Veterinary Master Files

This site contains a list of Veterinary Master Files (VMF’s), which are applicable only to the chemistry, manufacturing and controls for a finished dosage form and/or a bulk drug substance. The list has been redacted or edited to remove confidential information. The list contains file category (or type), number, status (active or inactive), holder’s name, and chemical name or subject.

The VMF’s are classified into five distinct categories:

Type I:	Manufacturing Site, Facilities, Personnel, and Operating Procedures.
Type II:	Manufacturing information for bulk drug substance or intermediates used in the further manufacture of the bulk drug substance, medicated articles, medicated feeds, or manufacturing information for finished dosage forms.
Type III:	Packaging materials.
Type IV:	Excipient, Color, Flavor, Essence, or material used in their preparation.
Type V:	Manufacturing site, facilities, personnel, operating procedures, and sterilization process validation to support the manufacture of sterile dosage forms and sterile bulk drugs.

The Center for Veterinary Medicine (CVM) has eliminated the need to submit or update a Type I VMF. The veterinary industry was informed of CVM’s intent to eliminate the Type I in a Policy Letter dated July 26, 1995. Consequently, all Type I VMF’s were classified as "inactive." The listing of the master files is available in four different reports:

• Data sorted by VMF #, then by VMF Holder
• Data sorted by File Type, then by VMF Holder
• Data sorted by VMF Holder, then by File Type
• Data sorted by chemical/subject, then File Type.

A VMF is inactive if:

1. The holder requested that the VMF be inactivated or withdrawn.
2. The VMF has not been updated since 1994.

A VMF is classified as "active" if the file has been updated on an annual basis.

Any errors found in the listing should be emailed to VMSTFILE@cvm.fda.gov . Please note that this e-mail address is only for correcting the VMF listing. Any e-mail inquiries concerning CVM, its activities and website, should be submitted to CVMHomeP@cvm.fda.gov. Written inquiries should go to:

Mai Huynh
Supervisory Team Leader, Division of Manufacturing Technologies
Office of New Animal Drug Evaluation
Center for Veterinary Medicine
7500 Standish Place
Rockville, MD 20855

Additional information regarding the types of master files, submission format, information needed, procedures governing the review of the master files, and obligations of the master file holder can be found in "Master Files, Guidance for Industry for the Preparation and Submission of Veterinary Master Files"