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Issue Date: 12Dec23 

Controlled by: APHIS Center for Veterinary Biologics, 515-337-6100 

Source Document: CVB-MAN-5100, CVB Operations Manual, Chapter 4.2.1 

Table of Contents

1. Purpose and Scope

2. Abbreviations, Barcode Concepts/Definitions, and References 

3. Precedents: General Information 

4. Precedents: Claims Language on Label 

5. Precedents: Packaging and Labeling Final Rule and Other Codified 

6. Precedents: Recommendation Statements on Label

7. Precedents: Product-Specific Statements on Label

8. Precedents: Species-Specific Statements on Label 

9. Precedents: Foreign Registration and Regulatory Authorizations 

10. Barcodes on Label 

Appendix I. Criteria/Wording for Labeling Precedents (Internal use only) 

 

 
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1. Purpose and Scope

This document provides precedents of regulatory flexibility in which non-compliance to 9 CFR 

112.8, labels for export only, or 112.2(e), special labels for export, is granted for use on labels 

for export only. All labels must comply with 9 CFR 112.1 and Special Labels for Export must 

also comply with 9 CFR 112.2(e). Mounting sheets are marked “For Export Only”. 

9 CFR 112.1 

Labels, stamps, marks, statements, stickers, or alterations to affixed labels shall not make the 

label false or misleading or illegible in any manner. 

9 CFR 112.2(e) 

Regulation for Special Labels for Export. 

9 CFR 112.8 For export only. 

“The applicable regulations for packaging and labeling a biological product produced in the 

United States shall apply to such biological product if exported from the United States except as 

otherwise provided in this section. Only labels approved as provided in § 112.5 shall be used.” 

The navigation pane may be helpful to review sections in this document. 

2. Abbreviations, Barcode Concepts/Definitions, and References 

2.1 Abbreviations used in this document: 

1D One (1)-dimensional barcode

2D Two (2)-dimensional barcode

9 CFR Title 9, Code of Federal Regulations

APHIS Animal and Plant Health Inspection Service

ATN Abbreviated True Name

BVDV Bovine Viral Diarrhea Virus

CLI Certificate of Licensing and Inspection

CVB Center for Veterinary Biologics

DOI Duration of immunity 

EHV Equine Herpes Virus 

IC Inspection and Compliance Unit of CVB

ICE International Electrotechnical Commission 

ISO International Organization for Standardization 

JMAFF Japan Ministry of Agriculture, Forestry, and Fisheries that regulates 

veterinary biologics 

NA Not applicable 

NCAH National Centers for Animal Health 

OOI Onset of immunity 

OP Outline of Production 

PCN Product Code Number 

PCS Product Compilation Summary 
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QR Code Quick Response Code

ST Single Tier

U.S. United States

USDA United States Department of Agriculture

VLN US Veterinary Biologics Establishment Number or Establishment Number 

VSM Veterinary Services Memorandum 

 2.2 Barcode Concepts/definitions used in this document: 

1D Codes Barcodes or graphical image (vertical lines and spaces) that allow 

data to be presented in one linear direction. Limited number of 

characters. Depends on a database. Scanned with a laser scanner to 

read. 

2D Codes Barcodes or graphical image (dots, shapes, and patterns) that allow 

data to be presented in two directions, both horizontal and vertical 

directions. Codes can work independently of a database. Requires

software and a camera or other imaging device to read. 

Data Matrix Code Barcodes or graphical image that allow use of alphanumeric and 

binary data with defined capacity for characters/letters/numbers. 

Typically an “L” shape grid on a white background. A type of a 

two-dimensional barcode. Follows ISO/IEC 16022 for data matrix 

symbology. 

QR Codes Barcodes or graphical image that allow use of alphanumeric and 

binary data with defined capacity for characters/letters/numbers. 

Typically a square grid on a white background. A type of a twodimensional barcode. Follows ISO/IEC 18004 for QR code 

symbology. 

