Florida Senate - 2011 COMMITTEE AMENDMENT
Bill No. CS for SB 1736
Barcode 136318
LEGISLATIVE ACTION
Senate . House
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The Committee on Budget (Hays) recommended the following:
1 Senate Amendment (with title amendment)
2
3 Delete lines 4033 - 4121
4 and insert:
5 Section 106. Paragraphs (a), (g), and (t) of subsection (2)
6 of section 499.01, Florida Statutes, are amended to read:
7 499.01 Permits.—
8 (2) The following permits are established:
9 (a) Prescription drug manufacturer permit.—A prescription
10 drug manufacturer permit is required for any person that is a
11 manufacturer of a prescription drug and that manufactures or
12 distributes such prescription drugs in this state.
13 1. A person that operates an establishment permitted as a
14 prescription drug manufacturer may engage in wholesale
15 distribution of prescription drugs manufactured at that
16 establishment and must comply with all of the provisions of this
17 part, except s. 499.01212, and the rules adopted under this
18 part, except s. 499.01212, which that apply to a wholesale
19 distributor.
20 2. A prescription drug manufacturer must comply with all
21 appropriate state and federal good manufacturing practices.
22 3. A blood establishment, as defined in s. 381.06014,
23 operating in a manner consistent with the provisions of Title 21
24 C.F.R. parts 211 and 600-640, and manufacturing only the
25 prescription drugs described in s. 499.003(54)(d) is not
26 required to be permitted as a prescription drug manufacturer
27 under this paragraph or to register products under s. 499.015.
28 (g) Restricted prescription drug distributor permit.—
29 1. A restricted prescription drug distributor permit is
30 required for:
31 a. Any person located in this state that engages in the
32 distribution of a prescription drug, which distribution is not
33 considered “wholesale distribution” under s. 499.003(54)(a).
34 b.1. Any A person located in this state who engages in the
35 receipt or distribution of a prescription drug in this state for
36 the purpose of processing its return or its destruction must
37 obtain a permit as a restricted prescription drug distributor if
38 such person is not the person initiating the return, the
39 prescription drug wholesale supplier of the person initiating
40 the return, or the manufacturer of the drug.
41 c. A blood establishment located in this state which
42 collects blood and blood components only from volunteer donors
43 as defined in s. 381.06014 or pursuant to an authorized
44 practitioner’s order for medical treatment or therapy and
45 engages in the wholesale distribution of a prescription drug not
46 described in s. 499.003(54)(d) to a health care entity. The
47 health care entity receiving a prescription drug distributed
48 under this sub-subparagraph must be licensed as a closed
49 pharmacy or provide health care services at that establishment.
50 The blood establishment must operate in accordance with s.
51 381.06014 and may distribute only:
52 (I) Prescription drugs indicated for a bleeding or clotting
53 disorder or anemia;
54 (II) Blood-collection containers approved under s. 505 of
55 the federal act;
56 (III) Drugs that are blood derivatives, or a recombinant or
57 synthetic form of a blood derivative;
58 (IV) Prescription drugs that are identified in rules
59 adopted by the department and that are essential to services
60 performed or provided by blood establishments and authorized for
61 distribution by blood establishments under federal law; or
62 (V) To the extent authorized by federal law, drugs
63 necessary to collect blood or blood components from volunteer
64 blood donors; for blood establishment personnel to perform
65 therapeutic procedures under the direction and supervision of a
66 licensed physician; and to diagnose, treat, manage, and prevent
67 any reaction of either a volunteer blood donor or a patient
68 undergoing a therapeutic procedure performed under the direction
69 and supervision of a licensed physician,
70
71 as long as all of the health care services provided by the blood
72 establishment are related to its activities as a registered
73 blood establishment or the health care services consist of
74 collecting, processing, storing, or administering human
75 hematopoietic stem cells or progenitor cells or performing
76 diagnostic testing of specimens if such specimens are tested
77 together with specimens undergoing routine donor testing.
78 2. Storage, handling, and recordkeeping of these
79 distributions by a person required to be permitted as a
80 restricted prescription drug distributor must comply with the
81 requirements for wholesale distributors under s. 499.0121, but
82 not those set forth in s. 499.01212 if the distribution occurs
83 pursuant to sub-subparagraph 1.a. or sub-subparagraph 1.b.
84 3. A person who applies for a permit as a restricted
85 prescription drug distributor, or for the renewal of such a
86 permit, must provide to the department the information required
87 under s. 499.012.
88 4. The department may adopt rules regarding the
89 distribution of prescription drugs by hospitals, health care
90 entities, charitable organizations, or other persons not
91 involved in wholesale distribution, and blood establishments,
92 which rules are necessary for the protection of the public
93 health, safety, and welfare.
94 (t) Health care clinic establishment permit.—Effective
95 January 1, 2009, a health care clinic establishment permit is
96 required for the purchase of a prescription drug by a place of
97 business at one general physical location that provides health
98 care or veterinary services, which is owned and operated by a
99 business entity that has been issued a federal employer tax
100 identification number. For the purpose of this paragraph, the
101 term “qualifying practitioner” means a licensed health care
102 practitioner defined in s. 456.001, or a veterinarian licensed
103 under chapter 474, who is authorized under the appropriate
104 practice act to prescribe and administer a prescription drug.
105 1. An establishment must provide, as part of the
106 application required under s. 499.012, designation of a
107 qualifying practitioner who will be responsible for complying
108 with all legal and regulatory requirements related to the
109 purchase, recordkeeping, storage, and handling of the
110 prescription drugs. In addition, the designated qualifying
111 practitioner shall be the practitioner whose name, establishment
112 address, and license number is used on all distribution
113 documents for prescription drugs purchased or returned by the
114 health care clinic establishment. Upon initial appointment of a
115 qualifying practitioner, the qualifying practitioner and the
116 health care clinic establishment shall notify the department on
117 a form furnished by the department within 10 days after such
118 employment. In addition, the qualifying practitioner and health
119 care clinic establishment shall notify the department within 10
120 days after any subsequent change.
121 2. The health care clinic establishment must employ a
122 qualifying practitioner at each establishment.
123 3. In addition to the remedies and penalties provided in
124 this part, a violation of this chapter by the health care clinic
125 establishment or qualifying practitioner constitutes grounds for
126 discipline of the qualifying practitioner by the appropriate
127 regulatory board.
128 4. The purchase of prescription drugs by the health care
129 clinic establishment is prohibited during any period of time
130 when the establishment does not comply with this paragraph.
131 5. A health care clinic establishment permit is not a
132 pharmacy permit or otherwise subject to chapter 465. A health
133 care clinic establishment that meets the criteria of a modified
134 Class II institutional pharmacy under s. 465.019 is not eligible
135 to be permitted under this paragraph.
136 6. This paragraph does not apply to the purchase of a
137 prescription drug by a licensed practitioner under his or her
138 license. A professional corporation or limited liability company
139 composed of dentists and operating as authorized in s. 466.0285
140 may pay for prescription drugs obtained by a practitioner
141 licensed under chapter 466, and the licensed practitioner is
142 deemed the purchaser and owner of the prescription drugs.
143
144 ================= T I T L E A M E N D M E N T ================
145 And the title is amended as follows:
146 Delete line 376
147 and insert:
148 prescription drugs by blood establishments;
149 authorizing certain business entities to pay for
150 prescription drugs obtained by practitioners licensed
151 under ch. 466, F.S.; providing