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Rulemaking History for OTC Anticaries Drug Products
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Final Monograph (21 CFR part 355):  
Anticaries Drug Products for Over-the-Counter Human Use
 


Date Federal Register Citation Description

3/28/1980

45FR20666 PDF document

Advance Notice of Proposed Rulemaking

5/20/1980

45FR33650 PDF document

Correction: Advance Notice of Proposed Rulemaking

8/26/1983

48FR38853 PDF document

Notice: Public meeting on final formulation testing

10/25/1983

48FR49304 PDF document

Extension of Comment Period: 8/26/1983 notice

9/30/1985

50FR39854 PDF document

Tentative Final Monograph

10/24/1985

50FR43233 PDF document

Correction: Tentative Final Monograph

6/15/1988

53FR22430 PDF document

Proposed Rule: Final formulation testing

2/21/1989

54FR7448 PDF document

Extension of Comment Period: Tentative Final Monograph

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

5/8/1992

57FR19823 PDF document

Reopening of Administrative Record: Package size limitation

5/19/1992

57FR21332 PDF document

Correction: 5/8/1992 Reopening of Administrative Record

11/24/1992

57FR55199 PDF document

Reopening of Administrative Record: Fluoride labeling

1/26/1993

58FR6102 PDF document

Extension of Comment Period: 11/24/1992 Reopening of Administrative Record

10/6/1995 60FR52474 PDF document
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Final Monograph

10/7/1996

61FR52285 PDF document
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Technical Amendment: Revises "dentrifice" definition & "accidental ingestion" warning

12/16/1996

61FR65944 PDF document

Partial Stay: Final Monograph

10/15/2001

66FR52418 PDF document

Request for Data: To comply with biological testing requirements (intraoral appliance models)

3/15/2002

67FR11704 PDF document
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Reopening of Comment Period: 10/15/2001 Request for Data

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Date updated: May 9, 2007

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