#231 
 
Guidance for Industry 
 
Distributor Labeling for New Animal Drugs 
 
Submit comments on this guidance at any time.  Submit electronic comments to 
http://www.regulations.gov.  Submit written comments to the Division of Dockets Management 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 
20852.  All comments should be identified with the Docket No. FDA-2015-D-3056. 
 
For further information regarding this document, contact Dorothy McAdams, Center for 
Veterinary Medicine, Division of Surveillance (HFV-210), Food and Drug Administration, 7519 
Standish Place, Rockville, MD 20855, 240-402-5763, email: dorothy.mcadams@fda.hhs.gov. 
 
Additional copies of this guidance document may be requested from the Policy and Regulations  
Staff (HFV-6), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish 
Place, Rockville, MD 20855, and may be viewed on the Internet at either 
http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/d
efault.htm  or http://www.regulations.gov. 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Veterinary Medicine 
April 2016 
    Contains Nonbinding Recommendations 
Table of Contents 
 
 
I.  INTRODUCTION................................................................................................................. 3 
II.  BACKGROUND ................................................................................................................... 3 
III.  REGULATORY REQUIREMENTS .............................................................................. 4 
IV.  CONTENT AND FORMAT OF DISTRIBUTOR LABELING ................................... 5 
A.  WORDING AND OTHER CONTENT ......................................................................................... 6 
B.  FONT .................................................................................................................................... 6 
C.  GRAPHICS AND COLOR......................................................................................................... 7 
D.  PROPRIETARY AND ESTABLISHED NAMES ............................................................................ 7 
E.  CONTACT INFORMATION ...................................................................................................... 7 
F.  NATIONAL DRUG CODE (NDC) NUMBERS ........................................................................... 7 
G.  OTHER LABELING REQUIREMENTS ...................................................................................... 7 
V.  ADVISORY REVIEW PRIOR TO INITIAL DISTRIBUTION ..................................... 8 
 
   
2  Contains Nonbinding Recommendations 
Guidance for Industry 
 
Distributor Labeling for New Animal Drugs 
 
This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on 
this topic.  It does not establish any rights for any person and is not binding on FDA or the public.  You 
can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.  
To discuss an alternative approach, contact the FDA office responsible for this guidance as listed on the 
title page. 
 
I.  INTRODUCTION 
 
This guidance describes FDAs current thinking with respect to the factors it considers in 
determining whether to take regulatory action against distributor labeling for new animal drugs 
that differs from the labeling approved as part of a New Animal Drug Application or 
Abbreviated New Animal Drug Application (NADA/ANADA) in ways other than those 
permitted in 21 CFR 514.80. 
 
In general, FDAs guidance documents do not establish legally enforceable responsibilities.  
Instead, guidances describe the Agencys current thinking on a topic and should be viewed only 
as recommendations, unless specific regulatory or statutory requirements are cited.  The use of 
the word should in Agencys guidances means that something is suggested or recommended, but 
not required. 
 
II.  BACKGROUND 
 
Distributor labeling refers to the labeling1 of an approved new animal drug marketed by a 
distributor2 who distributes the product under its own labeling rather than the approved labeling.  
Unlike the approved labeling, which CVM reviews as part of NADA/ANADA approval process 
to ensure the safe and effective use of the drug and compliance with the Federal Food, Drug, and 
Cosmetic Act (FD&C Act) and its implementing regulations, distributor labeling does not 
ordinarily go through a pre-market approval process. 
 
                                                 
1Under section 201(m) of the FD&C Act, the term labeling means all labels and other written, printed, or graphic 
matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such article. In this document, 
the discussion of labeling is limited to immediate container labels, secondary container or carton labeling, all 
inserts (and outserts), Client Information Sheets (CIS) and other product packaging approved as part of the 
NADA/ANADA. 
2 For the purpose of this document, distributor means any person whose name or other identifying information 
appears on the label and who sells, offers to sell, delivers, or offers to deliver a new animal drug product to any 
recipient (e.g., another distributor, an individual person, a veterinary practitioner, or a veterinary hospital). However, 
no person shall be considered a distributor solely because their name appears on the label placed on the immediate 
container of the drug when it is dispensed as described in section 503(f)(2)(B) of the FD&C Act, 21 U.S.C. 
353(f)(2)(B). 
3  Contains Nonbinding Recommendations 
FDA regulations require that distributor labeling be identical to the labeling approved in the 
NADA/ANADA, except for a different and suitable proprietary name, if used, and the name and 
address of the distributor preceded by an appropriate qualifying phrase. See 21 CFR 
514.80(b)(5)(iii)(A)(1).  These requirements are meant to ensure that distributor labeling 
complies with the requirements of the FD&C Act and its implementing regulations and to 
prevent distributor label products from reaching the market with labeling that compromises the 
safe and effective use of the new animal drug. 
 
