This article was published in Pharmacy Purchasing & Products.
According to the introduction to the article: "When performing hazardous drug (HD) sterile compounding, it is vital that both the sterile compounding environment and the compounded sterile preparations (CSPs) are protected from microbial bioburden, while simultaneously achieving protection of the workers and the environment outside of the containment secondary engineering controls (C-SECs) through containment of HD residues. Containment is realized through the use of properly functioning primary and secondary engineering controls, as well as proper work practices, including a precise approach to donning and doffing personal protective equipment (PPE)."
A video of proper donning of two pairs of HD gloves is available at the CriticalPoint Web site at: https://www.criticalpoint.info/video/donning-double-hd-sterile-gloves/
For more information: https://www.pppmag.com/article/1968
Showing posts with label USP 797 News. Show all posts
Showing posts with label USP 797 News. Show all posts
Monday, May 29, 2017
Sterile Compounding Tips & Best Practices
Need some assistance in staying USP 797 compliant?
With the help of industry expert Eric S. Kastango, MBA, RPh, FASHP Pharmacy One source has documented 46 tips that will ensure your sterile compounding practices are safe and USP 797 compliant.
Here are a couple of the tips that are highlighted:
Make sure documentation explains what was done
Properly pack any materials or CSPs that are being prepared for shipping
Weigh bulk ingredients on an electronic scale with a printer
Visit this page for more info: http://info.pharmacyonesource.com/46-tips-for-usp-797-success
With the help of industry expert Eric S. Kastango, MBA, RPh, FASHP Pharmacy One source has documented 46 tips that will ensure your sterile compounding practices are safe and USP 797 compliant.
Here are a couple of the tips that are highlighted:
Make sure documentation explains what was done
Properly pack any materials or CSPs that are being prepared for shipping
Weigh bulk ingredients on an electronic scale with a printer
Visit this page for more info: http://info.pharmacyonesource.com/46-tips-for-usp-797-success
Saturday, May 14, 2016
Proposed Revisions to USP 797 - Overview and Current Status
This article is an overview, including current status, of the proposed revisions to USP 797.
Brief History of USP 797 and the Current, Proposed Revisions:
USP 797 was first published in 2004.
The last official revision to USP 797 became official on June 1, 2008.
The Compounding Expert Committee of USP began a new set of revisions in July 2010, and on September 25, 2015, USP issued a set of proposed revisions to USP 797 for public comment. The public comment period ran through January 31, 2016.
Currently, as of May 14, 2016, USP is evaluating the comments received through the public comment process.
You can download the proposed revisions that were published on September 25, 2015, from the following link: http://www.usp.org/sites/default/files/usp_pdf/EN/USPNF/usp-gc-797-proposed-revisions-sep-2015.pdf
Key Components of the Proposed Revisions per USP:
According to USP (per http://www.usp.org/usp-nf/notices/general-chapter-797-proposed-revision), the major revisions of the General Chapter include:
1. Reorganization of existing sections and placement of procedural information in boxes
2. Collapsing of the three compounded sterile preparation (CSP) microbial risk categories (e.g. low-, medium-, and high-risk) into two categories (Category 1 and 2) distinguished primarily by the conditions under which they are made and the time within which they are used.
3. Removal of information on handling hazardous drugs and added cross-references to <800> Hazardous Drugs—Handling in Healthcare Settings
About USP:
Go to: http://www.usp.org/about-usp
Additional Private Resources About USP 797: (not affiliated with or endorsed by USP)
USP797.org: http://usp797.org
USP797.org on Blogger: http://usp797org.blogspot.com/
USP797.org on LinkedIn: https://www.linkedin.com/company/usp797-org-inc-
USP797.org on Facebook: https://www.facebook.com/USP797
Brief History of USP 797 and the Current, Proposed Revisions:
USP 797 was first published in 2004.
The last official revision to USP 797 became official on June 1, 2008.
The Compounding Expert Committee of USP began a new set of revisions in July 2010, and on September 25, 2015, USP issued a set of proposed revisions to USP 797 for public comment. The public comment period ran through January 31, 2016.
Currently, as of May 14, 2016, USP is evaluating the comments received through the public comment process.
You can download the proposed revisions that were published on September 25, 2015, from the following link: http://www.usp.org/sites/default/files/usp_pdf/EN/USPNF/usp-gc-797-proposed-revisions-sep-2015.pdf
Key Components of the Proposed Revisions per USP:
According to USP (per http://www.usp.org/usp-nf/notices/general-chapter-797-proposed-revision), the major revisions of the General Chapter include:
1. Reorganization of existing sections and placement of procedural information in boxes
2. Collapsing of the three compounded sterile preparation (CSP) microbial risk categories (e.g. low-, medium-, and high-risk) into two categories (Category 1 and 2) distinguished primarily by the conditions under which they are made and the time within which they are used.
3. Removal of information on handling hazardous drugs and added cross-references to <800> Hazardous Drugs—Handling in Healthcare Settings
About USP:
Go to: http://www.usp.org/about-usp
Additional Private Resources About USP 797: (not affiliated with or endorsed by USP)
USP797.org: http://usp797.org
USP797.org on Blogger: http://usp797org.blogspot.com/
USP797.org on LinkedIn: https://www.linkedin.com/company/usp797-org-inc-
USP797.org on Facebook: https://www.facebook.com/USP797
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