We are proposing to amend the Virus-Serum-Toxin Act regulations regarding the packaging and labeling of veterinary biological products to provide for the use of an abbreviated true name on small final container labeling for veterinary biologics; require labeling to bear a consumer contact telephone number; change the format used to show the establishment or permit number on labeling and require such labeling to show the product code number; change the storage temperature recommended in labeling for veterinary biologics; require vaccination and revaccination recommendations in labeling to be consistent with licensing data; require labeling information placed on carton tray covers to appear on the outside-face of the tray cover; remove the restriction requiring multiple-dose final containers of veterinary biologics to be packaged in individual cartons; require labeling for bovine virus diarrhea vaccine containing modified live virus to bear a statement warning against use in pregnant animals; reduce the number of copies of each finished final container label, carton label, or enclosure required to be submitted for review and approval; require labeling for autogenous biologics to specify the microorganism(s) and/or antigen(s) they contain; and require labeling for conditionally licensed veterinary biologics to bear a statement concerning efficacy and potency requirements. In addition, we also propose to amend the regulations concerning the number of labels or label sketches for experimental products required to be submitted for review and approval, and the recommended storage temperature for veterinary biologics at licensed establishments. These proposed amendments are necessary in order to update and clarify labeling requirements and ensure that information provided in labeling is accurate with regard to the expected performance of the product.
Document Subtype:
Proposed rule
Received Date:
January 13 2011, at 12:00 AM Eastern Standard Time
Start-End Page:
2268 - 2277
Comment Start Date:
January 13 2011, at 12:00 AM Eastern Standard Time
Viruses, Serums, Toxins, and Analogous Products; Packaging and Labeling
Details Information
Comments
View AllSubmitter: Thomas, John Posted: 03/14/2011 ID: APHIS-2008-0008-0005
Mar 14,2011 11:59 PM ET
Submitter: McClure, Kent Posted: 03/15/2011 ID: APHIS-2008-0008-0006
Mar 14,2011 11:59 PM ET
Submitter: McClure, Kent Posted: 03/15/2011 ID: APHIS-2008-0008-0007
Mar 14,2011 11:59 PM ET
Submitter: Gervais, Rebecca Posted: 03/15/2011 ID: APHIS-2008-0008-0008
Mar 14,2011 11:59 PM ET
Submitter: Evans, Tom Posted: 03/14/2011 ID: APHIS-2008-0008-0003
Mar 14,2011 11:59 PM ET
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