1. (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. (1) Comply with one of the following:

      1. (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
      2. (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. (2) Consist of only components which the intended use of each complies with one of the following:

      1. (A) A threshold of regulation exemption pursuant to 21 CFR Section 170.39 - Threshold of regulation for substances used in food-contact articles; or
      2. (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
      3. (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
      4. (D) A prior sanction listed under 21 CFR, Part 181 - Prior Sanctioned Food Ingredients, or
      5. (E) A food contact notification that is effective, and
   3. (3) Be applied only to hands that are cleaned as specified in OAC 310:257-3-10.

2. (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. (1) Followed by thorough hand rinsing in clean water before hand contact with food or by the use of gloves; or
   2. (2) Limited to situations that involve no direct contact with food by the bare hands.
3. (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.

Added at 23 Ok Reg 2358, eff 6-25-06

Amended at 28 Ok Reg 2289, eff 11-1-11

Amended at 33 Ok Reg 1520, eff 9-11-16

Amended at 38 Ok Reg 1947, eff 9-11-21