An Equal Opportunity Provider and Employer

VETERINARY SERVICES MEMORANDUM NO. 800.54

TO: Veterinary Services Leadership Team

Directors, Center for Veterinary Biologics

Biologics Licensees, Permittees, and Applicants

FROM: Jack A. Shere

Deputy Administrator

SUBJECT: Guidelines for the Preparation and Review of Labeling Materials

I. PURPOSE

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

labeling materials for USDA-licensed products. Most labeling requirements are found

in title 9, Code of Federal Regulations, part 112 (9 CFR 112). The Animal and Plant 

Health Inspection Service (APHIS) updated these requirements substantially in 2015 

and 2016 by publishing Final Rule 2008-0008 (Labeling and Packaging) and Final Rule 

2011-0049 (Single Label Claim). The guidance in this memorandum emphasizes or 

interprets aspects of labeling regulations that merit further detail. 

II. REPLACEMENT

This memorandum replaces Veterinary Services (VS) Memorandum No. 800.54 dated 

May 15, 2017. 

III. LABELING ELEMENTS

A. True Names

1. APHIS assigns True Names. Display the True Name on labeling with the 

exact wording printed on the product license or permit. Exception: Bovine 

parainfluenza may be presented as either Parainfluenza3 or Parainfluenza 3.

2. In the case of very small container labels, firms may use an abbreviated 

version of the True Name if the full True Name is also provided on 

accompanying labeling materials. The abbreviated True Name appears on 

the product license or permit and must be reproduced exactly on labeling. 

Click here for a list of standardized abbreviations. 

3. Give equal emphasis (e.g., color, size, boldness, capital letters) to each term 

in the principal part of the True Name.

Animal and Plant

Health Inspection

Service

Veterinary Services

1400 Independence

Ave, SW

Washington, DC

20250
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B. Trade Names

1. Except as otherwise provided, associate a Trade Name with a single product.

2. A manufacturer, distributor, or permittee must have the exclusive right – by 

ownership, assignment, exclusive-use license, or other means – to use a Trade 

Name on a product.

3. A distributor or permittee who owns an exclusive right to a Trade Name may 

transfer the Trade Name to a new manufacturer for use on the labeling of a 

substantially similar product for the distributor or permittee. APHIS will 

determine case by case whether a product is “substantially similar.” APHIS may 

require the new manufacturer to add a postscript to the Trade Name (Trade 

Name+x), where, in its opinion, the change of manufacturer creates a product 

that is substantially similar but not identical with respect to a factor posing a 

potential risk to users.

4. Configure the label so that the True Name is the most conspicuous feature. Place 

the Trade Name below the True Name, and do not allow the Trade Name to 

overshadow the True Name by size, color, or boldness. 

C. Functional Names

Use Functional Names to identify individual diagnostic kit components. This contrasts

to the True Name, assigned to the composite kit.

D. Establishment and Product Codes

The regulations at 9 CFR 112.2(a)(3) require labels to bear the U.S. Veterinary 

Biologics Establishment License Number (VLN) or the U.S. Veterinary Biological 

Product Permit Number (VPN), as well as the Product Code Number (PCN), except 

where specifically exempted. The current regulations state that ONLY the formats VLN, 

VPN, and PCN may be used.

In addition to the currently codified formats above, APHIS will continue to accept the 

following establishment abbreviations found in 9 CFR 112.2(a)(3) before implementing

the Labeling and Packaging Rule:

• U.S. Veterinary License No.

• U.S. Vet. License No.

• U.S. Vet. Lic. No.

• U.S. Veterinary Permit No.

• U.S. Permit No.
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Acceptable additional formats for PCN are:

• Product Code No.

• U.S. Vet. Prod. No.

• Prod. Code

Place an acceptable abbreviation next to the numbers; the numbers should not appear 

alone, without definition. The regulations also specify placing the establishment/permit 

number and product code number (VLN/PCN or VPN/PCN) adjacent to each other, in 

that order, on labeling. APHIS intends this to help the customer locate and recognize this 

information.

