USP Submissions

Docket Number Ingredient/Topic Date of Submission
  Multiple Active Ingredient Product Monographs 9/9/2016
 

41(5) The General Chapters - The Dosage Forms Expert Committee Proposed Revisions to (1), (2), (3), (4). (5), and (771)

11/30/2015

 

Proposed Revisions to USP-NF General Chapter <467> on Residual Solvents

11/27/2015

 

Packaging and Storage Requirements <659>, Correspondence C141017

7/30/2015

 

Proposals for Developing Compendial Quality Standards for OTC Drugs

4/3/2015

 

General Chapters for Uniformity of Dose from Oral Suspensions in Multi-Unit Containers

9/30/2014
 

OTC Product Monographs

9/18/2014
 

General Chapters: Organic Impurities in Drug Substance and Drug Products and Impurities in Drug Substances and Drug Products

7/31/2014

 

Dextromethorphan Proposals for Interim Revision Announcements

7/24/2014

 

Sodium Salicylate Proposed Monograph

7/24/2014

 

CHPA Submission to USP re: 4-Aminophenol in Acetaminophen-Containing Drug Products

(Attachment)

7/31/2013

 

Stimuli to the Revision Process, USP's Monographs in Support of FDA's OTC Monograph System: Modernization Opportunities

3/29/2013

 

General Notices Section 5.60.30 Elemental Impurities in USP and NF Articles

3/29/2013

 

CHPA's Proposal of Limit for the Process Degradant 4-aminophenol

7/12/2011

FDA-2008-D-0413

FDA Draft Guidance for Industry, Residual Solvents in Drug Products Marketed in the United States, August 2008

10/6/2008

 

Stimuli Article in PF Vol. 30(5) Entitled "Development of a New Official Compendium, Separate from USP-NF, for Articles Not Legally Marketed in the U.S."

1/25/2005