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FDA releases Q&A on importing prescription drugs from Canada

Posted May 25, 2022 | By Mary Ellen Schneider

The U.S. Food and Drug Administration (FDA) has clarified the legal requirements for small entities to import prescription drugs from Canada.

In the final guidelines, released May 25, 2022, the agency provided 12 questions and answers aimed at providing plain language guidance for implementing the final rule on the importation of prescription drugs, which came into effect. effective November 30, 2020. These regulations were intended to reduce prescription drug costs by implementing Section 804 of the Federal Food, Drug and Cosmetic Act, allowing the importation of certain prescription drugs from Canada . (RELATED: HHS paves the way for importing Canadian drugsRegulatory guidance September 25, 2020)

The 2020 final rule outlines how states or Indian tribes, and in some cases pharmacists or wholesale distributors, could seek FDA clearance to import prescription drugs under a drug program. importing under Section 804 (SIP). Under the regulations, prescription drugs are eligible if they are approved by Health Canada’s Health Products and Food Branch (HPFB) and bear HPFB-approved labeling when marketed in Canada. In addition to not having FDA-approved labeling when marketed in Canada, drugs must otherwise meet the conditions of an FDA-approved New Drug Application or Abbreviated New Drug Application.

Certain prescription drugs are excluded from this program, including controlled substances, biologics; infused drugs, drugs injected intravenously, intrathecally or intraocularly, and drugs subject to a risk assessment and mitigation strategy (REMS), among others.

Under the final rule, SIP sponsors must also show that they can provide significant cost reductions for US consumers through importing.

Get medicine

Recently released guidelines explain how importers can obtain eligible drugs through an authorized SIP. An importer would buy prescription drugs from a foreign seller in Canada who received the drugs directly from the manufacturer. The supply chain for each medicine must be limited to three entities: a manufacturer, a foreign seller and an 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 them to distribute drugs that are approved by countries other than Canada and that are not approved by HPFB for distribution in Canada,” wrote the agency.

The FDA may choose not to authorize a SIP or may discontinue a SIP if the foreign vendor 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 foreign seller information.

Once the FDA clears a SIP, the importer has 30 calendar days prior to the expected date of arrival or entry – whichever comes first – to submit a pre-import request to the FDA. Entry of eligible prescription drug shipments is limited to the US Customs and Border Protection FDA-cleared port of entry.

Testing and labeling

Medicines purchased under a SIP must undergo testing, either by the manufacturer or the importer, to ensure authenticity, verify degradation and establish compliance with specifications and standards. If the manufacturer does not perform the tests, the importer must submit a forensic test plan to the FDA outlining sample selection and testing methods, and the name and location of the qualified laboratory that will perform the tests.

All imported prescription drugs must be relabeled for use in the United States, including medication guides, user instruction documents, and patient package inserts. The new labeling must include the importer’s National Drug Code (NDC) and a statement that the drug was imported from Canada, among other information.

After importation, each SIP sponsor is required to provide the FDA with cost savings information for US consumers and submit any adverse event reports.

Final tips

© 2022 Society of Regulatory Affairs Professionals.


Joan J. Dean

The author Joan J. Dean