2VAC5-585-180: 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 "Approved Drug Products with Therapeutic Equivalence Evaluations, 39th Edition," 2019 (U.S. Food and Drug Administration) 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 (OTC) Health-Care Antiseptic Drug Products, 82 FR 60474 (December 20, 2017) as an antiseptic handwash;Pf

2. Consist only of components that the intended use of each complies with one of the following:

a. A threshold of regulation exemption under 21 CFR 170.39; Pf

b. 21 CFR Part 178, as regulated for use as a food additive with conditions of safe use;Pf

c. A determination of generally recognized as safe (GRAS). Partial listings of substances with food uses that are GRAS may be found in 21 CFR Part 182, 21 CFR Part 184, or 21 CFR Part 186; and in FDA's Inventory of GRAS Notices;Pf

d. A prior sanction listed under 21 CFR Part 181;Pf or

e. A food contact notification that is effective;Pf and

3. Be applied only to hands that are cleaned as specified under 2VAC5-585-140.Pf

B. If a hand antiseptic or a hand antiseptic solution used as a hand dip does not meet the criteria specified under subdivision 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 (ppm) chlorine.Pf