#240 
 
Proprietary Names for New Animal 
Drugs 
 
Guidance for Industry 
 
Submit comments on this guidance at any time.  Submit  electronic comments to 
https://www.regulations.gov.   Submit written comments to the Dockets Management Staff (HFA-
305), Food and Drug Administration,  5630 Fishers Lane, Rm. 1061, Rockville,  MD 20852.  All 
comments should be identified with the docket number FDA-2018-D-0626. 
 
For questions regarding this document, contact AskCVM@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,  7500 Standish 
Place, Rockville,  MD 20855, and may be viewed on the Internet at either  
https://www.fda.gov/animal-veterinary  or https://www.regulations.gov. 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Veterinary Medicine (CVM) 
May 2020    Contains Nonbinding  Recommendations 
 
 
Table of Contents 
 
I.  INTRODUCTION ........................................................................................................ 3 
II.  REGULATORY AUTHORITY ................................................................................... 3 
III.  DEFINITIONS ............................................................................................................. 4 
IV.  BACKGROUND .......................................................................................................... 5 
V.  NAMING ATTRIBUTES THAT MAY MISBRAND THE PRODUCT...................... 6 
A.  Similarities in Spelling and Pronunciation ................................................................ 6 
B.  Inert or Inactive Ingredients ...................................................................................... 7 
C.  Products with Multiple Active Ingredients.................................................................. 7 
D.  United States Adopted Names (USAN) Council Stems................................................ 7 
E.  Reuse of Proprietary Names ...................................................................................... 8 
F.  Names That Include Reference to Product-Specific Attributes ................................... 8 
G.  Dosing Interval .......................................................................................................... 9 
H.  Modifiers as Components of a Proprietary Name ....................................................... 9 
I.  Family Trade Names ............................................................................................... 12 
J.  Brand Name Extension............................................................................................ 13 
K.  Proprietary Names of Drug Products Marketed Outside the US ............................... 13 
L.  Use of Symbols ........................................................................................................ 14 
M.  Other Ways a Proprietary Name May Misbrand a Product....................................... 14 
VI.  SUBMISSION OF REQUEST FOR EVALUATION OF PROPOSED 
PROPRIETARY NAMES FOR APPROVED LABELING OF NEW ANIMAL 
DRUGS....................................................................................................................... 14 
A.  When to submit a proprietary name for review ......................................................... 14 
B.  What to submit......................................................................................................... 14 
C.  Where to submit....................................................................................................... 15 
D.  Final assessment before new animal drug approval ................................................. 15 
VII. SUBMISSION OF REQUEST FOR EVALUATION OF PROPOSED 
PROPRIETARY NAMES FOR DISTRIBUTOR PRODUCT LABELING OF NEW 
ANIMAL DRUGS ...................................................................................................... 15 
A.  When to submit a distributor product proprietary name for review ........................... 15 
B.  What to submit......................................................................................................... 16 
C.  Where to submit....................................................................................................... 16 
VIII.  APPENDIX........................................................................................................... 17 
Screening Checklist for Proposed Proprietary Name ....................................................... 17 
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  Contains Nonbinding Recommendations 
 
Proprietary Names for New Animal  Drugs 
 
Guidance for Industry 
 
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 staff responsible for 
this guidance as listed on the title page. 
 
I.  INTRODUCTION 
 
This guidance provides recommendations to help new animal drug sponsors (you) develop 
proprietary names1 that do not contribute to medication errors, negatively impact safe use of the 
drug, or misbrand the drug.  This guidance provides a framework for evaluating proposed 
proprietary names before submitting  them for review by the Center for Veterinary Medicine (CVM 
or we).  It also explains how you can request that CVM evaluate a proposed proprietary name.  This 
guidance does not address the established names of animal drugs.  This guidance does not apply to 
heritable intentional  genomic alterations in animals. 
 
In general, FDAs guidance documents do not establish legally  enforceable responsibilities.   Instead, 
guidances describe FDAs 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 Agency guidances means that something is suggested or recommended, but not 
required.  
 
II.  REGULATORY AUTHORITY 
 
Proprietary names are used in a products labeling,  including  promotional  labeling.   A drugs 
labeling  is often a key element in FDA oversight.  For example, under section 502(a) of the Federal 
Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 352(a)), a drug is misbranded if its labeling 
(including  labels) is false or misleading  in any particular.  A drug products labeling  can be 
misleading  because of the representations it makes, or because it omits material facts about possible 
consequences of using of the drug as intended.  See section 201(n) of the FD&C Act (21 U.S.C. 
321(n)).  The Code of Federal Regulations (CFR) also describes some of the ways that the 
proprietary name of a drug can make its labeling  misleading.   See 21 CFR 201.6(b) and 21 CFR 
201.10(c).  In addition,  labeling  is relevant to determining  whether a drug is, for example, a new 
animal drug under section 201(v) of the FD&C Act (21 U.S.C. 321(v)), for which premarket 
approval is required (see section 512(a) of the FD&C Act (21 U.S.C. 360b(a)). 
 
