G/TBT/N/USA/875/Add.4  
 
8 January  2021 
(21-0292) Page: 1/2 
Committee on Technical Barriers to Trade  Original: English  
 
 
NOTIFICATION  
Addendum  
The following communication , dated  7 January 2021 , is being circulated at the request of the 
delegation of the United States of America . 
 
_______________  
 
 
Title: Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for 
Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening 
of Administrative Record.  
 
Reason for Addendum:  
[  ] Comment period changed - date:   
[  ] Notified measure adopted - date:  
[  ] Notified measure published - date:  
[  ] Notified measure enters into force - date:  
[  ] Text of final measure available from1:  
[  ] Notified measure withdrawn or revoked - date:  
Relevant symbol if measure re -notified:   
[  ] Content or scope of notified measure changed  
New deadline for comments (if applicable):   
[X] Interpretive guidance issued and text available from1:  
https://www.govinfo.gov/content/pkg/FR -2020-12-31/html/202 0-28929.htm  
https://www.govinfo.gov/content/pkg/FR -2020-12-31/pdf/2020 -28929.pdf  
https://members.wto.org/crnattachments/2021/TBT/USA/interpretative_guidance/21_
0286_00_e.pdf  
[  ] Other:  
 
Description:  Consumer Antiseptic Rub Final Rule; Finding of Ineligibility for Inclusion in Final 
Monograph Questions and Answers; Guidance for Industry; Small Entity Compliance Guide; 
Availability  
AGENCY: Food and Drug Administration, HHS  
ACTION: Notice of availabilit y 
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a 
final guidance for industry entitled "Consumer Antiseptic Rub Final Rule Questions and Answers." 
We are issuing this guidance in accordance with the Small Busin ess Regulatory Enforcement Fairness 
 
1 This information can be provided by including a website address, a pdf attachment, or other 
information on where the text of the final measure and/or interpretive guidance can be obtained.  G/TBT/N/USA/875/Add.4  
 
- 2 - 
 
  Act to help small businesses understand and comply with the Consumer Antiseptic Rub Final Rule; 
Finding of Ineligibility for Inclusion in Final Monograph (Consumer Antiseptic Rub FR). In the 
Consumer Antiseptic Rub FR, F DA established that 28 active ingredients used in nonprescription 
(also known as over -the-counter (OTC)) consumer antiseptic products intended for use without 
water (consumer antiseptic rubs) are not eligible for evaluation under FDA's OTC Drug Review, whi ch 
was used to evaluate the safety and effectiveness of OTC drug products marketed in the United 
States on or before May 1972. The Consumer Antiseptic Rub FR also established that three active 
ingredients used in consumer antiseptic rubs are eligible for e valuation under the OTC Drug Review 
and granted requests to temporarily defer further rulemaking on these three eligible ingredients to 
allow for the development and submission of new safety and effectiveness data.  
The guidance is accessible from the FDA's  website at https://www.fda.gov/regulatory -
information/search -fda-guidance -docum ents/consumer -antiseptic -rub-final-rule-questions -and-
answers -guidance -industry , and is intended to help small businesses understand and comply with 
the Consumer Antiseptic Rub Final Rule; Finding of Ineligibility for Inclusion in Final Monograph 
(Consumer Antiseptic Rub FR) ( 84 FR 14847, 12 April 2019 ), which applies to active ingredients 
used in over -the-counter (OTC) consumer antiseptic rub products that are sometimes referred to as 
rubs, leave -on products, or hand sanitizers. The Consumer Antiseptic Rub FR also applies to active 
ingredients used in OTC consumer antiseptic wipes.  
This guidance represents the current thinking of the Food and Drug Admin istration (FDA or Agency) 
on this topic. It does not establish any rights for any person and is not binding on FDA or the public. 
You can use an alternative approach if it satisfies the requirements of the applicable statutes and 
regulations. To discuss an  alternative approach, contact the FDA office responsible for this guidance 
as listed on the title page: Office of Communications, Division of Drug Information, Center for Drug 
Evaluation and Research.  
DATES: The announcement of the guidance is published in the Federal Register on 31 December 
2020.  
This notice of availability, the proposed rule notified as G/TBT/N/USA/875  and the final rule notified 
as G/TBT/N/USA/875/Add.2  are identified by Docket Number FDA -2016-N-0124 (Formerly 
Docket  No. FDA -1975-N-0012). The Docket Folders are available on Regulations.gov  
at https://www.regulations.gov/docket?D=FDA -2016-N-0124 and 
https://www.regulations.gov/docket?D=FDA -1975-N-0012 and provide access to primary and 
supporting documents as well as comments received. Documents are also accessible from 
Regulations.gov  by sea rching the Docket Numbers.  
Related actions notified as G/TBT/N/USA/875/Add.1  and G/TBT/N/USA/875/Add.3  are identified by 
Docket Number FDA -2015-N-0101. The Docket Folder is available on Regulations.gov  at 
https://www.regulations.gov/docket?D=FDA -2015-N-0101 and provides access to primary and 
supporting documents as well as comments received. Documents are also accessible from 
Regulations.gov  by searching the Docket Number.  
G/TBT/N/USA/1167 and subsequent addenda  - Safety and Effectiveness o f Consumer Antiseptics; 
Topical Antimicrobial Drug Products for Over -the-Counter Human Use; Proposed Amendment of the 
Tentative Final Monograph; Reopening of Administrative Record.  
__________