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U.S. Department of Health and Human Services


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Rulemaking History for OTC Hormone Drug Products

Final Monograph (21 CFR 310.530):
Topically applied hormone-containing drug products for over-the-counter (OTC) human use

OTC Hormone Drug Products found on this page:

Hormone Drug Products: Drug Rulemakings
Advance Notice Of Proposed Rulemaking Date FR Citation
Advance Notice of Proposed Rulemaking [PDF] 1/5/1982 47FR430
    Correction [PDF] 5/18/1982 47FR21274
Proposed Rule Date FR Citation
Proposed Rule [PDF] 10/2/1989 54FR40618
Final Rule Date FR Citation
Final Rule [PDF] 9/9/1993 58FR47608

Hormone Drug Products: Related Cosmetic Rulemakings
Proposed Rule Date FR Citation
Proposed Rule: Cosmetic product concentration limits [PDF] 9/9/1993 58FR47611
Notice: Intent to withdraw 9/9/1993 proposed rule [PDF] 4/22/2003 68FR19766
Final Rule Date FR Citation
Notice: Withdraws 9/9/1993 proposed rule [PDF] 11/26/2004 69FR68831