 
                                              
1 Terms that initially appear in bold are defined in section III. Definitions. 
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  Contains Nonbinding Recommendations 
 
 
III.  DEFINITIONS 
 
The following  terms are described as they are used in this guidance only: 
 
Brand name extension: FDA uses the term brand name extension to refer to a naming practice that 
uses a proprietary name that is already associated with one or more marketed drug products, with or 
without a modifier,  for a product that does not share any active ingredient(s)  or active moiety(ies) 
with the marketed product(s). 
 
End user: The term end user includes, but is not limited  to, the prescribing veterinarian, veterinary 
technician, farmers, animal owners, pharmacist, pharmacy technician, and other individuals  who are 
involved  in routine procurement, stocking,  storage, and administration  of medications. 
 
Established name: Section 502(e)(3) of the FD&C Act (21 U.S.C. 352(e)(3)) states that: The term 
established name, with respect to a drug or ingredient  thereof, means (A) the applicable official 
name designated pursuant to section 508, or (B) if there is no such name and such drug, or such 
ingredient,  is an article recognized in an official compendium,  then the official title thereof in such 
compendium,  or (C) if neither clause (A) or clause (B) of this subparagraph applies, then the 
common or usual name, if any of such drug or such ingredient,  except that where clause (B) of this 
subparagraph applies to an article recognized in the United States Pharmacopeia and in the 
Homeopathic Pharmacopoeia under different official titles, the official title used in the United States 
Pharmacopeia shall apply unless it is labeled and offered for sale as a homeopathic  drug, in which 
case the official title used in the Homeopathic Pharmacopoeia shall apply.2  
 
Family Trade Name: A family trade name results from a naming practice involving  the use of a 
shared proprietary name to market multiple  products with a shared active ingredient,  using a suffix 
or modifier,  to distinguish  the products from one another.  This practice is also referred to as family 
branding. 
 
Label: As defined in section 201(k) of the FD&C Act (21 U.S.C. 321(k)), the term label means a 
display of written, printed, or graphic matter upon the immediate container of any article.  If any 
word, statement, or other information  is required by the FD&C Act to appear on the label, it must 
appear on the outside container or wrapper, if there is one, or be easily legible  through the outside 
container or wrapper. 
 
Labeling: As defined in 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. 
 
                                              
2 The term official compendium is defined in section 201(j) of the FD&C Act. 
 
 
 
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Medication Error: A medication error is any preventable event that may cause or lead to 
inappropriate  medication use or patient harm while the medication  is in the control of the health care 
professional or consumer.3  
 
Modifier: A modifier is a portion of the proprietary name.  Some proprietary names are constructed 
of a root proprietary name and added word(s) or other components.  These added words or other 
components are the modifier  portion of the proprietary name.  The modifier  portion of a proprietary 
name might be a letter, number, word, device name, or combination  of letters, numbers, and words 
attached to the beginning,  middle,  or end of a root proprietary name. 
 
Proprietary name: The proprietary name of a drug product is its brand name.4 
 
Root proprietary name: Some proprietary names are constructed of multiple  components.  When a 
proprietary name contains a modifier as one of the components, the non-modifier  portion of the 
proprietary name is referred to as the root proprietary name.  For example, in the proprietary names, 
Drugname, Drugname ER, and Drugname for Cats, the word Drugname is the root 
proprietary name, while ER and for Cats are modifiers. 
 
IV.  BACKGROUND 
 
CVM evaluates proprietary names as a part of the new animal drug approval process.  Selecting a 
proprietary name is a critical element in the design and development of drug product labeling 
because end users may rely, in part, on the proprietary name to identify which product, among 
thousands of available products, is intended for a given animal.  For this reason, accurate 
identification  by the end user is essential.  If end users cannot readily distinguish  among proprietary 
names, the animal may receive the wrong product or it may not be possible to correctly identify the 
product used. 
 
One aspect of CVMs review of proprietary names for new animal drugs focuses on the avoidance 
of medication  errors.  Examples of medication errors include incorrect drug selection, incorrect 
dosage or route of administration,  or use in unintended species or classes.  These types of errors may 
cause animal injury or a lack of drug effectiveness, which could contribute to outcomes like 
complication  of a disease and possible death of an animal.  Medication errors in food-producing 
animals may result in drug residues in edible tissues (including  milk or eggs) that may cause residue 
violations  for livestock owners, and may result in potentially  unsafe food for consumers. 
 
