Sec. 608.200 Prescription Use 
of Certain Injectable Animal Drugs 
 
Compliance Policy Guide 
 
Guidance for FDA Staff 
 
This version of the Compliance Policy Guide replaces the version made available March 1995.  
This revision of the CPG makes formatting changes and minor editorial changes for 
clarification. 
 
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-3338. 
 
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. 608.200 Prescription Use of Certain Injectable Animal Drugs 
 
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 the approach 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 
prescription legend requirements for certain injectable animal drugs. 
 
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 
 
Section 503(f) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), and title 21, Code of 
Federal Regulations  201.105 (21 CFR 201.105), set forth the conditions for prescription legend 
requirements for animal drugs.  These include such factors as the toxicity or other potentiality for 
harmful effect, or the method of use which necessitates the supervision of a licensed veterinarian 
for safe use.  Adequate directions for safe use of such drugs by laypersons cannot be written.  
Section 503(f)(4) of the FD&C Act recites the veterinary legend caution statement:  Caution:  
Federal law restricts this drug to use by or on the order of a licensed veterinarian.  Other terms 
such as for veterinary use only and for sale to graduate veterinarians are not the prescription 
legend. 
 
There are some animal injectable drugs which cannot be safely used except under the supervision 
of a licensed veterinarian.  These include the following: 
 
a.  All drugs labeled for intravenous (IV) administration in dogs, cats, and other small 
animals; 
b.  All drugs labeled for intra-articular, intrathecal, epidural, paravertebral, subconjunctival, 
and retrobulbar administration in all species; 
2  Contains Nonbinding Recommendations 
c.  All drugs labeled for intraperitoneal administration in horses. 
III.  Policy 
 
Those animal drugs in a., b., and c. above are in violation of section 502(f)(1) of the FD&C Act 
unless they bear the prescription legend statement. 
IV.  Regulatory Action Guidance 
 
If any of the above dosage forms listed in a., b., or c. are marketed without the veterinary 
prescription legend, they bear inadequate directions for use and are in violation of section 
502(f)(1) of the FD&C Act.  For follow up regulatory action, contact the CVM Division of 
Compliance, Post-Market Compliance Team (HFV-232) at 240-402-7001, or email:  
AskCVM@fda.hhs.gov. 
 
 
Issued:  10/1/1980 
Revised:  03/1995; 3/2019 
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