In 2018, several regulatory changes were announced that have an impact on the practice of pharmacy. The first was a continuation by the United States Pharmacopeia (USP) to revise general chapters <795> and <797>, which cover the topics of compounding nonsterile and sterile preparations. The goal was to better align these two chapters with USP <800> (“Hazardous Drugs – Handling in Healthcare Settings”), which was published in 2016. All three of these chapters are scheduled to go into effect on December 1, 2019.
The USP proposed revision to <795> was released on March 30, 2018, with a public comment period that ended on July 31, 2018. The proposed revision for <797> followed on July 27, 2018, with a public comment period that closed on November 30, 2018. Facilities that perform nonsterile or sterile compounding must understand the proposed changes and determine the potential impact.
Below are the revisions that will require attention.[Read more…] about Hospitals Facing More Rapidly Changing Regulations