Pharmaceutical Compounding is high-risk. Need help complying with USP <795>, <797>, and <800>? Get Solutions.

Maintaining compliance with established United States Pharmacopeia (USP) compounding standards is essential for patient safety. Accrediting bodies, and regulatory agencies expect full implementation of USP General Chapters <795> (non-sterile preparations), <797> (sterile preparations), and the new <800> (hazardous drugs) to keep patients and healthcare workers safe. NABP Solutions’ team of experts are ready to help you stay current and compliant with these ever-changing critical industry standards.

Millions of medications are compounded each year in the United States to meet the diverse needs of our patients. Whether non-sterile or sterile, pharmaceutical compounding is necessary to customize medication for patients who are unable to use commercially available formulations. A complete understanding of the risks and regulations that guide compounding is essential for ensuring compliance with standards, while providing safe care. Organizations not adhering to the newest USP <795>, <797>, and <800> standards may increase the likelihood of compounding sub-potent, super-potent or contaminated medication, resulting in patient harm or death. In addition, NABP’s Verified Pharmacy Program (VPP) inspection focuses on compounding and is required by select pharmacy boards as a condition of licensure. NABP Solutions offers consulting to get you ready for your VPP inspection.

Get Solutions.

Established in 1904, NABP has over 115 years of experience protecting the public health and safety through its collection of programs. Leveraging NABP’s Verified Pharmacy Program® (VPP®), NABP Solutions has developed a comprehensive facility inspection tool, guiding compounding pharmacies towards compliance with USP Chapters <795>, <797>, and the newest standard – USP <800>. Enforced beginning December 1, 2019, USP <800> outlines responsibilities of personnel that handle hazardous drugs (HD); facility and engineering controls; procedures for decontaminating and cleaning; spill control; and documentation. These standards apply to all healthcare personnel (not only pharmacists) who receive, prepare, administer, transport or handle HDs. The experts at NABP Solutions will work closely with you to assess your compliance readiness, identify gaps in applying the evolving standards, and develop an action plan for your organization.

Have questions? Need help with NABP credentialing?

Let’s Talk