HB 7095

1	A bill to be entitled
2	An act relating to prescription drugs; amending s.
3	499.003, F.S.; revising the definition of the term
4	"manufacturer" for purposes of the Florida Drug and
5	Cosmetic Act; amending s. 499.01, F.S.; revising
6	requirements for a prescription drug manufacturer permit,
7	nonresident prescription drug manufacturer permit, and
8	health care clinic establishment permit; amending s.
9	499.0121, F.S.; requiring a wholesale distributor to
10	maintain pedigree papers separately from other records of
11	prescription drugs under certain circumstances; providing
12	an effective date.
13
14	Be It Enacted by the Legislature of the State of Florida:
15
16	Section 1.  Subsection (31) of section 499.003, Florida
17	Statutes, is amended to read:
18	499.003  Definitions of terms used in this part.--As used
19	in this part, the term:
20	(31)  "Manufacturer" means:
21	(a)  A person who prepares, derives, manufactures, or
22	produces a drug, device, or cosmetic.
23	(b)  The holder or holders of a New Drug Application (NDA),
24	an Abbreviated New Drug Application (ANDA), a Biologics License
25	Application (BLA), or a New Animal Drug Application (NADA),
26	provided such application has become effective or is otherwise
27	approved consistent with s. 499.023.;
28	(c)  A private label distributor for whom the private label
29	distributor's prescription drugs are originally manufactured and
30	labeled for the distributor and have not been repackaged; or the
31	distribution point for the manufacturer, contract manufacturer,
32	or private label distributor whether the establishment is a
33	member of the manufacturer's affiliated group or is a contract
34	distribution site.
35	(d)  A person registered under the federal act as a
36	manufacturer who enters into an agreement with a manufacturer
37	described in paragraph (a), paragraph (b), or paragraph (c),
38	which agreement authorizes either manufacturer, consistent with
39	the federal act, to distribute a prescription drug as the
40	manufacturer of the drug.
41	(e)  A member of an affiliated group that includes persons
42	described in paragraph (a), paragraph (b), paragraph (c), or
43	paragraph (d), which member distributes prescription drugs
44	manufactured only by members of the affiliated group. As used in
45	this paragraph, the term "affiliated group" means an affiliated
46	group as defined in s. 1504 of the Internal Revenue Code of
47	1986, as amended.
48
49	The term does not include a pharmacy excludes pharmacies that is
50	are operating in compliance with pharmacy practice standards as
51	defined in chapter 465 and rules adopted under that chapter.
52	Section 2.  Paragraphs (a), (c), and (t) of subsection (2)
53	of section 499.01, Florida Statutes, are amended to read:
54	499.01  Permits.--
55	(2)  The following permits are established:
56	(a)  Prescription drug manufacturer permit.--A prescription
57	drug manufacturer permit is required for any person that is a
58	manufacturer of manufactures a prescription drug and that
59	manufactures or distributes such prescription drugs in this
60	state.
61	1.  A person that operates an establishment permitted as a
62	prescription drug manufacturer may engage in wholesale
63	distribution of prescription drugs manufactured at that
64	establishment and must comply with all of the provisions of this
65	part, except s. 499.01212, and the rules adopted under this
66	part, except s. 499.01212, that apply to a wholesale
67	distributor.
68	2.  A prescription drug manufacturer must comply with all
69	appropriate state and federal good manufacturing practices.
70	(c)  Nonresident prescription drug manufacturer permit.--A
71	nonresident prescription drug manufacturer permit is required
72	for any person that is a manufacturer of prescription drugs, or
73	the distribution point for a manufacturer of prescription drugs
74	unless permitted as a third party logistics provider, and
75	located outside of this state, or that is an entity to whom an
76	approved new drug application has been issued by the United
77	States Food and Drug Administration, or the contracted
78	manufacturer of the approved new drug application holder, and
79	located outside the United States and that, which engages in the
80	wholesale distribution in this state of such the prescription
81	drugs it manufactures or is responsible for manufacturing. Each
82	such manufacturer or entity must be permitted by the department
83	and comply with all of the provisions required of a wholesale
84	distributor under this part, except s. 499.01212.
85	1.  A person that distributes prescription drugs for which
86	the person is not the manufacturer that it did not manufacture
87	must also obtain an out-of-state prescription drug wholesale
88	distributor permit or third party logistics provider permit
89	pursuant to this section to engage in the wholesale distribution
90	of such the prescription drugs manufactured by another person
91	and comply with the requirements of an out-of-state prescription
92	drug wholesale distributor. This subparagraph does not apply to
93	a manufacturer as defined in s. 499.003(31)(e).
