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May 10, 2011 

VETERINARY SERVICES MEMORANDUM NO. 800.94 

TO: VS Management Team (VSMT) 

Directors, Center for Veterinary Biologics 

 Biologics Licensees, Permittees, and Applicants 

FROM: John R. Clifford /s/ John R. Clifford 

Deputy Administrator 

 

SUBJECT: Food and Drug Administration’s Export Reform and Enhancement 

Act of 1996 

I. PURPOSE 

This memorandum provides guidance to licensees, permittees, and applicants concerning 

Animal and Plant Health Inspection Service (APHIS) implementation of the Food and 

Drug Administration’s Export Reform and Enhancement Act (FDA–EREA) of 1996, 

Section 802 (21 U.S.C. 382), as it applies to veterinary biological products. 

II. REPLACEMENT 

This memorandum replaces Veterinary Services Memorandum No. 800.94, dated 

November 4, 1999. 

III. BACKGROUND 

Under the FDA–EREA, certain drugs, biologicals, animal drugs, and medical devices that 

are not approved for distribution and sale in the United States can be exported to another 

country if they meet the laws of the importing country and are approved for marketing in 

a country listed in the FDA–EREA. The FDA–EREA defines the term “drug” to include 

veterinary biological products, which require licensing by the Secretary of Agriculture 

under the Virus-Serum-Toxin Act (VSTA) of 1913. 

Under the VSTA, veterinary biological products shipped in or from the United States 

must comply with U.S. Department of Agriculture (USDA) regulations and be prepared 

at a USDA-licensed establishment. However, the FDA–EREA supersedes these 

requirements and under certain conditions, permits certain veterinary biological products 

that are not USDA-licensed to be prepared for export. The following guidelines describe 

how APHIS will apply the provisions of the FDA–EREA to the production and export of 

veterinary biological products that are not approved (unlicensed) for distribution and sale 

in the United States. 

United States 

Department of 

Agriculture

Animal and Plant 

Health Inspection 

Service 

Veterinary Services 

Washington, DC 

20250 
VETERINARY SERVICES MEMORANDUM NO. 800.94 

Page 2 

IV. POLICY 

The FDA–EREA is composed of two sections (801 and 802). Section 801, concerning 

imports for exports, does not apply to veterinary biological products. Section 802, 

however, concerning exports of certain unapproved products, applies to veterinary 

biological products that require licensing under the VSTA. This includes products that 

meet the definition of “biological products” in title 9 of the Code of Federal Regulations 

(9 CFR), section 101.2. 

A. Provisions of the FDA–EREA – A summary of the provisions of Section 802 of 

the FDA–EREA that apply to veterinary biological products is below. This 

summary includes references to the applicable sections of the FDA–EREA, 

which is available on the Internet at: 

http://www.fda.gov/RegulatoryInformation/Guidances/ucm125799.htm 

1. Export to Any Country – A person may export an unlicensed veterinary 

biological product to any country if the product complies with the laws of the 

import country and the exporter has a marketing authorization for the product 

from the appropriate authority in Australia, Canada, Israel, Japan, New 

Zealand, Switzerland, South Africa, the European Union, or a country in the 

European Economic Area. Reference: 802(b)(1)(A). 

2. Notification to Center for Veterinary Biologics–Policy, Evaluation, and 

Licensing (CVB–PEL) – If a person produces the product in facilities that are 

not USDA licensed and export is to one of the countries specifically listed in 

802(b)(1)(A), the person notifies CVB–PEL, identifying the unlicensed 

veterinary biological product being exported and providing his or her name 

and address. Reference: 802(g). 

a. If the import country is not one of the countries listed in 802(b)(1)(A), 

notification to CVB–PEL must include the name of the country to which 

the person is exporting the veterinary biological product, the identity of the 

veterinary biological product, and documentation as appropriate according 

to Sections IV.A. 5 or 6 of this memorandum. 

b. If a person plans to produce an unlicensed product in a USDA-licensed 

veterinary biologics establishment for export under the FDA–EREA, 

notification to CVB–PEL also includes a request for authorization to 

produce unlicensed product in a licensed production facility in accordance 

with Section IV.B of this memorandum. 
VETERINARY SERVICES MEMORANDUM NO. 800.94 

Page 3 

3. Maintain Records – Any exporter of a veterinary biological product must 

maintain records of all such products exported and the countries to which they 

were exported. Reference: 802(g). 

4. Prohibited From Export – A person may not export an unlicensed veterinary 

biological product under the FDA–EREA if the product: 

a. Does not conform with current good manufacturing practice (GMP) 

requirements or other international standards recognized by the Secretary 

of Agriculture in its manufacturing, processing, packaging, and holding. 

