Rulemaking History for OTC Nighttime Sleep-Aid Drug Products
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Date	Federal Register Citation	Description
12/8/1975	40FR57292	Advance Notice of Proposed Rulemaking
1/8/1976	41FR1498	Correction: Advance Notice of Proposed Rulemaking
1/26/1976	41FR3745	Correction: Advance Notice of Proposed Rulemaking
1/30/1976	41FR4600	Correction: Advance Notice of Proposed Rulemaking
6/13/1978	43FR25544	Tentative Final Monograph
10/26/1979	44FR61611	Reopening of Administrative Record: Tentative Final Monograph
11/16/1979	44FR65992	Correction: 10/26/1979 Reopening of Administrative Record
3/21/1980	45FR18399	Notice of acceptance of data and information into the administrative record
4/23/1982	47FR17740	Notice: Allows marketing of diphenhydramine
2/14/1989	54FR6814	Final Monograph
8/26/1993	58FR45217	Proposed Rule: Revises warnings to be consistent with antihistamines and antitussives
4/11/1994	59FR16982	Final Rule: Revises warnings to be consistent with antihistamines and antitussives
8/29/1997	62FR45767 [HTML]	Proposed Rule: Revises warnings to be consistent with antihistamines and antitussives
12/6/2002	67FR72555 [HTML]	Final Rule: Requires overdose warnings (also antiemetics, antihistamines, and antitussives)

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Date updated: December 28, 2006

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