On July 23, 2013, the U.S. Department of Health and Human Services Health Resources and Services Administration issued a long-anticipated Final Rule regarding the 340B Drug Pricing Program orphan drug exclusion.
http://www.jdsupra.com/legalnews/hrsa-finalizes-340b-program-orphan-drug-72491/
http://www.jdsupra.com/legalnews/hrsa-finalizes-340b-program-orphan-drug-72491/
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