[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2005]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR314.420]

[Page 160-161]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 314_APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG--Table of Contents
 
                   Subpart G_Miscellaneous Provisions
 
Sec. 314.420  Drug master files.

    (a) A drug master file is a submission of information to the Food 
and Drug Administration by a person (the drug master file holder) who 
intends it to be used for one of the following purposes: To permit the 
holder to incorporate the information by reference when the holder 
submits an investigational new drug application under part 312 or 
submits an application or an abbreviated application or an amendment or 
supplement to them under this part, or to permit the holder to authorize 
other persons to rely on the information to support a submission to FDA 
without the holder having to disclose the information to the person. FDA 
ordinarily neither independently reviews drug master files nor approves 
or disapproves submissions to a drug master file. Instead, the agency 
customarily reviews the information only in the context of an 
application under part 312 or this part. A drug master file may contain 
information of the kind required for any submission to the agency, 
including information about the following:

[[Page 161]]

    (1) [Reserved]
    (2) Drug substance, drug substance intermediate, and materials used 
in their preparation, or drug product;
    (3) Packaging materials;
    (4) Excipient, colorant, flavor, essence, or materials used in their 
preparation;
    (5) FDA-accepted reference information. (A person wishing to submit 
information and supporting data in a drug master file (DMF) that is not 
covered by Types II through IV DMF's must first submit a letter of 
intent to the Drug Master File Staff, Food and Drug Administration, 
5901-B Ammendale Rd., Beltsville, MD 20705-1266.) FDA will then contact 
the person to discuss the proposed submission.
    (b) An investigational new drug application or an application, 
abbreviated application, amendment, or supplement may incorporate by 
reference all or part of the contents of any drug master file in support 
of the submission if the holder authorizes the incorporation in writing. 
Each incorporation by reference is required to describe the incorporated 
material by name, reference number, volume, and page number of the drug 
master file.
    (c) A drug master file is required to be submitted in two copies. 
The agency has prepared guidance that provides information about how to 
prepare a well-organized drug master file. If the drug master file 
holder adds, changes, or deletes any information in the file, the holder 
shall notify in writing, each person authorized to reference that 
information. Any addition, change, or deletion of information in a drug 
master file (except the list required under paragraph (d) of this 
section) is required to be submitted in two copies and to describe by 
name, reference number, volume, and page number the information affected 
in the drug master file.
    (d) The drug master file is required to contain a complete list of 
each person currently authorized to incorporate by reference any 
information in the file, identifying by name, reference number, volume, 
and page number the information that each person is authorized to 
incorporate. If the holder restricts the authorization to particular 
drug products, the list is required to include the name of each drug 
product and the application number, if known, to which the authorization 
applies.
    (e) The public availability of data and information in a drug master 
file, including the availability of data and information in the file to 
a person authorized to reference the file, is determined under part 20 
and Sec. 314.430.

[50 FR 7493, Feb. 22, 1985, as amended at 50 FR 21238, May 23, 1985; 53 
FR 33122, Aug. 30, 1988; 55 FR 28380, July 11, 1990; 65 FR 1780, Jan. 
12, 2000; 65 FR 56479, Sept. 19, 2000; 67 FR 9586, Mar. 4, 2002; 69 FR 
13473, Mar. 23, 2004]