Drug Master Files for CBER-Regulated Products

What is a Drug Master File?

A Drug Master File (DMF) is a voluntary submission of information to the FDA that may be used to provide confidential, detailed information about the facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drug products.¹  DMFs are used to permit the person holding the DMF (DMF holder) to authorize sponsors or applicants to rely on the information in the DMF to support a submission to FDA without the DMF holders having to disclose the information to them. 

FDA ordinarily neither independently reviews DMFs nor approves or disapproves submissions to a DMF.  Instead, we customarily review the information in a DMF only in the context of an application, e.g., when a sponsor or applicant references material in a DMF within their application or supplement. 

What address should be used to send Drug Master Files to CBER?

Drug Master Files and Updates (when changes occur that might impact products) to Drug Master Files for CBER-regulated products should be sent to:

FDA/CBER
Document Control Center
1401 Rockville Pike, Suite 200N
Rockville, MD 20852-1448

To submit electronically, please refer to the guidance entitled “Guidance for Industry, Providing Regulatory Submissions in Electronic Format – Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications,” which can be found at http://www.fda.gov/RegulatoryInformation/Guidances/ucm126959.htm.

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