(a) Identity. When a specific identity test meeting the provisions of §610.14 of this chapter cannot be performed, the manufacture of each lot shall be separated from the manufacture of other products in a manner that will preclude adulteration, and records made in the course of manufacture shall be in sufficient detail to verify the identity of the product.

(b) [Reserved]

(c) Sterility. A sterility test shall be performed on each lot of each Allergenic Product as required by §610.12 of this chapter.

(d) [Reserved]

(e) Potency. The potency of each lot of each Allergenic Product shall be determined as prescribed in §610.10 of this chapter. Except as provided in this section, the potency test methods shall measure the allergenic activity of the product. Until manufacturers are notified by the Director, Center for Biologics Evaluation and Research, of the existence of a potency test that measures the allergenic activity of an allergenic product, manufacturers may continue to use unstandardized potency designations.

(f) Records. The records related to the testing requirements of this section shall be prepared and maintained as required by §§211.165, 211.167, 211.188, and 211.194 of this chapter.

[38 FR 32100, Nov. 20, 1973, as amended at 39 FR 19777, June 6, 1974; 41 FR 4015, Jan. 28, 1976; 52 FR 37607, Oct. 8, 1987; 55 FR 11013, Mar. 26, 1990; 67 FR 9587, Mar. 4, 2002; 77 FR 26175, May 3, 2012; 77 FR 30884, May 24, 2012; 80 FR 37974, July 2, 2015]