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HRSA Issues Three 340B Policy Clarifications

Documents cover manufacturer audits, allocation procedures during shortages, and penny pricing.
 

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November 22, 2011—The Health Resources and Services Administration’s (HRSA) Office of Pharmacy Affairs (OPA) issued three documents late yesterday clarifying its policies in three areas: manufacturer audits of 340B covered entities, procedures for allocating 340B-priced drugs in short supply, and the office’s “penny pricing” policy when the statutory 340B ceiling price formula yields a zero or negative price.

 
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