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  6. Historical Status of OTC Rulemakings
  7. Rulemaking History of General Labeling Requirements for OTC Drug Products
  1. Historical Status of OTC Rulemakings

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

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OTC Drug Product Labeling found on this page:

Labeling of Drug Products: Calcium, Magnesium and Potassium

Proposed Rule Date FR Citation
Proposed Rule: Requires labeling for oral OTC drug products 4/22/1996 61FR17807
    Extension of Comment Period 7/22/1996 61FR38047
    Correction 8/19/1996 61FR42826
Final Rule Date FR Citation
Final Rule 3/24/2004 69FR13725

Labeling of Drug Products: Exclusivity Policy

Advance Notice Of Proposed Rulemaking Date FR Citation
Notice: Public hearing 7/2/1982 47FR29002
Proposed Rule Date FR Citation
Proposed Rule: Allows alternative language for indications (exclusivity policy) 4/22/1985 50FR15810
Proposed Rule: Miscellaneous additional interchangeable terms 4/5/1993 58FR17553
Proposed Rule: Exclusivity policy applies to approved NDAs 11/9/1993 58FR59622
Proposed Rule: Additional interchangeable terms "do not mix drugs"; requests comment on revising "do not use" warning 8/3/1994 59FR39499
Proposed Rule: Additional interchangeable terms "do not use with" 10/4/1995 60FR52058
Proposed Rule: Additional interchangeable terms "unless a doctor tells you" 3/4/1996 61FR8450
Final Rule Date FR Citation
Final Rule: Allows alternative language for indications (exclusivity policy) 5/1/1986 51FR16258
    Correction 5/21/1986 51FR18580
    Correction 3/13/1987 52FR7830
Final Rule: Miscellaneous additional interchangeable terms 1/28/1994 59FR3998

Labeling of Drug Products: Phenylpropanolamine (PPA)

Proposed Rules Date FR Citation
Proposed Rule: Requires warning 2/14/1996 61FR5912
Notice of Withdrawal 12/12/2008 73FR75625

Labeling of Drug Products: Pregnancy Warning

Advance Notice Of Proposed Rulemaking Date FR Citation
Proposed Rule Date FR Citation
Proposed Rule: Requires warning for systemically absorbed OTC drugs 9/7/1982 47FR39470
    Correction 9/21/1982 47FR41580
    Reopening of Administrative Record: Requests comment on requiring warning for all OTC drugs 11/30/1983 48FR54077
Proposed Rule: Specific warning for oral and rectal aspirin- containing OTC products 11/16/1988 53FR46204
Final Rule Date FR Citation
Final Rule 12/3/1982 47FR54750
    Notice: Exemptions to 12/3/1982 final rule 8/31/1983 48FR39452
Final Rule: Specific warning for oral and rectal aspirin-containing OTC products 7/5/1990 55FR27776

Labeling of Drug Products: Sodium Labeling

Proposed Rule Date FR Citation
Proposed Rule: Requires labeling for oral OTC drugs 4/25/1991 56FR19222
    Correction 5/22/1991 56FR23619
    Extension of Comment Period 6/12/1991 56FR26946
Proposed Rule: Requires labeling for rectal OTC drugs 3/24/2004 69FR13765
Final Rule Date FR Citation
Final Rule: Requires labeling for oral OTC drugs 4/22/1995 61FR17798
    Extension of Comment Period 7/22/1996 61FR38046
   Correction 3/21/1997 62FR13733
    Partial Delay of Effective Date: Delays to coincide with calcium, magnesium, potassium final rule 4/24/1997 62FR19923
   Technical Amendment: Termination of delay of effective date 3/24/2004 69FR13717
Final Rule Requires labeling for rectal OTC drugs 11/29/2004 69FR69278

Labeling of Drug Products: Drug Facts Format

Advance Notice Of Proposed Rulemaking Date FR Citation
Notice: Request for comment on print size requirements 3/6/1991 56FR9363
   Extension of Comment Period 4/9/1991 56FR14384
Notice: Hearing on OTC labeling 8/16/1995 60FR42578
Proposed Rule Date FR Citation
Proposed Rule 2/27/1997 62FR9024
   Extension of Comment Period 6/19/1997 62FR33379
Notice: Availability of Study Data and Reopening of Comment Period 12/30/1997 62FR67770
Notice: Availability of Study Data and Reopening of Comment Period 2/13/1998 63FR7331
Final Rule Date FR Citation
Final Rule 3/17/1999 64FR13254
   Correction 4/15/1999 64FR18571
    Technical Amendment: Clarifies regulations 1/3/2000 65FR7
   Partial Extension of Compliance Dates 6/20/2000 65FR38191
   Partial Delay of Compliance Dates: Convenience size OTC drugs 4/5/2002 67FR16304
    Delay of Implementation: OTC sunscreen drugs 9/3/2004 69FR53801
Notice: Draft Guidance on Drug Facts 12/1/1999 64FR67291
Notice: Draft Guidance on submitting exemptions to Drug Facts 12/19/2000 65FR79371
Notice: Draft Guidance on Drug Facts
 12/9/2004 69FR71420
Notice: Draft Guidance on Drug Facts; Q and A
 Draft Guidance

 

 1/13/2005 70FR2415
Notice: Guidance on Drug Facts; Q and A
 Guidance

 

 1/5/2009 74FR303
PRA 60-Day Notice: Extension of Collection Activity 1/4/2005 70FR362
PRA 30-Day Notice: Extension of Collection Activity 3/29/2005 70FR15864
PRA 60-day Notice: Reinstatement of Collection Activity 6/3/2010 75FR31448
PRA 30-day Notice: Reinstatement of Collection Activity 8/13/2010 75FR49495
OMB Approval Notice: Reinstatement of Collection Activity 2/16/2011 76FR9022

Labeling of Drug Products: Statement of Identity

Proposed Rule Date  FR Citation
Proposed Rule: Requires for single actives and combinations as stated in OTC drug monographs 4/17/1986 51FR13023
    Extension of Comment Period 6/3/1986 51FR19853

Labeling of Drug Products: Adverse Event Reporting

Proposed Rule Date FR Citation
Proposed Rule: Requires toll-free number for reporting adverse events 4/22/2004 69FR21778
Final Rule Date FR Citation
Interim Final Rule: Requires toll-free number for reporting adverse events 1/3/2008 73FR402
Final Rule: Requires toll-free number for reporting adverse events 10/28/2008 73FR63886
Notice: Draft Guidance on Labeling: Q and A 12/11/2008 73FR75436
Notice: Guidance on Labeling: Q and A
Guidance		 9/1/2009 74FR45222

Labeling of Drug Products: Convenience-Size

Proposed Rule Date FR Citation
Proposed Rule: Defines "convenience-size" & allows alternative labeling 12/12/2006 71FR74474

Labeling of Drug Products: Label Comprehension Studies

Proposed Rule Date  FR Citation
Notice: Label Comprehension Studies
Draft Guidance		 5/1/2009 74FR20322
Notice of Availability: Final Guidance 8/3/2010 75FR45641

Labeling of Drug Products: Dosage Delivery Devices

Proposed Rule Date FR Citation
Notice: Draft Guidance on Dosage Delivery Devices for Liquid Products
Draft Guidance		 11/5/2009 74FR57319

 

 
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