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# FDA Approves Florida Drug Importation
- URL: https://www.fdaweb.com/fda-approves-florida-drug-importation/
- Published: 2024-01-05T12:00:00.000Z
- Updated: 2026-09-14T14:19:45.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156085

FDA has [authorized](https://lnks.gd/l/eyJhbGciOiJIUzI1NiJ9.eyJidWxsZXRpbl9saW5rX2lkIjoxMDIsInVyaSI6ImJwMjpjbGljayIsInVybCI6Imh0dHBzOi8vd3d3LmZkYS5nb3YvbWVkaWEvMTc1MjM3L2Rvd25sb2FkP2F0dGFjaG1lbnQ9JnV0bV9tZWRpdW09ZW1haWwmdXRtX3NvdXJjZT1nb3ZkZWxpdmVyeSIsImJ1bGxldGluX2lkIjoiMjAyNDAxMDUuODgwNDIxMzEifQ.lw%5Ft5H9vLLHj5Rxb7vj8e01L331QKL6IY8t-X0Q6OHI/s/1255931999/br/234319737225-l?ref=fdaweb.com) Florida’s drug importation program under section 804 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The drug importation program is authorized for two years from the date FDA is notified of the first shipment of drugs to be imported from Canada.

FDA says in a [notice](https://www.fda.gov/news-events/press-announcements/fda-authorizes-floridas-drug-importation-program?ref=fdaweb.com) that it will “exercise oversight to help ensure the authorized proposal is followed and that Florida’s program continues to meet the requirements in section 804 of the FD&C Act and the agency’s regulations. Florida’s obligations under the FDA’s regulations will include, among other things: ensuring supply chain integrity, monitoring and submitting adverse event reports, complying with drug recall procedures and reporting quarterly to the FDA. The sponsor of any program the FDA authorizes is responsible for implementing all aspects of their program such as importation and distribution.”

Before drugs can be imported, Florida’s Agency for Health Care Administration must:

- Submit additional drug-specific information for the FDA's review and approval
- Ensure that the drugs Florida seeks to import have been tested for, among other things, authenticity and compliance with the FDA-approved drugs’ specifications and standards
- Relabel the drugs to be consistent with the FDA-approved labeling

Additionally, FDA says Florida must submit a quarterly report that includes information about the imported drugs, cost savings and any potential safety and quality issues. 

Under the FDA [pathway](https://lnks.gd/l/eyJhbGciOiJIUzI1NiJ9.eyJidWxsZXRpbl9saW5rX2lkIjoxMDMsInVyaSI6ImJwMjpjbGljayIsInVybCI6Imh0dHBzOi8vd3d3LmZkYS5nb3YvYWJvdXQtZmRhL3JlcG9ydHMvaW1wb3J0YXRpb24tcHJvZ3JhbS11bmRlci1zZWN0aW9uLTgwNC1mZGMtYWN0P3V0bV9tZWRpdW09ZW1haWwmdXRtX3NvdXJjZT1nb3ZkZWxpdmVyeSIsImJ1bGxldGluX2lkIjoiMjAyNDAxMDUuODgwNDIxMzEifQ.yaDRGvWDpM7YeBMxMWg7Cb%5FQ36HVS9W9AUDTw90SjvQ/s/1255931999/br/234319737225-l?ref=fdaweb.com), the agency may authorize section 804 importation program (SIP) proposals from states or Indian tribes to import certain prescription drugs from Canada if the “SIP will significantly reduce the cost to the American consumer without imposing additional risk to public health and safety,” according to the agency. “President Biden’s Executive Order on Promoting Competition in the American Economy directed the FDA to work with states and Indian tribes on these plans to reduce costs to American consumers while supporting public health and safety.”

Meanwhile, Pharmaceutical Research and Manufacturers of America (PhRMA), which has been critical of proposed importation programs, hinted 1/5 that they may seek legal action to prevent the imports. “We are deeply concerned with the FDA’s reckless decision to approve Florida’s state importation plan,” the group says. “Ensuring patients have access to needed medicines is critical, but the importation of unapproved medicines, whether from Canada or elsewhere in the world, poses a serious danger to public health. Politicians need to stop getting between Americans and their health care. PhRMA is considering all options for preventing this policy from harming patients.”