U.S. Veterinary Biological Product License.

CFR · 2024-01-01 · US · Title 9

(a) Authorization to produce each biological product shall be specified on a U.S. Veterinary Biological Product License, issued by the Administrator, and supplementary to the U.S. Veterinary Biologics Establishment License named therein. (b) The following shall appear on the U.S. Veterinary Biological Product License: (1) The U.S. Veterinary Biologics Establishment License Number for the establishment from which the product is released for marketing. (2) The true name of the product. (3) The product code number for the product. (4) The date of issuance. (5) Any restrictions designated by the Administrator under paragraph (e) of this section. (6) When necessary to comply with § 102.6 of this part, a termination date and a brief description of requirements to be met for reissuance. (c) The following provisions shall apply to all licensed biological products: (1) Licensed biological products shall be prepared as required by the regulations and in accordance with a filed Outline of Production as prescribed in §§ 114.8 and 114.9 of this subchapter. No change shall be made in the preparation of a biological product without prior approval of the Administrator. (2) In addition to restrictions imposed by the Administrator pursuant to paragraph (e) of this section, biological products may be subject to restrictions which are imposed by any State or other jurisdiction pertaining to the distribution and use of such products, based on local disease conditions. (3) When requested by the Ad

official document · source cfr-2024 · id 9:§ 102.5