# Compliance Policy for Certain Compounding of Oral Oxitriptan (5-HTP) Drug Products for Patients With Tetrahydrobiopterin (BH4) Deficiency Immediately in Effect Guidance for Industry - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/compliance-policy-for-certain-compounding-of-oral-oxitriptan-5-htp-drug-products-for-patients-with-tetrahydrobiopterin-bh4-deficiency-immediately-in-effect-guidance-for-industry/d88af3f7-de54-4f46-bcc5-9dd57bf5f149

> FDA guidance document: Compliance Policy for Certain Compounding of Oral Oxitriptan (5-HTP) Drug Products for Patients With Tetrahydrobiopterin (BH4) Deficiency Immediately in Effect Guidance for Industry. Issue date: July 08, 2019. Get complete insights and analysis.

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## Details

- Title: Compliance Policy for Certain Compounding of Oral Oxitriptan (5-HTP) Drug Products for Patients With Tetrahydrobiopterin (BH4) Deficiency Immediately in Effect Guidance for Industry
- Communication Type: Guidance Document
- Product Type: drugs
- Office Name: Center for Drug Evaluation and Research
- Office URL: /offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c
- Issue Date: 2019-07-08
- Last Changed: 2020-05-06
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2019-D-2733">FDA-2019-D-2733</a>

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