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  5. Drug Master Files (DMFs)
  1. Forms & Submission Requirements

Drug Master Files (DMFs)

Quick Notes/Alerts

Drug master files (DMFs) are submissions to FDA used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products. They:

  • Allow parties to reference material without disclosing DMF contents to those parties.
  • Are not required by statute or regulation.
  • Are neither approved nor disapproved. Instead, FDA reviews the technical contents of DMFs in connection with the review of applications that reference them (e.g., NDAs, ANDAs, INDs, BLAs).

See the draft guidance for industry Drug Master Files for detailed information about preparing and submitting DMFs and to learn about FDA’s DMF review process. (When final, this guidance will represent FDA’s current thinking on DMFs.)

The following DMF web pages cover additional information about DMFs and their submission:

Contact Information

Please contact dmfquestion@fda.hhs.gov with all DMF-related submission questions. Include the DMF number, if applicable.

Physical Media Submissions (only accepted if submission is over 10 gigabytes):

CDER
Food and Drug Administration
Center for Drug Evaluation and Research
Central Document Room
5901-B Ammendale Road
Drug Master File Staff
Beltsville, MD 20705-1266
CBER
Document Control Center
10903 New Hampshire Avenue
Building 71, Room G112
Silver Spring, MD 20993-0002