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

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OTC Hormone Drug Products found on this page:

Hormone Drug Products: Drug Rulemakings

Advance Notice Of Proposed RulemakingDateFR Citation
Advance Notice of Proposed Rulemaking1/5/198247FR430
Proposed RuleDateFR Citation
Proposed Rule10/2/198954FR40618
Final RuleDateFR Citation
Final Rule9/9/199358FR47608

Hormone Drug Products: Related Cosmetic Rulemakings

Proposed RuleDateFR Citation
Proposed Rule: Cosmetic product concentration limits9/9/199358FR47611
Notice: Intent to withdraw 9/9/1993 proposed rule4/22/200368FR19766
Final RuleDateFR Citation
Notice: Withdraws 9/9/1993 proposed rule11/26/200469FR68831


Page Last Updated: 06/16/2017
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