404. HANDS AND ARMS - HAND ANTISEPTICS

404 HANDS AND ARMS ─ HAND ANTISEPTICS 404.1 A hand antiseptic used as a topical application, a hand antiseptic solution used as a hand dip, or a hand antiseptic soap shall: (a) Comply with one (1) of the following: (1) Be an approved drug that is listed in the Food and Drug Administration (FDA) publication Approved Drug Products with Therapeutic Equivalence Evaluations as an approved drug based on safety and effectiveness; Pf or (2) Have active antimicrobial ingredients that are listed in the FDA monograph for over-the-counter (OTC) Health-Care Antiseptic Drug Products as an antiseptic handwash; Pf and (b) Comply with one (1) of the following: (1) Have components that are exempt from the requirements of being listed in the federal food additive regulations as specified in 21 C.F.R. § 170.39 – Threshold of regulation for substances used in food-contact articles; Pf (2) Comply with and be listed in 21 C.F.R. part 178 − Indirect Food Additives: Adjuvants, Production Aids, and Sanitizers as regulated for use as a food additive with conditions of safe use; Pf or (3) Comply with and be listed in 21 C.F.R. part 182 – Substances Generally Recognized as Safe, 21 C.F.R. part 184 – Direct Food Substances Affirmed as Generally Recognized as Safe, or 21 C.F.R. part 186 – Indirect Food Substances Affirmed as Generally Recognized as Safe; Pf and (c) Be applied only to hands that are cleaned as specified in § 401.Pf 404.2 If a hand antiseptic or a hand antiseptic solution used as a hand dip does not meet the criteria specified in § 404.1(b), use shall be: (a) Followed by thorough hand rinsing in clean water before hand contact with food or by the use of gloves; Pf or (b) Limited to employees working in situations that involve no direct contact with food by the bare hands. Pf 404.3 A hand antiseptic solution used as a hand dip shall be maintained clean and at a strength equivalent to at least one hundred parts per million (100 ppm) of chlorine or twenty-five parts per million (25 ppm) of iodine and changed every four (4) hours while in use. Pf SOURCE: Final Rulemaking published at 50 DCR 4394 (June 6, 2003); as amended by Final Rulemaking published at 59 DCR 13690 (November 30, 2012).