USPNF section

General Chapter <12> Drug Product Performance

Type of Posting: 
Notice of Intent to Revise
Targeted Official Date: 
TBD
Expert Committee: 
Medicines Compendium—South Asia

In accordance with section 7.05(c) of the 2010–2015 Rules and Procedures of the Council of Experts, this is to provide notice that the Medicines Compendium—South Asia Expert Committee intends to revise General Chapter <12> Drug Product Performance. The purpose of the revision is to update the General Chapter to correlate it with a Commentary that was published in the July 2014 AAPS Journal.  The current General Chapter <12> Drug Product Performance is posted here: 

Monographs and General Chapters Affected by Omission of General Chapter <231> Heavy Metals

Type of Posting: 
Notice of Intent to Revise
Targeted Official Date: 
01–Aug–2014
Expert Committee: 
Various

In accordance with section 7.05(c) of the 2010–2015 Rules and Procedures of the Council of Experts, this is to provide notice that USP and its Expert Committees, as applicable, intend to revise multiple monographs and General Chapters in response to the omission of General Chapter <231> Heavy Metals.

Monographs and General Chapters Affected by Revision to Viscosity-Related General Chapters <911>, <912>, and <913>

Type of Posting: 
Notice of Intent to Revise
Targeted Official Date: 
TBD
Expert Committee: 
Various

In accordance with section 7.05(c) of the 2010–2015 Rules and Procedures of the Council of Experts, this is to provide notice that USP and its Expert Committees, as applicable, intend to revise multiple monographs and General Chapters in response to the revision of General Chapter <911> Viscosity-Capillary Viscometer Methods, General Chapter <912> Rotational Rheometer Methods, and General Chapter <913> Rolling Ball Viscometer Method.

New General Chapter <1223.1> Validation of Alternative Methods to Antibiotic Microbial Assays Proposed in Pharmacopeial Forum

Validation of Alternative Methods to Antibiotic Microbial Assays Proposed in Pharmacopeial Forum
Type of Posting: 
General Announcement
Expert Committee: 
General Chapters—Microbiology
File: 

A new General Chapter <1223.1> Validation of Alternative Methods to Antibiotic Microbial Assays was proposed in PF 40(4) [Jul.–Aug. 2014].  This proposed General Chapter contains guidelines to demonstrate equivalency between microbial assay procedures and chromatographic procedures. In addition to publishing in Pharmacopeial Forum, USP is providing this notice to further engage stakeholders (e.g., manufacturers, distributors, healthcare providers) to identify and discuss potential impacts of the General Chapter on the pharmaceutical industry.

New Revision Markup for Reference Changes in USP–NF

New Revision Markup for Reference Changes in USP–NF
Type of Posting: 
General Announcement

USP and its Expert Committees periodically deem it necessary to modify general chapter titles or similar text that may be referenced in other standards throughout the USP–NF. When this occurs, USP staff undertakes a rigorous process for identifying and updating such references. These updates may occur through a routine revision, or, in cases in which an update appears to present no significant change in the affected standard, through a direct update of the reference in that standard without providing an opportunity for notice and comment.

General Notices 6.50.20 Solutions Erratum Posted

General Notices 6.50.20 Solutions Erratum Posted
Type of Posting: 
Erratum
Expert Committee: 
Council of Experts Executive Committee

With oversight from the Council of Experts Executive Committee, the USP body that approves revisions to General Notices, USP is publishing an Erratum to General Notices 6.50.20 Solutions to reinstate text that was incorrectly removed from the current version that became official on May 1, 2014 with USP 37–NF 32. The second paragraph of General Notices 6.50.20 Solutions will now read as follows (reinstated text is underlined):

Verapamil Hydrochloride Extended-Release Tablets

Verapamil Hydrochloride Extended-Release Tablets
Type of Posting: 
Revision Bulletin
Official Date: 
01–Aug–2014
Expert Committee: 
Monographs—Small Molecules 2
Reason for Revision: 
Compliance

In accordance with the Rules and Procedures of the 2010-2015 Council of Experts, the Monographs—Small Molecules 2 Expert Committee has revised the Verapamil Hydrochloride Extended-Release Tablets monograph. The purpose for the revision is to add Dissolution Test 7 for drug products approved by the FDA.

Torsemide Tablets

Torsemide Tablets
Type of Posting: 
Revision Bulletin
Official Date: 
01–Aug–2014
Expert Committee: 
Monographs—Small Molecules 2
Reason for Revision: 
Compliance

In accordance with the Rules and Procedures of the 2010-2015 Council of Experts, the Monographs—Small Molecules 2 Expert Committee has revised the Torsemide Tablets monograph. The purpose of this revision is to widen the acceptance criteria listed in Table 1 under Organic Impurities section in accordance with the FDA approved specifications.

Pioglitazone and Metformin Hydrochloride Tablets

Pioglitazone and Metformin Hydrochloride Tablets
Type of Posting: 
Revision Bulletin
Official Date: 
01–Aug–2014
Expert Committee: 
Monographs—Small Molecules 3
Reason for Revision: 
Compliance

In accordance with the Rules and Procedures of the 2010-2015 Council of Experts, the Monographs—Small Molecules 3 Expert Committee has revised the Pioglitazone and Metformin Hydrochloride Tablets monograph. The purpose of this revision is to add Dissolution Test 2 for an FDA approved generic product.

General Chapter <561> Articles of Botanical Origin

General Chapter <561> Articles of Botanical Origin
Type of Posting: 
Revision Bulletin
Official Date: 
01–Aug–2014
Expert Committee: 
General Chapters—Chemical Analysis
Reason for Revision: 
Compliance
File: 

In accordance with the Rules and Procedures of the 2010-2015 Council of Experts, the General Chapters—Chemical Analysis Expert Committee has revised General Chapter <561> Articles of Botanical Origin.