Special additional requirements.

CFR · 2024-01-01 · US · Title 9

The label requirements in this section are additional to those prescribed elsewhere in this part. (a) In the case of biological products containing live Newcastle Disease virus, a caution statement indicating that Newcastle Disease can cause inflammation of the eyelids of humans, and a warning to the user to avoid infecting his eyes shall be included on the enclosure. (b) In the case of a biological product containing infectious bronchitis virus, all labels shall show the infectious bronchitis virus type or types used in the product. Abbreviation is permitted. (c) In the case of a biological product containing inactivated rabies virus, carton labels, enclosures, and all but very small final container labels shall include a warning against freezing and the recommendations provided in this paragraph. (1) That vaccine be administered to animals at 3 months of age or older, with a repeat dose 1 year later. (2) Subsequent revaccination as determined from the results of duration of immunity studies conducted as prescribed in § 113.209, paragraph (b) or (c), or both. (d) In the case of a biological product containing modified live rabies virus, the carton labels, enclosures, and all but very small final container labels shall include the recommendations provided in this paragraph. (1) For low egg-passage (below the 180th egg-passage level) the statement “For Use in Dogs Only! Not For Use in Any Other Animal!” (2) For other vaccines containing modified live rabies virus, the statemen

official document · source cfr-2024 · id 9:§ 112.7