CVM considers whether the name can cause confusion or otherwise contribute to medication errors.  
The medication use system for animal drugs in the United States (US) generally includes the 
following  phases: selection and procurement, ordering or prescribing,  order processing, dispensing, 
and administration.   Opportunities  for medication errors arise in each of these phases. 
                                              
3 See the National Coordinating Council for Medication Error Reporting and Prevention; 
http://www.nccmerp.org/about- medication-errors. 
4 Sometimes referred to as the products trade name. 
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  Contains Nonbinding Recommendations 
 
 
CVM also considers the entire medication  use system when evaluating the potential  of proprietary 
names to cause confusion and medication error.  This includes the specific environment  in which the 
product will be used (i.e., clinic, barn, home, etc.), the veterinary prescriber population,  and/or the 
knowledge and experience of the animal owner or animal caretaker who will be administering  the 
drug.  For example, for a product expected to be used exclusively  in beef cattle by beef cattle 
producers, the proprietary name review will consider a potential for confusion with other products 
used by beef cattle producers. 
 
Additionally,  CVM will compare the proposed proprietary name to other proposed proprietary 
names submitted to FDA for products not yet approved.  Such proposed names are often 
confidential;  therefore, it is possible that CVM may identify conflicts with pending products of 
which the sponsors or public is not aware.5  
 
CVM may object to a proposed name if it may misbrand the product for reasons not solely related to 
medication error prevention.  Among other things, the FD&C Act provides that a drug or device 
shall be deemed misbranded if its labeling  is false or misleading  in any particular (section 502(a) of 
the FD&C Act).  Labeling may be misleading,  for example, if it employs a fanciful proprietary 
name that suggests that a drug has some unique effectiveness or composition  when it does not, or 
makes misrepresentations with respect to safety or effectiveness (see 21 CFR 201.10(c)(3)). 
 
Distributor  product labeling  is not required to be reviewed and approved by FDA prior to 
distribution.   Nevertheless, distributor  products are subject to the provisions  of 21 CFR 
514.80(b)(5)(iii),  and so the principles  laid out in this guidance are applicable to proprietary names 
of distributor  products.  Distributor  products deemed misbranded are subject to the same sanctions 
applicable to any misbranded new animal drug. 
 
V.  NAMING ATTRIBUTES THAT MAY MISBRAND THE PRODUCT 
 
This section identifies attributes of proprietary names that may misbrand a new animal drug product.  
We recommend that you evaluate proposed proprietary names for these attributes.  The appendix 
provides a checklist to aid in the assessment of proposed proprietary names and provides FDAs 
thinking  with respect to each of these attributes. 
 
A.  Similarities in Spelling and Pronunciation 
 
Proprietary names that look alike or sound alike can increase the risk of medication errors 
when selecting, prescribing,  dispensing,  or administering  the product.  Generally,  proprietary 
names should not be similar in spelling  or pronunciation  to other proprietary names, 
                                              
5 Proposed names may be associated with drug products subject to (generic) investigational new animal drug ((J)INAD) 
files, (abbreviated) new animal drug applications ((A)NADA), investigational new drug applications (INDs), new drug 
applications (NDAs), biologics license applications (BLAs), or abbreviated new drug applications (ANDAs).  In those 
instances when a conflict is identified with a proposed proprietary name of a pending drug application, FDA will 
generally accept the proposed name of whichever application is approved first and notify the other applicant that they 
must seek a new name. 
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  Contains Nonbinding Recommendations 
 
established names, or ingredients  of other animal or human drug products.  FDA may 
consider a proposed proprietary name to be misleading  if it may be confused with the 
proprietary name or the established name of a different drug or ingredient  because of similar 
spelling  or pronunciation  (see 21 CFR 201.10(c)(5)). 
 
Proprietary names also should not incorporate the sponsors name or a part of the sponsors 
name across multiple  products (e.g., SponsorName X, SponsorName Y, SponsorName 
Z).  This practice can result in creating multiple  similar proprietary names, which may 
increase the risk of confusion among the products.  Confusion may occur when such 
products are stored alphabetically  in distributor  or pharmacy locations or when products are 
ordered from alphabetized  lists.6.7,8 
 
B.  Inert or Inactive Ingredients 
 
Proprietary names should not incorporate any reference to an inert or inactive ingredient  in a 
way that creates an impression  that the ingredients  value is greater than its true functional 
role in the formulation because such names may be misleading  (see 21 CFR 201.10(c)(4)). 
 
