21 CFR § 200.11 - Use of octadecylamine in steam lines of drug establishments.

---
identifier: "/us/cfr/t21/s200.11"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 200.11 - Use of octadecylamine in steam lines of drug establishments."
title_number: 21
title_name: "Food and Drugs"
section_number: "200.11"
section_name: "Use of octadecylamine in steam lines of drug establishments."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "C"
subchapter_name: "DRUGS: GENERAL"
part_number: "200"
part_name: "GENERAL"
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, 358, 360e, 371, 374, 375."
regulatory_source: "40 FR 13996, Mar. 27, 1975, unless otherwise noted."
cfr_part: "200"
---


# 200.11 Use of octadecylamine in steam lines of drug establishments.

The Food and Drug Administration will not object to the use of octadecylamine in steam lines where the steam may be used for autoclaving surgical instruments and gauze if the octadecylamine in the steam is not more than 2.4 parts per million.