E. Indications Statements For Products Within the Scope of the Single Label Claim Rule

The Single Label Claim Rule applies to domestic labeling for vaccines, bacterins, 

toxoids, and immunomodulators, except for autogenous and prescription products and 

allergenic extracts. It does not apply to antibody products or diagnostic test kits. 

1. First paragraph

a. Structure effectiveness claims according to the following formats:

Prophylactic products:

“This product has been shown to be effective for the vaccination of healthy 

(insert name of species) X weeks of age or older against (insert name of agent 

or disease). For more information regarding efficacy and safety data, see 

productdata.aphis.usda.gov.”

Variation for therapeutic products:

“This product has been shown to be effective for the treatment of (insert name 

of species) X weeks of age or older against (insert name of agent or disease). 

For more information regarding efficacy and safety data, see 

productdata.aphis.usda.gov.”

Variation for products providing passive protection:

“This product has been shown to be effective for the vaccination of healthy 

(insert name of species) to provide passive immunity against (insert name of 

agent or disease) in offspring.”

Synonyms for “offspring” (e.g., progeny, piglets, calves) may be used. 

Minimum age is not required; see Section III.F.2 of this memorandum.

Variation for products with conditional licenses:

“For the vaccination of <insert animal species> against <insert agent or 

disease>. This product license is conditional; efficacy and potency have not 

been fully demonstrated. For more information regarding safety data, see 

productdata.aphis.usda.gov.”
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b. If the agent can cause more than one distinct disease syndrome, include the 

syndrome in the claim. Examples include:

“...against respiratory disease due to BVD1 and 2”

“...against persistently infected calves due to BVD1 and 2.”

c. For prophylactic products, specify the demonstrated duration of immunity for 

each fraction or indicate that the duration is unknown. Clarify that it is a 

minimum duration of immunity, as the actual duration may be considerably 

longer. Place this information before the instruction to see 

productdata.aphis.usda.gov.

Example: “The duration of immunity against viruses A and B is at least 12 

months. The duration for the remaining viruses in this product has not been 

determined.”

d. If APHIS has approved onset of immunity claims, include these here also.

e. Do not include any other text in the first paragraph.

2. Optional second paragraph

If the product has been proven effective against specific disease signs or sequelae 

(e.g., mortality, viremia, shedding), firms may state this in a second paragraph.

a. Do not use language that could be construed as a four-tier claim. Example of 

permissible language: “The vaccine has been shown to be effective against 

viremia and virus shedding in the feces.”

b. Include only those signs/sequelae APHIS has specifically approved as part of a 

label claim.

F. Minimum Age

Labeling for biologics other than diagnostic kits must include the minimum age of 

animals recommended for product use. This is based on the age of the animals used in 

the pivotal efficacy and field safety studies. If the age is not consistent between the 

studies, cite the older age in the indication statement. In some cases, firms may refer also 

to the younger age study in a paragraph appearing below the indication statement.

Firms may specify minimum weight in lieu of age for aquaculture products or other 

products where weight is a more meaningful criterion than age. For certain live poultry 

vaccines that may be transmitted to eggs, APHIS may require a statement “not to be 

used within X weeks of lay”.
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Minimum age applies to an entire product, not individual fractions. For multivalent 

products with multiple supporting efficacy and safety studies, the minimum age for 

product use is based on the oldest animals used in any of the supporting studies.

1. Products Licensed Before Requirement to Establish Minimum Age

In 2002, APHIS published policy regarding the use of minimum-aged animals in 

licensing studies. For products licensed before APHIS required a minimum age for 

use, manufacturers may use the following indication statement: “This product has 

been shown to be effective for the vaccination of healthy (insert name of species) 

against (insert name of agent or disease). This product was licensed prior to the 

requirement to establish a minimum age for use. For more information regarding 

efficacy and safety data, see productdata.aphis.usda.gov.” 

2. Products for Use Only in Mature Animals

A minimum numeric age is not required for products used exclusively in mature 

animals. Examples include products with recommendations to use prior to 

breeding/parturition or if indicated for use in “adult” animals.

