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Rulemaking History of General Labeling Requirements for OTC Drug Products

OTC Drug Product Labeling Regulations (21 CFR part 201 subpart C):
Labeling Requirements for Over-the-Counter Drugs 

OTC Drug Product Labeling found on this page:

Labeling of Drug Products: Calcium, Magnesium and Potassium
Proposed RuleDateFR Citation
Proposed Rule: Requires labeling for oral OTC drug products [PDF]4/22/199661FR17807
    Extension of Comment Period [PDF]7/22/199661FR38047
    Correction [PDF]8/19/199661FR42826
Final RuleDateFR Citation
Final Rule [PDF]3/24/200469FR13725

Labeling of Drug Products: Exclusivity Policy
Advance Notice Of Proposed RulemakingDateFR Citation
Notice: Public hearing [PDF]7/2/198247FR29002
Proposed RuleDateFR Citation
Proposed Rule: Allows alternative language for indications (exclusivity policy) [PDF]4/22/198550FR15810
Proposed Rule: Miscellaneous additional interchangeable terms [PDF]4/5/199358FR17553
Proposed Rule: Exclusivity policy applies to approved NDAs [PDF]11/9/199358FR59622
Proposed Rule: Additional interchangeable terms "do not mix drugs"; requests comment on revising "do not use" warning [PDF]8/3/199459FR39499
Proposed Rule: Additional interchangeable terms "do not use with" [PDF]10/4/199560FR52058
Proposed Rule: Additional interchangeable terms "unless a doctor tells you" [PDF]3/4/199661FR8450
Final RuleDateFR Citation
Final Rule: Allows alternative language for indications (exclusivity policy) [PDF]5/1/198651FR16258
    Correction [PDF]5/21/198651FR18580
    Correction [PDF]3/13/198752FR7830
Final Rule: Miscellaneous additional interchangeable terms1/28/199459FR3998

Labeling of Drug Products: Phenylpropanolamine (PPA)
Proposed RulesDateFR Citation
Proposed Rule: Requires warning [PDF]2/14/199661FR5912
Notice of Withdrawal [PDF]12/12/200873FR75625

Labeling of Drug Products: Pregnancy Warning
Advance Notice Of Proposed RulemakingDateFR Citation
Proposed RuleDateFR Citation
Proposed Rule: Requires warning for systemically absorbed OTC drugs [PDF]9/7/198247FR39470
    Correction [PDF]9/21/198247FR41580
    Reopening of Administrative Record: Requests comment on requiring warning for all OTC drugs [PDF]11/30/198348FR54077
Proposed Rule: Specific warning for oral and rectal aspirin- containing OTC products [PDF]11/16/198853FR46204
Final RuleDateFR Citation
Final Rule [PDF]12/3/198247FR54750
    Notice: Exemptions to 12/3/1982 final rule [PDF]8/31/198348FR39452
Final Rule: Specific warning for oral and rectal aspirin-containing OTC products [PDF]7/5/199055FR27776

Labeling of Drug Products: Sodium Labeling
Proposed RuleDateFR Citation
Proposed Rule: Requires labeling for oral OTC drugs [PDF]4/25/199156FR19222
    Correction [PDF]5/22/199156FR23619
    Extension of Comment Period [PDF]6/12/199156FR26946
Proposed Rule: Requires labeling for rectal OTC drugs [PDF]3/24/200469FR13765
Final RuleDateFR Citation
Final Rule: Requires labeling for oral OTC drugs [PDF]4/22/199561FR17798
    Extension of Comment Period [PDF]7/22/199661FR38046
    Correction [PDF]3/21/199762FR13733
    Partial Delay of Effective Date: Delays to coincide with calcium, magnesium, potassium final rule [PDF]4/24/199762FR19923
    Technical Amendment: Termination of delay of effective date [PDF]3/24/200469FR13717
Final Rule: Requires labeling for rectal OTC drugs [PDF]11/29/200469FR69278

