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# Draft Guide on Drug Master Files
- URL: https://www.fdaweb.com/draft-guide-on-drug-master-files/
- Published: 2019-10-18T12:00:00.000Z
- Updated: 2026-09-15T01:57:43.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5145285

*Federal Register* notice: FDA has made available a draft guidance entitled “Drug Master Files.” The document provides FDA’s current thinking on submissions that may be used to provide confidential, detailed information about facilities, processes, or articles used in drug product manufacturing, processing, packaging, and storing. of human drug products. These are intended to be submitted solely at the discretion of their holders and are not required by statute or regulation. To view the notice, click [here](https://s3.amazonaws.com/public-inspection.federalregister.gov/2019-22821.pdf?ref=fdaweb.com).