Wis. Admin. Code Department of Health Services 2-301.16 - 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 the 31^st edition of FDA publication, Approved Drug Products with Therapeutic Equivalence Evaluations as an APPROVED drug based on safety and effectiveness; ^Pf or

(b) Have active antimicrobial ingredients that are listed in the FDA monograph for Over The Counter Health-Care Antiseptic Drug Products as an antiseptic handwash; ^Pf and

(2) 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; ^Pf 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 a FOOD ADDITIVE with conditions of safe use, ^Pf 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, ^Pf and

(3) Be applied only to hands that are cleaned as specified under § 2-301.12. ^Pf

(B) If a hand antiseptic or a chemical hand antiseptic solution used as a hand dip does not meet the criteria specified under Subparagraph (A) (2) of this section, use shall be:

(1) Followed by thorough hand rinsing in clean water before hand contact with FOOD or by the use of gloves; ^Pf or

(2) Limited to situations that involve no direct contact with FOOD by the bare hands. ^Pf

(C) A hand antiseptic solution used as a hand dip shall be maintained clean and at a strength equivalent to at least 100 mg/L chlorine. ^Pf

Notes

Wis. Admin. Code Department of Health Services 2-301.16