# Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B 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-approved-drug-products-under-section-503b-of-the-federal-food-drug-and-cosmetic-act-guidance-for-industry/01d6567b-d27c-4dc3-b329-01ed5a29bb89

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

---

## Details

- Title: Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B 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: 2020-05-07
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2016-D-1267">FDA-2016-D-1267</a>

## Related Documents

- [Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities:  Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/repackaging-of-certain-human-drug-products-by-pharmacies-and-outsourcing-facilities-guidance-for-industry/c324ad2d-8447-448c-b0ed-664984cf9ba6)
- [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](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)
- [Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance](https://www.globalkeysolutions.net/guidances/guidance-document/pharmacy-compounding-of-human-drug-products-under-section-503a-of-the-federal-food-drug-and-cosmetic-act-guidance/c027252e-0f07-4b88-baa1-313551e210ce)