USPNF section

Ganoderma Lucidum Fruiting Body

Ganoderma Lucidum Fruiting Body
Type of Posting: 
Revision Bulletin: POSTPONEMENT
Targeted Official Date: 
01–Aug–2014
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 intends to indefinitely postpone the Identification A by HPTLC section of the Ganoderma Lucidum Fruiting Body monograph. The purpose for the postponement is to reassess the specifications for the retardation factor reproducibility, and to finalize verbal color designation of the ergosterol band.

Ganoderma Lucidum Fruiting Body Powder

Ganoderma Lucidum Fruiting Body Powder
Type of Posting: 
Revision Bulletin: POSTPONEMENT
Official Date: 
01–Aug–2014
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 intends to indefinitely postpone the Identification A by HPTLC section of the Ganoderma Lucidum Fruiting Body Powder monograph. The purpose for the postponement is to reassess the specifications for the retardation factor reproducibility, and to finalize verbal color designation of the ergosterol band.

Carbidopa and Levodopa Orally Disintegrating Tablets

Carbidopa and Levodopa Orally Disintegrating Tablets
Type of Posting: 
Revision Bulletin
Targeted Official Date: 
01–Aug–2014
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 Carbidopa and Levodopa Orally Disintegrating Tablets monograph. The purpose for the revision is to widen the limit for 3,4-dihydroxyphenyl acetone from NMT 0.5% to NMT 1.0%.  

Additionally, minor editorial changes have been made to update the monograph to current USP style.

Tacrolimus

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 Organic Impurities Procedure 2 in the Tacrolimus monograph to improve the stability of solutions containing tacrolimus.

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.

Ganoderma Lucidum Fruiting Body and Ganoderma Lucidum Fruiting Body Powder

Type of Posting: 
Intent to Revise
Targeted Official Date: 
01–Mar–2015
Expert Committee: 
Monographs—Dietary Supplements and Herbal Medicines

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 Monographs—Dietary Supplements and Herbal Medicines Expert Committee intends to revise the Ganoderma Lucidum Fruiting Body and Ganoderma Lucidum Fruiting Body Powder monographs.

General Chapter <561> Articles of Botanical Origin

Type of Posting: 
Intent to Revise
Targeted Official Date: 
01–Aug–2014
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, this is to provide notice that the General Chapters—Chemical Analysis Expert Committee intends to revise General Chapter <561> Articles of Botanical Origin.

Compounded Preparations Title Changes

Type of Posting: 
General Announcement

The Compounding (CMP) and the Nomenclature, Safety, and Labeling (NSL) Expert Committees propose to revise the title of compounded preparations monographs consistent with the Nomenclature Guidelines and General Chapter <7> Labeling which will be published in USP 38–NF 33.

The word “compounded” will be added to the title of compounded preparation monographs using the following convention:

[DRUG SUBSTANCE] Compounded [ROUTE OF ADMINISTRATION] [DOSAGE FORM]

Additional Feedback Sought on Proposed Storage and Distribution General Chapters

Type of Posting: 
General Announceme
Expert Committee: 
General Chapters—Packaging, Storage, and Distribution

USP is offering stakeholders the opportunity to provide additional feedback on five recently-proposed General Chapters related to storage and distribution.

USP proposed five new General Chapters on Good Distribution Practices (GDP) in Pharmacopeial Forum 40(2) [Mar.–Apr. 2014]:

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

In an effort to answer stakeholder questions, USP held an open microphone web meeting on June 12, 2014 (2:00 pm – 4:00 pm EDT) to discuss the proposed general chapter <800> Hazardous Drugs – Handling in Healthcare Settings. The purpose of the new general chapter is to provide standards to protect personnel and the environment when handling hazardous drugs (HDs). Each year, approximately 8 million U.S. healthcare workers are potentially exposed to HDs.

Zolpidem Tartrate Extended-Release Tablets

Type of Posting: 
Revision Bulletin
Targeted Official Date: 
01–Jun–2014
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 Zolpidem Tartrate Extended-Release Tablets monograph. The purpose for the revision is to Dissolution Test 5 and Test 6 to reflect products approved by the FDA.