This article is Part 2 of 3 in our series on Understanding Certification Report Requirements. Part 1 discussed Certification Reports for SECs and is available at pppmag.com/article/2694. Part 3, which will be published in a subsequent issue of PP&P, will focus on certification testing for CAIs and CACIs.
While engineering control certification is a requirement of USP <797>, the chapter... Read more
Hazardous drug (HD) compounding requires dedicated equipment to prevent cross-contamination and to ensure staff safety. This applies to both sterile and non-sterile compounding activities. Given the importance of containment during HD compounding, there is a strong case for introducing automation into the negative pressure cleanroom. With more vendors providing HD specific equipment, it is incumbent... Read more
USP General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings, which was created to promote patient and worker safety, as well as environmental protection, states that each entity must have a designated person who is qualified and trained to be responsible for compliance with handling hazardous drugs (HDs). It is important to note that the scope of handling includes... Read more
Q&A with Robert Campbell, PharmD, BCSCP
Clinical Director, Standards Interpretation Group
Director, Medication Management
The Joint Commission
Pharmacy Purchasing & Products: How have The Joint Commission (TJC) surveys changed in response to COVID-19? Should facilities prepare any differently?
Robert Campbell, PharmD: The primary change is that we are requesting organizations... Read more
While the FDA continues to issue 483s to 503B facilities, hospital pharmacies report a significant reduction over the last year in quality problems such as mislabeled or wrong volume products received from their vendors. Just 9% of pharmacies have experienced a recent quality problem with their vendor. While most hospital pharmacies are confident in the corrective action plans their... Read more
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