What HRSA's New Rule Means For Hospitals And Pharma Cos.

Law360, New York (August 2, 2013, 1:15 PM EDT) -- On July 23, the Health Resources and Services Administration (HRSA) of the U.S. Department of Health and Human Services published a regulation[1] increasing the number of entities to which pharmaceutical manufacturers must sell orphan drugs at statutory ceiling prices under the 340B drug discount program and complicating the determination of eligibility to purchase these drugs at the 340B price.

This regulation conditions the ability of certain hospitals to purchase orphan drugs at the 340B price on implementation of costly new systems for tracking drug use and requires virtually every brand drug manufacturer...
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