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U.S. Department of Health and Human Services


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Rulemaking History for OTC Oral Fever Blister Drug Products

Final Monograph (21 CFR 310.537):
Drug products containing active ingredients offered over-the-counter (OTC) for oral administration for the treatment of fever blisters and cold sores


Oral Fever Blister Drug Products
Advance Notice Of Proposed Rulemaking Date FR Citation
Advance Notice of Proposed Rulemaking 1/5/1982 47FR502
Proposed Rule Date FR Citation
Tentative Final Monograph 6/17/1985 50FR25156
    Correction 7/15/1985 50FR28595
Final Rule Date FR Citation
Final Monograph 6/30/1992 57FR29166