Section 750.516  Hand Antiseptics

a)         A hand antiseptic used as a topical application, a hand antiseptic solution used as a hand dip, or a hand antiseptic soap shall:

1)         Comply with one of the following:

A)        Be an approved drug that is listed in "Approved Drug Products with Therapeutic Equivalence Evaluations" as an approved drug based on safety and effectiveness; or

B)        Have active antimicrobial ingredients that are listed in OTC Health-Care Antiseptic Drug Products as an antiseptic handwash; and

2)         Comply with one of the following:

A)        Have components that are exempted from the requirement of being isted in federal food additive regulations as specified in 21 CFR 170.39 − Threshold of regulation for substances used in food-contact articles; or

B)        Comply with and be listed in:

i)          21 CFR 178 − Indirect Food Additives:  Adjuvants, Production Aides, and Sanitizers (as regulated for use as a food additive with conditions of safe use); or

ii)         21 CFR 182 − Substances Generally Recognized as Safe, 21 CFR 184 − Direct Food Substances Affirmed as Generally Recognized as Safe, or 21 CFR 186 − Indirect Food Substances Affirmed as Generally Recognized as Safe (for use in contact with food); and

3)         Be applied only to hands that are cleaned as specified under Section 750.510.

b)         If a hand antiseptic or a hand antiseptic solution used as a hand dip does not meet the criteria specified under subsection (a)(2), use shall be:

1)         Followed by thorough hand rinsing in clean water before hand contact with food or by the use of gloves; or

2)         Limited to situations that involve no direct hand contact with food by the bare hands.

(Source:  Added at 32 Ill. Reg. 11980, effective July 10, 2008)