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Pharmaceuticals / Regulatory Affairs

Pennsylvania Compounder Calls for Oxitriptan’s Inclusion on 503A List

May 15, 2019
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Pennsylvania compounder Summit Health Pharmacy has petitioned the FDA to include oxitriptan on the agency’s 503A bulk substances list—and says the agency should also allow it for compounding in the meantime.

In February, the agency published a final rule that excluded oxitriptan and three other substances from the bulk drug list. Summit Health Pharmacy contends in its petition that oxitriptan deserves a place on the list because the compounded form has been prescribed for many years for the treatment of tetrahydrobiopterin deficiency. The compounder claims the agency failed to consider information on the drug’s treatment of the deficiency when evaluating it for treating insomnia and depression in December 2016.

“It is essential that oxitriptan be permitted to be compounded for patients with tetrahydrobiopterin deficiency until oxitriptan is added to the list,” the compounder said, citing a “long history of use of compounded oxitriptan for the treatment of diseases resulting from tetrahydrobiopterin deficiency.”

Critics of the agency’s February decision to remove oxitriptan from the list noted that the drug has long been used as a dietary supplement, but the FDA rejected the argument.

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