Administrative Code

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Virginia Administrative Code
Title 12. Health
Agency 5. Department of Health
Chapter 421. Food Regulations

12VAC5-421-180. 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 FDA publication "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 OTC (over the counter) Health-Care Antiseptic Drug Products as an antiseptic handwash;Pf

2. Consist only of components which 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 184, or 21 CFR Part 186 for use in contact with food and in FDA's Inventory of GRAS Notices;Pf

d. A prior sanction listed under 21 CFR 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 12VAC5-421-140.Pf

B. If a hand antiseptic or a hand antiseptic solution used as a hand dip does not meet the criteria specified in 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 ppm (mg/l) chlorine .Pf

Statutory Authority

§§ 35.1-11 and 35.1-14 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 18, Issue 10, eff. March 1, 2002; amended, Virginia Register Volume 24, Issue 2, eff. October 16, 2007; Volume 26, Issue 7, eff. January 1, 2010; Volume 32, Issue 22, eff. July 12, 2016; amended, Virginia Register Volume 37, Issue 18, eff. June 10, 2021.

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