Proposed Rule for Drug Importation from Canada Hits the Federal Register

Today’s prepublication of the Federal Register contains the proposed rule for drug importation from Canada.  The proposed rule is 172 pages long and outlines the FDA expectations for the safe importation of drug products from Canada.  Section 804 Importation Programs (SIPs) provides the basis for each request for importation and provides the importation requirements.  The supply chain for each drug under a SIP would be limited to three entities,