3717-1-02.2(E) Management and personnel: personal cleanliness

Hand antiseptics.

(1)

A hand antiseptic used as a topical application, a hand antiseptic solution used as a hand dip, or a hand antiseptic soap is to:

(a)

Comply with one of the following:

(i)

Be an approved drug that is listed in the current version of the FDA publication "Approved Drug Products with Therapeutic Equivalence Evaluations" as an approved drug based on safety and effectiveness; or

(ii)

Have active antimicrobial ingredients that are listed in the FDA monograph for over-the-counter health-care antiseptic drug products as an antiseptic handwash (as published on December 20, 2017); and

(b)

Consist only of components which the intended use of each complies with one of the following:

(i)

A threshold of regulation exemption under 21 C.F.R. 170.39; or

(ii)

21 C.F.R. 178 as regulated for use as a food additive with conditions of safe use; or

(iii)

A determination of generally recognized as safe. Partial listings of substances with food uses that are generally recognized as safe may be found in 21 C.F.R. 182, 21 C.F.R. 184 or 21 C.F.R. 186 for use in contact with food and in FDA's inventory of generally recognized as safe notices; or

(iv)

A prior sanction listed under 21 C.F.R. 181; or

(v)

A food contact notification that is effective; and

(c)

Be applied only to hands that are cleaned as specified under paragraph (B) of this rule.

(2)

If a hand antiseptic or a hand antiseptic solution used as a hand dip does not meet the criteria specified under paragraph (E)(1)(b) of this rule, use is to be:

(a)

Followed by thorough hand rinsing in clean water before hand contact with food or by the use of gloves; or

(b)

Limited to situations that involve no direct contact with food by the bare hands.

(3)

A hand antiseptic solution used as a hand dip is to be maintained clean and at a strength equivalent to at least one hundred parts per million (mg/L) chlorine.