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Rulemaking History for OTC Weight Control Drug Products
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Date Federal Register Citation Description

2/26/1982

 47FR8466 PDF document

Advance Notice of Proposed Rulemaking

4/20/1982

 47FR16796 PDF document

Correction: Advance Notice of Proposed Rulemaking

4/23/1982

 47FR17576 PDF document

Extension of Comment Period: Phenylpropanolamine (PPA) safety

4/27/1982

 47FR18004 PDF document

Correction: Advance Notice of Proposed Rulemaking

8/13/1982

 47FR35344 PDF document

Notice: Combinations containing caffeine, phenylpropanolamine (PPA), and ephedrine are nonmonograph

11/18/1983

48FR52513 PDF document

Notice: Combinations containing caffeine, phenylpropanolamine (PPA), and ephedrine are nonmonograph

10/30/1990

 55FR45788 PDF document

Tentative Final Monograph

10/30/1990

 55FR45782 PDF document

Proposed Rule: Requires choking warning for water-soluble gums

11/26/1990

 55FR49200 PDF document

Correction: Tentative Final Monograph

11/27/1990

 55FR49377 PDF document

Correction: 10/30/1990 Proposed Rule

3/6/1991

 56FR9312 PDF document

Clarification: Guar gums remain nonmonograph (10/30/1990 Proposed Rule)

4/1/1991

 56FR13295 PDF document

Reopening of Administrative Record: Advisory Committee on phenylpropanolamine (PPA)

4/11/1991

 56FR14730 PDF document

Correction: 4/1/1991 Reopening of Administrative Record

8/8/1991

 56FR37792 PDF document

Final Monograph: No GRASE active ingredients

8/13/1991

 56FR38391 PDF document

Reopening of Comment Period: 4/1/1991 Reopening of Administrative Record

9/16/1991

 56FR46823 PDF document

Correction: Final Monograph

8/26/1993

58FR45194 PDF document Final Rule: Requires choking warning for water-soluble gums

8/30/2000

65FR52775 PDF document Notice: Advisory Committee meeting
12/22/2005 70FR75988 PDF document
[HTML]
Proposed Rule: Reclassifies phenylpropanolamine (PPA) from category I to II
12/22/2005 70FR75988 PDF document
[HTML]
Proposed Rule: Reclassifies phenylpropanolamine (PPA) from category I to II
6/20/2008 73FR34895 PDF document Proposed Rule: 60+ Drug Categories

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Date updated: September 8, 2008

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