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USP <800>: Hazardous Drugs—Handling in Healthcare Settings

Allison R. Butts, PharmD
PGY2 Hematology/Oncology Pharmacy Resident
University of Kentucky HealthCare
Lexington, KY

Katie E. Long, PharmD
Hematology/Oncology Clinical Pharmacists
Markey Cancer Center
University of Kentucky HealthCare
Lexington, KY

What Is USP?

The United States Pharmacopeial Convention (USP) is a “scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed, and consumed worldwide.” USP publishes general chapters in the National Formulary (NF); those numbered under 1,000 contain standards that can be enforced by the U.S. Food and Drug Administration (FDA). These standards are used in more than 140 countries across the globe.1 USP issues a bimonthly online journal, the Pharmacopeial Forum (PF), in which proposed revisions to USP- NF are published for public review and comment. PF is a free, online-only resource available to the public after a one-time registration to the USP website.1

What Is USP <800>?

USP <800> is the newest chapter of the USP-NF and is designed to “guide the handling of hazardous drugs in healthcare settings.”2 USP <800> builds on previously published chapters USP <795> and USP <797>, which address sterile and nonsterile compounding practices. Although seemingly comprehensive in nature, these two chapters fail to address the growing concern of exposure to hazardous drugs. USP <800> states that “there is no acceptable level of personal exposure to hazardous drugs.”2 As such, this chapter provides guidelines for the minimization of exposure across the continuum of healthcare settings.

The chapter addresses all aspects of handling hazardous drugs, including receipt, storage, transportation, preparation, dispensing, and administration. The list of hazardous drugs can be found in the National Institute for Occupational Safety and Health (NIOSH) Alert.3

What Is Next for USP <800>?

Due to the significance of the comments received in response to the initial publication of USP <800> in the May/June 2014 issue of PF, USP announced on October 13, 2014, that the chapter would undergo revision prior to formal introduction into the NF. The updated General Chapter <800> proposal will reflect new and revised guidance documents, respond to stake- holder input, and improve clarity of General Chapter <800>. The revised proposal is tentatively projected to be published in Pharmacopeial Forum, 41(2) [Mar.–Apr. 2015].4

References

1. U.S. Pharmacopeial Convention. About USP. Available at: www.usp.org/about-usp. Accessed October 27, 2014.

2. U.S. Pharmacopeial Convention. General chapter <800> hazardous drugs—handling in healthcare settings. Pharmacopeial Forum. 2014;40(3):1-44.

3. NIOSH list of antineoplastic and other hazardous drugs in healthcare settings, 2014. Centers for Disease Control and Prevention Website. Available at: www.cdc.gov/niosh/docs/2014-138/. Accessed October 27, 2014.

4. U.S. Pharmacopeial Convention. General chapter <800> hazardous drugs—handling in healthcare settings. Available at: www.usp.org/usp-nf/notices/compounding-notice. Accessed October 27, 2014.


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