Reference: 802(f)(1). 

b. Is otherwise adulterated as defined in section 501of the Food Drug and 

Cosmetic Act (21 U.S.C. 381). Reference: 802(f)(2). 

c. Does not fulfill the requirements of Section 801(e)(1)(A) through (D) of the 

FDA–EREA, which states that a product is not deemed misbranded if the 

product: 

(1) Meets the specifications of the foreign purchaser 

(2) Is not in conflict with the laws of the country to which it is intended for 

export 

(3) Is labeled on the outside of the shipping package that it is intended for 

export 

(4) Is not sold or offered for sale in domestic commerce 

Reference: 802(f)(3). 

d. Presents an imminent hazard to the health and safety of the United States. 

Reference: 802(f)(4)(A). 

e. Presents an imminent hazard to the public health of the country to which 

the product would be exported. Reference: 802(f)(4)(B). 

f. Is not labeled in accordance with the requirements and conditions for use in 

both the country that has granted the marketing authorization for the 

product and the country to which the product would be exported. 

Reference: 802(f)(5)(A). 

g. Is not labeled in the language and units of measurement of the country to 
VETERINARY SERVICES MEMORANDUM NO. 800.94 

Page 4 

which the product would be exported or in the language designated by such 

country. Reference: 802(f)(5)(B). 

h. Is not promoted in accordance with the labeling requirements set forth in 

802(f)(5). Reference: 802(f)(6). 

5. Additions to the List of Approved Countries – Countries can be added to the 

list of countries in 802(b)(1)(B). 

a. The appropriate country official, manufacturer, or exporter may request the 

Secretary of Agriculture to take action under 802(b)(1)(B) by submitting 

documentation to CVB–PEL in support of designation. 

b. If a person other than the appropriate country official requests designation, 

that person’s request for designation must include a letter from the country 

official indicating the desire to be designated. Reference: 802(b)(1)(C). 

c. The Secretary of Agriculture may designate an additional country to be 

included in the list of countries in 802(b)(1)(A) if the country has: 

(1) Statutory authority for experts to review the safety and effectiveness of 

veterinary biological products based upon the evaluation of adequate 

and well-controlled investigations and only approves the marketing of 

products that have been determined to be safe and effective. Reference: 

802(b)(1)(B)(i). 

(2) Statutory requirements that ensure the methods, facilities, and controls 

used for the manufacture, processing, and packing of veterinary 

biological products are adequate to preserve their identity, quality, 

purity, and strength. Reference: 802(b)(1)(B)(ii). 

(3) Statutory requirements for the reporting of adverse reactions related to 

the use of veterinary biological products and for procedures that it 

follows to withdraw approval of unsafe or ineffective products. 

Reference: 802(b)(1)(B)(iii). 

(4) Statutory requirements that labeling and promotion of veterinary 

biological products are in accordance with the approval of the product. 

Reference: 802(b)(1)(B)(iv). 

(5) A valid marketing authorization system that is equivalent to the systems 

in the countries described in 802(b)(1)(A). Reference: 802(b)(1)(B)(v). 
VETERINARY SERVICES MEMORANDUM NO. 800.94 

Page 5 

6. Export to Countries Not Listed in the FDA–EREA – Persons may export 

unlicensed veterinary biological products to a country that is not listed in 

802(b)(1)(A) if: 

a. The product complies with the laws of the import country and has a valid 

marketing authorization by the responsible authority in that country. 

Reference: 802(b)(2)(A). 

b. The Secretary of Agriculture determines (based on documentation 

submitted to CVB–PEL) that the requirements below are met in that 

country. Reference: 802(b)(2)(B). 

(1) The importing country has statutory authority for experts to review the 

safety and effectiveness of veterinary biological products based upon 

the evaluation of adequate and well-controlled investigations and only 

approves the marketing of products that have been determined to be 

safe and effective. Reference: 802(b)(2)(B)(i). 

(2) The importing country has statutory requirements that ensure the 

methods, facilities, and controls used for the manufacture, processing, 

and packing of veterinary biological products are adequate to preserve 

their identity, quality, purity, and strength. Reference: 802(b)(2)(B)(ii). 

(3) The importing country has statutory requirements for the reporting of 

adverse reactions related to the use of veterinary biological products 

and for procedures that it follows to withdraw approval of unsafe or 

ineffective products. Reference: 802(b)(2)(B)(iii). 

(4) The importing country has statutory requirements that labeling and 

promotion of veterinary biological products are in accordance with the 

approval of the product. Reference: 802(b)(2)(B)(iv). 

