eCFR Reference Browser

---

title: "21 CFR §610.10"

source: "https://www.ecfr.gov/current/title-21/section-610.10"

title_number: "21"

volume_number: "7"

chapter_number: "Unknown"

subchapter_code: "F"

subchapter_subject: "BIOLOGICS"

part_code: "610"

part_subject: "GENERAL BIOLOGICAL PRODUCTS STANDARDS"

subpart_code: "B"

subpart_subject: "General Provisions"

section_number: "610.10"

section_subject: "Potency."

cfr_reference: "21 CFR 610.10"

title_name: "Title 21"

title_subject: "Food and Drugs"

parts_covered: "Parts 600 to 799"

revised_date: "Revised as of April 1, 2019"

publication_date: "As of April 1, 2019"

contains_description: "Containing a codification of documents of general applicability and future effect"

publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"

---

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.

§610.10 - Potency.