Regulatory Brief

 Packaging and Labeling of Viruses, Serums, Toxins, and Analogous Products


Formal title: Docket Number [APHIS-2008-0008] Viruses, Serums, Toxins, and Analogous Products; Packaging and Labeling

The U.S. Department of Agriculture (USDA) Animal Plant Health Inspection Service (APHIS) has announced its proposed rulemaking of the packaging and labeling of viruses, serums, toxins, and analogous products.

Brief Description:

The USDA APHIS has proposed to amend the Virus-Serum-Toxin Act regulations regarding the packaging and labeling of veterinary biological products. The USDA APHIS also proposed 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.

AVMA Response:

The AVMA has advocated for many years for improvements in the labeling of biologics and commends the USDA for its proposal to amend 9 CFR Parts 103, 112, and 114, and support the changes. The AVMA appreciates the USDA's proposed actions within this particular Federal Register publication; however, the AVMA asserts that additional actions are needed to modernize biologic labeling to the fullest extent, particularly simplified biologic labeling containing clinically relevant, scientifically supported information that incorporates pivotal safety and efficacy data.

Additionally, the AVMA supports the monitoring of vaccine safety and efficacy via a publicly available central reporting system. The system should collect reports of all vaccine associated adverse events including any perceived failures in safety and/or efficacy. The reporting system should be user-friendly and readily available to facilitate adverse event reporting by veterinary practitioners. The need for vaccinovigilance is significant and urgent to ensure that animal health, public health and food safety are protected.

Background Documents:

The AVMA responded on March 14, 2011 (PDF)

View Federal Register document (PDF)