Every year, hundreds of thousands of patients in the United States require medications specific to their own unique needs that are not readily available. To meet these individualized needs, compounding of millions of medications is necessary to create precise sterile injections and infusions. Preparation of patient’s medication may also include handling hazardous drugs (HD). Improper handling of HD may expose pharmacy personnel to significant risk. To keep patients and pharmacy teams safe, standards in compounding and HD handling, such as United States Pharmacopeia (USP) 797/800, are paramount.
The goal of USP 797 and USP 800 is to standardize practice to the safety of handling pharmaceutical products. USP 797 lays out the standards to help protect patients from compounding risks that may include over- or under-dosage, infection, and death. USP 800 defines standards for HD handling, encompassing HD storage, compounding, dispensing, and disposal. To help ensure accordance with USP 797 and USP 800, first start by reading to understand the updated guidelines and FAQ’s. Next, acknowledge how the changes will fit into your workflow, and plan team training and competency assessments. Once the changes are in effect, continue to monitor the environment and team actions, provide continuing education, and conduct reviews.
Standardizing practice, as guided by USP 797 and USP 800, will help promote and reinforce best practices for patients and pharmacy teams to avoid significant risk.
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REFERENCES:
1. Pharmacy Times. Expert: What pharmacies should be prioritizing to stay compliant with updated USP chapters <797>, <795>, <800>. https://www.pharmacytimes.com/view/expert-what-pharmacies-should-be-prioritizing-to-stay-compliant-with-updated-usp-chapters-797-795-800-
2. U.S. Pharmacist. Preparing personnel & facilities for USP 797 and USP 800. https://www.uspharmacist.com/article/preparing-personnel-and-facilities-for-usp-797-and-800#:~:text=Both%20USP%20797%20and%20800,leading%20to%20potential%20patient%20harm
3. U.S. Pharmacopeia. Pharmaceutical compounding sterile preparations. https://www.usp.org/compounding/general-chapter-797
4. U.S. Pharmacopeia. USP General Chapter <800>. https://www.usp.org/compounding/general-chapter-hazardous-drugs-handling-healthcare#:~:text=The%20goals%20of%20these%20standards,patients%20and%20the%20healthcare%20workforce