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  7. Rulemaking History for OTC Weight Control Drug Products
  1. Status of OTC Rulemakings

Rulemaking History for OTC Weight Control Drug Products

Final Monograph (21 CFR 310.545(a)(20)):
Drug products containing certain active ingredients offered over-the-counter (OTC) for certain uses

OTC Weight Control Drug Products found on this page:

Weight Control Drug Products: Benzocaine

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
Proposed Rule Date FR Citation
Proposed Rule: Proposes to reclassify benzocaine as nonmonograph 3/9/2011 76FR12916

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
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