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Executive Summary

OTC OPHTHALMICS FOR EMERGENCY FIRST AID: FDA REQUESTING DATA on the safety and efficacy of ingredients contained in eye-wash drug products used for the emergency first aid treatment of chemical burns of the eye. The agency intends to review data on the ingredients for possible inclusion in the OTC monograph for ophthalmic drug products. The final monograph for ophthalmics, which was issued March 4, 1988, did not address the use of eyewashs for burns because no data were submitted by firms during the rulemaking process. Subsequently, however, the agency received a request for an advisory opinion on the regulatory status of such products. FDA's call for data, published in the Dec. 5 Federal Register, notes that the agency is aware that "a number of these eyewash products for emergency first aid treatment of chemical burns have been marketed prior to the effective date of the ophthalmic drug products final monograph." However, FDA said, "the agency has little data on which to make a determination as to the safety, effectiveness, and labeling of these products." The notice reminds manufacturers that OTC products without approved NDAs may only remain on the market during FDA's review if they were marketed as OTCs prior to Dec. 4, 1975, are not hazardous to health, and do not bear claims for serious conditions that require the attention and supervision of a physician. The agency suggested that manufacturers submit information establishing that currently marketed products are not subject to regulatory action. FDA also emphasized that the current review is not intended for new chemical entities that have not previously been marketed OTC.

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