| Date |
Federal Register Citation |
Description |
| 7/2/1982 |
47FR29002  |
Notice: Public hearing on exclusivity policy |
| 9/7/1982 |
47FR39470 |
Proposed Rule: Pregnancy warning required for systemically absorbed OTC drugs |
| 9/21/1982 |
47FR41580 |
Correction: 9/7/1982 Proposed Rule |
| 12/3/1982 |
47FR54750 |
Final Rule: Requires pregnancy warning for systemically absorbed OTC drugs |
| 4/1/1983 |
48FR14048 |
Notice: Requires warning in professional labeling for reserpine |
| 8/31/1983 |
48FR39452 |
Notice: Exempts some drugs from pregnancy warning (12/3/1982 Final Rule) |
| 11/30/1983 |
48FR54077 |
Notice: Requests comment on requiring pregnancy warning for all OTC drugs |
| 4/22/1985 |
50FR15810 |
Proposed Rule: Allows alternative language for indications (exclusivity policy) |
| 4/17/1986 |
51FR13023 |
Proposed Rule: Requires statement of identity for single actives and combinations as stated in OTC drug monographs |
| 5/1/1986 |
51FR16258 |
Final Rule: Allows alternative language for indications (exclusivity policy) |
| 5/21/1986 |
51FR18580 |
Correction: 5/1/1986 Final Rule |
| 6/3/1986 |
51FR19853 |
Extension of Comment Period: 4/17/1986 Proposed Rule |
| 3/13/1987 |
52FR7830 |
Correction: 5/1/1986 Final Rule |
| 11/16/1988 |
53FR46204 |
Proposed Rule: Specific pregnancy warning for oral and rectal aspirin-containing OTC products |
| 7/5/1990 |
55FR27776 |
Final Rule: Specific pregnancy warning for oral and rectal aspirin-containing OTC products |
| 3/6/1991 |
56FR9363 |
Notice: Request for Comment on print size requirements |
| 4/9/1991 |
56FR14384 |
Extension of Comment Period: 3/6/1991 Notice |
| 4/25/1991 |
56FR19222 |
Proposed Rule: Requires sodium content labeling for oral OTC drugs |
| 5/22/1991 |
56FR23619 |
Correction: 4/25/1991 Proposed Rule |
| 6/12/1991 |
56FR26946 |
Extension of Comment Period: 4/25/1991 Proposed Rule |
| 4/5/1993 |
58FR17533 |
Proposed Rule: Miscellaneous additional interchangeable terms |
| 11/9/1993 |
58FR59622 |
Proposed Rule: Exclusivity policy applies to approved NDAs |
| 1/28/1994 |
59FR3998 |
Final Rule: Miscellaneous additional interchangeable terms |
| 8/3/1994 |
59FR39499 |
Proposed Rule: Additional interchangeable terms "do not mix drugs"; requests comment on revising "do not use" warning |
| 8/16/1995 |
60FR42578
[HTML] |
Notice: Hearing on OTC labeling |
| 10/4/1995 |
60FR52058
[HTML] |
Proposed Rule: Additional interchangeable terms "do not use with" |
| 2/14/1996 |
61FR5912
[HTML] |
Proposed Rule: Requires warnings for phenylpropanolamine (PPA) |
| 3/4/1996 |
61FR8450
[HTML] |
Proposed Rule: Additional interchangeable terms "unless a doctor tells you" |
| 4/22/1996 |
61FR17807
[HTML] |
Proposed Rule: Requires calcium, magnesium, and potassium content labeling for oral OTC drug products |
| 4/22/1996 |
61FR17798
[HTML] |
Final Rule: Requires sodium content labeling for oral OTC drugs |
| 7/22/1996 |
61FR38047
[HTML] |
Extension of Comment Period: 4/22/1996 Proposed Rule |
| 7/22/1996 |
61FR38046
[HTML] |
Extension of Comment Period: 4/22/1996 Final Rule |
| 8/19/1996 |
61FR42826
[HTML] |
Correction: 4/22/1996 Proposed Rule |
| 2/27/1997 |
62FR9024
[HTML] |
Proposed Rule: Drug Facts |
| 3/21/1997 |
62FR13733 |
Correction: 4/22/1996 Final Rule |
| 4/24/1997 |
62FR19923
[HTML] |
Partial Delay of Effective Date: Delays to coincide with calcium, magnesium, potassium final rule (4/22/1996 Final Rule) |
| 6/19/1997 |
62FR33379
[HTML] |
Extension of Comment Period: 2/27/1997 Proposed Rule |
| 3/17/1999 |
64FR13254
[HTML] |
Final Rule: Drug Facts |
| 4/15/1999 |
64FR18571
[HTML] |
Correction: 3/17/1999 Final Rule |
| 12/1/1999 |
64FR67291
[HTML] |
Notice: Draft Guidance on Drug Facts |
| 1/3/2000 |
65FR7
[HTML] |
Technical Amendment: Clarifies Drug Facts regulations (3/17/1999 Final Rule) |
| 6/20/2000 |
65FR38191
[HTML] |
Partial Extension of Compliance Dates: 3/17/1999 Final Rule |
| 12/19/2000 |
65FR79371
|
Notice: Draft Guidance on submitting exemptions to Drug Facts |
| 4/5/2002 |
67FR16304
[HTML] |
Partial Delay of Compliance Date: Convenience size OTC drugs (3/17/1999 Final Rule) |
| 3/24/2004 |
69FR13717
[HTML] |
Technical Amendment: Changes Dockets name to "Division of Dockets Management" (4/22/1996 Final Rule) |
| 3/24/2004 |
69FR13725
[HTML] |
Final Rule: Requires calcium, magnesium, and potassium content labeling for oral OTC drug products |
| 3/24/2004 |
69FR13765
[HTML] |
Proposed Rule: Requires sodium content labeling for rectal OTC Drugs |
| 4/22/2004 |
69FR21778
[HTML] |
Proposed Rule: Requires toll-free number for reporting adverse events |
| 9/3/2004 |
69FR53801
[HTML] |
Delay of Implementation: Sunscreen Drug Facts (3/17/1999 Final Rule) |
| 11/29/2004 |
69FR69278
[HTML] |
Final Rule: Requires sodium content labeling for rectal OTC Drugs |
| 12/9/2004 |
69FR71420
[HTML]
The Draft Guidance |
Notice: Draft compliance guidance on Drug Facts |
| 1/4/2005 |
70FR362
[HTML] |
Notice: Request for comment on Drug Facts information collection |
| 1/13/2005 |
70FR2415
[HTML]
The Draft Guidance |
Notice: Draft compliance guidance on Drug Facts; Questions and Answers |
| 3/29/2005 |
70FR15864
[HTML] |
Notice: OMB submission on Drug Facts information collection |
| 12/12/2006 |
71FR74474
[HTML]
|
Proposed Rule: Convenience-size labeling |
| 1/3/2008 |
73FR402
|
Interim Final Rule: Requires toll-free number for reporting adverse events |
| 10/28/2008 |
73FR63886
|
Final Rule: Requires toll-free number for reporting adverse events |
