Florida Senate - 2019 SB 1528
By Senator Bean
4-02077-19 20191528__
1 A bill to be entitled
2 An act relating to prescription drug importation
3 programs for public programs; creating s. 381.02035,
4 F.S.; establishing the Canadian Prescription Drug
5 Importation Program within the Agency for Health Care
6 Administration for a specified purpose; providing
7 definitions; requiring the agency to contract with a
8 vendor to facilitate wholesale prescription drug
9 importation under the program; providing
10 responsibilities for the vendor; providing eligibility
11 criteria for prescription drugs, Canadian suppliers,
12 and importers under the program; requiring
13 participating Canadian suppliers and importers to
14 comply with specified federal requirements for
15 distributing prescription drugs imported under the
16 program; prohibiting Canadian suppliers and importers
17 from distributing, dispensing, or selling prescription
18 drugs imported under the program outside of the state;
19 requiring the agency to request federal approval of
20 the program; providing requirements for such request;
21 requiring the agency to begin operating the program
22 within a specified timeframe after receiving federal
23 approval; requiring the agency, in consultation with
24 the vendor, to submit an annual report to the Governor
25 and Legislature by a specified date; providing
26 requirements for such report; authorizing the agency
27 to adopt rules; providing an effective date.
28
29 Be It Enacted by the Legislature of the State of Florida:
30
31 Section 1. Section 381.02035, Florida Statutes, is created
32 to read:
33 381.02035 Canadian Prescription Drug Importation Program.—
34 (1) PROGRAM ESTABLISHED.—The agency shall establish a
35 program for the importation of safe and effective prescription
36 drugs from Canada which have the highest potential for cost
37 savings to the state.
38 (2) DEFINITIONS.—As used in this section, the term:
39 (a) “Agency” means the Agency for Health Care
40 Administration.
41 (b) “Canadian supplier” means a manufacturer, wholesale
42 distributor, or pharmacy appropriately licensed or permitted
43 under Canadian law to manufacture, distribute, or dispense
44 prescription drugs.
45 (c) “County health department” means a health care facility
46 established under part I of chapter 154.
47 (d) “Department” means the Department of Health.
48 (e) “Free clinic” means a clinic that delivers only medical
49 diagnostic services or nonsurgical medical treatment free of
50 charge to low-income recipients.
51 (f) “Medicaid pharmacy” means a pharmacy licensed under
52 chapter 465 which has a Medicaid provider agreement in effect
53 with the agency and is in good standing with the agency.
54 (g) “Pharmacist” means a person who holds an active and
55 unencumbered license to practice pharmacy pursuant to chapter
56 465.
57 (h) “Prescription drug” has the same meaning as in s.
58 499.003.
59 (i) “Program” means the Canadian Prescription Drug
60 Importation Program.
61 (3) IMPORTATION PROCESS.—
62 (a) The agency shall contract with a vendor to provide
63 services under the program.
64 (b) By December 1, 2019, the vendor shall develop, and each
65 year thereafter shall revise, a Wholesale Prescription Drug
66 Importation List that identifies the prescription drugs that
67 have the highest potential for cost savings to the state. In
68 developing the list, the vendor shall consider, at a minimum,
69 which prescription drugs will provide the greatest cost savings
70 to state programs, including prescription drugs for which there
71 are shortages, specialty prescription drugs, and high-volume
72 prescription drugs. The agency, in consultation with the
73 department, shall review the Wholesale Prescription Drug
74 Importation List every 3 months to ensure that it continues to
75 meet the requirements of the program and may direct the vendor
76 to revise the list, as necessary.
77 (c) The vendor shall identify Canadian suppliers who are in
78 full compliance with relevant Canadian federal and provincial
79 laws and regulations and who have agreed to export prescription
80 drugs identified on the list. The vendor must verify that such
81 Canadian suppliers meet all of the requirements of the program
82 and will export prescription drugs at prices that will provide
83 cost savings to the state. The vendor shall contract with such
84 eligible Canadian suppliers, or facilitate contracts between
85 eligible importers and eligible Canadian suppliers, to import
86 prescription drugs under the program.
87 (d) The vendor must assist the agency with the annual
88 report required in subsection (9) and provide any information
89 requested by the agency for such report.
