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For drugs, the 2016 ACE final rule requires submission, at the time of entry, of the Drug Registration Number, the unique facility identifier of the foreign establishment where the drug was manufactured, prepared, propagated, compounded, or processed before being offered for import, when that establishment is required to register under Part 207 or Part 607

It has a longer track record in clinical use, a well-established safety profile, and a lower monthly cost in compounded form