29-Oct-14 10:00 AM  CST

Understanding USP <800>

USP<797> is the standard of practice for sterile IV compounding. Pharmacy technicians and pharmacists like have enacted the standards of USP<797> in order to provide patients with a safe and effective sterile IV compounds. Now the United States Pharmacopeial has proposed an additional chapter of standards, USP <800>. USP<800>, which was first introduced in May 2014, involves standards regarding the safe practice so of hazardous drugs.

Up until the recent proposal of USP<800>, USP did not contain any language specific to hazardous drugs (HD). The new proposal directly addresses the need for clear and precise standards for HD. USP<800> will address HD handling, storage, transportation, compounding, and administration. The clear objectives of USP <800> are to protect personnel, as well as enforce the safety standards set by the federal Occupational Safety and Health Administration (OSHA). One of the ways USP<800> will go about completing this task is by requiring facilities to name a Compounding Supervisor.

The Compounding Supervisor is to be an individual that has been named by the pharmacy to not only carry out the regulations associated with USP<800>, but also help to create policies and procedures within the facility as they relate to USP<800>.

 Finally, USP<800> will require that all HD be segregated from non-hazardous drug within the compounding area, as well as assuring that no hazardous drug is compounded in a non-vent hood. As well intended as USP<800> may be the cost associated to bring facilities up to compliance has been a controversial taking point.

Many professional pharmaceutical associations have requested that USP consider revising the standard in order better deal with the cost associated with the stand. Some believe the proposed standards are an over reach from USP. Still, many more argue the standards make it difficult for smaller facilities to continue to compound HD.





American Society of Consultant Pharmacists, 2014, https://www.ascp.com/sites/default/files/ASCP%20Comments%20re%20Proposed%20USP%20Chapter%20800_FINAL.pdf

“General Chapter<800> Hazardous Drugs Handling in a Healthcare Setting” U.S. Pharmacopeial Convention, June 2014,  http://www.usp.org/usp-nf/notices/compounding-notice

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Source: Sandy Andrews  

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