FDA issues guidance on compounding oral oxitriptan (5-HTP) for patients with tetrahydrobiopterin (BH4) deficiency

FDA issues guidance on compounding oral oxitriptan (5-HTP) for patients with tetrahydrobiopterin (BH4) deficiency

FDA today issued guidance informing stakeholders that it generally does not intend to take regulatory action against compounders who use the bulk drug substance oxitriptan (also known as 5-hydroxytryptophan or 5-HTP) to compound oral drugs for identified individual patients with tetrahydrobiopterin (BH4) deficiency. FDA developed this guidance in response to information provided by health care professionals and caregivers.    This guidance takes effect immediately. For more information, please see visit: Oxitriptan.

For more information, please visit FDA's  Human Drug Compounding web site.