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News & Press: Breaking News

FDA Releases Final Adverse Event Reporting Guidance

Thursday, October 8, 2015   (0 Comments)
Posted by: Dagmar Anderson
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The Food & Drug Administration (FDA) today issued the final guidance document for how 503B outsourcing facilities are to submit unexpected, serious adverse events with compounded preparations. First published in February for comments, the International Academy of Compounding Pharmacists (IACP) requested and received several clarifications by the agency in the guidance that narrowed the original requirements.


To review FDA's document, please click here.


Please click here to view IACP's comments submitted to FDA.

IACP is the only pharmacist association that submitted comments to FDA on this guidance.

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