Drugs

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
[PDF]

OTC Weight Control Drug Products found on this page:

Weight Control Drug Products: Benzocaine

Advance Notice Of Proposed RulemakingDateFR Citation
Advance Notice of Proposed Rulemaking [PDF]2/26/198247FR8466
    Correction [PDF]4/20/198247FR16796
    Correction [PDF]4/27/198247FR18004
Proposed RuleDateFR Citation
Proposed Rule: Proposes to reclassify benzocaine as nonmonograph disclaimer icon3/9/201176FR12916

Weight Control Drug Products: Original Active Ingredients and Labeling

Advance Notice Of Proposed RulemakingDateFR Citation
Advance Notice of Proposed Rulemaking [PDF]2/26/198247FR8466
    Correction [PDF]4/20/198247FR16796
    Correction [PDF]4/27/198247FR18004
    Extension of Comment Period: Phenylpropanolamine safety [PDF]4/23/198247FR17576
Notice: Combinations containing caffeine, phenylpropanolamine, and ephedrine are nonmonograph [PDF]8/13/198247FR35344
Notice: Combinations containing caffeine, phenylpropanolamine, and ephedrine are nonmonograph [PDF]11/18/198348FR52513
Proposed RuleDateFR Citation
Tentative Final Monograph [PDF]10/30/199055FR45788
    Correction [PDF]11/26/199055FR49200
Final RuleDateFR Citation
Final Monograph: No GRASE active ingredients [PDF]8/8/199156FR37792
    Correction [PDF]9/16/199156FR46823

Weight Control Drug Products: Nonmonograph Ingredients

Proposed RuleDateFR Citation
Proposed Rule: 60+ Drug Categories [PDF]6/19/200873FR34895

Weight Control Drug Products: Phenylpropanolamine (PPA)

Advance Notice Of Proposed RulemakingDateFR Citation
Advance Notice of Proposed Rulemaking [PDF]2/26/198247FR8466
    Correction [PDF]4/20/198247FR16796
    Correction [PDF]4/27/198247FR18004
    Extension of Comment Period: Phenylpropanolamine safety [PDF]4/23/198247FR17576
Reopening of Administrative Record: Advisory Committee meeting [PDF]4/1/199156FR13295
    Correction [PDF]4/11/199156FR14730
    Extension of Comment Period [PDF]8/13/199156FR38391
Notice: Advisory Committee meeting [PDF]
 
8/30/200065FR52775
Proposed RuleDateFR Citation
Proposed Rule: Reclassifies phenylpropanolamine from category I to II [PDF]12/22/200570FR75988

Weight Control Drug Products: Water-Soluble Gums

Proposed RuleDateFR Citation
Proposed Rule: Requires choking warning [PDF]10/30/199055FR45782
    Correction [PDF]11/27/199055FR49377
    Clarification: Guar gums remain nonmonograph [PDF]3/6/199156FR9312
Final RuleDateFR Citation
Final Rule [PDF]8/26/199358FR45194

 

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