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Rulemaking History of General
Labeling Requirements for OTC Drug Products View by Date
OTC Drug Product Labeling found on this page:
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 |
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Date created: December 28, 2006; Last updated May 9, 2007 |
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