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Home » FDA Issues Guidance on Compounding of Oral Oxitriptan Products
FDA Issues Guidance on Compounding of Oral Oxitriptan Products
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.