---
kind: "section"
citation: "9 C.F.R. § 113.50"
title: "9"
number: "113.50"
heading: "Ingredients of biological products."
url: "https://uscodex.org/cfr/9/113.50"
---

# §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.


## Notes

### Amendments

[38 FR 29889, Oct. 30, 1973]

### Authority

Authority: 21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.4.

### Source

Source: 34 FR 18004, Nov. 7, 1969, unless otherwise noted.

### Amendments

[38 FR 29889, Oct. 30, 1973]