Compliance Policy for Certain Compounding of Oral Oxitriptan (5-HTP) Drug Products for Patients With Tetrahydrobiopterin (BH4) Deficiency; Immediately in Effect Guidance for Industry; Availability

The Food and Drug Administration (FDA, we, or the Agency) is announcing the availability of an immediately in effect guidance for industry entitled "Compliance Policy for Certain Compounding of Oral Oxitriptan (5-HTP) Drug Products for Patients With Tetrahydrobiopterin (BH4) Deficiency." This guidance describes FDA's policy concerning the conditions under which the Agency does 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 oxitriptan (also known as 5-hydroxytryptophan or 5-HTP) to compound oral drug products for patients with tetrahydrobiopterin (BH4) deficiency. FDA developed this guidance in response to communications from pharmacists and caregivers regarding the use of oxitriptan to treat patients with BH4 deficiency following issuance of a final rule that placed oxitriptan on the list of substances that cannot be used to compound drug products in accordance with certain compounding provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act).