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# CDER Site-Selection Model MAPP
- URL: https://www.fdaweb.com/cder-site-selection-model-mapp/
- Published: 2023-07-10T12:00:00.000Z
- Updated: 2026-09-14T18:42:44.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154833

CDER has published a Manual of Policies and Procedures, *Understanding CDER’s Risk-Based Site Selection Model*, outlining how the Office of Pharmaceutical Quality manages the site selection model used by Center staff to prioritize manufacturing sites for routine quality-related (current good manufacturing practice) surveillance inspections. The [document](https://www.fda.gov/media/116004/download?ref=fdaweb.com) says sites excluded from prioritization are:

- human drug compounding outsourcing facilities registered under Section 503B of the Federal Food, Drug, and Cosmetic Act, because they are subject to a separate selection process;
- medical gas sites, which are managed by a separate selection process;
- inactive ingredients (may be inspected when deemed necessary); and
- drugs intended for use only in clinical trials (may be inspected when deemed necessary.