GroundRules
9 CFR 113.105: Leptospira Hardjo Bacterin.
Where this section sits in the code
- Title 9—Animals and Animal Products
- CHAPTER I—ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE
- SUBCHAPTER E—VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS
- PART 113—STANDARD REQUIREMENTS
Leptospira Hardjo Bacterin shall be produced from a culture of Leptospira hardjo which has been inactivated and is nontoxic. Each serial of biological product containing Leptospira hardjo fraction shall meet the applicable requirements in § 113.100 and shall be tested for purity, safety, and potency as prescribed in this section. A serial found unsatisfactory by any prescribed test shall not be released.
(a) Purity test. Final container samples of completed product from each serial and each subserial shall be tested for viable bacteria and fungi as provided in § 113.26.
(b) Safety test. Bulk or final container samples of completed product from each serial shall be tested for safety as provided in § 113.38.
(c) Potency test. Bulk or final container samples of completed product from each serial shall be tested for potency using the test written into the filed Outline of Production.
Collected 2026-08-27T02:24:03Z. Source file · JSON