2.3 The following regulations and guidance documents pertain: 

9 CFR Part 112 

9 CFR 112 Revision: 2015 Packaging and Labeling Final Rule APHIS-2008-008

9 CFR 112 Revision: 2016 Single Tier Claim Final Rule APHIS-2011-0049

VSM 800.54 Guidelines for the Preparation and Review of Labeling Materials

VSM 800.206 General Licensing Considerations: Preparing Outlines of 

Production for Vaccines, Bacterins, Antigens, and Toxoids and Diagnostic Test 

Kits

VSM 800.208 Special Labels for Product for Export

VSM 800.213 Licensing Guidelines for Production Platform-Based, NonReplicating, Nonviable Products

VSM 800.214 Prescription Platform Product Biologics

CVB Notices
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Reviewer Chapter(s) providing guidance on labeling on the APHIS website

ICSOP0044 on the APHIS website IC document, “Export Certificates and 

Certificates of Licensing and Inspection” 3. Precedents: General Information 

3.1 Regulatory flexibility

Sections 4-10 of this document provide regulatory flexibility extended to export only 

labels and Special Labels for Export. 

The use of “NA” for Special Labels for Export may not exclude regulatory flexibility; the 

decision will be based upon documentation from the regulatory authority of the importing 

country. Consult the CVB for additional guidance. 

3.2 Translations 

3.2.1 Requirement for translation 9 CFR 112.5

“(f) Special requirements for foreign language labels: 

(1) An accurate English translation must accompany each foreign language 

label submitted for approval. A statement affirming the accuracy of the 

translation must also be included. 

(2) Foreign language portion of a bilingual label shall be a true translation of 

the English portion. Reference to additional information on the enclosure shall 

not be made unless that enclosure is also bilingual.” 

3.2.2 English translation 

The English translation of non-English text must be accurate and correct. Certified 

translations are not required. Given the increasing accuracy of online translation 

tools, and the inherent cultural differences in translation that may lead to 

misunderstandings, firms are encouraged to translate as close to the approved English 

version as possible, and to avoid colloquialisms that may not lend themselves to 

adequate review. 

3.2.3 Accuracy of translation 

Firms are to affirm the accuracy of translations. 

NCAH Portal submission: Submission electronically through the NCAH 

Portal affirms the submission is accurate per the statement selected upon 

completion of the submission to CVB, “I agree that I’ve looked over this 

information and everything entered is true to my knowledge.” 

Hardcopy submission: Include a statement such as “The accuracy of the 

translation is affirmed” or similar in the submission or on the mounting 

sheet(s). 
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3.3 Specify destination country

The country of destination (importing country) must be identified on the mounting sheet 

for Special Labels for Export. The declaration is optional for export only labels.

3.4 Regulatory authority documentation 

Special Labels for Export require written authorization from regulatory officials 

of the importing country or region per 9 CFR 112.2(e). English translations must

be provided. Firms must include the documentation in the submission or provide 

the Mail Log number where the documentation and translation may be found on 

the mounting sheet.

Export only labels typically do not require regulatory documentation unless when 

required to support use of regulatory flexibility.

3.5 License Restrictions

Include wording required by license restrictions. 

4. Precedents: Claim Language on Label 

4.1 Claim language

Regulatory flexibility for the following list of topics regarding claim language is found in 

Section 4.2 Table 1 below: 

Claims-4 tier claim 

Claims-4 tier and DOI statement 

Claims-4 tier and OOI statement 

Claims-Production claims 

Claims-productdata.aphis.usda.gov website statement (ST eligible products)

Claims-ST claim (ST eligible products)

Claims-ST claim and minimum age not required prior to licensure statement (ST 

eligible products)

Claims-ST claim and DOI statement (ST eligible products)

Claims-ST claim and OOI statement (ST eligible products)

Claims-ST claim and 2nd paragraph (ST eligible products)

Meets USDA requirements statement

Minimum age 

Minimum age not assigned-4 tier claim 

Minimum age not assigned-ST claim 

Target species poultry wording 
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4.2 Table 1 Regulatory Flexibility for Topics by Claim Language on Label

Requirements/Reference 

9 CFR or Veterinary Services 

Memorandum (VSM) 

Regulatory Flexibility 

for Export Only Label 

Regulatory Flexibility 

for Special Label for 

Export

Claims- 4-tier claim 

Allergenic and allergenic 

prescription products; antibody 

products per 9 CFR 113.450; 

autogenous products; diagnostic 

products; AND 

historical claim granted for other 

products if stated in OP.