3. Therapeutic Products

A minimum age is not required for certain therapeutic products, such as cancer or 

atopy products, unless there is a specific safety concern. Such products are 

typically evaluated for efficacy in naturally affected animals from a variety of 

sources and covering a wide variety of ages. For therapeutic products where 

efficacy studies may feasibly be conducted in age-matched animals under a more 

controlled study design, minimum age requirements may apply.

G. ISO Symbols

APHIS allows specified symbols on container labeling in situations where the use of text 

is not practical. Permissible symbols are in accordance with ANSl/AAMl/ISO 15223-

1:2012 and ASTM D5445-11a (ISO 780).

1. Click here for a list of permissible symbols. 

2. When using these symbols, include an explanatory key on the carton or the 

product enclosure. For multi-language labels, the explanatory key must include all 

languages appearing in the labeling. 

H. Antigen Type/Strain When Not Included in the True Name

1. Some agents have multiple generally recognized types or strains that impact 

vaccine effectiveness. The True Name frequently specifies only the agent in the 

vaccine. Examples include, but are not limited to, vaccines containing equine 
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 An Equal Opportunity Provider and Employer

rhinopneumonitis virus, bovine virus diarrhea virus, and porcine circovirus. In 

these cases, provide additional detail on the type/strain included in the product 

elsewhere on the labeling.

2. Disclose the subtypes and strains included in influenza products. For 

recombinant/reassortant/subunit products, provide the subtype and strain of the 

parent isolate. Designate the strains according to accepted standards of influenza 

virus nomenclature (e.g., “A/equine/Miami/63(H3N8)” or “A/swine/Wisconsin/

458/98(H1N1)”). Further identify the strains with commonly used, scientifically 

justified terms such as “A2,” “European,” “American,” “atypical,” or “classical.” 

If the product does not contain the N subtype gene, disclose this information on 

the labeling. 

3. For products included under the Single Label Claim rule, place strain information 

in the paragraph following the first codified indication statement unless the 

labeling has a specific “Composition” section where this information could be 

placed.

I. Minimum Potency

Labeling may include minimum potency specifications but, if included, provide the 

through-dating specification. If a foreign marketing authority requires release 

specifications, indicate that the stated specifications are those for serial release.

J. Storage Temperature

The regulations in 9 CFR 112.2(a)(4) state that the storage temperature recommendation 

for biological products will be stated as 2 to 8 °C or 35 to 46 °F, or both. Some products, 

however, have special storage conditions with differing temperature ranges. In such 

cases, the labeling must match the approved storage conditions as specified on the 

Outline of Production for the finished product.

K. Revaccination Statement

1. Selective Enforcement

The regulations in 9 CFR 112.7(f) state that when no data support a revaccination 

interval, the following statement must be included on labeling: ‘‘The need for annual 

booster vaccinations has not been established for this product; consultation with a 

veterinarian is recommended.’’ APHIS will selectively enforce this regulation only 

for products intended for use in dogs, cats, and horses. Licensees and permittees may 

add similar information voluntarily to labeling for other animal species. Although the 

specific wording of this regulation discusses only annual revaccination, APHIS 

considers it applicable to any recommended revaccination interval, not just annual.
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2. Need to Vaccinate vs. Minimum Duration of Immunity

APHIS considers a “need” to revaccinate to occur when immunity has waned 

sufficiently that it no longer provides meaningful protection against disease. This is 

distinct from recommending revaccination at the interval defined in a minimum 

duration of immunity study. Such studies demonstrate that immunity continues to 

provide meaningful protection at that time; immunity may not wane until much later.

3. Acceptable Approaches

Address revaccination recommendations in one of the following ways:

a. Disclose the minimum duration of immunity in the indications statement and 

make no other comments about revaccination.

b. Disclose the minimum duration of immunity in the indications statement and

recommend contacting the veterinarian/manufacturer for more information on 

revaccination frequency.

c. For products licensed before November 2016, and which previously had 

labeling recommending a specific revaccination interval: In addition to the 

duration of immunity statement, add “Historically, annual (or other interval)

revaccination has been recommended for this product. The need for this 

booster has not been established. Contact your veterinarian or manufacturer 

for more information on revaccination frequency.”

