[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: 21CFR680.2]

[Page 123]
 
                        TITLE 21--FOOD AND DRUGS
 
          DEPARTMENT OF HEALTH AND HUMAN SERVICES--(Continued)
 
PART 680--ADDITIONAL STANDARDS FOR MISCELLANEOUS PRODUCTS--Table of Contents
 
Sec. 680.2  Manufacture of Allergenic Products.

    (a) Extraneous allergenic substances. All manufacturing steps shall 
be performed so as to insure that the product will contain only the 
allergenic and other substances intended to be included in the final 
product.
    (b) Cultures derived from microorganisms. Culture media into which 
organisms are inoculated for the manufacture of Allergenic Products 
shall contain no allergenic substances other than those necessary as a 
growth requirement. Neither horse protein nor any allergenic derivative 
of horse protein shall be used in culture media.
    (c) Liquid products for oral administration. Liquid products 
intended for oral administration that are filled in multiple dose final 
containers shall contain a preservative in a concentration adequate to 
inhibit microbial growth.
    (d) Residual pyridine. Products for which pyridine is used in 
manufacturing shall have no more residual pyridine in the final product 
than 25 micrograms per milliliter.
    (e) [Reserved]
    (f) Records. A record of the history of the manufacture or 
propagation of each lot of source material intended for manufacture of 
final Allergenic Products shall be available at the establishment of the 
manufacturer of the source material, as required by Sec. 211.188 (OMB 
control number 0910-0139) of this chapter. A summary of the history of 
the manufacture or propagation of the source material shall be available 
at the establishment of the manufacturer of the final product.

[38 FR 32100, Nov. 20, 1973, as amended at 49 FR 25433, June 21, 1984]