FDA Issues Guidance on Oral Oxitriptan Compounding
The US Food and Drug Administration (FDA) on Friday issued an immediately effective final guidance setting out its enforcement policy on pharmacy compounding oral oxitriptan, also known as 5-hydroxytryptophan or 5-HTP.Oxitriptan is one of the four substances FDA excluded from its list of bulk drug substances that may be compounded by physicians and state-licensed pharmacists when it issued its final rule on the list in February.
However, after issuing the final rule, FDA says it received communications from healthcare practitioners and pharmacists pointing out that oxitriptan is the standard of care for treating patients with tetrahydrobiopterin (BH4) deficiency, a rare genetic condition.
According to FDA, BH4 deficiency is also referred to as primary tetrahydrobiopterin deficiency, atypical phenylketonuria (PKU), GTP cyclohydrolase (GTPCH) deficiency, 6-pyruvoyl-tetrahydropterin synthase (6-PTPS) deficiency and dihydropteridine reductase (DHPR) deficiency.
FDA says it did not consider this use of oxitriptan when it decided to exclude the substance from the 503A bulks list as it was nominated for placement on the list to treat insomnia and depression and that none of the comments in response to the proposed rule cited this use.
FDA says it is now deciding whether to reevaluate its decision in light of the information it has received since issuing the final rule.
Under the enforcement policy detailed in the final guidance, FDA says it "does not intend to take action" for certain violations relating to oxitriptan compounding by state-licensed pharmacists or physicians who compound the drug under certain conditions.
FDA says that the drug must be intended for oral administration and dispensed to patients with BH4 deficiency. Additionally, the compounder must maintain records documenting that the drug was compounded to treat a patient with BH4 deficiency and that "all other conditions of section 503A and other applicable requirements of the [Federal Food, Drug, and Cosmetic] FD&C Act and FDA regulations are met."
Guidance, Federal Register Notice