4. Passive Protection Products

Products intended for use in pregnant animals to provide passive immunity to 

offspring may bear an unqualified statement to revaccinate upon each successive 

gestation.

5. Maternal Antibody Interference

If a statement on potential maternal antibody interference is desired and appropriate, 

use the standardized statement below or equivalent. Do not specify absolute 

revaccination intervals to overcome maternal antibody.

“The presence of maternal antibody is known to interfere with the development of 

active immunity in <name of animal species> and additional boosters will be required 

in most young animals. For advice on revaccination frequency, consult your 

veterinarian.”
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6. Revaccination During Stress or Disease Exposure

If a statement regarding booster vaccination during periods of stress or disease 

exposure is desired, use the standardized statement below or equivalent. Do not 

specify absolute revaccination intervals to overcome stress factors.

“For more information on revaccination in the face of stress or an exposure, contact 

your veterinarian.”

7. Who to Contact

When specifying who to contact for additional information, you may recommend 1) 

the veterinarian or 2) the veterinarian OR the manufacturer. It is not permissible to 

recommend only the manufacturer unless the product license has a restriction limiting 

sales only to veterinarians.

Widely accepted vaccination guidelines, such as the American Animal Hospital 

Association Canine Vaccination Guidelines and the American Association of Feline 

Practitioners Feline Vaccination Advisory Panel Report, may be cited if using the 

formal name of the guideline instead of slang terms.

8. Combination of Statements

The standardized revaccination statements in Section IV.K of this memorandum may 

be combined and edited into a more concise format when multiple statements apply to 

a single product.

Acceptable example: “For more information on revaccination frequency, in general or 

in the face of maternal antibody, stress, or a disease exposure, consult your 

veterinarian.”

L. Mixing Statement

The regulation at 9 CFR 112.2(a)(7)(i) states that products other than diagnostic kits

must bear the following statement: ‘‘Do not mix with other products, except as specified 

on this label.’’ The phrase “except as specified on this label” may be omitted when there 

is no other instruction recommending mixing.

M. Animal Use Statement

The regulation at 9 CFR 112.2(d)(3) states, “The statement ‘For use in animals only’ 

may appear on the labeling as appropriate for a product to indicate that the product is 

recommended specifically for animals and not for humans.” Before 2016, the codified 

term was “for veterinary use only.” APHIS changed it to prevent confusion with use by 
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veterinarians only. APHIS will allow either phrase, “For use in animals only” or “For 

veterinary use only,” in most situations, where there is negligible risk for confusion. 

N. Contact Physician Upon Exposure Statement

The regulation at 9 CFR 112.2(7)(ii) states that labeling for injectable products and other 

products containing hazardous components must include the statement, ‘‘In case of 

human exposure, contact a physician.’’ All injectable products, regardless of 

composition, must bear this statement. Additionally, it may be required for noninjectable products containing potentially hazardous components (chemical additives or 

live organisms).

IV. LABEL TYPES

A. Container Labels

1. Current regulations (9 CFR 112.2) specify the information that must appear on 

final container labels. APHIS makes certain allowances for small labels with 

limited space, provided that omitted information appears elsewhere on carton 

labels or enclosures.

a. For biologics other than diagnostic test kit components, include the following 

elements, at a minimum, on small container labels:

i. Complete or abbreviated True Name.

ii. Serial number.

iii. Expiration date.

iv. Location of full labeling information.

v. Storage temperature.

vi. Establishment or permittee and product code identification.

vii. Statement to inactivate unused contents if the product contains viable 

agents.

b. For small final containers of diagnostic test kit components, include the 

following minimum information on small container labels: 

i. Complete or abbreviated True Name of the kit*.

ii. Functional and/or chemical name and lot number of the component.

iii. Establishment number or permittee.

iv. Product code of kit*.

v. Storage temperature.

