21 CFR § 610.10 - Potency.

---
identifier: "/us/cfr/t21/s610.10"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 610.10 - Potency."
title_number: 21
title_name: "Food and Drugs"
section_number: "610.10"
section_name: "Potency."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "F"
subchapter_name: "BIOLOGICS"
part_number: "610"
part_name: "GENERAL BIOLOGICAL PRODUCTS STANDARDS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 321, 331, 351, 352, 353, 355, 360, 360c, 360d, 360h, 360i, 371, 372, 374, 381; 42 U.S.C. 216, 262, 263, 263a, 264."
regulatory_source: "38 FR 32056, Nov. 20, 1973, unless otherwise noted."
cfr_part: "610"
---


# 610.10 Potency.

Tests for potency shall consist of either in vitro or in vivo tests, or both, which have been specifically designed for each product so as to indicate its potency in a manner adequate to satisfy the interpretation of potency given by the definition in § 600.3(s) of this chapter.