9 CFR § 113.50 - Ingredients of biological products.

---
identifier: "/us/cfr/t9/s113.50"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "9 CFR § 113.50 - Ingredients of biological products."
title_number: 9
title_name: "Animals and Animal Products"
section_number: "113.50"
section_name: "Ingredients of biological products."
chapter_name: "ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE"
subchapter_number: "E"
subchapter_name: "VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS"
part_number: "113"
part_name: "STANDARD REQUIREMENTS"
positive_law: false
currency: "2026-03-24"
last_updated: "2026-03-24"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.4."
regulatory_source: "34 FR 18004, Nov. 7, 1969, unless otherwise noted."
cfr_part: "113"
---


# 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]