The following guideline can be ordered through the address listed in the "Source/Publisher"-category. In cases in which you can order through the Internet we have established a hyperlink.
FDA Guidance for Industry: Consumer Antiseptic Wash Final Rule - Questions and Answers
Origin/Publisher:
FDA, https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM568513.pdf
Content:
This guidance is intended to help small businesses better understand and comply with the final rule establishing that certain active ingredients used in over-the-counter (OTC) consumer antiseptic wash products are not generally recognized as safe and effective (GRASE), and thus, are ineligible for inclusion in the OTC topical antiseptic monograph.
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