Florida Senate - 2009 SB 1144
By Senator Peaden
2-00956B-09 20091144__
1 A bill to be entitled
2 An act relating to manufacturers and purchasers of
3 prescription drugs; amending s. 499.003, F.S.;
4 redefining the term “manufacturer” as it relates to
5 the Florida Drug and Cosmetic Act; amending s. 499.01,
6 F.S.; revising the business entities that are eligible
7 for a permit as a health care clinic establishment in
8 order to purchase prescription drugs; providing an
9 effective date.
10
11 Be It Enacted by the Legislature of the State of Florida:
12
13 Section 1. Subsection (31) of section 499.003, Florida
14 Statutes, is amended to read:
15 499.003 Definitions of terms used in this part.—As used in
16 this part, the term:
17 (31) “Manufacturer” means:
18 (a) A person who prepares, derives, manufactures, or
19 produces a drug, device, or cosmetic.
20 (b) The holder or holders of a New Drug Application (NDA),
21 an Abbreviated New Drug Application (ANDA), a Biologics License
22 Application (BLA), or a New Animal Drug Application (NADA),
23 provided such application has become effective or is otherwise
24 approved consistent with s. 499.023.;
25 (c) A co-licensee who has entered into an agreement with a
26 co-licensed partner to manufacture or market a product
27 consistent with the federal act.
28 (d) 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
31 (e) The distribution point for one of the persons
32 identified in paragraph (a), paragraph (b), paragraph (c), or
33 paragraph (d) if the distribution point is:
34 1. A member of the affiliated group of one of the persons
35 identified in paragraph (a), paragraph (b), paragraph (c), or
36 paragraph (d) who distributes prescription drugs manufactured by
37 affiliated group members only. The distribution point that is an
38 affiliated group member may acquire title to a prescription drug
39 before distributing the prescription drug, is exempt from s.
40 499.01(2)(c)1., and is a manufacturer for purposes of s.
41 499.01212. As used in this subparagraph, the term “affiliated
42 group” means an affiliated group as defined in 26 U.S.C. s.
43 1504, as amended.
44 2. A person under contract with one of the persons
45 identified in paragraph (a), paragraph (b), paragraph (c), or
46 paragraph (d) to distribute their prescription drugs, who may
47 not take title to the prescription drugs, and who is permitted
48 as a third-party logistics provider under s. 499.01 the
49 manufacturer, contract manufacturer, or private label
50 distributor whether the establishment is a member of the
51 manufacturer's affiliated group or is a contract distribution
52 site.
53 The term excludes pharmacies that are operating in compliance
54 with pharmacy practice standards as defined in chapter 465 and
55 rules adopted under that chapter.
56 Section 2. Paragraph (t) of subsection (2) of section
57 499.01, Florida Statutes, is amended to read:
58 499.01 Permits.—
59 (2) The following permits are established:
60 (t) Health care clinic establishment permit.—Effective
61 January 1, 2009, a health care clinic establishment permit is
62 required for the purchase of a prescription drug by a place of
63 business at one general physical location owned and operated by
64 a professional corporation or professional limited liability
65 company described in chapter 621, any other legal entity through
66 which qualified practitioners may practice their profession
67 under state law, or a corporation that employs a veterinarian as
68 a qualifying practitioner. For the purpose of this paragraph,
69 the term “qualifying practitioner” means a licensed health care
70 practitioner defined in s. 456.001 or a veterinarian licensed
71 under chapter 474, who is authorized under the appropriate
72 practice act to prescribe and administer a prescription drug.
73 1. An establishment must provide, as part of the
74 application required under s. 499.012, designation of a
75 qualifying practitioner who will be responsible for complying
76 with all legal and regulatory requirements related to the
77 purchase, recordkeeping, storage, and handling of the
78 prescription drugs. In addition, the designated qualifying
79 practitioner shall be the practitioner whose name, establishment
80 address, and license number is used on all distribution
81 documents for prescription drugs purchased or returned by the
82 health care clinic establishment. Upon initial appointment of a
83 qualifying practitioner, the qualifying practitioner and the
84 health care clinic establishment shall notify the department on
85 a form furnished by the department within 10 days after such
86 employment. In addition, the qualifying practitioner and health
87 care clinic establishment shall notify the department within 10
88 days after any subsequent change.
89 2. The health care clinic establishment must employ a
90 qualifying practitioner at each establishment.
91 3. In addition to the remedies and penalties provided in
92 this part, a violation of this chapter by the health care clinic
93 establishment or qualifying practitioner constitutes grounds for
94 discipline of the qualifying practitioner by the appropriate
95 regulatory board.
96 4. The purchase of prescription drugs by the health care
97 clinic establishment is prohibited during any period of time
98 when the establishment does not comply with this paragraph.
99 5. A health care clinic establishment permit is not a
100 pharmacy permit or otherwise subject to chapter 465. A health
101 care clinic establishment that meets the criteria of a modified
102 Class II institutional pharmacy under s. 465.019 is not eligible
103 to be permitted under this paragraph.
104 6. This paragraph does not prohibit a qualifying
105 practitioner from purchasing prescription drugs.
106 Section 3. This act shall take effect upon becoming a law.