An Equal Opportunity Provider and Employer

VETERINARY SERVICES MEMORANDUM NO. 800.101

TO: Veterinary Services Leadership Team

Directors, Center for Veterinary Biologics

Biologics Licensees, Permittees, and Applicants

FROM: Jack A. Shere

Deputy Administrator

SUBJECT: U.S. Veterinary Biological Product Permits for Distribution and Sale

I. PURPOSE

This memorandum provides guidance to persons wishing to import veterinary 

biological products for distribution and sale in the United States and applying for a U.S. 

Veterinary Biological Product Permit in accordance with Title 9, Code of Federal 

Regulations (9 CFR), Section 104.5.

II. REPLACEMENT

This memorandum replaces Veterinary Services (VS) Memorandum No. 800.101 dated 

June 6, 2013.

III. BACKGROUND

Persons wishing to import veterinary biological products for distribution and sale in the 

United States must apply for a U.S. Veterinary Biological Product Permit in accordance 

with 9 CFR 104.5. Permitted products must meet the standards of efficacy, potency, 

purity, and safety required under the Virus-Serum-Toxin Act, 21 U.S.C. 151-159 et. 

seq. (as amended December 23, 1985 (99 Stat.1654)). Licensing requirements are 

discussed in VS Memorandum No. 800.50. 

IV. POLICY

A. Obtaining a Permit for Distribution and Sale

1. Permit applicants must submit the same items required for issuance of a 

U.S. Veterinary Biological Product License, as described in VS 

Memorandum No. 800.50, except as follows:

a. Applicants must submit an “Application for a United States Veterinary 

Biological Product Permit” using APHIS Form 2005. Check “General 

Sale and Distribution” in box 2. To obtain the APHIS Form 2005, see 

section IV.A.3.b.(1).

Animal and Plant

Health Inspection

Service

Veterinary Services

1400 Independence

Ave, SW

Washington, DC

20250
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 An Equal Opportunity Provider and Employer

b. Establishment licenses are not issued to manufacturers or importers of 

foreign-produced products.

c. Additional data concerning inactivation procedures on exotic disease 

agents may be requested by the Center for Veterinary Biologics 

(CVB).

d. The following studies must be based on data generated in the United 

States:

(1) adjuvant Safety to determine the appropriate slaughter withholding

period;

(2) field safety; and

(3) diagnostic kit field evaluation.

2. In addition to those items described in section IV of VS Memorandum No. 

800.50 and in VS Memorandum No. 800.109, the following items must 

also be submitted or addressed, as applicable, in support of a permit 

application:

a. Applicants wishing to import veterinary biological products, Master 

Seed microorganisms, and Master Cell candidates into U.S. biologics 

facilities when they represent a risk of introducing foreign animal 

disease must complete a “Summary Information Format for the 

Importation of Veterinary Biological Products into the United States 

from Countries Where Foreign Animal Diseases Exist and Other 

Specified Countries.” This document enables the CVB to perform the 

required risk analysis and must provide a thorough evaluation of all 

potential sources of contamination during the development and 

manufacture of the item, identifying the information regarding the 

facilities, reagents, production procedures, and testing procedures that 

should be evaluated. Guidance for preparing this Summary 

Information Format (“SIF”) is available on the CVB Web site under 

Biologics Regulation and Guidance, Risk Analysis/Summary 

Information Formats.

(1) Countries from which importation of organisms, vectors, or 

biologics represents a risk include those where foreign animal 

diseases exist; those that supplement their meat supply by the 

importation of fresh, chilled, or frozen meat of ruminants or swine 

from countries where foreign animal diseases exist; and, those that 

have common land borders with countries where foreign animal 

diseases exist, as provided in 9 CFR part 94.
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 An Equal Opportunity Provider and Employer

(2) A separate SIF must be completed for each Master Seed 

microorganism, Master Cell, and final or finished product.

(3) The SIF is not required for bringing items into research and 

development facilities that are separate and apart from production 

facilities. In such a case, a National Import Export Services (NIES) 

permit allowing proposed Master Seeds and Master Cells into the 

United States is sufficient. If the facilities are not separate and 

apart, CVB permission for bringing the items into a facility is also 

required; the firm will contact its reviewer. See also section 

IV.A.3.b(2) regarding importing Master Seeds and Cells.

(4) A CVB Permit for Research and Evaluation is required for 

importation of a biological product for research and evaluation. 

