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.