Background

The Food and Drug Administration is amending its electronic import entries regulation to correct the statutory citation in the sections of that regulation requiring submission of the Drug Registration Number for human drugs and animal drugs. According to the FDA, these revisions are necessary to correct editorial errors and ensure that the codified cites the correct section of the Federal Food, Drug, and Cosmetic Act.

The electronic import entries regulation provides that the Drug Registration Number, which must be submitted at the time of entry in the Automated Commercial Environment or any other electronic data interchange system authorized by CBP, is the unique facility identifier specified in the FD&C Act. The FDA notes that this rule does not impose any new regulatory requirements on affected parties.

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