21 C.F.R. § 200.11

Use of octadecylamine in steam lines of drug establishments.

Last amended: 2016Year: 2026Length: 42 wordsOfficial source

Cite as 21 C.F.R. § 200.11 (2026)

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.
21 C.F.R. § 200.11: Use of octadecylamine in steam lines of drug establishments. | Justis AI