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Will 340B Orphan Drug Final Rule Come Out in May?

Projected timing of release appears in HHS regulatory agenda.
 

Print Article

January 24, 2012—The Health Resources and Services Administration (HRSA) has set May as its target for issuing its long-awaited final rule to implement health care reform’s prohibition on 340B discounts for orphan drugs purchased by hospitals that became eligible for 340B under reform.

The projected timeframe for publication was included in the Department of Health and Human Services’ (HHS) latest semiannual regulatory agenda, dated fall 2011 and issued on Jan. 20. The twice-a-year report gives details about the most important regulatory actions that HHS expects to take in the next six months.

 
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