Wording on label claim 

is not exactly as 

approved by the USDA 

in OP but meets the 

same intent without 

overt exaggeration. This 

includes the use of 4-tier 

language and 

substitutions of 

"prevention" for 

"control/reduction". 

Claim not approved and 

not supported by data 

on file with CVB. 

Claims- 4-tier claim and 

DOI statement 

Allergenic and allergenic 

prescription products; antibody 

products per 9 CFR 113.450; 

autogenous products; diagnostic 

products; AND 

historical claim granted for other 

products if stated in OP.

DOI wording on label 

claim is not exactly as 

approved by the USDA 

in OP but meets the 

same intent without 

overt exaggeration. 

Claim not approved and 

not supported by data 

on file with CVB. 

Claims- 4-tier claim and 

OOI statement 

Allergenic and allergenic 

prescription products; antibody 

products per 9 CFR 113.450; 

autogenous products; diagnostic 

products; AND 

historical claim granted for other 

products if stated in OP.

OOI wording on label 

claim is not exactly as 

approved by the USDA 

in OP but meets the 

same intent without 

overt exaggeration. 

Claim not approved and 

not supported by data 

on file with CVB. 

Claims-Production claims

e.g., weight gain, weight loss Not allowed. Production claims allowed. 

Claimsproductdata.aphis.usda.gov 

website statement (ST eligible products) 

112.2(a)(9)(v), 112.5(b) 

Optional to have website 

statement with either 4-

tier claim or ST claim 

when PCS present on 

APHIS website and 

website statement 

matches wording in OP 

or 9 CFR or VSM 

800.54. Variation to 

website address itself is 

not allowed.

Not allowed.
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Claims-ST claim 

112.2(a)(12), 112.2 (a)(5), 

VSM 800.54 III.E. 

Bacterins; immunomodulators; 

cancer therapeutic products; 

platform and prescription 

platform products per VSM 

800.213 and 214; toxoids; and 

vaccines.

Wording on label claim 

is not exactly as 

approved by the USDA 

in OP but meets the 

same intent without 

overt exaggeration. This 

includes the use of 4-tier 

language and 

substitutions of 

"prevention" for 

"control/reduction". 

Claim not approved and 

not supported by data 

on file with CVB. 

Claims-ST claim and minimum 

age not required prior to 

licensure statement 

112.2(a)(12), 112.2 (a)(5), 

VSM 800.54 III.E 

Bacterins; immunomodulators; 

cancer therapeutic products; 

platform and prescription 

platform products per VSM 

800.213 and 214; toxoids; and 

vaccines.

ST claim per OP or 

similar wording. 

Optional to have 

minimum age not 

required prior to 

licensure statement. 

Claim not approved and 

not supported by data 

on file with CVB. 

Claims-ST claim and DOI statement 

112.2(a)(12), 112.2 (a)(5), 

VSM 800.54 III.E 

Bacterins; immunomodulators; 

cancer therapeutic products; 

platform and prescription 

platform products per VSM 

800.213 and 214; toxoids; and 

vaccines.

ST claim per OP or 

similar wording. 

Optional to have 

DOI statement. 

If DOI statement is 

present, must match 

OP. 

Claim not approved and 

not supported by data 

on file with CVB. 

Claims-ST claim and OOI statement 

112.2(a)(12), 112.2 (a)(5), 

VSM 800.54 III.E 

Bacterins; immunomodulators; 

cancer therapeutic products; 

platform and prescription 

platform products per VSM 

800.213 and 214; toxoids; and 

vaccines.

ST claim per OP or 

similar wording. 

Optional to have 

OOI statement. 

If OOI statement is 

present, must match 

OP. 

Claim not approved and 

not supported by data 

on file with CVB. 

Claims-ST claim and 2nd paragraph 

112.2(a)(12), 112.2 (a)(5), 

VSM 800.54 III.E 

Bacterins; immunomodulators; 

cancer therapeutic products; 

platform and prescription 

platform products per VSM 

800.213 and 214; toxoids; and 

vaccines.

ST claim per OP: 

Optional to have 2nd

paragraph statement 

of ST claim. 