90 (4) ELIGIBLE PRESCRIPTION DRUGS.—Eligible importers may
91 import a prescription drug from an eligible Canadian supplier
92 if:
93 (a) The drug meets the United States Food and Drug
94 Administration’s standards related to safety, effectiveness,
95 misbranding, and adulteration;
96 (b) Importing the drug would not violate the patent laws of
97 the United States;
98 (c) Importing the drug is expected to generate cost
99 savings; and
100 (d) The drug is not:
101 1. A controlled substance as defined in 21 U.S.C. s. 802;
102 2. A biological product as defined in 42 U.S.C. s. 262;
103 3. An infused drug;
104 4. An intravenously injected drug;
105 5. A drug that is inhaled during surgery; or
106 6. A drug that is a parenteral drug, the importation of
107 which is determined by the United States Secretary of Health and
108 Human Services to pose a threat to the public health.
109 (5) ELIGIBLE CANADIAN SUPPLIERS.—A Canadian supplier may
110 export prescription drugs into this state under the program if
111 the supplier is:
112 (a) In full compliance with relevant Canadian federal and
113 provincial laws and regulations; and
114 (b) Identified by the vendor as eligible to participate in
115 the program.
116 (6) ELIGIBLE IMPORTERS.—The following entities may import
117 prescription drugs from a Canadian supplier under the program:
118 (a) A pharmacist or wholesaler employed by or under
119 contract with the department’s central pharmacy, for
120 distribution to a county health department or free clinic for
121 dispensing to clients treated in such department or clinic.
122 (b) A pharmacist or wholesaler employed by or under
123 contract with a Medicaid pharmacy, for dispensing to the
124 pharmacy’s Medicaid recipients.
125 (c) A pharmacist or wholesaler employed by or under
126 contract with the Department of Corrections, for dispensing to
127 inmates in the custody of the Department of Corrections.
128 (d) A pharmacist or wholesaler employed by or under
129 contract with a developmental disabilities center, as defined in
130 s. 393.063, for dispensing to clients treated in such center.
131 (e) A pharmacist or wholesaler employed by or under
132 contract with a treatment facility, as defined in s. 394.455,
133 for dispensing to patients treated in such facility.
134 (7) DISTRIBUTION REQUIREMENTS.—Eligible Canadian suppliers
135 and importers participating under the program:
136 (a) Shall comply with the tracking and tracing requirements
137 of 21 U.S.C. ss. 360eee et seq.; and
138 (b) May not distribute, dispense, or sell prescription
139 drugs imported under the program outside of the state.
140 (8) FEDERAL APPROVAL.—By July 1, 2020, the agency shall
141 submit a request to the United States Secretary of Health and
142 Human Services for approval of the program under 21 U.S.C. s.
143 384(l). The agency shall begin operating the program within 6
144 months after receiving such approval. The request must, at a
145 minimum:
146 (a) Describe the agency’s plan for operating the program;
147 (b) Demonstrate how the prescription drugs imported into
148 the state under the program will meet the applicable federal and
149 state standards for safety and effectiveness;
150 (c) Include a list of prescription drugs that have the
151 highest potential for cost savings to the state through
152 importation at the time that the request is submitted;
153 (d) Estimate the total cost savings attributable to the
154 program; and
155 (e) Include a list of potential Canadian suppliers from
156 which the state would import prescription drugs and demonstrate
157 that the suppliers are in full compliance with relevant Canadian
158 federal and provincial laws and regulations.
159 (9) ANNUAL REPORTING.—By December 1 of each year, the
160 agency shall submit a report to the Governor, the President of
161 the Senate, and the Speaker of the House of Representatives on
162 the operation of the program during the previous fiscal year.
163 The report must include, at a minimum:
164 (a) A list of the prescription drugs that were imported
165 under the program;
166 (b) The number of participating entities;
167 (c) The number of prescriptions dispensed through the
168 program;
169 (d) The estimated cost savings during the previous fiscal
170 year and to date;
171 (e) A description of the methodology used to determine
172 which prescription drugs should be included on the Wholesale
173 Prescription Drug Importation List; and
174 (f) Documentation demonstrating how the program ensures
175 that:
176 1. Canadian suppliers participating in the program are of
177 high quality, of high performance, and in full compliance with
178 relevant Canadian federal and provincial laws and regulations;
179 2. Prescription drugs imported under the program are not
180 shipped, sold, or dispensed outside of the state once in the
181 possession of the importer;
182 3. Prescription drugs imported under the program are pure,
183 unadulterated, potent, and safe;
184 4. The program does not put consumers at a higher health
185 and safety risk than if the program did not exist; and
186 5. The program provides cost savings to the state on
187 imported prescription drugs.
188 (10) RULEMAKING AUTHORITY.—The agency may adopt rules to
189 implement this section.
190 Section 2. This act shall take effect July 1, 2019.