Timeline for USP General Chapters <795>, <797>, and <800> as published on the USP website:

Note: This graphic shows the "remaining timeline" for USP General Chapters <795>, <797>, and <800>. For the complete timeline, please see USP's website.

General Chapter <795> Pharmaceutical Compounding-Nonsterile Preparations

• July 31, 2018 - The public comment period for the proposed revision to <795> closed.

General Chapter <797> Pharmaceutical Compounding-Sterile Preparations

• A revision to General Chapter <797> was proposed for public comment from September 25, 2015 to January 31, 2016, and remains in the development process with the Expert Committee.
  
  
• The chapter is published for a second round of public comment and will be formally published in the Pharmacopeial Forum 44(5) in September 2018.

Note: Since the first public comment period, which began in September 2015, there has been significant input from stakeholders including round table meetings, discussion forums, and review of more than 8,000 written public comments. The Expert Committee has reviewed all of the public comments from the September 2015 proposal along with additional guidance from many stakeholders to propose this new revision for a second round of public comment.

The public comment period for <797> will occur between July 27 and November 30, 2018. During this period, you will be able to provide written comments. The upcoming comment period for <797> includes the following activities:

• September 5, 2018
  USP will host an Open Microphone session.
  
  
• November 30, 2018
  Public comment period will close for <797>.
  
  Please submit your comments no later than November 30, 2018 at:
  
  http://www.usp.org/compounding/general-chapter-797

General Chapter <800> Hazardous Drugs-Handling in Healthcare Settings

• Completed and published in February 2016.
  
  
• Not currently under revision.

The three chapters (<795>, <797>, and <800>) are anticipated to be official and aligned on December 1, 2019.

In summary, there are no individual responses to the more than 8,000 comments posed to the committee, so one has to read it at face value to determine what changes have been made or get the previous revision and the newly revised version side-by-side.

Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition

News

E-Cigarette, Cigarette, and Hookah Use, and Subsequent Marijuana Use
Non-cigarette tobacco products may confer a risk of marijuana use similar to combustible cigarettes. We examined whether adolescent electronic cigarette (e-cigarette), hookah, or combustible cigarette use is associated with initiating and currently using marijuana as well as using both tobacco and marijuana concurrently. The association between tobacco use and subsequent marijuana use across adolescence extends to multiple tobacco products.
http://pediatrics.aappublications.org/content/early/2018/08/02/peds.2017-3616

The FDA Expands Recall of Heart Drug for Possible Cancer-causing Contamination
The FDA has expanded the recall of valsartan manufactured by Zhejiang Huahai Pharmaceuticals in Linhai, China, as it contains the chemical N-nitrosodimethylamine, or NDMA, which has been found to cause cancer in humans based on laboratory studies, the agency says.

The FDA issued a voluntary recall last month for some valsartan tablets and has since expanded it twice to include additional products from more drug companies, as well as some tablets with valsartan and hydrochlorothiazide.
https://www.usatoday.com/story/money/business/2018/08/07/fda-recall-expands-heart-drug-possible-cancer-causing-impurity/921566002/

Contaminated Valsartan Has Been on the Market for 4 Years, the FDA Discovers
China's Zhejiang Huahai Pharmaceutical set off a recall after it informed global regulators last month that it had discovered the suspected cancer-causing impurity N-nitrosodimethylamine in its valsartan API after changing its manufacturing process. The FDA is now reporting that the tainted ingredient may have been on the market for years, not weeks or months.
https://www.fiercepharma.com/manufacturing/tainted-valsartan-has-been-market-four-years-fda-discovers

Full Review of Compounded Oral Liquid Formulations Results in Many Updates
A comprehensive review of a university health system's formulations for pharmacy-compounded oral liquid medications led to 78 percent of them getting updated, Janice L. Stumpf and colleagues report in AJHP. The most common updates were changes in storage conditions and beyond-use dates.
http://www.ajhp.org/content/early/2018/07/24/ajhp180085

Did You Know ...

�that Walt Disney said the following? "The important thing is the family. If you can keep the family together - and that's the backbone of our whole business, catering to families - that's what we hope to do."

Tip of the Week

Keeping families together is far more important than just the business purpose explained by Walt Disney. The family is the social unit of our society; when the family unit breaks down, society suffers.

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Looking Back

Drowsy?
Just remember, pard,
That marble slab,
Is doggone hard!
     Burma Shave