Tennessee Pharmacists Association

USP Pharmacopoeial Convention logoAugust 12, 2019

USP Publishes New and Revised Compounding Standards
Make sure your pharmacy is prepared for changes coming December 1, 2019

United States Pharmacopeial Convention (USP) recently released new and revised standards to help ensure the quality of compounded medicines. The updates pertain to the USP General Chapters on compounding nonsterile medicines (USP Pharmaceutical Compounding—Nonsterile Preparations), compounding sterile medicines (USP Pharmaceutical Compounding—Sterile Preparations) and new standards for compounding radiopharmaceutical drugs (USP Radiopharmaceuticals—Preparation, Compounding, Dispensing, and Repackaging). Collectively, these USP General Chapters are a set of standards that assist healthcare practitioners with consistently producing quality compounded medicines to help ensure patients receive medicines that are the right strength and quality and are free of contaminants. Hazardous Drugs—Handling in Healthcare Settings is another relevant USP General Chapter for compounding to help promote the safe handling of hazardous drugs by healthcare workers.

Revisions to chapters and implementation of the new chapter reflect new science and evidence based on updated guidance documents, best practices and new learnings. The revisions also incorporate stakeholder input and clarify topics that are frequently misunderstood.

USP and many advocacy organizations offer educational programs and practical tools to support healthcare practitioners and organizations in adopting the updated standards and ensuring the safety of patients and healthcare workers.

Here some very important resources related to USP Chapters:

TPA hosted USP to deliver the keynote presentation at our Summer Meeting in Murfreesboro in June, and also hosted an educational session to help pharmacists navigate the upcoming changes. TPA is also actively working with the Tennessee Board of Pharmacy to address questions and concerns raised by members regarding implementation and enforcement of USP standards. The Tennessee Board of Pharmacy is working to produce additional resources to assist pharmacists in complying with the new provisions.

If you have specific questions or concerns, please email them to TPA.