C.  Products with Multiple Active Ingredients 
 
Proprietary names of drug products that contain more than one active ingredient  should not 
include or suggest the name of one or more, but not all, of its active ingredients  (see 21 CFR 
201.6(b)).  Such names can mislead the end user by implying  that the product contains only 
the ingredient(s) included  in the name.  (See section 201(n) of the FD&C Act). 
 
D.  United States Adopted Names (USAN) Council Stems 
 
Proprietary names should not incorporate United States Adopted Name (USAN) stems in the 
position  that the USAN Council designates for the stem.  The USAN Council is generally 
responsible for selecting simple,  informative,  and unique established names for drug 
substances.  USAN stems are standardized syllables within established names that relate new 
chemical entities to existing  drug families and are intended to indicate a pharmacological  or 
chemical trait of a drug.  For example, the stem cillin is used for penicillins,  such as 
ampicillin,  and the stem inib is used for kinase inhibitors,  such as oclacitinib.   A single 
stem may be applicable to multiple  drug products.  Stems may appear at the beginning, 
                                              
6 Lambert, BL, S-J Lin, K-Y Chang et al., 1999, Similarity as a risk factor in drug-name confusion errors: The look-alike 
(orthographic) and sound-alike (phonetic) model, Medical Care, 37(12):12141225.  
7 Shah, MB, L Merchant, IZ Chan et al., Characteristics that may help in the identification of potentially confusing 
proprietary drug names, Therapeutic Innovation and Regulatory Science, 51(2): September 2016. 
8IOM, 2006, Preventing Medication Errors, Institute of Medicine, National Academies Press: Washington, DC, 2000, 
Chapter 6, Recommendation 4, p. 274. pp. 281-282.  
 
 
 
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middle,  or the end of the established name.  Each stem can emphasize a specific chemical 
structure type, a pharmacologic  property, or a combination  of these attributes. 
 
Use of these stems in the position  designated by USAN within proprietary names, even when 
such use is consistent with the USAN meaning, can result in the creation of multiple  similar 
proprietary names and/or proprietary names that are similar  to established names, leading to 
an increased risk of medication errors because of name confusion.  You should screen 
proposed proprietary names against the stem list created by the USAN Council to ensure a 
USAN stem is not present in the stem position  in the proprietary name.9  
 
In rare circumstances, it might be acceptable to include a USAN stem in the USAN-
designated position  within the proposed proprietary name.  Such circumstances could arise if 
the proposed name includes a word that can only be spelled in the English language using a 
stem in the position  designated by USAN.  For example, if a proposed proprietary name 
includes the word congestion,  the use of the letters gest, which are the USAN stem, is 
unavoidable. 
 
E.  Reuse of Proprietary Names 
 
You should not reuse the proprietary name of a discontinued  product when marketing a 
different drug because there is a risk that users may continue to associate the name with the 
original  discontinued  product.10  Proprietary names associated with discontinued  drug 
products also may continue to appear in drug product reference texts for extended periods of 
time. 
 
F.  Names That Include Reference to Product-Specific Attributes 
 
We recommend that you avoid incorporating  product-specific attributes, such as 
manufacturing characteristics (e.g., DrugnameLyophylized),  dosage form (e.g., 
DrugnameTabs), or route of administration  (e.g., DrugnameOral) as part of the proposed 
proprietary name.  Including  references to product-specific attributes in the proprietary name 
might be acceptable if the reference to the product-specific attribute is accurate, consistent 
with the approved product labeling, and does not pose additional  risks for medication  error.  
However, when developing  proprietary names that include or make reference to product-
specific attributes, you should also consider that future changes in the product, such as 
changes in dosage form or route of administration  or manufacturing  characteristics, may 
render the original  proprietary name inaccurate. 
 
 
                                              
9 See the list of approved USAN stems, available at http://www.ama-assn.org/ama/pub/physician-resources/medical- 
science/united-states-adopted-names-council/naming-guidelines/approved-stems.page. 
10 See Tu, CM, Taylor, K, and Chai, G. Use of Proprietary Names by Prescribers for Discontinued Brand Drug Products 
With Existing Generic Equivalents. Drug Information Journal, published online August 21, 2012, available at 
http://dij.sagepub.com/content/early/2012/08/21/0092861512456282.full.pdf+html. 
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G.  Dosing Interval 
 
We recommend that you avoid incorporating  the products dosing interval,  such as 
DrugnameQD or DrugnameBID, as part of the proposed proprietary name, even when 
the name accurately reflects the products dosing instructions.  This information  is subject to 
change during the course of application  review and during marketing.  The approval of new 
dosing intervals, formulations,  indications,  or use in different target animal populations  may 
result in the original  proprietary name becoming misleading. 
 
