Hand antiseptics Pf

(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 as an approved drug based on safety and effectiveness; or (B) Have active antimicrobial ingredients that are listed in the FDA monograph for OTC Health-Care Antiseptic Drug Products as an antiseptic handwash, and (2) Consist of only components which the intended use of each complies with one of the following: (A) A threshold of regulation exemption pursuant to 21 CFR Section 170.39 - Threshold of regulation for substances used in food-contact articles; or (B) 21 CFR, Part 178 - Indirect Food Additives: Adjuvants; Production Aids, and Sanitizers as regulated for use as a food additive with conditions of safe use; or (C) A determination of generally recognized as safe (GRAS), partial listings of substances with food uses that are GRAS may be found at 21 CFR, Part 182 - Substances Generally Recognized as Safe, 21 CFR, Part 184 - Direct Food Substances Affirmed as Generally Recognized as Safe for use in contact with food, or 21 CFR, Part 186 - Indirect Food Substances Affirmed as Generally Recognized as Safe for use in contact with food, and in FDA's inventory of GRAS notices, or (D) A prior sanction listed under 21 CFR, Part 181 - Prior Sanctioned Food Ingredients, or (E) A food contact notification that is effective, and (3) Be applied only to hands that are cleaned as specified in OAC 310:257-3-10. (b) If a hand antiseptic or a hand antiseptic solution used as a hand dip does not meet the criteria specified under (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; 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 shall be maintained clean and at a strength equivalent to at least 100 mg/L chlorine. (d) A food establishment shall have written procedures for employees to follow when responding to vomiting or diarrheal events that involve the discharge of vomitus or fecal matter onto surfaces in the food establishment. The procedures shall address the specific actions employees must take to minimize the spread of contamination and the exposure of employees, consumers, food, and surfaces to vomitus or fecal matter. OAC 310:257 OKLAHOMA STATE DEPARTMENT OF HEALTH Page | 30