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The US FDA Reverses Decision And Allows Oxitriptan Compounding For Now

 
• By Joanne S. Eglovitch

The US FDA says new information brought to light by pharmacists and caregivers on compounded oxitriptan prompted the agency to reconsider its decision to exclude the substance from the 503A bulks list. Oxitriptan was placed on the do not compound list in February.

Side view of titration in a compounding pharmacy
Appeal gained reprieve for oxitriptan

The US Food and Drug Administration will exercise enforcement discretion and allow limited bulk compounding of oxitriptan pending a final decision on its inclusion on the 503A bulks list. This move is meant to address concerns raised by pharmacists and caregivers that oxitriptan is the “standard of care” for treating BH4 deficiency, which is caused by several rare enzyme defects that result from gene mutations. 

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