Section 5-6 - 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: - (i) Comply with one of the following:
- (A) Be an approved drug that is listed in the FDA publication 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:
- (I) The FDA monograph for OTC Health-Care Antiseptic Drug Products as an antiseptic handwash; and
- (ii) Comply with one of the following:
- (A) Have components that are exempted from the requirement of being listed 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 Aids, and Sanitizers as regulated for use as an 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
- (iii) Be applied only to hands that are cleaned as specified under Chapter 5, Section 3.
(b) If a hand antiseptic or a hand antiseptic solution used as a hand dip does not meet the criteria specified under Chapter 5, Section 6(a), use shall be: - (i) Followed by thorough hand rinsing in clean water before hand contact with food or by the use of gloves; or
- (ii) Limited to situations that involve no direct contact with food by the bare hands.
(c) A hand antiseptic solution used as a hand dip shall be maintained clean and at a strength equivalent to at least one hundred (100) mg/l chlorine.