The FDA released a compliance guide May 25 featuring 12 questions and answers to provide small entities with a better understanding of the Importation of Prescription Drugs Final Rule.
The rule, which became effective Nov. 30, 2020, is aimed at reducing costs by allowing the importation of certain prescription drugs from Canada.
The new guidance explains how importers can obtain supplies from authorized Section 804 Importation Programs (SIP). The supply chain for each drug must be limited to three entities: one manufacturer, one foreign seller and one importer. Foreign sellers must be licensed to wholesale drugs by Health Canada and registered with the FDA.
The agency retains the authority to not authorize or discontinue a SIP if a foreign seller does not meet all requirements.
The guidance also outlines testing and labeling requirements for all imported drugs.
Read the full guidance here.
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