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GUIDANCE DOCUMENT

CVM GFI #242 In-Use Stability Studies and Associated Labeling Statements for Multiple-Dose Injectable Animal Drug Products January 2017

Draft

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

Docket Number:
FDA-2016-D-4437
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine

The purpose of in-use stability testing is to establish a period of time during which a multiple-dose drug product may be used while retaining acceptable quality specifications once the container is opened (e.g., after a container has been needle-punctured). For multiple-dose injectable drug products intended for use in humans, there is a volume limit of 30 mL in the multiple-dose container. There is also a 28 day in-use period associated with multiple-dose injectable drug products intended for use in humans unless otherwise labeled, when supported by successful antimicrobial effectiveness testing (AET) per U.S. Pharmacopeial Convention (USP) <51> Antimicrobial Effectiveness Testing. Multiple-dose injectable animal drug products have no volume limit and are often packaged in much larger containers. In addition, some animal species weigh less than humans and, thus, individual doses are often smaller than those used in humans. As such, more punctures and a longer in-use period may be applicable to multiple-dose injectable animal drug products compared with their human counterparts. CVM recommends that all multiple-dose injectable animal drug products have an in-use statement on the labeling. This document serves to provide CVM’s current thinking on how to formulate in-use statements for multiple-dose injectable animal drug products as well as how to design and carry out in-use stability studies to support these in-use statements.


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2016-D-4437.

Questions?

Contact Point
J. Kevin Rice
Center for Veterinary Medicine
Office of New Animal Drug Evaluation
Food and Drug Administration
7500 Standish Place, HFV-140
Rockville, MD 20855
Kevin.Rice@fda.hhs.gov
240-402-0680