USPNF section

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.

General Chapter Prospectus: <197> Spectroscopic Identification Tests

Type of Posting: 
General Announcement
Archive Date: 
24–Jun–2016
Expert Committee: 
General Chapters—Chemical Analysis

Input Deadline: 25–Apr–2016

Current or Proposed GC Title:  <197> Spectroscopic Identification Tests

Suggested audience: Suppliers and manufactures of drug substance, drug products, excipients, dietary supplements and drug testing organizations and drug products related regulatory agencies.

Estimated proposal PF: 42 (5)

USP to Pilot Process for Early Input on General Chapters

Type of Posting: 
General Announcement

Based on feedback from stakeholders, USP is implementing a process intended to provide interested stakeholders with the opportunity to submit input on general chapters during the early stages of their development.

Stimuli Article: The Advisability and Feasibility of Developing USP Standards for Medical Cannabis Posted for Comment

Type of Posting: 
General Announcement
Archive Date: 
24–Jun–2016
Expert Committee: 
Botanical Dietary Supplements and Herbal Medicines

The members of the United States Pharmacopeia staff, have posted a Stimuli article to present their current thinking on Advisability and Feasibility of Developing USP Standards for Medical Cannabis in Pharmacopeial Forum 42(1) [Jan. –Feb. 2016].

Pimozide

Type of Posting: 
Notice of Intent to Revise
Targeted Official Date: 
Interim Revision Announcement, 01–Nov–2016
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 the Pimozide monograph which appears in USP 39–NF 34.

Based on the comments received, the Expert Committee proposes to add a process impurity with acceptance criteria.  In addition, the Identification A test, based on the Infrared absorption, is revised to allow more flexibility to the users.