Investigation of alleged violations of the Virus-Serum-Toxin Act (VSTA) involving veterinary biologics can be divided into three categories:
- Violation of the VSTA by unlicensed manufacturer.
This is the preparation, sale, barter, exchange or shipment of products by a manufacturer not licensed; the importation into the United States of an unlicensed product intended for the treatment, prevention, or diagnosis of disease in domestic animals; or the adulteration of licensed product by an unlicensed person.
- Violation of the VSTA by licensed manufacturer.
This includes illegal movement of a known defective, licensed product or of an unlicensed product produced by a licensed manufacturer; importation into the United States by a licensed manufacturer of an unlicensed product intended for the treatment, prevention, or diagnosis of disease in domestic animals; or a licensed manufacturer making false or misleading claims about a licensed product.
- Violation of Regulations under the VSTA by licensed manufacturer.
This occurs when conditions found upon inspection of a licensed manufacturer are not in accordance with 9 CFR, Parts 101 through 118. Action may also be taken under 9 CFR, Part 123.
Based on authority granted in the VSTA and regulations, CVB-IC takes appropriate action based on findings from product monitoring, inspection, or investigations. Recommendations for other actions are submitted to the Director, CVB.