USPNF section

Second Supplement to USP 39–NF 34 Online: Greek Symbols

Type of Posting: 
Publication Correction

USP recently discovered a technical error that is causing a data inconsistency with the Greek symbols between the USP–NF online and the USP–NF print products. In some instances the Greek symbols are displaying as upper case instead of lower case. Attached is a spreadsheet outlining which Greek symbols are affected and which General Chapters are impacted.

June 2016 USP–NF Errata Posting

Type of Posting: 
Publication Correction

The Errata to the introduction to the Reagents section contained a typo. The entry should read:

In the numerator of the equation: Change
2.8
to:
14
AND
Add
× f
AND
Line 10: Change
where %LOD is the percentage of loss on drying.
to:
where f is the correction factor obtained in the standardization of 0.2 N sodium hydroxide and %LOD is the percentage of loss on drying.

General Chapter Prospectus: <1220> The Analytical Procedure Lifecycle

Type of Posting: 
General Announcement
Expert Committee: 
General Chapters—Chemical Analysis

Input Deadline: 29–Jul–2016

Current or Proposed GC Title: <1220> The Analytical Procedure Lifecycle

Suggested audience: Drug product manufacturers, dietary supplement manufacturers, testing organizations, and drug product related regulatory agencies.

Estimated proposal PF: 43 (1) [Jan.–Feb. 2017]

June 2016 and April 2016 USP–NF Errata Postings

Type of Posting: 
Publication Correction

Due to a technical error, the errata to USPNF scheduled to post on May 27, 2016 were instead posted on May 31, 2016. All errata official on June 1, 2016 can currently be found in the errata table at http://www.usp.org/usp-nf/official-text/errata-table.

Early Input Sought on Proposed Naturally Occurring Endoxtoxin (NOE) Reference Standard

Type of Posting: 
General Announcement
Closing Date: 
30–Jun–2016
Expert Committee: 
General Chapters—Microbiology

USP is requesting early input from stakeholders on a new endotoxin reference standard which is being considered for development by USP. The proposed endotoxin reference standard would be prepared from cell wall extracts of a well characterized Gram negative bacterium

The purpose of this proposed reference standard will be for use in hold time studies, depyrogenation studies, and other pharmaceutical studies that require or would benefit from the use of a “naturally occurring” endotoxin (NOE)1.

First Supplement to USP 39–NF 34 Online: Errata Icon for GC <661.1>

Type of Posting: 
Publication Correction

USP recently discovered that General Chapter <661.1> Plastic Materials of Construction is missing the Errata icon in First Supplement to USP 39–NF 34 online.

The icon will be present in the Second Supplement to USP 39–NF 34 online, which posts June 1, 2016. The errata itself will appear corrected in the file in USP 40–NF 35.

Trihexyphenidyl Hydrochloride Oral Solution and Trihexyphenidyl Hydrochloride Extended-Release Capsules

Type of Posting: 
Notice of Intent to Revise
Targeted Official Date: 
To be Determined
Expert Committee: 
Chemical Medicines Monographs 4

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 4 Expert Committee intends to revise Trihexyphenidyl Hydrochloride Oral Solution and Trihexyphenidyl Hydrochloride Extended-Release Capsules monographs to correct an error that was introduced when the Assay for the Trihexyphenidyl Hydrochloride monograph was modernized.

Aspirin Monographs

Type of Posting: 
Notice of Intent to Revise
Targeted Official Date: 
01–Jan–2017, Interim Revision Announcement
Archive Date: 
24–Jun–2016
Expert Committee: 
Chemical Medicines Monographs 6

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 Monographs–Chemical Medicines 6 Expert Committee intends to revise the following monographs:

Aspirin Boluses

Type of Posting: 
Notice of Intent to Revise
Targeted Official Date: 
25–Nov–2016, Interim Revision Announcement
Official Date: 
01–Jan–2017
Archive Date: 
24–Jun–2016
Expert Committee: 
Chemical Medicines Monographs 3

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 3 Expert Committee intends to revise the Aspirin Boluses monograph.

<800> Hazardous Drugs—Handling in Healthcare Settings

Type of Posting: 
Notice of Intent to Revise
Targeted Official Date: 
26–May–2016; Errata
Expert Committee: 
Compounding Expert Committee

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 USP Compounding Expert Committee intends to revise General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings.