Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Maximal Usage Trials for Topically Applied Active Ingredients Being Considered for Inclusion in an Over-the-Counter Monograph: Study Elements and Considerations.” This guidance represents FDA's current thinking on the conduct of in vivo absorption trials for topically applied active ingredients that are under consideration for inclusion in an over-the-counter (OTC) monograph.
The announcement of the guidance is published in the
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Kristen Hardin, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 5443, Silver Spring, MD 20993-0002, 240-402-4246.
FDA is announcing the availability of a guidance for industry entitled “Maximal Usage Trials for Topically Applied Active Ingredients Being Considered for Inclusion in an Over-the-Counter Monograph: Study Elements and Considerations.” This guidance represents FDA's current thinking on the conduct of in vivo absorption trials for topically applied active ingredients that are under consideration for inclusion in an OTC monograph. A maximal usage trial (MUsT) is a standard approach to assessing the in vivo bioavailability of topical drug products. The methodology described in this guidance adapts MUsT principles for active ingredients being considered for inclusion in an OTC monograph. Because information from a MUsT can help identify the potential for systemic exposure to a topically applied active ingredient, such information can help inform an FDA determination of whether additional safety data are needed to support a finding that a topical OTC drug containing that active ingredient is generally recognized as safe and effective for its intended use.
This guidance was written, in part, in response to comments submitted to Docket No. FDA-2015-D-4021 for the draft guidance entitled “Over-the-Counter Sunscreens: Safety and Effectiveness Data” (80 FR 72975, November 23, 2015) and the final guidance that replaced it, entitled “Nonprescription Sunscreen Drug Products—Safety and Effectiveness Data,” (81 FR 84594, November 23, 2016), requesting that FDA provide further guidance and details on the MUsT recommended in that document. FDA has also recommended a MUsT to address data gaps regarding active ingredients under consideration for inclusion in the OTC monograph for topical antimicrobial drug products, and in the OTC sunscreen monograph rulemaking (see proposed rules “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” (81 FR 42912, June 30, 2016) and “Sunscreen Drug Products for Over-the-Counter Human Use” (84 FR 6204, February 26, 2019)). This guidance provides additional information on the study elements, data analysis, and considerations when designing a MUsT for a topically applied active ingredient being considered for inclusion in an OTC monograph.
This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on “Maximal Usage Trials for Topically Applied Active Ingredients Being Considered for Inclusion in an Over-the-Counter Monograph: Study Elements and Considerations.” 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. This guidance is not subject to Executive Order 12866.
Persons with access to the internet may obtain the guidance at either