An Equal Opportunity Provider and Employer

VETERINARY SERVICES MEMORANDUM NO. 800.59

TO: Veterinary Services Leadership Team

Directors, Center for Veterinary Biologics

Biologics Licensees, Permittees, and Applicants

FROM: Jack A. Shere

Deputy Administrator

SUBJECT: Veterinary Biological Product Samples

I. PURPOSE

This memorandum establishes policies and procedures for selecting, authenticating,

and submitting veterinary biological product samples in accordance with title 9, Code

of Federal Regulations (9 CFR), sections 113.3 and 113.52. It also provides

instructions for identifying samples containing merthiolate (thimerosal) to facilitate

their proper disposal.

II. REPLACEMENT

This memorandum cancels Veterinary Services (VS) Memorandum No. 800.59 dated

September 4, 2013, and provides updated information on reducing the number of 

samples required for submission. This memo also incorporates submission of sample 

information through the National Centers for Animal Health (NCAH) Portal.

III. PROCEDURES

A. Authorizations

1. The Center for Veterinary Biologics−Inspection and Compliance (CVB-IC) 

is responsible for sampling activities. This includes training and designating

authorized samplers. 

2. The CVB-IC designates authorized samplers and gives the licensee or 

permittee and the National Veterinary Services Laboratories (NVSL) 

Laboratory Resources Unit, Sample Processing, a list of the names of 

authorized persons.

3. Licensed or permitted firms must either submit an APHIS Form 2007, 

“Qualifications of Veterinary Biologics Personnel,” or provide Form 2007 

information through the NCAH Portal for each authorized sampler. See VS 

Memorandum No. 800.63.

Animal and Plant

Health Inspection

Service

Veterinary Services

1400 Independence

Ave, SW

Washington, DC

20250
VETERINARY SERVICES MEMORANDUM NO. 800.59

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 An Equal Opportunity Provider and Employer

CVB inspectors or other designated VS employees may also select 

samples during establishment visits.

4. An authorized sampler who has received USDA Level 2 eAuthentication 

and has provided that eAuthentication user name to the CVB may access 

the NCAH Portal, Sample Submission and will have the ability to generate 

a sample Packing Slip.

B. Sample Selection and Identification. The authorized sampler, CVB inspector, or 

other designated VS employee should select and identify samples as follows:

1. The sampler should select representative containers from each market serial

or subserial according to 9 CFR 113.3 or as set forth in the establishment’s 

Outline of Production filed with APHIS. 

a. From the representative samples, a subset of at least two containers or 

a sufficient quantity of containers to conduct potency testing requiring 

multiple containers (e.g., rabies) will be submitted to the CVB. 

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

representative samples from each shipment must be selected by an 

authorized sampler and submitted to the CVB.

c. The licensee or permittee will hold the selected containers not 

submitted to the CVB at the storage temperature recommended on the

label while awaiting the CVB’s request to submit the remaining 

samples. If additional samples are requested, mark 

“RESUBMISSION” in block 4 on the APHIS Form 2020, “Shipment 

and Receipt of Biologics Samples.” Do not mix sample types on the 

same APHIS Form 2020.

d. If the CVB does not request additional sample submission, additional 

samples may be returned to the serial inventory after the serial is 

released for marketing by the CVB.

e. This reduced sample submission is a privilege for the licensee or 

permittee. If there are regulatory or compliance concerns, this 

privilege can be revoked. In this case, the licensee or permittee will be 

required to submit a full complement of samples as required in 9 CFR 

113.3(b).
VETERINARY SERVICES MEMORANDUM NO. 800.59

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 An Equal Opportunity Provider and Employer

2. The sampler or designated employee should select and submit samples from 

Master Seeds, Master Cell Stocks, and Serials presented in support of an 

application for a license or permit, for an Outline of Production revision as 

required in 9 CFR 113.3(c), or as specified and authorized by the Center for 

Veterinary Biologics−Policy, Evaluation, and Licensing (CVB-PEL). Do not 

submit Master Seed samples until authorized by the reviewer. If the Master 

Seed is derived from recombinant technology, approval from the CVB’s 

Institutional Biosafety Committee (IBC) must be obtained before the CVB can 

accept samples of the Seed.

