> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Authorizes Colorado Prescription Drug Importation Program
- URL: https://www.fdaweb.com/fda-authorizes-colorado-prescription-drug-importation-program/
- Published: 2026-06-15T12:00:00.000Z
- Updated: 2026-09-14T13:41:12.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161311

FDA has authorized Colorado's prescription drug importation program, marking another step forward for state-led efforts to lower drug costs through imports from Canada under Section 804 of the Federal Food, Drug, and Cosmetic Act. In a 6/15 letter, the agency said the state's revised Section 804 Importation Program (SIP) meets federal statutory and regulatory requirements designed to ensure imported drugs can reduce costs without compromising safety or quality.

The [authorization](https://www.fda.gov/media/193117/download?attachment&ref=fdaweb.com) allows Colorado's program to operate for two years, provided the state complies with a series of federal oversight requirements and begins importing eligible drugs within one year. The action follows a lengthy review process. Colorado first submitted its importation proposal in 12/2022 and later revised the application multiple times, including updates submitted in 2024 and 2025\. FDA also considered clarifying information provided by the state as recently as January.

Before any drugs can enter the U.S. under the Colorado program, the state's designated importer must submit a drug-specific Pre-Import Request to FDA at least 30 days before the planned shipment. FDA must approve each request before importation can proceed.

Imported products also must also undergo testing to verify authenticity, assess degradation, and confirm compliance with established specifications. In addition, FDA must review and approve labeling for each imported product before entry.

The agency emphasized that authorization does not eliminate ongoing compliance obligations. Colorado must submit quarterly reports detailing importation activities, maintain required records, and obtain FDA approval before making any modifications to the program.

Colorado is joining Florida as the only states to have gained importation authorization. Florida was approved in 2024, but the long-promised program has yet to deliver any imported medicines more than two years after receiving final agency FDA approval. The state’s Section 804 drug importation initiative, championed by Gov. **Ron DeSantis** as a way to lower prescription drug costs, has stalled amid resistance from Canadian drug manufacturers and regulators, ongoing logistical challenges, and mounting scrutiny over more than $82 million in state spending with no drugs imported to date, according to a *Politico* [report](https://www.politico.com/news/2026/02/02/desantis-florida-canada-drug-imports-00759891?ref=fdaweb.com).

A central obstacle, according to *Politico*, has been the lack of cooperation from Canada’s pharmaceutical industry and government, which have repeatedly warned that U.S. importation programs could strain Canada’s drug supply. Canadian authorities have also implemented regulatory measures aimed at limiting exports that could contribute to domestic shortages. Health policy experts say that resistance has undermined Florida’s efforts from the outset.