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Making 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 the …

New Definition for Sterile Compounding Read More »

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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 »

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When renovating a cleanroom, or creating one from non-cleanroom space, understanding the details — of the site, building, planned research, and equipment — is essential. Cleanrooms are like race cars. When properly designed and built, they are highly efficient performance machines. When poorly designed and built, they operate poorly and are unreliable. The cost of cleanroom varies …

Don’t Stop Production for Cleanroom Renovation Read More »

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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 »

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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 »