Sec. 635.100 Large Volume 
Parenterals (LVPs) for Animal Use 
 
Compliance Policy Guide 
 
Guidance for FDA Staff 
 
This version of the Compliance Policy Guide replaces the version made available May 2015.  
The document has been revised to current CPG formatting standards and reflects minor editorial 
changes. 
 
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 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 No. FDA-
2018-N-2900. 
 
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. 635.100 Large Volume Parenterals (LVPs) for Animal Use 
 
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 
guidance as listed on the title page. 
 
I.  Introduction 
 
The purpose of this compliance policy guide (CPG) is to provide guidance for FDA staff on large 
volume parenterals (LVPs or large volume injections). 
 
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 Agencys guidances means that something is suggested 
or recommended, but not required. 
 
II.  Background 
 
For purposes of this document, large volume parenterals (LVPs or large volume injections) are 
aqueous solutions usually supplied in volumes of 100 ml to 5,000 ml. LVPs are typically used to 
provide fluid replacement therapy to animals. Routes of administration may include intravenous, 
intraperitoneal, or subcutaneous. Some examples of LVPs include solutions containing: 
 
  Sodium bicarbonate 
  Electrolytes 
  Dextrose (glucose) and other sugars 
  Amino acids, peptides and other protein-fractions  
  Vitamins, minerals 
  Dextrans, and other plasma expanders 
 
III.  Policy 
 
LVPs may be considered new animal drugs and considered unsafe under section 512(a)(1) of the 
Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360b(a)(1)) and adulterated 
2  Contains Nonbinding Recommendations 
under section 501(a)(5) of the FD&C Act (21 U.S.C. 351(a)(5)) if marketed in the absence of an 
approved new animal drug application. However, CVM generally does not intend to take action 
against LVPs and those marketing LVPs if all of the following criteria are met and the LVP is 
not otherwise adulterated or misbranded: 
 
Large volume parenterals must be: 
1.  Sterile 
2.  Free of preservatives, unless the LVP is the subject of an approved new animal drug 
application that specifically establishes the safety of and permits use of the preservative 
in that particular product 
3.  Supplied in appropriate volumes to ensure one-time, single-patient use 
4.  Labeled to indicate that: (a) they contain no preservatives, (b) they must be used 
promptly upon opening, and (c) any unused portion should be discarded 
5.  Labeled to clearly indicate concentration of individual ingredients and physiological 
parameters of the solution 
6.  Labeled with the U.S. Federal prescription legend: CAUTION: Federal law restricts this 
drug to use by or on the order of a licensed veterinarian. 
7.  In compliance with other applicable labeling requirements in the FD&C Act and its 
implementing regulations, including 21 CFR Part 201 
8.  Manufactured in accordance with current Good Manufacturing Practices 
9.  Manufactured by an establishment that is registered with FDA in accordance with section 
510 of the FD&C Act (21 U.S.C. 360) 
10. Drug listed with FDA in accordance with section 510 of the FD&C Act (21 U.S.C. 360) 
   
CVM will review labeling and may request batch records to determine compliance with this 
policy. 
 
Issued:  12/01/1982 
Revised:  03/1995; 05/2015; 3/2019 
3