APHIS Proposes Changes to Veterinary Biologics Labeling Rules
The Animal and Plant Health Inspection Service is proposing changes to its regulations on veterinary biological products under the Virus-Serum-Toxin Act to simplify labeling provisions. The proposed rule would replace the current four “indications statements” that vary based on a product’s effectiveness with a single statement saying the product is has been proven effective for vaccinating against a given disease. It would also require licensees to provide efficacy and safety data to APHIS for posting to the agency’s website.
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APHIS says currently licensed products would not need to be relicensed based on these proposed changes. Nor would efficacy requirements change for currently licensed products, it said. According to APHIS, if the changes are adopted, products that are not yet licensed but are within six months of getting a license at the effective date of any final rule would have to comply by one year after the date of licensure. Products that are more than six months away at the effective date of any final rule would have to comply at the time of licensure. Currently licensed products would have to comply within four years of the effective date of the final rule. That could be extended by an additional two years upon request.
(Federal Register 04/21/14)