September 21, 2016
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Ensure USP <800> Compliance Beyond the Pharmacy
Pharmacy Purchasing & Products
USP <800> builds on the patient safety issues addressed in <797> and <795>, while also encompassing personnel and environmental safety. As such, pharmacy must take the lead on ensuring compliance with <800>, but pharmacy cannot accomplish this alone.  READ MORE

Pharmaceutical compounding: The FDA is not the problem
Over the past few weeks, the FDA has devoted lots of attention to compounding pharmacies, issuing two new guidance documents pertaining to their fundamental scope, a guidance document regarding insanitary conditions, and revised inspection procedures. Given some recent high profile safety problems, including patient deaths as a result of contaminated sterile compounding products, the FDA has come under great scrutiny. But, it is not the FDA’s fault.  READ MORE

Compliant garbing practices for sterile compounding
Pharmacy Purchasing & Products
To protect the sterile compounding environment and ultimately the compounded sterile preparation, hand hygiene and garbing must be performed properly and in the correct sequence. USP has delineated the required processes in Chapter <797> for sterile compounding and in <800> for hazardous drug (HD) compounding; however, the chapters may not provide the granularity needed for practitioners.  READ MORE

Pharmaceutical compounding caters to individual needs
The Washington Times
Compounding used to be popular in the olden days, before major drug companies started manufacturing “cookie-cutter” medications, according to Shaun Klomp. But now, he said, compounding is making a comeback to help solve medical issues that those one-size-fits-all medications cannot.  READ MORE

USP <800>, and Pending California Board of Pharmacy Hazardous Drug Regulations
California Pharmacists Association
In addition to establishing various requirements for sterile compounding, the proposed regulations establish some standards for the compounding of hazardous drugs. CPhA is aware that there is some confusion regarding whether the BOP will enforce the entirety of USP Chapter <800> relating to handling of hazardous drugs in a healthcare settings, or whether the proposed regulations adopt USP <800> into state law.  READ MORE

USP <800> Delivers Standardization
Pharmacy Purchasing & Products
Historically, the approach to hazardous drug (HD) issues has varied greatly among regulatory bodies. Some state boards took an aggressive stance pursuant to HD compliance, while others demonstrated less interest. Given this, among the more strident benefits of USP <800> Hazardous Drugs — Safe Handing in Healthcare Settings is that it establishes a single, clear standard, to which health systems nationwide will be accountable.  READ MORE

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