General requirements for live bacterial vaccines.

CFR · 2024-01-01 · US · Title 9

When prescribed in an applicable Standard Requirement or in the filed Outline of Production, a live bacterial vaccine shall meet the requirements in this section. (a) (b) (i) The bacteria or agents in the vaccine are inherently lethal for mice. (ii) The vaccine is recommended for poultry. (2) Samples of completed product from each serial or first subserial of live bacterial vaccine shall be tested for safety in one of the species for which the product is recommended as follows: (i) Live bacterial vaccine recommended for use in dogs shall be tested as provided in § 113.40, except that dogs shall be injected with the equivalent of two doses of vaccine administered as recommended on the label. (ii) Live bacterial vaccine recommended for use in cattle shall be tested as provided in § 113.41, except that calves shall be injected with the equivalent of two doses of vaccine administered as recommended on the label. (iii) Live bacterial vaccine recommended for use in sheep shall be tested as provided in § 113.45. (iv) Live bacterial vaccine recommended for use in swine shall be tested as provided in § 113.44. (c) (1) (2) (3) (4) (d) (e) (1) (2) (3) Final container samples of completed product from each serial and subserial must be tested for moisture content in accordance with the test provided in § 113.29.

official document · source cfr-2024 · id 9:§ 113.64