USDA amends rules to allow vets to make custom vaccines in their offices

The U.S. Department of Agriculture has amended its rules to allow veterinarians to make vaccines in their offices for individual clients, as long as compounds aren't contracted out to unlicensed manufacturers.

The change in regulations follows three years of debate that revolved around concern by veterinarians that they would be unable to react quickly to mutating viruses. The proposed clarification to the Virus-Serum-Toxin Act was first made in July 2012. The new rule goes into effect July 10.

The federal agency said that veterinarians can continue making vaccines and other biologics for administration to their own patients under an exemption to the licensing requirements that apply to veterinary biologics manufacturers, however, now those veterinarians can make such products only in the same facilities they use for daily practice, the Journal of the American Veterinary Medical Association reported.

Additionally, veterinary assistants are allowed to prepare biologics when the licensed veterinarians responsible for the products are present at the site during preparation.

"We do not intend to hinder innovations and the development of valuable new technologies, nor do we anticipate that this rule will have such an effect," officials with the agency's Animal and Plant Health Inspection Service (APHIS) said. "Any manufacturing establishment wishing to provide its technology and expertise to veterinarians has several licensing options that will allows it to market its products."

The American Veterinary Medical Association has been active in lobbying for the clarification to the regulations as well as similar changes to rules governed by the agency.

- check out the new regs
- read the JAVMA story