010-5 Wyo. Code R. §§ 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.

Notes

010-5 Wyo. Code R. §§ 5-6