USPNF section

Saccharin

Type of Posting: 
Notice of Adoption of Harmonized Standard
Targeted Official Date: 
01–Dec–2014
Expert Committee: 
Monographs—Excipients
A revision to the harmonized standard for Saccharin has been approved by the Pharmacopeial Discussion Group (PDG) as described in its PDG Stage 6 sign-off Rev.1 cover sheet.  This revision to the Saccharin monograph has been formally approved by the USP Monographs—Excipients Expert Committee in accordance with the Rules and Procedures of the 2010–2015 Council of Experts.

Mannitol

Type of Posting: 
Notice of Intent to Revise
Targeted Official Date: 
01–Dec–2014
Expert Committee: 
Monographs—Excipients
A harmonized standard for Mannitol has been approved by the Pharmacopeial Discussion Group (PDG) as described in its PDG Stage 6 Sign-Off Cover Page.

Hydroxypropyl Cellulose

Type of Posting: 
Notice of Intent to Revise
Targeted Official Date: 
01–Dec–2014
Expert Committee: 
Monographs—Excipients

A harmonized standard for Hydroxypropyl Cellulose has been approved by the Pharmacopeial Discussion Group (PDG) as described in its PDG Stage 6 sign-off cover sheet. Having reached Stage 6 of the PDG process, the Hydroxypropyl Cellulose monograph has been formally approved by the USP Monographs—Excipients Expert Committee in accordance with the Rules and Procedures of the 2010–2015 Council of Experts.

Changes from the existing USP–NF monograph include:

Polymyxin B Sulfate

Type of Posting: 
Notice of Intent to Revise
Targeted Official Date: 
To be determined
Expert Committee: 
Monographs—Small Molecules 1

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 USP Monographs—Small Molecules 1 Expert Committee intends to revise the Polymyxin B Sulfate monograph to replace the system suitability requirements in the test for Organic Impurities with the requirements in the Composition of Polymyxins test.

The process for and timing of the revision will be determined following additional consideration by the Expert Committee and USP staff.

Dextromethorphan

Type of Posting: 
Notice of Intent to Revise
Targeted Official Date: 
Interim Revision Announcement, 01–Nov–2014
Expert Committee: 
Monographs—Small Molecules 2

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 USP Monographs—Small Molecules 2 Expert Committee intends to revise the Dextromethorphan monograph. This monograph does not currently possess a procedure for determining the controlled substance, levomethorphan (an enantiomer). This is a major safety concern, because recently, levomethorphan was found at toxic levels in the drug formulation and resulted in many deaths globally.

Dextromethorphan Hydrobromide

Type of Posting: 
Notice of Intent to Revise
Targeted Official Date: 
Interim Revision Announcement, 01–Nov–2014
Expert Committee: 
Monographs—Small Molecules 2

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 USP Monographs—Small Molecules 2 Expert Committee intends to revise the Dextromethorphan Hydrobromide monograph. This monograph does not currently possess a procedure for determining the controlled substance, levomethorphan (an enantiomer). This is a major safety concern, because recently, levomethorphan was found at toxic levels in the drug formulation and resulted in many deaths globally.

General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings

The Compounding Expert Committee is proposing new General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings. The purpose of the new proposed General Chapter is to provide standards to protect personnel and the environment when handling hazardous drugs (HDs). Each year, approximately 8 million U.S. healthcare workers are potentially exposed to HDs. The new proposed General Chapter defines processes intended to provide containment of HDs to as low as a limit as reasonably achievable.

First Supplement to USP 37–NF 32 Online and USB Flash Drive Correction

Type of Posting: 
Publications Correction

USP recently determined that three monographs were published incorrectly in the First Supplement to USP 37–NF 32 online product, which was posted online February 3, 2014, but is not official until August 1, 2014. The First Supplement to USP 37–NF 32 USB Flash Drive contains the same incorrect text. This notice advises affected customers not to use or rely on the incorrect text, and provides information on the steps USP is taking to provide customers with the corrected text.

The affected monographs are:

Levalbuterol Inhalation Solution

Type of Posting: 
Notice of Intent to Revise
Targeted Official Date: 
Interim Revision Announcement, 01–Nov–2014
Expert Committee: 
Monographs—Small Molecules 4

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 USP Monographs—Small Molecules 4 Expert Committee intends to revise the Levalbuterol Inhalation Solution monograph. USP is unable to maintain a reliable supply of the USP Levalbuterol Related Compound G RS utilized in the current test for Organic Impurities. The purpose of this revision is to eliminate the need for this Reference Standard. USP Levalbuterol Related Compound G RS is used to accomplish two specific purposes.

Call for Candidates: Olive Oil Authenticity and Quality Expert Panel

Type of Posting: 
General Announcement
Closing Date: 
28–Feb–2014
Expert Committee: 
General Chapters—Chemical Analysis

In accordance with Section 6 of the Rules and Procedures of the 2010–2015 Council of Experts, the Chairperson of the Council of Experts forms with this charge an Olive Oil Authenticity and Quality Expert Panel. The Expert Panel will make recommendations to and work under the direction of the Monographs—Food Ingredients Expert Committee chaired by Dr. Andrew Ebert.