(a)A hand antiseptic used as a topical application, a hand antiseptic solution used as a hand dip, or a hand antiseptic soap shall meet either one of the following requirements:
(1)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.
(2)Have active antimicrobial ingredients that are
listed in the FDA monograph for OTC Antiseptic Health-Care Drug Products as an antiseptic handwash.
(b)In addition to the requirements of subdivision (a), the hand antiseptic used as a topical application, hand antiseptic solution used as a hand dip, or hand antiseptic soap shall meet either one of the following requirements:
(1)Have components that are exempted from the require
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(a)
A hand antiseptic used as a topical application, a hand antiseptic solution used as a hand dip, or a hand antiseptic soap shall meet either one of the following requirements:
(1)
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.
(2)
Have active antimicrobial ingredients that are
listed in the FDA monograph for OTC Antiseptic Health-Care Drug Products as an antiseptic handwash.
(b)
In addition to the requirements of subdivision (a), the hand antiseptic used as a topical application, hand antiseptic solution used as a hand dip, or hand antiseptic soap shall meet either one of the following requirements:
(1)
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.
(2)
Comply with, and be listed in, either of the following federal regulations:
(A)
21 CFR 178 – Indirect Food Additives: Adjuvants, Production Aids, and Sanitizers as regulated for use as a Food Additive with conditions
of safety use.
(B)
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.
(c)
A hand antiseptic used as a topical application, a hand antiseptic solution used as a hand dip, or a hand antiseptic soap that meets the requirements of subdivisions (a) and (b) shall be applied only to hands that are cleaned in a manner described in Section 113953.3.
(d)
If a hand antiseptic or a hand antiseptic solution used as a hand dip does not meet the requirements of subdivision (b), the hand antiseptic or hand antiseptic solution used as a hand dip may be used only if its use is either of the following:
(1)
Followed by thorough hand rinsing in clean water before hand contact with food directly or with the use of gloves.
(2)
Limited to situations where bare hands do not come in direct contact with food.
(e)
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.