U.S. flag An official website of the United States government
  1. Home
  2. Drugs
  3. Development & Approval Process | Drugs
  4. Development Resources
  5. Over-the-Counter (OTC) Drugs
  6. Status of OTC Rulemakings
  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 RulemakingDateFR Citation
Advance Notice of Proposed Rulemaking2/26/198247FR8466
    Correction4/20/198247FR16796
    Correction4/27/198247FR18004
Proposed RuleDateFR Citation
Proposed Rule: Proposes to reclassify benzocaine as nonmonograph3/9/201176FR12916

Weight Control Drug Products: Original Active Ingredients and Labeling

Advance Notice Of Proposed RulemakingDateFR Citation
Advance Notice of Proposed Rulemaking2/26/198247FR8466
    Correction4/20/198247FR16796
    Correction4/27/198247FR18004
    Extension of Comment Period: Phenylpropanolamine safety4/23/198247FR17576
Notice: Combinations containing caffeine, phenylpropanolamine, and ephedrine are nonmonograph8/13/198247FR35344
Notice: Combinations containing caffeine, phenylpropanolamine, and ephedrine are nonmonograph11/18/198348FR52513
Proposed RuleDateFR Citation
Tentative Final Monograph10/30/199055FR45788
    Correction11/26/199055FR49200
Final RuleDateFR Citation
Final Monograph: No GRASE active ingredients8/8/199156FR37792
    Correction9/16/199156FR46823

Weight Control Drug Products: Nonmonograph Ingredients

Proposed RuleDateFR Citation
Proposed Rule: 60+ Drug Categories6/19/200873FR34895

Weight Control Drug Products: Phenylpropanolamine (PPA)

Advance Notice Of Proposed RulemakingDateFR Citation
Advance Notice of Proposed Rulemaking2/26/198247FR8466
    Correction4/20/198247FR16796
    Correction4/27/198247FR18004
    Extension of Comment Period: Phenylpropanolamine safety4/23/198247FR17576
Reopening of Administrative Record: Advisory Committee meeting4/1/199156FR13295
    Correction4/11/199156FR14730
    Extension of Comment Period8/13/199156FR38391
Notice: Advisory Committee meeting8/30/200065FR52775
Proposed RuleDateFR Citation
Proposed Rule: Reclassifies phenylpropanolamine from category I to II12/22/200570FR75988

Weight Control Drug Products: Water-Soluble Gums

Proposed RuleDateFR Citation
Proposed Rule: Requires choking warning10/30/199055FR45782
    Correction11/27/199055FR49377
    Clarification: Guar gums remain nonmonograph3/6/199156FR9312
Final RuleDateFR Citation
Final Rule8/26/199358FR45194
Back to Top