If distributor labeling differs from the labeling approved in the NADA/ANADA in ways other 
than those permitted in 21 CFR 514.80, these differences may misbrand the product under 
section 502 of the FD&C Act and adulterate the product under section 501 of the FD&C Act. 
 
It has become a common practice for distributors to develop labeling for purposes of branding 
that differs from the approved labeling with respect to font, color, and graphics.  Such 
differences do not necessarily undermine public health, animal health, or the approval process  
particularly when the differences are not false or misleading and do not decrease readability, 
alter the meaning, or otherwise inhibit the safe and effective use of the drug.  This guidance 
describes FDAs current thinking with respect to factors it will consider in determining whether 
to take enforcement action against distributor labeling that differs from the approved labeling. 
 
III.  REGULATORY REQUIREMENTS 
 
FDA regulations require applicants3 to submit distributor labeling to CVM at the time of initial 
distribution of a distributor label product.  Specifically, under 21 CFR 514.80(b)(5)(iii), 
applicants must submit a special drug experience report accompanied by a completed Form FDA 
2301 containing the distributor's current product labeling and a signed statement by the 
distributor. 
 
Under 21 CFR 514.80(b)(5)(iii)(B), the distributors statement must state the following: 
 
(1) The category of the distributor's operations (e.g., wholesale or retail), 
(2) That the distributor will distribute the new animal drug only under the approved 
labeling, 
(3) That the distributor will promote the product only for use under the conditions stated 
in the approved labeling, 
(4) That the distributor will adhere to the records and reports requirements of this section, 
and 
(5) That the distributor is regularly and lawfully engaged in the distribution or dispensing 
of prescription products if the product is a prescription new animal drug. 21 CFR 
514.80(b)(5)(iii)(B). 
 
The regulations at 21 CFR 514.80 also have requirements for the content of distributor labeling.  
Specifically, they require the following: 
                                                 
3 Applicant means a person or entity who owns or holds on behalf of the owner the approval for an NADA or 
ANADA, and is responsible for compliance with applicable provisions of the act and regulations. 21 CFR 514.3. 
4  Contains Nonbinding Recommendations 
 
(1) The distributor's labeling must be identical to that in the approved NADA/ANADA 
except for a different and suitable proprietary name (if used) and the name and address of 
the distributor. The name and address of the distributor must be preceded by an 
appropriate qualifying phrase as permitted by the regulations such as manufactured for 
or distributed by. 
(2) Other labeling changes must be the subject of a supplemental NADA or ANADA as 
described under 514.8. 21 CFR 514.80(b)(5)(iii)(A). 
 
The applicants submission of distributor labeling to FDA at the time of initial distribution must 
include all labeling components required by FDA to accompany the product.  For example, if the 
approved labeling for a new animal drug product includes labeling such as a secondary container 
or a client information sheet, the distributor labeling must also include these components and this 
labeling must be submitted to FDA. See 21 CFR 514.80(b)(5)(iii)(A). 
 
In addition to the requirements of 21 CFR 514.80, the provisions of the FD&C Act and its other 
implementing regulations for new animal drug labeling and proprietary names apply to 
distributor labeling.  Under 21 CFR 201.1(h)(5), qualifying phrases that are permitted before the 
distributors name and address as required by 514.80(b)(5)(iii)(A)(1) are limited to: 
 
Manufactured for _____, Distributed by _____, Manufactured by_____ for _____, 
Manufactured for _____by_____, Distributor:_____, Marketed by_____. 
 
FDA regulations request but do not require that NDC numbers appear on all drug labels and in 
all drug labeling.  21 CFR 201.2.  NDC numbers uniquely identify the particular product and 
firm marketing the product.  Therefore, distributor labeling should not include the NDC number 
that appears in the approved product labeling.  Rather, distributor labeling should include only 
the unique NDC number assigned to that particular distributor drug product.  If a distributor label 
does include the NDC number assigned to that particular distributor drug product, the NDC 
number must be placed on the label as specified in 21 CFR 207.35(b)(3). 
 
In addition, 21 CFR 201.10(g)(2) requires that on all drug labeling, the established name be 
printed in letters that are at least half the size of the proprietary name. 
 
IV.  CONTENT AND FORMAT OF DISTRIBUTOR LABELING 
 
As discussed above, 21 CFR 514.80 requires distributor labeling to be identical to the labeling in 
the approved NADA/ANADA except for a different and suitable proprietary name, if used, and 
the name and address of the distributor preceded by an appropriate qualifying phrase as 
permitted by 21 CFR 201.1(h)(5), such as manufactured for or distributed by.  However, as 
discussed below, CVM is less concerned about differences from the approved labeling with 
respect to font, color, and graphics unless such differences decrease readability, are false or 
misleading, alter the meaning, or otherwise inhibit the safe and effective use of the drug. 
 