Labeling of Drug Products: Drug Facts Format
Advance Notice Of Proposed RulemakingDateFR Citation
Notice: Request for comment on print size requirements [PDF]3/6/199156FR9363
    Extension of Comment Period [PDF]4/9/199156FR14384
Notice: Hearing on OTC labeling [PDF]8/16/199560FR42578
Proposed RuleDateFR Citation
Proposed Rule [PDF]2/27/199762FR9024
   Extension of Comment Period [PDF]6/19/199762FR33379
Notice: Availability of Study Data and Reopening of Comment Period [PDF]12/30/199762FR67770
Notice: Availability of Study Data and Reopening of Comment Period [PDF]2/13/199863FR7331
Final RuleDateFR Citation
Final Rule [PDF]3/17/199964FR13254
    Correction [PDF]4/15/199964FR18571
    Technical Amendment: Clarifies regulations [PDF]1/3/200065FR7
    Partial Extension of Compliance Dates [PDF]6/20/200065FR38191
    Partial Delay of Compliance Dates: Convenience size OTC drugs [PDF]4/5/200267FR16304
    Delay of Implementation: OTC sunscreen drugs [PDF]9/3/200469FR53801
Notice: Draft Guidance on Drug Facts [PDF]12/1/199964FR67291
Notice: Draft Guidance on submitting exemptions to Drug Facts [PDF]12/19/200065FR79371

Notice: Draft Guidance on Drug Facts [PDF]

 Draft Guidance [PDF]

12/9/200469FR71420

Notice: Draft Guidance on Drug Facts; Q and A [PDF]

 Draft Guidance [PDF]

1/13/200570FR2415

Notice: Guidance on Drug Facts; Q and A

 Guidance [PDF]

1/5/200974FR303
PRA 60-Day Notice: Extension of Collection Activity [PDF]1/4/200570FR362
PRA 30-Day Notice: Extension of Collection Activity [PDF]3/29/200570FR15864
PRA 60-day Notice: Reinstatement of Collection Activity [PDF]6/3/201075FR31448
PRA 30-day Notice: Reinstatement of Collection Activity [PDF]8/13/201075FR49495
OMB Approval Notice: Reinstatement of Collection Activity2/16/201176FR9022

Labeling of Drug Products: Statement of Identity
Proposed RuleDate FR Citation
Proposed Rule: Requires for single actives and combinations as stated in OTC drug monographs [PDF]4/17/198651FR13023
    Extension of Comment Period [PDF]6/3/198651FR19853

Labeling of Drug Products: Adverse Event Reporting
Proposed RuleDate FR Citation
Proposed Rule: Requires toll-free number for reporting adverse events [PDF]4/22/200469FR21778
Final RuleDateFR Citation
Interim Final Rule: Requires toll-free number for reporting adverse events [PDF]1/3/2008  73FR402
Final Rule: Requires toll-free number for reporting adverse events [PDF]10/28/200873FR63886
Notice: Draft Guidance on Labeling: Q and A [PDF]12/11/200873FR75436

Notice: Guidance on Labeling: Q and A [PDF]

Guidance [PDF]

9/1/2009  74FR45222

Labeling of Drug Products: Convenience-Size
Proposed RuleDate FR Citation
Proposed Rule: Defines "convenience-size" & allows alternative labeling [PDF]12/12/200671FR74474

Labeling of Drug Products: Label Comprehension Studies
Proposed RuleDate FR Citation
Notice: Label Comprehension Studies [PDF]
Draft Guidance [PDF]
5/1/200974FR20322
Notice of Availability: Final Guidance [PDF]8/3/201075FR45641

Labeling of Drug Products: Dosage Delivery Devices
Proposed RuleDate FR Citation
Notice: Draft Guidance on Dosage Delivery Devices for Liquid Products [PDF]
Draft Guidance [PDF]
11/5/200974FR57319