IV. EXCEPTIONS

A. Exceptions to Number of Samples. The CVB may permit variations from the

number of samples required in 9 CFR 113.3(b) and (c) for the following

products:

1. Liquid products marketed or exported in large containers, either 

concentrated or as completed product.

2. High-value products.

3. Products marketed in low-volume serials.

4. Products whose testing requires substantially larger or smaller quantities than those 

specified.

B. Exceptions to Sample Quantities and Procedures. The CVB may accept the 

following exceptions to sample quantities and procedures stated in 9 CFR 

113.3(b) and (c), if authorized in a filed Outline of Production:

1. Representative samples may be submitted in smaller containers, but the 

volume should be recovered from product filled in a final use container.

2. Samples may be selected in regular containers that are partially filled.

3. The number or volume of samples may be increased.

C. Autogenous Serials. See VS Memorandum No. 800.69.

V. SAMPLE IDENTIFICATION

A. Product Samples. Establishments should properly identify each sample from a

market serial or subserial with a legible and indelible label showing:

1. The producer's name.
VETERINARY SERVICES MEMORANDUM NO. 800.59

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 An Equal Opportunity Provider and Employer

2. The license or permit number.

3. The true name of the product (abbreviations are acceptable).

4. The serial or subserial number.

5. The volume of contents.

6. The number of doses or tests.

7. The expiration date, if available.

8. The Product Code.

9. A red check mark, using permanent ink, if the contents contain thimerosal.

B. Identifying Master Seed and Master Cell Samples. Unless otherwise authorized

by the CVB-PEL, establishments should identify samples of Master Seeds and

Master Cell Stocks by a unique number or other identification which reflects the

identity of material stored at the establishment and as specified in the Outlines

of Production. REMINDER: If the Master Seed is derived from recombinant 

technology, approval from the CVB’s IBC must be obtained before the CVB 

can accept samples of the Seed.

C. Use of APHIS Form 2020. On the APHIS Form 2020 that accompanies 

submitted samples, establishments should place an asterisk in front of the name

of all products containing thimerosal. Use a separate form for each sample type

indicated in block 4 of the form.

D. Use of the NCAH Portal. The NCAH Portal may be used in lieu of an APHIS 

Form 2020. The Sample Submission Form should be filled out as directed. A 

single packing slip may be generated for all samples that are contained within 

one shipment to the CVB. There will be a daily notification both through the 

NCAH Portal and email to the manufacturers of the assigned sample codes upon 

receipt and validation of the samples at the NCAH/CVB.

VI. ADDITIONAL SAMPLE REQUIREMENTS

A. Bulk Samples. The CVB-PEL will no longer conduct safety and potency tests 

on bulk samples, with the exception of tuberculin intradermic products. The 

CVB usually does not accept bulk samples for product other than tuberculin. 
VETERINARY SERVICES MEMORANDUM NO. 800.59

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 An Equal Opportunity Provider and Employer

B. Serum Samples. Samplers should select, authenticate, and submit serum samples 

from host animal potency tests intended for confirmatory testing in accordance 

with the procedures specified in VS Memorandum No. 800.79. These 

submissions should NOT be entered through the NCAH Portal. They may be 

submitted on an APHIS Form 2020 in conjunction with serial release submission.

C. Panel Members. Panel members may be submitted to the CVB on an APHIS 

Form 2020 in conjunction with the serial release submission. These submissions 

should NOT be entered through the NCAH Portal.

D. Sampler Responsibility. Negligent or deliberate disregard for proper sampling 

procedures, specified in 9 CFR 113.3, may be grounds for revocation or 

suspension of product and/or establishment licenses or permits.

E. Reserve Samples. Samplers should select reserve samples as set forth in 9 CFR 

113.3(e) and render them tamper-evident. The submitting firm should hold such 

samples in an approved secure storage area until at least six months after the 

expiration date of the serial or subserial, unless otherwise directed by the CVBIC.

VII. SUBMISSION OF SAMPLES

Send the required number of samples, in appropriate and adequate packaging, and the 

APHIS Form 2020 or sample Packing Slip to:

Center for Veterinary Biologics

NVSL, Laboratory Resources Unit − Sample Processing

1920 Dayton Avenue

Ames, IA 50010

VIII. IMPLEMENTATION/APPLICABILITY

The implementation of the NCAH Portal is the alternative to submission of APHIS Form 

2020 with the publication of this memorandum.