21 CFR § 601.40 - Scope.

---
identifier: "/us/cfr/t21/s601.40"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 601.40 - Scope."
title_number: 21
title_name: "Food and Drugs"
section_number: "601.40"
section_name: "Scope."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "F"
subchapter_name: "BIOLOGICS"
part_number: "601"
part_name: "LICENSING"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "15 U.S.C. 1451-1561; 21 U.S.C. 321, 351, 352, 353, 355, 356b, 360, 360c-360f, 360h-360j, 371, 374, 379e, 381; 42 U.S.C. 216, 241, 262, 263, 264; sec 122, Pub. L. 105-115, 111 Stat. 2322 (21 U.S.C. 355 note), sec 7002(e), Pub. L. 111-148, 124 Stat. 817, as amended by sec. 607, Division N, Pub. L. 116-94, 133 Stat. 3127."
regulatory_source: "38 FR 32052, Nov. 20, 1973, unless otherwise noted."
cfr_part: "601"
---


# 601.40 Scope.

This subpart applies to certain biological products that have been studied for their safety and effectiveness in treating serious or life-threatening illnesses and that provide meaningful therapeutic benefit to patients over existing treatments (e.g., ability to treat patients unresponsive to, or intolerant of, available therapy, or improved patient response over available therapy).