USPNF section

Methylphenidate Hydrochloride Extended-Release Tablets

Type of Posting: 
Notice of Intent to Revise
Targeted Official Date: 
Interim Revision Announcement, 01–Mar–2016
Expert Committee: 
Monographs—Small Molecules 4

In accordance with section 7.05(c) of the Rules and Procedures of the Council of Experts, this is to provide notice that the USP Monographs—Small Molecules 4 Expert Committee intends to revise the Methylphenidate Extended-Release Tablets monograph.

Dutasteride

Type of Posting: 
Notice of Intent to Revise
Targeted Official Date: 
Interim Revision Announcement, 01–Mar–2016
Expert Committee: 
Monographs—Small Molecules 4

In accordance with the Rules and Procedures of the Council of Experts, the Monographs—Small Molecules 4 Expert Committee intends to revise the Dutasteride monograph as follows.

Reinstatement of References to General Chapter <231> Heavy Metals in Monographs and General Chapters Published in the Second Supplement to USP 38–NF 33

Type of Posting: 
Notice of Intent to Revise
Targeted Official Date: 
Errata, 01–Oct–2015
Archive Date: 
26–Jun–2015
*This Notice of Intent to Revise was withdrawn and superseded by a new Intent to Revise on June 26, 2015.
 
In accordance with the Rules and Procedures of the 2010-2015 Council of Experts, USP intends to revise by Errata, multiple monographs and general chapters that were published in the Second Supplement to USP 38–NF 33.

Changes to Pending Monographs Program

Type of Posting: 
General Announcement
USP has developed a new version of its Pending Monograph Guideline, which reflects substantial changes to eliminate the use of a separate web-based process for Pending Monographs. Instead, monograph proposals pending FDA approval will utilize the standard USP–NF revision processes. 
 
The Pending Monograph approach was implemented in 2007 to allow USP to develop new monographs or monograph revisions while a sponsor was awaiting FDA approval.

Divalproex Sodium Delayed-Release Capsules

Official Date: 
01 December 2011
Expert Committee: 
Monographs - Small Molecules 4
Reason for Revision: 
Compliance
In accordance with the Rules and Procedures of the 2010-2015 Council of Experts, the Monographs - Small Molecules 4 Expert Committee has revised the Divalproex Sodium Delayed-Release Capsules monograph. The purpose for the revision is to add Dissolution Test 3 for a product approved by the FDA. The new test was validated using a Waters Nova Pak Phenyl brand of L11 column.

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 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.

Methocarbamol Tablets

Official Date: 
01–May–2015
Expert Committee: 
Monographs— Small Molecules 4
Reason for Revision: 
Compliance

In accordance with the Rules and Procedures of the 2010-2015 Council of Experts, the Monographs—Small Molecules 4 Expert Committee has indefinitely postponed the test for Organic Impurities in the Methocarbamol Tablets monograph.

Methocarbamol

Official Date: 
01–May–2015
Expert Committee: 
Monographs—Small Molecules 4
Reason for Revision: 
Compliance

In accordance with the Rules and Procedures of the 2010-2015 Council of Experts, the Monographs—Small Molecules 4 Expert Committee has revised the Methocarbamol monograph.

Stearic Acid

Type of Posting: 
Notice of Adoption of Harmonized Standard
Official Date: 
01–May–2016
Expert Committee: 
Monographs—Excipients
Coordinating Pharmacopoeia: 
EP
A revision to the harmonized standard for Stearic Acid has been approved by the Pharmacopeial Discussion Group (PDG) as described in its PDG Stage 6 Rev. 1 Corr. 1 Sign-Off Cover Page.

Sodium Lauryl Sulfate

Type of Posting: 
Notice of Adoption of Harmonized Standard
Official Date: 
01–May–2016
Expert Committee: 
Monographs—Excipients
Coordinating Pharmacopoeia: 
USP
A new harmonized standard for Sodium Lauryl Sulfate has been approved by the Pharmacopeial Discussion Group (PDG) as described in its PDG Stage 6 Sign-Off Cover Page.