In February of last year, the Compounding Expert Committee and the Compounding with Hazardous Drugs Expert Panel released a revised USP Chapter 800 that outlines the standards that should be maintained while handling hazardous drugs (HDs) in healthcare settings. Whereas these standards will not necessarily impact your daily operations, they do impact compounding pharmacies and we feel that it is extremely relevant to you to understand the importance of these new regulations as they not only protect our staff, but also further our responsibility and pledge to providing our clients with the safest, highest quality compounded medications available.
The revised USP Chapter 800 builds on existing compounding chapters; 795 Pharmaceutical Compounding - Nonsterile Preparations and 797 Pharmaceutical Compounding - Sterile Preparations, as well as adding in the elements of containment of hazardous drugs. The standards identify the requirements for receipt, storage, mixing, preparing, compounding, dispensing, and administration of hazardous drugs in order to better protect the patient, healthcare personnel, and the compounding environment. They apply to all personnel who compound HDs preparations and all places where HDs are prepared (e.g., pharmacies, hospitals and other healthcare institutions, physicians’ practice facilities, veterinarians’ offices).
The Board of Pharmacy defines HDs as all anti-neoplastic agents identified by the National Institute for Occupational Safety and Health (NIOSH) as meeting the criteria for a hazardous drug and any other drugs, compounds, or materials identified as hazardous by the pharmacist-in-charge. Those identified are drugs that exhibit one or more of the following six characteristics in humans or animals: carcinogenicity, teratogenicity or other developmental toxicity, reproductive toxicity, organ toxicity at low doses, genotoxicity, and/or structure and toxicity profiles of new drugs that mimic existing drugs determined hazardous by the above criteria. The complete list can be viewed here: https://www.cdc.gov/niosh/docs/2014-138/pdfs/2014-138_v3.pdf
As are consistant with GGVCP’s current policies and procedures, USP 800 further outlines sections that include; facility design and engineering controls, personal protective equipment, OSHA hazard communication program, training for compounding personnel, receiving, transporting, cleaning (deactivation, decontamination, disinfection), disposal, environment quality and control, documentation, etc.
Our continued commitment to meeting these and many other regulations have been an integral part of the growth we have experienced over the 16 years that we have been serving California veterinarians and pet owners. It is that very growth that has lead us to begin preparations on a new home for GGVCP. Construction has already begun on our new pharmacy in Novato, CA and we are hopeful that we will be settling in within the next few months. We are so excited for the opportunity that this relocation will allow. Our new facility will be constructed and designed with very careful attention to all Board of Pharmacy regulations as well as all the guidelines and standards set forth by USP 800.
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For more information on USP 800 visit www.usp.org.