There are circumstances in which it might be appropriate for a proprietary name to include a 
reference to the products dosing interval.  For example, if you market several drug products 
with different dosing intervals, proprietary names that include this information  (such as 
Daily and Monthly)  might help users distinguish  between the products and appropriately 
select and administer the correct drug. 
 
H.  Modifiers as Components of a Proprietary Name 
 
Often, modifiers are included  in a proprietary name to convey distinguishing  product 
characteristics, for example ER might be used for extended-release.  Frequently, multiple 
new animal drug products containing  at least one common active ingredient  within a product 
line are named using a common root proprietary name with various modifiers to 
distinguish  the products from one another. 
 
Inconsistent use of modifiers and the absence of a standardized meaning for such terms can 
be confusing to end users.  End users may understand and interpret modifiers  used in animal 
drug proprietary names in different ways.11.12.13  When users do not readily understand the 
intended meaning of a modifier,  they may make medication errors if they incorrectly select 
and/or use a product.  End users may also omit modifiers when selecting, ordering, or 
prescribing drugs, potentially  leading to medication  errors. 
 
Conversely, the inclusion  of a modifier  can in some cases mitigate the risk of drug 
confusion,  thus enhancing safe use of a drug by aiding in differentiation  between products.  
This may be particularly  true in situations  when two or more drugs have similar proprietary 
names, active ingredients,  or conditions  of use, thereby increasing the potential for product 
confusion.  In those circumstances, inclusion  of an appropriate modifier  may help reduce the 
potential for confusion.  An example is Drugname Horse and Drugname Dog, where 
both drug products contain the same active ingredient,  but in different concentrations for 
different species. 
                                              
11 Pennsylvania Patient Safety Authority. Drug Name Suffix Confusion is a Common Source of Errors. 2004 
Dec;1(4):17-8. 
12 Institute for Safe Medication Practices. ISMP Medication Safety Alert! 2003 Oct;(8)21. 
13 Institute for Safe Medication Practices. ISMP Medication Safety Alert! 2004 Nov;(9)14. 
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If you use a modifier,  its meaning should be generally understood and should not be a source 
of confusion. 
 
The following  considerations  could help you assess the suitability  of using a modifier in a 
proprietary name: 
 
1.  Considerations  for the selection and evaluation of a modifier. 
 
You should consider the following  points carefully when deciding whether to include a 
modifier in a proprietary name and when evaluating  the potential risk of a medication 
error associated with a specific proposed modifier. 
 
a.  Do you currently market one or more products using the proposed root proprietary 
name?  If so, evaluate the similarities  and differences between the proposed product 
and the existing  product(s).  You should consider how to minimize  the risk of 
confusion among the products, especially if the products have overlapping 
characteristics (such as immediate-release and extended-release products with the 
same active ingredient  and dosage strength).  You should also consider the potential 
for product confusion if the modifier is omitted by the prescriber or overlooked 
during dispensing  or administration. 
 
b.  What is the rationale for the proposed modifier?  Is it intended to differentiate the 
proposed product from other products or to convey a characteristic of the proposed 
product?  Does the modifier contribute to safe and effective use of the product?  
Would marketing the proposed product without a modifier or under a different 
proprietary name raise concerns that could be addressed by an effective modifier in 
the proprietary name? 
 
c.  If a proposed modifier describes a product characteristic, does it accurately describe 
the product characteristic? 
 
d.  Where will the modifier be placed in the proprietary name?  What is the rationale for 
this placement? 
 
e.  What is the modifiers intended meaning?  What information is available to support 
that animal health professionals and/or consumers understand this meaning? 
 
f.  Is the proposed modifier  currently used in the marketplace?  We recommend 
checking whether the proposed modifier already is used in the marketplace and 
whether it has been used consistently  with a commonly  recognized meaning.  If an 
existing modifier  with the same intended meaning is in the marketplace and familiar 
to and understood by end users without error, it might be appropriate to adopt the 
existing modifier.  When deciding whether to use a different modifier  instead of an 
existing modifier  with the same intended meaning, you should consider whether the 
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proposed modifier conveys the intended meaning as clearly as, or more clearly than, 
the existing modifier. 
 
g.  Is there a risk that end users could misinterpret  the modifiers intended meaning?  
What is the risk of medication errors if an end user confuses the modifier with some 
other element of a prescription  or order (such as frequency, strength, route of 
administration)?   What is the risk if a user omits a modifier when communicating  a 
drug name? 
 
