Sec. 665.300 Use of Type A Medicated 
Article Proprietary Names in the 
Names of Medicated Feeds 
 
Compliance Policy Guide 
 
Guidance for FDA Staff 
 
This version of the Compliance Policy Guide replaces the version made available June 1986.  
The document has been revised to current CPG formatting standards, update contact 
information, and clarify existing language. 
 
Additional copies are available from: 
Policy and Regulations Staff (HFV-6) 
Center for Veterinary Medicine 
Food and Drug Administration 
7500 Standish Place 
Rockville, MD 20855 
https://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/default.htm 
 
 
Submit either electronic or written comments on this compliance policy guide (CPG) 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 docket number FDA-2018-
N-3189. 
 
For further information regarding this document, contact AskCVM@fda.hhs.gov. 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Office of Regulatory Affairs 
and 
Center for Veterinary Medicine 
 
March 2019 Contains Nonbinding Recommendations 
Sec. 665.300 Use of Type A Medicated 
Article Proprietary Names in the 
Names of Medicated Feeds 
 
Compliance Policy Guide 
 
Guidance for FDA Staff  
 
This compliance policy guide represents the current thinking of the Food and Drug Administration (FDA) 
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 compliance policy guide 
as listed on the title page. 
 
I.  Introduction 
 
The purpose of this compliance policy guide (CPG) is to provide guidance for FDA staff on the 
inclusion of proprietary names (i.e., brand or trade name) of Type A medicated articles in the 
names of medicated feeds. 
 
In general, FDAs guidance documents, including this CPG, do not establish legally enforceable 
responsibilities.  Instead, they describe the Agencys current thinking on various topics 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.  Background 
 
In this CPG, the term proprietary name refers to the trademark or brand name of a drug 
product.  The proprietary name is the exclusive name of a drug product owned by a 
company under trademark law regardless of registration status with the United States Patent 
and Trademark Office.  To identify the source of the new animal drug used in a medicated 
feed, a medicated feed manufacturer may choose to include the proprietary name of the Type 
A medicated article in the name of the medicated feed manufactured from the Type A 
medicated article. 
 
III.  Policy 
 
When the Type A medicated article proprietary name is included in the name of the 
medicated feed, the medicated feed labeling should include the name of the active 
ingredient(s), i.e., drug product.  The proprietary name may only be used in the product 
name in a manner which is not misleading in any particular.  To minimize the potential for 
confusion, the numerical part of the proprietary name, if any, should not be included in the 
2  Contains Nonbinding Recommendations 
name of the medicated feed because a numerical part of a Type A medicated articles 
proprietary name could be interpreted as a drug concentration in the feed. 
The proprietary name of the Type A medicated article is confined to the use in the name of 
the medicated feed and should not be used in place of the required label statement of active 
ingredients or in any other listing of ingredients or in any statement of guaranteed analysis.  
Any other use of the Type A medicated article proprietary name elsewhere on the labeling 
must adhere to the use on the applicable representative (i.e., Blue Bird) label for the feed 
(see the Federal Food, Drug, and Cosmetic Act, section 512(a)(1)(A) (21 U.S.C. 
360b(a)(1)(A))). 
This policy is consistent with the Model Regulations under the Model Bill, and the labeling 
guidelines adopted by the Association of American Feed Control Officials (AAFCO), as set 
forth in their Official Publication and enacted into law by most states. 
Issued: 10/1/80 
Revised: 6/1/86;3/12/19 
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