If 2nd paragraph 

statement present, 

must match OP. 

Claim not approved and 

not supported by data 

on file with CVB. 
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Meets USDA requirements 

statement 

Optional Statement not allowed.

Minimum age Age is stated per OP or 

older than stated in OP. 

Recommended 

minimum age for use is 

less than what is 

approved by APHIS. 

Minimum age not assigned4 tier claim

112.2 (a)(5) 

Age was not required per 112 

prior to regulation revision in 

2015/2016 except as stated in 9 

CFR 113.

If age is not stated in OP 

for 4-tier, then not 

required to appear on 

labeling; instead healthy 

<species> is stated. 

Recommended 

minimum age for use is 

less than what is 

approved by APHIS. 

Minimum age not assignedST claim

112.2 (a)(5) 

Age was not required per 112 

prior to regulation revision in 

2015/2016 except as stated in 9 

CFR 113. No minimum age 

assigned during conversion from 

4-tier to ST claim wording. 

If age is not stated in OP 

for ST, then does not 

appear on labeling; 

instead healthy 

<species> is stated. 

Recommended 

minimum age for use is 

less than what is 

approved by APHIS. 

Target species poultry wording 

112.2 (a)(5) 

State specific species in 

claim then allow use of 

translation of "birds" 

elsewhere on label; 

chick=chicken, 

poults=turkey, 

breeding hen/layer 

acceptable. 

Claim not approved and 

not supported by data 

on file with CVB. 

5. Precedents: Packaging and Labeling Final Rule and Other Codified

5.1 Packaging and Labeling Requirements

Regulatory flexibility for the following list of topics regarding Packaging and Labeling 

Final Rule requirements is found in Section 5.2 Table 2 below: 

ATN-Firm generated 

Address 

Animal Use/Veterinary Use statement 

Do not mix statement 

Expiration date 

Full directions-see other label for full directions 

Human exposure statement 

Inactivation statement as disposal method 
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Instructions for use 

Preservatives 

PCN 

Recoverable quantity 

Route of administration

Safety in breeding animals

Serial or lot number 

Storage temperature 

Telephone number (contact phone number) 

Trade Name 

True Name

True Name same font and size Trade Name 

Use entire contents statement for multiple dose container 

VLN 

Withdrawal period 

5.2 Table 2 Regulatory Flexibility for Topics by Packaging and Labeling Final Rule and 

Other Requirements on Label 

Requirements/Reference 

9 CFR or Veterinary Services 

Memorandum (VSM) 

Regulatory Flexibility 

for Export Only 

Regulatory 

Flexibility for Special 

Label for Export

ATNFirm generated 

Abbreviation is firm 

generated and 

represents the 

composition or 

adequate description of 

the product. 

NA

Address 

Producer (manufacturer)/ 

subsidiary/division/ distributor 

Not required on very 

small container if 

present on other 

labeling. 

Producer/subsidiary/ 

division: provide 

State & U.S. 

Distributor: provide 

country. 

NA
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Animal Use/Veterinary Use 

statement 

112.2 (d)(3), 112.7(d)(1-2) 

VSM 800.54 III.M. 

Optional animal 

use/veterinary use 

statement. Animal or 

veterinary use 

indicates use in 

animals (and not 

humans). This does 

not mean use by or 

under the supervision 

of a veterinarian for 

use or administration. 

112.7(d)(1-2) 

required wording for 

live Rabies Virus 

products is not 

optional.

Note-this wording is 

not the same as 

wording to match a 

license restriction for 

use by or under a 

veterinarian.

NA

Do not mix statement 

112.2 (a)(7)(i), VSM 800.54 Section III.L 

Optional wording per 

9 CFR. 

States permissible to 

mix with another 

licensed product; 

need data on file with 

CVB to allow and/or 

stated in OP.

Mixing with another 

specific product 

without data on file by 

CVB. 

Expiration date 

112.2(a)(9)(i) Must match OP. 

Longer dating period 

than approved in OP. 

Full directions-see other label 

for full directions 

No statement on 

small final container, 

container and/or box 

to see insert for 

complete instructions 

when insert is always 

included in 

packaging. 

