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January 8, 2024

FDA Authorizes Florida’s Plan Under FD&C Act Section 804 To Import Prescription Drugs From Canada


On January 5, 2024, the U.S. Food and Drug Administration (FDA or Agency) authorized Florida’s proposed program to import prescription drugs from Canada under section 804 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. § 384). This means FDA has formally determined that Florida has met the state’s obligation under section 804 of the FD&C Act (Section 804) to demonstrate that the program (referred to as a Section 804 importation program or SIP) will result in a significant reduction in the cost of the prescription drugs covered by the SIP to the American consumer without posing additional risk to the public’s health and safety. Florida must meet certain additional requirements, however, before the state can begin bringing shipments of prescription drugs into the U.S. from Canada under the SIP.

FDA’s authority to permit the importation of drugs from Canada under a SIP stems from the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, which added section 804 to the FD&C Act. Section 804 authorized FDA to issue regulations allowing for the importation of certain types of prescription drugs from Canada if the Department of Health and Human Services (HHS) certifies to Congress that doing so will both result in a significant reduction in the cost of covered products to the American consumer and pose no additional risk to the public’s health and safety. Otherwise, the FD&C Act generally prohibits importation of prescription drugs into the U.S. without the authorization of the drug manufacturer. For many years, HHS did not make such a certification to Congress, but in December of 2019, FDA issued a proposed rule to implement Section 804, and then in December of 2020 HHS issued the certification to Congress concurrent with FDA issuing the final rule implementing Section 804 (the Section 804 rule) (codified at 21 CFR Part 251). The Section 804 rule initially only permits SIP proposals from States or American Indian Tribes (SIP Sponsors), but further provides that FDA may consider SIP proposals from other types of SIP Sponsors in the future. Section 804 and the Section 804 rule prohibit the importation of certain types of prescription drugs under a SIP, including biologics, controlled substances, infused drugs, and intravenously injected drugs.1 Florida’s authorized SIP proposal should include a list of the specific prescription drugs Florida intends to import under the SIP, although at this time a copy of Florida’s authorized SIP proposal has not been made public.

In accordance with the Section 804 rule and FDA’s letter authorizing Florida’s SIP, before any shipment of prescription drugs can be imported under Florida’s SIP, Florida must ensure certain information about the shipment is submitted to FDA by the importer in the form of a “Pre-Import Request.” No shipment can be imported under the SIP until FDA grants a Pre-Import Request that covers the shipment. SIP Sponsors must also ensure several other requirements are met related to import of the shipment, including ensuring that the drugs are relabeled with the FDA-required labeling and a statement that the drugs were imported under a SIP; that the drugs are screened for evidence that they are adulterated, counterfeit, damaged, tampered with, expired, suspect foreign product, or illegitimate; and that the drugs are subjected to laboratory testing for authenticity, stability, and compliance with established specifications and standards. Other SIP Sponsor obligations include ensuring integrity of the supply chain, monitoring and submitting adverse event reports, complying with drug recall procedures, and submitting quarterly reports to FDA.

In line with the provisions of the Section 804 rule, FDA’s letter authorizing Florida’s SIP provides that the SIP will automatically terminate after two years unless reauthorized by FDA. Currently Florida’s SIP is the only SIP authorized by FDA, although over the past few years several other states have also announced that they have submitted SIPs to FDA for review and approval.

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© Arnold & Porter Kaye Scholer LLP 2024 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.

  1. The Section 804 rule (at the definition of “Eligible Prescription Drug,” in 21 CFR § 251.2), provides a more comprehensive list of drugs prohibited from being imported under a SIP.