§113.38. Guinea pig safety test. — Inbound Citations

(1) In such instances, the guinea pig safety test provided in § 113.38 shall be conducted in place of the mouse safety test.

(b) Bulk or final container samples of completed product from each serial shall be tested for safety as provided in § 113.38.

(b) Bulk or final container samples of completed product from each serial shall be tested for safety as provided in § 113.38.

(b) Bulk or final container samples of completed product from each serial shall be tested for safety as provided in § 113.38.

(b) Bulk or final container samples of completed product from each serial shall be tested for safety as provided in § 113.38.

(b) Bulk or final container samples of completed product from each serial shall be tested for safety as provided in § 113.38.

(b) Bulk or final container samples of completed product from each serial shall be tested for safety as provided in § 113.38.

(b) Bulk or final container samples of completed product from each serial shall be tested for safety as provided in § 113.38.

(b) Bulk or final container samples of completed product from each serial shall be tested for safety as provided in § 113.38.

(b) Bulk or final container samples of completed product from each serial shall be tested for safety as provided in § 113.38.

(1) Final container samples of completed product from the first serial or subserial of an autogenous biologic produced from an isolate shall be tested for purity as prescribed in § 113.26, and for safety as prescribed in § 113.33(b) or § 113.38 except that:

(i) When the number of final containers in a serial or subserial is 50 or less, two final container samples from each serial and subserial shall be tested as prescribed in § 113.26(b): Provided, That, 1 ml aliquots from each sample may be inoculated into five corresponding individual test vessels of each of the test media required.

(ii) Serials which are satisfactory after the third day of observation of purity test cultures and of safety test animals may be released for shipment to the customer and the tests continued throughout the required period; and

(iii) Serials released on the basis of satisfactory results of third day observations shall be immediately recalled if evidence of contamination occurs in test cultures or if any of the test animals used to demonstrate product safety, sicken, or die during the observation period.

(iv) Test summaries must be submitted 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) on a quarterly basis by the 21st day of January, April, July, and October or more often as required by the Administrator.

(b) Bulk or final container samples of completed product from each serial shall be tested for safety as provided in § 113.38.

(d) Final container samples of completed product from each serial shall be tested for safety in guinea pigs as prescribed in § 113.38 and for safety in mice as prescribed in § 113.33: Provided, That, vaccines recommended for use only in poultry are exempt from this requirement.

(b) Bulk or final container samples of completed product shall meet the requirements for safety as prescribed in §§ 113.33(b) and 113.38.

(1) Bulk or final container samples of completed product from each serial shall be tested for safety as prescribed in § 113.38.

(b) Final container samples of completed product from each serial shall be tested for safety as prescribed in § 113.38.