See section IV.A.3.b(1) for information on submitting APHIS 

Form 2005 for research and evaluation through the Web-based ePermits portal.

b. Ingredients, including ingredients of animal origin, must comply with 

requirements in VS Memorandum No. 800.51, section IV.A.

c. The applicant must also provide a statement of organisms maintained 

at the manufacturing site that are etiological agents exotic to the 

United States. Also, a statement characterizing all ingredients of 

animal origin used in the production of the Master Seed and the final

or finished product must be available on site for review during the prepermit site inspection. The statement must include a country of origin 

for each ingredient, with supporting evidence (e.g., certification).

d. CVB must receive written permission to inspect all parts of the foreign 

manufacturing facility in which biological products are prepared in 

accordance with 9 CFR 104.5(a)(2).

e. Although an official dossier submitted to foreign regulatory officials 

for registration in other countries may be submitted to the CVB in 

addition to the above information, it may not satisfy all requirements 

for the U.S. permit application. Portions of the dossier may be 

considered, as applicable, with other data, as required.

3. These additional requirements must be met before a Permit for 

Distribution and Sale may be issued:

a. The CVB-Inspection and Compliance (CVB-IC) section must conduct 

a pre-permit inspection of the facilities.
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 An Equal Opportunity Provider and Employer

(1) The CVB-IC requires a minimum of 3 months to schedule this 

inspection after the CVB-Policy, Evaluation, and Licensing

(“CVB-PEL”) Directorate requests it. The CVB-PEL reviewer 

requests the pre-permit inspection when submissions indicate 

facility documents (e.g., the Outline of Production) and production 

processes will be acceptable and in place at the predicted time of 

inspection. The request is made according to CVB policy, with the 

assigned biologics specialist and the inspection section leader of 

the CVB-IC.

(2) The permit applicant must prepay all expenses (i.e., salary and 

travel) and arrange for a cooperative service agreement by 

contacting the CVB-IC.

(3) If 24 months elapse between a satisfactory pre-permit inspection 

and issuance of a Permit for Distribution and Sale, a repeat 

inspection may be required at the prepaid expense of the permit 

applicant before the permit is issued.

(4) If conditions change (e.g., a significant change in conditions that 

may affect products) at the manufacturing plant after a pre-permit 

CVB inspection, an additional inspection may be required at the 

prepaid expense of the permit applicant.

b. Master Seeds and Cells imported pursuant to issuance of a Permit for 

Distribution and Sale must be accompanied by an import permit from 

NIES; see 9 CFR 122.2. NIES may require that certain Master Seeds 

and Cells be tested for exotic extraneous agents by the Foreign Animal 

Disease Diagnostic Laboratory, National Veterinary Services

Laboratories, at Plum Island, New York, before entry into the U.S. 

mainland. The NIES permit applicant will bear the expense of the 

associated user fees. 

A veterinary biological product (e.g., vaccine or test kits being

imported to conduct required studies) must be accompanied by a CVB 

Permit for Research and Evaluation. Final or finished product 

imported for pre-permit evaluation (e.g., pre-license serials for 

confirmatory testing) is shipped with a copy of the Permit for Research 

and Evaluation directly from the manufacturer to the CVB-PEL 

laboratory.

(1) To obtain a Permit for Research and Evaluation, submit a 

completed APHIS Form 2005 to the CVB-PEL Operational 

Support unit. This form can be accessed, completed, and submitted 
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 An Equal Opportunity Provider and Employer

by registering for Level 1 access through the e-Permits portal by 

visiting the Permits page within the Imports and Exports section of 

the APHIS Web site.

Additional instructions on registering and using e-Permits can be 

obtained by calling 301-851-3300, option 1, or via email 

AskNIES.Products@aphis.usda.gov.

(2) To obtain the NIES permit, submit a VS Form 16-3, “Application 

for Permit to Import Controlled Material or Transport Organisms 

or Vectors,” to NIES. This form can also be accessed and 

submitted through the e-Permits portal with a Level 2 

eAuthentication access.

If the Master Seed was derived by recombinant methods, also 

submit a supplemental VS Form 16-7, “Application for Permit to 

Import Cell Cultures and Their Products (Supplemental to the VS 

16-3)”.

4. Eligibility for a U.S. Veterinary Biological Product Permit for Distribution 

and Sale

a. Permittees are limited to persons residing in the United States, or who 

operate a business establishment within the United States, or both. See 

9 CFR 104.1(b).

b. One permittee number will be assigned to a permittee for all products 

imported from the same source (geographic location). The CVB will 

issue a separate permit for General Sale and Distribution for each 

imported product (see CVB Notice No. 13-03); the permittee number 

remains the same on each permit.

c. Separate permittee numbers will be assigned to permittees for product

or products imported from different sources.

d. Eligibility may be adversely affected by the disease status of the 

manufacturing country, by U.S. State Department restrictions on 

Federal employee travel (i.e., inspectors cannot travel to the 

manufacturing country), or by trade embargos in effect.

5. Quarantine Facility. The permit applicant must establish a permanent U.S. 

site where the product will be received and held in quarantine until the 

product serial receives authorization from the CVB-IC to be distributed. 

