Posted May 25, 2022 | By
The US Food and Drug Administration (FDA) has offered some clarity on the legal requirements for small entities to import prescription drugs from Canada.
In final guidance, issued on 25 May 2022, the agency provided 12 questions and answers aimed at providing a plain language guide to implementation of the Importation of Prescription Drugs final rule, which became effective on 30 November 2020. That regulation was aimed at reducing prescription drug costs by implementing section 804 of the Federal Food, Drugs, and Cosmetic Act, allowing importation of certain prescription drugs from Canada. (RELATED: HHS opens pathway to importing Canadian drugsRegulatory Focus September 25, 2020)
The 2020 final rule outlines how states or Indian tribes, and in some cases pharmacists or wholesale distributors, could seek authorization from FDA for importation of prescription drugs as part of a Section 804 Importation Program (SIP). Under the regulation, prescription drugs are eligible if they are approved by Health Canada’s Health Products and Food Branch (HPFB) and have HPFB-approved labeling when marketed in Canada. Aside from the lack of FDA-approved labeling when marketed in Canada, drugs must otherwise meet the conditions of an FDA-approved new drug applications or abbreviated new drug application.
Some prescription drugs are excluded under this program, including controlled substances, biological products; infused drugs, drugs that are injected intravenously, intrathecally, or intraocularly, and drugs that are subject to a Risk Evaluation and Mitigation Strategy (REMS), among others.
Under the final rule, SIP sponsors must also show that they can provide significant cost reductions for American consumers through importation.
The newly released guidance spells out how importers can obtain eligible drugs through an authorized SIP. An importer would purchase prescription drugs from a foreign seller in Canada that has received the drugs directly from the manufacturer. The supply chain for each drug must be limited to three entities: one manufacturer, one foreign seller and one importer.
A foreign seller must be licensed to wholesale drugs by Health Canada and registered with the FDA as a foreign seller. “The Foreign Seller cannot have an international pharmacy license that allows it to distribute drugs that are approved by countries other than Canada and that are not HPFB-approved for distribution in Canada,” the agency wrote.
FDA can choose not to authorize a SIP or can discontinue a SIP if the foreign seller does not meet all requirements. An initial SIP submission does not need to identify a foreign seller, but the agency will not authorize the SIP proposal without information on the foreign seller.
Once FDA has authorized a SIP, the importer has 30 calendar days before the scheduled date of arrival or entry – whichever is earlier – to submit a Pre-Import Request to FDA. Entry of eligible prescription drug shipments is limited to the US Customs and Border Protection port of entry authorized by FDA.
Testing and labeling
Drugs purchased under a SIP are required to undergo testing, either by the manufacturer or the importer, to ensure authenticity, to check for degradation, and to establish compliance with specifications and standards. If the manufacturer does not perform the testing, the importer must submit a Statutory Testing plan to FDA describing sample selection and testing methods, and the name and location of the qualified laboratory that will conduct the testing.
Any imported prescription drug must be relabeled for use in the US, including Medications Guides, Instruction for Use documents, and patient package inserts. The new labeling must have the importer’s National Drug Code (NDC) and a statement saying that the drug was imported from Canada, among other information.
After importation, each SIP sponsor is required to provide FDA with information on the cost savings provided to American consumers and to submit any adverse event reports.
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