Drugs

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 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	4/22/1996	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
Notice: Request for comment on Drug Facts information collection	1/4/2005	70FR362
Notice: OMB submission on Drug Facts information collection	3/29/2005	70FR15864
Proposed Rule	Date	FR Citation
Proposed Rule	2/27/1997	62FR9024
Extension of Comment Period	6/19/1997	62FR33379
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 Draft Guidance	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

**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

**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