USPNF section

<382> Elastomeric Closure Functionality in Injectable Pharmaceutical Packaging/Delivery Systems

Type of Posting: 
General Chapter Prospectus
Expert Committee: 
General Chapters—Packaging and Storage
Input Deadline: January 30, 2017
 
Suggested audience: Drug product manufacturer using elastomeric component with a packaging system 
 
Estimated proposal Pharmacopeial Forum:  PF 43(3) [May–Jun.

<381> Elastomeric Closure for Injections

Type of Posting: 
General Chapter Prospectus
Expert Committee: 
General Chapters—Packaging and Storage
Input Deadline: January 30, 2017
 
Suggested audience: Suppliers of elastomeric materials and components used for packaging systems (primary packaging components) and drug product manufacturers using elastomeric component and system primary containers
 
Estimated proposal Pharmacopeial Forum:  PF 43(3) [May–Jun.

<87> Biological Reactivity, In Vitro, <88> Biological Reactivity, In Vivo, and <1031> The Biocompatibility of Materials used in Drug Containers, Medical Devices and Implants

Type of Posting: 
General Chapter Prospectus
Expert Committee: 
General Chapters—Biological Analysis
Input Deadline: January 30, 2017
 
Suggested Audience: Suppliers and users of elastomeric and plastic materials and components used in medical devices and packaging systems (primary packaging components) for drug product.
 
Estimated proposal Pharmacopeial Forum:  PF 43(5) [Sep.–Oct.

Theophylline Oral Solution

Type of Posting: 
Notice of Intent to Revise
Targeted Official Date: 
Revision Bulletin, 01–Feb–2017
Expert Committee: 
Chemical Medicines Monographs 5

In accordance with section 7.04(c) of the 2015–2020 Rules and Procedures of the Council of Experts, this is to provide notice that the Chemical Medicines Monographs 5 Expert Committee intends to revise the Theophylline Oral Solution monograph.

Based on a comment received, the Expert Committee proposes to make the following change to the test of Organic impurities:

Promethazine Hydrochloride Oral Solution

Type of Posting: 
Notice of Intent to Revise
Targeted Official Date: 
Revision Bulletin, 01–Feb-2017
Expert Committee: 
Chemical Medicines Monographs 5

In accordance with section 7.04(c) of the 2015–2020 Rules and Procedures of the Council of Experts, this is to provide notice that the Chemical Medicine Monographs 5 Expert Committee intends to revise the Promethazine Hydrochloride Oral Solution monograph.

Based on a comment received, the Expert Committee proposes to make the following change to the test of Organic impurities:

USP Monographs Will No Longer Cite Reference Standards Required by a General Chapter as of USP 41–NF 36

Type of Posting: 
General Announcement

For purposes of uniformity, starting with USP 41–NF 36 print and online editions, reference standards required by general chapters’ procedures will no longer be referenced in the USP Reference Standards <11> section of each monograph.  Such references will be contained in the applicable general chapters. The change will be presented in printed and online versions as it is indicated in the example below:

USP Reference Standards <11> 

USP XXXXX RS

<1xxx> Fc Function Assays

Type of Posting: 
General Chapter Prospectus
Expert Committee: 
Biologics Monographs 2—Proteins

Input Deadline: November 28, 2016

Proposed Title: Fc Function Assays

Suggested Audience: Biopharmaceutical industry, regulatory agencies, pharmaceutical scientists, biologists, immunologists, academicians and therapeutic drug manufacturers

Estimated proposal PF: 44(2) [Mar.–Apr. 2018]

Removal of 3D Chemical Structures in USP–NF Online

Type of Posting: 
General Announcement

USP recently discovered a technical issue in the USP–NF online product regarding the accessibility of the 3D Image chemical structures available in some monographs. The 3D image viewer is no longer compatible with the newest versions of Chrome and Internet Explorer that USP supports.

While we work to determine a solution for future online editions, we will be removing the 3D Image link from the USP–NF online product starting on November 1, 2016.

Addition of UNII Codes in USP 40–NF 35 Online

Type of Posting: 
General Announcement

This is a general announcement to alert users to the addition of UNII codes into the USP 40–NF 35 online product. UNII codes will appear in monographs which contain CAS information, displaying at the end of the chemical information section. Not every monograph will contain a UNII code, and some monographs may contain multiple UNII codes.

For example:

Update to Style for Latin Binomials in USP 40–NF 35

Type of Posting: 
General Announcement

For purposes of uniformity, starting with USP 40–NF 35 print and online editions, the style for Latin Binomials has been updated. This style change does not affect the content. A list of files affected by the restyled Latin Binomials can be found here.

Should you have any questions, please contact Hellen Oketch, Senior Scientific Liaison (301-230-3249 or hao@usp.org