(a) In order for a canine rabies vaccine to be approved for use in California, it shall adhere to the following requirements:
(1) Meet Animal and Plant Health Inspection Service (APHIS) standards for sterility and safety. Evidence of product conformance to APHIS Standards will be demonstrated by the United States Department of Agriculture (USDA) product licensing; and
(2) If an inactivated vaccine, it shall have a minimal relative potency (RP) at vaccination of at least 2.0 as determined by the National Institute of Health (NIH)Test for potency or if a modified live virus (MLV) vaccine it shall meet USDA potency Requirements; and
(3) Demonstrate an immunity duration of three or more years based on an immunity duration challenge study conducted in conformity with section 2652; and
(4) Comply with the origin and integrity of Rabies Vaccine Virus Requirements in section 2653.
Credits
Note: Authority cited: Section 1920(b), Health and Safety Code. Reference: Section 1920(b), Health and Safety Code.
1. New section filed 09-07-90; operative 10-07-90 (Register 90, No. 44).
This database is current through 5/10/24 Register 2024, No. 19.
Cal. Admin. Code tit. 17, § 2651, 17 CA ADC § 2651
