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Frequently Asked Questions for Pharmacists on Compounding / USP <800>

 

THURSDAY, OCTOBER 5, 2017

BOARD OF PHARMACY STATEMENT ON UNITED STATES PHARMACOPEIA CHAPTER <800> IMPLEMENTATION.  In light of questions to Board members and staff concerning the implementation of USP chapter <800>, which sets standards for hazardous drug handling by health-care personnel, as well as USP’s announcement on Friday, September 29, 2017 concerning the chapter’s effective date, the Board has issued the following statement concerning USP <800>: http://www.ncbop.org/PDF/NCBOP_USP_800_Statement.pdf. *UPDATE 11/16/17* The United States Pharmacopeia has some additional guidance and information about USP chapter <800> implementation: http://www.ncbop.org/PDF/USP%20800%20FAQ%20Nov2017.pdf.

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Q: What are USP standards governing hazardous drug handling?

A: On February 1, 2016, USP published the final version of chapter <800>, which sets forth standards for handling hazardous drugs in health care settings – including, obviously, pharmacies.  Chapter <800> helps ensure patient safety, worker safety, and environmental protection.  These standards apply to healthcare personnel who handle hazardous drugs, and to all entities that store, prepare, transport, or administer hazardous drugs. The standards become effective on  July 1, 2018.  After that, Board of Pharmacy staff will be inspecting and enforcing these new standards, which are incorporated by reference into USP chapters <795> and <797> governing compounding.  You can access the USP <800> standards through this link: http://www.ncbop.org/faqs/USPChapt800HazardousDrugsFeb2016.pdf.

 

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