2.  Specific issues associated with particular types of modifiers. 
 
a.  Numeric Modifiers 
 
CVM generally discourages the use of numbers in proprietary names.  The meaning 
of numbers used as modifiers can be ambiguous and subject to misinterpretation.   
Both Roman and Arabic numerals have been mistaken for the strength, quantity, 
duration, or controlled substance class of prescription drug products.14,15  For 
example, using the number 3 in a proprietary name to represent the product 
strength may be misinterpreted to mean that three tablets are administered or that the 
product should be used for only 3 days when the name appears in a drug order or 
prescription. 
 
The use of numbers in proprietary names may be useful if they help to distinguish  the 
drug from similar  products.  For example, when two products exist with the same or 
similar proprietary names, but different strengths, numbers may enhance the safe use 
of a drug by allowing  users to distinguish  between drugs of various strengths, 
provided that the numbers clearly convey that they relate to the strength of the 
product.  Drugname 10, for a 10 mg tablet, may be confusing because it may not be 
obvious whether the number 10 refers to the strength or to the number of tablets.  In 
contrast, Drugname 10 mg would less likely  be confusing because the unit strength 
provides the context needed to understand the specific meaning. 
 
Numbers may be used in proprietary names of Type A medicated articles16 to 
distinguish  different concentrations of these Type A medicated articles in a product 
line with the same root proprietary name.  If a number is used for this purpose in the 
proprietary name of a Type A medicated article, the number should match the active 
                                              
14 Institute for Safe Medication Practices. Misidentification of alphanumeric characters. ISMP Medication Safety Alert! 
Community/Ambulatory Care Edition. 2014 Jun; (19)11. See https://www.ismp.org/resources/misidentification-
alphanumeric-symbols.  
15 Institute for Safe Medication Practices. ISMP Medication Safety Alert! 2002 Jun;(7)13. 
16 Type A medicated articles are concentrated forms of animal drugs intended solely for further manufacture of other 
approved Type A medicated articles, or Type B or C medicated feeds (21 CFR 558.3(b)(2)).  Type A medicated articles 
cannot be legally fed directly to animals.  They are sold to feed mills or livestock producers and are intended to be 
further diluted by mixing into feed before feeding to animals. 
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ingredient  concentration listed on the Type A label to the same decimal point.  
Furthermore, numbers used in the proprietary names of all Type A medicated articles 
within a product line should be based on the same unit of measure for concentration, 
for example grams per pound (g/lb) or grams per kilogram  (g/kg). 
 
b.  Descriptive Modifiers 
 
Descriptive modifiers are words or abbreviations that describe some aspect of the 
product (e.g., indication,  formulation,  species, or class).  You should consider 
whether descriptive modifiers are ambiguous,  misleading,  or subject to 
misinterpretation.  A primary factor you should consider when evaluating  the 
appropriateness of a modifier associated with a proprietary name is whether the 
modifiers intended meaning is supported by the proposed labeling  and whether it is 
understood by the end user. 
 
c.  Abbreviations  (including  Acronyms and Initials) 
 
Abbreviations  used as modifiers are less likely  to cause confusion if their meaning is 
unequivocal  and they are consistently  and correctly understood by the intended users 
of the product. However, the meaning of some abbreviations  can be ambiguous  and 
subject to misinterpretation.17,18  For example, LA could be interpreted as either 
large animal or long acting.  Also, using abbreviations for indicating  target 
species or class in proprietary names may be ambiguous and thus lead to medication 
errors.  For example, S may be interpreted as referring to swine, sheep, or steer; 
C may be interpreted as referring to cattle, cat, chicken, or canine.  Therefore, these 
abbreviations  should not be used as part of the proprietary name.  If you want to 
include the target species in the proprietary name, the target species should be spelled 
out (e.g., Drugname for Swine). 
 
I.  Family Trade Names 
 
Proprietary names within family trade names are evaluated to consider whether: 
 
  all the products share the same active ingredient(s) contained in the original  marketed 
product 
  the products are differentiated by labeling  (carton and container) 
  the modifier(s) conveys accurate information  about the product  
  the modifier(s) effectively differentiates the product from other products in the 
product line 
                                              
17 The Joint Commissions Official Do Not Use List of Abbreviations, 2016, available at 
https://www.jointcommission.org/facts_about_do_not_use_list/. 
18 The Institute for Safe Medication Practices List of Error-Prone Abbreviations, Symbols, and Dose Designations, 
2015, available at https://www.ismp.org/tools/errorproneabbreviations.pdf. 
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For example, Drugname might be the proprietary name for a tablet containing  active 
ingredient  #1 for treatment of intestinal  worms in dogs.  If you want to expand your product 
line to include active ingredient #1 in a new dosage form for use in swine, Drugname for 
Swine might be acceptable.  However, if you wanted to expand your product line without 
active ingredient #1, the use of the root proprietary name Drugname in the proprietary 
name would be brand name extension which may not be appropriate because it may be 
misleading  (see section V.J. Brand Name Extension).  
 
