FDA Drug Information Update on Compounding Oral Oxitriptan (5-HTP) for patients with Tetrahydrobiopterin (BH4) Deficiency

PUBLISHED: Jul 8, 2019
Relevant to: All Healthcare Organizations

The U.S. Food and Drug Administration (FDA) has issued a drug information update to inform stakeholders that the agency 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.

The new FDA guidance describes the agency’s policy concerning the conditions under which the FDA will not generally intend to take regulatory action against a licensed pharmacist in a State-licensed pharmacy or Federal facility or a licensed physician using the bulk drug substance to compound oral drug products for patients with tetrahydrobiopterin (BH4) deficiency.

On February 19, 2019, FDA issued a final rule (84 FR 4696) that established the list of bulk drug substances that can be used to compound drug products under section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act), even though they are not the subject of an applicable United States Pharmacopoeia (USP) or National Formulary (NF) monograph or a component of an FDA approved drug product. The final rule, (21 CFR 216.23) placed six bulk drug substances on the 503A Bulks List and identified four others, including oxitriptan, that cannot be used to compound drug products under section 503A of the FD&C Act (21 CFR 216.23(b)). Additional bulk drug substances nominated by the public for inclusion on this list are currently under consideration and will be the subject of future rulemaking.

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