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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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CPG Sec. 665.200 Checklist Labeling for Custom Mixed Medicated Feeds

 

BACKGROUND:
 

Questions often arise regarding the status of "checklist" type labeling for custom mixed medicated feeds. This type of label has been in common use by the medicated feed industry for a number of years. The *Center* has objected to "checklist" labeling that lists multiple drugs, withdrawal periods and other use instructions where the mill intends to *effect* proper labeling by manually check marking the proper entries.

For bulk medicated feeds, 21 CFR 225 allows a placard or other label to be attached to the manufacturer's invoice or allows the invoice to be labeling for these products, provided this labeling bears adequate directions for safe and effective use. The *Center for* Veterinary Medicine does not interpret this as condoning "checklist" labeling of the kind described above for custom mixed medicated feeds. The *Center has considered* that "checklist" labels of the type described above allow too much room for error since multiple entries have to be filled out by hand on an individual basis.


 

POLICY:
 

For custom mixed medicated feed the *Center for* Veterinary Medicine objects to the use of "checklist" type labeling containing multiple items requiring entry of appropriate check marks. However, for a product to be deemed violative solely because of a "checklist" label, it must be shown that an error on the particular label caused the violation(s).

The *Center* does not object to the concept of "checklist" labeling where the label lists a single drug or drug combination and a single withdrawal period or other warning statement with the only checklist variable being drug levels and use instructions as combined entries.

Violations of Sections 501(a)(2)(B) and 502(f)(1) would occur when labeling of this kind is incorrectly checked by the manufacturer.

*Material between asterisks is new or revised*

Issued: 10/1/80
Revised: 3/95