*The True Name and product code are not required on small containers of 

interchangeable kit components, which may be packaged with multiple 

products.
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2. The product code of the individually licensed component is not required on 

labeling used for component containers of a combination package. On the 

container label, refer the user to the carton for the product code. Separate 

container labels are not required for products marketed both as an individual 

product and as a component in a combination package. 

3. Beyond the indications statement described in section III.E above, do not include 

supporting studies or other promotional statements about product effectiveness on 

the container label of products subject to the Single Label Claim rule. The 

following statements, however, are permissible on the container:

a. Product-specific warnings (e.g., may cause transient swelling) or other 

restrictions on use (e.g., only for use in seropositive herds).

b. Whether it can be used in breeding and/or pregnant animals (or other special 

animal category).

c. A general disclaimer that the product may not work as intended in ill, 

malnourished, or immunosuppressed animals.

d. A general description of disease an agent causes.

B. Carton Labels

The term “carton” in this section applies to boxes or other outer packaging in which 

product containers are marketed and also to “tray covers” that display underneath the 

surface of clear “clamshell” boxes.

1. Current regulations (9 CFR 112.2) specify the information that must appear on a 

carton, particularly if it is not included on the container. Place required elements 

on the outside of the carton, to view them without opening the carton.

2. Cartons also may bear non-required information if APHIS determines it is not 

false or misleading. Place non-required information on the outside or the inner 

surface of the carton, except as specified in section IV.B.3.

3. For products subject to the Single Label Claim Rule, place optional study data, or 

other information regarding product use, only on the inner surface of the carton. 

In such situations, the inner surface of the carton is analogous to an enclosure and 

is subject to the guidance for enclosures in section IV.C.

C. Enclosures

Label enclosures (aka circulars, inserts, or leaflets) are used to disseminate a wide variety 

of information about a product. 
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1. Study summaries appearing on productdata.aphis.usda.gov may be reprinted on 

enclosures (or the inner surface of a carton), if desired. Ensure the reproduction is 

exact and without embellishment. Do not make any other remarks about these 

studies.

2. Additional data, not used in direct support of product licensure, may be printed on 

enclosures with APHIS approval. 

a. APHIS does not intend this policy to provide a forum for product comparisons 

or to generate a marketing advantage. The following is an acceptable example 

of additional information: Data showing no loss in vaccine titer X hours after 

reconstitution.

b. Submit full study reports for any additional data to be included on regulated 

labeling. Before approving labels bearing the information, APHIS evaluates 

the labels and the supporting studies for potentially false or misleading 

implications but does not make a full regulatory determination regarding the 

study.

c. When such additional data appear on an enclosure, insert the following 

statement prominently at the top of the enclosure:

d. “See productdata.aphis.usda.gov for a summary of the studies approved by the 

USDA for licensing this product. This package insert also contains additional 

information developed by the licensee.”

3. When describing additional information on labeling, use plain language:

a. Do not use subjective descriptors, such as the data “clearly” demonstrate a 

“robust” effect.

b. Do not use terminology that could be construed as promoting historical fourtier label claims.

c. Do not include complex statistical analyses, such as p-values, prevented 

fractions, or confidence intervals.

d. Do not summarize data to the point where conclusions could be misleading.

e. Do not state that the data are “on file” with APHIS, as this implies full 

regulatory review and endorsement.

D. Shipping Labels

Shipping labels are labels on bulk outer packaging solely for means of identifying a 

product during shipment. Shipping labels for product shipped in bulk or unlabeled final 
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containers must contain, at a minimum, the following elements: True Name; serial 

number; name, address, and establishment number of the licensee or permittee; Product 

Code; volume or mass of contents; storage conditions; and, if applicable, a “For Export 

Only” statement. The terms “batch ID,” “lot number”, or similar term, may be used in 

lieu of serial numbers on For Further Manufacture products.

The regulations at 9 CFR 112.2(f)(1) state that manufacturers do not need to submit 

shipping labels for domestic use to APHIS for approval. The regulations at 9 CFR 112.8, 

however, require manufacturers to submit export shipping labels (9 CFR 112.8(c)). 

