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U.S. Department of Health and Human Services


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Rulemaking History for OTC Oral Insect Repellent Drug Products

Final Monograph (21 CFR 310.529):
Drug products containing active ingredients offered over-the-counter (OTC) for oral use as insect repellents

Insect Repellent Drug Products

Advance Notice Of Proposed Rulemaking Date FR Citation
Advance Notice of Proposed Rulemaking [PDF] 1/5/1982 47FR424
Proposed Rules Date FR Citation
Proposed Rule [PDF] 6/10/1983 48FR26986
    Correction [PDF] 7/15/1983 48FR32361
Final Rule Date FR Citation
Final Rule [PDF] 6/17/1985 50FR25170