Statutes, codes, and regulations
Delaware Administrative Code
Title 16 - Health and SafetyDepartment of Health and Social ServicesDivision of Public HealthHealth Systems Protection (HSP)State of Delaware Food CodeChapter 2 - Management and PersonnelPart 2-3 - PERSONAL CLEANLINESS
Subpart 2-301 - Hands and Arms
Section 2-301.16 - Hand Antiseptics

16 Del. Admin. Code § 2-301.16

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Current through Register Vol. 27, No. 12, June 1, 2024
Section 2-301.16 - 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 Evaluationsas an approved drug based on safety and effectiveness; Pf or
(b) Have active antimicrobial ingredients that are listed in the FDA monograph for OTC Health-Care Antiseptic Drug Products as an antiseptic handwash, pf and
(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 - Threshold of regulation for substances used in FOOD-contact articles;pf or
(b) 21 CFR 178 - Indirect FOOD Additives: Adjuvants, Production Aids, and Sanitizers as regulated for use as a FOOD ADDITIVE with conditions of safe use,Pf or
(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 - Substances Generally Recognized as Safe, 21 CFR 184 - Direct FOOD Substances Affirmed as Generally Recognized as Safe, or 21 CFR 186 - Indirect FOOD Substances Affirmed as Generally Recognized as Safe for use in contact with FOOD, and in FDA's Inventory of GRAS Notices,pf or
(d) A prior sanction listed under 21 CFR 181 - Prior Sanctioned FOOD Ingredients,Pf or
(e) a FOOD Contact Notification that is effective,PF and
(3) Be applied only to hands that are cleaned as specified under § 2-301.12. pf
(B) If a hand antiseptic or a hand antiseptic solution used as a hand dip does not meet the criteria specified under Subparagraph (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 chlorine. pf

16 Del. Admin. Code § 2-301.16

17 DE Reg. 1084( 5/1/2014) (Final)