Ask the Expert Question-and-Answer Archive

by Ron Joseph

June, 2004

FDA Food Grade Coating for Pharmaceutical Company

Q. Should a facility which produces a bulk drug (related to cosmetical ingredient) apply food grade epoxy on the wall and doors of the production unit? The facility proposes to approach USFDA for approvals. Will they insist on the application of food grade epoxy? Is a mere application of ordinary epoxy acceptable? Could you please clarify?

Thank you.

A. My first reaction is to say that you should not be required to apply a FDA certified coating to the interior areas of manufacture for cosmetics, typically this type of coating requirement is reserved for food and or drug processing facilities.

There may be a requirement for use of certified coatings on the processing materials or the equipment that come directly in contact with the cosmetics, however this is a question that is best directed to the FDA.

You can contact them directly on their internet web site at www.fda.org and post your question there.

Regards,

Jim Burke