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Labelling Regulations for Veterinary Biological Products Amended

The U.S. Department of Agriculture’s Animal and Plant Health Inspection Service has amended effective 31 October the Virus-Serum-Toxin Act regulations regarding the packaging and labelling of veterinary biological products. APHIS believes these changes are necessary in order to update and clarify labelling requirements and ensure that information provided in labelling is accurate with regard to the expected performance of the product.

Specifically, the final rule (i) provides for the use of an abbreviated true name on small final container labelling for veterinary biologics; (ii) requires labelling to bear a consumer contact telephone number; (iii) changes the format used to show the establishment or permit number on labelling and requires such labelling to show the product code number; (iv) changes the storage temperature recommended in labelling for veterinary biologics; (v) requires vaccination and revaccination recommendations in labelling to be consistent with licencing data; (vi) requires labelling information placed on carton tray covers to appear on the outside face of the tray cover; (vii) removes the restriction requiring multiple-dose final containers of veterinary biologics to be packaged in individual cartons; (viii) requires labelling for bovine virus diarrhoea vaccine containing modified live virus to bear a statement warning against use in pregnant animals; (ix) reduces the number of copies of each finished final container label, carton label or enclosure required to be submitted for review and approval; (x) requires labels for autogenous biologics to specify the organism(s) and/or antigen(s) they contain; (xi) and requires labelling for conditionally licenced veterinary biologics to bear a statement concerning efficacy and potency requirements. APHIS has also amended the regulations concerning the number of labels or label sketches for experimental products required to be submitted for review and approval as well as the recommended storage temperature for veterinary biologics at licenced establishments.

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