USPNF section

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
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]

General Chapter Prospectus: Metal Packaging Components and their Materials of Construction

Type of Posting: 
General Announcement
Expert Committee: 
General Chapters—Packaging and Storage

Input Deadline: 29–Mar–2016

Dutasteride

Type of Posting: 
Notice of Intent to Revise
Official Date: 
TBD
Expert Committee: 
Chemical Medicines Monographs 5

In accordance with section 7.04 (c) of the Rules and Procedures of the 2015-2020 Council of Experts, this is to provide notice that the Chemical Medicines Monographs 5 Expert Committee intends to revise the Dutasteride monograph to change the relative response factor of dihydrodutasteride from 0.38 to 1.0 to accommodate a drug substance from another FDA approved manufacturer.

The proposed revision will replace the Interim Revision Announcement (IRA) for Dutasteride published in Pharmacopeial Forum (PF) 41(5) [Sep.–Oct. 2015], which becomes official on March 1, 2016.

Doxorubicin Hydrochloride Injection

Type of Posting: 
Notice of Intent to Revise
Targeted Official Date: 
To be determined
Expert Committee: 
Chemical Medicines 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 Chemical Medicines Monographs 1 Expert Committee intends to revise the Doxorubicin Hydrochloride Injection monograph.

The Expert Committee proposes to revise the test for Organic Impurities to widen the limits for specified and unspecified impurities to be consistent with FDA approved acceptance criteria.

Diphenhydramine and Phenylephrine Monographs

Type of Posting: 
Notice of Intent to Revise
Targeted Official Date: 
Revision Bulletin; 01–May–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 Chemical Medicines Monographs 6 Expert Committee intends to  postpone the Organic Impurities section in the following monographs:

·         Diphenhydramine Hydrochloride

·         Phenylephrine Hydrochloride

·         Diphenhydramine and Phenylephrine Hydrochloride Tablets,

Dicloxacillin Sodium

Type of Posting: 
Notice of Intent to Revise
Targeted Official Date: 
To be determined
Expert Committee: 
Chemical Medicines 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 Chemical Medicines Monographs 1 Expert Committee intends to revise the Dicloxacillin Sodium monograph.

The Expert Committee proposes to revise the test for Organic Impurities to revise the limits for specified and unspecified impurities to be consistent with FDA approved acceptance criteria.

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

Cloxacillin Sodium

Type of Posting: 
Notice of Intent to Revise
Targeted Official Date: 
To be determined
Expert Committee: 
Chemical Medicines 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 Chemical Medicines Monographs 1 Expert Committee intends to revise the Cloxacillin Sodium monograph.

The Expert Committee proposes to revise the limits for specified and unspecified impurities in the Organic Impurities section to be consistent with FDA approved acceptance criteria.

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

General Chapter <1> Injections and Implanted Drug Products (Parenterals)—Product Quality Tests

Type of Posting: 
Notice of Intent to Revise
Targeted Official Date: 
Interim Revision Announcement; 01–May–2016
Expert Committee: 
General Chapters—Dosage Form

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 General Chapters—Dosage Form Expert Committee intends to revise the recently published General Chapter <1> Injections and Implanted Drug Products (Parenterals)—Product Quality Tests to narrow the General Chapter’s scope.