410 IAC 7-26-144 Hand antiseptics

Sec. 144. (a) A hand antiseptic used as a topical application, a hand antiseptic solution used as a hand dip, or a hand antiseptic soap must be as follows: (1) Comply with one (1) of the following: (A) Be an approved drug 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 over-the-counter Health-Care Antiseptic Drug Products as an antiseptic handwash. (2) Consist only of components which the intended use of each component complies with one (1) of the following: (A) A threshold of regulation exemption under 21 CFR 170.39. (B) 21 CFR 178. (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 182, 21 CFR 184, or 21 CFR 186, and in the FDA's Inventory of GRAS Notices. (D) A prior sanction listed under 21 CFR 181. (E) A Food Contact Notification that is effective. (3) Be applied only to hands that are cleaned as specified under section 141 of this rule. (b) If a hand antiseptic or hand antiseptic solution used as a hand dip does not meet the criteria specified under subdivision (a)(2), use must 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 hand antiseptic solution used as a hand dip must be maintained clean and at a strength equivalent to at least one hundred (100) ppm of chlorine. (d) For purposes of this section, a violation of subsection (a), (b), or (c) is a PF item.