In some cases, using family trade names has caused confusion when they are used for 
multiple  products without modifiers that adequately differentiate among the products.19,20  
The potential for confusion among products with the same root proprietary name may also 
be reinforced by visual cues created by the use of uniform trade dress and/or store or clinic 
displays that group products by brand name rather than by active ingredients or intended 
uses.  The types of errors that may result from the confusion of family trade names include 
the use of the product for the wrong indication,  the administration  of an unnecessary active 
ingredient,  and the use of a product in the wrong species or class of animals. 
 
J.  Brand Name Extension 
 
Brand name extension should not be used to introduce a new product.  End users familiar 
with an existing  product may, in some cases, strongly equate that products proprietary name 
with the products active ingredients  (or active moieties) and uses.  In some cases, the use of 
the same proprietary name has led to the use of a product for the wrong indication,  in the 
wrong patient population,  at the wrong dose, or in a contraindicated manner.  
 
K.  Proprietary Names of Drug Products Marketed Outside the US 
 
You should not propose a proprietary name that is identical or nearly identical  to that of a 
marketed foreign product that contains a different active ingredient,  even if the proposed 
product will be marketed only in the US.  Medication  errors resulting in dispensing  and 
administration  of the wrong drug may occur when a proprietary name for a product marketed 
in the US is identical  or nearly identical in spelling  and pronunciation,  to a foreign product 
containing  an entirely different active ingredient  marketed in a foreign country.  Identical or 
nearly identical  proprietary names can be identified  with, for example, an Internet search. 
 
Please note that if a proposed proprietary name is already in use in a foreign market, this will 
not necessarily be a justification  for CVM concurrence with use of the same proprietary 
name for the same or similar  product in the US market. 
                                              
19 Institute for Safe Medication Practices, 2010, Maalox Total Relief isnt the same great Maalox, ISMP Med Saf Alert 
Acute Care, 15(4):1-4. 
20 FDA Drug Safety Communication: Product Confusion with Maalox Total Relief and Maalox Liquid Products.  
Available at: https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/fda-drug-safety-
communication-product-confusion-maalox-total-relief-and-maalox-liquid-products.  Accessed 5/20/20. 
13 
 