If insert not included 

in the submission for 

review, then firm 

should comment on 

the mounting sheet 

the insert Label 

number that applies 

to the insert to always 

be included in 

packaging.

NA
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Human exposure statement

112.2 (a)(7)(ii)

VSM 800.54 III.N.

Optional and if present 

may use alternative 

wording.

NA

Inactivation statement as 

disposal method 

e.g., burn, inactivate, local 

authority, etc. 

112.2 (a)(7)(iii)

Optional and if present 

may use alternative 

wording to refer to burn 

or per local/federal/state 

authority or similar.

NA

Instructions for use 

112.2(a)(5) Must match OP. Use not approved by APHIS. 

Preservatives 

112.2 (a)(10)

Export only to Japan; New 

Zealand; Canada; Australia; 

South Africa; EU; European 

Economic Area (EEA) countries 

when included in EU 

registrations: Iceland, 

Liechtenstein, and Norway; UK; 

Switzerland when included in or 

recognizing an EU registration. 

Must match OP.

Not declared or 

partially declared 

when importing 

country 

documentation 

explicitly states 

preservatives are not 

allowed/required to 

be stated on labeling.

Not declared or 

partially declared. 

Preservatives 

112.2 (a)(10) 

Export only to countries that are 

NOT

Japan; New Zealand; Canada; 

Australia; South Africa; EU; 

European Economic Area (EEA) 

countries when included in EU 

registrations: Iceland, 

Liechtenstein, and Norway; UK; 

Switzerland when included in or 

recognizing an EU registration. 

Must match OP.

Not declared or 

partially declared 

when importing 

country 

documentation 

explicitly states 

preservatives are not 

allowed to be stated 

on labeling.

If not present and 

lack of importing 

country 

documentation that 

wording is prohibited, 

grant 2-year 

temporary label 

approval to allow 

time to update 

registration.

Not declared and 

importing country 

documentation does 

not explicitly include 

wording to prohibit 

preservatives on label. 
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PCN 

112.2 (a)(3), VSM 800.54 III.D. 

Optional 

PCN number as 

assigned by CVB and 

on product license if 

present. 

If present may use 

alternative format to 

define PCN per 112 

and VSM 800.54. 

Flexibility to not be 

near or adjacent to 

VLN/VPN.

Must not appear.

Recoverable quantity 

112.2(a)(9)(iii) 

Not specified on 

container and stated on 

box.

NA

Route of administration 

112.2 (a)(5) Must match OP. Routes not approved by APHIS. 

Safety in breeding animals 

112.7(c) pregnancy statement

Optional unless antigen 

is known to be unsafe 

in pregnant 

animals/other classes of 

animals (breeding male) 

then must state or 

importing country 

provides documentation 

that a statement 

regarding safety in 

breeding animals 

statement is specifically 

not required.

NA

Serial or lot number 

112.2 (a)(9)(iv) 

Use of lot or similar 

except for diagnostic 

products.

NA

Storage temperature 

112.2 (a)(4), VSM 800.54 III.J. 

2-7°C/35-46°F or not 

over 45°F. 

Other temp if in OP.

Must be present on 

box if not on 

container and 

container refers to 

box. 

Not required on very 

small container for 

poultry products 

stored in liquid 

nitrogen.

Temp not approved 

as written in OP. 

Holding at room 

temp for a period of 

time is not approved 

by APHIS. 

Telephone number 

(contact phone number) 

112.2(a)(2), VSM 800.54

Optional

NA
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Trade Name 

112.5(d)(2)(ii), VSM 800.54

Optional.

For IC to issue a 

Certificate of 

Licensure and 

Inspection, one label 

(domestic or export 

only or special label 

for export) must be 

active with the Trade 

Name; see IC manual 

ICSOP0044 on the 

APHIS website or 

contact IC for 

additional guidance

NA

True Name 

112.2 (a)(1), VSM 800.54 III.A. 

True Name not as stated 

on license though 

wording indicates 

composition or 

adequate description of 

the product either 

where the True Name 

would be expected or 

elsewhere on the label.

NA

True Name similar/same font 

and size True Name 

112.2(c) and 800.54 to not 

overshadow 

Similar/same font and 

size of Trade Name to 

True Name allowed; 

cannot overshadow. 

