Regulations Governing Custom Vaccines

Government-regulated: Custom vaccines, like commercial vaccines, must be produced in a USDA-licensed production facility. In-depth, unannounced inspections ensure compliance with USDA standards.

Herd-specific: The microorganisms used to prepare custom vaccines must be isolated from sick or dead animals in the herd of origin.

Diagnosis required: There must be reason to believe these microorganisms (bacteria or viruses) are the cause of the current disease.

Combination vaccines: More than one microorganism may be used. Bacterial and viral antigens may be combined in a single vaccine.

Veterinarian required: Custom biologic products must be prepared only for use under the direction of a veterinarian with a veterinarian-client-patient relationship.

Use in other herds: Under normal circumstances, microorganisms from one herd shall not be used to prepare custom biologics for another herd. However, the USDA can authorize the use of custom biologics in adjacent or nonadjacent herds when necessary. Contact Novartis Animal Health for additional information on the use of custom biologics in adjacent or non-adjacent herds.

Short-term use: Under normal circumstances, microorganisms used to produce custom vaccines may not be older than 15 months from the date of isolation, or 12 months from the date of harvest of the first serial of product produced from the microorganism(s), whichever comes first. The USDA may authorize the production of additional serials from microorganism(s) older than stated above. Contact Novartis Animal Health for more information.

Regulations: Custom biologics are tested for purity and safety in accordance with 9 CFR § 113.26 and 113.33(b) or 113.38, respectively.