(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)Safety. A safety test shall be performed on the contents of a final container of each lot of each product as prescribed in § 610.11 of this chapter, except for the following:
(1) For lots consisting of no more than 20 final containers or 20 sets of individual dilutions, or where the final container contains no more than one intended human dose, the safety test need not be performed on the contents of a final container provided the safety test is performed on each lot of stock concentrate and on each lot of diluent contained in the final product. Only stock concentrates and diluents which have passed the general safety test shall be kept in the work areas used for the manufacture of Allergenic Products. A stock concentrate is an extract derived from a single allergenic source and used in the manufacture of more than one lot of product, and from which final dilutions or mixtures, are prepared directly.
(2) For powders for scratch tests, a sample shall be suspended in a suitable diluent and injected into each animal, and the sample size shall be the single human dose recommended.
(c)Sterility. A sterility test shall be performed on each lot of each Allergenic Product as required by § 610.12 of this chapter.
(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]
Title 21 published on 2015-04-01.
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