With the enforcement deadline for USP <800> less than three months away, now is the time to get answers to your practice’s most pressing questions and ensure you’re in compliance. Although USP <800> guidelines were first published in early 2016, there are still several common misconceptions among healthcare providers and many organizations are still somewhat unfamiliar with the requirements.
Recently, Cardinal Health experts Patricia Kienle, RPh, MPA, FASHP, Karen Kellogg, PharmD, and Richard Green, BS Pharm, RPh, BCNP, FAPhA, addressed these misconceptions in a webinar with Becker’s Hospital Review. Some of the most common misconceptions include:
- The focus on hazardous drug handling is relatively new – Discussions around the safe handling of hazardous drugs have been taking place since the 1970s in medical literature and the Occupational Health and Safety Administration (OSHA) and National Institute for Occupational Safety and Health (NIOSH) have also published regulations. By updating its standards, USP is now taking steps to make hazardous drug handling requirements enforceable.
- USP <800> only applies to pharmacies – These occupational safety standards apply to any healthcare facility where hazardous drugs exist. The standards not only cover compounding and manipulations but also receipt, dispensing, administration, patient care activities, spills, transport and waste.
- USP <800> approves certain personal protective equipment (PPE) for use – While USP does set quality standards for safe handling that are enforceable by accreditation and regulatory bodies, it does not have regulatory authority over the manufacturing, marketing and use of PPE.
In addition to dispelling these USP <800> myths, the Cardinal Health expert team received dozens of other questions related to how USP <800> will impact distribution, receiving and product storage, as well as how it will be enforced. We’ve compiled some of the most common questions and answers below.