§ 46.134. Hand sanitizers.

 (a)  Requirements. A hand sanitizer and a chemical hand sanitizing solution used as a hand dip shall:

   (1)  Comply with one or more of the following:

     (i)   Be an approved drug that is listed in the most current FDA publication Approved Drug Products with Therapeutic Equivalence Evaluations as an approved drug based on safety and effectiveness.

     (ii)   Have active antimicrobial ingredients that are listed in the most current FDA monograph for OTC (over-the-counter) Health-Care Antiseptic Drug Products as an antiseptic handwash.

   (2)  Comply with one or more of the following:

     (i)   Have components that are exempted from the requirement of being listed in Federal food additive regulations as specified in 21 CFR 170.39 (relating to threshold of regulation for substances used in food-contact articles).

     (ii)   Comply with, and be listed in, one or more of the following:

       (A)   21 CFR 178 (relating to indirect food additives: adjuvants, production aids, and sanitizers as regulated for use as a food additive with conditions of safe use).

       (B)   21 CFR 182 (relating to substances generally recognized as safe), 21 CFR 184 (relating to direct food substances affirmed as generally recognized as safe) or 21 CFR 186 (relating to indirect food substances affirmed as generally recognized as safe).

     (iii)   Be limited to situations when use is followed by a thorough hand rinsing in clean water before hand contact with food, or when hand contact with food is avoided by the use of gloves, or where there is no direct contact with food by bare hands.

   (3)  Be applied only to hands that are cleaned as specified in §  46.131(b) (relating to cleanliness of hands and exposed portions of arms).

 (b)  Chemical hand sanitizing solution. A chemical hand sanitizing solution used as a hand dip shall be maintained clean and at a strength equivalent to at least 100 mg/L (ppm) chlorine.