[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR680.3]

[Page 123-124]
 
                        TITLE 21--FOOD AND DRUGS
 
          DEPARTMENT OF HEALTH AND HUMAN SERVICES--(Continued)
 
PART 680--ADDITIONAL STANDARDS FOR MISCELLANEOUS PRODUCTS--Table of Contents
 
Sec. 680.3  Tests.

    (a) Identity. When a specific identity test meeting the provisions 
of Sec. 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 Sec. 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 prescribed in Sec. 610.12 of this chapter, 
with the following exceptions:
    (1) When bulk material is not prepared, the sterility test 
prescribed for bulk material shall be performed on each container of 
each stock concentrate at the time a stock concentrate is prepared, and 
the test sample shall be no less than 1 ml. from each stock concentrate 
container.

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    (2) For lots consisting of no more than 5 final containers, the 
final container test shall be performed in accordance with 
Sec. 610.12(g)(6) of this chapter using the sample therein prescribed or 
using a sample of no less than 0.25 ml. of product from each final 
container, divided in approximately equal proportions for testing in 
Fluid Thioglycollate and Soybean-Casein Digest Media. The test sample in 
the later alternative method may be an overfill in the final container.
    (3) For products prepared in sets of individual dilution series, a 
test sample of 0.25 ml. shall be taken from a final container of each 
dilution, which samples may be pooled and one half of the pooled 
material used for the test with Fluid Thioglycollate Medium and one half 
used for the test with Soybean-Casein Digest Medium.
    (4) Tablets and capsules need not be tested for sterility provided 
aseptic techniques are employed in their manufacture.
    (d) [Reserved]
    (e) Potency. The potency of each lot of each Allergenic Product 
shall be determined as prescribed in Sec. 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 Secs. 211.165, 
211.167, 211.188, and 211.194 of this chapter.

(Information collection requirements in this section were approved by 
the Office of Management and Budget under control number 0910-0139)

[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]

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