HBW Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


Healthcare antiseptics

This article was originally published in The Rose Sheet

Executive Summary

Persistence/cumulative testing requirement should be eliminated for alcohol hand antiseptics in the Healthcare Antiseptic Drug Products Tentative Final Monograph for the antiseptic handwash/health care personnel handwash category, Elaine Larson, RN, PhD, Columbia University, states in comments to FDA July 30. Performance criteria threaten the availability of alcohol-based hand disinfectants, she says. Although ethyl and isopropyl alcohol are Category I for safety and efficacy in the 1994 TFM, the Health Care Personnel Handwash test outlined in the monograph requires products to exhibit cumulative ("persistent" or "residual") antimicrobial effect. Alcohol-based products, however, lack this effect, Larson adds, noting these items therefore must be reformulated to contain biocidal ingredients to display a cumulative effect. Comments respond to FDA's reopening of the administrative record for the topical antimicrobial drug products monograph in May (1"The Rose Sheet" June 2, 2003, In Brief)...

You may also be interested in...

Antimicrobial monograph

FDA is reopening administrative record for OTC topical antimicrobial drug products monograph until Aug. 27 to accept comments and data on OTC healthcare antiseptic drugs, agency says in 1May 29 Federal Register notice. Record for TFM closed in August 1995, but agency has since received several petitions, comments containing new data on proposed non-monograph ingredients, testing criteria for antiseptic drugs. FDA will review new information because it is relevant to final ingredient classification and testing criteria, agency says. Comments previously submitted need not be resubmitted, and additional comments should only address data provided after August 1995. Triclosan, salicylic acid are among the ingredients requested by industry for Category I status; CTFA and SDA have submitted data on test protocols, antimicrobial performance, filing four petitions in 2001 alone (2"The Rose Sheet" Dec. 10, 2001, p. 4)...

Tiofarma Admits Involvement On UK Fludrocortisone

Following Aspen’s admission last year that it was party to an illegal, anti-competitive agreement on fludrocortisone, Tiofarma has now also conceded to the UK’s Competition and Markets Authority that it took part in the deal.

Tecentriq Disappoints In Post-Surgery Bladder Cancer

Failure is a knock-back for the blockbuster product, but Tecentriq has many more opportunities for trial success in 2020.



Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts