Large volume parenterals or LVPs (sometimes called large volume injections) are aqueous solutions usually supplied in volumes of at least 100 ml with sizes of 250 ml, 500 ml, 1000 ml, 3000 ml, and 5000 ml most common. Directions usually recommend that large quantities be administered. The usual route of administration is intravenous (IV) but other routes, such as intraperitoneal (IP) or subcutaneous (SQ or SC), are sometimes recommended. Examples of LVPs include:
- Calcium solutions
- Sodium chloride, Ringer's, sodium bicarbonate and other electrolyte solutions
- Dextrose (glucose) and other sugar solutions
- Amino acid, peptide and other protein-fraction solutions
- Solutions containing a combination of the above, sometimes with vitamins added
- Dextrans, and other plasma expanders
All parenterals for animal use including LVPs must be sterile.*
LVPs should be 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.
LVPs should be supplied in container sizes appropriate for their intended use or uses so that the majority of the contents would ordinarily be used promptly following initial entry. Too large a container size relative to intended use would encourage retention of unused contents which could result in microbial contamination of a product containing no preservatives. Labeling of LVPs should clearly indicate the lack of preservatives and should promote use of contents promptly following initial entry and disposal of unused contents. The concentration of individual ingredients should be clearly expressed. If the product is not a compendial item or the physiologic parameters are not otherwise clearly defined, the label should bear an indication of the pH and osmolarity (tonicity) of the solution.
Labeling should in all other respects bear adequate directions for use and not be false or misleading in any particular.
LVPs may be considered new animal drugs and thus LVPs may be 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 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:
- The LVP is sterile.
- The LVP is free of preservatives.
- The LVP is supplied in sizes appropriate to label claims facilitating use of the contents promptly following initial entry.
- The LVP is labeled to indicate that: (a) they contain no preservatives, (b) they are intended for use promptly following initial entry, and (c) any portions not used promptly should be discarded.
- The LVP is labeled to clearly indicate concentration of individual ingredients and physiological parameters of the solution.
- The LVP complies with other applicable labeling requirements in the FD&C Act and its implementing regulations, including 21 CFR Part 201.
- The LVP is manufactured in accordance with current Good Manufacturing Practices.
- The LVP is manufactured by an establishment that is registered with FDA and the LVP is drug listed with FDA in accordance with section 510 of the FD&C Act (21 U.S.C. 360).
CVM will review labeling and batch records to determine compliance with this policy.
Revised: 3/95; 5/15