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In this section: Historical Status of OTC Rulemakings

Rulemaking History for OTC Sweet Spirits of Nitre Drug Products

Final Monograph (21 CFR 310.502(a)):
Certain drugs accorded new drug status through rulemaking procedures

OTC Sweet Spirits of Nitre Drug Products found on this page:

Original Classification
Consolidation of Drug Regulations

Sweet Spirits of Nitre Drug Products: Original Classification

Proposed Rule	Date	FR Citation
Proposed Rule: Classifies sweet spirits of nitre as nonmonograph	2/22/1980	45FR11846
Correction	3/25/1980	45FR19265
Final Rule	Date	FR Citation
Final Rule	6/27/1980	45FR43400

Sweet Spirits of Nitre Drug Products: Consolidation of Drug Regulations

Proposed Rule	Date	FR Citation
Proposed Rule: Removes 21 CFR 310.525 and adds 21 CFR 310.502	6/11/1996	61FR29502
Final Rule	Date	FR Citation
Final Rule	3/14/1997	62FR12083

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