# Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/interim-policy-on-compounding-using-bulk-drug-substances-under-section-503a-of-the-federal-food-drug-and-cosmetic-act/37088f71-b697-408b-9b76-44a304f6d475

> FDA guidance document: Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act. Issue date: January 06, 2025. Get complete insights and analysis.

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## Details

- Title: Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A 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: 2025-01-06
- Comment Close Date: 2024-01-08
- Last Changed: 2025-01-07
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2015-D-3517">FDA-2015-D-3517</a>

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- [Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/prescription-requirement-under-section-503a-of-the-federal-food-drug-and-cosmetic-act-guidance-for-industry/2deca755-c1a3-4959-81be-63a489f8e69c)
- [Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act](https://www.globalkeysolutions.net/guidances/guidance-document/interim-policy-on-compounding-using-bulk-drug-substances-under-section-503b-of-the-federal-food-drug-and-cosmetic-act/eabbf240-5386-496d-ad18-2d7246237567)