   
5  Contains Nonbinding Recommendations 
In addition, CVM encourages distributor labeling to include the following statement on how to 
contact FDA for information about reporting side effects, even if the approved labeling does not 
contain such information: For additional information about adverse drug experience reporting 
for animal drugs, contact FDA at 1-888-FDA-VETS, or 
http://www.fda.gov/AnimalVeterinary/SafetyHealth. 
 
CVM is less likely to initiate regulatory action against distributor labeling when all of the 
following factors are present: 
 
A.  Wording and Other Content 
 
  The distributor labeling uses the same wording and other content, including but 
not limited to dosage charts, boxes, and compressed arrows, in their entirety and 
in the same order and location as on the approved labeling.  For example, wording 
and content from the front or primary display panel of a secondary container of 
the approved labeling appears in its entirety and in the same order on the front or 
primary display panel of a secondary container for the distributor labeling. 
 
B.  Font 
 
  If the distributor labeling uses different font type, size or color than the approved 
labeling, and such differences: 
  do not alter the emphasis or meaning of a label statement;  
o
  do not adversely affect the ability of the user to read and understand the 
o
labeling; and 
  maintain the same relative prominence and emphasis as that used on the 
o
approved labeling. 
 
For example, if the font size of a statement on the approved labeling is 50% larger 
than the font size of other statements on the labeling, the font size of this 
statement on the distributor labeling is also 50% larger than that of other 
statements on the distributor labeling. 
 
  The distributor labeling uses bolding, italicizing and other formatting effects for 
text, charts, boxes, etc., that have the same relative prominence and emphasis as 
that used on the approved labeling.  For example, text that is bolded, italicized, or 
otherwise differentiated on the approved labeling is also bolded, italicized, or 
otherwise differentiated on the distributor labeling. 
 
   
6  Contains Nonbinding Recommendations 
C.  Graphics and Color 
 
  If the distributor labeling uses different graphics and color other than the 
approved labeling, such differences: 
 
  are not false or misleading and do not otherwise suggest that the drug is safer, 
o
more effective, or useful in a broader range of conditions than those approved 
in the application; 
  do not adversely affect the readers ability to read and understand the labeling; 
o
and 
  do not distract the reader from information on the approved labeling. 
o
 
D.  Proprietary and Established Names 
 
  If the distributor labeling uses a different proprietary name than the one used in 
the approved labeling, the proprietary name used is suitable, as required by 21 
CFR 514.80(b)(5)(iii)(A)(1). 
 
  The established name is at least half the size of the proprietary name, as required 
by 21 CFR 201.10(g)(2). 
 
E.  Contact Information 
 
  The distributor labeling includes the distributors name and the address of its 
place of business, as required by 21 CFR 514.80(b)(5)(iii)(A)(1). 
 
  If the approved labeling includes information providing access to technical 
support and adverse drug experience (ADE) reporting, the distributor labeling 
also includes information providing such access. For example, if the approved 
labeling includes a telephone number to call for assistance, the distributor labeling 
also includes a telephone number to call for assistance. 
 
F.  National Drug Code (NDC) Numbers 
 
  If the distributor labeling includes an NDC number, it is the unique NDC number 
assigned to that particular distributor drug product, and not the NDC number that 
appears on the approved product labeling. 
 
  If the distributor labeling includes the unique NDC number assigned to that 
particular distributor drug product, the NDC number is placed on the label as 
required by 21 CFR 207.35(b)(3). 
 
G.  Other Labeling Requirements 
 
  The distributor labeling otherwise complies with applicable labeling requirements 
in the FD&C Act and its implementing regulations, including 21 CFR Part 201. 
7  Contains Nonbinding Recommendations 
V.  ADVISORY REVIEW PRIOR TO INITIAL DISTRIBUTION 
 
Applicants may request an advisory review of distributor labeling prior to initial product 
distribution. This may allow the applicant to become aware of potential compliance issues with 
the labeling prior to initial distribution of the product.  For this review, applicants should submit 
a special drug experience report accompanied by a completed Form FDA 2301 and a complete 
set of the distributor labeling.  The submission should be identified as Request for Pre-
dissemination Review and submitted at least 120 days prior to initial product distribution.  
Following review, CVM will respond to the applicant with comments explaining potential 
concerns CVM has regarding the labeling. 
 
A submission requesting advisory review will not replace the requirement to submit a distributor 
statement as described in 21 CFR 514.80(b)(5)(iii). 
8