# Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/compounded-drug-products-that-are-essentially-copies-of-a-commercially-available-drug-product-under-section-503a-of-the-federal-food-drug-and-cosmetic-act-guidance-for-industry/57a1209c-86f8-4813-bb35-0bd3d8265bc2

> FDA guidance document: Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry. Issue date: January 19, 2018. Get complete insights and analysis.

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## Details

- Title: Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act 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: 2018-01-19
- Last Changed: 2020-05-06
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2016-D-1309">FDA-2016-D-1309</a>

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