 
  Contains Nonbinding Recommendations 
L. Use of Symbols
CVM encourages using words (e.g., plus or and) rather than symbols (e.g., + or &) 
to link  components in proprietary names because symbols can be misinterpreted or 
confusing on labeling  or when handwritten (e.g., & can be read as 8). 
M. Other Ways a Proprietary Name May Misbrand a Product
A proprietary name may misbrand a product for reasons not solely related to medication 
error prevention.  A proprietary name could result in such misbranding  if it is false or 
misleading,  such as by making misrepresentations  with respect to safety or effectiveness. 
CVM recommends against using proprietary names that imply comparison to other drug 
products or treatments.  For example, CVM likely  would object to a proposed proprietary 
name that contained best, max, or pro because they imply superiority  over other drugs. 
VI. SUBMISSION OF REQUEST FOR EVALUATION OF PROPOSED PROPRIETARY 
NAMES FOR APPROVED LABELING OF NEW ANIMAL DRUGS
A. When to submit a proprietary name for review
You are encouraged to submit proposed proprietary name(s) of new animal drugs for 
preliminary  review and comment by CVM, early in the product development  process.  The 
preliminary  review will determine if CVM has any concerns about the proposed proprietary 
name based on the information  available at the time of the review. 
If concerns about the proposed proprietary name(s) arise during the preliminary  review, we 
recommend submitting an alternative proposed proprietary name(s) for review prior to 
approval of a new animal drug.  Submitting  proposed proprietary name(s) for preliminary 
review early in the development process may help avoid delays in the new animal drug 
approval process. 
B. What to submit
The request for review of the proprietary name(s) should include the following  information: 
1. The proposed proprietary name(s) and intended pronunciation(s).
2. Product characteristics, such as:
 Established name
 Pharmacological  class
 Target animal and class, if applicable
 Proposed indication(s)
14  Contains Nonbinding Recommendations 
 Proposed dose or frequency of dose
 Route of administration
 Dosage form
 Type A medicated article
3. Any additional  information  that could help in the review (e.g., the derivation  of the
name or the name of the product if approved in another country).
C. Where to submit
Requests for review of proprietary names for new animal drug applications,  including 
generic applications,  should be submitted to the appropriate Division  in the Office of New 
Animal Drug Evaluation  (ONADE) under the appropriate file21 for the drug product.  
Requests for review of proprietary names for indexed products should be submitted to the 
Office of Minor Use and Minor Species (OMUMS). 
D. Final assessment before new animal drug approval
CVM will reassess the proprietary name during the final review of labeling  prior to approval. 
During the final review of the labeling,  CVM determines if there are concerns with the 
proprietary name based on previously  unavailable  information.   Examples include changes 
in the drug product characteristics or the approval of another drug application  in the interim 
with a proprietary name that is similar  in spelling  or pronunciation  to that of the proposed 
drug. 
VII. SUBMISSION OF REQUEST FOR EVALUATION OF PROPOSED PROPRIETARY 
NAMES FOR DISTRIBUTOR PRODUCT LABELING OF NEW ANIMAL DRUGS
A. When to submit a distributor product proprietary name for review
Distributor  product labeling  is required to be submitted at the time of initial  distribution  (see 
21 CFR 514.80).  However, applicants may voluntarily  request an advisory review of the 
distributor  labeling  proprietary names prior to initial  product distribution.  CVM encourages 
applicants to do so in order to avoid the use of a false or misleading  proprietary name. 
To allow adequate time for CVM to review and respond, we recommend requests for 
advisory review of proposed proprietary names for distributor  products be submitted at least 
120 days prior to printing  final distributor  product labeling.   Following  review, CVM will 
respond to the applicant with comments explaining  any identified  proprietary name 
compliance issues.  This allows the applicant to become aware of potential compliance 
issues prior to printing  final distributor  product labeling. 
21 Files include (J)INAD or (A)NADA. 
15  Contains Nonbinding Recommendations 
B. What to submit
For an advisory review of the distributors  product proprietary name, applicants should 
submit a special drug experience report (DER) accompanied by a completed Form FDA 
230122and a complete set of the distributor  labeling.   The submission  should be identified  as 
Request for Pre-dissemination  Review. 
C. Where to submit
Requests for review of proprietary names for distributor  products should be submitted to the 
Division  of Surveillance,  Office of Surveillance  and Compliance,  as a Drug Experience 
Report (DER) accompanied by a completed Form FDA 2301. 
22 You can find this and other FDA forms at https://www.fda.gov/about-fda/forms/animal-drug-forms. 
16  Contains Nonbinding Recommendations 
VIII. APPENDIX
Screening Checklist for Proposed Proprietary Name 
(This checklist does not include all the potential  concerns discussed in this guidance regarding 
selection of an appropriate proprietary name.) 
Answering yes to any of these questions indicates a potential area of concern that should 
be carefully evaluated as described in this guidance. 
Y/N  Is the proposed name obviously  similar in spelling  and pronunciation  to 
other names? 
Proprietary names should not be similar in spelling  or pronunciation  to 
proprietary names, established names, or ingredients of other products. 
Y/N  Are there medical or other abbreviations  in the proprietary name? 
Proprietary names should not incorporate medical abbreviations  (e.g., QD, 
BID, or others commonly  used for prescription  communication)  or 
abbreviations  that have no established meaning. 
Y/N  Are inert or inactive ingredients referenced in the proprietary 
name? 
A drugs labeling  may be misleading  if it incorporates any reference to an inert 
or inactive ingredient  in a manner that creates an impression  that the ingredients 
value is greater than its true functional role in the formulation  (see 21 CFR 
201.10(c)(4)). 
Y/N  Does the proprietary name include combinations  of active ingredients? 
A drugs labeling  may be misleading  if its proprietary name includes or suggests 
the name of one or more, but not all, of its active ingredients (see 21 CFR 
201.6(b)). 
Y/N  Is there a United States Adopted Name (USAN) stem in the proprietary 
name? 
Proprietary names generally should not incorporate a USAN stem in the position 
that USAN Council designates for the stem. 
Y/N  Is this p roprieta ry name us ed f or a nothe r product that does not share at 
least one common active ingredient? 
Drug products that do not contain at least one common active ingredient should 
not use the same (root) proprietary name. 
Y/N  Is this a proprietary name of a discontinued  product? 
Proprietary names should not use the proprietary name of a discontinued 
product. 
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