Electronic Code of Federal Regulations
We invite you to try out our new beta eCFR site at
https://ecfr.federalregister.gov. We???ve made big
changes to make the eCFR easier to use. Be sure to leave feedback using the Help button on the bottom
right of each page!
|
e-CFR data is current as of August 5, 2020 |
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]