NA

Use entire contents statement 

for multiple dose container 

112.2(a)(6) multi-dose 

112.2(a)(9)(ii) # doses

Optional multi-dose 

statement to use 

entire contents when 

first opened. 

Number of doses is 

required. 

NA
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VLN 

112.2 (a)(3), VSM 800.54 III.D. 

VLN as assigned by 

CVB and on Est. 

license. 

May use alternative 

format to define or 

write VLN per 112 

and VSM 800.54. 

Flexibility to not be 

near or adjacent to 

PCN. 

Name of 

producer/subsidiary/ 

division/distributor 

must be clearly stated 

so as not to cause 

confusion to end user.

Importing countries 

provides regulatory 

documentation that 

prohibits per 9 CFR 

112.2(e)(2) and label 

meets all other 

requirements for noncompliances that 

would NOT be 

grounds for a special 

label.

Must not appear.

Withdrawal period 

112.2(a)(8) food producing 

animals and horses

Optional or state as zero 

(0) days. 

NA

6. Precedents: Recommendation Statements on Label

6.1 Recommendation statements 

Regulatory flexibility for the following list of topics regarding recommendation 

statements is found in Section 6.2 Table 3 below: 

Maternal antibody interference statement 

Revaccination statement outside of the initial series allowed under 4-tier 

Vaccination schedule-initial series 

Vaccination-revaccination outside of initial series ST claim 
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6.2 Table 3 Regulatory Flexibility for Recommendation Statements on Label

Requirements/Reference 

9 CFR or Veterinary Services 

Memorandum (VSM) 

Regulatory Flexibility 

for Export Only 

Regulatory 

Flexibility for Special 

Label for Export

Maternal antibody interference 

statement 

VSM 800.54, III.K.

Optional and if 

present may use 

alternative wording. 

Historically under 4-

tier claim language to 

revaccinate when 

maternal antibody 

waned for species 

was allowed; 

statement allowable 

without data

NA

Revaccination statement 

outside of the initial series 

allowed under 4-tier 

Optional.

Historically under the 

4-tier claim language, 

a statement to 

revaccinate annually 

was allowed and not 

data driven by DOI 

study; inclusion of a 

statement for annual 

revaccination is 

allowable without 

data. 

DOI not approved.

Vaccination schedule-initial 

series 

112.2(a)(5) 

Importing country 

provides 

documentation 

specifically stating 

that initial series not 

required and meets 

other requirements 

for export only. 

Drinking water / 

spray vaccine; label 

has statement that 

animals must be 

revaccinated; 

revaccination 

statement is not in 

OP.

Differs from approved 

in OP.
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Vaccination-revaccination 

outside of initial series ST claim 

112.7(f), 113 

Allowed revaccination statement 

for products licensed under 4-tier 

language in conversion to ST 

claim wording for export only 

labels without data to support 

revaccination time period. 

Optional unless 

Rabies Virus product 

or 9 CFR 112/113 

requirement.

Optional to state 

revaccinate at each 

pregnancy if passive 

immunity claim.

Differs from approved 

in OP or outside of 

annual revaccination. 

7. Precedents: Product-Specific Statements on Label

7.1 Product-specific statements

Regulatory flexibility for the following list of topics regarding product-specific statements 

is found in Section 7.2 Table 4 below:

Antigen content statement per Section IV.I. of the OP statement including 

maximum antigen content

Antigen content below Section IV.I. of the OP statement 

Antigen content above Section IV.I. of the OP statement 

Composition statement and Strain/Type/Genotype of Master Seed 

ISO symbols 

License restriction for Export Only due to manufacturing ingredient 

Master Seed strain identity 

Titer/value for potency below required for release per Section V.C. of the OP 

Titer/value for potency above required for release per Section V.C. of the OP

Trade Name and liquid fractions of combination package

Warning and caution statements and any other vital information for product’s use 

that is product specific (codified 9 CFR 112 and 113)

Warning and caution statements and any other vital information for product’s use 

that is product specific (not codified, APHIS approved) 

7.2 Table 4 Regulatory Flexibility for Product-Specific Statements on Label 

Requirements/Reference 

9 CFR or Veterinary Services 

Memorandum (VSM) 

Regulatory Flexibility 

for Export Only 

Regulatory 

Flexibility for Special 

Label for Export

Antigen content statement per 

Section IV.I. of the OP 

statement including maximum 

antigen content 

*This is not potency 

Optional text stating 

"minimum" antigen 

content per OP 

Section IV.I. 

