USPNF section

Potassium Citrate Extended-Release Tablets

Type of Posting: 
Revision Bulletin
Official Date: 
01–Feb–2015
Expert Committee: 
Monographs—Dietary Supplements and Herbal Medicines
Reason for Revision: 
Compliance
In accordance with the Rules and Procedures of the 2010-2015 Council of Experts, the Monographs—Dietary Supplements and Herbal Medicines Expert Committee has revised the Potassium Citrate Extended-Release Tablets monograph. The purpose for the revision is to revise the Definition section to be consistent with the labeling information for Potassium Citrate Extended-Release Tablets approved by FDA and to add Dissolution Test 2 for drug product approved by the FDA.

Oxycodone Hydrochloride Oral Solution

Type of Posting: 
Revision Bulletin
Official Date: 
01–Feb–2015
Expert Committee: 
Monographs—Small Molecules 2
Reason for Revision: 
Compliance
In accordance with the Rules and Procedures of the 2010-2015 Council of Experts, the Monographs—Small Molecules 2 Expert Committee has revised the Oxycodone Hydrochloride Oral Solution monograph.

Ketorolac Tromethamine Tablets

Type of Posting: 
Revision Bulletin
Official Date: 
01–Feb–2015
Expert Committee: 
Monographs—Small Molecules 2
Reason for Revision: 
Compliance
In accordance with the Rules and Procedures of the 2010-2015 Council of Experts, the Monographs—Small Molecules 2 Expert Committee has revised the Ketorolac Tromethamine Tablets monograph.

Fosphenytoin Sodium Injection

Type of Posting: 
Revision Bulletin
Official Date: 
01–Feb–2015
Expert Committee: 
Monographs—Small Molecules 4
Reason for Revision: 
Safety, Urgent
In accordance with the Rules and Procedures of the 2010-2015 Council of Experts, the Monographs—Small Molecules 4 Expert Committee has revised the Fosphenytoin Sodium Injection monograph. The purpose for the revision is to remove the word “prominently” from the Labeling section of the monograph per request of the U.S. FDA.
 
The Fosphenytoin Sodium Injection Revision Bulletin supersedes the currently official monograph.

Desoxycorticosterone Pivalate Injectable Suspension

Type of Posting: 
Revision Bulletin
Official Date: 
01–Feb–2015
Expert Committee: 
Monographs—Small Molecules 3
Reason for Revision: 
Compliance
In accordance with the Rules and Procedures of the 2010-2015 Council of Experts, the Monographs—Small Molecules 3 Expert Committee has revised the Desoxycorticosterone Pivalate Injectable Suspension monograph. The purpose for the revision is to increase the upper limit of the melting point acceptance criteria from 204° to 206° in the test for Identification A.
 
The Desoxycorticosterone Pivalate Injectable Suspension Revision Bulletin supersedes the currently official monograph.

Trazodone Hydrochloride

Type of Posting: 
Revision Bulletin
Official Date: 
01–Feb–2015; updated 27–Feb–2015*
Expert Committee: 
Monographs—Small Molecules 4
Reason for Revision: 
Safety

In accordance with the Rules and Procedures of the 2010-2015 Council of Experts, the Monographs—Small Molecules 4 Expert Committee has revised the Trazodone Hydrochloride monograph. The purpose for the revision is to remove USP Trazodone Hydrochloride RS from the Standard solution within the test for the Limit of Trazodone Related Compound F and Cyclophosphamide Related Compound A.

General Notices Section 5.60.30 Elemental Impurities in USP Drug Products and Dietary Supplements

Type of Posting: 
Revision Bulletin
Official Date: 
01–Apr–2015
Expert Committee: 
Council of Experts Executive Committee
Reason for Revision: 
Compliance
In accordance with section 7.02 of the 2010–2015 Rules and Procedures of the Council of Experts, the Council of Experts Executive Committee (CoE EC) has revised General Notices Section 5.60.30 Elemental Impurities in USP Drug Products and Dietary Supplements as a Revision Bulletin published on March 27, 2015.

General Chapter <231> Heavy Metals and Affected Monographs and General Chapters

Type of Posting: 
Revision Bulletin
Official Date: 
01–Apr–2015 (Implementation Date: 01–Jan–2018)
Expert Committee: 
General Chapters—Chemical Analysis

In accordance with section 7.05(c) of the 2010–2015 Rules and Procedures of the Council of Experts, the General Chapters—Chemical Analysis Expert Committee, has revised the omission date of General Chapter <231> Heavy Metals, concurrent with the Revision Bulletin for General Notices Section 5.60.30 Elemental Impurities in USP Drug Products and Dietary Supplements approved by Council of Experts—Executive Committee.

Open-Microphone Web Meeting for General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings

Type of Posting: 
General Announcement
Expert Committee: 
Compounding
In December 2014, the Compounding Expert Committee republished General Chapter <800> due to the nature and significance of the comments received on the original Pharmacopeial Forum (PF) proposal.  The General Chapter, which was originally published in PF 40(3) [May–Jun. 2014], provides standards to protect personnel and the environment when handling hazardous drugs.

Amoxicillin

Type of Posting: 
Notice of Intent to Revise
Targeted Official Date: 
To be determined
Expert Committee: 
Monographs—Small Molecules 1
In accordance with section 7.05(c) of the 2010–2015 Rules and Procedures of the Council of Experts, this is to provide notice that the USP Monographs—Small Molecules 1 Expert Committee intends to revise the test for Organic Impurities in the Amoxicillin monograph to include a limit for amoxicillin D-hydroxyphenylglycyl ester.
 
It is anticipated that the proposed revision will be published as an In-Process Revision at a date yet to be determined, pursuant to section 7.02 of the Rules and Procedures.
 
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