Oklahoma Administrative Code
Title 310 - Oklahoma State Department of Health
Chapter 257 - Food Establishments
Subchapter 3 - Management and Personnel
Section 310:257-3-14 - Hand antiseptics
Universal Citation: OK Admin Code 310:257-3-14
Current through Vol. 42, No. 1, September 16, 2024
(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.
Added at 23 Ok Reg 2358, eff 6-25-06; Amended at 28 Ok Reg 2289, eff 11-1-11
Disclaimer: These regulations may not be the most recent version. Oklahoma may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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