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e-CFR data is current as of January 14, 2021 |
Title 9 → Chapter I → Subchapter E → Part 113 → §113.50 |
Title 9: Animals and Animal Products
PART 113—STANDARD REQUIREMENTS
§113.50 Ingredients of biological products.
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]