Today, the Department of Health and Human Services (HHS) through a Notice published in the Federal Register announced the withdrawal of guidance documents issued as part of the Unapproved Drugs Initiative. HHS Chief of Staff Brian Harrison issued the following statement:

“We are committed to putting American patients first by ending government programs like the Unapproved Drugs Initiative that, while well-intentioned, have distorted markets and produced the unintended consequences of price spikes and drug shortages.” – HHS Chief of Staff Brian Harrison

Read the Frequently Asked Questions Regarding the Department of Health and Human Services’ Announcement on the Unapproved Drugs Initiative*

*This content is in the process of Section 508 review. If you need immediate assistance accessing this content, please submit a request to digital@hhs.gov.