Drugs

Compounded Oxitriptan Compliance Policy

FDA has issued an “immediate effect” guidance, Compliance Policy for Certain Compounding of Oral Oxitriptan (5-HTP) Drug Products for Patients with Tetrahydrobiopterin (BH4) Deficiency, giving 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 to compound oral drug products for patients with tetrahydrobiopterin deficiency. FDA says the document was developed in response to communications from pharmacists and caregivers regarding use of oxitriptan to treat patients with BH4 deficiency following issuance of a 2/19 Final Rule establishing a list of bulk drug substances that can be used to compound drug products under Section 503A of the Federal Food, Drug, and Cosmetic Act even though they are not the subject of an applicable United States Pharmacopeia or National Formulary monograph or a component of an FDA approved drug product.

The guidance says the final rule placed six drug substances on the 503A Bulks List and identified four others, including oxitriptan, that cannot be used to compound drug products under Section 503A.

The communications from pharmacists and caregivers, FDA says, indicated that oxitriptan is the standard of care for treating BH4 deficiency. The guidance addresses the conditions under which the agency does not intend to take regulatory action against licensed pharmacists or doctors who use bulk oxitriptan to compound oral drug products to treat identified individual patients with BH4 deficiency.

The guidance takes effect immediately because FDA has determined that prior public participation is not feasible or appropriate due to the public health need for patients with BH4 deficiency to access compounded oxitriptan products.

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