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Rulemaking History for OTC Hormone Drug Products
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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:

Note: This page links to PDF files which require the free Adobe Acrobat Reader.


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

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

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Date created: December 28, 2006; Last updated: May 4, 2007

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