On Jan. 5, 2024, the U.S. Food and Drug Administration (FDA) announced its approval of the Florida Agency for Health Administration (AHCA) application to import prescription drugs from Canada to the state of Florida. Upon satisfying certain labeling corrections, the FDA is authorizing Florida to import certain prescription drugs from Canada for a period of two years. Florida, as such, becomes the first state approved by the FDA to import prescription drugs from Canada.

AHCA originally filed its application in 2020 under Section 804 of the Importation Program (SIP) in accordance with Section 804 of the federal Food, Drug, and Cosmetic Act and 21 C.F.R. part 251. The SIP allows a state or Indian tribe to request FDA permission to have a pharmacist and/or wholesaler in that state or Indian tribe import prescription drugs from Canada. Requests under the SIP cannot include any controlled substances, biologics, infused drugs, IV drugs, drugs inhaled for surgery (e.g., anesthesia), intrathecally/intraocularly drugs, or drugs subject to a risk evaluation and mitigation strategy with the FDA.

The FDA’s approval of AHCA’s SIP application applies, at least initially, to a limited number of prescription drugs for the treatment of HIV/AIDS, mental illness, prostate cancer, and urea cycle disorder. These drugs will be distributed by the Florida Agency for Persons with Disabilities, the Florida Department of Children and Families, the Florida Department of Corrections, and the Florida Department of Health.

Initially, only one company is an approved wholesaler, which is to import the approved prescription drugs only from Metapharm Inc., a Canadian manufacturer. Along with AHCA, the importer is responsible for ensuring the prescription drugs, which will be imported from Canada, comply with FDA requirements, adverse event reporting, and recordkeeping. Throughout the two-year approval period, Florida maintains responsibility for implementing all aspects of its SIP application, including importation and distribution.

The FDA has previously published guidance to assist sponsors under the SIP.