21 CFR § 200.11 General

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

Current through Sep 8, 2026 · Read all of Part 200

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.

← § 200.10 Contract facilities (including consulting laboratories) utilized as extramural facilities by pharmaceutical manufacturers.§ 200.15 Definition of term “insulin.” →