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FOUNDATION OVERVIEW

Note: United States Pharmacopeia (USP) Chapter 800 has become an official chapter of USP 42 NF 37. However, due to an appeal process of USP Chapter 797 that was initiated at that time, USP General Chapter 800 is, at this time, only informational and not applicable unless otherwise specified by regulators and enforcement bodies.

Health care workers face a significant risk of being exposed to hazardous drugs (HDs) on a daily basis as they manage distribution, preparation, compounding, and administration of medications and provide care to patients receiving treatment. Pharmacists and pharmacy technicians in particular may experience higher risks of exposure due to repeated contact with various medications. Exposure to HDs has been associated with negative impact on health, as many long-term and acute reactions have been reported by health care professionals after occupational exposure to HDs. Numerous studies and reports have shown increased risk of incidence of cancer and fertility impairment due to occupational exposure to HDs.

In 2004, the National Institute for Occupational Safety and Health (NIOSH) published an alert containing guidance on standard and universal precautions that should be taken when handling HDs by health care providers. The NIOSH alert also published a listing of HDs. This peer-reviewed list is now updated every 2 years to include information about newly approved drugs as well as any new information about existing drugs. The most current edition was published in 2016, while the next version—“NIOSH List of Hazardous Drugs in Healthcare Settings 2018” is being finalized after the public comment period and should be published in early March 2020. The “NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, 2016” classifies all hazardous medications into three groups:

  • Group 1: Antineoplastic drugs (AHFS Classification 10:00) [ASHP/AHFS DI 2016]. Note that many of these drugs may also pose a reproductive risk for susceptible populations.

  • Group 2: Non-antineoplastic drugs that meet one or more of the NIOSH criteria for a HD. Note that some of these drugs may also pose a reproductive risk for susceptible populations.

  • Group 3: Drugs that primarily pose a reproductive risk to men and women who are actively trying to conceive and women who are pregnant or breastfeeding, because some of these drugs may be present in breast milk.

While USP had addressed HD handling in Chapter 797, the guidance is mostly focused only on patient safety and it only addresses parenteral preparations. A need for guidance on handling of HDs (sterile and nonsterile) in all pharmacy and health care settings was needed. In 2014, USP published an early draft version of USP Chapter 800 which has since undergone a number of rounds of public comments and subsequent revisions. The final approval for the currently published version of USP Chapter 800 was on February 1, 2016. Chapter 800 has been published with an implementation date of December 1, 2019, to provide sufficient time for ...

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