Rulemaking History for OTC Weight Control Drug Products

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Rulemaking History for OTC Weight Control Drug Products
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Final Monograph (21 CFR 310.545(a)(20)):
Drug products containing certain active ingredients offered over-the-counter (OTC) for certain uses
[PDF]

OTC Weight Control Drug Products found on this page:

Original Active Ingredients and Labeling
Nonnonograph Ingredients
Phenylpropanolamine (PPA)
Water-Soluble Gums

Note: This page links to PDF files which require the free Adobe Acrobat Reader.

**Weight Control Drug Products: Original Active Ingredients and Labeling**
Advance Notice Of Proposed Rulemaking	Date	FR Citation
Advance Notice of Proposed Rulemaking	2/26/1982	47FR8466
Correction	4/20/1982	47FR16796
Correction	4/27/1982	47FR18004
Extension of Comment Period: Phenylpropanolamine safety	4/23/1982	47FR17576
Notice: Combinations containing caffeine, phenylpropanolamine, and ephedrine are nonmonograph	8/13/1982	47FR35344
Notice: Combinations containing caffeine, phenylpropanolamine, and ephedrine are nonmonograph	11/18/1983	48FR52513
Proposed Rule	Date	FR Citation
Tentative Final Monograph	10/30/1990	55FR45788
Correction	11/26/1990	55FR49200
Final Rule	Date	FR Citation
Final Monograph: No GRASE active ingredients	8/8/1991	56FR37792
Correction	9/16/1991	56FR46823

**Weight Control Drug Products: Nonmonograph Ingredients**
Proposed Rule	Date	FR Citation
Proposed Rule: 60+ Drug Categories	6/19/2008	73FR34895

**Weight Control Drug Products: Phenylpropanolamine (PPA)**
Advance Notice Of Proposed Rulemaking	Date	FR Citation
Advance Notice of Proposed Rulemaking	2/26/1982	47FR8466
Correction	4/20/1982	47FR16796
Correction	4/27/1982	47FR18004
Extension of Comment Period: Phenylpropanolamine safety	4/23/1982	47FR17576
Reopening of Administrative Record: Advisory Committee meeting	4/1/1991	56FR13295
Correction	4/11/1991	56FR14730
Extension of Comment Period	8/13/1991	56FR38391
Notice: Advisory Committee meeting	8/30/2000	65FR52775
Proposed Rule	Date	FR Citation
Proposed Rule: Reclassifies phenylpropanolamine from category I to II	12/22/2005	70FR75988

**Weight Control Drug Products: Water-Soluble Gums**
Proposed Rule	Date	FR Citation
Proposed Rule: Requires choking warning	10/30/1990	55FR45782
Correction	11/27/1990	55FR49377
Clarification: Guar gums remain nonmonograph	3/6/1991	56FR9312
Final Rule	Date	FR Citation
Final Rule	8/26/1993	58FR45194

Date created: December 28, 2006;Last updated: September 8, 2008