U.S. flag An official website of the United States government
  1. Home
  2. Drugs
  3. Development & Approval Process | Drugs
  4. How Drugs are Developed and Approved
  5. Over-the-Counter OTC | Nonprescription Drugs
  6. Status of OTC Rulemakings
  7. Rulemaking History for OTC Hormone Drug Products
  1. 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:

Search for Federal Register documents:

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