contractor or subcontractor required under sub-sub-subparagraph
116	(V).
117	(VII)  In addition to the departmental inspection authority
118	set forth in s. 499.051, the establishment of the contract
119	provider and subcontractor and all records pertaining to
120	prescription drugs subject to this sub-subparagraph shall be
121	subject to inspection by the agency or entity. All records
122	relating to prescription drugs of a manufacturer under this sub-
123	subparagraph shall be subject to audit by the manufacturer of
124	those drugs, without identifying individual patient information.
125	2.  Any of the following activities, which is not a
126	violation of s. 499.005(21) if such activity is conducted in
127	accordance with rules established by the department:
128	a.  The sale, purchase, or trade of a prescription drug
129	among federal, state, or local government health care entities
130	that are under common control and are authorized to purchase
131	such prescription drug.
132	b.  The sale, purchase, or trade of a prescription drug or
133	an offer to sell, purchase, or trade a prescription drug for
134	emergency medical reasons. For purposes of this sub-
135	subparagraph, the term "emergency medical reasons" includes
136	transfers of prescription drugs by a retail pharmacy to another
137	retail pharmacy to alleviate a temporary shortage.
138	c.  The transfer of a prescription drug acquired by a
139	medical director on behalf of a licensed emergency medical
140	services provider to that emergency medical services provider
141	and its transport vehicles for use in accordance with the
142	provider's license under chapter 401.
143	d.  The revocation of a sale or the return of a
144	prescription drug to the person's prescription drug wholesale
145	supplier.
146	e.  The donation of a prescription drug by a health care
147	entity to a charitable organization that has been granted an
148	exemption under s. 501(c)(3) of the Internal Revenue Code of
149	1986, as amended, and that is authorized to possess prescription
150	drugs.
151	f.  The transfer of a prescription drug by a person
152	authorized to purchase or receive prescription drugs to a person
153	licensed or permitted to handle reverse distributions or
154	destruction under the laws of the jurisdiction in which the
155	person handling the reverse distribution or destruction receives
156	the drug.
157	g.  The transfer of a prescription drug by a hospital or
158	other health care entity to a person licensed under this chapter
159	to repackage prescription drugs for the purpose of repackaging
160	the prescription drug for use by that hospital, or other health
161	care entity and other health care entities that are under common
162	control, if ownership of the prescription drugs remains with the
163	hospital or other health care entity at all times. In addition
164	to the recordkeeping requirements of s. 499.0121(6), the
165	hospital or health care entity that transfers prescription drugs
166	pursuant to this sub-subparagraph must reconcile all drugs
167	transferred and returned and resolve any discrepancies in a
168	timely manner.
169	3.  The distribution of prescription drug samples by
170	manufacturers' representatives or distributors' representatives
171	conducted in accordance with s. 499.028.
172	4.  The sale, purchase, or trade of blood and blood
173	components intended for transfusion. As used in this
174	subparagraph, the term "blood" means whole blood collected from
175	a single donor and processed either for transfusion or further
176	manufacturing, and the term "blood components" means that part
177	of the blood separated by physical or mechanical means.
178	5.  The lawful dispensing of a prescription drug in
179	accordance with chapter 465.
180	6.  The sale, purchase, or trade of a prescription drug
181	between pharmacies as a result of a sale, transfer, merger, or
182	consolidation of all or part of the business of the pharmacies
183	from or with another pharmacy, whether accomplished as a
184	purchase and sale of stock or of business assets.
185	Section 3.  Paragraph (h) of subsection (6) of section
186	499.0121, Florida Statutes, is amended to read:
187	499.0121  Storage and handling of prescription drugs;
188	recordkeeping.--The department shall adopt rules to implement
189	this section as necessary to protect the public health, safety,
190	and welfare. Such rules shall include, but not be limited to,
191	requirements for the storage and handling of prescription drugs
192	and for the establishment and maintenance of prescription drug
193	distribution records.
194	(6)  RECORDKEEPING.--The department shall adopt rules that
195	require keeping such records of prescription drugs as are
196	necessary for the protection of the public health.
197	(h)1.  This paragraph applies only to an affiliated group,
198	as defined by s. 1504 of the Internal Revenue Code of 1986, as
199	amended, which is composed of chain drug entities, including at
200	least 50 retail pharmacies, warehouses, or repackagers, which
201	are members of the same affiliated group, if the affiliated
202	group:
203	a.  Discloses to the department the names of all its
204	members; and
205	b.  Agrees in writing to provide records on prescription
206	drug purchases by members of the affiliated group not later than
207	48 hours after the department requests such records, regardless
208	of the location where the records are stored.
209	2.  Each warehouse within the affiliated group must comply
210	with all applicable federal and state drug wholesale permit
211	requirements and must purchase, receive, hold, and distribute
212	prescription drugs only to a retail pharmacy or warehouse within
213	the affiliated group. Such a warehouse is exempt from providing
214	a pedigree paper in accordance with paragraphs (d), and (e), and
215	(f) to its affiliated group member warehouse or retail pharmacy,
216	provided that:
217	a.  Any affiliated group member that purchases or receives
218	a prescription drug from outside the affiliated group must
219	receive a pedigree paper if the prescription drug is distributed
220	in or into this state and a pedigree paper is required under
221	this section and must authenticate the documentation as required
222	in subsection (4), regardless of whether the affiliated group
223	member is directly subject to regulation under this chapter; and
224	b.  The affiliated group makes available to the department
225	on request all records related to the purchase or acquisition of
226	prescription drugs by members of the affiliated group,
227	regardless of the location where the records are stored, if the
228	prescription drugs were distributed in or into this state.
229	3.  If a repackager repackages prescription drugs solely
230	for distribution to its affiliated group members for the
231	exclusive distribution to and among retail pharmacies that are
232	members of the affiliated group to which the repackager is a
233	member:
234	a.  The repackager must:
235	(I)  In lieu of the written statement required by paragraph
236	(d), or paragraph (e), or paragraph (f), for all repackaged
237	prescription drugs distributed in or into this state, state in
238	writing under oath with each distribution of a repackaged
239	prescription drug to an affiliated group member warehouse or
240	repackager: "All repackaged prescription drugs are purchased by
241	the affiliated group directly from the manufacturer or from a
242	prescription drug wholesaler that purchased the prescription
243	drugs directly from the manufacturer.";
244	(II)  Purchase all prescription drugs it repackages:
245	(A)  Directly from the manufacturer; or
246	(B)  From a prescription drug wholesaler that purchased the
247	prescription drugs directly from the manufacturer; and
248	(III)  Maintain records in accordance with this section to
249	document that it purchased the prescription drugs directly from
250	the manufacturer or that its prescription drug wholesale
251	supplier purchased the prescription drugs directly from the
252	manufacturer.
253	b.  All members of the affiliated group must provide to
254	agents of the department on request records of purchases by all
255	members of the affiliated group of prescription drugs that have
256	been repackaged, regardless of the location where the records
257	are stored or where the repackager is located.
258	4.  This paragraph expires July 1, 2006.
259	Section 4.  This act shall take effect upon becoming a law.

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