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Rulemaking History for OTC Anorectal Drug Products
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Final Monograph (21 CFR part 346):
Anorectal Drug Products for Over-the-Counter Human Use
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| Date |
Federal Register Citation |
Description |
| 5/27/1980 |
45FR35576  |
Advance Notice of Proposed Rulemaking |
| 7/22/1980 |
45FR48920 |
Correction: Advance Notice of Proposed Rulemaking |
| 8/15/1980 |
45FR54354 |
Correction: Advance Notice of Proposed Rulemaking |
| 9/26/1980 |
45FR63876
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Reopening of administrative record: Camphor-containing
products |
| 8/15/1988 |
53FR30756
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Tentative
Final Monograph |
| 8/3/1990 |
55FR31776 |
Final Monograph |
| 9/2/1993 |
58FR46746
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Technical
Amendment: Live yeast cell derivative (LYCD) |
| 6/3/1994 |
59FR28766
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Technical
Amendment: USP name change ("Hammamelis water" to
"witch hazel") |
| 8/26/2003 |
68FR51167
[HTML] |
Technical
Amendment: Combination of hydrocortisone and pramoxine hydrochloride is nonmonograph |
| 3/24/2004 |
69FR13765
[HTML]
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Proposed Rule: Sodium phosphate-containing products |
| 11/29/2004 |
69FR69278
[HTML]
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Final
Rule: Sodium phosphate-containing products |
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Date updated: May 9, 2007 |
