GUIDELINE - FOR - DRUG - MASTER - FILES(1989)(3)

VI. PROCESSING AND REVIEWING POLICIES

VI. A. Policies Related to Processing Drug Master Files VI. A.1.

Public availability of the information and data in a DMF is determined under 21 CFR Part 20, 21 CFR 314.420(e), and 21 CFR 314.430. VI. A.2.

An original DMF submission will be examined on receipt to determine whether it meets minimum requirements for format and content. If the submission is administratively acceptable, FDA will acknowledge its receipt and assign it a DMF number.

If the submission is administratively incomplete or inadequate, it will be

returned to the submitter with a letter of explanation from the Drug Master File Staff, and it will not be assigned a DMF number.

VI. B. Drug Master File Review

A DMF IS NEVER APPROVED OR DISAPPROVED.

The agency will review information in a DMF only when an IND sponsor, an applicant for an NDA, ANDA, or Export Application, or another DMF holder incorporates material in the DMF by reference. As noted, the incorporation by reference must be accompanied by a copy of the DMF holder's letter of authorization.

If FDA reviewers find deficiencies in the information provided in a DMF, a letter describing the deficiencies is sent to the DMF holder. At the same time, FDA will notify the person who relies on the information in the deficient DMF that additional information is needed in the supporting DMF. The general subject of the deficiency is identified, but details of the deficiency are disclosed only to the DMF holder. When the holder submits the requested information to the DMF in response to the agency's deficiency letter, the holder should also send a copy of the accompanying transmittal letter to the affected persons relying on the DMF and to the FDA reviewing division that identified the deficiencies. The transmittal letter will provide notice that the deficiencies have been addressed.

VII. HOLDER OBLIGATIONS

Any change or addition, including a change in authorization related to specific customers, should be submitted in duplicate and adequately cross referenced to previous submission(s). The reference should include the date(s), volume(s), section(s), and/or page number(s) affected.

VII. A. Notice Required for Changes to a Drug Master File

A holder must notify each affected applicant or sponsor who has referenced its DMF of any pertinent change in the DMF (21 CFR 314. 420(c)). Notice should be provided well before making the change in order to permit the

sponsor/applicant to supplement or amend any affected application(s) as needed.

VII. B. Listing of Persons Authorized To Refer to a Drug Master File VII. B.1.

A DMF is required to contain a complete list of persons authorized to

incorporate information in the DMF by reference [21 CFR 314.420(d)]. The holder should update the list in the annual update. The updated list should contain the holder's name, DMF number, and the date of the update. The update should identify by name (or code) the information that each person is authorized to incorporate and give the location of that information by date, volume, and page number.

VII. B.2.

Any person whose authorization has been withdrawn during the previous year should be identified under a suitable caption. VII. B.3.

If the list is unchanged on the anniversary date, the DMF holder should also submit a statement that the list is current. VII. C. Annual Update

The holder should provide an annual report on the anniversary date of the original submission. This report should contain the required list as described in B.1., and should also identify all changes and additional information

incorporated into the DMF since the previous annual report on the subject matter of the DMF. If the subject matter of the DMF is unchanged, the DMF holder should provide a statement that the subject matter of the DMF is current.

Failure to update or to assure FDA annually that previously submitted material and lists in the DMF remain current can cause delays in FDA review of a pending IND, NDA, ANDA, Export Application, or any amendment or

supplement to such application; and FDA can initiate procedures for closure of the DMF (see Section IX).

VII. D. Appointment of an Agent

When an agent is appointed, the holder should submit a signed letter of appointment to the DMF giving the agent's name, address, and scope of responsibility (administrative and/or scientific). Domestic DMF holders do not need to appoint an agent or representative, although foreign DMF holders are encouraged to engage a U.S. agent.

VII. E. Transfer of Ownership

To transfer ownership of a DMF to another party, the holder should so notify FDA and authorized persons in writing. The letter should include the following:

1. 2. 3. 4. 5. 6.

Name of transferee Address of transferee

Name of responsible official of transferee Effective date of transfer

Signature of the transferring official

Typewritten name and title of the transferring official.

The new holder should submit a letter of acceptance of the transfer and an update of the information contained in the DMF, where appropriate. Any

change relating to the new ownership (e.g., plant location and methods) should be included.

VIII. MAJOR REORGANIZATIONOF A DRUG MASTER FILE

A holder who plans a major reorganization of a DMF is encouraged to submit a detailed plan of the proposed changes and request its review by the Drug Master File Staff. The staff should be given sufficient time to comment and provide suggestions before a major reorganization is undertaken.

IX. CLOSURE OF A DRUG MASTER FILE

A holder who wishes to close a DMF should submit a request to the Drug Master File Staff stating the reason for the closure. See Section IV.D.5.a for the address.

The request should include a statement that the holder's obligations as detailed in Section VII have been fulfilled.

The Agency may close a DMF that does not contain an annual update of persons authorized to incorporate information in the DMF by reference and a list of changes made since the previous annual report. The holder will be notified of FDA's intent to close the DMF.

Many of the guidelines referred to in the text and a current list of available guidelines may be obtained from the following:

Legislative, Professional, and Consumer Affairs Branch (HFD-365) Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, MD 20857

Copies of the Code of Federal Regulations (CFR) may be purchased from the following:

Superintendent of Documents U.S. Government Printing Office Washington, D.C. 20402

Back to Top Guidance Page

Date updated: March 11, 2005

Drug Master Files

Important Guidance Information See below IMPORTANT ADDRESS INFORMATION

Please note that the current address for the Central Document Room for filing original DMFs and subsequent DMF documents is now: Food and Drug Administration

Center for Drug Evaluation and Research Central Document Room 5901-B Ammendale Road Beltsville MD 20705-1266

Submissions mailed to the old address will also be forwarded to the new address for a period of time. If you have previously submitted an original DMF or subsequent DMF document to the old address please DO NOT resubmit it to the new address.

This site contains lists of Drug Master Files (DMFs) as well as information concerning submission of DMFs. See below for information regarding the current DMF Guideline. The list of DMFs is current as of September 30, 2005, through DMF 18781 Changes to the DMF activity status, DMF type, holder name, and subjects made since the last update of June 30, 2005 are included. The lists are updated quarterly.

For people who downloaded the previous list (through DMF 18437, June 30, 2005) and do not wish to download the entire updated lists the following lists are available: 1. New DMFs since the last list.

2. A list of changes in DMF activity status, DMF type, holder name, and subject.

The lists are available in Microsoft Excel and in ASCII (Tab-delimited). Please note that only ACTIVE DMFs have been sorted into different types.

? All DMFs ? Active DMFs ? Active Type II DMFs ? Active Type III DMFs ? Active Type IV DMFs ? Active Type V DMFs ? New DMFs since the last list ? Changes

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