(a) The test methods and procedures contained in all applicable Standard Requirements shall be complied with unless otherwise exempted by the Administrator and provided that such exemption is noted in the filed Outline of Production for the product.

(b) Test methods and procedures by which the biological products shall be evaluated shall be designated in the Outline of Production for such products.

[38 FR 29887, Oct. 30, 1973, as amended at 56 FR 66784, Dec. 26, 1991]