The Agency for Healthcare Research and Quality (AHRQ) is collaborating with the National Patient Safety Foundation (NPSF), which will merge with the Institute for Healthcare Improvement in May, to celebrate Patient Safety Awareness Week (March 12-18) through a series of activities recognizing the importance of keeping patients safe in all health care settings:

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The Health Resources and Services Administration (HRSA) has just released an interpretive rule explaining its position with respect to inclusion/exclusion of orphan drugs in the 340B program. This follows comments last week from HRSA in the wake of a court ruling that called the Agency's authority into question with respect to orphan drugs. The rule is available at http://www.ofr.gov/(S(ngyx2dlwh3mfa5sankgk5q04))/OFRUpload/OFRData/2014-17409_PI.pdf.

According to the summary, "The interpretive rule states that section 340B(e) of the PHSA excludes drugs with an orphan designation only when those drugs are transferred, prescribed, sold, or otherwise used for the rare condition or disease for which the drug was designated under section 526 of the Federal Food, Drug, and Cosmetic Act (FD&C Act)."

Another, more comprehensive 340B proposed rule has been under Office...