Manatt Health January 22, 2024
On January 5, 2024, the Food and Drug Administration (FDA) authorized the state of Florida’s proposal under the Section 804 Importation Program (SIP) for a period of two years. FDA’s action marks the first time a state drug importation program has been authorized pursuant to the 2020 final rule implementing the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA). The MMA amended Section 804 of the Federal Food, Drug, and Cosmetic Act to permit FDA to issue regulations governing the importation of prescription drugs from Canada only after the Secretary of Health and Human Services has certified that implementation of section 804 would “pose no additional risk to the public’s health and safety” and “result in a significant...
Today's Sponsors
Today's Sponsor