US · guidance
CMS Pub. 100-18, ch. 6, § 10.7
Drugs Purchased in Another Country
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.
In 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 submissions with national
drug codes for foreign versions of Part D drugs, imported under the FDA’s exercise of its
enforcement discretion. PDE allowances will be limited to the specific drug product(s),
conditions, and the duration of the shortage as specified by the FDA. Such products cannot be
discounted under the Medicare Coverage Gap Discount Program.
History
(Rev. 18, Issued: 01-15-16, Effective: 01-15-16; Implementation: 01-15-16)
Provenance
- Source
- cms.gov
- Retrieved
- 2026-09-17
- Edition
- iom-2026-09-17
- Content hash
92cbc9da4f62856d1efc4e5a142ff21eb512b388ade643e151d5f953e9802c1e
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