“My business produces veterinary biological products. Are there any licenses required?”
Yes. Federal law prohibits the distribution of veterinary biologics unless they are manufactured in compliance with certain regulations. Veterinary biologics for commercial use must be produced at a USDA-approved establishment and proven to be pure, safe, potent, and efficacious. APHIS issues an establishment license to acceptable manufacturing facilities and an individual product license for each veterinary biologic that the establishment markets. In addition, APHIS issues permits for importing veterinary biologics for research, transit shipment, or distribution and sale in the United States.
Depending on the state, you may need to be licensed as a pharmacy, a wholesaler and/or a manufacturer. For example, in Mississippi and South Carolina, veterinary biological products are covered under a typical pharmacy license. However, in Tennessee and Idaho, the business is required to obtain a wholesale pharmacy license. In other states, such as South Dakota and Nebraska, no pharmacy license is required at all.
In some states, veterinary biological products are regulated by neither the state’s Board of Pharmacy nor the Board of Health, but by the State Veterinarian’s Office. For example, in Connecticut and Iowa, the state veterinarian requires that a producer of biological products submit a letter of permission to distribute biological products. Often, supplementary forms are required in addition to the letter, such as: (1) a copy of the business’ USDA-issued establishment and product licenses, as well as (2) relevant documentation issued by the FDA (i.e. product restrictions). In Oklahoma, application for a biological products permit is obtained through the Department of Agriculture.
LicenseLogix can help navigate the maze of federal and state licensure for businesses that produce veterinary biological products, as well as manage your ongoing license renewals. For additional help you can click here or give us a call at (800) 292-0909.