Antigen content 

statement cannot 

exceed any maximum 

antigen content 

approved in OP.

NA
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Antigen content stated on label 

is below approved in Section 

IV.I. of the OP statement 

*This is not potency

Sketch if antigen 

content on label below 

level in OP. 

NA

Antigen content stated on label 

is above approved in Section 

IV.I. of the OP statement 

*This is not potency 

 Sketch if antigen 

content states above 

maximum level in OP. 

Label has statement 

for antigen content 

that is above stated 

in OP. 

Above maximum if 

present in OP. 

Both instances 

above require firm 

to add comment on 

mounting sheet that 

only serials meeting 

the criteria will have 

the label. Reviewers 

add statement if firm 

does not.

Composition statement 

112.7, 113 

VSM 800.54, VSM 800.54, III.H.

Required for the 

following: 

EHV type 1, 4 

Required BVDV 

type 1, 2 

Infectious 

bronchitis 

Influenza

NA

ISO symbols 

VSM 800.54 III.G.

Alternatives to 

wording in VSM 

800.54 if meaning is 

understood in symbol 

or explanation 

provided; cannot be 

false or misleading.

NA

License restriction for Export 

Only due to manufacturing 

ingredient 

Firm has a license 

restricted for export 

only because of a 

manufacturing 

ingredient that is not 

allowed in the US. All 

statements on label are 

in compliance with 

filed export-only OP.

NA

Master Seed strain identity 

Seed strain not in OP: 

firm provides 

information to prove 

the strain identity of the 

Seed though not written 

into OP. Firm should 

add to OP at next 

revision if not present. 

Seed strain not in OP 

and firm cannot 

credibly demonstrate 

the strain identity of 

the Seed. 
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Titer/value for potency stated 

on label is below required for 

release per Section V.C. of the 

OP 

Label has statement for 

minimum titer/potency 

value that is below that 

required in OP. CVB 

will release according 

to the OP. Firm adds a 

statement in the 

comment section of the 

mounting sheet “For 

export to <country>. To 

be affixed only to 

serials having a release 

titer of at least <titer>”. 

to indicate CVB 

recognizes the potency 

discrepancy and only 

releases serials 

according to the OP. If 

firm did not add the 

statement, then 

reviewer adds to 

mounting sheet.

NA

Titer/value for potency stated 

on label is above required for 

release per Section V.C. of the 

OP 

Label has statement for 

titer/potency value that 

is above stated in OP. 

CVB will release 

according to the OP. 

Firm adds a statement 

in the comment section 

of the mounting sheet, 

“For export to 

<country>. To be 

affixed only to serials 

having a release titer of 

at least <titer>”. If firm 

did not add the 

statement, then 

reviewer adds to 

mounting sheet. 

The higher titer must be 

in Section VI.A. of the 

OP per VSM 800.206 

for IC to issue a 

Certificate for 

Licensure and 

Inspection Otherwise, 

following guidance in 

IC document 

ICSOP0044available on 

the APHIS website. 

NA
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Trade Name and liquid 

fractions of combination 

packages 

Trade Names must not 

be false or misleading. 

In a combination 

package, the Trade 

Name of the liquid 

fractions was changed 

to match the Trade 

Name of the freezedried fraction.

Warning and caution 

statements and other vital 

information for product’s use 

that is product specific 

(codified 9 CFR 112 and 113) 

Must be present as 

written in OP especially 

if impact purity, safety, 

potency, and/or efficacy 

of product use. 

Alternatively, 

importing country 

documentation 

explicitly stating not 

required.

NA

Warning and caution 

statements and other vital 

information for product’s use 

that is product specific 

(not codified, APHIS 

approved)

Should be present as 

written in OP especially 

if impact purity, safety, 

potency, and/or efficacy 

of product use. 

