4 things to know about the USDA's stricter regulation of veterinary biologics
Exemption allowing practitioners to prepare vaccines and other biologics is specified to clarify the relationship between the practitioner and the facility.
Biologics prepared under the 1913 Virus-Serum-Toxin Act's veterinary practitioner exemption must be prepared in the facilities used for veterinarians' day-to-day activities, according to a change by the U.S. Department of Agriculture Animal and Plant Health Inspection Service (USDA-APHIS).
The move intends to stop unlicensed establishments from producing biologics (vaccines, bacterins and diagnostics used for prevention and treatment and to diagnose diseases), according to the release from APHIS. APHIS proposed the change in July 2012. Veterinarians, associations, educators, laboratories, manufacturers and other groups submitted feedback. Here are four things to be aware of:
1. There's no forced relocation. Some feedback suggested the change would force practitioners to move the production of biologics to unfit sites, whether due to poor conditions or staff not trained for specialized laboratory work. The agency responded that veterinarians can partner with licensed establishments that prepare biologics.
2. Multiple locations aren't overlooked. Commentators questioned how the change would impact practices with multiple locations. APHIS responded that a veterinarian can prepare the biologics at any location used for day-to-day activities. A veterinary assistant can prepare the biologics with the licensed veterinarian's “direct supervision,” which means the veterinarian is responsible for the product and must be available at the site.
3. Innovators must get licensed. One concern raised the possibility that not allowing unlicensed laboratories to prepare biologics would slow down advancements in veterinary medicine. The agency responded that a manufacturer can pursue a license by going through the appropriate process.
4. The economic impact is minimal. Following federal law, APHIS reviewed the change's economic effects on small groups and determined “for the most part, there should be little or no effect on veterinary practitioners,” according to the release.
The change took effect July 10.
