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Proposed 427.303(b)(5) provides that CMS would remove units of refundable single-dose container or single-use package drugs subject to discarded drug refunds, from the calculation of rebate amounts, generally in the reconciliation process

Cyber Incident Update 9/28/25 at 6:00 pm EST: StreamlineMD applications are up and live

Meanwhile 11.8% of Japanese adults were current users of HTP in 2025, which amounted to 12.9 million people.[19] In contrast, only 2.1 million people in Japan were currently using nicotine vapes in 2025.[20] This is still a significant number of people, but is six times lower than the figure for HTP users, primarily due to the fact that vapes are banned (unless licensed as a medicinal product), while HTP can be legally bought online and in-store

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This does not include standard restatements to AMP or other data outside of the standard process of issuing the reconciled rebate amount