# Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/evaluation-of-bulk-drug-substances-nominated-for-use-in-compounding-under-section-503b-of-the-federal-food-drug-and-cosmetic-act/32f6b565-3151-4e63-8311-63f0e604bece

> FDA guidance document: Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act. Issue date: March 13, 2019. Get complete insights and analysis.

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## Details

- Title: Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act
- 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: 2019-03-13
- Last Changed: 2019-06-17
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2018-D-1067">FDA-2018-D-1067</a>

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