7. Products Not Meeting the Provisions of the FDA–EREA – A veterinary 

biological product described in 802(a) that would not meet the conditions for 

approval under the FDA–EREA or conditions for approval of a country 

described in 802(b)(1)(A) or 802(b)(2) may be considered for export if the 

exporter petitions APHIS. APHIS must take action within 60 days of receipt 

of a petition sent to CVB–PEL containing the following: 

a. Certification by the person exporting the product that the veterinary 

biological product would not meet the conditions for approval of a country 

described in 802(b)(1)(A). Reference: 802(b)(3)(B). 
VETERINARY SERVICES MEMORANDUM NO. 800.94 

Page 6 

b. Credible evidence that the veterinary biological product would be safe and 

effective under the conditions of use in the country to which it is being 

exported. Reference: 802(b)(3)(A). 

c. A request for approval of the export of the product from the appropriate 

animal health authority in the importing country certifying that it is 

understood that APHIS has not approved the veterinary biological product 

for export under the FDA–EREA and concurring that the scientific 

evidence that the product would be reasonably safe and effective is 

credible. Reference: 802(b)(3)(B). 

8. Export of Experimental Products – A person may export an experimental 

product (produced in a licensed establishment according to 9 CFR 103.1 or in 

an unlicensed establishment that conforms to GMP or other recognized 

international standard) to a country listed in 802(b)(1)(A) in accordance with 

the laws of that country. Reference: 802(c). 

9. Export in Anticipation of Marketing Authorization – A person may export a 

product intended for formulation, filling, packaging, labeling, or further 

processing in anticipation of marketing authorization in any country listed in 

802(b)(1)(A) in accordance with the laws of that country. Reference: 802(d). 

10. Products for Tropical Diseases or Diseases Not of Significant Prevalence in 

the United States – Veterinary biological products for tropical diseases or 

other diseases not of significant prevalence in the United States that do not 

otherwise qualify for export under the FDA–EREA may also be permitted to 

be exported under certain conditions, if production of the product in the 

United States does not endanger the livestock and poultry of the United States. 

Reference: 802(e). 

B. Production of Unlicensed Veterinary Biological Products in USDA-Licensed 

Veterinary Biologics Establishments for Export Under the FDA–EREA – The 

regulations in 9 CFR 114.2 prohibit the production of unlicensed veterinary 

biological products in USDA licensed veterinary biologics establishments except 

for experimental products authorized according to 9 CFR 103.1. Regulations in 

9 CFR 114.2 prohibit production of unlicensed products in licensed production 

facilities unless authorized by CVB–PEL in accordance with 9 CFR 114.1. 

CVB–PEL may authorize an establishment to produce an unlicensed product in 

licensed production facilities if such production does not result in a risk of 

contamination of licensed products or a risk to the health of U.S. livestock or 

poultry. 
VETERINARY SERVICES MEMORANDUM NO. 800.94 

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1. Authorization to Produce Unlicensed Products – CVB–PEL may authorize 

the production of unlicensed products in USDA-licensed establishments for 

export under the FDA–EREA if the establishment: 

a. Produces unlicensed products only for export under the FDA–EREA, the 

product’s labeling does not bear a U.S. Veterinary Biologics Establishment 

License Number, and the exporter does not otherwise represent the product 

in any manner as having met the requirements for licensure. 

b. Prepares all products, whether licensed or unlicensed, in locations indicated 

in blueprints and legends filed in accordance with 9 CFR part 108. Center 

for Veterinary Biologics–Inspection and Compliance may inspect the 

production facilities before the entity prepares FDA–EREA products to 

ensure production of the unlicensed product(s) does not pose a risk of 

contamination to licensed products or a risk to the health of U.S. livestock 

or poultry. 

c. Prepares an Outline of Production in accordance with 9 CFR 114.9 for each 

unlicensed product. CVB will not stamp outlines as “filed,” but will review 

them to ensure they provide an adequate description of the method of 

production. 

d. Appropriately tests the Master Seeds, Master Cell Stocks, and ingredients 

used in the production of the unlicensed product to ensure freedom from 

contamination with bacteria, fungi, mycoplasma, viruses, and other agents 

in accordance with 9 CFR part 113 or other acceptable national standards. 

e. Fully characterizes and identifies Master Seeds and Master Cell Stocks 

used in the production of the unlicensed product as indicated in the Outline 

of Production. 

f. Maintains records in accordance with 9 CFR 116.1 and 116.2 that include 

all products, whether licensed or unlicensed. 

g. Submits reports prescribed in 9 CFR 116.5 for all products, whether 

licensed or unlicensed. 

 
VETERINARY SERVICES MEMORANDUM NO. 800.94 

Page 8 

2. Licensing of Products Produced Under the FDA–EREA

a. If authorized by CVB–PEL, a person may produce unlicensed products for 

export under the FDA–EREA in the USDA-licensed establishment even 

though the person is not pursuing a U.S. Veterinary Biological Product 

License for the product. 

b. However, if the person applies for a license for the product and CVB–PEL 

issues the license, the person must stop producing and exporting the 

product under FDA–EREA on the date CVB–PEL issues the license. Also, 

the person must notify CVB–PEL in writing of his or her action of 

stopping within 10 business days of receiving the product license.