May 13, 2005 

United States

Department of

Agriculture

Animal and Plant 

Health Inspection 

Service 

Washington, DC

20250 

VETERINARY SERVICES MEMORANDUM NO. 800.87 

Subject: Guidelines for Licensing Establishments with Separated Premises 

To: Veterinary Services Management Team, Biologics Licensees, Permittees, and 

 Applicants Directors, Center for Veterinary Biologics 

I. PURPOSE

This memorandum provides guidance for licensing two or more separate premises as one 

establishment under the provisions of 9 CFR 102.4. 

II. CANCELLATION

This memorandum cancels Veterinary Biologics Memorandum No. 800.87 dated August 

23, 1999. 

III. GENERAL

The regulations in 9 CFR 102.4 prohibit the Animal and Plant Health Inspection Service 

(APHIS) from issuing an establishment license unless, in the opinion of the

Administrator, the establishment can be operated in compliance with the Virus-SerumToxin Act (VSTA). The regulations in 9 CFR 115 authorize APHIS inspectors to inspect 

licensed facilities and products to determine whether they comply with the VSTA and 

regulations. It is APHIS policy to inspect all licensed premises of an establishment that 

are used for preparation, testing, and distribution of veterinary biologics. When premises 

separated by a great distance are listed on the same establishment license, there may be 

problems in carrying out these inspections at the same time to determine compliance with 

the VSTA. These guidelines establish criteria for documenting activities and maintaining 

records to address these problems and permit APHIS to inspect under such conditions. 

IV. GUIDELINES 

APHIS will consider the licensing of two or more remotely located premises as one 

establishment under the following conditions: 

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Veterinary Services Memorandum No. 800.87 2

A. Responsibility for Operations - Each licensed establishment must have one person 

legally responsible for all activities at all premises listed on the establishment license. 

This person will sign the APHIS Form 2001, Application for United States Veterinary 

Biologics Establishment License, listing all the sites for the establishment. 

B. Mailing Address - The licensed establishment should have one mailing address for all 

government correspondence as listed on the establishment license. 

C. Government Liaison - Each licensed establishment must have one government liaison 

representing all premises listed on the establishment license. This liaison is responsible 

for and should handle all government submissions and correspondence and will 

coordinate inspection activities and compliance. The licensee will designate a site 

contact that is approved by the Center for Veterinary Biologics, (CVB) to coordinate 

compliance and unannounced inspections at locations beyond a reasonable travel time 

from the normal location of the liaison. 

D. Serial Release - One person representing the licensed establishment should be 

responsible for control of serial release submissions. APHIS will report serial releases 

for all products to that person at the mailing address listed on the establishment license. 

E. Submission of Serials and Serial Records for Release - In the event of an establishment 

purchase, sale or other consolidation, veterinary biologics will maintain the 

establishment number and product code identification of the first submission received 

by CVB for a given serial. If an APHIS Form 2008, serial reprocessing request, 

extension of dating, inventory correction, or samples listing one of the two original 

establishment numbers are submitted before the firms are consolidated, the serial will 

keep this original identification throughout dating and any other post release actions 

such as reprocessing, rebottling or extension of dating. 

New serials (including samples) and serial records submitted for the first time after the 

new or consolidated establishment license has been issued will have the identification

of the new combined establishment. 

F. Records - All premises listed on the establishment license must use the same system to 

maintain and retain records. This includes the record keeping system for serial

assembly and subsequent handling. The licensee should maintain the original copies of 

records at the premises where the activity occurs. 

G. Official Documents - The licensee must maintain appropriate CVB approved plot plans, 

blueprints, legends, outlines of production, labels and other official documents at each 

premises for use by APHIS inspectors. A controlled copy of each applicable currently

approved document is acceptable for sites other than the site where the official liaison 

is located. 
Veterinary Services Memorandum No. 800.87 3

H. Movement of Biological Materials Between Premises - The plot plan legend must 

describe how materials move between premises. Materials include component parts to 

be combined to form a biological product, all biological products in the course of 

preparation, and all completed biological products. It also must describe the 

precautions taken to protect such materials during movement between premises. Firms 

should identify and describe the mode of transportation for such materials in the plot 

plan legend as they would describe a piece of equipment such as a cooler. The plot 

plan legend should also describe how such materials move between the mode of 

transportation and the production or in-process cooler. Firms should revise their plot 

plan legends as necessary to ensure that they include all such materials being moved 

and all current procedures being used for movement of the materials between sites. 

I. Transfer Documents - Firms must use transfer documents to certify that they are 

following the procedures established to ensure product protection during movement 

between premises. The records should show how and when periodic checks are 

conducted on refrigeration equipment and temperature recording devices used in such 

transfers to ensure proper temperatures are being maintained.

J. Distribution Centers – Distribution centers that are wholly owned and controlled by a 

firm licensed to produce veterinary biologics may be included on the establishment 

license. These sights will be subject to APHIS inspections to determine whether they 

comply with the VSTA and regulations. 

K. Licensing Documents – Within one year of the date when premises previously licensed 

as separate establishments are consolidated and licensed as one establishment, the firm

must resubmit official Outlines of Production, labels, plot plans, legends, blueprints, 

and other documents to reflect the change. 

During the first year, the documents on file will be used to determine compliance with 

the VSTA and regulations. Outlines of Production should specify the premises where 

production will occur and APHIS Form 2007s should indicate the site where the 

employee works. 

L. Technology Transfer – When firms transfer the production or testing of veterinary 

biologics from one location to another, appropriate records must be maintained of the 

training and process of transferring the production or testing. The CVB must be 

notified of this movement prior to final production or testing occurring at the new 

location. The CVB may test serials prepared or tested at the new location. The records 

of the technology transfer must be maintained for review by CVB during the next indepth inspection or be made available for review if requested by CVB.