Products not prepared under license.

CFR · 2024-01-01 · US · Title 9

(a) When an establishment license is issued, if biological products which were not prepared in compliance with the regulations are in the establishment, such products shall not be shipped or delivered for shipment or otherwise dealt with as having been prepared under such regulations. (b) Except as provided in 9 CFR part 103, a biological product shall not be prepared in a licensed establishment unless the person to whom the establishment license is issued holds an unexpired, unsuspended, and unrevoked product license issued by the Administrator to prepare such biological product, or unless the products prepared are subject to the provisions of § 107.2 of this subchapter. (c) A biological product produced in a USDA-licensed establishment shall be produced under a U.S. Veterinary Biological Product License or a license granted by a State under § 107.2 (referred to as a State biological product license and the products prepared pursuant thereto as State-licensed biological products, including autogenous biologics), but not under both a U.S. Veterinary Biological Product License and (1) State-licensed biological products (including autogenous biologics) shall only be distributed or shipped intrastate, must not bear a U.S. Veterinary Biologics Establishment License Number, and must not otherwise be represented in any manner as having met the requirements for a U.S. Veterinary Biological Product license. Labeling of State- and USDA-licensed biological products produced in the same

official document · source cfr-2024 · id 9:§ 114.2