The volume of drug contained within a vial may exceed the labeled volume, according to the AVMA Council on Biologic and Therapeutic Agents.
In response to an inquiry from a practitioner, the COBTA examined the Food and Drug Administration's regulations regarding the filling volume of vials and found:
- Drug companies are required to manufacture drugs in accordance with the FDA's Good Manufacturing Practices, which specify an acceptable range of filling volume for parenteral products.
- The filling volume may exceed the labeled volume, provided the volume is within FDA specifications.
- The filling volume of the vial may not fall short of the labeled volume.
If you have concerns about the filling volume of vials you have purchased, contact Dr. Lynn Post, director of surveillance, FDA Center for Veterinary Medicine, 7519 Standish Place, Building MPN II, Room N461, Rockville, MD 20855.