Signed by Governor Ron DeSantis

Vote Smart's Synopsis:

Vote to pass a bill that authorizes the importation of prescription drugs from Canada.

Highlights:

• Establishes the Canadian Prescription Drug Importation Program for the importation of safe and effective prescription drugs from Canada which have the highest potential for cost savings to the state (Sec. 1).

• Defines “Canadian supplier” as a manufacturer, wholesale distributor, or pharmacy appropriately licensed or permitted under Canadian law to manufacture, distribute, or dispense prescription drugs (Sec. 1).

• Specifies that “agency” refers to the Agency for Health Care Administration (Sec. 1).

• Specifies that “department” refers to the Department of Health (Sec. 1).

• Specifies that “program” refers to the Canadian Prescription Drug Importation Program (Sec. 1).

• Requires the agency to contract with a vendor to provide services under the program (Sec. 1).

• Requires the vendor to (Sec. 1):

• Develop a Wholesale Prescription Drug Importation List identifying the prescription drugs with the highest potential for cost savings to the state, by December 1, 2019, and each subsequent year;

• Identify Canadian suppliers to export drugs identified on the list;

• Contract with such eligible Canadian suppliers, or facilitate contracts between eligible importers and Canadian suppliers, to import these drugs;

• Maintain a list of all registered importers participating in the program;

• Ensure that all suppliers, importers, distributors, and participants in the program are in compliance with Title II of the federal Drug Quality and Security Act;

• Assist the agency in the preparation of the annual report; and

• Provide an annual financial audit of its operations to the agency.

• Prohibits the importation of any drug that is (Sec. 1):

• A controlled substance;

• A biological product;

• An infused drug;

• An intravenously injected drug;

• A drug inhaled during surgery; or

• A parenteral drug.

• Authorizes the agency to submit a request to the United States Secretary of Health and Human Services for approval of the program, and to begin operating the program within 6 months after receiving approval (Sec. 1).

• Requires the vendor to ensure the safety and quality of drugs imported under the program (Sec. 1).

• Requires an annual report on the operation of the program, to be presented to the Governor, the President of the Senate, and the Speaker of the House of Representatives, by December 1 of each year (Sec. 1).

• Requires a pharmacy located outside of the United States to hold an international export pharmacy permit in order to participate as an exporter of prescription drugs into this state (Sec. 2).

• Requires the department to adopt rules governing the financial responsibility of a pharmacy permittee (Sec. 2).

• Requires the department to establish a program for the importation of safe and effective prescription drugs from foreign nations with which the United States has current mutual recognition agreements, cooperation agreements, memoranda of understanding, or other federal mechanisms recognizing their adherence to current good manufacturing practices for pharmaceutical products (Sec. 10).

• Authorizes an eligible importer to import a prescription drug from an eligible exporter if (Sec. 10):

• The drug meets the standards of the United States Food and Drug Administration regarding safety, efficacy, misbranding, and adulteration;

• No patent laws would be violated with the importation of the drug; and

• The drug is not:

• A controlled substance;

• A biological product;

• An infused drug;

• An intravenously injected drug;

• A drug inhaled during surgery; or

• A parenteral drug.

• Authorizes the following entities to export prescription drugs into this state under the program (Sec. 10):

• An international prescription drug wholesale distributor;

• A nonresident prescription drug manufacturer; and

• An international export pharmacy.

• Requires the Department of Business and Professional Regulation, in collaboration with the Department of Health, to negotiate a federal arrangement to operate a pilot program for importing prescription drugs into this state (Sec. 11)

Full Bill Text

Vote Smart's Synopsis:

Vote to pass a bill that authorizes the importation of prescription drugs from Canada.

Highlights:

• Establishes the Canadian Prescription Drug Importation Program for the importation of safe and effective prescription drugs from Canada which have the highest potential for cost savings to the state (Sec. 1).

• Defines “Canadian supplier” as a manufacturer, wholesale distributor, or pharmacy appropriately licensed or permitted under Canadian law to manufacture, distribute, or dispense prescription drugs (Sec. 1).

• Specifies that “agency” refers to the Agency for Health Care Administration (Sec. 1).

• Specifies that “department” refers to the Department of Health (Sec. 1).

• Specifies that “program” refers to the Canadian Prescription Drug Importation Program (Sec. 1).

• Requires the agency to contract with a vendor to provide services under the program (Sec. 1).

• Requires the vendor to (Sec. 1):

• Develop a Wholesale Prescription Drug Importation List identifying the prescription drugs with the highest potential for cost savings to the state, by December 1, 2019, and each subsequent year;

• Identify Canadian suppliers to export drugs identified on the list;

• Contract with such eligible Canadian suppliers, or facilitate contracts between eligible importers and Canadian suppliers, to import these drugs;

• Maintain a list of all registered importers participating in the program;

• Ensure that all suppliers, importers, distributors, and participants in the program are in compliance with Title II of the federal Drug Quality and Security Act;

• Assist the agency in the preparation of the annual report; and

• Provide an annual financial audit of its operations to the agency.

• Prohibits the importation of any drug that is (Sec. 1):

• A controlled substance;

• A biological product;

• An infused drug;

• An intravenously injected drug;

• A drug inhaled during surgery; or

• A parenteral drug.

• Authorizes the agency to submit a request to the United States Secretary of Health and Human Services for approval of the program, and to begin operating the program within 6 months after receiving approval (Sec. 1).

• Requires the vendor to ensure the safety and quality of drugs imported under the program (Sec. 1).

• Requires an annual report on the operation of the program, to be presented to the Governor, the President of the Senate, and the Speaker of the House of Representatives, by December 1 of each year (Sec. 1).

• Requires a pharmacy located outside of the United States to hold an international export pharmacy permit in order to participate as an exporter of prescription drugs into this state (Sec. 2).

• Requires the department to adopt rules governing the financial responsibility of a pharmacy permittee (Sec. 2).

• Requires the department to establish a program for the importation of safe and effective prescription drugs from foreign nations with which the United States has current mutual recognition agreements, cooperation agreements, memoranda of understanding, or other federal mechanisms recognizing their adherence to current good manufacturing practices for pharmaceutical products (Sec. 10).

• Authorizes an eligible importer to import a prescription drug from an eligible exporter if (Sec. 10):

• The drug meets the standards of the United States Food and Drug Administration regarding safety, efficacy, misbranding, and adulteration;

• No patent laws would be violated with the importation of the drug; and

• The drug is not:

• A controlled substance;

• A biological product;

• An infused drug;

• An intravenously injected drug;

• A drug inhaled during surgery; or

• A parenteral drug.

• Authorizes the following entities to export prescription drugs into this state under the program (Sec. 10):

• An international prescription drug wholesale distributor;

• A nonresident prescription drug manufacturer; and

• An international export pharmacy.

• Requires the Department of Business and Professional Regulation, in collaboration with the Department of Health, to negotiate a federal arrangement to operate a pilot program for importing prescription drugs into this state (Sec. 11)

Full Bill Text