APHIS no longer enforces the regulation to submit export shipping labels for approval, 

but these labels continue to be subject to regulatory action.

E. Stickers

Occasionally, APHIS receives requests to use auxiliary stickers with approved labeling. 

Examples include, but are not limited to, informing the customer of a change in product 

formulation or instructions for use, or adding country-specific codes on labels otherwise 

suitable for many countries.

Submit stickers to APHIS in the following manner:

1. Place the sticker on a mounting sheet, either separately or in combination with the 

label with which it will be used.

2. If the sticker appears on a separate mounting sheet from the companion label, 

include information on the sticker mounting sheet regarding the manner in which 

it will be used. Examples: 1) “For use on the neck of the container with all 

approved container labels for export to Country X” 2) “For use with carton label 

12345, affixed in the empty space to the left of the True Name, for 6 months after 

product launch.”

3. If the sticker is only intended for temporary use, provide a suggested expiration 

date on your submission. In this manner, APHIS will not require a separate action 

to inactivate/archive the label once its use is discontinued.

4. Make the label type for the sticker the same as the label with which the sticker 

will be used. For example, if placing the sticker on a carton, submit the sticker as 

a carton label.

F. Experimental Labels

Experimental labels are required for product shipped under 9 CFR 103.3. See VS

Memorandum No. 800.67 for additional information on experimental labels.
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G. Distributor Labels 

1. Arrange the names and addresses of the manufacturer and distributor on 

distributor labels in a manner that gives equal or greater emphasis to the 

manufacturer compared to the distributor.

a. Position the complete names and addresses of the manufacturer and distributor 

side by side with the manufacturer on the left. Alternatively, stack the 

information with the manufacturer on top of the distributor.

b. If only one name and address can fit on the front label panel, place the 

manufacturer on the front panel and the distributor on the back panel.

c. Give equal or greater emphasis to the manufacturer in all other aspects of the 

label. Examples include, but are not limited to, logo, size, shape, coloring, 

shading, font, print boldness, text arrangement, and print quality.

2. If using a distributor logo, ensure that the label, when considered in its entirety, 

does not create the impression that the distributor is the manufacturer. 

3. Use the licensee’s (producer’s) telephone number, not the distributor’s number, as 

the consumer contact telephone number. Alternatively, list telephone numbers for 

both the manufacturer and distributor.

H. Export-Only Labels

Many countries accept labeling that does not meet all current APHIS regulations. APHIS 

extends considerable regulatory flexibility for differences that do not impact the claimed 

use or administration of the product and do not make false or misleading statements. 

Licensees may continue to use APHIS-approved non-expired export-only labeling as long 

as the importing authority accepts the labeling. There is no requirement to convert such 

labeling to meet the Single Label Claim or Labeling and Packaging rules.

New labeling proposed for export-only use, if it does not meet all APHIS regulations, 

will be considered for APHIS approval based on documentation of approval by the 

importing country’s registration authority. APHIS will consider exceptions to current 

labeling regulations if the foreign approval allows such differences. Export-only labeling 

must, however, bear the U.S. Establishment Number unless the labeling qualifies as a 

Special Label for Export, per VS Memorandum No. 800.208, or the importing country 

specifically prohibits the inclusion of the U.S. Establishment Number. 

Special Labels for Export are limited solely for use on product destined for the approving 

country or countries having reciprocal agreements with the approving country. Specify 

the destination country or countries on the label submission, either as part of the label text 

or as a comment in the body of the mounting sheet.
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I. Import Labels

If a foreign manufacturer affixes labels approved by APHIS for use on individual serials 

imported into the United States, the manufacturer cannot use those labels for serials

distributed elsewhere. APHIS evaluates and releases for marketing only those serials 

imported into the United States. Other product cannot bear labeling with a U.S.

Establishment Number.

V. PRODUCT-SPECIFIC LABELING

A. Autogenous Labels

By their nature, autogenous products may not bear any claims for efficacy or safety. 

