Rulemaking History for OTC Acne Drug Products

Final Monograph (21 CFR part 333 subpart D)
Topical Anti-Microbial Drug Products for Over-the-Counter Human Use

OTC Acne Drug Products found on this page:

• Original Active Ingredients & Labeling
• Benzoyl Peroxide
• Nonmonograph Ingredients
• Time and Extent Application

Acne Drug Products: Original Active Ingredients & Labeling

Advance Notice Of Proposed Rulemaking	Date	FR Citation
Advance Notice of Proposed Rulemaking	3/23/1982	47FR12430
Correction	4/23/1982	47FR17575
Proposed Rule	Date	FR Citation
Tentative Final Monograph	1/15/1985	50FR2172
Final Rule	Date	FR Citation
Final Monograph	8/16/1991	56FR41008

Acne Drug Products: Benzoyl Peroxide

Advance Notice Of Proposed Rulemaking	Date	FR Citation
Advance Notice of Proposed Rulemaking	3/23/1982	47FR12430
Correction	4/23/1982	47FR17575
Proposed Rule	Date	FR Citation
Tentative Final Monograph	1/15/1985	50FR2172
Proposed Rule: Reclassifies benzoyl peroxide from GRASE to Category III	8/7/1991	56FR37622
Correction	10/8/1991	56FR50754
Proposed Rule: Additional labeling	2/17/1995	60FR9554
Extension of Comment Period	5/19/1995	60FR26853
Final Rule	Date	FR Citation
Final Monograph	3/4/2010	75FR9767

Acne Drug Products: Nonmonograph Ingredients

Proposed Rule	Date	FR Citation
Proposed Rule: Classifies category II and III ingredients without data as nonmonograph	5/16/1990	55FR20434
Correction	6/7/1990	55FR23235
Final Rule	Date	FR Citation
Final Rule: Classifies category II and III ingredients without data as nonmonograph	11/7/1990	55FR46914
Correction	12/3/1990	55FR49973
Technical Amendment: Corrects an ingredient name	1/30/1992	57FR3526

Acne Drug Products: Time and Extent Application

Advance Notice Of Proposed Rulemaking	Date	FR Citation
Request for Data: triclosan	12/5/2005	70FR72447