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21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.4.
34 FR 18004, Nov. 7, 1969, unless otherwise noted.
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Subscribe to: 9 CFR 113.50
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Nomenclature changes to part 113 appear at 79 FR 55969, Sept. 18, 2014.
All ingredients used in a licensed biological product shall meet accepted standards of purity and quality; shall be sufficiently nontoxic so that the amount present in the recommended dose of the product shall not be toxic to the recipient; and in the combinations used shall not denature the specific substances in the product below the minimum acceptable potency within the dating period when stored at the recommended temperature.
[38 FR 29889, Oct. 30, 1973]