Structure the indication statement to read:

“For vaccination against the organisms listed.”

Alternatively, the indication statement may be omitted from autogenous labeling. Labels 

for autogenous products are also exempt from the following requirements:

• Minimum animal age for use.

• Revaccination recommendation (beyond initial two-dose series).

• Statement regarding safety in pregnant animals.

• Reference to productdata.aphis.usda.gov.

• Statement to use entire contents when first opened.

B. Prescription Labels

By their nature, prescription platform products licensed in accordance with VS

Memorandum 800.214 may not bear any claims for efficacy. Structure the indication 

statement to read:

“For vaccination against the organisms and strains listed. This product is a 

prescription platform veterinary biologic to be used under the supervision of a 

licensed veterinarian. Efficacy and potency have not been demonstrated. For more 

information regarding safety data, see productdata.aphis.usda.gov.”

Prescription labels should direct the user to the prescribing veterinarian for more 

information on vaccination frequency. 

C. Rabies Vaccine

The regulations at 9 CFR 112.7(c) and (d) contain specific labeling language for rabies 

virus vaccines. Each section specifies that product is to be administered at 3 months of 
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age or older, with a repeat dose 1 year later. Subsequent vaccination is determined from 

the results of duration of immunity studies.

Consistent with all other products, APHIS expects the minimum age to agree with the age 

of animals used in the efficacy and safety studies, which may be more than 3 months. 

APHIS will not consider rabies label claims for animals less than 3 months.

Because of these regulations, APHIS bases the revaccination interval for Rabies Vaccine 

on the interval between vaccination and challenge used in the minimum duration of 

immunity study. This contrasts to all other products where the minimum duration of 

immunity is not considered to represent a need to immunize (see section III.K.2 of this 

memorandum). The subsequent revaccination interval may be rounded down to the 

nearest year.

For example, the following label text is acceptable where efficacy was demonstrated in 4-

month-old dogs, challenged 39 months after vaccination:

“This product has been shown to be effective for the vaccination of healthy dogs, 4 

months of age or older, against rabies. For more information regarding efficacy and 

safety data, see productdata.aphis.usda.gov.

Vaccinate animals with a single dose, followed by a dose 1 year later. Vaccinate 

every 3 years subsequently.”

D. Feline Panleukopenia Vaccine

The regulations at 9 CFR 112.7(i) provide codified labeling language for Feline 

Panleukopenia Vaccine: 

“Vaccinate healthy cats with one dose, except that if the animal is less than 12 weeks of 

age, a second dose should be given no earlier than 16 weeks of age.”

The label and packaging rule was intended to update this regulation to agree with 

currently accepted scientific thought that the final dose against panleukopenia in a kitten 

vaccination series should not occur younger than 16 weeks of age. The current regulation

suggests, however, that a kitten needs, at most, two doses of vaccine, regardless of when 

the first dose was given. This may not be sufficient in kittens with a high level of 

maternal antibody. In this regard, the regulation should instead read: “Vaccinate healthy 

cats, except that if the animal is less than 16 weeks of age, the final dose should be given 

no earlier than 16 weeks of age.”

APHIS also recognizes that feline panleukopenia vaccine virus is most frequently found 

in multi-valent combinations with other common feline pathogens. It is cumbersome to 

combine the language of 9 CFR 112.7(i) with the preferred language in section III.K.5 of 

this memorandum. Therefore, labeling for multi-valent products containing feline 
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panleukopenia vaccine may contain the standardized maternal antibody statement in 

section III.K.5 without any specific mention of 9 CFR 112.7(i). Alternatively, products 

containing feline panleukopenia vaccine may contain the standardized maternal antibody 

statement in section III.K.5, and a final sentence stating the final dose should be given at 

no less than 16 weeks of age.

E. Marek’s Disease Vaccine

For all Marek’s disease products licensed before publication of 9 CFR 113.330 and for 

products solely containing Marek’s virus serotype 3 (regardless of license date), the 

appropriate claim is against Marek’s disease. Products containing Marek’s virus serotype 

1 or 2 and licensed with efficacy studies structured according to 9 CFR 113.330 may bear 

a claim against very virulent Marek’s disease. 

