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# Compliance Policy Guide on Oxitriptan Compounding
- URL: https://www.fdaweb.com/compliance-policy-guide-on-oxitriptan-compounding/
- Published: 2019-07-09T12:00:00.000Z
- Updated: 2026-09-15T01:36:38.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5144481

*Federal Register* notice: FDA has made available an immediately in effect guidance entitled “Compliance Policy for Certain Compounding of Oral Oxitriptan (5-HTP) Drug Products for Patients With Tetrahydrobiopterin (BH4) Deficiency.” The document describes FDA’s policy concerning 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. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2019-07-08/pdf/2019-14355.pdf?ref=fdaweb.com).