D.C. Mun. Regs. tit. 25, r. 25-A404

Current through Register Vol. 71, No. 52, December 27, 2024

Rule 25-A404 - HANDS AND ARMS - HAND ANTISEPTICS

404.1

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

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

(1) Be an approved drug that is listed in the Food and Drug Administration (FDA) publication Approved Drug Products with Therapeutic Equivalence Evaluations as an approved drug based on safety and effectiveness; ^Pf or

(2) Have active antimicrobial ingredients that are listed in the FDA monograph for over-the-counter (OTC) Health-Care Antiseptic Drug Products as an antiseptic handwash; ^Pf and

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

(1) Have components that are exempt from the requirements of being listed in the federal food additive regulations as specified in 21 C.F.R. § 170.39 - Threshold of regulation for substances used in food-contact articles; ^Pf

(2) Comply with and be listed in 21 C.F.R. part 178 - Indirect Food Additives: Adjuvants, Production Aids, and Sanitizers as regulated for use as a food additive with conditions of safe use; ^Pf or

(3) Comply with and be listed in 21 C.F.R. part 182 - Substances Generally Recognized as Safe, 21 C.F.R. part 184 - Direct Food Substances Affirmed as Generally Recognized as Safe, or 21 C.F.R. part 186 - Indirect Food Substances Affirmed as Generally Recognized as Safe; ^Pf and

(c) Be applied only to hands that are cleaned as specified in § 401.^Pf

404.2

If a hand antiseptic or a hand antiseptic solution used as a hand dip does not meet the criteria specified in § 404.1(b), use shall be:

(a) Followed by thorough hand rinsing in clean water before hand contact with food or by the use of gloves;^Pf or

(b) Limited to employees working in situations that involve no direct contact with food by the bare hands. ^Pf

404.3

A hand antiseptic solution used as a hand dip shall be maintained clean and at a strength equivalent to at least one hundred parts per million (100 ppm) of chlorine or twenty-five parts per million (25 ppm) of iodine and changed every four (4) hours while in use. ^Pf

D.C. Mun. Regs. tit. 25, r. 25-A404

Final Rulemaking published at 50 DCR 4394 (June 6, 2003); as amended by Final Rulemaking published at 59 DCR 13690 (November 30, 2012)

Authority: Sections 4 and 10 of An Act Relating to the adulteration of foods and drugs in the District of Columbia, approved February 17, 1898 (30 Stat. 246: D.C. Official Code §§ 48-104 and 48-110 (2009 Repl.)); Section 7 of An Act Making Appropriations to provide for the expenses for the government of the District of Columbia for the fiscal year ending June thirtieth, nineteen hundred and three, and for other purposes (32 Stat.627: D.C. Official Code § 47-2834(a)(1), (a)(2), and (b) (2005 Repl.)); and Mayor's Order 2002-103, dated June 18, 2002 and Mayor's Order 98-139, dated August 20, 1998.