F. Porcine Reproductive and Respiratory Syndrome Virus (PRRSV) Vaccine

Labeling for live PRRSV vaccines requires the following warning statement or 

equivalent:

“Not for use in pregnant swine or boars. Vaccine virus may be shed and transmitted 

to other populations of swine in contact with vaccinated swine. The duration of 

potential vaccine virus transmission may vary. Use of the vaccine in herds intended to 

remain PRRS virus seronegative is contraindicated. Introduction of vaccinated pigs 

into herds intended to remain PRRS virus seronegative is contraindicated.”

G. Foreign Animal Disease Products

APHIS issues licenses for domestic production of products against foreign animal 

diseases (FADs) when the risk of introducing exotic agents into the United States is 

negligible (e.g., products containing synthetic peptides or antigens produced in 

recombinant systems). These products bear a license restriction, “For Export Only.” If a 

foreign disease incursion occurs, these licenses may be reissued quickly without the 

restriction, for domestic use. To this end, labeling which is fully compliant with domestic 

regulations and policy should be on file with APHIS for these products. Include the 

following statement on the label mounting sheet: “For domestic use as directed by 

APHIS in the event of a foreign animal disease outbreak.”
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 An Equal Opportunity Provider and Employer

VI. IMPLEMENTATION/APPLICABILITY

A. Applicability

The Single Label Claim rule applies to USDA-licensed vaccines, bacterins, toxoids, and 

immunomodulators. The Labeling and Packaging rule applies to all USDA-licensed 

products. Exceptions to both rules may be made for Export-Only labeling (see section 

IV.H).

B. Implementation

The Single Label Claim rule was effective September 8, 2015, with a 4-year 

implementation period. The Labeling and Packaging rule became effective 

October 31, 2016, with immediate implementation. APHIS delayed implementing the 

Single Label Claim rule until publication of the Labeling and Packaging rule, to minimize 

the number of individual label revisions. Thus, implementation of the Single Label Claim 

rule extends through October 31, 2020. Approximately 25 percent of labeling should be 

updated each year, 2017 through 2020.

1. If labels approved before November 2016 do not need to be replaced, or if they 

only require codified “minor” changes (9 CFR 112.5(d)), changes related to the 

Labeling and Packaging rule may be delayed until the product is scheduled for 

conversion to single-label claim language, according to the 4-year schedule. This 

prevents doing two major revisions to labeling when two would not otherwise be 

needed. Single-label claim language may not be added to labels until supporting 

efficacy and safety study summaries have been filed with APHIS to be posted on 

productdata.aphis.usda.gov. 

Licensees and permittees will be allowed a similar 4-year schedule to convert 

labeling for products outside the scope of the Single Label Claim rule if existing 

labeling does not require change (or only codified minor change) before the 

scheduled conversion date.

2. If labels approved before November 2016 require replacement for reasons other 

than codified minor changes, APHIS expects replacement labels to comply with 

the Labeling and Packaging rule, even if labeling for the product is not yet 

scheduled for conversion to comply with the Single Label Claim rule. In this case, 

the labeling will require at least two revisions anyway, so there is no reason to 

delay making changes due to the Labeling and Packaging rule. 

APHIS expects labeling for products not within the scope of the Single Label 

Claim rule to comply with the Labeling and Packaging rule when submitting 

replacement labels for reasons other than codified minor changes, provided that all 

labeling is converted within the 4-year implementation period. 
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 An Equal Opportunity Provider and Employer

3. Labeling for products licensed before November 2016 not in full compliance with 

both rules will be processed with temporary approval, with a default expiration 

date of October 31, 2020. APHIS reserves the right to reduce the dating for special 

circumstances or for licensees or permittees who are not making acceptable 

progress toward yearly conversion goals.

4. Update corresponding label text in Outlines of Production no later than when 

revised labels are submitted.