NA

8. Precedents: Species-Specific Statements on Label 

8.1 Species-Specific Statements

Regulatory flexibility for the following list of topics regarding product-specific statements 

is found in Section 8.2 Table 5 below: 

Dose Volume in Limited Administrations to Poultry and Swine 

Equine Parvovirus-Hepatitis statement 

Species use not approved 

8.2 Table 5 Regulatory Flexibility for Species-Specific Statements on Label 

Requirements/Reference 

9 CFR or Veterinary Services 

Memorandum (VSM) 

Regulatory Flexibility 

for Export Only 

Regulatory 

Flexibility for Special 

Label for Export

Dose Volume in Limited 

Administrations to Poultry and 

Swine 

Allowable to not 

include a dose volume 

for administrations as 

listed: 

Poultry: wing web, 

drinking water, 

Beak-O-Vac, 

aerosol/coarse 

spray 

Swine: drinking 

water 

NA
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Equine Parvovirus-Hepatitis 

statement for antibody 

products per 9 CFR 113.450 

when derived from horses 

Statements needed:

Product 

administered to 

horses must have a 

caution statement 

regarding use of 

product is 

associated with 

Theiler’s Disease 

Products not 

administered to 

horses must have a 

caution statement 

to not use in horses. 

Lack of statements 

above allowed when 

importing country 

documentation provides 

wording that the 

statements may be 

omitted. 

Not present and no 

documentation from 

importing regulatory 

authority that 

statement must be 

omitted. 

Species not approved by 

APHIS Must match OP. Use in species not 

approved by APHIS. 

9. Precedents: Foreign Registration and Regulatory Authorizations 

9.1 Foreign Registration and Foreign Regulatory Authority Authorizations 

List of topics regarding foreign registration and foreign regulatory authority authorizations 

is found in Section 9.2 Table 6 below: 

Foreign registration numbers 

Foreign regulatory authority identification 

Foreign regulatory authorization expiration dating

9.2 Table 6 Regulatory Flexibility for Foreign Registration and Foreign Regulatory 

Authority Authorizations 

Requirements/Reference 

9 CFR or Veterinary Services 

Memorandum (VSM) 

Regulatory Flexibility 

for Export Only 

Regulatory 

Flexibility for Special 

Label for Export

Foreign registration number 

Foreign registration 

numbers present and 

otherwise meets 

requirement for export 

only. 

NA

Foreign regulatory authority 

identification 

Foreign regulatory 

authority ID present 

and otherwise meets 

requirement for export 

only.

NA
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Foreign regulatory 

authorization expiration dating 

When the regulatory 

authorization has an 

expiration date; grant 

temporary approval to 

label and add 2 years to 

the expiration date. 

Export only does not 

require regulatory 

authorization unless as 

needed in this 

document 

When the regulatory 

authorization has an 

expiration date; grant 

temporary approval to 

label and add 2 years 

to the expiration date. 

10. Barcodes on Label

10.1. Barcodes on Label

Regulatory flexibility for the following list of topics regarding barcodes is found in 

Section 10.2 Table 7 below: 

JMAFF

Use of barcodes for export only labels, and special labels for export to Japan. 

The use is based on our understanding that JMAFF has control of the barcode. 

10.2 Table 7 Regulatory Flexibility for Barcodes on Label 

Requirements/Reference 

9 CFR or Veterinary Services 

Memorandum (VSM) 

Regulatory Flexibility 

for Export Only 

Regulatory 

Flexibility for Special 

Label for Export

Labels for export only to Japan 

with barcodes linking to 

JMAFF website 

JMAFF QR codes for 

website. Firm should 

ensure the label has an 

active QR code that can 

be scanned to direct to 

the JMAFF website or 

provide a document 

with the active link 

and/or website link. 

CVB understands that 

the Japanese regulatory 

authority reviews labels 

with 2D Codes before 

use in Japan. 

JMAFF QR codes for 

website. Firm should 

ensure the label has an 

active QR code that 

can be scanned to 

direct to the JMAFF 

website or provide a 

document with the 

active link and/or 

website link. 

 CVB understands that 

the Japanese 

regulatory authority 

reviews labels with 2D 

Codes before use in 

Japan.