Autogenous biologics.

CFR · 2024-01-01 · US · Title 9

Autogenous biologics shall be prepared from cultures of microorganisms which have been inactivated and are nontoxic. Such products shall be prepared only for use by or under the direction of a veterinarian under a veterinarian-client-patient relationship, Each serial of an autogenous biologic shall meet the requirements in this section, and if found unsatisfactory by any prescribed test shall not be used. (a) (1) More than one microorganism isolated from the same herd may be used as seed. (2) Under normal circumstances, microorganisms from one herd must not be used to prepare an autogenous biologic for another herd. The Administrator, however, may authorize preparation of an autogenous biologic for use in herds adjacent to the herd of origin, when adjacent herds are considered to be at risk. To request authorization to prepare a product for use in herds adjacent to the herd of origin, the establishment seeking authorization must submit to the Administrator (in c/o the Director, Center for Veterinary Biologics, Inspection and Compliance, 1920 Dayton Avenue, P.O. Box 844, Ames, IA 50010) the following information. (If any of the data are unavailable, the applicant for authorization (i) Name, address, and phone number of the owner of the herd of origin. (ii) Attending veterinarian's name, address, and phone number. (iii) Animal species and number in herd of origin. (iv) Identification of microorganism(s), at least to genus. (v) Diagnosis or clinical signs of the disease observed

official document · source cfr-2024 · id 9:§ 113.113