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Submit Your Last Comments to USP 797 Revisions

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  Next Friday, November 30th, The USP 797 closes for public commenting. There is still plenty of time for more comments to be made. All comments should be submitted via the <797> web page, no later than November 30, 2018. A lot of questions and points were made during the open mic session on the USP […]

Submit Your Last Comments to USP 797 Revisions Read More »

  Next Friday, November 30th, The USP 797 closes for public commenting. There is still plenty of time for more comments to be made. All comments should be submitted via the <797> web page, no later than November 30, 2018. A lot of questions and points were made during the open mic session on the USP

What are common TPN complications and How to Prevent Them

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There are many complications related to the administration of TPN. Total parenteral nutrition (TPN), also known as parenteral nutrition (PN) is a form of nutritional support given completely via the bloodstream, intravenously with an IV pump. Catheter-related bloodstream infection (CR-BSI), also known as sepsis are the most common TPN complications. During an inspection by the California

What are common TPN complications and How to Prevent Them Read More »

There are many complications related to the administration of TPN. Total parenteral nutrition (TPN), also known as parenteral nutrition (PN) is a form of nutritional support given completely via the bloodstream, intravenously with an IV pump. Catheter-related bloodstream infection (CR-BSI), also known as sepsis are the most common TPN complications. During an inspection by the California

Mandatory Steps for Effective Cleanroom Design

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Many manufacturing processes need the very stringent environmental conditions that can only be provided by a cleanroom. Because of the complex mechanical systems and high construction, operating, and energy costs that are associated with cleanrooms, it is important to perform the cleanroom design in a methodical way. When designing and building your cleanroom it is

Mandatory Steps for Effective Cleanroom Design Read More »

Many manufacturing processes need the very stringent environmental conditions that can only be provided by a cleanroom. Because of the complex mechanical systems and high construction, operating, and energy costs that are associated with cleanrooms, it is important to perform the cleanroom design in a methodical way. When designing and building your cleanroom it is

New Definition for Sterile Compounding

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manufacturing of sterile products is the most critical and difficult type of compounding. The whole chapter was open for public comments during September. We managed to get our hands on a non-paper that has been submitted from the USP. The new law Defines “sterile compounding” as compounding drug products for injection, inhalation or administration in

New Definition for Sterile Compounding Read More »

manufacturing of sterile products is the most critical and difficult type of compounding. The whole chapter was open for public comments during September. We managed to get our hands on a non-paper that has been submitted from the USP. The new law Defines “sterile compounding” as compounding drug products for injection, inhalation or administration in

VA Publishes their Pharmacy Design Guide

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Earlier this year, The Veteran Administration decided to step into the game of assuring pharmacy compliance with the upcoming USP 797 and USP 800 revisions. From the study that we published this summer, we can clearly see that over a third of the facilities are not meeting much needed requirements. A huge portion of these

VA Publishes their Pharmacy Design Guide Read More »

Earlier this year, The Veteran Administration decided to step into the game of assuring pharmacy compliance with the upcoming USP 797 and USP 800 revisions. From the study that we published this summer, we can clearly see that over a third of the facilities are not meeting much needed requirements. A huge portion of these

Reduce Downtime While Renovating Sterile Lab

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Reduce Downtime While Renovating Sterile Lab or Pharmacy Facilities Reduce downtime while renovating sterile lab or pharmacy spaces by understanding the critical details of your site, building, planned research, and equipment requirements. When renovating a cleanroom, or creating one from non-cleanroom space, proper planning is essential. Cleanrooms are like race cars. When properly designed and

Reduce Downtime While Renovating Sterile Lab Read More »

Reduce Downtime While Renovating Sterile Lab or Pharmacy Facilities Reduce downtime while renovating sterile lab or pharmacy spaces by understanding the critical details of your site, building, planned research, and equipment requirements. When renovating a cleanroom, or creating one from non-cleanroom space, proper planning is essential. Cleanrooms are like race cars. When properly designed and

Guidelines on Quality Assurance for Pharmacy Prepared Sterile Products

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  guidelines on quality assurance for pharmacy prepared sterile products that can be compounded (i.e., prepared from component ingredients) if needed, including capsules or tablets, products like creams and gels that are used on the skin, and medications that are injected into the skin, muscle or vein using a syringe or infusion. Hospitals use a

Guidelines on Quality Assurance for Pharmacy Prepared Sterile Products Read More »

  guidelines on quality assurance for pharmacy prepared sterile products that can be compounded (i.e., prepared from component ingredients) if needed, including capsules or tablets, products like creams and gels that are used on the skin, and medications that are injected into the skin, muscle or vein using a syringe or infusion. Hospitals use a

USP 800 Checklist: Priority Areas to Address

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  To prepare for USP Chapter <800>, pharmacies must ensure that they are meeting the right compounding compliance standards.   Identify High-Risk Compounding Practices and Develop Strategies to Reduce Risks, pharmacy staff should develop strategies to reduce risk of compounding sterile products (CSPs) in the practice setting. This could include: Outsourcing high-volume CSPs to 503B facilities

USP 800 Checklist: Priority Areas to Address Read More »

  To prepare for USP Chapter <800>, pharmacies must ensure that they are meeting the right compounding compliance standards.   Identify High-Risk Compounding Practices and Develop Strategies to Reduce Risks, pharmacy staff should develop strategies to reduce risk of compounding sterile products (CSPs) in the practice setting. This could include: Outsourcing high-volume CSPs to 503B facilities

Three things to consider when upgrading to meet USP 800

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Pharmacies around The United States are in various stages of planning and implementing facility and operational changes to meet the requirements of USP 800. The mile markers are slipping by, but wherever you are on the road to compliance, we helped out by listing the 3 most important steps in achieving USP Compliance.    

Three things to consider when upgrading to meet USP 800 Read More »

Pharmacies around The United States are in various stages of planning and implementing facility and operational changes to meet the requirements of USP 800. The mile markers are slipping by, but wherever you are on the road to compliance, we helped out by listing the 3 most important steps in achieving USP Compliance.    

Pharma D Solutions voluntarily recalls all sterile compounded drugs

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All sterile compounded drug products from Pharma D Solutions are being voluntarily recalled due to a potential contamination risk at the pharmacy, according to a company press release. The drugs affected by the recall include any compounded at the pharmacy within the past 12 months, which were distributed nationwide and directly to customers and medical

Pharma D Solutions voluntarily recalls all sterile compounded drugs Read More »

All sterile compounded drug products from Pharma D Solutions are being voluntarily recalled due to a potential contamination risk at the pharmacy, according to a company press release. The drugs affected by the recall include any compounded at the pharmacy within the past 12 months, which were distributed nationwide and directly to customers and medical

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