USPNF section

<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.

Pimozide Tablets

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 Tablets monograph which appears in USP 39–NF 34.

Octyldodecanol

Type of Posting: 
Notice of Intent to Revise
Targeted Official Date: 
01–Jan–2017, Interim Revision Announcement, TBD
Expert Committee: 
Excipient Monographs 1

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 Excipient Monographs 1 Expert Committee intends to revise the Octyldodecanol NF monograph.

Insulin Glargine

Type of Posting: 
Notice of Intent to Revise
Targeted Official Date: 
01–Nov–2016
Expert Committee: 
Biologics Monographs 1—Peptides

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 Biologics Monographs 1—Peptides intends to revise the Insulin Glargine.

Insulin Glargine Injection

Type of Posting: 
Notice of Intent to Revise
Targeted Official Date: 
01–Nov–2016
Expert Committee: 
Biologics Monographs 1—Peptides

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 Biologics Monographs 1—Peptides Expert Committee intends to revise the Insulin Glargine and Insulin Glargine Injection.

Based on the comments with supporting data were received, the Expert Committee proposes to revise the Insulin Glargine Injection as follows to reflect the FDA-approved specification.

General Chapter Prospectus: Storage and Transportation of Investigational Drug Products (IDPs)

Type of Posting: 
General Announcement
Archive Date: 
24–Jun–2016
Expert Committee: 
General Chapters—Packaging and Storage

Input Deadline: 29–Mar–2016

Proposed Title:  <1079.1> Storage and Transportation of Investigational Drug Products (IDPs)

Suggested audience: Clinical trial sponsors (Drug product manufacturers, Research Organizations, etc.) and clinical trial personnel

Estimated proposal PF:  Pharmacopeial Forum 43(4) [Jul.–Aug. 2016]