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In this section: Historical Status of OTC Rulemakings

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

FDA Archive-It webpage:

Rulemaking History for OTC Hormone Drug Products

Search for Federal Register documents:

GPO Federal Register Database (1994 to present)
HeinOnline provides online access to Federal Registers from 1936-forward

OTC Hormone Drug Products found on this page:

Drug Rulemakings
Related Cosmetic Rulemakings

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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