"Part D sponsors must exclude Part D drugs from qualified prescription drug coverage if they are not sold in the United States. In addition, Part D sponsors may only pay for drugs that satisfy the definition of Part D drug. In general, such definition requires FDA approval for sale in the United States. Therefore, even if the manufacturer has FDA approval for a drug, the version produced for foreign markets usually does not meet all of the requirements of the U.S. approval, and thus it is considered to be unapproved.[emphasis and links added]
[However, i]n the event of a drug shortage, in order to ensure access to critically needed drugs in conjunction with the actions taken by the FDA, CMS will accept PDE [prescription drug event] submissions with national drug codes [NDCs] for foreign versions of Part D drugs, imported under the FDA’s exercise of its enforcement discretion.
PDE [prescription drug event] allowances will be limited to the specific drug product(s), conditions, and the duration of the shortage as specified by the FDA."