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Latest USP <800> Guidance: Postponement of 795 and 797
The United States Pharmacopeial Convention (USP) recently communicated the postponement of the revised 795 and 797, and the new 825 chapters because of appeals put forth for chapters 795 and 797. While USP 800 will still be official on December 1, 2019, it will be informational only and not compendially applicable until the appeals are resolved.
USP is an advisory organization that recommends but does not enforce standards. Regulating entities, such as the Occupational Safety and Health Administration (OSHA) and State Boards of Pharmacy, can inspect, audit, and issue sanctions. As rules and regulations will vary by state, your practice should check with your state’s regulating organizations to understand any requirements and when those requirements go into effect.
We continue to believe that USP <800> will be enforceable. As the focus of the chapter is staff safety, we encourage your practice to continue moving forward with implementing initiatives to comply with USP standards.
|The USP <800> requirements standardizing the safe handling of hazardous drugs will go into effect December 1, 2019.|
|The updated USP <800> requirements include:
|The National Institute for Occupational Safety and Health (NIOSH) defines hazardous drugs as those exhibiting “one or more of the following characteristics in humans or animals: carcinogenicity, teratogenicity or developmental toxicity, reproductive toxicity, organ toxicity at low doses, genotoxicity, or structure and toxicity profiles of new drugs that mimic existing hazardous drugs.”1|
|USP <800> was developed by USP Compounding Expert Committee, USP Compounding with Hazardous Drugs Expert Panel, US Food and Drug Admin (FDA) and US Center for Disease Control and Prevention (CDC) including NIOSH.2|
All healthcare personnel who receive, prepare, administer, transport or otherwise come in contact with hazardous drugs (HDs), and all entities that store, prepare, transport or administer hazardous drugs, including, but not limited to: pharmacies, hospitals, health systems and other healthcare institution personnel, patient treatment clinics and physicians’ practices or veterinarians’ offices.
The USP Compounding Expert Committee developed General Chapter <800> to standardize the safe handling of hazardous drugs throughout healthcare environments, in order to help protect both patients and healthcare workers.
New USP <800> standards are designed to protect all involved. Failure to comply with these new standards can not only impact the health of your staff, it can also result in fines for your health system. USP <800> will effect both the supply chain and the clinical environment. Download this article to learn about best practices for safeguarding your health system when handling NIOSH hazardous drugs.
Supply chain will play an important role in helping health systems meet the new USP General Chapter <800> standards. And because the standards apply to all healthcare personnel who receive, prepare, administer, transport or otherwise come in contact with hazardous drugs, supply chain will have to reach into all areas of the health system – not just pharmacy, but nursing, lab/phlebotomy, specialty clinics (such as urology), EVS, sterile processing, couriers, and more.
Entities must maintain lists of all hazardous drugs (HDs) used in their facilities
Identifying types of exposure
Personnel responsibilities and training
Facilities and engineering controls
Personal protective equipment (PPE)
Receiving hazardous drugs
Labeling, packaging, transport & disposal
Administering hazardous drugs
Deactivating, decontaminating, cleaning & disinfecting
February 1, 2016
USP <800> is published
September 29, 2017
USP postpones the official date of USP <800>
December 1, 2019
Official date of USP <800>: affected users should begin meeting the new requirements
MedTrainer, a healthcare compliance training provider for medical practices, offers a USP <800> Toolkit containing a systematic set of processes to conduct an assessment of risk and create the documentation and tracking that is required of the standard.
The landscape of patient care is rapidly shifting outside of the traditional hospital setting. Managing the broad spectrum of care settings requires solutions developed for the unique requirements of each facility, from the physician office to the patient’s home. We have robust solutions and resources to help you take control of your non-acute care continuum, now.
Unless otherwise noted, the recommendations in this document were obtained from: U.S. Pharmacopeia General Chapter <800>. Be advised that information contained herein is intended to serve as a useful reference for informational purposes only and is not complete clinical information. This information is intended for use only by competent healthcare professionals exercising judgment in providing care. McKesson cannot be held responsible for the continued currency of or for any errors or omissions in the information.