USP <800> Official Date Postponed

We have heard from many of you regarding the changed date for the official publishing of USP Chapter <800>, now anticipated to be December 1, 2019, and what this means for your current and new/revision projects scheduled in your pharmacy. We would like to take this opportunity to provide you with our, Clinical IQ/CriticalPoint/Controlled Environment Consulting, current thinking on what this all means. Please note that these views are our own and we do not have any additional knowledge other than what USP has published on their website - These views are based on our companies collective 200+ years of experience in the business.

While some groups may see this as an opportunity to put all construction projects on hold for any number of reasons, we DO NOT share that approach and strongly urge the pharmacy and hospital administrations that they DO NOT STOP what they have started. These Chapters represent much needed minimum changes to facilities to protect the compounding employees, pharmacy staff as well as the patients they serve and delaying or worse cancelling your projects continues to put everyone in harms way. During our many visits over the past few years, we have seen facilities that are so bad that all sterile compounding, including and especially hazardous drug, should stop until changes are implemented. If your facility is bad enough today that you need renovations, it would be irresponsible to wait until Dec 2019 and continue to put everyone at risk.

We will continue to inform all our customers first and foremost that USP <800> is not going away nor do we expect there are going to be ANY changes to this Chapter that was first posted by USP in February 2016. USP is on the record as stating USP <800> will not be changed between now and December 2019. Additionally, if your facility is not currently compliant with USP <797>, published and enforceable since 2008, waiting another 2 years continues to put the patients you serve and the staff working for you at unneeded risk. We strongly recommend continuing with existing plans and if you are thinking about or on the fence about making changes, we would tell you to move forward to protect your staff and the patients as it is not just the right thing to do but your professional responsibility.

Thank you,

Clinical IQ, Controlled Environmental Consulting, CriticalPoint

Quality standards for large scale compounding

The Pew Charitable Trusts commissioned Clinical IQ to publish a paper, titled Quality Standards for Large Scale Sterile Compounding. The paper chronicles the changes in scope and magnitude of sterile drug compounding from the 1980s to the present day and contrasts the quality systems established for pharmaceutical companies that manufacture drugs with those established to guide traditional pharmacy sterile compounding practice....

Read PaperView the CGMP-797 Crosswalk Resource

USP 797 Compliance Map

Use our interactive compliance map to see how each State measures up against USP 797.  Includes State Board Contact information, and several checkpoints to consider.

View Map

NIH News Release

Clinical IQ, along with Working Buildings, is working with NIH to review their current facilities and processes to ensure patient’s are receiving the highest standard of care at all of NIH’s facilities.  Click the article below to read about NIH and Clinical IQ’s efforts.

NIH News Release - Statement on Review of NIH Sterile Productions Facilities

What Pharmacists Need to Know Ahead of USP <800>

Read coverage of a symposium that was held at the ASHP Midyear Meeting and Exhibition in December of 2014.  The faculty included Patricia C. Kienle, M.P.A., B.S.Pharm., FASHP, Thomas H. Connor, Ph.D., and Jeannell Mansur, Pharm.D., FASHP, FSMSO, CJCP.  Coverage focus on how pharmacists can start preparing for the new standards in handling hazardous drugs.

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