Research News

  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

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

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

        Under the FCDA Act, outsourcing facilities register with, and are regulated and inspected by FDA as 503B outsourcing facilities. An outsourcing facility will be able to qualify for exemptions from the FDA approval requirements and the requirement to label products with adequate directions for use, but not the exemption from CGMP

USP Compounding General Chapters are now available for public comment. The USP team has scheduled an Open Microphone session for September 5, 2018. During the Open Microphone session, USP will highlight changes in the proposed revised standard and answer stakeholder questions about the approach and methodology of the revision.   To register please follow this link

The risks to health care workers handling hazardous drugs (HDs) under non-USP compliant conditions are often underappreciated. The development of the USP 800 chapter provides a framework of 18 sections that guide HD compounding practices to ensure the safety not only of patients, but also of the health care workers who prepare and administer these