On January 5, 2024, the U.S. Food and Drug Administration (FDA) approved Florida’s Agency for Health Care Administration drug importation program under section 804 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This is the first approval of its kind.
Section 804 of the FD&C Act empowers FDA to approve importation of eligible prescription drugs from Canada by states, Indian Tribes, and specific pharmacists or wholesale distributors. Under this program, FDA has the authority to evaluate and potentially authorize section 804 importation program (SIP) proposals provided that the SIP demonstrates a substantial reduction in costs for American consumers without imposing additional risks to public health and safety.
Florida’s SIP authorization extends for two years from the date the FDA is informed of the first drug shipment being imported. To fulfill its SIP obligations, Florida’s Agency for Health Care Administration must: (1) Submit additional drug-specific information for the FDA’s review and approval; (2) 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; and (3) Relabel the drugs to be consistent with the FDA-approved labeling. Only prescriptions intended to aid individuals with chronic health conditions, including HIV/AIDS, mental illness, prostate cancer, and urea cycle disorder, are eligible for importation. Potential beneficiaries of these imported drugs is limited to individuals under the care of the Agency for Persons with Disabilities, Department of Children and Families, Department of Corrections, and Department of Health.
Learn more here.
Last Updated on January 18, 2024 by Aimed Alliance
