(a) U.S. Veterinary Biologics Establishment License.

(1) The operator of each establishment of the kind specified in §102.2 shall make written application to the Administrator for a license. Blank forms of application will be furnished upon request to Animal and Plant Health Inspection Service.

(2) When a person conducts more than one establishment, a separate application shall be made for each establishment.

(3) Whenever subsidiaries are to operate in an establishment for which license application is made, the applicant shall apply for permission for such subsidiaries to operate in the establishment and furnish therewith a complete statement regarding the relationship between the applicant and the subsidiaries.

(4) Facilities documents, prepared as prescribed in part 108 of this subchapter, shall accompany the application for license unless previously filed with Animal and Plant Health Inspection Service.

(5) Each application for a U.S. Veterinary Biologics Establishment License shall be accompanied by an application for one or more U.S. Veterinary Biological Product Licenses and the supporting documents required by paragraph (b)(2) of this section.

(6) A new application shall be made when a change of ownership, operation, or location of an establishment occurs; or prior to the expiration of a U.S. Veterinary Biologics Establishment License issued for an interim period of time.

(b) U.S. Veterinary Biological Product License.

(1) The licensee of each establishment or applicant for an establishment license shall make written application to the Administrator for a U.S. Veterinary Biological Product License for each biological product to be prepared in the licensed establishment.

(2) Each application for a U.S. Veterinary Biological Product License shall be supported by:

(i) At least two copies of an Outline of Production prepared in accordance with §§114.8 and 114.9 of this subchapter; and

(ii) At least three copies of test reports and research data sufficient to establish purity, safety, potency, and efficacy of the product; and

(iii) Legends prepared as prescribed in §108.5 of this subchapter designating which facilities are to be used in the preparation of each fraction; and

(iv) Labels in finished form or sketches prepared as prescribed in §112.5 of this subchapter, together with information regarding all claims to be made on labels and in advertising matter to be used in connection with or related to the biological product.

(Approved by the Office of Management and Budget under control number 0579-0013)

[39 FR 37763, Oct. 24, 1974, as amended at 48 FR 57472, Dec. 30, 1983; 49 FR 21043, May 18, 1984; 50 FR 50763, Dec. 12, 1985; 56 FR 66783, Dec. 26, 1991; 75 FR 20772, Apr. 21, 2010]