The FDA’s 15 June authorization letter said Colorado’s revised Section 804 Importation Program proposal met federal requirements and authorized the programme for two years. STAT reported that Colorado became the second state to receive such authorization after Florida, whose programme was approved in 2024 but had not yet begun importing drugs.
The delay is built into the structure. The FDA said importation may not proceed until the importer files a complete pre-import request and the agency grants that request for the covered drug. The same letter said eligible drugs must undergo statutory testing for authenticity, degradation and compliance with established specifications before distribution.
That makes the approval a regulatory opening, not a supply chain. Colorado’s Department of Health Care Policy and Financing says the programme relies on a Canadian foreign seller, a U.S. importer, testing and relabeling before drugs can reach participating Colorado pharmacies. Each of those steps can create friction before any price saving reaches a patient.
The state’s case is still substantial. Colorado’s amended application says it identified 20 eligible drugs and dosages that could save consumers, employers and other payers an estimated $46.2mn over 2025-27 if imported and adopted. That figure is a projection from the state’s own application, not observed savings. It depends on which drugs clear the FDA’s next stage, whether supply is available and whether pharmacies and payers use the programme.
Section 804 is the part of U.S. law that allows state importation programmes under federal conditions meant to protect safety and produce significant cost savings. In plain terms, Colorado has permission to build a legal channel from selected Canadian supplies into the state. The FDA has not given blanket permission for any pharmacy to buy any Canadian drug and sell it in Colorado.