94	2.  Any such person must comply with the licensing or
95	permitting requirements of the jurisdiction in which the
96	establishment is located and the federal act, and any product
97	wholesaled into this state must comply with this part. If a
98	person intends to import prescription drugs from a foreign
99	country into this state, the nonresident prescription drug
100	manufacturer must provide to the department a list identifying
101	each prescription drug it intends to import and document
102	approval by the United States Food and Drug Administration for
103	such importation.
104	3.  A nonresident prescription drug manufacturer permit is
105	not required for a manufacturer to distribute a prescription
106	drug active pharmaceutical ingredient that it manufactures to a
107	prescription drug manufacturer permitted in this state in
108	limited quantities intended for research and development and not
109	for resale, or human use other than lawful clinical trials and
110	biostudies authorized and regulated by federal law. A
111	manufacturer claiming to be exempt from the permit requirements
112	of this subparagraph and the prescription drug manufacturer
113	purchasing and receiving the active pharmaceutical ingredient
114	shall comply with the recordkeeping requirements of s.
115	499.0121(6), but not the requirements of s. 499.01212. The
116	prescription drug manufacturer purchasing and receiving the
117	active pharmaceutical ingredient shall maintain on file a record
118	of the FDA registration number; the out-of-state license,
119	permit, or registration number; and, if available, a copy of the
120	most current FDA inspection report, for all manufacturers from
121	whom they purchase active pharmaceutical ingredients under this
122	section. The department shall specify by rule the allowable
123	number of transactions within a given period of time and the
124	amount of active pharmaceutical ingredients that qualify as
125	limited quantities for purposes of this exemption. The failure
126	to comply with the requirements of this subparagraph, or rules
127	adopted by the department to administer this subparagraph, for
128	the purchase of prescription drug active pharmaceutical
129	ingredients is a violation of s. 499.005(14).
130	(t)  Health care clinic establishment permit.--Effective
131	January 1, 2009, a health care clinic establishment permit is
132	required for the purchase of a prescription drug by a business
133	entity as defined in s. 606.03 that operates place of business
134	at one general physical location, provides health care or
135	veterinary services, and owned and operated by a professional
136	corporation or professional limited liability company described
137	in chapter 621, or a corporation that employs a veterinarian as
138	a qualifying practitioner. A health care clinic establishment is
139	not required to obtain a permit if a qualifying practitioner
140	employed by the establishment obtains prescription drugs under
141	his or her license in accordance with s. 499.03(1)(b). For the
142	purpose of this paragraph, the term "qualifying practitioner"
143	means a licensed health care practitioner defined in s. 456.001,
144	or a veterinarian licensed under chapter 474, who is authorized
145	under the appropriate practice act to prescribe and administer a
146	prescription drug.
147	1.  An establishment must provide, as part of the
148	application required under s. 499.012, designation of a
149	qualifying practitioner who will be responsible for complying
150	with all legal and regulatory requirements related to the
151	purchase, recordkeeping, storage, and handling of the
152	prescription drugs. In addition, the designated qualifying
153	practitioner shall be the practitioner whose name, establishment
154	address, and license number is used on all distribution
155	documents for prescription drugs purchased or returned by the
156	health care clinic establishment. Upon initial appointment of a
157	qualifying practitioner, the qualifying practitioner and the
158	health care clinic establishment shall notify the department on
159	a form furnished by the department within 10 days after such
160	employment. In addition, the qualifying practitioner and health
161	care clinic establishment shall notify the department within 10
162	days after any subsequent change.
163	2.  The health care clinic establishment must employ a
164	qualifying practitioner at each establishment.
165	3.  In addition to the remedies and penalties provided in
166	this part, a violation of this chapter by the health care clinic
167	establishment or qualifying practitioner constitutes grounds for
168	discipline of the qualifying practitioner by the appropriate
169	regulatory board.
170	4.  The purchase of prescription drugs by the health care
171	clinic establishment is prohibited during any period of time
172	when the establishment does not comply with this paragraph.
173	5.  A health care clinic establishment permit is not a
174	pharmacy permit or otherwise subject to chapter 465. A health
175	care clinic establishment that meets the criteria of a modified
176	Class II institutional pharmacy under s. 465.019 is not eligible
177	to be permitted under this paragraph.
178	6.  This paragraph does not prohibit a licensed qualifying
179	practitioner from obtaining purchasing prescription drugs under
180	his or her license in accordance with s. 499.03(1)(b).
181	Section 3.  Paragraph (e) of subsection (6) of section
182	499.0121, Florida Statutes, is amended to read:
183	499.0121  Storage and handling of prescription drugs;
184	recordkeeping.--
185	(6)  RECORDKEEPING.--The department shall adopt rules that
186	require keeping such records of prescription drugs as are
187	necessary for the protection of the public health.
188	(e)  When pedigree papers are required by this part, a
189	wholesale distributor must maintain the pedigree papers separate
190	and distinct from other records required under this part
191	chapter.
192	Section 4.  This act shall take effect October 1, 2009.

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