PART 680—ADDITIONAL STANDARDS FOR MISCELLANEOUS PRODUCTS Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371; 42 U.S.C. 216, 262, 263, 263a, 264. Source: 38 FR 32100, Nov. 20, 1973, unless otherwise noted. Cross References: For U.S. Customs Service regulations relating to viruses, serums, and toxins, see 19 CFR 12.21-12.23. For U.S. Postal Service regulations relating to the admissibility to the United States mails see parts 124 and 125 of the Domestic Mail Manual, that is incorporated by reference in 39 CFR part 111. § 680.1 Allergenic Products. (a) Definition. (b) Source materials Criteria for source material. (2) Molds. (ii) Mold cultures shall be free of contaminating materials (including microorganisms) prior to harvest, and care shall be taken to minimize contamination during harvest and subsequent processing. (iii) Mold manufacturers shall maintain written standard operating procedures, developed by a qualified individual, that will ensure the identity of the seed culture, prescribe adequate processing of the mold, and specify the acceptable limits and kinds of contamination. These limits shall be based on results of appropriate tests performed by the manufacturer on at least three consecutive lots of a mold that is a representative species of mold subject to the standard operating procedures. The tests shall be performed at each manufacturing step during and subsequent to harvest, as specified in the standard operating procedures. Before use of the mold as a source material for Allergenic Products, in accordance with 21 CFR 601.2, the standard operating procedures and test data from the three representative lots described above shall be submitted to and approved by the Director, Center for Biologics Evaluation and Research (see mailing address in § 600.2(a) of this chapter). (3) Mammals and birds Care of animals. (ii) Health of animals. (iii) Immunization against tetanus. (iv) Reporting of certain diseases. (v) Dead animals. Provided, a b (vi) Mammals and birds inspected by the U.S. Department of Agriculture. (c) Listing of source materials and suppliers. (d) Exemptions. (2) Nonlicensed source material suppliers are exempt from drug registration. [38 FR 32100, Nov. 20, 1973, as amended at 49 FR 25432, June 21, 1984; 49 FR 31395, Aug. 7, 1984; 55 FR 11014, Mar. 26, 1990; 67 FR 9587, Mar. 4, 2002; 70 FR 14986, Mar. 24, 2005; 80 FR 18093, Apr. 3, 2015] § 680.2 Manufacture of Allergenic Products. (a) Extraneous allergenic substances. (b) Cultures derived from microorganisms. (c) Liquid products for oral administration. (d) Residual pyridine. (e) [Reserved] (f) Records. [38 FR 32100, Nov. 20, 1973, as amended at 49 FR 25433, June 21, 1984; 67 FR 9587, Mar. 4, 2002] § 680.3 Tests. (a) Identity. (b) [Reserved] (c) Sterility. (d) [Reserved] (e) Potency. (f) Records. [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]