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GUIDANCE DOCUMENT

CVM GFI #264 Standardized Medicated Feed Assay Limits February 2020

Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2019-D-5664
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine

CVM establishes assay limits for drugs in medicated feeds (i.e., Type B and Type C medicated feeds) as part of the approval process for Type A medicated articles. The term “assay limits” refers to how much the measured amount of drug can deviate from the labeled amount of drug. The assay limits for Type B and Type C medicated feeds are specified as a range and published in 21 CFR §558.4(d). When a medicated feed assay value falls within this range using a validated method accepted by CVM, it indicates that the measured drug level in medicated feed is consistent with the labeled drug level. The assay limits are not intended to permit a feed manufacturer to add more or less than the labeled amount of drug to the medicated feed. Assay limits are used pre-approval to ensure that medicated feeds in Target Animal Safety (TAS), Effectiveness (EFF), Chemistry, Manufacturing, and Controls (CMC), Bioequivalence (BE), and Human Food Safety (HFS) residue chemistry studies contain the appropriate amount of drug, and post-approval for compliance and customer service purposes.

This guidance recommends a standardized set of assay limits for medicated feeds. Standardized medicated feed assay limits allow predictability in the review process as sponsors can determine early in the drug development process what assay limits they should expect to meet for medicated feeds used in TAS, EFF, CMC, and HFS residue chemistry studies. 


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-2019-D-5664.

Questions?

Contact Point
Katie Ciesienski
Center for Veterinary Medicine
Food and Drug Administration
7500 Standish Place, HFV-141
Rockville, MD 20855
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