FDA Issues Guidance on Compounding of Oral Oxitriptan Products

July 12, 2019

The FDA released final guidance on compounding of oral oxitriptan drugs for patients with tetrahydrobiopterin (BH4) deficiency — a rare condition caused by gene mutations — saying the agency doesn’t intend to take regulatory action against pharmacists or physicians using the bulk drug to compound oral drugs for those patients.

In a February final rule, the agency placed oxitriptan on the list of substances that cannot be used for compounding under section 503A of the Food, Drug and Cosmetic Act, but said it would apply the criteria on a substance-by-substance basis and allow “some measure of flexibility.”

The final rule established the list of six bulk drug substances — Brilliant Blue, cantharidin, diphenylcyclopropenone, N-acetyl-D-glucosamine (NAG), squaric acid dibutyl ester and thymol iodide — that can be used to compound drugs under section 503A, even though they are not covered by a U.S. Pharmacopoeia or National Formulary monograph, or are not a component of an approved drug.

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