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:
- Calcium, Magnesium, and Potassium
- Exclusivity Policy
- Phenylpropanolamine (PPA)
- Pregnancy Warning
- Sodium Labeling
- Drug Facts Format
- Statement of Identity
- Adverse Event Reporting
- Convenience-Size
- Label Comprehension Studies
- Dosage Delivery Devices
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 |