410 Ind. Admin. Code 7-24-131

Current through October 23, 2024

Section 410 IAC 7-24-131 - Hand sanitizers

Authority: IC 16-42-5-5

Affected: IC 16-42-5

Sec. 131.

(a) A hand sanitizer and a chemical hand sanitizing solution used as a hand dip shall be as follows:

(1) Comply with one (1) 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.

(B) Have active antimicrobial ingredients that are listed in the FDA monograph for OTC Health-Care Antiseptic Drug Products as an antiseptic hand wash.

(2) Consist of components that are one (1) of the following:

(A) Listed for such use in contact with food in 21 CFR 178 - Indirect Food Additives: Adjuvants, Production Aids, and Sanitizers.

(B) Exempt from regulation as food additives under 21 CFR 170.39 - Threshold of regulation for substances used in food-contact articles.

(C) Generally recognized as safe (GRAS) for the intended use in contact with food within the meaning of the Federal Food, Drug and Cosmetic Act (FFDCA).

(D) Permitted for such use by an effective Food Contact Substance Notification as defined by paragraph 409(h) of the FFDCA and listed in FDA's Inventory of Effective Premarket Notifications for Food Contact Substances.

(3) Be applied only to hands that are cleaned as specified under section 128 of this rule.

(b) If a hand sanitizer or a chemical hand sanitizing solution used as a hand dip does not meet the criteria specified under subsection (a)(2), use shall be:

(1) followed by thorough hand rinsing in clean water before hand contact with food or by the use of gloves; or

(2) limited to situations that involve no direct contact with food by the bare hands.

(c) A chemical hand sanitizing solution used as a hand dip shall be maintained clean and at a strength equivalent to at least one hundred (100) milligrams per liter chlorine.

(d) For purposes of this section, a violation of subsection (a), (b), or (c) is a noncritical item.

410 IAC 7-24-131

Indiana State Department of Health; 410 IAC 7-24-131; filed Oct 13, 2004, 12:30 p.m.: 28 IR 844; errata filed Dec 13, 2004, 8:20 a.m.: 28 IR 1485; readopted filed Jul 15, 2010, 12:12 p.m.: 20100728-IR-410100261RFA

Readopted filed 11/10/2016, 8:45 a.m.: 20161207-IR-410160371RFA

Readopted filed 9/15/2022, 10:01 a.m.: 20221012-IR-410220206RFA