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ST. PAUL, Minn. -- After nine years, the Food and Drug Administration (FDA) is reopening its Tentative Final Monograph Standards for Healthcare Antiseptic Products for comment, signaling willingness to consider new data before setting final criteria.
Until the monograph is final, there is no federal regulation of OTC healthcare antiseptics. Practitioners must evaluate products for themselves. This sometimes misunderstood but significant situation demands attention from infection control practitioners, according to Rita McCormick, RN, CIC, of the University of Wisconsin. Speaking at a 3M-sponsored breakfast seminar during the American Association for Professionals in Infection Control and Epidemiology (APIC) meeting in San Antonio in June, McCormick explained that on May 29, 2003, the FDA opened a 90-day comment period related to the FDA's Tentative Final Monograph (TFM) for Healthcare Antiseptic Drug Products, covering patient skin prep, handwash and scrub products.
Proposed tentative and final monographs are published in the Federal Register<$> and detail allowable active ingredients, labeling and testing requirements for OTC drug products. Years can elapse between the publications of a proposed, tentative and final monograph. The FDA has published a TFM for almost every therapeutic category in the over-the-counter drug review, but it has published a final monograph for only two-thirds of them.
"The TFM regulates the antimicrobial products that are available to you and the claims that can be made about those products," McCormick told more than 300 practitioners attending the seminar. "It can also be useful in knowing how to interpret the marketing claims from various manufacturers. When the TFM is final, it carries the weight of law. While tentative, there is leeway in product formulations and the claims that can be made. There are no requirements that products be tested according to standardized test methods, with the exception of products submitted under an NDA (New Drug Application)."
As things stand now, she said, there is a situation of caveat emptor or "buyer beware" in the healthcare antiseptic market, so practitioners must scrutinize ingredients and ask questions about products. Standardized test methods, such as those being evaluated during the FDA comment period, "provide a way to fairly test and compare products" and benefit both healthcare professionals and manufacturers, McCormick added.
McCormick, who has participated in several important committees on infection control, was an early member of the Healthcare Infection Control Practices Advisory Committee, which developed a number of national guidelines for the Centers for Disease Control and Prevention (CDC).
In her presentation she explained that the current TFM for antiseptics contains three categories of active antiseptic ingredients. Category I includes products such as alcohol and iodophors that have been on the market for a long time and are regarded as safe and effective. Category II includes products such as hexachlorophene that are not recognized as safe and effective. Category III is for ingredients such as triclosan that have insufficient data for classification as safe and effective.
Products containing active ingredients not in Category I would require a New Drug Application to market them. Under the NDA process, the FDA reviews all study protocols and study reports and may audit pivotal study sites for compliance with protocol, study conduct and reports.3M Avagard (Chlorhexidine Gluconate 1 percent Solution and Ethyl Alcohol 61 percent w/w) Surgical and Healthcare Personnel Hand Antiseptic with Moisturizers was placed in the NDA category.
"That required us to undergo prolonged, rigorous testing before we could market the products, but that testing has proved quite beneficial in light of the new CDC hand hygiene guideline recommending alcohol-based scrubs and persistence," said John Dell, 3M Health Care division scientist. "3M Avagard hand prep with CHG is the first-and so far, the only- waterless, brushless hand prep to be approved by the FDA for use as a surgical scrub. In meeting FDA standards, Avagard with CHG proved to have the added advantage of persistence for up to six hours. No other waterless, brushless surgical scrub has gone through the NDA process."
To submit written comments and data for the TFM, contact the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, Md. 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments.
Avagard and Avagard D are trademarks of the 3M Company.