The CVB-IC will conduct periodic unannounced inspections of the site.
VETERINARY SERVICES MEMORANDUM NO. 800.101

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 An Equal Opportunity Provider and Employer

6. Length of Permit

a. A U.S. Veterinary Biological Product Permit for Distribution and Sale 

does not have an expiration date. However, the permittee must submit 

a written agreement for periodic re-inspection of the manufacturing 

site, at permittee expense.

b. The permit may be revoked if the permittee violates, or fails to comply 

with, the Virus-Serum-Toxin Act.

c. Conditional permits are not issued.

7. Restrictions on Permits. Restrictions, as applicable, may be listed on the 

Permit.

B. Importation of Product Under a Permit for Distribution and Sale. After the 

permit has been issued, the manufacturing firm may ship the product to the 

permittee’s quarantine facility. Each shipment must be accompanied by a 

copy of the permit, plus an original and a copy of a completed APHIS Form 

2008 (or equivalent). The Form 2008 is prepared in accordance with VS

Memorandum No. 800.53. However, the entire inventory prepared must be 

listed in “Total Doses Manufactured” for marketing, as noted in block 11, 

“Remarks.” Additionally, the portion of the inventory included in the current 

shipment to the United States is noted in block 10, “Inventory for Release.”

When a serial of product is imported in more than one shipment, each 

shipment must be accompanied by a separate Form 2008 (original and copy) 

or equivalent. When submitting the additional Form 2008 for a serial 

previously processed by the CVB, indicate in block 12 that it is a repeat (e.g., 

second, third) shipment of a previously-submitted serial by selecting “Firm 

Disposition of Other – Subsequent Shipment.” The permittee receiving the 

shipment into quarantine shall:

1. Certify the inventory. A responsible individual at the U.S. permittee site 

(in the role of Liaison or Serial Release) must certify in block 10 of the 

original Form 2008 the total number of containers, doses and the date 

received by signing in block 11 and submitting the information to the 

CVB. If this information is entered in the Inventory for Release in the 

NCAH Portal in lieu of an APHIS Form 2008, the responsible individual 

at the permittee site will certify this information is correct by submitting 

the information. See the “Description of Portal Roles” user guide located 

within the NCAH Portal Guidance Web site at the CVB Veterinary 

Biologics home page for an explanation of roles.

2. Submit the certified original and one copy of the Form 2008 to the CVBIC. Employees with the Liaison or Serial Release role and Level 2 
VETERINARY SERVICES MEMORANDUM NO. 800.101

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 An Equal Opportunity Provider and Employer

eAuthentication may submit the information to the CVB through the 

NCAH Portal in lieu of submitting the hard copy Form 2008.

3. Submit, as required, representative product samples to the CVB-PEL 

laboratory, as specified in 9 CFR 113.3. Final containers of product

selected as APHIS samples by an authorized sampler must be shipped in 

the same shipment as the remaining inventory to the U.S. permittee site. 

The sampler at the U.S. Permittee site should submit the Form 2020 or 

submit the information through the NCAH Portal. See VS Memorandum

No. 800.59 for further guidance.

4. Maintain the product at proper storage conditions.

5. Retain the shipment in quarantine until the shipment has been released by 

the CVB. A shipment which has been found unsatisfactory by a required 

test specified in a filed Outline of Production shall not be released for 

distribution or sale (9 CFR 113.6).

6. Retain government reserve samples as specified in the filed Outline of 

Production.

7. Maintain complete records of all approved labels, cartons, and inserts 

associated with the product.

8. The use of labeling approved by the CVB is limited to the biological 

product imported by the permittee (i.e., limited to use in the United 

States). Permittees must add to the “Exceptions” section of the APHIS 

Form 2015, “This label is to be used only on containers and packaging 

imported into the United States. Use of this label on serials (or portions 

thereof) not imported into the United States is prohibited.”

9. The permittee must hold, in quarantine, all shipments with an APHIS 

unsatisfactory disposition for disposal under APHIS supervision.

C. APHIS Release of Quarantined Product. Per the procedures outlined in VS 

Memorandum No. 800.53, the CVB-IC will review each Form 2008 or release 

information submitted through the NCAH Portal. The CVB-PEL laboratory 

may perform confirmatory testing. When the evaluation is complete, the 

permittee will be notified, by the return of a processed Form 2008 or 

Electronic Notification of Serial Release, of the APHIS disposition of the 

shipment. 

IV IMPLEMENTATION/APPLICABILITY
VETERINARY SERVICES MEMORANDUM NO. 800.101

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 An Equal Opportunity Provider and Employer

The NCAH Portal is the alternative to submission of APHIS Form 2020s with the release of 

this memorandum.