External Analgesic Drug Products for Over-the-Counter Human Use; Reopening of the Administrative Record and Amendment of Tentative Final Monograph

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The Food and Drug Administration (FDA) is reopening the administrative record for the rulemaking for over-the-counter (OTC) external analgesic drug products to accept comments and data concerning OTC external analgesic drug products that have been filed with the Division of Dockets Management, FDA, since the administrative record officially closed. FDA is also amending the tentative final monograph (TFM) (proposed rule) to clarify the status of patch, plaster, and poultice dosage forms for OTC external analgesic drug products. FDA is providing for the administrative record to remain open for 90 days to allow for public comment on the comments and data being accepted into the rulemaking and on the status of patch, plaster, and poultice dosage forms for OTC external analgesic drug products. This action is part of FDA's ongoing review of OTC drug products.